BioWorld International Correspondent
BRUSSELS, Belgium - The European Parliament's agenda this week includes two more major debates concerning the European biotechnology industry. It is aiming to reach agreement on new rules for human tissues and cells and on the major rewrite of the EU's extensive rules on authorization and monitoring of pharmaceuticals.
Parliament is to vote on proposals for standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells. The new rules would cover all tissues and cells that are used for application to the human body (excluding blood and blood products), as well as organs, tissues or cells of animal origin. The draft opinion before the Parliament urges that donations should be voluntary and unpaid and seeks assurances on traceability, donor consent and anonymity. It also calls for a ban on commercial trading in unmodified human tissues and cells - although for cases in which the tissues or cells are used as source material for manufacturing products for medical use they may be modified by organizations that are operating for profit. And it recommends special rules to govern the procurement of tissues after an abortion - and a ban on abortions to obtain fetal tissue.
But attempts by some European members of parliament (Euro-MPs) to incorporate amendments that would ban stem cell research have so far failed to win wide support in committee. Rather than calling for a ban on embryonic stem cells, the Parliament now is likely to vote to allow member states to decide for themselves, as long as public health is protected.
"We need specific rules to ensure the quality and the safety of human cells and tissues, but if this directive tries to include highly sensitive issues where we know member states have differing views, it will defeat the purpose of the rules, because they will certainly end up running into problems at the implementation phase," said Hugo Schepens, secretary general of EuropaBio, the European association for bioindustries.
Later in the week, Parliament will vote on the proposals to speed up the European authorization process for new medicines and to bring in better-quality scientific expertise for the assessment of authorization applications for high-technology medicines.
François Gross te, one of the Euro-MPs who is piloting the legislation through the Parliament, said before the vote that she was aiming to remove any risk of confusion over definitions of high-technology products. She said she was putting forward proposals on the precise meaning of biogeneric medicines, because she felt it was important to make clear what sort of testing would be required for copies of biotechnology-derived medicines.
And she insisted on what she saw as the underlying need to help develop the innovative capacity of the European pharmaceutical industry. For that reason, she urged Parliament to back the call from innovative drug firms for increased protection against the copying of data generated in support of marketing authorization applications.
"Research and development help to lay the foundations for health protection," she said. "We all know that innovation comes at a price. It is thus our duty to prevent European industry from being relegated to the second division in the global league and from trailing behind the U.S. and Asia, as that would be a disaster for Europe."