Notes for an address by Dr. Eugene Bereza, Chair, Committee on Ethics, Canadian Medical Association : Bill C-13 - An act respecting assisted human reproduction : Presentation to the House of Commons Standing Committee on Health
BILL C-13 - AN ACT RESPECTING ASSISTED HUMAN REPRODUCTION
Presentation to the House of Commons Standing Committee on Health
November 20, 2002
BILL C-13 - AN ACT RESPECTING ASSISTED HUMAN REPRODUCTION
Madame Chair and Members of the Committee:
My name is Dr. Eugene Bereza. I am a physician and clinical ethicist at the Royal Victoria Hospital in Montreal and Chair of the Canadian Medical Association Committee on Ethics. I am here today representing our members, more than 54,000 physicians from across Canada. I also wish to speak as a advocate for our patients, especially those affected by infertility and those who are or will suffer from diseases for which medical science is searching for cures.
I am accompanied today by Dr. John Williams, our Director of Ethics.
You will recall that we appeared before this Committee on October 23, 2001 in company with representatives from eight other national health provider and scientific organizations to present our views on draft legislation on assisted human reproduction. Although we were pleased that your December 2001 report recommended the establishment of an assisted reproduction regulatory body outside the Department of Health, we were disappointed that you did not find favour with other recommendations we put forward.
The government responded to your report with Bill C-56, now Bill C-13. It is this bill that we are here to address today. Although there are many details in the bill on which we would like either clarification or changes, we intend to focus our remarks on the issue that we consider of greatest importance for our patient’s wellfare and the practice of medicine. That issue is the use of the criminal power to deal with medical and scientific activities.
The Standing Committee Report and Bill C-13
In your December 2001 report, you acknowledged our position on this issue: “Some witnesses recommended the elimination of the prohibited activities category altogether. Citing the benefits of regulatory flexibility, they felt that all activities should come under the controlled activity category, including the more reprehensible activities like reproductive cloning for which licences, arguably, would never be allowed under the regulations” (page 9). However, you rejected this view on the grounds that “a licence-related prohibition of this sort would not carry the same weight or degree of social censure as the statutory prohibition…. An outright statutory ban signals more clearly that certain activities are either unsafe or socially unacceptable.
The use of the statutory ban also signals that these activities are of such concern to Canadians that their status as a prohibited activity may not be altered except with the approval of Parliament” (page 9).
Bill C-13 reflects your views on this matter. We recognize your good faith in proposing and defending this position but we are convinced that its potential for harm outweighs its potential benefits. And so we are pleased to have this opportunity to reiterate the reason why the CMA believes that Bill C-13 will adversely affect the patient-physician relationship and the advance of medical science.
Need to Change Bill C-13
As you know, our position on this matter is supported by legal scholars such as Patrick Healy, McGill University Faculty of Law, Tim Caulfield, Director of the University of Alberta Health Law Institute, and Bartha Knoppers, Université de Montréal Centre de Recherche en Droit Publique. In essence, our position is that the criminal law is a blunt instrument and very difficult to change and is therefore appropriate for activities whose status is unlikely to change over time, such as murder and theft, rather than medical and scientific activities that are constantly developing. The latter are better left to a representative regulatory body to determine if and when changes in health and safety considerations and public attitudes and values might justify allowing certain formerly prohibited activities to take place under specific conditions.
Bill C-13 begins with the statement: “This enactment prohibits assisted reproduction procedures that are considered to be ethically unacceptable.” This echoes the conclusions in your report. However, as the transcripts of your hearings demonstrate, many Canadians, especially those who are infertile, do not consider some or all of these procedures to be ethically unacceptable. As a matter of public policy, should Canadians who hold this view be denied access to medical treatment for infertility because others consider such treatments to be ethically unacceptable? Should patients who suffer from conditions for which research that is forbidden in Bill C-13 might lead to a cure be denied that opportunity? We question whether criminal prohibitions are appropriate for dealing with activities on which there is considerable ethical disagreement among Canadians.
In Canada legislators have been justifiably reluctant to use the criminal law to deal with medical and scientific issues such as abortion, withdrawal of life-sustaining treatment and the conduct of medical research. Why is an exception being made for assisted reproduction? What sort of precedent will this set for other controversial bioethical issues?
