Go-ahead for EU drugs copyright

The European Parliament on Wednesday voted through a plan to introduce common data protection for medicines within the EU.

Under the proposal, manufacturers of new medicines will be able to keep their copyright for ten years from when it goes on sale.  

The data protection period for conventional medicines currently varies from six to ten years throughout the EU, but can be as low as three in some accession countries.

Two years before the protection expires, generic drugs makers will be able to start the necessary paperwork for approval to sell ‘copycat’ medicines.

This concession will enable them to market their versions of the drug as soon as possible after the protection expires.

French MEP Francoise Grossetete, responsible for steering the so-called ‘pharmaceuticals review’ through the European Parliament, said the package struck the right balance between patient protection and support for research.

The new laws, she said, would ensure “a balance between better health for all and better access to medicines for all.”

“Lots of us regret Europe’s shortcomings in research and we want to do what we can to support it,” she argued.

The legislation also aims to provide better patient information and will make it easier for side-effects to be reported to the relevant medical authorities.

Parliament also voted to leave the door open for the European Commission to table later proposals to prevent legitimate information being hijacked by intrusive advertising.

The new laws will reform procedures at the EU’s medicines approval agency, ensuring that the same patent protection is offered whether drugs firms apply through it or national approval bodies.

The pharmaceuticals review has now gone through its second reading in Parliament.

If it avoids going to conciliation with the Council, it could be adopted in February 2004, and transposed to national law by 2006.

 

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