Mr. Chair, I thank my colleague for the insight that she has provided on this very important issue, certainly from her own personal experience.
The safety of human cells, tissues and organs for transplantation regulations, or CTO regulations as my colleague referred to them, came into force on December 2007 as she stated. The purpose of the CTO regulations are to minimize the potential health risks to Canadian recipients of human CTO. Prior to the coming into force of these regulations, Health Canada had extensive consultations and communications with stakeholders to provide guidance and clarification on the basic safety requirements with regard to the processing and distributing of human CTO used in transplantation. The CTO regulations are based on the national standard and were developed using a risk-management approach, as well as information obtained during extensive consultations with the provinces, territories and transplantation experts. The national standard has been made available and is a model for other nations through international regulatory co-operation.
Following these extensive collaborations with experts in the field, federal and provincial governments and interested stakeholders on the content of proposed regulations took place. The national standard was published in June 2003 by the Canadian Standards Association, the 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 and organizations who expressed an interest. As they were drafted through a consensus development process, the national standard met the requirements of the Standards Council of Canada, having provided multiple opportunities for Canadians to express their points of view and/or their 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.
Significant consultation with stakeholders occurred during the entire regulatory drafting process. The regulations were published for a 75 day consultation period prior to their implementation.