November 24, 2017 - Ottawa, ON
Health Canada wishes to address some inaccuracies in the article "A bloody mess: The story behind paid plasma in Canada," which was published in the November 22 edition of Maclean's.
Protecting the safety and security of Canada's blood supply, including plasma products, is a priority of Health Canada.
As the regulator of Canada's blood system, Health Canada is responsible for assessing the safety and quality of all blood products, including plasma collected for manufacturing into commercial drugs known as plasma products. The same regulations and safety standards apply, regardless of who collects the plasma or whether the donors are paid.
Health Canada conducts unbiased reviews based on scientific evidence and strict safety requirements. Communications with stakeholders are a standard part of our review processes.
The article could leave readers with the impression that the integrity of Canada's blood system is at risk. This is an erroneous conclusion. Canadians can be assured that Health Canada maintains the strictest requirements for the licensing of plasma collection.
The article also contains many inaccuracies and misleading statements warranting clarification:
- To date, Health Canada has seen no data supporting a decline in voluntary blood donations in regions where paid plasma clinics operate in Canada. Due to public concerns about this possibility, as part of its license, Canadian Plasma Resources has been instructed by Health Canada to monitor the history of its donors with respect to prior blood donation, in order to ensure that there is no negative impact on voluntary blood donations in their areas of operation.
- The Dublin Consensus Statement was convened by a group of patient organizations, not an industry lobby group. International blood operators, including Canadian Blood Services also attended the conference, as well as the International Patients Organisation for Primary Immunodeficiency (IPOPI), the World Federation of Hemophilia (WFH), the Plasma Protein Therapeutics Association and the World Health Organization.
- Suggesting that new emerging viruses would go undetected in a paid model is incorrect. Both Health Canada and the Public Health Agency of Canada monitor emerging pathogens and take action to prevent their entry into the blood and plasma supplies. Furthermore, the modern techniques used to treat plasma have been validated to eliminate a wide range of different types of viruses.
- Finally, any allegation that Health Canada is phasing out the recommendations of the Krever report is incorrect. Health Canada's current approach to the regulation of blood and plasma collection in Canada is based on the recommendations of the Krever report. The current Blood Regulations under the Food and Drugs Act were developed in response to the Krever recommendations and work to ensure that our blood and plasma products supply remains the safest in the world. As a responsible regulator, it is Health Canada's role to continue to evolve and incorporate advances in science and modern techniques, such as those that are now used in plasma product manufacturing, into its regulatory processes.
Provincial and territorial governments take different approaches to the issue of payment - some permit it and others do not. The Government of Canada's focus is on the health and safety of Canadians, regardless of which choice a jurisdiction makes.
Further, to objectively assess concerns that have been raised, Health Canada appointed a panel of experts in July 2017 to assess the sustainability of Canada's immune globulin product supply and whether plasma clinics could affect the voluntary blood supply. The panel is also looking at emerging international practices and lessons learned that are relevant to the Canadian context.
Protecting the safety and security of Canada's blood supply, including plasma products, has been, and will continue to be a critical priority of Health Canada.