Policy Type

Court submission

Last Reviewed

2011-03-05

Date

2014-08-27

Topics

Ethics and medical professionalism

Population health/ health equity/ public health

Text

S.C.C. No. 35591 IN THE SUPREME COURT OF CANADA (ON APPEAL FROM THE COURT OF APPEAL FOR BRITISH COLUMBIA) BETWEEN: LEE CARTER, HOLLIS JOHNSON, DR. WILLIAM SHOICHET, THE BRITISH COLUMBIA CIVIL LIBERTIES ASSOCIATION and GLORIA TAYLOR Appellants - and - ATTORNEY GENERAL OF CANADA and ATTORNEY GENERAL OF BRITISH COLUMBIA Respondents -and- ATTORNEY GENERAL OF ONTARIO, ATTORNEY GENERAL OF QUEBEC, ALLIANCE OF PEOPLE WITH DISABILITIES WHO ARE SUPPORTIVE OF LEGAL ASSISTED DYING SOCIETY, ASSOCIATION FOR REFORMED POLITICAL ACTION CANADA, THE CANADIAN CIVIL LIBERTIES ASSOCIATION, THE CANADIAN HIV/AIDS LEGAL NETWORK AND THE HIV & AIDS LEGAL CLINIC ONTARIO, THE CANADIAN MEDICAL ASSOCIATION, THE CANADIAN UNITARIAN COUNCIL, THE CATHOLIC CIVIL RIGHTS LEAGUE, THE FAITH AND FREEDOM ALLIANCE AND THE PROTECTION OF CONSCIENCE PROJECT, THE CATHOLIC HEALTH ALLIANCE OF CANADA, THE CHRISTIAN LEGAL FELLOWSHIP, THE CHRISTIAN MEDICAL AND DENTAL SOCIETY OF CANADA, THE CANADIAN FEDERATION OF CATHOLIC PHYSICIANS' SOCIETIES, THE COLLECTIF DES MEDECINS CONTRE L'EUTHANASIE, THE COUNCIL OF CANADIANS WITH DISABILITIES AND THE CANADIAN SOCIETY FOR COMMUNITY LIVING, THE CRIMINAL LA WYERS' ASSOCIATION (ONTARIO), DYING WITH DIGNITY, THE EV ANGELICAL FELLOWSHIP OF CANADA, THE FAREWELL FOUNDATION FOR THE RIGHT TO DIE and THE ASSOCIATION QUEBECOISE POUR LE DROIT DE MOURIR DANS LA DIGNITE, and THE EUTHANASIA PREVENTION COALITION AND THE EUTHANASIA PREVENTION COALITION - BRITISH COLUMBIA FACTUM OF THE INTERVENER THE CANADIAN MEDICAL ASSOCIATION Rules 37 and 42 of the Rules of the Supreme Court of Canada Interveners POLLEY FAITH LLP The Victory Building 80 Richmond Street West Suite 1300 Toronto, Ontario M5H 2A4 Harry Underwood and Jessica Prince Tel: ( 416) 365-1600 Fax: (416) 365-1601 hunderwood@polleyfaith.com jprince@polleyfaith.com Jean Nelson Tel: (613) 731-8610 Fax: (613) 526-7571 j ean.nelson@cma.ca Counsel for the Intervener, the Canadian Medical Association GOWLING LAFLEUR HENDERSON LLP 160 Elgin Street, Suite 2600 Ottawa, Ontario KIP 1 C3 D. Lynne Watt Tel: (613) 786-8695 Fax: (613) 788-3509 email lynne. watt@gowlings.com Ottawa Agent for the Intervener, the Canadian Medical Association ORIGINAL TO: The Registrar Supreme Court of Canada 301 Wellington Street Ottawa, Ontario KIA OJI COPIES TO: Counsel for the Appellants, Lee Carter, Hollis Johnson, Dr. William Shoichet, The British Columbia Civil Liberties Association and Gloria Taylor Joseph J. Arvay, Q.C. and Alison M. Latimer Farris, Vaughan, Wills & Murphy LLP 25 th Floor, 700 West Georgia Street Vancouver, BC V7Y 1B3 Tel: (604) 684-9151 Fax: (604) 661-9349 Email: jarvay@farris.com -and- Sheila M. Tucker Davis LLP 2800- 666 Burrard Street Vancouver, BC V6C 2Z7 Tel: (604) 643-2980 Fax: (604) 605-3781 Email: stucker@davis.ca Agent for the Appellants Jeffrey W. Beedell Gowling Lafleur Henderson LLP 160 Elgin Street, Suite 2600 Ottawa, Ontario KIP 1C3 Tel: (613) 233-1781 Fax: (613) 788-3587 Email: jeff. beedell@gowlings.com Counsel for the Respondent, Attorney General of Canada Donnaree Nygard and Robert Frater Department of Justice Canada 900 - 840 Howe Street Vancouver, BC V6Z 2S9 Tel: (604) 666-3049 Fax: (604) 775-5942 Email: donnaree.nygard@justice.gc.ca Counsel for the Respondent, Attorney General of British Columbia Jean M. Walters Ministry of Justice Legal Services Branch 6th Floor - 1001 Douglas Street PO Box 9230 Stn Prov Govt Victoria, BC V8W 9J7 Tel: (250) 356-8894 Fax: (250) 356-9154 Email: jean.walters@gov.bc.ca Counsel for the Intervener, Attorney General of Ontario Zachary Green Attorney General of Ontario 720 Bay Street, 4th Floor Toronto, ON MSG 2Kl Tel: ( 416) 326-4460 Fax: (416) 326-4015 Email: zachary.green@ontario.ca Agent for the Respondent, Attorney General of Canada Robert Frater Department of Justice Canada Civil Litigation Section 50 O'Connor Street, Suite 50 Ottawa, Ontario KIA 0H8 Tel: (613) 670-6289 Fax: (613) 954-1920 Email: ro bert. frater@ j ustice. gc.ca Agent for the Respondent, Attorney General of British Columbia Robert E. Houston, Q.C. Burke-Robertson 441 MacLaren Street, Suite 200 Ottawa, Ontario K2P 2H3 Tel: (613) 236-9665 Fax: (613) 235-4430 Email: rhouston@burkerobertson.com Agent for the Intervener, Attorney General of Ontario Robert E. Houston, Q.C. Burke-Robertson 441 MacLaren Street, Suite 200 Ottawa, Ontario K2P 2H3 Tel: (613) 236-9665 Fax: (613) 235-4430 Email: rhouston@burkerobertson.com Counsel for the Intervener, Attorney General of Quebec Sylvain Leboef and Syltiane Goulet Procureur general du Quebec 1200, Route de L'Eglise, 2eme etage Quebec, QC GlV 4Ml Tel: (418) 643-1477 Fax: ( 418) 644-7030 Email: sylvain.leboeuf@justice.gouv.gc.ca Counsel for the Intervener, Council of Canadians with Disabilities and the Canadian Association for Community Living David Baker Sarah Mohamed Bakerlaw 4 711 Yonge Street, Suite 509 Toronto, Ontario M2N 6K8 Tel: (416) 533-0040 Fax: ( 416) 533-0050 Email: dbaker@bakerlaw.ca Counsel for the Intervener, Christian Legal Fellowship Gerald D. Chipeur, Q.C. Miller Thomirson LLP 3000, 700-9t A venue SW Calgary, Alberta T2P 3V4 Tel: (403) 298-2425 Fax: (403) 262-0007 Agent for the Intervener, Attorney General of Quebec Pierre Landry Noel & Associes 111 Champlain Street Gatineau, QC J8X 3Rl Tel: (819)771-7393 Fax: (819) 771-5397 Email: p.landry@noelassocies.com Agent for the Intervener, Council of Canadians with Disabilities and the Canadian Association for Community Living Marie-France Major Supreme Advocacy LLP 397 Gladstone A venue, Suite 100 Ottawa, Ontario K2P 0Y9 Tel: (613) 695-8855 Ext: 102 Fax: (613) 695-8580 Email: mfmajor@supremeadvocacy.ca Agent for the Intervener, Christian Legal Fellowship Eugene Meehan, Q.C. Supreme Advocacy LLP 397 Gladstone A venue, Suite 100 Ottawa, Ontario K2P 0Y9 Tel: (613) 695-8855 Ext: 101 Fax: (613) 695-8580 Email: emeehan@supremeadvocacy.ca Counsel for the Intervener, Agent for the Intervener, Canadian HIV/AIDS Legal Network and the Canadian HIV/AIDS Legal Network and the HIV & AIDS Legal Clinic Ontario HIV & AIDS Legal Clinic Ontario Gordon Capern Michael Fenrick Paliare, Roland, Rosenberg, Rothstein, LLP 155 Wellington Street West, 35 th Floor Toronto, Ontario M5V 3Hl Tel: ( 416) 646-4311 Fax: (416) 646-4301 Email: gordon.capem@paliareroland.com Counsel for the Intervener, Reformed Political Action Canada Andre Schutten ARPA Canada I Rideau Street, Suite 700 Ottawa, Ontario KIN 8S7 Tel: (613) 297-5172 Fax: (613) 670-5701 Email: andre@ARP A Canada.ca Counsel for the Intervener, Collectif des medecins contre l'euthanasie Pierre Bienvenu Andres C. Garin Vincent Rochette Norton Rose Fulbright Canada LLP 1, Place Ville Marie, Bureau 2500 Montreal, Quebec H3B IRI Tel: (514) 847-4452 Fax: (514) 286-5474 Email: pierre. bienvenue@nortonrose.com Marie-France Major Supreme Advocacy LLP 397 Gladstone Avenue, Suite 100 Ottawa, Ontario K2P 0Y9 Tel: (613) 695-8855 Ext: 102 Fax: (613) 695-8580 Email: mfmajor@supremeadvocacy.ca Agent for the Intervener, Collectif des medecins contre l'euthanasie Sally Gomery Norton Rose Fulbright Canada LLP 1500-45 O'Connor Street Ottawa, Ontario KIP 1A4 Tel: (613) 780-8604 Fax: (613) 230-5459 Email: sally. gomery@nortonrose.com Counsel for the Intervener, Evangelical Fellowship of Canada Geoffrey Trotter Geoffrey Trotter Law Corporation 1185 West Georgia Street, suite 1700 Vancouver, British Columbia V6E 4E6 Tel: (604) 678-9190 Fax: (604) 259-2459 Email: gt @ gtlawcorp .com Counsel for the Intervener, Christian Medical and Dental Society of Canada Albertos Polizogopoulos Vincent Dagenais Gibson LLP 260 Dalhousie Street, Suite 400 Ottawa, Ontario KlN 7E4 Tel: (613) 241-2701 Fax: (613) 241-2599 Email: albertos @ vdg.ca Counsel for the Intervener, Canadian Federation of Catholic Physicians' Societies Geoffrey Trotter Geoffrey Trotter Law Corporation 1185 West Georgia Street, suite 1700 Vancouver, British Columbia V6E 4E6 Tel: (604) 678-9190 Fax: (604) 259-2459 Email: gt@gtlawcorp.com Agent for the Intervener, Evangelical Fellowship of Canada Albertos Polizogopoulos Vincent Dagenais Gibson LLP 260 Dalhousie Street, Suite 400 Ottawa, Ontario K 1 N 7E4 Tel : (613) 241-2701 Fax: (613) 241-2599 Rmail: albertos@vdg.ca Agent for the Intervener, Canadian Federation of Catholic Physicians' Societies Marie-France Major Supreme Advocacy LLP 397 Gladstone Avenue, Suite 100 Ottawa, Ontario K2P 0Y9 Tel: (613) 695-8855 Ext : 102 Fax: (613) 695-8580 Email: mfmajor@.supremeadvocacy.ca Counsel for the Intervener, Dying with Dignity Cynthia Petersen Kelly Doctor Sack Goldblatt Mitchell LLP 1100-20 Dundas Street West, Box 180 Toronto, Ontario MSG 2G8 Tel: (416) 977-6070 Fax: (416) 591-7333 Email: cpetersen@sgmlaw.com Counsel for the Intervener, Catholic Health Alliance of Canada Russell G. Gibson Albertos Polizogopoulos Vincent Dagenais Gibson LLP 260 Dalhousie Street, Suite 400 Ottawa, Ontario K 1 N 7E4 Tel: (613) 241-2701 Ext. 229 Fax: (613) 241-2599 Email: russell.gibson@vdg.ca Counsel for the Intervener, Criminal Lawyers' Association (Ontario) Marlys A. Edwarth Daniel Sheppard Sack Goldblatt Mitchell LLP 1100-20 Dundas Street West Toronto, Ontario MSG 2G8 Tel: (416) 979-4380 Fax: (416) 979-4430 Email: medwarth@ sgmlaw.com Agent for the Intervener, Dying with Dignity Raija Pulkkinen Sack Goldblatt Mitchell LLP 500-30 Metcalfe Street Ottawa, Ontario KIP 5L4 Tel: (613) 235-5327 Fax: (613) 235-3041 Email: rpulkkinen@sgmlaw.com Agent for the Intervener, Criminal Lawyers' Association (Ontario) D. Lynne Watt Gowling Lafleur Henderson LLP 160 Elgin Street, Suite 2600 Ottawa, Ontario K 1 P 1 C3 Tel: (613) 786-8695 Fax: (613) 788-3509 Email: lynne. watt@gowlings.com Counsel for the Intervener, Farewell Foundation For The Right To Die Joseph J. Arvay, Q.C. Alison Latimer Farris, Vaughan, Wills & Murphy LLP 700 West Georgia Street, 25th Floor Vancouver, British Columbia V7Y 1B3 Tel: (604) 684-9151 Fax: (604) 661-9349 Email: jarvay@farris.com Counsel for the Intervener, Association Quebecoise pour le droit de mourir dans la dignite Joseph J. Arvay, Q.C. Alison Latimer Farris, Vaughan, Wills & Murphy LLP 700 West Georgia Street, 25th Floor Vancouver, British Columbia V7Y 1B3 Tel: (604) 684-9151 Fax: (604) 661-9349 Email: jarvay@farris.com Counsel for the Intervener, Canadian Civil Liberties Association Christopher D. Bredt Ewa Krajewska Margot Finley Borden Ladner Gervais LLP Scotia Plaza, 40 King Street West Toronto, Ontario M5H 3Y4 Tel: (416) 367-6165 Fax: (416) 361-7063 Email: cbredt@blg.com Agent for the Intervener, Farewell Foundation For The Right To Die Jeffrey W. Beedell Gowling Lafleur Henderson LLP 160 Elgin Street, Suite 2600 Ottawa, Ontario KIP 1C3 Tel: (613) 786-0171 Fax: (613) 788-3587 Email: jeff.beedell@gowlings.com Agent for the Intervener, Association Quebecoise pour le droit de mourir dans la dignite Jeffrey W. Beedell Gowling Lafleur Henderson LLP 160 Elgin Street, Suite 2600 Ottawa, Ontario K 1 P 1 C3 Tel: (613) 786-0171 Fax: (613) 788-3587 Email: jeff.beedell@gowling .com Agent for the Intervener, Canadian Civil Liberties Association Nadia Effendi Borden Ladner Gervais LLP World Exchange Plaza 100 Queen Street, Suite 100 Ottawa, Ontario KlP 119 Tel: (613) 237-5160 Fax: (613) 230-8842 Counsel for the Intervener, Catholic Civil Rights League Ranjan K. Agarwal Jack R. Maslen Bennett Jones LLP 3400 One First Canadian Place P.O. Box 130, Station 1st Canadian Place Toronto, Ontario M5X 1A4 Tel: (416) 863-1200 Fax: (416) 863-1716 Email: agarwalr@bennettjones.com Counsel for the Intervener, Faith and Freedom Alliance and Protection of Conscience Project Geoffrey Trotter Ranjan K. Agarwal Jack R. Maslen Geoffrey Trotter Law Corporation 1185 West Georgia Street, suite 1700 Vancouver, British Columbia V6E 4E6 Tel: (604) 678-9190 Fax: (604) 259-2459 Email: gt@gtlawcorp.com Agent for the Intervener, Catholic Civil Rights League Sheridan Scott Bennett Jones LLP 1900-45 O'Connor Street World Exchange Plaza Ottawa, Ontario KlP 1A4 Tel: (613) 683-2302 Fax: (613) 683-2323 Email: scotts@bennettjones.com Agent for the Intervener, Faith and Freedom Alliance and Protection of Conscience Project Marie-France Major Supreme Advocacy LLP 397 Gladstone Avenue, Suite 100 Ottawa, Ontario K2P 0Y9 Tel: (613) 695-8855 Ext: 102 Fax: (613) 695-8580 Email: mfmajor@supremeadvocacy.ca Counsel for the Intervener, Alliance of People with Disabilities who are Supportive of Legal Assisted Dying Society Angus M. Gunn, Q.C. Borden Ladner Gervais LLP 1200-200 Burrard Street Vancouver, British Columbia V7X 1 T2 Tel: (604) 687-5744 Fax: (604) 687-1415 Counsel for the Intervener, Canadian Unitarian Council Tim A. Dickson R.J.M. Androsoff Farris, Vaughan, Wills & Murphy LLP 700 West Georgia Street, 25 th Floor Vancouver, British Columbia V7Y 1 B3 Tel: (604) 661-9341 Fax: (604) 661-9349 Email: tdickson@farris.com Counsel for the Intervener, Euthanasia Prevention Coalition and Euthanasia Prevention Coalition -British Columbia Hugh R. Scher Scher Law Professional Corporation 69· Bloor Street East, Suite 210 Toronto, Ontario M4W 1A9 Tel: (416) 515-9686 Fax: ( 416) 969-1815 Email: hugh@sdlaw.ca Agent for the Intervener, Alliance of People with Disabilities who are Supportive of Legal Assisted Dying Society Nadia Effendi Borden Ladner Gervais LLP World Exchange Plaza 100 Queen Street, Suite 100 Ottawa, Ontario KIP 1J9 Tel: (613) 237-5160 Fax: (613) 230-8842 Agent for the Intervener, Canadian Unitarian Council Nadia Effendi Borden Ladner Gervais LLP World Exchange Plaza 100 Queen Street, Suite 100 Ottawa, Ontario KIP 1J9 Tel: (613) 237-5160 Fax: (613) 230-8842 Agent for the Intervener, Euthanasia Prevention Coalition and Euthanasia Prevention Coalition -British Columbia Yael Wexler Fasken Martineau DuMoulin LLP 55 Metcalfe Street, Suite 1300 Ottawa, Ontario MlP 6L5 Tel: (613) 236-3882 Fax: (613) 230-6423 Email: ywexler@fasken.com Index Part I: Overview of Argument .... ... .. . ... . ... . ...... . ............. ... ... ... ......... .. .. .. . .. ... ... ... .. ... .. ..... .... .. ... ..... 1 Part II: Statement of Argument. ... ... .. ...... ... .. ........ ... ... ..... .... ... .. ..... ... ... ... .. .. ... .... ... ......... ...... ... ..... 2 A. The CMA's policy on euthanasia and assisted suicide .. ....... ......... .... .. ..... ...... ..... ... ... .. 2 B. The implications of a change in the law ...................... .... ... ................. ..... ... ...... .. ... ...... 5 1. Palliative care .............................................................. ...... ... .. ... ... ....... ... ............ . 5 2. Concerns over safeguards .................................. ..... . ........ . .......... .. ......... ........... .. 7 3. Protections for physicians ...... ..... .. .... ......... ... .... ... .. ... .. .. ... ... . .......... . .. ... ... .. ... .. .. ... 8 Part III: Submissions regarding remedy ............. ... ...... ... ... ... .... ... ... ... ........ ............................. ... . 9 Part IV: Submissions regarding costs ..... . ...... ........ ..... .. ........ . ... .. .. ....... ....... ... .... .. ..... ..... .. ... . ..... .. 9 Part V: Request for oral argument.. .... ... .. .. .......... .. .. ... .. ..... .. ..... .. ... . ........ ... .. .... .......... ....... ...... .. 10 -1- Part I: Overview of Argument 1. The policy of the Canadian Medical Association ( the "CMA") on euthanasia and assisted suicide1 forms part of the trial record.2 The policy was debated at successive annual meetings of the CMA's members in 2013 and 2014, resulting in its amendment. In 2013, new definitions were added to clarify key terminology used. In August 2014, a motion was passed by delegates to CMA's General Council, and affirmed by the CMA Board of Directors, supporting the right of all physicians, within the bounds of existing legislation, to follow their conscience when deciding whether or not to provide medical aid in dying. 3 The policy will be amended as a consequence. 2. It is anticipated that the policy, once amended, will continue to reflect the ethical principles for physicians to consider in choosing whether or not to participate in medical aid in dying. 3. The statement of support for matters of conscience now exists alongside the statement in the CMA policy that "Canadian physicians should not participate in euthanasia or assisted suicide." As long as such practices remain illegal, the CMA believes that physicians should not participate in medical aid in dying. If the law were to change, the CMA would support its members who elect to follow their conscience. 4. A portion of the CMA's membership believes that patients should be free to choose medical aid in dying as a matter of autonomy. Other voices highlight that participation would undermine long-established ethical principles applicable to the practice of medicine. Amidst this 1 CMA Policy: Euthanasia and Assisted Suicide (Update 2014), https://www.cma.ca/Assets/assetslibrary/ document/en/about-us/PD14-06.pdf#search=assisted%20death. 2 Carter v. Canada (Attorney General}, 2012 BCSC 886, paragraphs 6 and 274. 3 Resolutions adopted at the 14ih Annual Meeting of the Canadian Medical Association, Aug. 18-20, 2014: ~www.cma.ca/Assets/assets-lib rary/document/en/advocacy/ Flnal -Resolutions-GC-2014-end-of-lifecare. pdf. -2- diversity of views, however, there is a unifying theme: one of respect for the alternative perspective. This element was highlighted in the policy motion coming out of the CMA's August 2014 General Council meeting. 