Future access to Plasma Derived Medicinal Products: Patient Centred Decision Making
29 September 2020, 15:00 – 16:30 hrs
Online event co-organised with the support of MEP Sirpa Pietikainen (EPP, Finland)
Platform of Plasma Protein Users is an umbrella patient platform formed by the patient groups: European Haemophilia Consortium, Alpha-1 Global, GBS/CIDP, HAEI, World Federation of Haemophilia, APLUS and IPOPI. PLUS meets every year to discuss pressing topics concerning plasma products and their impact on patients’ health.
Plasma derived medicinal products (PDMPs) are products prepared from human plasma. These products include life-saving therapeutics for several chronic and acute life-threatening diseases.
Grasping the full benefits of PDMPs is dependent on overcoming multiple challenges to optimal patient access. In the EU, these challenges include sufficient supply of plasma to meet the health needs of patients, ensuring the availability of safe PDMPs, ensure cooperation between the blood and plasma sectors etc.
Following the publication of the European Commission’s final evaluation on the EU blood, tissues and cells legislation on 11 October 2019 and the meeting of the Committee on the Environment, Public Health and Food Safety on 3 December, it appears likely that the European Parliament’s work on the Blood, Tissues and Cells (BTC) legislation will begin soon. The European Commission is also foreseeing a study to determine follow-up actions to address shortcomings identified in the evaluation of the BTC legislation (Commission Third Work Programme).
In addition, DG SANTE, and in particular the team in charge of Substances of Human Origin, is working on an inception impact assessment (IIA) on the revision of the Blood Directive, which will be published soon. Building on the IIA, the Commission will prepare an impact assessment (IA) examining whether there is a need for EU action and analysing the impacts of available solutions.
Members of PLUS are committed to addressing the various shortcomings in the current policy framework from a patient perspective. They have followed the developments surrounding the BTC legislation closely. Through this event, PLUS intends to catalyse a discussion on a patient centred approach in future decision-making.