Notes for an address by Dr. Eugene Bereza, Chair, Committee on Ethics, Canadian Medical Association : Bill C-6 (An act respecting assisted human reproduction) : Presentation to the Senate Standing Committee on Social Affairs, Science and Technology
My name is Dr. Eugene Bereza. I am a physician and clinical ethicist at McGill University Health Centre in Montreal and Chair of the Canadian Medical Association’s Committee on Ethics. I am accompanied today by Dr. Jeff Blackmer, our Director of Ethics.
I am here today representing the CMA, but I would also like to advocate on behalf of those patients affected by infertility and those patients suffering, or who will suffer, from the myriad diseases for which medical science is searching out a cure.
While there has been considerable debate over the past decade on the moral and ethical issues associated with assisted human reproduction, discussion of this as a health issue has been overlooked all to often.
We must remember this is about the practice of medicine and above all, the health of Canadians.
My remarks today will focus on the inappropriateness of using criminal sanctions to deal with medical and scientific activities.
It is important to make it clear at the outset that the CMA does not oppose the prohibition of certain medical and scientific activities.
Others here today are in a better position to address concerns regarding the specific prohibitions proposed under Bill C-6.
Our issue is the means chosen to give effect to these prohibitions and their potential impact on the ability of a physician to ensure the welfare of his or her patients.
Criminal law is a blunt instrument. As parliamentarians, you know how difficult it can be to change the law.
For some activities prohibited under the criminal law, such as murder and theft, change is not an issue. However, the science of medicine evolves constantly, doubling every 18-24 months.
Advances in science and medical practice, coupled with the difficulty of anticipating new developments, make it difficult to adjust the law to remove criminal prohibitions as science and society changes.
In the context of prohibiting medical and scientific activities, it is the CMA’s position that the use of criminal law is inappropriate, as it would ultimately not serve our patient’s best interests.
Prohibitions, specifically those listed as prohibited activities under Bill C-6, (formerly Bill C-13) could be secured through much less drastic means than criminalization.
The CMA proposes that the determination of permissible activities, temporarily or for the longer-term, should be made by the proposed Regulatory Agency working with up-to-date scientific information while providing for public input and ethical review.
The Regulatory Agency, as proposed in the Bill, would determine if and when changes in health and safety considerations, public attitudes and values might justify allowing certain formerly prohibited activities to take place under specific conditions.
Questions to Consider
Bill C-6 begins with the statement: “This enactment prohibits assisted reproduction procedures that are considered to be ethically unacceptable.” However, many Canadians, especially those who are infertile, do not consider some or all of these procedures to be ethically unacceptable nor do the many physicians charged with their care.
The CMA questions whether criminal prohibitions are appropriate for dealing with activities about which there is considerable ethical disagreement among Canadians.
Legislators in Canada have been justifiably reluctant to use 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?
What about the chilling effect criminalization will have on research in this important area?
For the CMA, the most important question is: what about the patients?
What about patients suffering from conditions for which research is banned but may lead to a cure?
Should they be denied the opportunity to benefit from this research?
Just as Bill C-6 unfairly targets patients, so too does the Bill’s penalties for infractions.
Jail terms of up to 10 years and fines up to $500,000 will create a climate of fear and excessive caution for physicians and scientists working in this area.
The chill created by these penalties will be such that scientists may well avoid any activity potentially covered by the bill even to the detriment of patient care.
The CMA recognizes the good faith among parliamentarians in proposing statutory bans to prohibit certain activities.
However, we are convinced in this case the potential for harm outweighs the potential benefits.
There is a better way to prohibit these activities while still facilitating important research and necessary treatments.
An Alternative Solution
Instead of instituting criminal prohibitions within the legislation, the CMA suggest the Assisted Human Reproduction Agency of Canada manage procedures deemed permissible by moving the procedures listed under “Prohibited Activities” to “Controlled Activities.” We recommend that criminal sanctions apply to breaches of agency directives such as performing activities prohibited by the agency and performing controlled activities without a license.
Such an approach would have the dual advantage of being able to both prohibit activities deemed unethical while still providing the flexibility to ensure legitimate medical and scientific progress in the treatment of infertility.
The regulatory agency should be established as soon as possible and should build on the experience and expertise of existing assisted reproduction organizations and structures that deal with practice standards, education, certification and accreditation.
The CMA’s overriding concern in addressing this legislation is the well-being of patients, in this case patients who are infertile and patients afflicted by conditions for which medical research offers significant promise of treatment.
We support government efforts to regulate assisted human reproduction and related activities, including the prohibition of certain practices temporarily or permanently where necessary.
However, we do not believe that criminalization of medical and scientific activities named in the bill is an appropriate way to achieve those objectives. We believe we have advanced a workable alternative within the spirit of the Bill.
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