5. The CMA accepts that the decision of whether or not medical aid in dying should be allowed as a matter of law is for lawmakers, not medical doctors, to determine. The policy itself acknowledges, uniquely among CMA policies in this respect, that "[i]t is the prerogative of society to decide whether the laws dealing with euthanasia and assisted suicide should be changed." 6. As the national voice of physicians across the country, the CMA intervenes in this appeal desiring to assist the Court by providing its perspective on the rationale for the diverse views expressed by its membership, and to highlight practical considerations that must be assessed if the law were to change. Part II: Statement of Argument A. The CMA's policy on euthanasia and assisted suicide 7. The CMA's policy on euthanasia and assisted suicide4 was adopted in 2007, replacing and consolidating two previous CMA policies5 , and has been amended twice since then as noted above. 8. In an effort to promote broad public and member discussion, in the first half of 2014 the CMA hosted a series of town hall meetings across Canada on end of life care issues. Members of the public and the profession were able to attend the town halls in person, or post comments 4 CMA Policy: Euthanasia and Assisted Suicide (Update 2014): https://www.cma.ca/Assets/assetslibrary/ document/en/about-us/PD14-06.pdf#search=assisted%20death. 5 Physician Assisted Death 1995 and Euthanasia and Assisted Suicide (1998). -3 - online, to provide their perspectives and opm1ons on, inter alia, euthanasia and physicianassisted suicide. 6 9. The CMA adopts policies in order to inform the organization's advocacy efforts, and to provide physician members with an understanding of the views and opinions of their national representative organization and to reflect the views of its membership. The CMA' s policies are not meant to mandate a standard of care for members or to override an individual physician's conscience. 10. The CMA recognizes that many of its policies are referenced by other health care groups and the courts, as well as the provincial and territorial medical regulatory authorities. 11. In general, those CMA members who oppose medical aid in dying do so because of the derogation from established medical ethical principles and clinical practices that would result. Those who support medical aid in dying do so because of the equally established principles of considering patient well-being and patient autonomy. The policy in its current form reflects these various considerations . 12. Physicians have a tremendous amount of compassion and concern for patients who are suffering near the end of their lives, and strive to improve their patients' quality of life for the remainder of their lives. Physicians are trained to be healers. For most Canadian physicians , the question is not a simple matter of balancing between patient autonomy and professional standards, but goes much deeper, to the very core of what it means to be a medical professional. 6 The CMA published two reports coming out of the end of life care town halls - a public report in June 2014 and a CMA members' report in July 2014 - both of which can be found on the CMA's website. -4- 13. One rationale for the position in opposition to physician participation is that euthanasia and assisted suicide would have, as the policy states, "unpredictable effects on the practice of medicine" as well as the physician-patient relationship. 7 14. At the same time, the policy recognizes the principle of patient autonomy, and the fact that it is a competing consideration. It cites several articles from the CMA Code of Ethics 8 that emphasize the importance of patient well-being and autonomy. 9 Physicians are advised to "consider first the well-being of your patient." 15. Opposition to paiiicipation is found in statements from the World Medical Association and various national medical associations akin to the CMA. 10 In jurisdictions where medical aid in dying has been legali zed , the practice is considered "ethically sound .. . and part of end of life care" by the national medical association in the Netherlands and the Belgian association has not published any policy . 11 7 CMA Policy: Euthanasia and Assisted Suicide (Update 2014): https://www.cma.ca/Assets/assetslibrary/ document/en/about-us/PD14-06.pdf#search=assisted%20death. 8 For example, "Provide your patients with the information they need to make informed decisions about their medical care, and answer their questions to the best of your ability"; "Respect the right of a competent patient to accept or reject any medical care recommended"; and "Ascertain wherever possible and recognize your patient's wishes about the initiation, continuation or cessation of life-sustaining treatment." 9 The concept of patient autonomy is usually associated with allowing or at least enabling patients to make their own decisions about which health care treatments they will or will not receive, or incorporating their point of view into assessments of the appropriateness and effectiveness of treatment options. See: Entwistle, VA. , Carter, SM ., Cribb, A. & Mccaffery, K. (2010) . 'Supporting patient autonomy : The importance of clinician-patient relationships'. Journal of General Internal Medicine, vol 25, no. 7, pp. 741-745; and Sullivan MD. "The new subjective medicine: taking the patient's point of view on health care and health" . Soc Sci Med 56:1595 - 1604, 2003 . 10 World Medical Association Statement on Physician-Assisted Dying. Adopted by the 44th World Medical Assembly, Marbella, Spain, September 1992 and editorially revised by the 170th WMA Council Session, Divonne-les-Bains, France, May 2005: http ://www.wma.net/en/30publications/10policies/p13/. British Medical Association. What is the current BMA policy on assisted dying? http://bma.org.uk/practical-support-at-work/ethics/bma-policyassisted- dying. Australian Medical Association. Position Statement on the Role of the Medical Practitioner in End of Life Care 2007, section 10 : https://ama .com.au/position -statement/role-medical- pr actit ioner-end -life-ca re-2007 . American Medical Association' s Opinion 2. 211- Physician-Assisted Suicide: http://www .amaass n.org/ama/pub/p hys i cian-r esources/ medi ca1 -ethic s/ co de-med ica l-ethi cs/o pin ion2211 .page ?. 11 KNMG. Euthanasia in the Netherlands. Available at: http://knmg.artsennet.nl/Dossiers-9/Dossiersthematrefwoord / Levenseinde/ Eu t hanasia-in-the-Netherlands -1.htm. -5- 16. It is acknowledged that just moral and ethical arguments form the basis of arguments that both support and deny assisted death. The CMA accepts that, in the face of such diverse opinion, based on individuals' consciences, it would not be appropriate for it to seek to impose or advocate for a single standard for the medical profession. 1 7. In any event, the CMA accepts that the decision as to the lawfulness of the current prohibition on medical aid in dying is for patients and their elected representatives as lawmakers to determine, not physicians. B. The implications of a change in the law 18. The CMA and its members have practical and procedural concerns to bring to the Court for reflection with respect to the legalization of medical aid in dying and the implications for medical practice. Three such implications are addressed below. 1. Palliative care 19. One question and element highlighted in CMA policy formulation is the role of palliative care and whether adequate public access is a precondition to changing the law. The CMA acknowledges that the desire to access medical aid in dying is predicated, at least in part, on the inadequacy or inability of palliative care to address a patient's needs in particular circumstances. The policy currently recognizes that adequate palliative care is a prerequisite to the legalization of medical aid in dying. That is because patients should never have to choose death because of unbearable pain which can, in fact, be treated, but the treatment cannot, in reality, be accessed. 20. However, even if palliative care were readily available and effective, there would likely be some patients who would still opt for medical aid in dying over palliative care. Moreover, it -6- seems wrong to deny grievously ill patients the option of medical aid in dying simply because of systemic inadequacies in the delivery of palliative care. 21. The public and the medical profession lack current, specific and non-anecdotal information as to the availability of adequate palliative care across Canada. Notwithstanding this lack of rigorous data, concerns are often expressed. 12 As Justice Smith held at trial, "High quality palliative care is far from universally available in Canada."13 The policy itself provides that "[ e ]fforts to broaden the availability of palliative care in Canada should be intensified." 22. Canada has no national strategy to ensure the delivery of a uniformly high standard of palliative care across the country. Similarly, there are no national uniform standards which direct when and how palliative care is to be provided and by which physicians. At the CMA's annual meeting in August 2014, motions were passed as policy affirming that (i) all health care providers should have access to referral for palliative care services and expertise, (ii) a strategy should be developed for advance care planning, palliative and end of life care in all provinces and territories, and (iii) the CMA will engage in physician human resource planning to develop an appropriate strategy to ensure the delivery of quality palliative care throughout Canada. 14 23. Regardless of the outcome of this appeal, the Canadian public and the medical profession must unite in insisting upon the dedication of appropriate resources to overcome the deficiencies identified above. Palliative care will continue to be a focus of the CMA's future policy development. 12 The Senate of Canada: the Honourable Sharon Carstairs, Raising the Bar: A Roadmap for the Future of Palliative Care in Canada, June 2010, http://www.chpca.net/media/7859/Raising the Bar June 2010.pdf, pages 12 and 16. 13 Carter v. Canada (Attorney General). 2012 BCSC 886, paragraph 192. 14 Resolutions adopted at the 14ih Annual Meeting of the Canadian Medical Association, Aug. 18-20, 2014: https://www.cma.ca/Assets/assets~libra ry/document/en/advocacy/Final-Resolutions-GC-2014-end-of-!ife-care.pdf -7- 2. Concerns over safeguards 24. The trial judge placed great reliance on the ability of physicians to assess the competency of patients requesting medical aid in dying and the voluntariness of their wishes. 15 The CMA submits that the challenges physicians will face in making these assessments have been understated, especially in the end of life care context where the consequences of decisions are particularly grave and in a public medical system in which resource constraints are a pressing issue. 16 25. The CMA submits that these assessments will involve significant new responsibilities that warrant comprehensive study by and with physicians for the following reasons: 15 a) Patients must be afforded a full right of informed consent, but the ordinary context in which a physician obtains the patient's informed consent would not apply since the intervention would be initiated not by the physician's recommendation but by the patient's request and since the patient's decision may tum more than usually is the case upon considerations apart from the expected efficacy of the treatment. b) A patient may be subject to influences which the patient is motivated not to disclose to his or her physician and which may be very difficult to detect. c) Such important decisions are best made following careful discussions between physician and patient, well in advance, concerning the patient's end of life wishes generally. The CMA and its provincial and territorial medical association colleagues note that these types of discussions do not now routinely occur, and that when they do, patients' assessments of their goals can and do evolve over the course of their illness. 17 Carter v. Canada (Attorney General}, 2012 BCSC 886, paragraphs 883, 1240 and 1367. 16 Chaoulli v. Quebec (Attorney General}, (2005] 1 SCR 791, paragraphs 173 and 221-222. 17 The Policy urges that "a Canadian study of medical decision making during dying" be undertaken. It explains that "relatively little" is known about "the frequency of various medical decisions made near the end of life, how these -8- d) It may be very difficult to assess competency and voluntariness in some patients (for example, the very old, the very ill and the depressed) and in some settings (for example, the emergency room and the intensive care unit) where there may not be an established physician-patient relationship. e) Institutional supports are lacking, including recognition in provincial fee schedules of the time that is required for meetings with patients and their families. 3. Protections for physicians 26. The CMA submits that, if the law were to change, any regime of medical aid in dying must legally protect those physicians who choose to participate from criminal, civil or disciplinary proceedings or sanctions. 27. In addition, if the law were to change, no physician should be compelled to participate in or provide medical aid in dying to a patient, either at all, because the physician conscientiously objects to medical aid in dying, or in individual cases, in which the physician makes a clinical assessment that the patient's decision is contrary to the patient's best interests. Notably, no jurisdiction that has legalized medical aid in dying compels physician participation. 18 If the decisions are made and the satisfaction of patients, families, physicians and other caregivers with the decisionmaking process and outcomes." See also the Ontario Medical Association, 'Ontario Doctors Launch End of Life Care Plan'. Available at: https:Uwww.oma.org/resources/documents/eolcstrategyframework.pdf. 18 Quebec: Bill 52, An Act respecting end-of-life care, 1st Sess, 41st Leg, Quebec, 2014 cl 50 (assented to 10 June 2014), SQ 2014, c2; Netherlands: Termination of Life on Request and Assisted Suicide (Review Procedures) Act (2002) .b.1ti;! ://www .eu th anasi ecom missie .n 1/1 mages/Wet%20toetsi ng%201evensbeei nd iging%20op%20verzoek%20en%20 hulp%20bij%20zelfdoding%20Engels tcm52-36287.pdf; Switzerland: Suiss Criminal Code, Book Two : Specific Provisions, Title One: Offences against Life and Limb, Article 115 (1942). http://www.admin.ch/ opc/ en/ classifiedcompilation/ 19370083/index.html; Belgium: Loi relative a l'euthanasie, Chapitre 6, article 14 (2002) http://www.ejustice.just.fgov.be/cgi lei/change lg.pl?language=fr&la=F&ta ble name=loi&cn=2002052837; Luxembourg: Loi du 16 mars 2009 sur l'euthanasie et /'assistance au suicide, Chapitre 7, article 15 (2009). http://www.legil ux. pu bl ic.Ju/1 eg/a/arch ives/2009/0046/a046. pdf#page= 7; Washington: The Washington Death with Dignity Act, RCW, 70 §70.245.190 (2009). http://apps.leg.wa.gov/RCW/default.aspx?cite=70.245.190; Oregon: The Oregon Death with Dignity Act, ORS, 127 §127.885 4.01 (1997). http ://public. hea Ith. oregon .gov /P roviderP a rtnerReso u rces/Eva I u ati on Res ea rch/Deathwith Dign i tyAct/Docu men ts/ statute.pdf; Vermont: An act relating to patient choice and control at the end of life, VSA, 113 § 5285 (a) {2013). -9- attending physician declines to participate, every jurisdiction that has legalized medical aid in dying has adopted a process for eligible patients to be transferred to a participating physician. 19 28. While the Court cannot and should not set out a comprehensive regime, the CMA submits that it can indicate that a practicable legislative regime for medical aid in dying must legally protect those physicians who choose to provide this new intervention to their patients, as well as those who do not. Part III: Submissions regarding remedy 29. If the law is changed, the CMA would ask this Court to adopt a remedy that would preserve the autonomy and constitutional rights of patients and their health care providers. To that end, the CMA asks the Court to adopt a remedy akin to what Justice Smith ordered at the trial level: suspending the effect of a declaration for one year from the date of any decision and instituting a process for individual exemptions such as that afforded to the late Ms. Taylor. Part IV: Submissions regarding costs 30. The CMA seeks no costs and asks that none be awarded against it. http://www.leg.state.vt.us/docs/2014/Acts/ACT039.pdf; New-Mexico: Morris v New-Mexico (2014); and Montana: Baxter v Montana, 482 LEXIS at 59 (2008). 19 Canadian Medical Association, Schedule A: Legal Status of Physician-Assisted Dying (PAD) in Jurisdictions with Legislation, https://www.cma.ca/ Assets/ assets-II bra ry/ document/ en/advocacy/ EO L/Leg a 1-status-p hysicia nassi sted-d eat h-j u risd i cti on slegislation. odf#search=schedule%20A%3A%201egal%20stacus%20of%20physician%2Dassisted%20death, page 3. -10- Part V: Request for oral argument 31. The CMA requests permission to make fifteen minutes of oral argument at the hearing of this appeal. ALL OF WHICH IS RESPECTFULLY SUBMITTED, this 27th day of August, 2014. /_/ - Harry Underwood Jean Nels

Less detail

Policy Type

Policy resolution

Date

2014-03-01

Topics

Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs

Resolution

BD14-05-159

The Canadian Medical Association will continue to make prescription drug shortages a priority in its lobbying efforts; review its current efforts, define further possibilities and report back to the Board at its May 2014 meeting.