We are also concerned about the bill’s penalties for infractions: jail terms up to 10 years and fines up to $500,000. These are disproportionate to the penalties for crimes that injure persons or property and, as such, will create a climate of undue fear and excessive caution for physicians and scientists working in this area, such that they will avoid any activity that is potentially covered by the bill, even to the detriment of patient care. Given the rapid advance of science and medical practice and the difficulty of anticipating new developments, it will be difficult to adjust the law to deal with new applications of prohibited activities that may be ethically acceptable.
An Alternate Solution
The CMA has stated repeatedly that we are not opposed to the prohibition of certain assisted human reproduction activities. Instead of instituting criminal prohibitions within the legislation, we remain convinced that an independent body on an ongoing basis should determine the activities that are permissible or prohibited on the basis of up-to-date scientific research, public input and ethical review. This can be accomplished very easily in Bill C-13 by moving the procedures listed under “Prohibited Activities” (sections 5-9) to “Controlled Activities” and adding the words “except in accordance with the regulations and a licence” to each of the provisions in sections 5-9.
Consistent with this recommendation we consider that the regulatory agency should be established as soon as possible and be given as much authority as possible over the matters that Bill C-13, section 65, reserves to regulations of Governor in Council. We hope that the agency will build upon the experience and expertise of existing organizations and structures in the field of assisted reproduction that deal with practice standards, education, certification and accreditation.
To summarize, we strongly support government efforts to regulate assisted human reproduction and related activities, including the prohibition of certain practices either temporarily or permanently. However, like others who have appeared before this Committee, we do not believe that criminalizing the medical and scientific activities named in the bill is an appropriate way to achieve those objectives. We consider that the objectives could be as well achieved by far less drastic means than criminalization and, moreover, that criminalization would create major obstacles to legitimate medical and scientific progress in the treatment of infertility. We recommend that the proposed agency be empowered to regulate these practices and that the criminal power be invoked when controlled activities are performed without authority of a licence from the agency or in defiance of the licensing conditions established by the agency.
Thank you, Madame Chair and members of the Committee. We will be pleased to respond to your questions.
Review of the Personal Information Protection and Electronic Documents Act (PIPEDA) : CMA's Presentation to the House of Commons Standing Committee on Access to Information, Privacy and Ethics - December 13, 2006
The Canadian Medical Association (CMA) is pleased to be here today to participate in your review of the Personal Information Protection and Electronic Documents Act, or PIPEDA.
The CMA has had a long-standing interest in privacy-related matters, including enhancing measures to protect and promote the privacy of health information. We welcome the opportunity to share our policies and thoughts on these vital matters.
As a pediatric oncologist from Winnipeg and Chair of the CMA's Committee on Ethics, I come here today with one bottom line: Physicians have always- and continue to - take their patients' privacy very seriously. This is the cornerstone of the special bond between patients and their doctor and has been thus since the time of Hippocrates. In recognition of the importance of privacy, the CMA has produced such documents as the CMA Code of Ethics and the CMA Health Information Privacy Code to guide our more than 64,000 members across the country. These documents existed before the federal government introduced PIPEDA.
It is out of our concern for protecting and ensuring the privacy of medical information that we speak to you today.
There are three specific areas which we would like to raise:
1) Recognition in law of the unique nature of health care;
2) Physician information as "work product"; and
3) Emerging Privacy and Health information issues.
1. Recognition in law of the unique nature of health care
I would like to highlight the importance of recognizing in law the special circumstances of protecting health information. In fact, when PIPEDA was first being debated, CMA posed questions about the scope of the Act and was told that the legislation, originally designed for commerce and the private sector, would not capture health information. We were also told that even if it did, PIPEDA wouldn't change how we practiced medicine.
The passing of PIPEDA generated enough concern and uncertainty that government agreed to delay its application to health for 3 years. For example, PIPEDA failed to clarify the issue of implied consent for the sharing of patient information between health professionals providing care.
For example, when the family physicians says to a patient "I'm going to send you to see an oncologist to run some tests" and the patient agrees and follows that course of action, then clearly there is "consent" to the sharing of their health information with others. As an oncologist I assume there is consent to send the test results to other specialists that I may need to consult in order to advance the patient's care in a timely fashion. This, however, needed to be addressed before PIPEDA was applied to health care.
The delayed application allowed the federal government and health care community to work together and develop a set of guidelines for how PIPEDA would be applied. The resulting PIPEDA Awareness Raising Tools, known as PARTs, contain a series of questions and answers that make up guidelines for health care providers. They answered many of our concerns, provided necessary definitions and allowed for the implied consent model to continue to be used within the circle of care. The CMA applauds the government for this collaborative effort and the resulting guidelines have been used by health care providers ever since.
