PPTA's Response to Ontario's Proposal to Ban Compensated Plasma Donation

Members of the Plasma Protein Therapeutics Association (PPTA) are deeply concerned regarding the proposed legislation in the province of Ontario. It appears to have a goal of eliminating the possibility of compensating devoted donors for their time and inconvenience associated with a process called plasmapheresis, used to collect source plasma, the essential ingredient of life-saving plasma protein therapies.

PPTA and its members are studying the proposal and its ramifications, but are taking this opportunity to communicate important facts for consideration by concerned individuals.

  • Plasma collected as source plasma is distinct and different from transfusible components. That is, donors who donate at such centers are donating plasma to be made into highly complex and highly effective protein therapies which are administered to patients who are critically ill. These diseases are often genetic, chronic, life-threatening conditions that require patients to receive regular infusions or injections of plasma protein therapies for the duration of their lives. Plasma protein therapies include clotting-factor therapies for individuals with hemophilia A and B and other bleeding disorders; immunoglobulins to treat a complex of diseases in individuals with immune deficiencies; therapies for individuals who have alpha-1 anti-trypsin deficiency, which typically manifests as adult onset emphysema and limits substantially life expectancy; and albumin, which is used in emergency-room settings to treat individuals with shock, trauma, burns, and other conditions. PPTA members are committed to assuring the safety and availability of these medically needed, life-sustaining therapies. Any “fact” asserting otherwise is either uninformed or misleading.

  • For centers licensed by respected national scientific authorities, compensated donation is subject to a strict regulatory battery of requirements. These requirements include physical examination, health history screening, and testing processes at the time of donation and, in addition, further downstream testing and processing which combines for a thorough and complete quality process. Products made from source plasma have been roundly accepted as being of the highest possible levels of quality and safety, including by regulatory authorities within the European Union and the United States. Plasma protein therapies made by PPTA member companies and collected from compensated donors in centers independently certified under the International Quality Plasma Program (IQPP) are therapies for which there have been no reported cases of HIV or hepatitis transmission for over two decades. Again, any “fact” asserting otherwise is misleading and dangerous.

  • Plasma donation is safe and well-tolerated. In recent years in the United States, plasma collections have exceeded twenty-five million compensated donations. This supplies not only the United States, but many other parts of the world, including products sent to Canada. Plasma donors in IQPP-certified centers are required to be Qualified Donors, which encourages repeat donations from committed donors. Because plasmapheresis typically takes far longer than a collection of blood components, donors are recognized for their time and commitment.

  • Global supply of safe and effective products to rare-disease patients is of the highest importance to PPTA member companies. The United States is the only country which is truly self-sufficient in blood and plasma protein therapeutics. This is a simple definition: the United States system of non-compensated and compensated donations not only meet its own needs with very high levels of patient access to care, but has sufficient ability to supply other markets around the world, including Canada. Canada, and dozens of other countries, routinely import products made from compensated donations in the United States; virtually all of these self-sufficiency goalsincluding Canada'shave been extremely hard to achieve in the absence of compensated donation.  As long as such prohibitions are in place, self-sufficiency will be very difficult to achieve.

If Ontario is truly interested in having safe plasma routinely donated by committed individuals, it will encourage the well-regulated placement of plasma collection centers which compensate donors for their time and effort. Using legislation as a tool to block individual initiative and choice is at odds with fundamental understanding of autonomy. Furthermore, basing such legislation on historical events that have long been superseded by technological advancement and operational improvement is, at best, inaccurate and problematic. It is far better to support policies which protect patients—including access to therapies—and are in the best interests of all citizens, using the most recent information and understanding of today’s industry.

PPTA and its member companies have long encouraged donation in all forms – compensated, non-compensated; community works and volunteering; participation of charity and awareness campaigns. It further underscores the importance of a diverse populace who should decide on their own the best ways to commit their own time for causes of their choice.

 

To view all relevant information concerning PPTA's response to Ontario's proposal to ban compensated plasma donation, please click here.

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