Text

The Canadian Medical Association will continue to make prescription drug shortages a priority in its lobbying efforts; review its current efforts, define further possibilities and report back to the Board at its May 2014 meeting.

Less detail

Policy Type

Response to consultation

Date

2014-03-17

Topics

Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs

Text

The Canadian Medical Association (CMA) is pleased to provide this brief in response to Health Canada's consultation on the Controlled Drugs and Substances Act (CDSA) "regarding any challenges, gaps or suggested improvements." The CMA welcomes the consultation and review of the CDSA and its associated regulations. This is an important legislative framework with direct implications for public health, quality care and patient safety. The CMA's recommendations outlined in this brief aim to establish new measures and mechanisms under the CDSA that would contribute to improved public health and patient safety. The CMA looks forward to the opportunity to discuss these issues in greater detail with Health Canada as this consultation proceeds. Part 1: Supporting a Regulatory Approach that Advances Public Health, Quality Care and Patient Safety As an overarching principle, it is the CMA's position that the modernization of the CDSA legislative and regulatory framework should be guided first and foremost by the objective of improving public health, promoting quality care and enhancing patient safety. In enacting the CDSA and promulgating its regulations, enforcement objectives have been emphasized, as demonstrated by the report on program spending in the National Anti-Drug Strategy Evaluation. The modernization of the CDSA legislative framework offers a significant opportunity to contribute to the greater advancement of public health and patient safety goals by establishing mechanisms that support prevention, treatment and harm reduction. This approach supports the Government of Canada's Throne Speech commitment to address prescription drug abuse as part of the National Anti-Drug Strategy. In 2013, the CMA's General Council, often referred to the Parliament of Canadian Medicine, recommended "that there be an increased emphasis on public health-oriented approaches by regulatory authorities responsible for psychoactive substances." Substance abuse is a complex behaviour influenced by many factors, and a therefore a public health approach to addressing it should incorporate a comprehensive multi-factorial strategy. A public health approach would place an increased focus on preventing drug abuse and misuse; on treatment of addiction and other consequences of misuse; on monitoring, surveillance and research; and on harm reduction. It would seek to ensure the harms associated with enforcement (e.g. crime, disease due to use of dirty needles) are not out of proportion to the direct harms caused by substance abuse. The CMA recommends that the modernization of the CDSA legislative framework focus on enabling and supporting such a public health approach. It should be noted that the substances governed by the CDSA include medications used by patients and prescribed by health care professionals for legitimate therapeutic purposes. We note that the schedules attached to the CDSA do not make a distinction between illicit substances of abuse and prescription medication. For example, Schedule I includes both illicit substances such as heroin, and opioid prescription medicines like oxycodone and hydrocodone. The potential of a drug or medication to cause harm has little if anything to do with its legal status. Therefore, the CMA recommends that as part of the review of the CDSA and its regulations, Health Canada undertake a review of the schedules, including the organization of the schedules, and the listing of substances within each schedule. The purpose of this review is to ensure that: (1) the schedules are up-to-date; (2) the CDSA allows for the incorporation of new illicit substances and prescription medication on the basis of available evidence and in a timely manner; and, (3) the schedules are organized based on risk status, legal status or other consideration. In the following sections, the CMA outlines recommendations that would facilitate the expansion of a public health approach. A) Establish Mechanisms to Address Prescription Drug Misuse and Abuse The misuse and abuse of controlled psychoactive prescription medicines, notably opioids such as oxycodone, fentanyl and hydrocodone, is a significant public health and patient safety issue. Canada has the second highest per capita consumption of prescription opioids in the world, after the United States. The abuse and misuse of prescription opioids among vulnerable populations, remains a significant concern. For instance, in 2013 opioids were reported as the third most common drug (after alcohol and marijuana) used by students in Ontario. While accurate data on the prevalence of the misuse of prescription medication among seniors is lacking, the CMA is concerned that as Canada's population ages, an increasing number of seniors will need treatment for harms related to prescription medication use, such as drug interactions, falls due to drowsiness or lack of coordination. Controlled prescription medications are legal products intended for legitimate therapeutic purposes, i.e. to control pain from cancer or terminal illness, or from chronic conditions such as nerve damage due to injury. However, they may also be misused or abused, and addiction may drive some users to illegal behaviour such as doctor-shopping, forging prescribers' signatures, or buying from street dealers. Canada's physicians are deeply concerned about the misuse and abuse of prescription opioid medication for a number of reasons. First, physicians need to assess the condition of the patient who requests the medication, and consider whether its use is clinically indicated and if the benefits outweigh the risks. Secondly, they may need to prescribe treatment for patients who have become addicted to the medication. Finally, they are vulnerable to patients who forge the physician's signature or use other illegal means to obtain prescriptions, or who present with fraudulent symptoms, or plead or threaten when denied the drugs they have requested. The 2014 federal budget promises $44.9 million over 5 years to the National Anti-Drug Strategy to address prescription drug abuse, and CMA believes that this is a positive step. Health Canada, in its role as drug regulator, could use the Controlled Drugs and Substances Act to help further this strategy in the following ways: i) Improving the approval, labelling and safety monitoring of controlled substances The CMA recommends that new sections be introduced to the CDSA to require higher levels of regulatory scrutiny for controlled prescription medication, during both the approval process and post-approval surveillance. Specifically, the CDSA should be amended to require: * More stringent pre-approval requirements for controlled prescription medication. Because of their high level of risk, Health Canada could require that they be subject to higher levels of scrutiny than other medications during the review of pre-approval clinical trial results, special post-approval conditions(e.g. formal post-market studies); * Stricter conditions on the marketing of controlled medication by the pharmaceutical industry to health professionals. * Tamper-resistant formulations of prescription opioid medication. New opioid medication or potentially addictive formulations should be tamper-resistant to reduce the potential for misuse or abuse. * Improved patient information and counseling to be offered to prescribers, dispensers, and patients receiving opioid prescriptions. ii) Establishing consistent requirements for prescription monitoring In our brief to the House of Commons Standing Committee on Health (see Appendix A), during its study on prescription drug abuse, the CMA encouraged all levels of government to work with one another and health professional regulatory agencies to develop a pan-Canadian system of real-time prescription monitoring and surveillance. Indeed, all stakeholders who testified before the Committee recognized the importance of prescription monitoring programs in addressing prescription drug abuse. While prescription monitoring programs (PMPs) exist in most provinces, they vary considerably in terms of quality, the nature of the information they require, whether health care practitioners have real-time access, and in the purpose for which the data is collected. Standardization of surveillance and monitoring systems can contribute to addressing the misuse and abuse of prescription medication by: * Allowing health care practitioners to identify fraudulent attempts to obtain a prescription, such as an attempt to fill prescriptions from a number of different providers, at the time the prescription is requested or filled. * Deter interprovincial or jurisdictional fraud, again, by allowing health care practitioners to identify fraudulent attempts at the time the prescription is requested or filled. * Improve professional regulatory bodies' capacity for oversight and intervention, by establishing a mechanism for real-time monitoring. * Finally, help Canada's researchers improve our knowledge of this serious public health concern, identify research priorities, and determine best practices to address crucial issues. Such a system should be compatible with existing electronic medical and pharmacy record systems and with provincial pharmaceutical databases such as that of British Columbia. Participation in prescription monitoring programs should not impose an onerous administrative burden on health care providers. Integration with electronic health records and the widespread use of electronic databases and transmission would go far to minimize the potential burden. The CMA recommends that a new reporting regulation be promulgated under the CDSA that addresses reporting requirements and disclosure requirements of practitioners, manufacturers and other stakeholders, in order to establish consistent standards for prescription monitoring. This regulation should: * Enable inter-jurisdictional accessibility and operability; * Ensure that practitioners have real-time access to the monitoring system; * Enable electronically-based prescription monitoring; and; * Conform to privacy laws, protecting patient confidentiality while enabling the sharing of necessary information. (Privacy concerns are addressed in greater detail in Part 2). B) Supporting harm reduction as a component of a drug strategy The CMA fully endorses harm reduction strategies and tools, including supervised injection sites, and believes that the CDSA should support and enable them. It is the CMA's position that addiction should be recognized and treated as a serious medical condition. Section 56 of the CDSA sets out conditions under which applicants may obtain exemptions from the provisions of the Act. Bill C-2, currently at Second Reading in the House of Commons, proposes new, far reaching, and stringent conditions that must be met by a proponent who is applying to establish a supervised injection site. The CMA maintains that safe injection sites are a legitimate form of treatment for the disease of addiction, that their benefit is supported by a body of research, and that the conditions proposed under Bill C-2 are overly restrictive. In addition, to support harm reduction, the CMA encourages Health Canada to amend section 2 (2) (b) (ii) (B) of the CDSA that states a controlled substance includes "any thing that contains or has on it a controlled substance and that is used or intended or designed for use... in introducing the substance into a human body" in order to enable the important role of safe injection sites. C) Developing clinical knowledge base about the medical use of marijuana The CMA has already made its position on the Marihuana for Medical Purposes Regulations known to Health Canada (see Appendix B). Despite repeated revisions since they were first established in 2001, the regulations do not address CMA's primary concern; that physicians are made gatekeepers for a product whose medical benefits have not been sufficiently researched, and which has not undergone the clinical trial process required for therapeutic products under the Food and Drugs Act. The absence of clinical evidence means that physicians lack scientific information and guidance on the uses, benefits and risks of marijuana when used for medicinal purposes. To address these issues, the CMA recommends that Health Canada invest in scientific research on the medical uses of marijuana. This could include establishing market incentives for Licensed Producers to undertake research, or requiring them to contribute to a research fund administered by the Canadian Institutes of Health Research. In addition, the CMA encourages the development and dissemination of evidence-based clinical support tools for physicians. Part 2: Ensuring protection of patient privacy In any legislative framework pertaining to patient care, physicians consider protecting the privacy of patient information to be paramount; indeed, privacy, confidentiality and trust are cornerstones of the patient-physician relationship (see Appendix C). For these reasons, the CMA strongly recommends that Health Canada undertake a privacy impact assessment of the existing CDSA and its regulations as well as of future proposed amendments. The CMA encourages Health Canada to make this assessment available to stakeholders as part of its consultation process on this legislative framework. As previously mentioned, the new regulation proposed under Part 1 (A) (ii) above must conform to privacy laws, and protect patient confidentiality while enabling the sharing of necessary information. The CMA is deeply concerned with the search provision under s.31 of the CDSA in which an exception to this broad authority for patient records is mentioned in subsection (1) (c). The CMA is concerned that this exception may not be sufficient to meet the existing privacy laws governing patient information and records, both federally and provincially. As such, the CMA recommends that the CDSA be amended to ensure that patient information and records are exempt from search authorities, consistent with the most stringent privacy laws at the federal and provincial jurisdictions. Part 3: Enabling e-prescribing As part of the review of the CDSA and its associated regulations, Health Canada should assess how this legislative framework may be used to facilitate and support the advancement of e-health, specifically e-prescribing. Electronic health records can support individual physicians or pharmacists to quickly identify potential diversion and double-doctoring, at the point where a prescription is written or filled. The electronic health record also facilitates the sharing of information among health professionals, as well as programs that allow physicians to compare their prescribing practices to those of their peers. For instance, sections of the Benzodiazepines and Other Targeted Substances Regulations, Narcotic Control Regulations, and Precursor Control Regulations, establish the conditions within which pharmacists may accept a prescription. The CMA recommends that these regulations be amended to specifically include electronic prescriptions in addition to verbal and written prescriptions among the forms that may be accepted by a pharmacist. This recommendation is consistent with the joint statement by the CMA and the Canadian Pharmacists Association on e-prescribing (see Appendix D). Health Canada should also ensure that regulatory amendments facilitate prescription monitoring, as discussed in a previous section. Part 4: Establishing a mechanism for changes to scope of practice The New Classes of Prescribers Regulations, promulgated in 2012, grants nurse practitioners, midwives and podiatrists the authority to prescribe controlled substances if their provincial scope of practice laws permit. The CMA's 2012 submission in response to this regulatory change is attached to this brief for information (Appendix E.) In it, the CMA recommended that "A regulatory framework governing prescribing authority, or any other aspect of scope of practice, should always put patient safety first. The primary purpose of scope of practice determination is to meet the health care needs and serve the health interests of patients and the public safely, efficiently, and competently." One of our main concerns at the time was that the more practitioners who could prescribe controlled substances, the greater the potential for the illegal diversion of products to street dealers. This remains a concern for us. Given the significance of scope-of-practice determinations to patient safety and patient care, the CMA strongly recommends that future changes to the scope of practice of a health care practitioner be undertaken only within a defined, transparent evaluation process based on clinical criteria and protection of patient safety. To this end, the CMA strongly recommends the introduction of new clauses to the CDSA and its associated regulations to establish a mechanism that governs future changes to scope of practice. These clauses should require, prior to the implementation of any change: * Demonstration that it will improve public health and patient safety; * Meaningful consultation with professional organizations and regulatory authorities; and, * Support of provincial and territorial ministers of health. Further, the CMA recommends that such a new regulation governing possible future changes to scope of practice require: * That new classes of prescribers have conflict of interest policies; * That new classes of prescribers be incorporated under the prescription monitoring regulation recommended under Part 1 (A) (ii) above; and * That a mandatory five-year review be established for new classes of prescribers. Part 5: Recognizing the authority of physician regulatory colleges As previously mentioned, many controlled substances governed under the CDSA and its associated regulations are prescribed by physicians and other health professionals, for therapeutic purposes. Medicine is a regulated profession, and the colleges of physicians have ultimate authority and responsibility for the oversight of physician practice, including monitoring prescribing activity, investigating practice and when required, taking disciplinary action. In its present form, section 59 of the Narcotic Control Regulations includes a duplicative and redundant provision for oversight and disciplinary action. The CMA strongly recommends that this section be amended to recognize the established authority of physician regulatory colleges for the oversight of the medical profession. Conclusion The CMA welcomes the consultation and review of the Controlled Drugs and Substances Act and its associated regulations. As mentioned before, this submission is not an exhaustive analysis of the Controlled Drugs and Substances Act¸ but an initial summary of CMA's position on issues of particular concern to patient safety and public health. This brief outlines numerous opportunities within the CDSA and its associated regulations to establish new measures and mechanisms that would contribute to improved public health and patient safety. In light of the breadth and importance of the issues raised in this review, CMA encourages further consultation and welcomes the opportunity to discuss these issues in greater detail. List of Appendices: * Appendix A: CMA Brief to the House of Commons Standing Committee on Health - The Need for a National Strategy to Address Abuse and Misuse of Prescription Drugs in Canada * Appendix B: CMA Policy Statement - Medical Marijuana * Appendix C: CMA Policy Statement - Principles for the Protection of Patient's Personal Health Information * Appendix D: CMA Policy Statement - Vision for e-Prescribing: a joint statement by the Canadian Medical Association and the Canadian Pharmacists Association * Appendix E: CMA submission - Response to the proposed New Classes of Practitioners regulations published in the Canada Gazette Part I (Vol. 146, No. 18 - May 5, 2012) Overview of recommendations The CMA recommends that the modernization of the CDSA legislative and regulatory framework should be guided first and foremost by the objective of improving public health, promoting quality care and enhancing patient safety. The CMA recommends that as part of the review of the CDSA and its regulations, Health Canada undertake a review of the schedules, including the organization of the schedules, and the listing of substances within each schedule. The CMA recommends that new sections be introduced to the CDSA to require higher levels of regulatory scrutiny as part of the approval and post-approval process for prescription opioid medication. The CMA recommends that a new reporting regulation be promulgated under the CDSA that addresses reporting requirements and disclosure requirements of practitioners, manufacturers and other stakeholders in order to establish consistent standards for prescription monitoring. To support harm reduction, the CMA recommends an amendment to section 2 (b) (ii) of the CDSA, which states a controlled substance includes "any thing that contains or has on it a controlled substance and that is used or intended or designed for use... in introducing the substance into a human body". The CMA recommends that Health Canada invest in scientific research on the medical uses of marijuana. This could include establishing market incentives that require Licensed Producers to undertake research, or requiring them to contribute to a research fund administered by the Canadian Institutes of Health Research. In addition, the CMA encourages the development and dissemination of evidence-based clinical support tools for physicians. The CMA recommends that Health Canada undertake a privacy impact assessment of the existing CDSA and its regulations as well as future proposed amendments, and provide this assessment to stakeholders as part of its consultation process on this legislative framework. The CMA recommends that the CDSA, specifically s.31 (1) (c), be amended to ensure that patient information and records are exempt from search authorities, consistent with the most stringent privacy laws at the federal and provincial jurisdictions. The CMA recommends that the CDSA and its regulations be amended to specifically include electronic prescriptions in addition to verbal and written prescriptions among the forms that may be accepted by a pharmacist, including sections within the Benzodiazepines and Other Targeted Substances Regulations, Narcotic Control Regulations, and Precursor Control Regulations. The CMA recommends the introduction of new clauses to the CDSA and its associated regulations to establish a mechanism that governs future changes to scope of practice, based on the introduction of a new regulation governing changes to scope of practice that will require, prior to the implementation of any change: * Demonstration of public health and patient safety improvement; * Meaningful consultation with professional organizations and regulatory authorities; and, * Support of provincial and territorial ministers of health. The CMA recommends that the new mechanism of the CDSA legislative framework governing possible future changes to scope of practice require: * That new classes of prescribers have conflict of interest policies; * That new classes of prescribers be incorporated under the prescription monitoring regulation recommended under Part 1 (A) (ii) above; and * That a mandatory five-year review be established for new classes of prescribers. The CMA strongly recommends that s.59 of the Narcotic Control Regulations be amended to recognize the established authority of physician regulatory colleges for the oversight of the medical profession.

