EU increases powers, and speeds up actions, of the European medicines agency

Graham McKerrow, HIV i-Base

The European Parliament has decided to give wide new powers to the European Medicines Evaluation Agency (EMEA) so that it can approve new drugs more rapidly and so that they can be introduced throughout all EU countries simultaneously.

The EMEA, based at Canary Wharf, London, will be responsible for approving all drugs containing a new active ingredient. At the moment EMEA approval is only required for “innovative” drugs such as those developed from biotechnology research.

These changes, which need the approval of the EU Council of Ministers, would replace the current division of responsibilities between the EMEA and national authorities. Pharmaceutical companies had argued that this division of responsibilities led to useful “competition” between European and national bodies.

National regulators would continue to operate with reduced responsibilities for approving generic versions of existing drugs and reformulations of drugs that have already been approved.

The measures include changes to the regulations governing generic drugs to accelerate their availability and cut the prescribing costs for public health systems. The EU’s national state health systems spent 78.5 billion euros (£50 billion) on drugs last year, about twice the annual cost 10 years ago.

MEPs supporting the bill, which was approved at the end of October, said they were concerned that national agencies worked at different speeds and so drugs became available in some states while residents of other countries could not access them.

Irish MEP Avril Doyle said: “All patients should have equal access to state of the art drugs regardless of where they live in Europe.”

The new measures are intended to avoid ever more complicated regulation as the EU expands to as many as 25 nations in the next few years. Supporters of the changes also see them as an important step in transforming the EMEA into an authority with similar powers to the US Food and Drug Administration.

The MEPs rejected a proposal for a five year trial that would have allowed pharmaceutical companies to produce more disease and treatment information aimed at patients with HIV, asthma and diabetes. The Parliamentarians feared it would be a first step towards deregulating drug advertising on the American model.

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