BRUSSELS, Belgium - European Union health ministers gave their preliminary
approval on sweeping new rules for drug approvals Monday, creating a single EU
drugs agency with similar powers to the U.S. Food and Drug Administration.
Under the proposal, the drug industry would be required to follow a centralized
procedure to register certain drugs at the European Agency for the Evaluation of
Medicinal Products (EMEA) in London, which EU officials say will make decisions
faster than the FDA.
The plan will cover the approval process of drugs to fight AIDS, cancer,
diabetes, and neurodegenerative diseases, such as Parkinson's Disease. For other
drugs, companies could chose whether to use the EMEA or national authorities.
Now, about 40 percent of new products currently use the national route, where a
drug approved in one EU country is then recognized by other European
governments. Drug companies have lobbied to retain that choice.
The proposed rules go back to the European Parliament which must approve the
legislation before it can be implemented. EU officials hope final approval can
be reached before the end of the year.
Monday's agreement waters down earlier proposals, however, that called for all
new drugs to be approved via the EMEA, though generics could still be vetted by
"With today's agreement, we have taken an important step toward ensuring the
Europe gets a more robust, modern, effective and competitive regulatory
framework for pharmaceuticals," said EU Enterprise Commissioner Erkki Liikanen.
Liikanen said the health ministers' decision was a "well balanced compromise."
The plan also aims to reverse the trend of many European drug companies which
have shifted research activities to the United States, where the regulatory
system is seen as more business friendly and less bureaucratic than in Europe.
The new rules would also standardize how long drug companies can have exclusive
intellectual property rights over data generated on new medicines. Health
ministers proposed 10 years plus one extra year if drug companies could show the
drug had an alternative use.
European drug companies welcome the 10-year protection period but have voiced
concern over having to register new drugs with an EU agency