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Policy Type

Parliamentary submission

Date

2014-03-26

Topics

Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs

Text

The Canadian Medical Association (CMA) is pleased to present this submission to the Senate Standing Committee on Social Affairs, Science and Technology for consideration as part of its study on prescription pharmaceuticals in Canada. In this phase, the Committee is studying the unintended consequences of pharmaceuticals, and witnesses to date have identified a broad range of such consequences. In recognition of the important role of prescription medication in patient care, the CMA has developed an extensive body of policy on pharmaceutical medication and prescribing-related issues, some of which we have shared with this Committee on previous occasions. Physicians are concerned that all Canadians have access to medically-necessary medication that is safe, effective, affordable, appropriately prescribed and administered, and part of a comprehensive, patient-centered health care and treatment plan. In this brief, the CMA identifies and discusses five issues that are unintended consequences of prescription pharmaceuticals related to public health, quality care and patient safety. These are: addressing shortages in the supply of prescription pharmaceuticals; addressing the abuse and misuse of prescription medication; improved post-market surveillance and reporting tools; supporting optimal prescribing; and, addressing gaps in insurance coverage. 1) Addressing shortages in the supply of prescription medication Over the past few years Canada's doctors have become deeply concerned about the persistent shortages of prescription medication. Drug shortages have serious consequences for patient care. For example, if a patient on long-term therapy has been stabilized on a drug which becomes unavailable, and is switched to another drug that produces poorer results, this can lead to a decline in health status. The cost of the substitute medication might be beyond a patient's financial capacity. In some cases a therapeutic alternative may not be available at all. The CMA has participated on a Multi Stakeholder Working Group on Drug Shortages, with Health Canada, the pharmaceutical industry and health professional organizations, to establish a Canadian drug shortage reporting website. Although a drug shortage reporting website has been established, there is significant room for improvement. While this website may provide information on products in shortage, it is not clear that all shortages are reported, no mechanism for redress is identified, and most importantly drug shortages are persisting. The CMA supports an investigation into the underlying causes of prescription drug shortages in Canada. One frequently cited reason for shortages is product manufacturing disruptions, such as the 2011 production stoppage at a Sandoz facility in Quebec which resulted in a scramble to find alternate sources of many essential medications. Such disruptions are of particular concern when the drugs in question have been "single sourced" due to government bulk purchasing policies, and no clear substitutes are available. Therefore, the CMA supports the development of strategies at the provincial/territorial and federal level to discourage single source purchasing decisions. The CMA continues to call on governments and manufacturers to take meaningful action to address the impacts of shortages includingdeveloping appropriate mitigation strategies to reduce the number of drug shortages in Canada and their impact on patient health and patient care. To support this goal, the CMA recommends that the Committee extend its study on prescription pharmaceuticals to explore the root causes of shortages in the supply of prescription medication in Canada and strategies to mitigate the impacts on patients and patient care. 2) Addressing the misuse and abuse of prescription medication The use of prescription opioid pain relievers is on the rise, in Canada and internationally. Latest reports indicate that Canada has the second highest per capita consumption of prescription opioids in the world, after the United States. The misuse and abuse of prescription medication is a serious problem and because of its complexity, requires a complex and multifaceted solution. Canada's physicians are concerned about the abuse and misuse of prescription medication for a number of reasons. For one, physicians need to assess the condition of patients who request the medication, and consider whether the use is clinically indicated and whether the benefits outweigh the risks. This can be challenging as there is no objective test for assessing pain, and therefore the prescription of opioids rests to a great extent on mutual trust between the physician and the patient. For another, physicians may need to prescribe treatment for patients who become addicted to the medications. Finally, they are vulnerable to patients who forge their signatures or use other illegal means to obtain prescriptions, or who present with fraudulent symptoms, or plead or threaten when denied the drugs they have requested. Opioid prescription pharmaceuticals are legal products intended for legitimate therapeutic purposes, such as pain management or palliative and end-of-life care. However, they may also be used for recreational purposes or to feed an addiction. It must be recognized that it is addiction which drives the drugs' illegal acquisition through means such as doctor-shopping, forging prescribers' signatures, or buying from street dealers or the Internet. The CMA recommends that the federal government work with provincial/territorial governments and other stakeholders to develop and implement a comprehensive national strategy to address the problem of prescription drug misuse and abuse in Canada. Such a strategy should include: a) Programs to prevent misuse: The aim of prevention programs should be to reduce both recreational use and inappropriate therapeutic use. Awareness programs and social marketing campaigns could include: * Information on the benefits and harms of prescription drug misuse, and signs of abuse, addiction or overdose; * Instructions regarding safe storage and disposal. This is important since young recreational users frequently report that they obtain drugs from the family medicine cabinet. CMA supports national prescription drug "take back" days, and recommends that patients be educated about the importance of returning unused prescription drugs to the pharmacy. b) Measures to reduce the risk of overdose: Overdose deaths due to opioid use have grown dramatically over the past ten years. The risk of harm from overdose may be compounded if recreational users are afraid to call for emergency assistance for fear of facing criminal charges. However, opioid overdoses can be prevented with appropriate medication and prompt emergency response. c) Access to treatment services: A national strategy should also improve patient access to specialized pain management services, and to treatment for opioid addiction. Many believe that if specialized pain treatments were widely available, patients and prescribers would be less likely to rely solely on medication to treat their often debilitating pain. d) A pan-Canadian prescription monitoring program: Programs to monitor the prescribing of opioids and other controlled substances exist in most provinces, but they vary in quality, in the nature of the information they require, and in the purpose for which data is collected. The CMA recommends that all levels of government work with one another and health professional regulatory agencies to develop a pan-Canadian system of real-time prescription drug abuse monitoring and surveillance. This should include the development of national standards for prescription monitoring, to ensure that all jurisdictions across Canada are collecting the same information in a standard way. Standardization of surveillance and monitoring systems can have a number of positive effects, including: * Identifying fraudulent attempts to obtain a prescription, such as an attempt to fill prescriptions from a number of different providers. * Deterring inter-provincial fraud. * Supporting professional regulatory bodies actively monitor and intervene, as needed, with practitioners suspected of over-prescribing or over-dispensing frequently-misused medications. * Finally, supporting researchers gather consistent data to improve our knowledge of the problem, identify research priorities, and determine best practices to address crucial issues. We are pleased that federal, provincial and territorial health ministries have expressed interest in working together on prescription drug abuse issues, and we hope that this will result in a coherent national system for monitoring and surveillance, and thus to improved knowledge about the nature of the problem and its most effective solutions. 3) Improving post-market surveillance and reporting tools Health Canada has traditionally approved drugs for general use based on clinical trials that tend to be of short duration and have relatively few participants. As a result, when a prescription pharmaceutical comes on the market there is still limited information about its safety or effectiveness, and there is a need to keep gathering information from people who are using it in "real-world" conditions. As a consequence, adverse drug reactions (ADRs) are all too common in Canada; according to the Canadian Institute for Health Information, one in 200 patients over 65 are hospitalized because of adverse reactions to their medication. As such, CMA once again recommends that Health Canada work to strengthen the capacity of its post-market surveillance system by ensuring that it includes: a) Comprehensive processes for gathering drug safety and effectiveness data: Since most safety data reaches Health Canada in the form of spontaneous adverse drug reaction (ADR) reports, reporting processes should make it easier for physicians and other health professionals to report ADRs voluntarily, by making the reporting system user-friendly and easy to incorporate into a practitioner's busy schedule. Ideally, ADR reporting could be incorporated directly into the Electronic Medical Record (EMR) as this is developed. Spontaneous reports could be augmented with information gathered through other, more systematic means such as formal post-market studies. b) A capacity for rigorous and timely data analysis to identify significant threats to drug safety: The monitoring and analysis that occurs once an adverse drug reaction (ADR) report has been received are critical elements of the post-surveillance system. Monitoring capacity requires rigorous data analysis that can sort "signal from noise" - in other words, sift through the reports, find the ones that indicate unusual events, investigate their cause, and isolate those that indicate a serious public health risk. It also requires that the analysis be timely: we note that in 2011 the Auditor General was particularly critical of Health Canada's post-market surveillance timeliness, noting that it could take several years for reports to be reviewed internally. c) Communication of useful information to health care providers and the public: When new information is uncovered about a prescription drug, it is important that physicians and other health professionals are made aware of it as quickly and efficiently as possible. Therefore, post-approval surveillance requires a system for communicating timely, reliable and objective information to physicians and other health professionals, which they can absorb quickly and incorporate into their everyday practice. Ideally, this communication would report not the safety problem alone but also its implications for their patients and practice: for example, whether some patients are particularly at risk, or whether therapeutic alternatives are available. The CMA supports the expanded ministerial authorities of recall proposed in Bill C-17, the Protecting Canadians from Unsafe Drugs Act, and the intent to address the short-comings of Canada's post-market surveillance system. We will be providing comments on this legislation in the near future. 4) Supporting Optimal Prescribing In an ideal world, all patients would be prescribed the medications that have the most beneficial effect on their condition while doing the least possible harm. The CMA encourages collaborative efforts toward the achievement of this ideal. For example, medication misuse among seniors is a major concern. According to a 2011 report from the Canadian Institute for Health Information (CIHI), 62% of seniors on public drug programs use five or more drug classes, and nearly 30% of those 85 and older have claims for 10 or more prescription drugs. Heavy medication use by people over 65 has a number of consequences: * The risk of adverse drug reactions is several-fold higher for older patients than for younger; * Medication regimes, particularly for those taking several drugs a day on different dosage schedules, can be confusing and lead to errors or non-adherence; and, * Patients may receive prescriptions from multiple providers who, if they have not been communicating with each other, may not know what other medications have been prescribed. This increases the risk of duplicate prescriptions, harmful drug interactions and other medication errors. It is to address such concerns that the CMA developed its 2010 position statement: "A Prescription for Optimal Prescribing This statement recommends that governments at all levels work with prescribers, the public, industry and other stakeholders to develop and implement a nationwide strategy to encourage optimal prescribing and medication use. This strategy should include, among other elements: a) Provision of Relevant, Objective Information: The CMA supports the development and dissemination of information for prescribers that is based on the best available scientific evidence, relevant to clinical practice, and easy to incorporate into a practitioner's daily workflow. At present, physicians receive much of their information from pharmaceutical manufacturers. Since manufacturers have generous budgets to support their information dissemination, their campaigns are impressive and effective; but their impartiality has frequently been called into question. Objective, evidence-based information to health professionals on prescription drugs and their uses could be disseminated in the following ways: * Well-crafted online continuing medical education (CME), funded by objective sources. * Academic detailing, in which teams of experts visit prescribers to provide impartial prescribing advice. Academic detailing programs have demonstrated success; but because they are expensive and labour intensive, it has often been difficult to persuade governments to invest in them. * Making drug information available to prescribers at the point of care, through such means as mobile phone apps and electronic health records. * Programs that monitor a prescriber's habits and compare them to those of peers. CMA encourages such programs if their purpose is to educate rather than to enforce a certain behaviour. Information for prescribers should be augmented by unbiased, up-to-date, practical information for consumers about prescription drugs and their appropriate use. b) Support e-prescribing. Electronic prescribing has the potential to dramatically improve drug therapy. For example an effective e-prescribing system could: * List all the drugs a patient is taking, and identify duplicate prescriptions for the same drug from different providers, thus helping to reduce medication error and prescription fraud; * Incorporate decision-support tools; for example, a warning could appear on the screen if a physician proposes to prescribe a drug that interacts harmfully with another the patient is already taking. * Improve decision making and communication between providers, providing all of a patient's caregivers access to a common, comprehensive medication profile; and * Increase convenience for the patient and eliminate illegible handwriting, which is a major cause of medication error. The CMA recommends that governments, health care leadership and clinical organizations in all jurisdictions commit to make e-prescribing a reality by 2015, and ensure the policy/regulatory environment that supports e-prescribing. 5) Addressing gaps in insurance coverage for prescription medication Finally, another consequence of the increased role of pharmaceuticals in health care is that, because they are not generally covered by the Canada Health Act, many Canadians, particularly those in the lowest income groups, are unable to afford them. Data from the 2007 Community Health Survey estimate that 1 in 10 Canadians does not adhere to their prescription regimes for reasons of cost. The CMA recommends that governments, in consultation with the life and health insurance industry and the public, establish a program of comprehensive prescription drug coverage to be administered through reimbursement of provincial/territorial and private prescription drug plans to ensure that all Canadians have access to medically necessary drug therapies. Conclusion As previously mentioned, CMA has focussed its discussion of unintended consequences on recommendations to support public health, quality care, and patient safety. The CMA commends the Committee for making this issue the subject of study, and hope that our recommendations, and those of other witnesses, will lead to action to address the unintended consequences of prescription pharmaceuticals in Canada. Summary of Recommendations 1) The CMA recommends that the Senate Social Affairs, Science and Technology Committee extend its study on prescription pharmaceuticals to explore the root causes of shortages in the supply of prescription medication in Canada and strategies to mitigate the impacts on patients and patient care. 2) The CMA recommends that the federal government work with provincial/territorial governments and other stakeholders to develop and implement a comprehensive national strategy to address the problem of prescription drug misuse and abuse in Canada. 3) The CMA recommends that all levels of government work with one another and health professional regulatory agencies to develop a pan-Canadian system of real-time prescription drug abuse monitoring and surveillance. 4) The CMA recommends that Health Canada continue to improve the capacity of its post-approval surveillance system to: * Make it easier for health professionals to submit voluntary ADR reports * Analyze the data that has been gathered, in a rigorous and timely manner; and * Communicate essential information to health care providers and the public in a timely and user-friendly manner. 5) The CMA recommends that governments at all levels work with prescribers, the public, industry and other stakeholders to develop and implement a nationwide strategy to encourage optimal prescribing and medication use. 6) The CMA supports the development and dissemination of prescribing information that is: * based on the best available scientific evidence; * relevant to clinical practice; and, * easy to incorporate into a physician's workflow. 7) The CMA calls on governments to support and deliver funding for impartial continuing medical education programs on optimal prescribing. 8) The CMA recommends that governments, health care leadership and clinical organizations in all jurisdictions commit to make e-prescribing a reality by 2015, and ensure the policy/regulatory environment that supports e-prescribing. 9) The CMA recommends that governments, in consultation with the life and health insurance industry and the public, establish a program of comprehensive prescription drug coverage to be administered through reimbursement of provincial/territorial and private prescription drug plans to ensure that all Canadians have access to medically necessary drug therapies.

