Changing dynamics in the world of plasma: is Europe ready?

Plasma is a hot topic. The liquid component of blood is vital for many health treatments, particularly for rare diseases. Now, COVID-19 has caused shortages, making donors shy away while demand surges on plasma’s potential as a coronavirus treatment. Europe was already heavily dependent on imports, particularly from the United States. As the European Union revises its Blood Directive, there are calls for a rethink of how plasma is regulated to overcome differences among member states, generate public-private synergies and guarantee supply chains that protect patients and donors.

“We are at a crossroads because the COVID crisis clearly pointed out that we have too little Europe in healthcare,” (20:09) said Katalin Cseh, Member of the European Parliament Committee on Industry, Research and Energy (ITRE), “We see the problems of coordination; the problems of over-reliance on external actors; the problems that come with health inequalities within our communities. And I can hope that in the coming months we will do whatever we can to fix it.”

Cseh was joined by contributors from the European Commission, patients’ organisations, industry and non-profit blood establishments for the hour-long Friends of Europe online debate.

More plasma for Europe, more Europe for plasma

In Europe, more than 300,000 chronic-disease patients depend on plasma, often for life-saving treatments. But Europe does not produce enough. More than 35% of its supply comes from the United States. COVID-19 has highlighted the fragility of supply chains, triggering appeals for a more joined-up EU approach to replace the mosaic of national policies governing plasma collection and distribution.

“It is important … to reduce our dependence, especially from the US, because we see now how the market can be fragile, we see shortages of plasma products,” (9:44) said Andrzej Rys, Director for Health Systems, Medical Products and Innovation at the European Commission Directorate-General for Health and Food Safety. “We should reduce the fragility of the European system, but how do we do it? There are many complex processes, but also steps that we should take together.”

14:46 Patients are anxious, there are fears that life-preserving treatments could be phased out. (Martine Pergent, Chair of the International Patient Organisation for Primary Immunodeficiencies)

17:31 Overconcentration of plasma production in a handful of countries weakens supply chains and endangers patients everywhere; Europe must avoid waste of plasma which still happens. (Pergent)

21:34 The best thing Europe can do is have more harmonisation and coordination, with better guidelines and more resources for health and research to make Europe a world leader. (Cseh)

41:26 To minimise the risk for patients, politicians should agree plasma is a strategic good; we are too dependent on imports from the United States. (Paul Strengers, Medical Director of the Division of Plasma Products at the International Plasma and Fractionation Association)

50:50 We need new technology to solve the dependency on plasma products, through investment in research for alternative or more effective treatments for patients dependent on plasma and plasma-derived medicines. (Cees Smit, Patient Expert at the Haemophilia Group)

52:48 The Commission expects the update of the EU blood products directive to be completed in 2021; it should produce a better regulation based on facts and science, and through consultation with stakeholders. (Rys)

To pay or not to pay?

There was broad agreement plasma should be treated as a ‘strategic product’, but the debate revealed differences over whether Europe should move closer to the US system of remunerated plasma donations. That option is currently only allowed in Austria, the Czech Republic, Germany and Hungary. While some argued payment is the way to prevent shortages, others raised ethical and donor-safety concerns if plasma donation becomes a business transaction.

“Blood and plasma must be considered a public service, not a market-based one; this designation protects the EU domestic blood and plasma chain. Plasma should not be considered a good in the internal market sense,” (28:18) said Catherine Hartmann, Executive Director of the European Blood Alliance (EBA). “Not-for-profit blood establishments are fully committed to increasing their plasma collection without paying their donors and have measures in place to achieve this goal on donor recruitment and retention.” (29:31)

27:46 An increase in donations to meet demand should be achieved by generating a higher donor base rather than increasing donations per donor as is common in a remuneration system. (Hartmann)

31:30 Plasma products should be regulated on public health rather than internal market legal basis; EU legislation should be updated and aligned so blood and plasma products are regulated consistently. (Hartmann)

36:03 Public sector monopolies are a barrier to increased plasma collection in many states; that needs to be changed and the European Commission can play a leadership role. (Maarten Van Baelen, Executive Director Europe at the Plasma Protein Therapeutics Association)

37:29 Remunerated collection can overcome dependence on imports so that the supply chain is protected, and the non-profit and private sector can meet growing demand while assuring the well-being of donors. Plasma collections are three-times higher per capita in countries where the private sector operates (Van Baelen)

39:39 Lawmakers should side with plasma being classified as a public good, while incentivising the involvement of business in production. (Cseh)

42:22 Plasma should be treated as a public good, to distinguish it from other medicines. (Strengers)

45:48 Remunerated plasma donation does not lead to ‘crowding out’ of free blood donation. (Van Baelen)

47:34 Paid plasma donation with high-profile marketing has a negative impact on the image of blood donation. (Hartmann)

What Should Europe Do?

All the speakers had clear ideas of what they would like to see from Europe in order to recognise the importance of plasma, improve the regulatory framework governing its collection and use, and guarantee security of supply.

“We all agree that plasma is a strategic resource and that should lead us to overcome the usual debates, think out of the box,” (1:00:32) said Pergent. “There is a need for patient-centred policymaking on PDMPs (Plasma-derived Medicinal Products).”

1:01:55 Europe should recognise plasma as a strategic service and protect it as such; we need to bear in mind donor health. (Hartmann)

59:56 We need to find the European denominator, that balances the approach of different member states, public and private operators, protects donors and patients, and guarantees supply chains. (Rys)

1:01:19 We need more Europe to reduce inequalities in health, to meet the needs of patients, and make sure that everybody has the same access to plasma and treatments. (Cseh)

1:02:26 Plasma should be recognised as a strategic resource; promote co-existence between the private and public sector in collecting plasma. (Van Baelen)