Yes, I'm going to speak on behalf of the CSA.
Good morning. My name is Marc Germain. I am here today as the incoming chair of the technical committee on cells, tissues and organs for transplantation and assisted reproduction. In my regular job, I am also vice-president and medical director of the human tissue division at Héma-Québec. I would like to thank the committee for the opportunity to speak today.
The CSA standards on cells, tissues and organs were developed over the course of several years through a careful and well-defined process, as just described by Ms. Kiraly. I would like to make a couple of specific points related to the standards, in particular with regard to the criteria that are applied to qualify cells, organ or tissue donors.
First, as has already been said, it is important to recall that the goal of these qualification criteria, often called exclusion criteria, is to decrease the risk of disease transmission by transplantation and to make the donated cells, tissues or organs as safe as possible for the recipient.
Second, I must also repeat that, with communicable diseases, the qualification criteria based on the assessment of high-risk behaviours are only one of several ways in which the risk of disease transmission by transplantation is reduced. Other steps that are taken to reduce this risk include, for example, the testing of donors' blood for specific transmissible infections. However, for the reasons previously mentioned, it is important to recall that the assessment of high-risk behaviours remains an essential component of the overall safety of transplanted cells, tissues and organs.
Third, I must emphasize that, when developing standards for the safety of cells, tissues and organs, the technical committee took into consideration existing consensus and best practices in the field of transplantation. In particular, the committee attempted to harmonize with other existing standards and regulations, both nationally and internationally, whenever this was felt to be justified. It should be noted that the exclusion criteria related to high-risk behaviours that were included in the CSA standards are very much in agreement with other national and international standards.
The fourth point has also already been mentioned, but it bears repeating. The CSA technical committee and all other stakeholders recognized from the outset that organ donation represents a unique situation. Organs are and probably always will be in short supply. They can very often be life-saving to the potential recipient. Because of this, the standards allow the retrieval and transplantation of organs obtained from donors who might not meet all the qualification criteria, through a process called exceptional release. This process requires only that the transplantation physician and the potential recipient be made aware of the specific situation in order to be able to make an informed decision about the relative risks and benefits of accepting a transplant from a donor who might not fully qualify according to the criteria set forth in the standards.
In conclusion, I want to emphasize that the selection of the best possible qualification criteria, especially the exclusion criteria based on high-risk behaviours, has been discussed extensively over the last several years. Some of you are already well aware of these discussions. For example, in 2006, there was a meeting sponsored by the FDA in the United States to look specifically at those issues, both from the blood donation point of view, and from the cell, tissue and organ donation perspective. Several international stakeholders attended that meeting, including representatives from Canada such as myself. It is an area of intense scrutiny and I can assure you that the CSA technical committee will continue to monitor the situation closely.
I would like to thank you again for your time. I will be happy to take your questions.
I'll be happy to take your questions in English too.
Thank you.