Less detail

Policy Type

Parliamentary submission

Date

2014-05-15

Topics

Health care and patient safety

Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs

Text

The Canadian Medical Association (CMA) welcomes the opportunity to provide input to the Standing Senate Committee on Banking, Trade and Commerce study of Bill C-31 the Budget Implementation Bill, in particular the section concerned with tobacco taxation. Tobacco use is still the number one cause of preventable disease and death in Canada, claiming 37,000 or more Canadians' lives every year. It is a major risk factor for the chronic diseases that burden Canadians and their health care system, and it costs the country over $17 billion per year for medical treatment, social assistance, lost productivity and reduced quality of life. While progress has been made in lowering smoking rates and changing attitudes towards smoking much work remains - nearly 4.6 million Canadians still smoke. Physicians have been warning of the dangers of smoking for over 50 years. Canada's doctors treat the harmful effects of tobacco use every day in their offices, and see first-hand the devastation it causes to patients and their families. The CMA has consistently recommended tough legislative and regulatory measures to control tobacco use. Comprehensive tobacco control efforts must include legislation, regulation, together with public education and smoking cessation programs. Impact of Price on Smoking Research has shown that an increase in cigarette prices has an impact on reducing both the number of cigarettes smoked and smoking prevalence rates. Permanent, inflation-adjusted increases in cigarette prices, which could be achieved by increasing cigarette taxes, will contribute to reducing cigarette smoking rates in Canada. Youth are up to three times more sensitive to price than adults, with a 10 per cent price increase estimated to reduce youth smoking prevalence by 5 per cent or more and also to reduce cigarette consumption among continuing young smokersi With the current smoking rate of 20 per cent among Canadian young adults, higher than the smoking rate for the rest of Canada which is 16 per cent, additional initiatives to reduce smoking in this population are urgently required. Research has also shown that persons of low socioeconomic status are more responsive to price than the general population but it is less clear on the impact on long-term heavy smokers and aboriginal smokersii Estimates imply that the long-run effect of a permanent price increase is approximately double the short-run impact. Thus, a 10 per cent increase in cigarette price is expected to reduce the prevalence of cigarette smoking by approximately 8 per cent in the long run.iii Excise Tax Adjustments The current proposal to adjust the domestic rate of excise duty on tobacco products to account for inflation and eliminate the preferential excise duty treatment of tobacco products available through duty free markets will increase the cost of cigarettes and other tobacco products like fine-cut tobacco for use in roll-your-own cigarettes, chewing tobacco and cigars. For example, the government has stated that the excise "duty free" rate for cigarettes will increase from $15.00 to $21.03 per carton of 200 cigarettes. The commitment to make an automatic inflation adjustment every 5 years is a means to ensure that tobacco tax rates retain their real value in the future. The CMA recommends passage of the proposal under Part 3 of Bill C-31 to increase the domestic rate of excise duty, accounting for inflation and eliminating the preferential excise duty treatment of tobacco products. This proposal represents a positive step toward the development of a federal integrated tobacco tax strategy for both domestic and imported products, and speaks to the importance of the relationship between health policy and tax policy. Unintended Consequences There is a risk that a rise in tobacco taxes with the resultant rise in the cost of smoking will lead to an increase in the smuggling of lower-cost cigarettes. To avoid potential unintended consequences, such as smuggling, the CMA recommends that the federal government work with other countries to ensure that tobacco prices are harmonized across national borders. In addition, all levels of government should take the most stringent measures possible to control the sale and distribution of contraband tobacco, on their own and in cooperation with other affected jurisdictions. Investing Tobacco Taxes in Health Promotion The Minister of Finance has estimated that increasing tobacco taxes, including excise taxes on tobacco products, will increase federal tax revenues by $96 million in 2013-14, 685 million in 2014-15 and $660 million in 2015-16. The CMA recommends that the revenue from increased taxation should be directed towards strengthening Canada's tobacco control strategy. The CMA recommends that tobacco taxation policy should be used in conjunction with other strategies for promoting healthy public policy, such as public education programs to reduce tobacco use. The federal government should place a high priority for funding tobacco prevention and evidence-based cessation programs for young Canadians as early as primary school age. For these, substantial and sustainable funding is required. A portion of these tobacco taxes should also be used to defray the costs of tobacco interventions, including physician-based clinical tobacco intervention services and up to 12 weeks stop-smoking medication annually per smoker. We encourage the government to focus their efforts on "high-risk" and "hard-to-reach" populations. Research For Canada's Tobacco Control strategy to continue to reduce smoking rates in Canada we must continue to assess evolving best practices in smoking cessation programs, and conduct research on the impact of policies on high risk populations. The CMA recommends that a portion of the revenues from tobacco taxes can be directed towards supporting evidence-based action to reduce tobacco use. This evidence comes from surveying Canadians on smoking behavior, conducting research and evaluation, and keeping track of trends and emerging issues. Conclusion The CMA supports increasing the excise duty on tobacco products. An increase in the excise duty tax on tobacco products is long overdue and a welcome contribution to efforts already underway to further reduce smoking rates in Canada. Summary of Recommendations The CMA recommends passage of the proposal under Part 3 of Bill C-31 to increase the domestic rate of excise duty, accounting for inflation and eliminating the preferential excise duty treatment of tobacco products. The CMA recommends that the federal government work with other countries to ensure that tobacco prices are harmonized across national borders to avoid potential unintended consequences, such as smuggling. The CMA recommends that the revenue from increased taxation should be directed towards strengthening Canada's tobacco control strategy. The CMA recommends that tobacco taxation policy should be used in conjunction with other strategies for promoting healthy public policy, such as public education programs to reduce tobacco use. The CMA recommends that a portion of the revenues from tobacco taxes can be directed towards supporting evidence-based action to reduce tobacco use. i The Impact of Price on Youth Tobacco Use, Tobacco Control Monograph NO. 14 Frank J. Chaloupka, Rosalie Liccardo Pacula ii Effects of Tobacco Taxation and Pricing on Smoking Behavior in High Risk Populations: A Knowledge Synthesis Pearl Bader, David Boisclair, Roberta Ferrence Int J Environ Res Public Health. 2011 November; 8(11): 4118-4139. Published online 2011 October 26. doi: 10.3390/ijerph8114118 PMCID: PMC3228562 iii The Impact of Price on Youth Tobacco Use, Tobacco Control Monograph NO. 14 Frank J. Chaloupka, Rosalie Liccardo Pacula

Less detail

Policy Type

Parliamentary submission

Date

2014-05-27

Topics

Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs

Text

The Canadian Medical Association (CMA) is pleased to present this brief to the House of Commons Standing Committee on Health for consideration as part of its study on the health risks and harms associated with the use of marijuana. Marijuana, or cannabis, is a Schedule II drug under the Canadian Controlled Drugs and Substances Act, and growing, possessing, distributing and selling marijuana is illegal, subject to penalties. Despite that, according to the latest Canadian Alcohol and Drug Use Monitoring Survey1, about 10% of Canadians ages 15 years and over had used marijuana at least once in the past year. It is the second most used substance, following alcohol (at 78%). Even though there has been a decrease in marijuana use among youth (ages 15 to 24) in recent years, usage is still double that of the general population, at 20%. A quarter of youth that had used marijuana in the past 3 months, used it daily, however most use is infrequent and experimental. The average age of initiation is 16.1 years, and it is very concerning that continued use is most common among those who initiate use early. In some provinces, about 50% of students in grade 12 have reported using marijuana in the past year.2 The 2012 Canadian Community Health Survey - Mental Health3 reported that 1.3% of people aged 15 and over met the criteria for cannabis abusea or dependenceb - double that of any other drugs. The lifetime risk of dependence is estimated at about 9%, increasing to almost 17% in those who initiate use in adolescence.4 Similar estimates for other substances are 15% for alcohol, 23% for heroin and 32% for nicotine. CMA has longstanding concerns about the health risks associated with smoking marijuana. While our comments have more recently been made in the context of medical marijuana, the core issue is the same: marijuana usage poses serious health risks5. Teenagers are particularly at risk for marijuana-related harms, given their brain is undergoing rapid, extensive development. It is estimated that marijuana contains more than 400 active chemicals, including over 60 cannabinoids, of which delta-9 tetra-hydrocannabinol (THC) is the most often studied due to its psychoactive properties. The concentration of the various chemicals varies for different plants, batches and growth locations, and has varied over time. There is the potential for contamination by pesticides or other substances. Rates and quantities of components absorbed will also vary depending on whether the drug is smoked, used in food, inhaled with a vaporizer or applied topically. This is challenging for research on the health effects of marijuana. When marijuana is smoked, THC and other components are inhaled and absorbed through the lungs, rapidly entering the bloodstream. Effects are perceptible within seconds and fully apparent in a few minutes. The main feature of its use is that it produces a feeling of euphoria (or 'high') and sensory alterations, but it is also sought out to reduce pain, relieve anxiety, decrease vomiting and increase appetite. Adverse reactions can occur, such as drowsiness, sedation, blurred vision, photophobia, difficulty breathing and vomiting. However, its acute toxicity is extremely low, as no deaths directly due to acute cannabis use have been reported. Toxic dose-related effects that can occur include anxiety, panic, depression, paranoia or psychosis. Acute impairment typically clears 3-4 hours after use. Marijuana slows reaction times, impairs motor coordination and concentration as well as the completion of complex tasks. Marijuana use is associated with an increased risk of motor vehicle crashes. Young people, particularly males, are more likely to drive after using marijuana. The Cross-Canada Student Alcohol and Drug Use6 report states that 14-21% of students in Grade 12 reported having driven within an hour of using marijuana, and more than 33% of Grade 12 students reported having been a passenger in a car where the driver had used the drug. Chronic use is more common among those that start using as young teens; those that are tobacco smokers and heavy alcohol consumers and have used other illegal drugs. People with a number of pre-existing diseases who are chronic smokers of marijuana are probably at increased risk of exacerbating the symptoms of their diseases. For example, adults with hypertension, ischaemic or cerebrovascular disease could be at increased risk due to the cardiovascular stimulatory effects of marijuana. There is an increased risk of psychosis, depression and anxiety, particularly among those who have a personal or family history. A persistent lack of energy in chronic users has been referred to as an "amotivational syndrome". Although cognitive impairments (loss of memory, focus and the ability to think and make decisions) are likely reversible a few weeks after discontinued use, this seems not to be true for those who began using in early teen years, while the brain is still developing. Smoke from marijuana preparations contains many of the same compounds as tobacco cigarettes including increased levels of tar. Smoking marijuana may be more harmful than tobacco, as it often involves unfiltered smoke and deeper, longer inhalation. Chronic users often have shortness of breath after exercise, coughing and chest tightness. It is probably associated with bronchitis and emphysema and may have risks for chronic lung disease and lung cancer, comparable to cigarette smoking. This is less of a problem for those that use vaporizers, as a harm reduction strategy. The use of marijuana during pregnancy has been shown to affect the development and learning skills of children, more noticeably from the age of three, with these effects lasting into the teen years. Studies have shown an increase in hyperactivity, inattention and impulsivity. These children will be more prone to addiction and mental health issues as well as decreased cognitive functioning, and could require supports when in school. Some studies point to a lower birth weight. Besides health concerns, marijuana use can lead to social and interpersonal problems, including difficulties at school, in relationships and with the law. Awareness of Canadians of the harms of marijuana is generally low. 7 Youth tend to emphasize the drug's ability to help them focus, relax, sleep, reduce violent behaviour and improve creativity. There were also many myths, such as that it would counter cigarette effects, preventing cancer. Many stated that they did not consider marijuana as a drug because it was "natural" and relatively benign compared to other drugs. It is concerning that some teens said that marijuana actually made people better drivers by increasing their focus. There seems to be skepticism around prevention programs which aim exclusively at abstinence. Feedback has been that effective approaches would involve providing more fact-based information at an earlier age and using programs that aim at reducing the harms of using marijuana. It is essential that youth and users from other age groups be involved in the conceptualization and development of any such programs. CMA makes the following recommendations to the Committee: 1) Public Health Approach to Psychoactive Substance Use The CMA recommends that the federal government adopt a public health approach to increase the focus on preventing drug abuse, on treatment of addiction, on monitoring, surveillance and research and on harm reduction. Addiction should be recognized and treated as a serious, relapsing chronic disease, and substance use is a complex behaviour influenced by many factors. Therefore, a comprehensive multi-factorial strategy is necessary, and lessons can be learned from work that has been done to decrease tobacco and alcohol use and to reduce the harms related to these substances. A public health approach would place an increased focus on preventing drug abuse and dependence; on the availability of assessment, counselling and treatment services for those who wish to stop using; and on harm reduction to increase the safety for those that are using. It would seek to ensure the harms associated with enforcement are not out of proportion to the direct harms caused by substance abuse. Individuals with drug dependency should be diverted, whenever possible, from the criminal justice system to treatment and rehabilitation. The CMA believes that resources currently devoted to combating simple marijuana possession through the criminal law could be diverted to public health strategies, particularly for youth. A public health approach also includes efforts around the monitoring, surveillance and research of marijuana use to better inform the strategy. This is essential to better understand the short and long term harms as well as policy options to address prevention, treatment, harm reduction and enforcement. 2) Comprehensive Education and Awareness Program to Address Marijuana Use The CMA recommends that the federal government develop, in collaboration with the provinces and territories and key stakeholders, a comprehensive education and awareness program to minimize marijuana use. A comprehensive program to minimize marijuana use should include, but not be limited to: - Education and awareness raising of the known and potential harms of marijuana; - Strategies to prevent early use in adolescence; - Support for programs that decrease stigma associated with mental health and addiction; and - Support for health professionals' awareness and evidence-informed practice in the prevention, management and treatment of drug use. A specific focus on youth is essential, as they are not only more likely than adults to engage in risky drug use, particularly boys, but also disproportionately experience greater harms from that use. It is also particularly important for women of child bearing age, due to the risk to the fetus during pregnancy. Information that is tailored to the needs of specific populations will help people make informed choices. Efforts to prevent, reduce or delay the use of marijuana could result in a reduction of suffering and costs to the health care system. Health professionals must be involved and supported in this area, and it is important to ensure the availability of evidence informed clinical practice guidelines, practice tools and continuing medical education resources. 3) Driving Under the Influence Prevention The CMA recommends that the federal government continue to support, in collaboration with the provinces and territories and key stakeholders, strategies for the prevention of impaired driving. The CMA believes that comprehensive long-term efforts that incorporate both deterrent legislation and public awareness and education constitute the most effective approach to reducing the number of lives lost and injuries suffered in crashes involving impaired drivers due to marijuana. Efforts to prevent, reduce or delay marijuana use, especially in youth, are particularly important. Education is also important as many are not aware that marijuana affects driving ability or even that there are procedures that the police can use to identify impairment due to psychoactive substances. The CMA supports a similar multidimensional approach such as has been adopted with alcohol and driving. However, the specificities of impairment due to marijuana must be understood and investments made in research. Collaboration with key stakeholders such as schools, drivers' education and licensing bodies, as well as enforcement organizations is essential. In conclusion, the Canadian Medical Association reiterates the concern of Canada's physicians around marijuana use, particularly by young people. We are committed to working with governments and stakeholders to address this issue. a Abuse is characterized by a pattern of recurrent use where at least one of the following occurs: failure to fulfill major roles at work, school or home, use in physically hazardous situations, recurrent alcohol or drug related problems, and continued use despite social or interpersonal problems caused or intensified by alcohol or drugs. b Dependence is when at least three of the following occur in the same 12 month period: increased tolerance, withdrawal, increased consumption, unsuccessful efforts to quit, a lot of time lost recovering or using, reduced activity, and continued use despite persistent physical or psychological problems caused or intensified by alcohol or drugs. 1 Health Canada (2013) Canadian Alcohol and Drug Use Monitoring Survey (CADUMS). Retrieved from: http://www.hc-sc.gc.ca/hc-ps/drugs-drogues/stat/_2012/summary-sommaire-eng.php 2 Young, M.M. et al. (2011) Cross-Canada report on student alcohol and drug use: Technical report. Ottawa, ON: Canadian Centre on Substance Abuse. Retrieved from: http://www.ccsa.ca/Resource%20Library/2011_CCSA_Student_Alcohol_and_Drug_Use_en.pdf 3 Statistics Canada (2013) Canadian Community Health Survey - Mental Health. Retrieved from: http://www.statcan.gc.ca/daily-quotidien/130918/dq130918a-eng.htm 4 Hall, W. & Degenhardt, L. (2009) Adverse health effects of non-medical cannabis use. The Lancet, 374; October 17. Retrieved from: http://mobile.legaliser.nu/sites/default/files/files/Adverse%20health%20effects%20of%20non-medical%20cannabis%20use.pdf 5 Beirness, D.J., & Porath-Waller, A.J. (2009). Clearing the smoke on cannabis: Cannabis use and driving. Ottawa, ON: Canadian Centre on Substance Abuse. Retrieved from http://www.ccsa.ca/2009%20CCSA%20Documents/ccsa-11789-2009.pdf. Diplock, J., & Plecas, D. (2009). Clearing the smoke on cannabis: Respiratory effects of cannabis smoking. Ottawa, ON: Canadian Centre on Substance Abuse. Retrieved from http://www.ccsa.ca/2009%20CCSA%20Documents/ccsa-11797-2009.pdf. Gordon, A.J., Conley, J.W. & Gordon, J.M. (2013) Medical consequences of marijuana use: a review of the current literature. Curr Psychiatry Rep 15:419. Hall, W. & Degenhardt, L. (2009) Adverse health effects of non-medical cannabis use. The Lancet, 374; October 17. Retrieved from: http://mobile.legaliser.nu/sites/default/files/files/Adverse%20health%20effects%20of%20non-medical%20cannabis%20use.pdf Holmes, E., Vanlaar, W. & Robertson, R. (2014) The problem of youth drugged driving and approaches to prevention: a systematic literature review: Technical report. Ottawa, ON: Canadian Centre on Substance Abuse. Retrieved from: http://ccsa.ca/Resource%20Library/CCSA-Youth-Drugged-Driving-technical-report-2014-en.pdf Kalant, H., & Porath-Waller, A.J. (2012). Clearing the smoke on cannabis: Medical use of cannabis and cannabinoids. Ottawa, ON: Canadian Centre on Substance Abuse. Retrieved from http://www.ccsa.ca/2012%20CCSA%20Documents/CCSA-Medical-Use-of-Cannabis-2012-en.pdf. Porath-Waller, A.J. (2013). Clearing the smoke on cannabis: Highlights. Ottawa, ON: Canadian Centre on Substance Abuse. Retrieved from http://www.ccsa.ca/2013%20CCSA%20Documents/CCSA-Clearing-Smoke-on-Cannabis-Highlights-2013-en.pdf. Porath-Waller, A.J. (2009a). Clearing the smoke on cannabis: Chronic use and cognitive functioning and mental health. Ottawa, ON: Canadian Centre on Substance Abuse. Retrieved from http://www.ccsa.ca/2009%20CCSA%20Documents/ccsa0115422009_e.pdf. Porath-Waller, A.J. (2009b). Clearing the smoke on cannabis: Maternal cannabis use during pregnancy. Ottawa, ON: Canadian Centre on Substance Abuse. Retrieved from http://www.ccsa.ca/2009%20CCSA%20Documents/ccsa0117832009_e.pdf. 6 Young, M.M. et al. (2011) Cross-Canada report on student alcohol and drug use: Technical report. Ottawa, ON: Canadian Centre on Substance Abuse. Retrieved from: http://www.ccsa.ca/Resource%20Library/2011_CCSA_Student_Alcohol_and_Drug_Use_en.pdf 7 Cunningham, J.A., Blomqvist, J., Koski-Jannes, A., & Raitasalo, K. (2012). Societal Images of Cannabis use: Comparing Three Countries. Harm reduction journal, 9(1), 21-7517-9-21. Retrieved from: http://www.biomedcentral.com/content/pdf/1477-7517-9-21.pdf Porath-Waller, A., Brown, J., Frigon, A., & Clark, H. (2013). What Canadian youth think about cannabis: Technical report. Ottawa: Canadian Centre on Substance Abuse. Retrieved from: http://www.ccsa.ca/Resource%20Library/CCSA-What-Canadian-Youth-Think-about-Cannabis-2013-en.pdf Racine, S., Flight, J., & Sawka, E. (Eds.). (2006). Canadian Addiction Survey (CAS): A national survey of Canadians' use of alcohol and other drugs: Public opinion, attitudes and knowledge. Ottawa: Canadian Centre on Substance Abuse. Retrieved from: http://publications.gc.ca/site/eng/349980/publication.html

