HESA Committee Report
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Government Response to the Fourth Report of the Standing Committee on Health
Briefing on the New Organ Donor Regulations
The Government of Canada is pleased to respond to the Fourth Report of the House of Commons Standing Committee on Health, entitled Briefing on the New Organ Donor Regulations. The Government shares the Committee’s commitment to encourage everyone to consider organ donation in Canada and to minimize the potential health risks to Canadian recipients resulting from transplantation.
On April 15, 2008, the Committee recommended that the Minister of Health amend the organ donor criteria in the Regulations since it “specifically excludes gay men from becoming organ donors” and to replace the Regulations with voluntary guidance.
The Government has carefully reviewed the Committee’s recommendations and welcomes to opportunity to respond to them.
“That the Minister of Health take action, at the earliest possible opportunity, to amend the new health regulations on organ donor criteria since the current wording specifically excludes gay men from being organ donors.”
The Government understands the issues raised by the Committee, but it must be made clear that the Regulations do not ban gay men from becoming organ donors. The Regulations include provisions to allow the use of organs deemed of higher risk, as long as there is informed consent of the transplant recipient and authorization by the physician, who can then make decisions on follow-up testing and necessary precautions. In this way, the Regulations seek to limit possible restrictions on access to organs by recipients in order to maintain safety.
The designation of men who have had sex with men in the past five years (MSM) as a high risk behaviour is based on scientific evidence. The Public Health Agency of Canada (PHAC) Report, HIV and AIDS in Canada: Surveillance Report to December 31, 2006, shows that the MSM category continues to account for the highest number of new HIV cases in Canada each year, representing 41.4% of new cases in 2006, 42.6% of new cases reported to date in 2007 and 60.1% of all HIV positive cases reported since 1985. After a period of decline in HIV diagnoses in MSM in the 1990s, rates have begun to rise again, not only in Canada but also in the US and Europe.
MSM behaviour is also considered a risk factor for disease transmission in the United States, the European Union and Australia. It is important that Canada’s requirements remain in step with those elsewhere.
Unfortunately, the testing of donors for infectious diseases cannot substitute for risk factor screening as a donor can be in the “window” phase of infection when disease is not yet detectable by testing but can still be transmitted. Furthermore, for certain agents such as human herpes virus type-8 which are prevalent in these higher risk groups, there is no available test. Recently, on November 2007, Health Canada was informed that officials in Chicago were investigating the circumstances around the infection of four American transplant recipients with HIV and hepatitis. If has since been confirmed that these individuals had all received organs from a single high-risk donor (identified in the media as a 38-year-old American male who had engaged in MSM activity) who had tested negative for these diseases.
The Regulations apply not just to organs but to tissues. Tissue is used daily across Canada in many elective surgeries and routine dental procedures. One donor with undetected disease donating both organs and tissues could infect up to hundreds of recipients, making stringent safety regulations for tissues essential. Furthermore, MSM is also considered a risk factor for blood donation and donation of semen for assisted human conception.
The Government understands the concerns that were raised by the Committee about designating high risk behaviours. It also recognizes the need to constantly review the latest scientific data as well as international evidence in order to ensure that the safety standards are based on the best available evidence so as to not unduly restrict Canadians, and that the views of those affected are taken into account. As such, the Government has identified a number of actions to address issues raised in the Committee’s hearings.
In relation to the need for ongoing monitoring of scientific evidence and international best practices, Health Canada (HC) will task its independent Expert Advisory Committees on blood and cells, tissues and organs (CTOs) to review annually the current scientific evidence and associated ethical considerations supporting the donor screening criteria. Both committees operate according to Health Canada’s Policy on Advisory Committees: (http://www.hc‑sc.gc.ca/dhp‑mps/md‑im/activit/sci‑consult/implant‑breast‑ mammaire/sac_mst_hc_policy_adv_com03‑eng.php).
Health Canada is expecting the first review by December 2008 and reserves the right to seek additional reviews, if at anytime new evidence becomes available. A copy of this first review will be filed with HESA as will copies of any subsequent reviews which result in a recommendation to change the screening criteria. Recommendations to change the criteria would be submitted by HC to the CSA accompanied by a proposal to change the existing criteria.
