Benefits of the Substances of Human Origin (SoHO) Regulation.

At the end of June, the European Parliament’s Committee on the Environment, Public Health and Food Safety (ENVI) will vote on amendments to the European Commission’s draft proposal for a regulation on quality and safety standards for substances of human origin intended for human application (SoHO Regulations). This includes plasma. It is essential that the new regulation is informed by science and facts and that agreed solutions for sustainable sourcing across Europe are grounded in reality, putting the well-being of donors and patients first.

Plasma is the single largest component of human blood that contains proteins that are vital to the human body.

Plasma is the single largest component of human blood that contains proteins that are vital to the human body. Plasma-derived medicinal product (PDMP) medicines are essential therapies that treat a variety of rare and complex chronic diseases, replacing missing or deficient proteins and enabling people with lifelong conditions to lead a healthier and more productive life. Some patients have no alternatives. It is only through the selfless donation of plasma by healthy volunteers that these medicines can be produced.

As confirmed by the recently released independent Marketing Research Bureau (MRB), Europe currently relies on the United States for almost 40% of the plasma needed to produce PDMP to treat its citizens. Demand in Europe for essential PDMPS, such as immunoglobulins, grew by 6.7% per year in the period 2010-2021[i]. Therefore, it is crucial that the new legal framework helps EU member countries to increase plasma collection in Europe to support increased patient access to PDMPs.

Europe currently relies on the United States for nearly 40% of the plasma it needs to make plasma-derived medicines to treat its citizens.

Plasma collectors rigorously and continuously monitor and evaluate plasma donation procedures and practices, and report all donor adverse events (AEDs). Indeed, the donation of plasma at the source via plasmapheresis during which the plasma is separated from the other blood components which are then returned to the donor has very few AEDs. An evaluation of over 12 million plasma donations showed how rare AEDs are, with 15.85 events per 10,000 donations[ii]a number comparable to donating blood.

The EU needs more plasma! | via PPTA

Plasma manufacturers also continue to invest in new studies. The safety of donor plasma has been demonstrated in a number of studies[iii]. Donor health and donor health parameters are monitored regularly, as required by national regulations, to ensure donor safety is maintained.

Furthermore, EU regulations establish requirements for the collection and analysis of human plasma for further production, regardless of its origin. The requirements for the quality, safety and efficacy of the starting material (plasma) and the final product (PDMP) are the same, regardless of where the plasma comes from (US or EU) or how it is obtained (plywood vs. plywood)[iv].

For some, however, it is the act of compensation in the form of a flat-rate allowance, with conditions set by member countries, that has prompted calls for changes to the SoHO text that are likely to discourage donors and prevent reliable patient access. Donor compensation recognizes the inconvenience donors face and the special effort they have to make when donating plasma. This is because while a blood donation can take 15 to 20 minutes, a plasma donation done via plasmapheresis takes about four times as long.

The European Commission has clearly stated in the proposed regulation that compensating plasma donors in the form of a flat-rate indemnity is consistent with the principle of voluntary unpaid donation (VUD)[v]. The amount and form of compensation must be determined and regulated by the authorities of the member countries.

Policies that encourage compensation for source plasma donors have been shown to increase plasma donation rates.

Most European countries provide some form of compensation. Policies that encourage compensation for source plasma donors have been shown to increase plasma donation rates. This compensation varies in form, from paid days off, to tax breaks, vouchers and fixed allowances. In Austria, Germany, Czechia and Hungary, where compensation takes the form of flat-rate allowances and private industry is authorized to collect, they not only meet the plasma needs of their citizens, but also contribute more than 46 per cent of the total amount of plasma needed to produce PDMP for patients in Europe.

Significantly, EMA recognizes the contribution of compensated donation to the treatment of rare diseases in the EU: it is important to recognize that a very large part of the total plasma used in the production of PDMPs used in Europe comes from paid or remunerated donations. A requirement for unpaid or unpaid donors would create serious supply problems and product shortages without any justification for safety reasons.[vi] Not allowing EU countries the option to allow for redress, whether by the public, private or third sector, would lead to declining plasma donation volumes and reduced access to life-saving PDMPs. While many EU countries have sought to increase national plasma sufficiency, the new MRB report underlines that there is still a long way to go. France and Italy have long-term goals to be self-sufficient, but in 2020 they had immunoglobulin self-sufficiency rates of only 27.5% and 32%, respectively. While these countries and many others in the EU rely on immunoglobulin imports, Austria, Czechia, Germany and Hungary harvest more plasma than the immunoglobulin demand and support supply in other countries.

The bottom line is that donating plasma is safe. And Europe will only succeed in achieving strategic autonomy in plasma if it recognizes that compensation through a fixed monetary allowance provides an important option for EU member countries. Whether plasma is collected by the public, private or third-party sectors (such as NGOs), offsetting is a proven tool to reduce dependency on other countries, strengthen European healthcare systems, and make accessible and uplifting the experience of donation so more people choose to donate plasma and save more lives.

Why should plasma donors be compensated for expenses and inconveniences? | via PPTA

[i] Facts and figures on self-sufficiency for the production of immunoglobulins from plasma of European origin; Available here: https://marketingresearchbureau.com/plasma-flows-on-a-global-level/data-pertaining-to-soho-regulations-and-european-union-plasma-self-sufficiency/ (last accessed May 2023 )

[ii] Cho J, Hiskey M. Plasmavigilance: Source plasma joins call to arms, Transfusion. 2021;61:28032805. https://doi.org/10.1111/trf.16668

[iii] Purohit M, Berger M, Malhotra R, Simon T. Review and assessment of donor safety among plasma donors. Transfusion. 2023. https://doi.org/10.1111/trf.17369

[iv] Guidelines on Epidemiological Data on Bloodborne Infections (EMA/CHMP/BWP/548524/2008): https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-epidemiological-data-blood -transmissible-infections-revision-1_en.pdf ; Guidelines on scientific data requirements for a plasma master file (PMF)/EMEA/CHMP/BWP/3794/03: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-scientific -data -master-plasma-requirements-file-pmf-revision-1_en.pdf; Guideline on plasma-derived medicinal products/ EMA/CHMP/BWP/706271/2010/ 21 July 2018: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-plasma-derived- medicinal-products_it.pdf

[v] Commission staff working document on the implementation of the principle of voluntary and unpaid donation of human blood and blood components as set out in Directive 2002/98/EC: https://eur-lex.europa.eu/legal-content/en /TXT /?uri=CELEX:52016SC0130

[vi] CMP position statement: Unpaid and paid donors: safety and supply of plasma-derived medicines (EMEA/CPMP/BWP/1818/02/Final) https://www.ema.europa.eu/en/documents /position /cpmp-position-statement-non-remunerated-donors-remunerated-supply-of-safety-plasma-derived-drugs_en.pdf

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