Less detail

Policy Type

Parliamentary submission

Date

2014-06-02

Topics

Population health/ health equity/ public health

Health systems, system funding and performance

Text

The Canadian Medical Association is pleased to present this submission to the House of Commons Standing Committee on Health regarding Bill C-422, National Lyme disease strategy. The Canadian Medical Association (CMA) is the national organization representing over 80,000 physicians in Canada; its mission is to serve and unite the physicians of Canada and to be the national advocate, in partnership with the people of Canada, for the highest standards of health and health care. Lyme disease is a growing problem in Canada. According to the Public Health Agency of Canada (PHAC) there were 315 cases of Lyme disease reported in Canada in 2012 -two and one-half times more cases than the 128 reported in 2009, the year that it became a reportable disease. In the Ottawa area, cases have increased almost 8 fold from 6 in 2009 to 47 in 2013. The PHAC surveillance indicates that established populations of blacklegged ticks are spreading their geographic scope, and are increasing in number, in much of southern Canada. In 2013 the US Center for Disease Control and Prevention released new estimates of Lyme disease that was 10 times higher than the previous yearly reported number of 30,000 reported cases.1 This highlights the difficulty in establishing the true burden of illness from Lyme disease. Why this matters to Canada's physicians The Canadian Medical Association supports the implementation of a national strategy that can address the breath of public health and medical issues surrounding the spread of Lyme disease in Canada. As with any new infectious disease threat, Canada needs to ensure that we are prepared to address the impact of Lyme disease on Canadians. CMA's policy on climate change and human health notes that changes in the range of some infectious disease vectors such as blacklegged ticks, are a possible consequence of climate change in Canada. Research has suggested that the tick vector of Lyme disease has been expanding into southeastern Canada which can lead to increased disease risk for those living in areas with tick populations.2 In this policy, CMA recommends that the federal government report diseases that emerge in relation to global climate change, and participate in field investigations, as with outbreaks of infectious diseases like Lyme disease, and develop and expand surveillance systems to include diseases caused by global climate change. The World Medical Association Declaration of Delhi on Health and Climate Change urges colleges and universities to develop locally appropriate continuing medical and public health education on the clinical signs, diagnosis and treatment of new diseases that are introduced into communities as a result of climate change. Diagnosis of Lyme disease can be difficult, as signs and symptoms can be non-specific and found in other conditions. 3 If Lyme disease is not recognized during the early stages, patients may suffer seriously debilitating disease, which may be more difficult to treat.4 Given the increasing incidence of Lyme disease in Canada, continuing education for health care and public health professionals and a national standard of care would improve identification, treatment and management of Lyme disease. Greater awareness of where blacklegged ticks are endemic in Canada, as well as information on the disease and prevention measures, can help Canadians protect themselves from infection. Recommendation The CMA supports a national Lyme disease strategy which includes the federal, provincial and territorial governments and the medical and patient communities. This strategy must address concerns around research, surveillance, diagnosis, treatment and management of the disease and public health prevention measures will advance our current knowledge base, and improve the care and treatment of those suffering from Lyme disease. Conclusion Once again, CMA is pleased to provide this brief to the Standing Committee on Health as part of its study on this important issue. Canada's physicians recognize the importance of monitoring all emerging infectious diseases in Canada. In addition, Canada's physicians recognize the importance of developing strategies to treat, manage, and prevent Lyme disease in Canada. 1 CDC provides estimate of Americans diagnosed with Lyme disease each year, media release August 19, 2013 Accessed at http://www.cdc.gov/media/releases/2013/p0819-lyme-disease.html on Feb 21, 2014. 2 Ogden, N., L. Lindsay, and P. Leighton. 2013. Predicting the rate of invasion of the agent of Lyme disease Borrelia burgdorferi. Journal of Applied Ecology. April, 2013. 50(2):510-518. 3 Mayo Clinic, accessed at http://www.mayoclinic.org/diseases-conditions/lyme-disease/basics/tests-diagnosis/con-20019701 on Feb 21, 2014. 4 Wormser GP, Dattwyler RJ, Shapiro ED, et al. The clinical assessment, treatment, and prevention of Lyme disease, human granulocytic anaplasmosis, and babesiosis: clinical practice guidelines by the Infectious Diseases Society of America. Clin Infect Dis 2006;43: 1089-134.

Less detail

Policy Type

Parliamentary submission

Date

2014-06-09

Topics

Health information and e-health

Ethics and medical professionalism

Text

The Canadian Medical Association (CMA) is pleased to make submissions on Bill S-4. CMA has followed the history of PIPEDA and participated in the studies of various Standing Committees, most notably and recently in 2007 to the House of Commons Standing Committee on Access to Information, Privacy and Ethics. CMA is pleased that amendments to PIPEDA are once again being considered. The Canadian Medical Association represents over 80,000 physicians in Canada. Privacy is an important value to physicians and the patients to whom they serve. This is reflected in our Code of Ethics and policies, in particular, Principles for the Protection of Patients' Personal Health Information and Statement of Principles: The Sale and Use of Data on Individual Physicians' Prescribing. Physicians are also required to abide by privacy and confidentiality standards of practice. Thus, the CMA has a strong interest and valuable insights into the topic of personal information and privacy with respect to health information. We thank the Standing Committee for the opportunity to comment on the proposed amendments to PIPEDA. Our key comments are outlined below: Issue 1: CMA supports the existing legislative framework on the collection, use and disclosure of personal information produced by an individual in the course of their employment, business or profession ("work product") and suggests further amendments focus on strengthening it further. CMA supports the current standing of work products, that work products are considered to be personal information. That is, we support the framework defining personal information as information about an identifiable individual and that there is no carved out definition or exemption for "work product". CMA supports the position of the Office of Privacy Commissioner's following its 2007 investigation on work products, that they should not be exempted for two main reasons: * The exemption is not needed, and it would be inconsistent with the balanced approach in the current definition of personal information. The current definition of personal information and the approach to deciding issues based on that definition have worked well. They have promoted a level of privacy protection that balances the right of privacy in personal information with the needs of organizations for the reasonable and appropriate collection, use and disclosure of personal information. ...Because the concept of "work product" is ambiguous, excluding it from the definition of personal information could have unpredictable consequences that would diminish privacy unnecessarily. * (http://www.priv.gc.ca/parl/2007/sub_070222_03_e.asp) It is the CMA's position that work products should be considered personal information and given the section 7 amendments, work products should only be collected, used or disclosed without consent only if it is consistent with the purposes for which the information was produced. In the case of physicians, a prime example of a physician's work product is prescribing information. Prescribing information is a synthesis of assessing patients - by probing into their health, familial, social and sometimes financial background - infused with medical knowledge, skill and competencies resulting in a diagnosis and treatment plan, which often includes prescribing a medication or test. Not only is the physician's prescribing information a product of physicians' work but would not exist but for a trusting physician-patient relationship wherein the patient's private and personal information are shared under circumstances of vulnerability and trust. The outcome is that this is personal information. Prescribing information is about an individual: it includes the name of the patient, the name of the prescribing physician, and the drug name, dosage, amount and frequency; giving major clues as to what the patient's health issue(s) are. For further clarity, however, CMA recommends that physician information, and physician work products, should be specifically recognized within the legislation as personal information. To this end, we would propose that the following addition be made to the definition section under personal health information: Section 2.(1) "personal health information", with respect to an individual, whether living or deceased, means .....(d) information that is collected or is the outcome of collecting information in the course of providing health services to the individual; CMA supports the amendments to subsections 7(1)-(3) of the Act that any subsequent collection, use and disclosure of work products without consent must be related to the original purpose (of collection, use and disclosure). This relationship reflects the government's understanding and faithfulness to privacy principles. This is particularly critical when dealing with health information, and is even more critical in today's world given the ease of linking information through advancements in technology. In the absence of a causal relationship, personal information should not be used for system performance, commercial enterprise, data brokering, research, assessment or other purposes. CMA recommends that the legislation should go further and allow persons who believe that protection cannot be afforded under the legislation that they have the authority to refuse to communicate the information. This is the conceptual approach taken in Quebec's Act Respecting the Protection of Personal Information in the Private Sector wherein persons have an opportunity to refuse that professional information (as defined therein) be used for commercial purposes. Physicians are constantly writing prescriptions and such information should only be used for other purposes in the interests of patients and the health care system, and not to serve commercial interests or marketing strategies. If physicians do not feel that such protection is afforded patients, then they should be permitted to refuse that such information be collected, used or disclosed. Patient privacy should be primary. And finally, addressing work products in legislation clears up past differences of interpretation by Privacy Commissioners thus, providing certainty and clarity to the public. Recommendation 1: That Section 2. (1) "personal health information", be amended to read as follows: "personal health information", with respect to an individual, whether living or deceased, means .....(d) information that is collected or is the outcome of collecting information in the course of providing health services to the individual; Issue 2: CMA is pleased to see a section on breaches of security safeguards and recommends greater specificity. As noted above, physicians have responsibilities as data stewards and custodians of health information. As such, CMA supports breach notification measures that would enhance and protect patient privacy. In principle, we support the proposed amendments of breach disclosures to the Privacy Commissioner, to individuals and to organizations. However, CMA is concerned that meeting the requirements may be confusing. For example, in the health care context, it is easy to surmise that all health information is "sensitive". A far more difficult matter is determining whether the risk reaches the threshold of "significant harm" and the "probability" that the information "will be misused". The result being that incidental disclosures will be reported causing unnecessary concern and confusion in the patient population. Further specificity is recommended and we suggest something akin to Ontario's Personal Health Information Protection Act, 2004 (PHIPA). The PHIPA is an act specifically dealing with personal health information. One of its purposes is "to establish rules for the collection, use and disclosure of personal health information about individuals that protect the confidentiality of that information and the privacy of individuals with respect to that information, while facilitating the effective provision of health care" (section 1a ). The PHIPA notification provision states that the individual shall be notified "...at the first reasonable opportunity if the information is stolen, lost or accessed by unauthorized persons", [section 12(2)]. CMA is unaware of any concerns with this approach. The language of PIPIEDA is one of reasonable belief of real risk of significant harm to an individual. The issue is the test for required notification of patients for incidental inadvertent breaches and decreasing "notification fatigue". To illustrate the issue, if physicians were told today that patient data could be retrieved from the drums of discarded photocopiers and printers, it would be inappropriate for legislation to suggest that the entire patient population during the life of the photocopier or printer be notified. To this end, we recommend that there be acknowledgement that in some circumstances notification may not be required. The probability of misuse under PIPEDA is more ambiguous than the PHIPA test. Under PHIPA, the approach is more objective in that the data must be stolen, lost or accessed by unauthorized persons. To our knowledge, the Ontario model has been in place for almost a decade with no significant issues and thus we submit is one that works. In other jurisdictions (eg., Newfoundland and Labrador, Nova Scotia, New Brunswick) with health privacy legislation, there is acknowledgement of trying to balance notification and those breaches unlikely to result in harm by directly indicating when notification is not required. Recommendation 2: CMA recommends that the statute move towards a more objective test and acknowledge that there are situations when notice is not required. Issue 3: CMA supports disclosure without consent under limited circumstances, but finds the current list of disclosures overly inclusive. Health information is considered highly sensitive information and is initially collected for the purpose of individual patient health care. It should only be disclosed with consent and in only some exceptions without consent. The PIPEDA amendments for disclosure without consent have been broadened. Privacy, confidentiality and trust are the foundations of the patient-physician relationship. Without these fundamental values in play, open and honest communications cannot occur and patients would not receive the care they require. Both the patient and the physician have significant investment in the relationship. CMA respects the requirements to disclose information without consent under certain premises, such as required by court order or statute. However, any kind of activity requiring physicians to disclose patient's information without consent for the purposes of advancing a government or institution's goal could jeopardize the relationship. Both the patient's consent and the physician's consent should be required if there is potential to disturb this relationship. The physician is fiduciary of the relationship and is appropriately situated to assess and determine whether disclosure will disturb the relationship. While CMA acknowledges that certain situations may require that disclosure occur without consent (eg. purposes of investigating fraud, national security, abuse or as legally required), disclosure for less malicious activities (e.g., breaches of an agreement, insurance claims) ought to require a court order or warrant. For example, under the proposed section 7(3)(d.1) if a physician were in default of a contract with a technology company supplying electronic medical record software or app to his/her clinic, the company could disclose health information without consent for the "purposes of investigating a breach of an agreement". While we appreciate that there is a caveat that disclosure without advising the patient can only occur if there is a reasonable expectation that the disclosure would compromise the investigation, we submit that leaving the determination of what is "reasonable" to an interested party to the breach is unfair to all. Another example, if a physician is a witness to a dispute between an employer and union representing an employee for denial of long term disability by an insurance company, and has filed a witness statement which includes a medical report he/she wrote to the employer's insurance company, under the proposed section 7(3)(e.1) disclosure of health information without consent is permitted in order to assess, process or settle an insurance claim. CMA is concerned that the disclosure amendments are overly broad and do not differentiate sufficiently between highly time sensitive or grossly malicious situations, and those where it is merely expedient or an administrative encumbrance to seek consent. In addition, the disclosure requirements are framed in permissive (ie., may) and not mandatory language (ie., shall). This is very problematic when the "organization" is a physicians' clinic unless the physician's own consent is made as a pre-condition. CMA believes this suggestion is a progressive one in keeping with the broadened disclosure amendments. Physicians are in a relationship of trust and take seriously the protection of patient privacy and confidentiality, for which they are trained and are ethically and legally required to protect. To place physicians in a position which might entail breaching this trust may impact the confidence of the physician and the patient in the patient-physician relationship which is required to properly formulate appropriate treatment plans; thus, negatively impacting the health of Canadians. Recommendation 3: That disclosures of health information without consent require a warrant or subpoena or court order. Furthermore, disclosures of health information require the physician's consent that in his/her opinion the disclosure does not harm the patient-physician relationship. And, finally any broadened disclosure situations be restricted to criminal activity or that impacting national security. Conclusion Once again, CMA appreciates the opportunity to provide comment as part of the committee's study of Bill S-4. CMA is prepared to work with Parliament, governments, health professionals and the public in ensuring legislative frameworks for the collection, usage and disclosure of personal information for legitimate and reasonable purposes.

