EU pharma legislation reforms agreed

EU health ministers have agreed on reforms to current pharmaceutical legislation that will compel manufacturers of products containing new substances for treating AIDS, cancer, neuro-degenerative disorders and diabetes to submit them to a centralised EU procedure in future.

Ministers also said there should be protection of up to eight years after authorisation for the marketing of the original product, plus a further two years before a generic product could be sold. The Council said this was the period during which a company would be able to keep its rights for commercialising a medical product, without competition from generic medicine containing the same active ingredients and sold at a lower cost. Currently, this period is six years.

The European Commission said it was a 'well balanced compromise', but added the issues would be discussed further with the European Parliament before becoming law, which it hoped would be by the end of the year.