Drug giants in fight for child-medicine windfall

By Anna McLauchlin

Date: 30/06/05

Europe's pharmaceutical industry could win an extra six-month patent for its medicines for producing children's versions, depending on the outcome of a Parliamentary committee vote on 13 July.

But opponents of the extension claim that it is an unnecessary windfall for the industry.

As currently drafted, the paediatric regulation will force pharmaceutical companies to run trials on certain medicines under patent, as well as future medicines coming on patent, in order to produce paediatric formulae. As compensation for the cost of doing so, it will extend their patent by six months.

The industry argues that six months is the absolute minimum compensation and that any reduction could discourage research.

"We know the system works, we've seen it in the US," said Brian Ager, director-general of the European Pharmaceutical Industry Federation, Efpia.

"And granting six months in a distorted market like the EU is not the same as the six months US companies have," he added.

But others argue that six months is too generous and that it simply amounts to an unearned bonus for industry at the expense of government healthcare budgets.

The extension will also delay the generic medicines industry's access to the adult formulae, as the patent covers all uses of a drug.

Greg Perry, director-general of the European Generic Medicines Association (EGA), said that a six-month patent extension of a mid-range product with €100 million in EU sales would amount to a €50m windfall, while for a blockbuster drug this could be as much as €500m.

The European Commission estimates that the cost of running paediatric trials will be €1m-4m.

"We accept that the industry should be rewarded, but it should be proportional," Perry said. "Who's going to pay for this?

"It will be government health services which could be putting their cash into paediatric research."

The EGA wants members of the European Parliament to back an automatic three-month extension, followed by an extra three months for low sales products.

French paediatrician Gérard Pons, clinical pharmacologist at the Société Française de Pédiatrie, called for a "balance between incentives and obligation", pointing out that clinical studies in children are much more difficult than those for adults and that "the cost-benefit ratio could be quite low for some companies".

French centre-right MEP Françoise Grossetête, in charge of drafting the Parliament's view, has backed the Commission's original text which lays out the six-month extension, but there are other amendments which fall in line with EGA's demands.

Grossetête has also backed industry's request that paediatric results for new drugs should not have to be submitted at the same time as adult studies. "This could delay development of medicines for adults," said Ager.

MEPs in the environment and public health committee will vote on the regulation on 13 July with a plenary vote to take place in the first week of September.

Article reports that Europe's pharmaceutical industry could win an extra six-month patent for its medicines for producing children's versions, depending on the outcome of a vote in the European Parliament's Environment and Public Health Committee vote on 13 July 2005.