Less detail

Policy Type

Parliamentary submission

Date

2014-06-11

Topics

Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs

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The Canadian Medical Association (CMA) is pleased to present this brief to the House of Commons Standing Committee on Health for consideration as part of its study of Bill C-17, Protecting Canadians from Unsafe Drugs Act, which proposes amendments to the Food and Drugs Act. The CMA has over 80,000 physician-members. Its mission is to serve and unite the physicians of Canada and to be the national advocate, in partnership with the people of Canada, for the highest standards of health and health care. Prescription medication has a very important role as part of a high-quality, patient-centred and cost-effective health care system. Prescription medication can prevent serious disease, reduce the need for hospital stays, replace surgical treatment and improve a patient's capacity to function productively in the community. As such, the CMA has developed a substantial body of policy on pharmaceutical issues, including on the post-approval surveillance of prescription medication. Over the last several years, the CMA has prepared several briefs and reports on pharmaceutical medication and prescribing-related issues.1 It is a priority to physicians that all Canadians have access to medically-necessary drugs that are safe, effective, affordable, appropriately prescribed and administered, as part of a comprehensive, patient-centered health care and treatment plan. The CMA supports a robust legislative framework and unbiased, evidence-based system for the oversight of pharmaceutical products. As outlined below, the CMA has identified opportunities to strengthen elements of Bill C-17 toward this end. 1) Clarify ministerial authority and responsibility The current legislative limit to the health minister's authorities is troubling. The CMA, along with many other stakeholders, has long called for an expansion of ministerial authorities related to the pharmaceutical legislative framework, including both pre- and post-approval, in support of patient safety. The CMA supports the underlying intent to expand the authority of the health minister to require the submission of information, modify the label or replace the package, to order a recall or relocation of a product. However, the CMA has two concerns regarding the limitations to this expanded authority (section 3, proposed new FDA sections 21.1, 21.2 and 21.3): * Firstly, that the threshold for the new authorities in section 3 (new proposed section 21.1, 21.2, and 21.3 of the FDA) may be too high. The term "serious risk of injury to health" will be the standard for these new ministerial powers and may limit the authority of the minister to take action when the concern may be serious, but not necessarily permanently debilitating or life threatening. * Secondly, that the minister is not required to take any of the actions proposed in Bill C-17 even if the threshold is met (these sections specify that the minister "may" take the specified action, rather than the minister "shall"). While seemingly minor, the difference between "may" and "shall" is the difference between having the authority to take action and being responsible to take this action. This difference is critical to a robust legislative framework for patient safety. Recommendation 1 In order to clarify the health minister's authority to take appropriate measures to protect patient safety, the CMA recommends that the standard "a serious risk of injury to human health" in section 3 proposed new FDA section 21.1 and "serious or imminent risk of injury to health" in section 3 proposed new FDA section 21.3 be amended to ensure an appropriate threshold that does not constrain ministerial authority. Recommendation 2: To ensure that the health minister has the clear responsibility to take appropriate measures to protect patient safety, the CMA recommends that the word "may" is replaced with "shall" in section 3, proposed new FDA sections 21.1, 21.2 and 21.3. 2) Oversight of natural health products The extensive use of natural health products, such as vitamins and herbal medicines, is partially due to a belief that such products are "natural" and thus low risk. Increasingly, it has become clear that these products can have adverse effects, including drug interactions. However, relatively little is known about the adverse effects associated with natural health products due to its limited legislative and regulatory requirements, including reporting. To ensure that patient safety risks associated with natural health products are addressed, these products should be included in the new patient safety legislation, as proposed in the previous iteration of this legislation in 2008, Bill C-51 An act respecting foods, therapeutic products and cosmetics. The CMA encourages the Health Committee to include natural health products within the scope of Bill C-17, as a first step toward ensuring that natural health products are subject to the same regulatory requirements and oversight as are prescription and over-the-counter pharmaceuticals in order to promote patient safety. Recommendation 3: The ministerial authorities and measures proposed in Bill C-17 should be extended to include natural health products and, as such, CMA recommends that the definition of "therapeutic product" in section 2(3), be amended to include natural health products. 3) Comprehensive post-market surveillance and response system The CMA has advocated for significant improvements to Health Canada's post-market surveillance and response system in light of significant shortcomings. A) Increasing accountability and public transparency Robust accountability and transparency are important elements in the legislative framework governing the post-market surveillance and response system. The 2011 report of the Office of the Auditor General of Canada (OAG) highlighted significant concerns regarding this system, not least of which being Health Canada's failure to meet its own benchmarks in reviewing and responding to pharmaceutical safety issues. While there was no assessment of the benchmarks themselves, as is typical with an audit, the OAG report highlighted a number of issues with Health Canada's approach to measuring its performance against its benchmarks. Following the publication of the OAG audit report, Health Canada's 2013-14 Main Estimates and Report of Plans and Priorities2 shows cuts in both budget and staff allocation for health products (which includes drug oversight). The 2011 OAG report states that "Canada's small population reduces the likelihood of serious, rare adverse drug reactions being identified in this country; therefore, the capacity to search and analyze foreign reports electronically would contribute to more comprehensive safety monitoring."3 Of note, the audit found that Health Canada "does not take timely action in its regulatory activities" (...). "In particular, the Department is slow to assess potential safety issues. It can take more than two years to complete an assessment of potential safety issues and to provide Canadians with new safety information."4 Despite Health Canada's March 2013 update on its efforts to address the OAG recommendations5 the status of the improvements to the reporting tools, timeliness of information or quality of information provided to practitioners and patients remains unclear. The preceding paragraphs capture a number of issues pertaining to the post-approval surveillance and response system; it is imperative that Health Canada not only address these issues, but that Health Canada has adequate resources to do so. This is paramount prior to any consideration of expanding the input of reporting data. Recommendation 4: The CMA recommends that Bill C-17 be amended to require Health Canada undertake public consultations in establishing its performance benchmarks related to adverse drug reaction reporting, analysis and response communication. Recommendation 5: The CMA recommends that Bill C-17 be amended to establish a new public reporting requirement of its performance in meeting its performance benchmarks. B) Improving the reporting and communication system The CMA cautions against the advancement of new legislative authority with respect to mandatory reporting of serious adverse drug reactions prior to the improvement of the system and model currently in place. Information gathering does not in itself constitute post-market surveillance. In our opinion, the most important element of the process is the monitoring and analysis that occurs once an adverse drug reaction report has been received. Monitoring capacity requires rigorous data analysis and, to be useful in preventing further adverse events, it must be timely. As well, it should also provide information about a drug's efficacy and effectiveness. When new information is uncovered about a prescription drug, it is important that health professionals are made aware of it as quickly and efficiently as possible. Therefore, post-approval surveillance requires a system for communicating timely, reliable and objective information in a manner that allows them to incorporate it into their everyday practice. Ideally, this communication would report not the safety problem alone but also its implications for their patients and practice: for example, whether some patients are particularly at risk, or whether therapeutic alternatives are available. Such feedback will encourage further reporting. In order to improve patient safety, the CMA recommends that Health Canada's establish a model that includes: * Making it easier for physicians and other health professionals to report adverse drug reactions by making the reporting system user-friendly and easy to incorporate into a practitioner's busy schedule. Currently the existing system imposes an unnecessary administrative burden that comes at the expense of time dedicated to patient care. * Making the reporting process even more efficient by incorporating it directly into the Electronic Health Record systems. Health Canada has improved the process by introducing online reporting, which may have contributed to the significant increase in the number of reports over the past 10 years, but being able to connect patient information with drugs they are taking, reporting of adverse drug reactions and safety information would improve care on the front line. * Augmenting spontaneous reports with information gathered through other, more systematic means. These could include formal post-market studies of specific drugs, or recruitment of "sentinel" groups of health care providers who would contract to report adverse drug reactions in detail, and who would be committed to assiduous reporting. * Linking to international post-approval surveillance systems, thus increasing the body of data at researchers' disposal, as well as the capacity for meaningful analysis. Health Canada should take a leadership role in ensuring that the public has access to appropriate information on drugs and drug safety, engaging civil society at the appropriate phases of the process. In providing this information, Health Canada should consider the management and communication of risk, and take into account the diversity of Canada's population. Access to accurate, unbiased information allows people to make decisions regarding their own health. In addition to ensuring a comprehensive model is in place, it is essential that there be more clarity in Bill C-17 regarding what constitutes a "prescribed health care institution". There are very different changes to the system that would need to be in place should it refer to tertiary care hospitals, community hospitals, clinics or doctors in family practice. Bill C-17 must not place an unnecessary administrative burden, which would ultimately fall on health professionals. Further, it is unclear whether a cost assessment of the proposed new requirements for health care institutions with respect to provincial/territorial resources has been undertaken. Only those health care institutions that are best positioned to improve the quantity and quality of reporting should be required to report. Another term that requires clarification in the legislation is "serious adverse drug reaction". It should be clear whether it means adverse drug reactions that require visits to emergency departments or hospitalization, or whether there are other criteria to define it. Recommendation 6: The CMA recommends that Bill C-17 be amended to require that Health Canada implement comprehensive post-surveillance monitoring and reporting model that includes: * Accessible, comprehensive and user-friendly reporting tools that are clinically relevant and linked to electronic health records; * Rigorous and timely analysis of reports for the early identification and response to emerging drug safety threats; and * Communication of timely, user-friendly and clinically-relevant information to health care practitioners and the public. Recommendation 7: The CMA recommends amendment of Bill C-17 section 5, proposed new FDA section 21.8, to require that an assessment by the minister for reporting regulations be undertaken following a prescribed period after this new model is established; that this assessment precede the coming into force of expanded mandatory reporting. Recommendation 8: The CMA recommends that essential terminology be defined in Bill C-17, including (a) "serious adverse drug reaction" and (b) "health care institution". Canada's physicians are prepared to work with governments, health professionals and the public in strengthening Canada's post-approval surveillance system, to ensure that the prescription drugs Canadians receive are safe and effective. 1 Canadian Medical Association (2005) Building a Comprehensive Post-Market Surveillance System. CMA's Response to Health Canada's Discussion Paper 'Designing a Mandatory System for Reporting Serious Adverse Reactions'. CMA. Retrieved from: http://www.cma.ca/multimedia/CMA/Content_Images/Inside_cma/Submissions/2005/English/Mandatory_Response.pdf Canadian Medical Association (2014) Federal levers to address unintended consequences of prescription pharmaceuticals and support public health, quality care, and patient safety. CMA Submission to the Senate Committee on Social Affairs, Science and Technology. CMA. Retrieved from: http://www.cma.ca/multimedia/CMA/Content_Images/Inside_cma/Submissions/2014/SOCI_BriefEnglish-Final.pdf Canadian Medical Association (2008) Post-Market Surveillance of Pharmaceutical Products. CMA Submission to the House of Commons Standing Committee on Health. CMA. Retrieved from: https://www.cma.ca/multimedia/CMA/Content_Images/Inside_cma/Submissions/2008/brief-drug-en-08.pdf Canadian Medical Association (2012) Prescription Drugs: Clinical Trials and Approval. CMA Presentation to the Senate Standing Committee on Social Affairs, Science and Technology. CMA. Retrieved from: https://www.cma.ca/multimedia/CMA/Content_Images/Inside_cma/Submissions/2012/Senate-ClinicalTrials_en.pdf Canadian Medical Association (2012) Prescription Pharmaceuticals in Canada: The Post-Approval Monitoring of Prescription Pharmaceuticals. CMA Submission to the Senate Committee on Social Affairs, Science and Technology. CMA. Retrieved from: http://www.cma.ca/multimedia/CMA/Content_Images/Inside_cma/Submissions/2012/Senate-Pharmaceuticals-Oct2012_en.pdf Canadian Medical Association (2014) Review of Controlled Drugs and Substances Act. Submission to Health Canada in response to the consultation on the Controlled Drugs and Substances Act and its regulations. CMA. Retrieved from: http://www.cma.ca/multimedia/CMA/Content_Images/Inside_cma/Submissions/2014/CMA_SubmissiontoHealthCanada-CDSA_Modernization.pdf Canadian Medical Association (2013) The need for a national strategy to address abuse and misuse of prescription drugs in Canada. CMA Submission to the House of Commons Standing Committee on Health. CMA. Retrieved from: http://www.cma.ca/multimedia/CMA/Content_Images/Inside_cma/Submissions/2013/Prescription-Drug-Abuse_en.pdf 2 Health Canada (2013) 2013-14 Report on Plans and Priorities. Government of Canada. http://www.hc-sc.gc.ca/ahc-asc/alt_formats/pdf/performance/estim-previs/plans-prior/2013-2014/report-rapport-eng.pdf (pg 30) 3 Office of the Auditor General of Canada (2011) Chapter 4 Regulating Pharmaceutical Drugs - Health Canada. 2011 Fall Report of the Auditor General of Canada. Government of Canada. Retrieved from: http://www.oag-bvg.gc.ca/internet/docs/parl_oag_201111_04_e.pdf (pg 21) 4 Office of the Auditor General of Canada (2011) Chapter 4 Regulating Pharmaceutical Drugs - Health Canada. 2011 Fall Report of the Auditor General of Canada. Government of Canada. Retrieved from: http://www.oag-bvg.gc.ca/internet/docs/parl_oag_201111_04_e.pdf (pg 2) 5 Health Canada (2013) Update and response to OAG recommendations for the regulation of pharmaceutical drugs in Fall 2011. Government of Canada. Retrieved from: http://www.hc-sc.gc.ca/ahc-asc/pubs/hpfb-dgpsa/oag-bvg-eng.php

Less detail

Policy Type

Response to consultation

Date

2014-06-23

Topics

Physician practice/ compensation/ forms

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The Canadian Medical Association (CMA) is pleased to provide the comments below in response to Finance Canada's consultation document Pension Innovation for Canadians: The Target Benefit Plan. The CMA is the professional voluntary association representing over 80,000 physicians across Canada. Its mission is to serve and unite the physicians of Canada and to be the national advocate, in partnership with the people of Canada, for the highest standards of health and health care. The CMA has participated in, and made recommendations to, Finance Canada over the course of the government's multi-year consultation process on Canada's pension framework. Indeed, in light of the importance of the pension framework to our membership, the CMA has been an active participant in previous consultations regarding the pension framework. The CMA's participation in the current, multi-year initiative included responding to the 2010 consultative paper Ensuring the Ongoing Strength of Canada's Retirement Income System as well as participating in the legislative and regulatory consultation on the Pooled Registered Pension Plan (PRPP) framework. While the CMA recognizes that this consultation is focused narrowly on the federally regulated pension plans governed by the Pension Benefits Standards Act 1985, the CMA supports additional consultation on Canada's pension framework. The CMA recommends that Finance Canada expand its consultation to explore options to address weaknesses in Canada's pension framework, including a focus on the third pillar: tax-incentivized savings vehicles. As part of a consultation on the third pillar, the CMA recommends that Finance Canada explore three issues, as elaborated further below: * Increasing the combined contribution limit for registered retirement savings plans (RRSPs); * Enabling well-governed professional organizations that represent a particular membership as pension plan sponsors; and, * Possible impacts of registered retirement income funds (RRIF) mandatory drawdown rates. Like the Canadian population at large, physicians represent an aging demographic - 42% of Canada's physicians are 55 or older - for whom retirement planning is an important concern. In addition, the vast majority of CMA members are self-employed physicians and, as such, they are unable to participate in workplace registered pension plans (RPPs). This makes physicians more reliant on Registered Retirement Savings Plans (RRSPs) relative to other retirement savings vehicles. The Summary Report on Retirement Income Adequacy Research presented to the F/P/T Ministers of Finance in 2009, suggests that higher-earning Canadians may not be saving enough for retirement. This report highlighted that income replacement rates in retirement fall below 60 per cent of after-tax income for about 35 per cent of Canadians in the upper income quintile. This is related to the effect of maximum contribution limits on tax-incentivized retirement savings vehicles. Tax-incentivized private saving vehicles are a critical element of Canada's pension framework. As highlighted in the 2010 interim report of the Senate Banking Trade and Commerce Canadians Savings for Their Future: A Secure Retirement, the introduction of the RRSP framework in 1957 sought to address a tax inequity due to the ineligibility of private savings for tax-incentive in comparison with registered pension plans. From 1972 to 1991 the RRSP contribution limit was set at 20 percent of earned income and in 1991, the government reduced the contribution limit to 18 percent of earned income; further, over this time period the real value of the absolute dollar limit reduced significantly. Recent increases to the absolute dollar limits have been strongly welcomed. To ensure that contribution limits do not pose a barrier to saving for future retirement income needs, the CMA recommends that Finance Canada initiate a consultation on future increases to the RRSP contribution limit, both absolute and percent of earned income. As part of the 2010 Finance Canada consultation and as reiterated during the legislative and regulatory consultation period on the PRPP framework, the CMA highlighted its support for exploring measures to enable organizations to sponsor plans on behalf of the self-employed. During the PRPP consultation, the CMA recommended amending the legislation such that well-governed professional organizations representing a particular membership are able to sponsor and administer PRPPs for their own members, including self-employed members. Once again, the CMA supports an extension of this recommendation to the broader pension framework. Finally, the CMA has taken note of the concerns regarding the registered retirement income funds (RRIF) mandatory drawdown rates expressed in the C.D. Howe Institute's recent pension policy e-brief Outliving our savings: Registered retirement income funds rules need a big update. The CMA recommends that Finance Canada include RRIF mandatory drawdown rates as part of a consultation. The CMA appreciates the opportunity to provide comment as part of Finance Canada's consultation on enabling target benefit plans within the federally regulated pension framework. The CMA supports further consultation on Canada's pension plan with an aim to ensure optimization of the third pillar, tax-incentivized savings vehicles, to ensure it enables adequate savings levels by self-employed individuals for their future retirement income needs.

