Author
Dr.-Ing. Heinz Stutzenberger, as published in Alpha1 Journal 1/2023.
The International Plasma Protein Congress (IPPC2023), organized by the Plasma Protein Therapeutics Association (PPTA), took place in Lisbon from June 20th to 21st, 2023. The following report summarizes the presentations relevant to individuals with alpha-1 antitrypsin deficiency.
The first session dealt extensively with the topic of "donor safety." This concerns the question of whether plasma donors might suffer health problems due to the high frequency of donations and the associated removal of blood plasma components. It's important to know that, depending on country-specific regulations, plasma can be donated up to 60 times per year in the EU (approximately 100 times in the USA) because its components can be regenerated relatively quickly in the liver (unlike whole blood, for which a waiting period of several weeks is necessary between donations, as red blood cells are produced comparatively slowly in the marrow of the larger bones). There are several reasons why the topic of donor safety generally receives considerable attention, and especially so at present:
- the aforementioned fear of the deprivation of vital blood components
- the fact that plasma donation is likely to be classified as high-risk in the new EU directive on SoHO (= Substances of Human Origin = substances of human origin, such as blood, plasma, skin, egg cells).
- The experience that blood purification often leads to side effects, and that a similar apparatus and procedure to plasma donation are used in its execution.
Several presentations, based on the results of long-term studies of plasma donors as well as targeted experiments, demonstrated that even frequent plasma donation does not lead to adverse health effects. For example, the blood level of immunoglobulins, which are essential for defending against pathogens, drops significantly after the first few donations made at short intervals, but then stabilizes at a level sufficient to protect donors from infections to the same extent as the general population who do not donate. This has been proven to be true even for donors who donate plasma beyond the limits permitted in Germany. Bone fractures do not occur more frequently in plasma donors (as one might fear due to the depletion of calcium-containing blood components), and iron deficiency-related problems are not more common. A more conscious lifestyle among plasma donors (e.g., abstaining from smoking and alcohol in the hours before donation) and the intensive testing of donors and their blood can even have a positive impact on health, as diseases are detected early. The fact that blood purification often leads to undesirable effects in test subjects is simply due to the fact that these individuals are already very ill, whereas plasma donors must demonstrably be very healthy to even be eligible to donate. Overall, one couldn't help but get the impression that the operators of plasma donation centers feel unnecessarily hampered by the corresponding SoHO regulations, since (understandably) the health and well-being of their donors is of paramount importance to them, purely out of self-interest: without healthy donors, there is no usable plasma, and without plasma, there are no marketable plasma products.
Besides the availability of plasma products, which will be discussed further below, access regulations for plasma-derived medications, such as reimbursement by health insurance companies, are crucial in determining whether these medications are available to patients. Within Europe, there is a wide range of regulations in this regard, as illustrated by the example of alpha-1 antitrypsin: at one end of the spectrum are countries like Germany and Spain, where, despite a comparatively high number of affected individuals, treatment is covered up to 100% of % if the relevant prescription criteria are met. In contrast, there are numerous countries where treatment is not covered at all, and between these extremes, there is a large number of sometimes curious and even macabre regulations. For example, in some countries, health insurance companies only cover treatment for a limited number of patients; newly diagnosed individuals are placed on a waiting list, from which someone is only admitted for treatment when someone on the waiting list drops out.
Another session was dedicated to the security of supply of blood plasma products. The importance of this issue became particularly clear to all participants during the COVID-19 pandemic, which led to supply shortages of plasma products due to a lack of deliveries from the USA. Globally, Europe is dependent on plasma imports from the USA, and after the pandemic, the political goal was set to reduce this dependence. However, this is hampered by internal EU regulations: within the EU, only four countries are able to meet their own needs: Germany, Austria, the Czech Republic, and Hungary. This is because, in addition to the public sector blood donation organizations, such as the Red Cross or large hospitals, these countries also have privately operated plasma centers. But these, too, are subject to the regulation that only voluntary, unpaid donations (in EU legal terms: VUD = voluntary unpaid donation) are permitted within the EU. Compensation for the donor's expenses related to the donation is permissible, but the amount can be set individually by each country, usually in the low double-digit euro range. However, there are some very unusual solutions, such as in Poland: there, donors may only be compensated with chocolate bars, a maximum of seven per donation (though health-conscious plasma donors don't eat them due to their high sugar content!). However, the employer must grant the donor a day off for each donation, which would theoretically allow them to more than double their vacation entitlement. This is purely theoretical, though, and cannot be implemented due to a lack of donation centers.
„"A more conscious lifestyle among plasma donors and the intensive examinations of donors and their blood can even have a positive effect on health."“
To reduce Europe's dependence on imports, establishing a privately run blood donation system appears helpful, as can be concluded from the successes of the four countries mentioned above. However, public blood donation centers often fear that this will lead to a loss of donors (a so-called "crowding out"). Whether this is a real threat is certainly debatable, since, for example, donation centers are not profitable in rural areas, yet the blood drives of public organizations are very successfully established there. Smart regulations can also specifically prevent the feared exodus of donors, as the example of Hungary shows: there, plasma donors must donate blood at least once a year before they can donate plasma regularly again after a correspondingly long waiting period (plasma is, of course, also obtained from whole blood donations).
The next session focused on the ethical aspects of plasma donation. While in Anglo-American countries it is generally considered acceptable, or even desirable, to incentivize people to donate plasma through payment (which naturally provides a greater incentive for the poorer segment of the population), many Europeans are rather skeptical or even opposed to this type of motivation. However, it is striking that the concerns of plasma recipients are often not acknowledged at all, or not adequately, in this discourse: receiving plasma products in acute situations is often a matter of life or death, and long-term treatments are only considered if they can achieve a significant improvement in the recipient's health, prevent or delay its deterioration, or significantly improve their quality of life. Paying for this is, of course, widely accepted, including in Europe.
In summary, the event described provided a comprehensive overview of the topic of plasma donation. It is understandable that the majority of the speakers expressed views aligned with the organizers' objectives. However, the emotional encounter between a highly motivated plasma donor and a young woman who relies on plasma donations to lead a somewhat normal life beyond being confined to a reclining/standing wheelchair impressively demonstrated that the interests of plasma recipients were also strongly represented.
