BioWorld International Correspondent

BRUSSELS, Belgium - European Union ministers watered down plans to boost innovative high-technology pharmaceuticals when they met here Monday.

Their fears about the impact on national health care costs drove them to nuance proposals for up to 11 years of market exclusivity for new medicines. Instead, they agreed to limit protection to 10 years of intellectual property protection for some innovations. And they weakened that further with a provision that would allow generic firms to start preparing copy products after only eight years have elapsed, to allow immediate launch at the end of the 10-year period.

The deal offers some small improvement on what is already available in most of the EU's 15 member states, by providing for an 11th year of protection for a new indication on an existing product. It would, however, improve the situation in the handful of current member states that offer only six years of exclusivity, and in the 10 new member states - mainly from the former Soviet bloc - that will join the EU in May 2004. Even this diluted package was adopted only by majority, in the face of fierce opposition from many EU countries, and all the EU candidates, which were backing intellectual property protection limited to only six to eight years.

At the same time, ministers backed off from requiring all new medicines to use the EU's centralized marketing authorization system run by the European Agency for the Evaluation of Medicinal Products in London. Only treatments for cancer, AIDS, neurodegenerative diseases and diabetes would have to use this system; for all other products, companies instead would remain free to choose national authorization procedures.

The European Commission welcomed the agreement. Erkki Liikanen, the senior official responsible for business affairs, said: "We have taken an important step toward ensuring that Europe gets a more robust, modern, effective and competitive regulatory framework for pharmaceuticals. Despite the fact that the member states on some issues did not follow our proposal, this is a well-balanced compromise."

European pharmaceutical companies had been insisting that without additional research incentives, the industry would be weakened. "Europe will take a serious step backward" if the proposals did not go through, warned the president of the European Federation of Pharmaceutical Industries and Associations, Sir Tom McKillop, also CEO of AstraZeneca plc, at the end of May. "We call on EU member states to encourage pharmaceutical innovation. In light of current and future disease threats, it is clear that patients and Europe in general can only benefit from the industry's capacity to innovate to defeat disease. In any event, the future of Europe will not be secured by its ability to copy."

Now that ministers have given their view, the proposal will go back into the EU's lawmaking system for further consultation, notably with the European Parliament. Since a compromise has been reached, it is possible the discussions may be completed by the end of this year.

Gene Therapy Group Considering Updates

The newly established ad hoc gene therapy expert group set up by the European Agency for the Evaluation of Medicinal Products has been examining possible updates to European Union regulatory guidance, according to a just-released note of its deliberations.

In particular, it has been discussing new information on insertional oncogenesis, based on the analysis of available nonclinical and clinical data following two serious adverse events reported in a gene therapy trial in France for the treatment of children affected by X-linked severe combined immunodeficiency. Two patients developed uncontrolled lymphoproliferative disorders three years after treatment, and underwent chemotherapy.

However, the group concluded that this type of treatment still offers "unprecedented success," and the associated risk is no higher than in the alternative therapy of unmatched bone marrow transplantation. But it called for more preclinical investigation in assessing the risk of gene therapy, including more basic research in the development of safer gene transfer vectors.

The group also has been assessing published nonclinical testing studies on potential inadvertent germline alteration using retroviral, AAV-derived and adenoviral vectors as well as plasmid DNA, each encompassing a specific expression vector. It concluded that testing of gonads for the presence or expression of vector sequence "does not give sufficient information as to whether the germline has been altered."