Less detail

Policy Type

Response to consultation

Date

2014-07-11

Topics

Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs

Text

The Canadian Medical Association (CMA) is pleased to provide this brief in response to Health Canada's consultation on the proposed regulatory amendments to the Narcotic Control Regulations and the Marihuana for Medical Purposes Regulations of the Controlled Drugs and Substances Act, published in the Canada Gazette Part I, on June 14, 2014. The CMA has already made its position on the Marihuana for Medical Purposes Regulations known to Health Canada (see Appendix A). While recognizing the needs of those suffering from terminal illness or chronic disease, and for whom marijuana may provide relief, the CMA has raised significant concerns and objections to the regulatory framework since it was first proposed in 2001. Put simply, the CMA has significant and grave concerns with the regulatory framework governing medical marijuana. Of particular concern to physicians is the scarcity of evidence- based information about the use of marijuana as medical therapy, including on dosage, risks and benefits, and contraindications. While several amendments to the regulatory framework have been promulgated since its initial establishment, the CMA's primary concerns have yet to be addressed. In brief, as the CMA's position on the regulatory framework is detailed in Appendix A, the CMA opposes the approach placing physicians in the role of gatekeepers for a product whose medical benefits have not been sufficiently researched. The CMA continues to recommend that marijuana for medical purposes be held to the same standards as prescription pharmaceutics, including the clinical trial process required for therapeutic products under the Food and Drugs Act and be subject to the same safety and efficacy standards as pharmaceuticals if used for medical purposes. There remain fundamental concerns about quality, safety and efficacy of marijuana used for medical purposes, and the Canadian Medical Protective Association has advised physicians who are uncomfortable with the regulations to refrain from authorizing marijuana to their patients due to potential liability. The CMA advocates for education and licensing programs, clinical guidance and practice supports for health care practitioners who decide to authorize the use of marijuana for patients. The CMA recommends that Health Canada further revise the proposed amendments to the Marihuana for Medical Purposes Regulations to: 1) Enable consistent and best practice oversight In the CMA's submission to Health Canada as part of its review of the Controlled Drugs and Substances Act, as well as in parliamentary briefs on the prescription pharmaceutical regulatory framework, the CMA has recommended high regulatory standards for prescription medication; and even more stringent requirements for controlled substances, both during the approval and the post-approval phases. These recommendations are driven by the potential for harm to patients and the possibility for misuse or abuse of medications, particularly opioids and other such substances. For these reasons, the CMA advocates for an inter-operable, pan-Canadian system of real-time prescription monitoring and surveillance for controlled substances. Robust monitoring and surveillance programs facilitate professional regulatory bodies' oversight and intervention, by enabling the identification of prescribing outliers which include fraudulent attempts to access controlled medications. Prescription monitoring programs also gather information to improve the understanding of prescription drug abuse and to support the development and adoption of best practices. In order to be streamlined and optimized, such a system should be compatible with existing electronic medical and pharmacy record systems and with provincial pharmaceutical databases, and accessible as a point-of-care tool for health care practitioners. Currently, marijuana for medical purposes is exempt from the regulatory requirements of the Food and Drugs Regulations that apply to prescription pharmaceuticals in Canada. Under the Marihuana for Medical Purposes Regulations there is no system in place to monitor the authorization of marijuana for medical purposes. It is in this context that CMA supports the underlying principle of the proposed amendment to the Marihuana for Medical Purposes Regulations which requires licensed producers to provide information to the provincial professional licensing authorities for health practitioners regarding authorizations for marijuana for medical purposes in response to a request by the licensing authority. However, aligned with the CMA's support of a pan-Canadian prescription monitoring system, the CMA recommends that the provision of relevant information to licensing authorities should be part of required regular reporting procedures for the licensed producers, consistent with the prescription monitoring program requirements of the respective provincial and territorial jurisdictions. Finally, the CMA recommends that Health Canada support the integration marijuana for medical purposes within provincial/territorial prescription monitoring programs, including facilitating the availability of a point-of-care access tool for health care practitioners. 2) Safeguard protection of privacy As articulated in the CMA's Code of Ethics, physicians consider protecting the privacy of patient information to be paramount, and as such, the CMA has developed policy guidance concerning patient as well as physician information. The CMA's Principles for the Protection of Patients' Personal Health Information (see Appendix B) emphasizes that privacy, confidentiality and trust are cornerstones of the patient-physician relationship. Recognizing that health information is highly sensitive, this policy statement articulates foundational privacy principles that must be adhered to with respect to patient information. In addition to the provision of patient information, authorizations include physician information. The CMA's Principles Concerning Physician Information (see Appendix C) specify 11 conditions that must be met including with respect to the collection, use, access, storage and disclosure of physician information. The CMA recommends that the proposed amendments to the Marihuana for Medical Purposes Regulations be reviewed and revised as necessary to ensure it meets the standards of the CMA's Principles for the Protection of Patients' Personal Health Information and the CMA's Principles Concerning Physician Information. The CMA is concerned with the fact that licensed producers, not Health Canada, are the custodians of patient and licensed health practitioner information, in that they collect, use, have access to or disclose this information. For example, security safeguards, written privacy policies and designated accountable privacy officers, must be in place to protect personal health information and licensed practitioner identification in order to ensure that only authorized collection, use and disclosure or access occurs. The text of the proposed amendment addresses "secure transmission" of data, but it must also address secure storage. Safeguards must ensure that there is the same rigour as required for pharmacies as custodians of sensitive private information. The proposed period of record retention of two years should be reviewed in consultation with the professional licensing bodies, to ensure it is sufficient or if it should be extended. In recognition of the importance of health information privacy, including privacy of patient and physician information, the CMA strongly reiterates its recommendation that Health Canada undertake a privacy impact assessment of the proposed amendment. It is of the utmost importance that the proposed amendments to the Marihuana for Medical Purposes Regulations must conform to privacy laws, and protect patient confidentiality while enabling oversight by licensing authorities. The CMA recommends Health Canada to engage stakeholders as part of its consultation process as part of this privacy assessment. 3) Clarify and enforce consumer advertising requirements Regarding direct-to-consumer advertising, while marijuana for medical purposes is exempt from the Food and Drug Regulations, it is subject to requirements specified in the Narcotic Control Regulations and the Food and Drug Act. The CMA is concerned that licensed producers are circumventing existing direct-to-consumer advertising legislative and regulatory standards. Marijuana for medical purposes is subject to the following sections of the Food and Drugs Act: 3. (1) No person shall advertise any food, drug, cosmetic or device to the general public as a treatment, preventative or cure for any of the diseases, disorders or abnormal physical states referred to in Schedule A. 9. (1) No person shall label, package, treat, process, sell or advertise any drug in a manner that is false, misleading or deceptive or is likely to create an erroneous impression regarding its character, value, quantity, composition, merit or safety. (2) A drug that is not labelled or packaged as required by, or is labelled or packaged contrary to, the regulations shall be deemed to be labelled or packaged contrary to subsection (1). Marijuana for medical purposes is subject to the following section of the Narcotic Control Regulations: 70. No person shall (a) publish or cause to be published or furnish any advertisement respecting a narcotic unless the symbol "N" is clearly and conspicuously displayed in the upper left-hand quarter thereof or, if the advertisement consists of more than one page, on the first page thereof; (b) publish or cause to be published or furnish any advertisement to the general public respecting a narcotic; or (c) advertise in a pharmacy a preparation referred to in section 36. While the legislative and regulatory requirements appear consistent with the requirements governing the advertising of prescription and non-prescription medication, it appears that licensed producers are in gross contravention of these standards. The CMA recommends additional effort and action on the part of Health Canada to ensure compliance and enforcement of direct-to-consumer advertising provisions of the Food and Drugs Act and Narcotic Control Regulations. To this end, the CMA recommends that Health Canada issue guidance documentation outlining compliance with these standards and ensure enforcement of these regulations. The CMA welcomes the consultation and review of the amendments to the Marihuana for Medical Purposes Regulations with the view of promoting quality care to improve patient safety and public health. The CMA encourages further consultation and welcomes the opportunity to discuss these issues in greater detail. Overview of recommendations 1. The CMA recommends that the provision of relevant information to licensing authorities should be part of required regular reporting procedures for the licensed producers, consistent with the prescription monitoring program requirements of the respective provincial and territorial jurisdictions. 2. The CMA recommends that Health Canada support the integration of marijuana for medical purposes within provincial/territorial prescription monitoring programs, including facilitating the availability of a point-of-care access tool for health care practitioners. 3. The CMA recommends that the proposed amendments to the Marihuana for Medical Purposes Regulations be reviewed and revised as necessary to ensure it meets the standards of the CMA's Principles for the Protection of Patients' Personal Health Information and the CMA's Principles Concerning Physician Information. 4. The CMA recommends that Health Canada undertake a privacy impact assessment of the proposed amendments to the Marihuana for Medical Purposes Regulations. 5. The CMA recommends additional effort and action on the part of Health Canada to ensure compliance and enforcement of direct-to-consumer advertising provisions of the Food and Drugs Act and Narcotic Control Regulations. 6. The CMA recommends that Health Canada issue guidance documentation outlining compliance with these standards. List of Appendices: * Appendix A - CMA Policy Statement: Medical Marijuana * Appendix B - CMA Policy Statement: Principles for the Protection of Patient ' s Personal Health Information * Appendix C - CMA Policy Statement: Principles Concerning Physician Information

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Policy Type

Parliamentary submission

Date

2014-08-06

Topics

Population health/ health equity/ public health

Text

"The 2014-15 budget signals the end to a tough but necessary period of fiscal consolidation. Current expectations are for a surplus of $6.4-billion in 2015-16, plus a contingency reserve of $3-billion; there is finally some room to manoeuvre in the years ahead." Glen Hodgson, Senior VP and Chief Economist Conference Board of Canada - February 2014 Having emerged from the global economic downturn, now is the time for the federal government to make strategic investments that will ensure Canada's long-term economic sustainability. The ageing of Canada's population is the most pressing policy imperative of our time. As highlighted in Finance Canada's 2012 report, Economic and Fiscal Implications of Canada's Ageing Population, action to prepare for an ageing population will support the sustainability of Canada's public finances and social programs. The CMA's recommendations for the 2014-15 federal budget focus on strategic investments in three key areas: 1. Supporting Canadian families and seniors A) Pan-Canadian Seniors Strategy The CMA is concerned that Canada is ill-prepared for the demographic shift already underway. By 2036, it is expected that a quarter of Canada's population will be over age 65; almost double the proportion of today. Already, patients aged 65 and older account for nearly half of Canada's health care spending. Seniors also face challenges accessing health services across the continuum of care. These challenges are getting worse, despite growing efforts to provide sustainable, high-quality health care for seniors, and despite most provinces having seniors care strategies in place. Canadians share our concern. According to an Ipsos Reid poll commissioned by the CMA, a majority of respondents (83%) said they were concerned about their health care in their retirement years. This poll found that nine out of ten Canadians (93%) believe Canada needs a national strategy for seniors health care that integrates home care, hospitals, hospices, and long-term care facilities into the continuum. Recommendation: The CMA recommends that the federal government provide targeted funding to support the development of a pan-Canadian strategy to address the needs of the aging population. B) Incenting savings for future continuing care needs According to the Organization for Economic Cooperation and Development (OECD), long-term care spending in Canada averaged 1.2% of GDP over the 2006-10 period and could more than double to 2.5% by 2060. The Canadian Life and Health Insurance Association estimates there will be an unfunded long-term care liability of $590 billion over and above existing government programs as the boomer generation passes through their old age1. Of the approaches available to address this unfunded liability, encouraging and incentivizing individuals to save for their future continuing care needs is the least demanding of public finances as compared with increased personal or business income taxes or mandatory contributions. There has been increasing interest among Canadians with focused savings vehicles established by the federal government. There continues to be increased uptake with Registered Education Savings Plans (RESPs) to support post-secondary education. The growth in RESP assets was significant in 2011 and 2012, representing an average annual rate of 12.6%.2 There has also been increased uptake in the use of tax sheltered individual savings vehicles, such as the Tax Free Savings Account (TFSA). According to a Finance Canada report, as of 2011 there were 8.2 million individuals with a TFSA, representing 31% of tax filers, and they contributed $30.7 billion in that year. The report noted that the greatest proportionate growth in TFSA uptake was observed among those with incomes of less than $20,000, with their participation rate almost doubling from 11% in 2009 to 20% in 20113. Recommendation: The CMA recommends that the federal government use its economic levers to encourage Canadians to save over their lifetime for future continuing and long-term care needs not covered under the Canada Health Act. C) Promoting Healthy Ageing The Public Health Agency of Canada (PHAC) defines healthy ageing as "the process of optimizing opportunities for physical, social and mental health to enable seniors to take an active part in society without discrimination and to enjoy independence and quality of life." Such initiatives could focus on: * Physical activity - 57% of seniors in 2008 reported being physically inactive4; * Injury prevention - 40% of admissions to nursing homes, 62% of injury-related hospitalizations, and almost 90% of hip fractures are due to falls by seniors5; * Nutrition - 28% of men and 31% of women over 65 were obese (BMI = 30); this is higher than the population average. Underweight is also a problem among seniors, 17% of whom report a BMI of 20 or less6. The federal government has already undertaken steps to address healthy ageing among Canada's seniors, such as 'Seniors: Active. Engaged. Informed'. In funding over 13,000 projects across Canada, the New Horizons for Seniors Program has demonstrated success in enabling new programs to achieve specific goals; this program can be harnessed to deliver projects focused on promoting healthy ageing. Recommendation: The CMA recommends that the New Horizons for Seniors program be expanded by $5 million per year to include funding for programs promoting healthy ageing activities for Canadian seniors. 2. Ensuring the availability and access to continuing care "When we poll CARP members, they call for leadership in helping Canadians save for retirement, get home care when they need it and get access to affordable drug." Susan Eng, VP, Advocacy for CARP - February 2014 A) Addressing the Continuing Care Infrastructure Crisis A major issue facing health care systems across the country is the high number of alternate level of care patients (ALC) in acute care hospitals. ALC patients-many of whom are seniors-are those who have completed the acute care phase of their treatment but remain in an acute care bed or who are admitted into a hospital bed due to the lack of more appropriate assisted living settings. The CMA supports efforts to allow Canadian seniors to remain in the community as long as possible. However, there are increasing pressures on the continuing care sector given the rise in the number of seniors with complex health and social needs. These pressures not only relate to the construction of new facilities, including assisted living units and other innovative residential models for seniors, but apply as well to the need to upgrade and retrofit existing facilities7. Despite increasing the availability of home care, Canada will face a significant infrastructure shortage in the continuing care sector. The CMA estimates this infrastructure shortage costs the health care system about $2.3 billion a year; this cost is estimated to skyrocket as our population ages. Recommendation: The CMA recommends the federal government deliver $2.3 billion in funding to leverage provincial/territorial strategic investment in the construction, renovation and retrofitting of assisted living units, other innovative residential models, and long-term care facilities. B) Supporting Caregivers The 2011 Budget introduced a new non-refundable Family Caregiver Tax Credit to provide tax relief to those who provide informal care for a dependent relative within their home. However, the credit is limited to 15% of a maximum $2,040 in expenses for 2013 or a maximum sum of $306. While this credit can be added to other tax credits, the total amount is small in relation to the burden experienced by caregivers and it remains non-refundable. The CMA is concerned that the scarcity of financial support and programs supporting caregivers represents significant risks in relation to economic costs, lower productivity, impacts on the labour market, inefficiencies within the health care system and, most importantly, patient care. Informal caregivers are the backbone of any health care and social care system. The work of the 1.5 to 2 million caregivers in Canada is estimated at $25-26 billion annually, while incurring $80 million dollars annually in out-of-pocket costs8. The role of informal caregivers will only increase with the move to providing more care at home. Recommendation: The CMA recommends the federal government make the Family Caregiver Tax Credit a refundable tax credit as part of an effort to better support informal caregivers. 3. Accelerating innovation in health care through enhanced use of electronic medical records (EMRs) "The need for innovation ..., both in terms of medical technologies and healthcare delivery systems, is one of the most pressing public policy challenges of our times." Hon. Rona Ambrose, Health Minister - January 2014 The CMA supports prioritizing continuing the development and meaningful use of electronic medical records (EMRs). A recent report estimates the costs of a pan-Canadian electronic health record (EHR) between $7.9 billion and $16.0 billion9 while total gross savings over a 20-year range were projected at over $82 billion. To date, approximately $2.1 billion in federal funding has been invested. Five national benefit evaluation studies have been commissioned since 2008 and these analyses estimated $7.7 billion in benefits to date as a result of this investment10. This initial investment has resulted in digitized health care information and paper processes, and created a robust marketplace for innovation by EMR vendors. As such, the value of investments in EMRs is emerging. The 2013 National Physicians Survey11 indicated that: * Almost 70% of medical general practitioners (GPs) and specialists now use an EMR, up from 56% in 2012 and 37% in 2009. * 45% of GPs and 40% of specialists report increased or greatly increased efficiency due to the use of EMRs. * 63% of GPs and 50% of specialists report the quality of patient care they provide is better or much better since they started using an EMR. The next step in the evolution of EMRs is enhanced use. In Canada, federal investment does not extend beyond the equivalent of the first stage of the U.S. framework for Meaningful Use. There remain significant gaps in funding to achieve enhanced use of EMRs by clinicians, regional interoperability, and to structure EMR data to leverage big data analytics. Recommendation: The CMA recommends the federal government continue to fund Canada Health Infoway (CHI) to administer remaining project funds from the $500 million allocated in 2009, and allocate an additional $500 million, to be administered by CHI, for projects to achieve enhanced use of EMRs. 1 Canadian Life and Health Insurance Association. Helping Canadians prepare for long-term care costs. CLHIA report on long-term care policy. 2014. 2 Employment and Social Development Canada. 2012 CESP Annual Statistical Review. http://www.esdc.gc.ca/eng/jobs/student/reports/statistics/cesp_2012.shtml#h2.4-h3.1 3 There is a detailed analysis of the TFSA in the 2012 Tax Expenditures and Evaluations report by Finance Canada (Pages 31-42 in http://www.fin.gc.ca/taxexp-depfisc/2012/taxexp-depfisc12-eng.pdf). 4 PHAC 2010 5 PHAC 2010 6 PHAC 2010 7 Canadian Medical Association, The Need for Health Infrastructure in Canada. Submitted to Hon. Denis Lebel, PC, MP Minister of Transport, Infrastructure and Communities. March 18, 2013. 8 Hollander, M.J, Liu, G., Chappeell, N.L. (2009). Who cares and how much? The imputed economic contribution to the Canadian health care system of middle aged and older unpaid caregivers providing care to the elderly. Healthcare Quarterly, 12(2), 42-59. 9 https://www.infoway-inforoute.ca/index.php/resources/video-gallery/doc_download/86-canada-health-infoway-s-10-year-investment-strategy-vol-3 10 Remote Patient Monitoring (RPM) Evaluation; EMR Evaluation; Telehealth evaluation; Drug Information Systems (DIS) evaluation; Diagnostic Imaging (DI) systems evaluation 11 http://nationalphysiciansurvey.ca/wp-content/uploads/2013/10/2013-National-ENr.pdf

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Policy Type

Policy resolution

Date

2014-08-20

Topics

Ethics and medical professionalism

Physician practice/ compensation/ forms

Resolution

GC14-20

The Canadian Medical Association believes that all health care providers should have access to referral for palliative care services and expertise.

Text

The Canadian Medical Association believes that all health care providers should have access to referral for palliative care services and expertise.

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Policy Type

Policy resolution

Date

2014-08-20

Topics

Health human resources

Resolution

GC14-23

The Canadian Medical Association will engage in physician human resource planning to develop an appropriate strategy to ensure the delivery of quality palliative end-of-life care throughout Canada.

Text

The Canadian Medical Association will engage in physician human resource planning to develop an appropriate strategy to ensure the delivery of quality palliative end-of-life care throughout Canada.

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Policy Type

Policy resolution

Date

2014-08-20

Topics

Population health/ health equity/ public health

Health systems, system funding and performance

Ethics and medical professionalism

Resolution

GC14-26

The Canadian Medical Association supports in principle emergency funding for end-of-life care for uninsured people residing in Canada.

Text

The Canadian Medical Association supports in principle emergency funding for end-of-life care for uninsured people residing in Canada.

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Policy Type

Policy resolution

Date

2014-08-20

Topics

Ethics and medical professionalism

Health care and patient safety

Resolution

GC14-40

The Canadian Medical Association recommends that all home-care agencies be mandated to have on staff a director who is in good standing as a registered health professional.

Text

The Canadian Medical Association recommends that all home-care agencies be mandated to have on staff a director who is in good standing as a registered health professional.

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Policy Type

Policy resolution

Date

2014-08-20

Topics

Health care and patient safety

Resolution

GC14-42

The Canadian Medical Association supports the development of improved screening tools to detect drug-impaired drivers.

Text

The Canadian Medical Association supports the development of improved screening tools to detect drug-impaired drivers.

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Policy Type

Policy resolution

Date

2014-08-20

Topics

Health systems, system funding and performance

Ethics and medical professionalism

Resolution

GC14-38

The Canadian Medical Association calls for accessible, comprehensive and high-quality care for transgender patients.

Text

The Canadian Medical Association calls for accessible, comprehensive and high-quality care for transgender patients.

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Policy Type

Policy resolution

Date

2014-08-20

Topics

Health human resources

Ethics and medical professionalism

Resolution

GC14-48

The Canadian Medical Association calls for the integration of sex/gender diversity education into medical school curricula and programs.

Text

The Canadian Medical Association calls for the integration of sex/gender diversity education into medical school curricula and programs.

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Policy Type

Policy resolution

Date

2014-08-20

Topics

Ethics and medical professionalism

Health systems, system funding and performance

Resolution

GC14-49

The Canadian Medical Association encourages the directors of all medical trainee programs to provide early training in cultural awareness.

Text

The Canadian Medical Association encourages the directors of all medical trainee programs to provide early training in cultural awareness.

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