Pharma in parliament

MEPs are set this week to tackle proposals limiting data protection rights for pharmaceuticals companies.

Under the proposed laws, known as the Pharmaceutical Review, or Pharma, medicine manufacturers would only keep the copyright on their drugs for eight years.

The European Parliament's environment committee last month went against Pharma rapporteur, French conservative MEP Francoise Grossetête, who wanted to increase the data protection period to 11 years.

Instead, a two year period was tacked on to the eight, during which other companies can base research on original products but not market them.

Particularly hard hit was the biotechnology industry, which currently enjoys a standard ten year protection period across Europe.

The proposals will be debated on this Tuesday and voted on in a plenary session the following day.

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.

The protection period delays the prospects for other companies to create copycat 'generic' medicines based on the original product, and often cheaper.

But industry argues that it needs data protection in order to be competitive.

However industry has welcomed changes that make it easier for patients to report side effects of medicines to the competent health or medicines authority.

“It is in everybody's interest that medicines are closely monitored”, said Jim Murray, director of the European consumers organisation (BEUC).

“Direct reporting of side effects would allow patients and doctors to make better choices.”

Pharma is currently at its second reading in Parliament.

It needs the approval of both parliament and council.

If it avoids going to conciliation – which industry hopes it will – it could be adopted in February 2004, and transposed to national law by 2006.

Pharma proposes an extensive revision of EU pharmaceuticals laws.

It is made up of two directives and a regulation, adopted by the commission in 2001.

These cover the authorisation, registration and supervision of both human and animal medicines.

This is the first time they have introduced to EU law specific requirements for medicines produced by biotechnology.

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