To ensure that the regulatory approach continues to be informed by any new public health data, HC will continue to collaborate with PHAC, as appropriate, to assess any changes in potential risk to recipients from different donor groups with high risk sexual behaviour, based on any new surveillance data, whether domestic or international, as well as any new developments in virus testing and inactivation.
Furthermore, Health Canada and CSA will continue to provide timely and clear information to stakeholders affected by the Regulations, and enhanced opportunities for consultations. For example, all correspondence regarding these standards will be sent on CSA's behalf by Health Canada to a broad list of stakeholders, including those affected by the regulations.
Health Canada will implement communication strategies to enhance transparency and explain to the public why and how donor risk factors are used, and continue to work with provincial/territorial counterparts and CSA on sharing of best practices in transplant safety. One key area could be sharing best practices in how the identification of risk behaviours are operationalized in a sensitive way through the use of donor questionnaires, which vary across the country.
“That the Minister also replace the current regulations with scientifically based guidelines to medical practitioners that protect the supply of organs, promote participation of donors and preserve the integrity of the organ supply.”
The Government is committed to protecting the supply of organs. However, it is important that the requirements to protect the health and safety of Canadians who receive transplanted organs and tissues remain in regulations, as opposed to voluntary guidelines. The Regulations include a wide range of safety requirements covering both organs and tissues, and it would be a significant safety gap to move all of these requirements into voluntary guidelines for medical practitioners with no enforcement ability.
The Safety of Human Cells, Tissues and Organs for Transplantation Regulations (CTO Regulations) contain safety requirements with respect to processing, storage, record keeping, distribution, importation, error, accident and adverse reaction investigation reporting. These Regulations are intended to protect the health and safety of Canadian transplant recipients.
HESA’s 1999 report Organ and Tissue Donation and Transplantation: A Canadian Approach called for safety standards for transplantation to be made mandatory by referencing in regulation. Recommendation 12.1 specifically stated that "The Minister of Health ensure that the Canadian General Standard for Safety of Organs and Tissues for Transplantation and its subsets be approved and made mandatory through incorporation by reference into regulations made under the Food and Drugs Act as soon as possible, preferably within six months.”
The creation of a mandatory system through regulations was the result of 11 years of extensive consultations with the Canadian transplant community. Regulations were identified as essential to the safety of the transplant system for both tissues and organs in Canada, specifically standards-based regulations, as they could evolve readily with the science. In addition, the Krever Commission of Inquiry into the Blood System recommended standards-based regulations for biological products.
The Regulations are based on standards, which are scientifically-based, and which have been developed with the full participation of a wide range of stakeholders, including the medical community. The use of standards-based regulations has already proven to provide greater responsiveness in the updating of technical requirements. For example, it has allowed for recent updates to address risks involving West Nile Virus.
By moving to guidelines instead of regulations, Canada would be out of step with international best practices which it has played a leadership role in establishing. This could affect Canada’s ability to share tissues and organs with the United States under a system of common regulatory approaches. The organ donation system in the United States is regulated and adheres to strict risk management policies (including identifying the same MSM risk factor as in Canada) which are de facto mandatory for participating institutions. There are also regulations governing the safety of tissues.
There have been recent international examples of transmission of infectious disease through donated organs, and it is critical that a strong safety system be maintained in Canada. Furthermore, the World Health Organization stated in the drafting of its Guiding Principles (2008) on Transplantation that “comprehensive legal frameworks are needed to increase donation rates as it depends on public acceptance/trust of safe, legal donation and transplantation practices.”
It is important, however, to ensure that the Regulations are evaluated to determine their effectiveness, and that they are consistently assessed in light of international and domestic developments. As referenced in the response to the Committee’s first recommendation, Health Canada will work to ensure that the Regulations remain updated, scientifically based and reflect current medical and international best practices. Furthermore, the Committee will be interested to know that the Regulations will be subject to an evaluation. Health Canada has developed an evaluation framework to assess on an going basis the effectiveness of the Regulations, and the first stage of that evaluation will be initiated this year. Preparatory work for this evaluation has already been initiated.