For International Plasma Awareness Week (IPAW) 2023, there are quite a few new, exciting, and science-based advancements to report in regard to plasma donations worldwide. Allowing science to guide the discussion and drive policy throughout the world is key, and these new guidelines represent significant progress in that regard. Thankfully, updated regulations in several countries will increase the global supply of plasma. Internationally, the need for plasma is at an all-time high—6,500 units of plasma are needed daily in the U.S. alone.
The U.K., for example, just lifted a 20-year ban in 2021 that now allows its citizens to donate plasma for domestic use and has opened three donation sites in Birmingham, Reading, and Twickenham since the ban was lifted. While the ban was put into place originally as a preventative measure against transmitting variant Creutzfeldt-Jakob disease (vCJD, also known as mad cow disease), cases of the disease have remained low since 2004. This drop in cases, combined with the fact that processes have developed to reduce plasma infectivity, makes the risk of transmitting vCJD through blood products extremely small. The U.K.’s Minister for Innovation has such confidence that he stated all those thinking about donating plasma should “absolutely take the plunge.”
In Canada, Canadian Blood Services (CBS), which is a nonprofit funded by provincial governments, reached a deal in September 2022 with the Spanish pharmaceutical company Grifols, allowing individuals to be compensated for their donations of plasma. CBS banned paid donations in 2014 after tainted blood products from HIV and hepatitis C-positive donors resulted in 8,000 deaths in the 1980s.
Today, however, measures such as extensive testing and virus removal procedures are in place to make plasma products safe regardless of monetary incentive. In fact, these regulatory and safety measures have resulted in not a single case of tainted blood since that outbreak. Grifols now has a plasma donation center in Winnipeg, Manitoba, and is developing one in Edmonton, Alberta. A center in Ontario is also expected to be operational in 2024 to continue to work toward meeting the healthcare needs of Canadians.
Based on medical evidence, Australia is leading the way in replacing a previous policy of deferring entire groups of people based on sexual risk factors. For example, this individual risk assessment being adopted internationally allows, for the first time, men who have sex with men (MSM) to donate. The new approach evaluates risk with individual assessments for every donor and could impact upwards of 57,000 people. Australia will also be the first country to allow men on pre-exposure prophylaxis (PrEP), a medication taken to prevent getting HIV, to donate. To prevent HIV transmission, measures are still in place regarding an individual's sexual conduct, with various restrictions to ensure safe plasma collection. The donor is also tested for HIV, hepatitis B, and hepatitis C, and the plasma is also tested post-donation for antibodies that the body produces in response to a virus.
These new measures will not only remove unnecessary restrictions that apply to only certain groups, reducing discrimination and stigma, but also will allow many individuals who wish to donate plasma and were turned away in the past to do so. Ultimately, these policy changes are projected to significantly boost the amount of plasma collected.
The health of plasma donors is just as important as the patients who need plasma-derived therapies, which is why research is being conducted to ensure donor safety. This research shows that plasma donation may result in a brief reduction of immunoglobulin (IgG) before levels return to baseline within 48 hours. The study tracked both physical and mental components over different periods of time and found little to no meaningful changes relative to before and after donation, regardless of the frequency of donation. The most common reporting is cold, fatigue, cough, and sore throat after donation. The goal of the study was to ensure donor health and well-being as a key to sustaining and fostering participation in plasma donation programs. These findings provide evidence refuting critics who fear that plasma donors being compensated will lead to negative health outcomes.
Still, of the 171 countries that report on plasma-derived medicinal products (PDMP), 115 do not produce any at all. Despite that, the World Health Organization (WHO) has been at the forefront of improving blood safety and availability and states, “providing safe and adequate blood should be an integral part of every country’s national healthcare policy and infrastructure.” Of the countries that do collect plasma donations, the median per 1000 citizens is still only approximately 5 liters per year.
The European Union (EU) Commission, Council, and Parliament are currently discussing legislation that was introduced in 2022 on substances of human origin (SoHO) intended for human application. On September 12, 2023, the EU moved forward with language stating donors can only be compensated for quantifiable losses/expenses incurred during donation. At this point, it's unclear if the paid donations system that is in place already in a handful of EU countries will be able to continue under that language. Barring donor compensation may have the opposite effect if, in the next leg of this legislative process, restrictive language around plasma donation compensation is adopted. This would be in contrast to the goal of making EU countries less dependent on imported plasma.
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