The report on ‘An EU-wide overview of the market of blood, blood components and plasma derivatives focusing on their availability for patients’ was published by the European Commission (EC) in April 2015. The document states that its key objective is to provide an economic perspective on the European blood sector. This was done against the background of understanding and improving the safety, quality and availability of therapies delivered by the sector to European patients.
The authors of the report remind that while safety and quality of blood and blood components are within the mandate of the EC, availability, which is a recurring concern for patients, healthcare authorities and healthcare professionals, is a competence of the Member States.
The report indicates that plasma collection for manufacturing has almost doubled between 1993 and 2010 going from eight and half to 16.6 million litres collected, which has naturally affected the growth for plasma derivatives. Unlike blood components for transfusion, plasma derivatives are considered as proper pharmaceutical products and have to comply with the pharmaceutical legislation in place in the country where they are marketed. The report estimates that the value of the plasma derivatives market in Europe in 2011 was close to three billion euros while the market for recombinant coagulation factors for the same year was worth another one point three billion euros.
The document denotes that the market is quite complex due to diverging activities and interests of the stakeholders some of which belong to the private sector while others belong to public or semi-public sectors. These differences often create divergent opinions on, for example, the interpretation of the principle of voluntary and unpaid donation. Another topic of divergency is the definition of self-sufficiency, a concept strongly encouraged at European level. Finally, the definition of shortage also creates controversies. Other aspects examined by the document are trade barriers and demand management.
The Commission concludes on a clear tension between the transfusion and plasma derivatives sectors. The report also denotes that both sectors rely on citizen’s donations. However, the difference in growth and the stakes that go with it, has put different expectations and pressures on the required number of donations and lead to different views on issues like voluntary unpaid donation, self-sufficiency and shortages. The EC recommends the development of common definitions for clearer interpretation, common understanding and transparency. Finally, the EC concludes that these differences in approach lead to different views on risks, e.g. related to epidemiology or processing steps, and related safety and quality measures.
On the issue of shortages, the European pharmaceutical industry has teamed up to develop a set of joint principles regarding quality, manfuacturing and supply disruption. The Association of the European Self-Medication Insutry (AESGP), the European Federation of Pharmaceutical Industries and Associations (EFPIA), the European Generic medicines Association (EGA) and the Plasma Protein Therapeutics Association (PPTA) released the ‘Communication of information on quality and manufacturing potential supply disruption,’ which forms part of the industry response to the European Medicines Agency (EMA) call for voluntary and proactive action to provide European patients with continuous access to medicines. As manufacturing and quality issues can causes medicine shortages, and Marketing Authorisation Holders (MAH) are obliged to notify Competent Authorities (CA) about these issues, this ‘Principles’ document introduces a harmonised approach to the communication of information by MAHs, meeting the complex and divergent data requirements across national Competent Authorities and the EMA.
The group of pharmaceutical companies have proposed the following measures to streamline reporting to the EMA:
- An identical trigger point for notification based on:
- an agreed definition of a meaningful disruption, and
- a triage process that evaluates the risk associated with a potential supply disruption
- Harmonised reporting content and format
- An agreed time point and recipient of the information for all nationally and centrally approved products.
The trade associations believe that the framework for communication between the MAH and CA can form part of a more comprehensive approach to prevent and mitigate medicine shortages when combined with the outputs from other work streams.