BRUSSELS, Belgium ¿ The European pharmaceutical industry is gearing up for a battle over product registration procedures for biotechnology-derived medicines. Within weeks, the European Commission is scheduled to propose major changes to the EU¿s authorization system, and there are industry fears that it may try to force companies to put applications for all new chemical entities through the ¿centralized¿ EU registration procedure, operated by the European Medicines Evaluation Agency in London.

But the industry says that will put too much strain on the system, which was set up primarily to handle medicines derived from biotechnology. Instead, says the European Federation of Pharmaceutical Industries and Associations, there should be more scope, not less, for companies to use the alternative ¿mutual recognition¿ procedure that operates bilaterally between EU member states, on the basis of purely national marketing authorizations.

The current obligation for all biotechnology-derived medicines to use the centralized procedure should be relaxed, argues the industry. Some biotechnology products will have to be dealt with through the centralized procedure, which is where sufficient regulatory expertise on the most advanced high-technology products can be mustered from across Europe. So EFPIA urges that the classification used in the new EU directive on clinical trials could be used here, too, which would mean making the centralized procedure the obligatory route for those products for which prior approval is required for clinical trials: gene therapy products, somatic cell therapy (including xenogenic cell therapy), products containing genetically modified organisms, and other products with special characteristics.

But now not all biotechnology products should have to go through the centralized procedure, the industry argues. For instance, monoclonal antibodies could now be assessed through the mutual recognition procedure, because sufficient expertise in this branch of biotechnology has now accumulated across the national regulatory authorities of Europe. The essence of the EFPIA proposal is that the restrictions should reflect the current state of science ¿ and since science is moving so fast, so should the regulations.

Debate Continues On Ethics In Biotech

The apparently unlimited capacity of the European Union for debating rather than deciding led to yet another high-level meeting on biotechnology and ethics, organized by Sweden, currently in the rotating chair of the EU, in the northern Swedish city of Umea.

The principal conclusion: ¿The ethical debate must be strengthened.¿

Sweden¿s minister for Education and Science, Thomas Vstros, said, ¿Bioethics must become an issue for us all and the ethical debate must become a natural part of the research and development process,¿ when he spoke last week at the conference titled ¿Ethics and biomedical research ¿ the process of balancing benefits and risks.¿

During the Swedish EU chairmanship, EU leaders have formally identified biotechnology as one of the most important fields for Europe ¿ for the first time in the history of the EU. They have given instructions that greater attention should be paid to the importance of basic science, the need for entrepreneurship within biotechnology, and the need for a broad and open ethical debate. The European Commission has been given until the spring of 2002 to draw up a report on making the progress in supporting biotechnology that EU leaders have called for. As a consequence, diplomats and officials have been energetically, almost frantically, trying to work out how to deal with this challenge.

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