by Dr Peter Liese, MEP, European People's Party Coordinator – Environment, Public Health and Food Safety

In Europe over 2000 establishments provide hospitals and clinicians with tissues and cells to help treat a great variety of medical conditions. These include leukemia, burn wounds, infertility, cardiac insufficiency and blindness. Continuous innovations in this rapidly growing sector allow for more and better treatments for the benefit of patients. Tissues and cells are also the starting material for many advanced therapy medicinal products.

The role of the European Union in this important sector is to ensure that patients can rely on high quality and safety standards applied throughout the EU.  The original legislation dating from 2004 calls in particular for a thorough screening of donors, testing of all donations and high standards for handling/processing tissues and cells. In the past decade, the European Commission has complemented the basic legislation with new rules and guidelines.

This April the Commission adopted two new Directives, which should be warmly welcomed. The first will ensure that tissues and cells imported from third countries meet the same safety and quality standards as those originating within the EU. The second improves the tracing of substances across Europe, from donor to recipients. A new coding system will allow the actors and authorities to alert each other and take corrective actions whenever needed.

The biotechnology sector is currently undergoing significant changes. These changes bring about a number of challenges/questions. In particular they raise the question of whether the current regulatory framework is still fit for purpose. They also raise a number of ethical issues, e.g. how the principle of non-commercialisation is respected in the EU. In my view, the time has come to review the legislative framework (in particular tissues and cells and advanced therapies) in a holistic/comprehensive manner.