October 30, 2019
Press release: EBA reasserts need for robust strong EU legislation for BTC
News
European Blood Establishments reassert the need for robust a European legislation on Blood, Tissues and Cells to protect patients and donors.
More than 20 million of units of blood are donated and collected every year in the EU, thanks to 15 million donors and through 1400 Blood establishments. Blood collection, testing, processing, storage and distribution is regulated at EU level by several Directives that are deemed outdated and not fit for purpose anymore, as the European Commission evaluation of these texts revealed.
The European Blood Alliance (EBA), representing 26 countries of the European Union and EFTA, reaffirmed at the conference held on 28th October by the European Commission the need to protect donors and patients through sound legislation and guidelines based on latest scientific developments. Future legislation should not include technical aspects other than a reference to the EDQM Blood Guide, for an easier and faster adaptation to scientific progression in the field.
EBA reiterated the role of blood establishments in providing Member States quality blood and blood components, including plasma as a raw material for medicines, through voluntary and non remunerated donations.
Professor Philippe Vandekerckhove, President of the EBA stated: “European Member States must increase their collection of plasma via long-term national strategic plans that would not risk eroding the donor basis through a market driven system; it is not a paid versus unpaid donation discussion. The introduction of EU internal market for pharmaceutical products without accompanying measures to ensure sourcing from within Europe led to import of cheap plasma from the USA which led the blood establishments to downscale their plasma donor base; the EU must correct this now”.
EBA strongly advised EU policy makers to keep all blood and its components’ legislation into the present legal framework, which legal basis in public health and not be moved into medicinal legislation; there should not be a parallel system for, e.g. plasma, including for fractionation, as blood products must not have a status of commodities or good, but remain a strategic service.
