Future member states call for input into EU drug laws

Date: 11/09/03

By Karen Carstens

HEALTH ministers from the ten nations set to join the EU next year have issued a joint declaration demanding that a massive package of new pharmaceuticals laws take their concerns into consideration.

At issue are highly controversial 'data protection' rules for medicines which, once approved by MEPs by the end of the year, would be in force for at least a decade.

Pharmaceuticals firms lobbied hard to safeguard a ten-year data protection period before manufacturers may begin producing far cheaper equivalent copies of patent-expired brand pharmaceuticals, known as generic medicines.

But the ten new member states all observe a six-year period, which they would like to maintain.

They claim in a declaration issued on the sidelines of an EU health ministers meeting in Milan that the effects of the longer period would wreak havoc on their health care systems.

They write that it would "influence significantly the fragile national health systems and the public health situations in our countries".

It would also seriously irk the generics industry, which stresses that generic medicines make up 70% of all medicines sold in accession countries by volume, yet account for only 30% of pharmaceutical spending.

"If data exclusivity provisions are too long, then lower-priced generics can only enter the market several months or even years after patent expiry, thus extending the monopoly of the originator product and costing patients and health care systems millions of euro in lost savings," said Greg Perry, director general of the European Generics Association.

The European Federation for Pharmaceutical Industries and Associations, however, claims that it takes an average of 12-13 years "for a promising compound to be tested and eventually approved as a new medicine".

The federation argues that ten years - plus an extra year for data generated to support certain new indications (the so-called '10+1' formula) - would foster innovation.

To Perry, however, this is a clear case of bullying, of big member states and their big pharmaceutical firms trying to push a sensitive measure through the EU policy pipeline before the new member states can have any real say in the matter.

"What I find quite disturbing is that this is being purposefully rushed through," he said. "There is obvious concern this might not be adopted after accession."

French MEP Françoise Grossetête, rapporteur for the law, has said she would like to see it approved before Christmas.

But Dorette Corbey, a Dutch Socialist and member of the Parliament's environment and health committee, has been trying to fight the future EU countries' corner.

"It would have been good if the Council [of Ministers] had listened to the candidate countries," she said.

"This is about member states wanting to settle their business quickly."

Currently, seven member states - Austria, Denmark, Ireland, Finland, Spain, Greece and Portugal - as well as non-EU members Norway and Iceland, have six-year data protection periods. The remaining member states - Belgium, Luxembourg, the Netherlands, France, Italy, Germany, Sweden and the UK - have ten-year periods.

Erkki Liikanen, the EU's enterprise commissioner, in a Parliamentary appearance on Tuesday (9 September), said the longer periods protect innovation.

But Corbey pointed out that the United States, the EU pharmaceutical sector's main rival, has a five-year data protection period.

In a first reading last year, Corbey proposed a six-year period which ended up as a compromise of eight years.

Yet the Union's health ministers, in a common position reached with the Parliament last June, pushed this period back to ten years.

Now, in a second reading, a health committee vote is due in November followed by a plenary session vote in December.