What are the new regulations?

The Cells, Tissues and Organs (CTO) Regulations came into force on December 7, 2007, following extensive consultation, over a period of 11-years with the transplant community and Canadians.

The safety of CTOs intended for transplantation is paramount. As such, the purpose of these regulations is to minimize the potential health risks to Canadian recipients resulting from transplantation. The CTO Regulations include requirements for the screening and testing of potential donors, which is intended to protect the health and safety of Canadian transplant recipients.

These regulations enshrine into law the best practices that have been ongoing in Canada in the field of transplantation since the mid 1990's so that transplantation will remain safe to Canadian patients.

If transplantation is already safe, why are regulations needed?

In 1995, the National Consensus Conference on the Safety of Tissues and Organs recommended that standards be developed for cells, tissues and organs. In response, Health Canada immediately appointed a working group of independent experts to develop safety standards for CTO. This working group included representatives from the transplant community, provincial and territorial governments, transplant recipients and the ethics community.

In 1999, the House of Commons Standing Committee on Health delivered a report recommending that national standards for cells, tissues and organs intended for transplantation be made mandatory by incorporation by reference into regulations under the Food and Drugs Act.

How did Health Canada consult with stakeholders on these new regulations?

Following extensive collaboration with experts in the field, federal and provincial governments and interested stakeholders on the content of proposed regulations, national safety standards were published in June 2003 by the Canadian Standards Association (CSA). To meet the requirement for public consultation in the development of national standards, the CSA posted each of the draft standards on its website for a 60-day comment period, in addition to distributing copies to individuals/organizations that expressed an interest. As they were drafted through a consensus-development process, the national standards had met the requirements of the Standards Council of Canada, having provided multiple opportunities for Canadians to express their points of view and/or concerns about these standards.

Health Canada then began to draft federal regulations around these standards to make portions of them mandatory by law under the Food and Drugs Act. Comments from transplant experts and the public were solicited on different drafts of the regulations before the final version was published in June 2007.

Who can become an organ donor?

Everyone can be considered for organ donation in Canada. Neither the regulations nor transplant programs will prevent any Canadian from becoming an organ donor based on gender, race, age or sexual orientation. However, in order to minimize the potential health risks to Canadian donor recipients, the regulations also state that all donors must be assessed for medical conditions. Health and risk factors are used in the determination of which recipients, if any, should receive a transplant from a high risk donor. In certain cases, the transplant may be unsuccessful or could potentially transmit an infectious disease because of the donor's medical history.

If a donor falls into high risk category, it is a decision between the recipient and his or her physician as to whether a transplant is appropriate. In fact, Section 40 of the regulations permits the use of organs from donors with risk factors based on the judgment of the transplanting physician and with the informed consent of the recipient. This provision was included because of the often life-and-death circumstances that make transplantation essential, and the limited number of donors available.

What kind of health and risk factors are considered?

Donation may not be possible if the donor died of certain diseases or had evidence of having an infectious disease at the time of his/her death. Donors are also assessed for risk factors for certain diseases, notably hepatitis B and C and human immunodeficiency virus (HIV) because although all donors are tested for these infectious diseases, in rare cases, these diseases may be present but undetectable in the donor via either examination or testing. Among donors considered a potential higher risk for these diseases are current or recent inmates of the correctional system, those with a recent tattoo or body piercing done with shared equipment, those who have used injection drugs in the past 5 years, men who have had sex with another man in the preceding 5 years, or anyone who has had sex in exchange for money or drugs in the same timeframe.

How did Health Canada determine the risk factors for CTO donation?

The risk factors were determined by a group of Canadian experts in the field of transplantation. Although customized for Canada, these risk factors are the internationally accepted practice for screening donors. These criteria were originally based on guidelines set out by the Centre for Disease Control in the U.S. The regulations formalize into Canadian law what has been standard practice in donor screening worldwide for several years. Other jurisdictions such as the US and Europe use the same risk factors, and in fact the Canadian Standards, which contain these risk factors are referenced in World Health Organization Safety Guidelines.

These risk factors are based strictly on scientific evidence and are used in an assessment that evaluates behaviours and medical circumstances, and is not meant to target specific groups.

Where can I get more information on these new regulations?

For more information on the CTO regulations and their development, please visit our Web site.

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