EU agency eases the painful process of getting new medicines licensed

Date: 15/07/1999

By Simon Coss

THE EU's single market has now been in existence for more than six years, but you would not know it by looking at the Union's pharmaceutical industry.

Prices for legally available drugs vary enormously between Union member states and the situation is unlikely to change significantly in the near future. EU governments have widely different pricing policies for medicinal products and made it clear when they were drawing up the 1986 Single European Act - the blueprint for the internal market - that they wanted the pharmaceutical industry to be treated as a special case.

But while the cost of drugs remains very much a national issue, progress has been made on the question of licensing new pharmaceutical products for use within the Union.

In 1995, the European Agency for the Evaluation of Medicinal Products (EMEA) opened for business in London, creating a 'one-stop shop' for EU-wide drug approvals which would do away with the need for pharmaceuticals companies to seek country-by-country permission to market their products in the Union's 15 member states.

Drugs are cleared by the EMEA using two distinct procedures.

The centralised procedure is reserved for drugs created using cutting-edge techniques such as biotechnology. It is the most straightforward of the Union's drug-approval systems as the EMEA is solely responsible for deciding whether a new product should be granted a licence for EU-wide sale or not.

For 'traditional' drugs, the EMEA uses the more cumbersome decentralised procedure. Here, the agency acts as an arbitrator between national agencies in cases where EU member states cannot agree amongst themselves to recognise each other's decision to approve a particular drug.

The EMEA says its work has been widely supported by drugs companies, doctors and patients' organisations over the past four years. "The confidence of industry, health professionals and consumers in the system is clear. European patients are now able to have speedier access to new drugs, usually within one year," it said in a recent statement.

The EMEA has a relatively small staff at its London headquarters, but it can draw on a network of more than 2,300 scientific experts in the Union's 15 member states when preparing its reports.

Opinions published by the EMEA's two scientific committees - one for human medicines and the other for veterinary products - are automatically supported by the European Commission and are legally binding throughout the Union.

Since 1995, the agency has used the centralised procedure to approve 117 new drugs for EU-wide sale.

Under the decentralised procedure, EU governments have reached mutual recognition agreements on 466 products and the EMEA has only had to arbitrate on a handful of occasions. The agency has also cleared 12 new products for veterinary use since 1995, and it gives advice on EU regulations to firms developing new drugs.