| Author (Person) | Carstens, Karen |
|---|---|
| Series Title | European Voice |
| Series Details | Vol.9, No.37, 6.11.03, p24 |
| Publication Date | 06/11/2003 |
| Content Type | News |
|
By Karen Carstens Date: 06/11/03 PROPOSED EU pharmaceuticals legislation could considerably increase the financial burden on patients and health care systems across Europe, a consumer group has warned. The Medicines in Europe Forum, backed by Dutch Socialist MEP Dorette Corbey, is campaigning against extending the "data protection" period for pharmaceuticals across Europe. French Conservative MEP Françoise Grossetête, rapporteur for the "pharma" proposals, has recommended an 11-year data protection timescale; the European Parliament had previously suggested it should be for only eight years. The upshot of Grossetête's proposal is that no competing company could produce a "generic" medicine (a copy of a brand-name drug) for 11 years. At present, data-protection periods range from six to ten years in EU member states, where pharmaceuticals comprise an average of 10% of total public health budget costs. But studies show costs would rise by up to €170 million in France, €225m in the Netherlands and by as much as €400m in Poland for every extended year, since the "availability of cheaper generic medicines will be delayed", Corbey claimed. And "in most countries, patients will pay for this, not insurance companies," the Dutchwoman added. The ten accession countries - in which generics account for 70% of all medicines consumed, but only 30% of pharmaceutical spending - could be hardest hit. Most observe six-year periods, and Poland maintains just three. Their health ministers have issued a joint declaration stating that the 11-year period would "influence significantly the fragile national health systems and the public health situations in our countries". Accession country officials presented a similar plea at a lively environment and health committee debate on the proposals on Monday (3 November). Corbey also appealed yesterday (5 November) to Enlargement Commissioner Günter Verheugen, expressing her dismay that the EU executive had accused Polish, Hungarian and other observers in the Parliament of exaggerating the impact of the issue. Meanwhile, the European Federation for Pharmaceutical Industries and Associations (EFPIA), insists it takes an average of 12-13 years "for a promising compound to be tested and eventually approved as a new medicine". It argues that ten years - plus an extra year for data generated to support certain new indications - would foster innovation, a view echoed by Enterprise Commissioner Erkki Liikanen and a majority of EU health ministers. But the generics industry and Corbey are fond of citing that the United States has a five-year data-protection period. Roy Gentry, of the European Generics Association, moreover said that fostering innovation was not just about data protection, but funding. "The US government provides &036;25 billion (l21.75bn) annually to the National Institutes of Health (NIH)," he said. "The European Commission provides about €1-2 billion annually." Even though the EU figure is due to increase, this discrepancy provides a more plausible explanation for why the US pharma sector dominates 70% of the EU market, Gentry claimed. The Commission's pharmaceuticals package proposes an extensive revision of EU laws. It is made up of two directives and a regulation, adopted by the EU executive in 2001. These cover the authorization, registration and supervision of both human and animal medicines. In addition, they introduce into EU law for the first time specific requirements for medicines produced by biotechnology. An environment and health committee vote is due later this month, followed by a plenary vote in December. The pharmaceutical and biotech industries would like to see the process wrapped up before Christmas. But Corbey and the generics industry claim that the pharma package is being rushed through on purpose to stop the accession states having a say after they join the Union - and gain full European Parliament voting rights - next June. At the same time, the biotech industry has argued that it could be hit hard if the data protection period, already fixed at ten years for biotech products, is reduced to eight years. "We would not accept that this position be weakened from the one that we have enjoyed for the past ten years," said Hugo Schepens of industry umbrella group EuropaBio. More than 20% of medicines on the market are biotech based, as are more than half those currently under production. Many serious diseases, including cancer, are treated using biotech medicines. If the pharmaceuticals review package avoids going to conciliation, it could be adopted by Februry 2004, and transposed into national law by 2006. The Medicines in Europe Forum, backed by Dutch MEP Dorette Corbey is campaigning against extending the 'data protection' period for pharmaceuticals across Europe. |
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