BRUSSELS, Belgium ¿ The European Union announced two major changes it intends to make to its rules governing biotechnology products.

Last week it proposed new rules on labeling and tracing of GMOs in Europe that would, according to the European Commission, enable freedom of choice and ensure environmental safety. And on July 18 it revealed plans to modify the way the European Medicines Evaluation Agency operates in assessing and authorizing new medicines based on biotechnology.

In a comprehensive reform it is proposing for EU pharmaceutical legislation, the European Commission is aiming to boost the competitiveness of the European pharmaceutical industry. The shake-up is intended to bring increased professionalism into the operation of the London-based EMEA, strengthening the existing structures by the addition of more working groups and experts. Increased flexibility is being introduced for creating expert-specialized groups, working parties and scientific committees. There would also be a possibility of using experts from outside the EU.

A ¿fast-track¿ registration procedure for products of significant therapeutic interest is envisaged, to bring Europe into line with U.S. procedures, along with a new conditional one-year marketing authorization where there is an important expected health benefit for the patients concerned and where the company undertakes to perform additional monitoring and clinical studies.

The Commission said it expects ¿concrete benefits for European consumers, patients and for animal health in a rapidly changing world of scientific advances in medicines.¿ The central objective, it says, is to provide benefits for patients by increasing access to new and innovative medicines. The pharmaceutical industry is also targeted, introducing clearer procedures and cutting bureaucratic rules.

Erkki Liikanen, the European commissioner responsible for industrial affairs, said the decision was ¿a major step towards achieving a more innovative and competitive industry in Europe.¿

The legislative package on genetically modified organisms aims to establish an effective EU system to trace and label GMOs and to regulate the placing on the market and labeling of food and feed products derived from them. It will require that GMOs are traceable throughout the chain from farm to table, and that consumers are given information via the labeling on all food and feed produced from a GMO. And it will establish what it calls a ¿one door, one key¿ procedure for the authorization of GMOs for food and feed, consisting of a single scientific assessment by the scientific committees of the European Food Authority.

The new system is designed to provide a stringent regulatory framework that closes existing legal gaps. Two further pieces of new legislation on GM seeds will be proposed in the fall.

Environment Commissioner Margot Wallstrvm said, ¿The provisions for traceability ensure a high level of environmental and health protection and pave the way for a proper labeling system. Certainly, there is a cost for the producers and for trade, but what is at stake is our ability to build public confidence. European companies will only be able to seize the opportunities provided by biotechnology if this confidence is established.¿

Health and Consumer Protection Commissioner David Byrne said the laws would set new standards. ¿After that it is for consumers to decide if they want to buy food produced from a GMO,¿ he said. ¿The proposed labeling regime will allow consumers to make that choice.¿

The proposals now have to be debated by the 15 member states and by the European Parliament. The aim is for the GMO labeling and tracing package to enter into force in 2003 at the latest. But the changes to medicines legislation face a longer and tougher battle in the EU¿s complex consultation mechanisms ¿ even industry optimists believe it will be five years before the new proposals become law.

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