New EU’s pharma rules: a game-changer for strategic autonomy on plasma?

Ensuring sufficient plasma collection in Europe remains a thorny issue but the forthcoming revision of the EU framework for pharmaceuticals offers the potential to turn the tide.

Plasma is the main raw material used in the manufacturing of plasma-derived medicinal products (PDMPs), which treat a variety of rare, chronic, and potentially life-threatening conditions.

That includes diseases of genetic origin, as well as immunodeficiencies, bleeding disorders and neurological illnesses associated with the absence or deficiency of specific proteins.

It is estimated that 300,000 patients in Europe rely on these essential medicines, without which they might not survive or would have a substantially diminished quality of life.

However, more than 30% of PDMPs manufactured in Europe uses plasma bought from the US, as was recently remarked by a Commission official.

“Europe and the whole planet is quite dependent on the plasma collected in the US. That means that 5% of the world population is collecting 60% of plasma,” said Stefaan Van der Spiegel, the head of the sector for substances of human origin at the Commission’s DG SANTE

This concern was one of the key findings identified by the Commission in the 2019 evaluation of the EU legal frameworks on blood, tissues and cells

“The most important sufficiency challenges, however, relate to the EU reliance on imports for plasma for the manufacture of plasma-derived medicinal products and for some tissues, and to a lack of provisions for ensuring sufficiency in emergency situations,” the evaluation said.

According to the non-profit plasma manufacturing association International Plasma Fractionators Association (IPFA), eight million additional plasma collections would need to be organised in the EU in order to supply all patients with PDMPs.

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.

Meeting unmet needs

A much-awaited initiative to overhaul the current EU’s legislation on medicines is due to be presented at the very end of next year, according to a Commission’s working programme for 2022 presented on Tuesday (19 October).

The EU executive launched a public consultation on revising the general pharmaceutical, legal framework on 28 September, after publishing a roadmap last March that scheduled the final adoption by the fourth quarter of 2022.

The revision is part of the pharmaceutical strategy presented last November by the EU executive in a bid to “future-proof” the European healthcare sector in the wake of the COVID-19 pandemic.

In the pharmaceutical strategy, it is stated that this “patient-centred strategy” aims not only to ensure the quality and safety of medicines but also to boost the sector’s global competitiveness.

The focus falls on unmet medical needs as the strategy stated that systems of incentives need to be tailored “better in order to stimulate innovation in areas of unmet medical needs”.

Wide stakeholder engagement and multidisciplinary input are also highlighted.

For the industry plasma manufacturing association PPTA, there is currently a shortfall of 3.8 million litres in Europe of the plasma needed to manufacture PDMPs, which ultimately hampers the possibility to meet the needs of these patients.

Strategic autonomy

More importantly, the strategy had been expected to mark a milestone in the development of strategic autonomy in the field of European drug manufacturing.

One of its main goals was expected to be the launch of specific actions to avoid a future recurrence of shortages experienced during the COVID-19 crisis, when medicine-producing third countries put in place protectionist measures such as export bans on life-saving drugs.

Reducing over-reliance on the US when it comes to the collection of plasma, the starting material for PMDPs, is considered to be a step in the direction of bringing back medicine production to Europe.

The pharmaceutical strategy provided the opening of a “structured dialogue with and between the actors in the pharmaceuticals manufacturing value chain and public authorities” in order “to formulate policy options and propose actions to strengthen the continuity and security of supply in the EU.”

However, this study period, currently ongoing, will take another one year to identify vulnerabilities in the global supply chain of critical medicines, raw pharmaceutical materials, intermediates and active pharmaceutical substances.

The global context appeared to be key in addressing the revisions needed to current legislation.

Since plasma is collected and manufactured globally, concrete steps are needed to streamline and harmonise regulatory and pharmaceutical quality standards and requirements for plasma and PDMPs.

The strategy also highlights that the EU has an interest in working with its international partners towards a more ambitious level of quality, efficacy and safety standards in international cooperation. Common international standards are said to be a key tool as they facilitate the global development of pharmaceuticals.

Commission slows down on returning drug manufacturing to Europe

Despite widespread hopes for a quick shift towards ‘strategic autonomy’, the European Commission has made clear it needs another two years of reflection before coming up with proposals to reduce the risk of shortages caused by over-reliance on third-country medicine production.

[Edited by Gerardo Fortuna/Zoran Radosavljevic]

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