Adoption of the EP report “EU Pharmaceutical Strategy”
November 24, 2021 (Brussels, Belgium) — The Plasma Protein Therapeutics Association (PPTA) congratulates MEP Montserrat (EPP, Spain) for the adoption of the report “EU Pharmaceutical Strategy” during the European Parliament’s Plenary session. The report was adopted by 527 MEPs on Wednesday 24 November.
However, PPTA considers it a missed opportunity that plasma is not recognised as a critical starting material for the manufacture of essential medicines. The report calls for national and EU measures to guarantee that all patients have safe and timely access to essential and innovative medicines. It also recommends an increase in the EU’s resilience and sustainability while stressing that the “EU's open strategic autonomy and security of supply should be ensured through the diversification of supply chains for essential medicines and medicinal products.” The EU Pharmaceutical Strategy is a major initiative of the European Commission and the European Parliament and sets some main goals to be achieved on the long-term vision of the EU’s pharmaceutical policy.
PPTA regrets that the report does not include “starting materials such as plasma” next to "active substances” for the manufacture of medicinal products. As human plasma is not an ‘active substance’ per definition, the report fails to recognize the unique nature of plasma as starting material for the manufacture of lifesaving plasma-derived medicines (PDMPs). Nevertheless, human plasma is considered essential by the ECDC (European Centre for Disease Control) to manufacture PDMPs.
Maarten Van Baelen, Executive Director PPTA Europe says: “Today, some 30% (or 3.8 million litres) of the plasma used to manufacture plasma-derived medicines for EU patients comes from the U.S. The EU Pharmaceutical strategy aims to reduce the strategic dependency on third countries, such as for starting materials to manufacture essential medicines. Following that objective, policymakers need to make use of this opportunity for a change of new policies to collect more plasma in Europe. PPTA is ready to work with policymakers to support increasing plasma collection in the EU.”
Director, Global Communications
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