Belgium to set up own medicines agency
Belgium has decided to create its own medicines regulatory agency, bringing it into line with other European countries.
Belgium has decided to create its own medicines regulatory agency, bringing it into line with other European countries.
The new federal medicines and health products agency, which got the go-ahead from the Belgian senate at the end of June, will replace the medicines directorate-general, which is part of the health ministry.
One of its first tasks will be to deal with a mountain of delayed files. In Belgium delays in granting marketing authorisation continue to increase. About 15,000 dossiers are currently held up. "With this agency, we want to absorb the backlog of thousands of files and get up to date," said the Belgian health minister, Rudy Demotte.
As the European Medicines Agency (EMEA) confirms its dominance, competition between national agencies is getting stronger, notably in the areas of marketing authorisation and clinical trials. The minister said that the creation of the agency brings Belgium into line with other European countries.
As an autonomous body - under the direct authority of the health ministry - the agency will have its own budget. However, no extra money will be provided above that currently allocated to the medicines directorate-general, the health minister said.
The new structure is expected to become operational in 2007. To help it on its way, the ministry has designated the ex head of the Belgian food safety agency (AFSCA), Piet Vanthemsche, as interim administrator. He will leave public office in April 2007 to move into the private sector. And will have less than a year to get the agency up and running, by reorganising computer systems, setting up a personnel plan and installing equipment on the new premises.
The creation of the agency is seen by some in Belgium as part of the authorities' efforts to keep employment and investment-generating pharma companies on Belgian soil. Demotte confirmed that it "is sending a signal so that research activities will stay in Belgium".
US group Pfizer sparked a crisis in November 2005, when it announced that it was abandoning the idea of investing e185m, an initiative which was perceived to be a reaction to the government's policy towards the pharma industry. Last June, Eli Lilly in turn announced that it was closing its Belgian research site.