EU regulator submits expansion plans
pharmafile | October 27, 2003 | News story | |Â Â Â
Medicines regulator the EMEA has asked the European Union for a subsidy increase of nearly 13% to pay for its expansion, including the induction of new EU member states.
Much of the additional funding will go towards recruiting 27 extra staff to bring the agency's total workforce to 314, although this number will undoubtedly increase if Commission plans to expand its remit become a reality.
The Commission wants the EMEA's centralised approval procedure to be the single marketing authorisation for new medicines in order to speed the process and reduce inequalities across Europe.
The current alternative 'mutual recognition' route overseen by national medicines regulators would be relegated to approving 'me-toos' and generics, but the plans have met considerable opposition from some MEPs and member states.
European health ministers have been considering the issue since November, but have been unable to reach an agreement, and uncertainty on this and other reform issues is causing concern among the industry and regulators.
The proposal is part of a larger package of measures intended to modernise European drug approval for the benefit of patients, the industry and other stakeholders.
European bodies and lobby groups are keen to see momentum restored to the cumbersome EU legislative process, with industry body EFPIA demanding the reforms are finalised by May 2004 when EU enlargement begins.
It says member states must agree on the future of marketing authorisation before June this year when the current Greek presidency of the EU ends.
MEPs and ministers are due to vote on the EMEA's budget proposals towards the end of 2003, and any confusion over the wider issues could jeopardise the agency's financial plans.
In December Executive Director Thomas Lonngren warned MEPs that a dramatic drop in new drug applications from pharmaceutical companies threatened a financial crisis at the EMEA, which depends heavily on fees from the industry.
A 16% rise in industry fees is due to come into force shortly, which the EMEA forecasts will contribute to a fees revenue growth of 9% to E52 million in 2004. The agency says the number of applications for new human medicines will remain static at 38 in 2004, but needs to cover wider costs as its workload from national agencies and an IT infrastructure programme will increase demand on its resources.
Former Chief Executive of the UK Medicines Control Agency Dr Keith Jones has been re-elected as Chairman of the agency, with a former head of the French national agency, Dr Phillipe Duneton, elected Vice-Chairman.