However, we remain concerned that the PARTs guidelines have no legal status. This limitation creates a degree of uncertainty that the CMA would like this legislative review to see addressed by ensuring the PARTs series of questions and answers are referenced in PIPEDA.
In addition to participating in the PARTS initiative, since PIPEDA's implementation, the CMA has designed practical tools for physicians and patients:
* adopted the CMA policy Principles Concerning Physician Information to address the importance of protecting the privacy of physician information;
* produced Privacy in Practice: a handbook for Canadian physicians to help physicians maintain best practices in the protection of patient health information; and
* created the PRIVACYWIZARD(tm) designed to help physicians record their current privacy practices, communicate these to patients and identify possible areas for enhancement.
2. Physician Practice Information as "Work Product"
I referred earlier to CMA's Policy document on physician information. The CMA strongly believes that physicians have legitimate privacy concerns about the use by third parties of information - such as prescribing and other practice data for commercial purposes. Currently deemed "work product" this information can be collected, used and disclosed without consent.
We feel PIPEDA inadequately protects this information. We recognize that it is information generated out of the patient-physician relationship. We disagreed with findings of the previous Privacy Commissioner that physician prescribing information is not subject to PIPEDA's privacy protection provisions for "personal information". The CMA has consistently advocated that physician prescribing data and other practice information is personal information and appeared as an intervener in a Federal Court review of this issue that was ultimately settled by the main parties.
Also, insufficient regard for the privacy of prescribing and other physician data could have a negative impact on the sanctity of the physician-patient relationship. Patients confide highly sensitive information to physicians with the expectation this information will be kept in the strictest confidence. This expectation exists because they know that physicians are under ethical and regulatory dictates to safeguard their information and that physicians take this responsibilities very seriously. The perceived and indeed actual loss of control by physicians over information created in the patient encounter, such as prescribing data, could undermine the confidence and faith of our patients that we are able to safeguard their health information. This concern is not hypothetical.
For physicians, so called "work product" information also encompasses practice patterns such as discharge rates, referral rates, billing patterns, hospital length of stays, complaints, peer review results, mortality and re-admittance rates. With the advent of electronic medical records and growth in pay-for-performance and outcome-based incentive programs for physicians, there is an enormous potential for the resulting physician "performance" data or "work product" to be "mined" by other parties and used to influence performance review (traditionally the purview of the medical licensing authorities) as well as decisions around treatment funding and system planning.
The lack of transparency in the sale and compilation of physicians' prescribing and other performance data means that physicians might find themselves to be the unwitting subject and targets of marketing research. We believe practice decisions must be made in the best interest of patients and not the bottom-line interests of businesses and marketers.
CMA therefore recommends a legislative change to include physician information as personal information under PIPEDA. Legislation in Quebec provides an example that is consistent with CMA's approach since it requires regulatory oversight and gives individuals the right to opt out of the collection, use and disclosure of "professional" information.
3. Emerging Privacy and Health information issues
With budgetary and demographic pressures, our health care system is under strain and physicians are striving to deliver timely, quality care to patients, often with competing and multiple demands. Physicians are therefore seeking assurances from law makers that any amendments to PIPEDA will take into account the potential impact on them and their patients. Therefore, we seek assurances that:
* health care is recognized as unique when it comes to the disclosure of personal information before the transfer of a business (one physician transferring his/her practice to another) because it is regulated at the provincial level through the appropriate licensing body. As a general rule, physicians must give notice to the public, whether via a newspaper ad or a notice in the office about the change in practice.
* the federal government will consider the impact of the trans-border flow of personal information on telehealth and Electronic Health Record activities. Communications between patients and physicians via electronic means are likely to increase and to move across geographic boundaries with increasing frequency; and
* the federal government will study the issue of international cross border data flows, particularly among Canadian researchers who receive funding from US drug companies. These arrangements should be governed by Canadian law (PIPEDA) not American (HIPAA or the US Patriot Act).
In closing, the privacy protection of personal health information is a responsibility that my colleagues and I do not take lightly. It is a key pillar of our relationship with Canadians, they not only expect it-they deserve it. I look forward to taking questions from Committee members.
Canadian Medical Association Ottawa, December 13, 2006