Little hope of new EU states assessing medicines, says EMEA director

Regulatory agencies from new EU members states are unlikely to take on the role of rapporteur, or reference agency, for centralised EU marketing applications, according to the EMEA's executive director, Thomas Lonngren. Since EU enlargement, Hungary has taken on the role of co-rapporteur in one filing but there have been no other successful applications from the 10 new EU states, Lonngren said.

He did not expect this low involvement of the eastern agencies to change for the foreseeable future, and recent EU legislation, stipulating that the most competent agencies carry out assessments of new medicines, would reinforce the status quo of a small group of states investigating nearly all new drugs. Historically five countries - Sweden, the UK, France, Germany and the Netherlands - take the role of rapporteur for between 80% and 90% of new medicine filings and this looks likely to be reinforced by the implementation of new European legislation.

"The intention of the legislation is to get the best scientific resources. I do think the scenario in the coming years will be the top five countries continuing to take the lion's share of the work," Lonngren confirmed.

The EMEA recently published a 28-page document outlining how rapporteurs will be chosen to ensure they meet the legislation's demand that the best science available is used to evaluate filings.

In a two-stage process, the EMEA will firstly use data it already collects using links with industry to inform national agencies twice a year what work will be required over the forthcoming period and invite them to express an interest in taking the role of rapporteur for any of the anticipated filings. Following this the CHMP will decide who carries out what work based solely on an objective look at who will do the best job.

Would-be rapporteurs will be chosen on various criteria including:

• Scientific competence to handle methodological and statistical aspects of reports, risk management and pharmacovigilance as well as environmental risk toxicity.
• Regulatory experience in reviewing dossiers, preparation and provision of assessment reports for central and/or national MAAs in the relevant scientific area.
• Regulatory experience sufficient to deliver reports on time and in accordance with European pharmaceutical legislation.

"The number of new medicines filed is not more than 40 to 50 per year. In order to maintain an interest (as a rapporteur) you need at least five per year," he explained. "The mathematical fact is that with 25 member states if you divide equally there will be two (per agency), and that kind of distribution will not maintain the expertise."

It is not known how many, if any, bids for rapporteurship the new EU states have made in addition to Hungary's successful one. That said, the role of co-rapporteur may offer a way of gaining some experience, Lonngren said.

The new rules for choosing rapporteurs have their roots in earlier changes that removed companies' influence in choosing reference states for European filings. Lonngren said this option still remained if companies wanted to use the mutual recognition filing route rather than the centralised procedure.

But he was not surprised that more or less all new molecules are going through the centralised procedure because historically companies did not tend to choose lesser agencies as reference bodies. Companies realised that if they went for a rapporteur who might give them a possibly unjustified good assessment report, they would immediately run into trouble with the other agencies.

"Companies want to avoid that. They want to get highest reputation for the first report rather than start with a bad one and try to rescue it," Lonngren stated.