MEP: Clear EU definition of plasma would pave way for better awareness

"Communication is essential to ensure that citizens understand the crucial difference between blood and plasma and understand the unique role that plasma plays in producing certain medicines," said Deirdre Clune, an MEP for the constituency of Ireland South, having been first elected in 2014. [MARVAUX/EP]

Communication about the importance of plasma donations can be improved by focusing on a clear definition in the EU legislation, ensuring that more awareness is raised about the role it plays in producing life-saving medical products, a centre-right EU lawmaker told EURACTIV.

Deirdre Clune is an Irish MEP for the European People’s Party (EPP). She spoke to EURACTIV’s health editor Gerardo Fortuna.

Today (14 June) is World Blood Donor Day, an initiative by the World Health Organisation (WHO) to spread awareness about blood donation – and plasma is a blood component too. What can be done to raise awareness about this at the EU level?

This day serves as a reminder of how important donations of blood and blood components are. EU-wide public campaigns can play a role in making citizen aware of the need for plasma and educating them about plasmapheresis – a more efficient method for plasma collection than traditional blood donation techniques and their associated benefits.

Plasmapheresis allows for a much larger collection of plasma per donation while also permitting donors to donate more frequently. Also, the EU has to ensure that there is the right legislative framework in place to increase the volume of plasma collected by strengthening supply chains and reducing dependency on third countries.

Speaking of that, it is estimated that plasma volumes currently collected in Europe fulfil only around 62% of the clinical need, while the rest of plasma is mainly imported from the United States. How the EU can encourage donations?

The overreliance on the US for plasma is a strategic vulnerability for the EU. Plasma is the raw material used in the manufacturing of plasma-derived medicinal products (PDMPs), life-saving therapeutics for hundreds of thousands of European citizens.

It’s important to keep in mind that there is no alternative raw material that can be used to produce these products. These medicines are used to treat rare and chronic diseases, often of genetic origin, including immunodeficiencies, bleeding disorders and neurological illnesses associated with the absence or deficiency of specific proteins.

Commission: EU's new blood directive to address dependency on US plasma

The ongoing revision of the European legislation on blood, tissues, and cells offers an opportunity to tackle the highly problematic dependency on plasma collected in the US for manufacturing plasma-derived medicinal products (PDMPs), according to an EU health official.

There’s also a lack of information on plasma donations. What’s the role of communication and how can it be improved?

In Europe, citizens are very familiar with blood donations, but few people know about plasma and the role it plays in providing life-saving medicines. Private companies are active in raising awareness among the public in those countries where they can collect plasma. As a public health issue, there is also room for public institutions to further promote campaigns that aim to increase plasma collection within the EU.

Communication is essential to ensure that citizens understand the crucial difference between blood and plasma and understand the unique role that plasma plays in producing certain medicines. A clear definition of plasma in the EU legislation would pave the way for medical organisations and associations to emphasise this difference in their campaigns, ensuring that the importance of plasma donations can be highlighted among the target audience most affected.

The Commission is currently in the process of overhauling the two blood, tissues and cells directives. Do you think this review could offer opportunities to ensure a more sustainable plasma supply in the EU?

Indeed, this legislative review presents a unique opportunity to update and modernise the legislative framework, recognising the importance of plasma for the production of certain medicines that are vital for many EU citizens.

The COVID-crisis has highlighted the fragility of the plasma supply and the risks to PDMP availability associated with relying heavily on one market for plasma, as collectors have experienced declines in collections during the pandemic.

But what can the Commission actually do?

The Commission should consider how to best support and reinforce Member States’ national plans on plasma collection. An important first step will be to explicitly differentiate within the legislative frameworks between plasma for further manufacturing from blood intended for transfusion and facilitating the involvement of private sector actors in the plasma collection processes, including supporting the implementation of plasmapheresis programs.

Incentives are proven to be effective in supporting a greater level of plasma sufficiency. What’s your take on compensation for donors?

It is important to note that the process of plasma donation can take around 1-2 hours. Compensation for a donor’s effort and inconvenience is consistent with the voluntary unpaid donation (VUD) principle, as applied in other legislative frameworks.

It is not a payment for a biological product neither a source of financial gain, but compensation for effort, time spent travelling or in donation centre and inconvenience associated with donation. Many countries in the EU that do not allow monetary compensation choose to reward donors in other ways such as a paid day off work, tax benefits or gifts such as cinema tickets.

The form of such reward does not have to be monetary and not all forms of compensation are monetary in nature, but compensation is ethically compatible with the VUD principle and reflects the societal value that donors contribute to supplying vital products for the production of medicines.

Private actors are allowed to play an active role in plasma collection only in a few countries. Do you think this could be a source of shortcomings?

The organisation and delivery of health is primarily an EU member state competence and it is up to countries to make decisions that best serve to guarantee citizens’ access to medicines. That being said, data on member state per capita plasma collection demonstrates that the countries which allow for the involvement of the private sector in collecting plasma contribute disproportionally to addressing the dependency on third countries.

In four countries – Austria, Czechia, Germany and Hungary – where both public and private institutions may collect plasma, donation volumes are substantially higher than in the rest of Europe. Where it operates, the private sector contributes effectively to the collection of plasma along with public institutions.

Another related issue is the access to plasma therapies for patients who rely on them. What are the main pitfalls that need to be addressed?

Patient access to PDMPs starts with the EU countries imperative to ensure there is a sufficient supply of plasma, the key raw material for manufacturing these products. The current framework could be improved by ensuring that donor eligibility regulations are based on the latest scientific evidence thereby harmonizing rules on donation frequency. In addition, explicitly differentiating plasma for further manufacturing from blood intended for transfusion would serve to improve the blood regulation.

COVID-19 pandemic casts new light on plasma therapies

The use of COVID-19 convalescent plasma (CCP) as a therapeutic option, despite its ups and downs, has shown the European Union’s renewed interest in plasma-derived medicinal products (PDMPs).

[Edited by Zoran Radosavljevic]

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PPTA

The Plasma Protein Therapeutics Association (PPTA) is the global industry trade association with a strong European presence representing the private sector manufacturers of plasma-derived medicinal products (PDMPs), and privately-owned plasma donation centres, which includes more than 150 centres in Europe. PPTA is steadfast in its mission to promote the availability of, and access to, safe and effective plasma protein therapies for patients around the world.






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