The Plasma Protein Therapeutics Association (PPTA) remains deeply concerned about the proposal to ban compensated plasma donation in the Province of Ontario, Canada. The proposed legislation, Ontario Bill 178, unfairly targets compensated plasma donation on alleged bases of safety and Canada’s goal of self-sufficiency in regards to the supply of plasma-derived medicinal products.
Safety is the preeminent focus for our industry. Over the past twenty years, there has not been a single reported transmission of HIV or hepatitis by any PPTA member company therapies. This has been documented thoroughly by the FDA, Australian, and European authorities and is available for review in both regulatory policy statements and peer-reviewed scientific literature. New testing technology, donor assessment methods, and manufacturing processes have made significant advances in product safety and quality since the dated claims of the Krever Commission report, which contains information that is, at best, more than twenty years old.
In fact, compensated donation is strongly supported by patients – the very individuals this well-intentioned but misguided legislation seeks to protect. Leading patient advocacy groups support compensated donation as a time-tested, safe, and reliable means of ensuring continued access to the plasma-derived therapies they need to address chronic, life-threatening conditions, such a hemophilia, primary immunodeficiency, alpha-1 antitrypsin deficiency, and hereditary angioedema.
Canada is dependent on certain products imported from the United States. According to Canadian Blood Services, approximately 70% of immunoglobulin therapies in Canada are imported from the United States, most of which is derived from compensated donation. This same proportion has been acknowledged in the current debates in the Ontario Parliament concerning this proposal. Banning compensated plasma donation in Ontario will not further the goals of Canadian self-sufficiency; indeed, the effect is likely to reinforce the status quo while, at the same time, making self-sufficiency that much more difficult to attain in the future.
There is a crucial distinction to be made between blood components intended for transfusion and plasma collected for further manufacture. The mix of high-technology testing, donor assessment, and manufacture of finished products, complete with viral inactivation and removal steps, differentiates plasma protein therapeutics from transfused components. They are separate processes and separate products, which should not be joined together under the same policies.
Furthermore, decades of experience show that parallel systems for compensated source plasma donation and uncompensated whole blood donation can co-exist and thrive. Compensated plasma donations do not reduce or “crowd out” uncompensated blood donations.
As always, PPTA and its member companies support donation in all forms. These donations can be of non-remunerated whole blood, remunerated plasma, and supporting and volunteering in charitable causes. The important factor is that each individual person can best decide how she would wish to do so, rather than having it imposed upon them in the absence of safety or other material concerns.
- Proposed Ontario Bill 178
- Transcript of Health Ministers Comments: [the transcript from March 20th floor proceedings; Introduction of Bill 178 begins on page 31 and the Minister's comments begin on page 32]
- Ontario Regulation 66/14
- Ontario Regulation 65/14
- PPTA's Response to Ontario's Proposal to Ban Compensated Plasma Donation
- In My View - Jan M. Bult, President & CEO, PPTA
- Why Compensated Donation is Ethically Imperative - James Stacey Taylor, Ph.D., The College of New Jersey
- Farrugia, A, Penrod J, and Bult JM. "Letter to the editor--Response to 'How Expanding Voluntary Non-remunerated Blood Donations Would Benefit Patients, Donors and Healthcare systems?'--F. Rossi, R. Perry, J. De Wit,T. Evers & G. Folléa, Vox Sanguinis DOI: 10.1111/j.1423-0410.2011.01495.x." Vox sanguinis 102.3 (2012): 269–270.