BioWorld International Correspondent

BRUSSELS, Belgium - Disagreements over the ethics of advanced therapies have derailed talks on new European Union rules aimed at improving patients' safe access to gene therapy, somatic cell therapy and tissue-engineered products.

The European Parliament was scheduled to debate the proposals in October, but sharp conflicts of view in the parliament's health committee have led to a postponement until early 2007. (See BioWorld International, Sept. 6, 2006.)

The new rules, proposed by EU officials in 2005, would create a harmonized system for obtaining EU-wide market access for new products. But skeptical politicians tabled numerous objections in advance of the scheduled debate, claiming that the draft legislation ignored vital ethical issues. In the resulting confusion, the draft opinion the health committee was intending to adopt was withdrawn, and the parliamentarian responsible for drafting the committee's opinion is unlikely to present a revised text until 2007.

The delay means that the vacuum in the regulatory framework - with no "one-stop-shop" for European authorization - will persist. At present, the biotech industry said it faces real difficulties in putting new advanced therapy products on all member state markets at the same time, because of the financial and administrative burden of meeting 25 different legal requirements.

EuropaBio, the biotech industry association, wants the new rules to focus on patient safety and on the needs of industry and the regulatory authorities. Ethical questions, it said, should be dealt with at national level. Ethics are not a subject that this law can - or should - regulate at European level, in the industry's view. It pointed to the divergence of national views revealed by recent debates on subjects such as embryonic stem cell research. And the situation will become more complex since the EU's membership will rise from 25 member states to 27 at the beginning of 2007, when Bulgaria and Romania join.

"Unnecessary repetition of recently concluded ethical debates that are reflected in existing EU legislation should not be allowed to delay this urgently needed product regulation," EuropaBio said. "Member states should decide for themselves which products will be allowed and which not."

The industry association plans to use the delay to win support for its views on what the rules should cover. One of the key demands from industry is for the European medicines agency in London to be empowered to provide a Europe-wide authorization procedure that would be obligatory for advanced therapies. But it also wants an adequate transition period for the new procedure to come fully into effect, and for clear guidelines and definitions for advanced therapies so that companies do not run into unexpected or unpredictable regulatory barriers.

The industry also wants loopholes to be closed that could allow hospitals an easier route than companies in obtaining market authorization for advanced therapies. "No matter who prepares the treatment - companies or hospitals - it should adhere to the highest standards of safety and efficacy," EuropaBio said.

No Comments