Pharmaceutical companies eye patent extension for child drugs

Date: 20/07/05

Pharmaceutical companies that develop paediatric versions of their drugs could win a six-month patent extension, under a draft law approved by MEPs in the European Parliament's public health committee on Wednesday (13 July).

Under the law, pharmaceutical companies will have to run trials on certain medicines under patent, as well as future medicines coming on patent, to produce paediatric formulae. The European Commission puts the cost of such trials at between €1m-4m.

Deputies backed - by 40 votes to nine with nine abstentions - a report by French centre-right MEP Françoise Grossetête that would compensate the pharmaceutical industry for fulfilling its obligation by granting an extra six months on the patent.

But MEPs approved one exception, which would increase the exclusive commercial rights of 'orphan drugs' that treat rare illnesses from ten to 12 years if they are developed specifically for children.

Deputies also backed an amendment to strengthen the creation of a programme for paediatric research called MICE (Medicines Investigation for the Children of Europe) that would group researchers and research centres. EFPIA, the European Federation of Pharmaceutical Industries and Associations, welcomed the vote, saying that it showed a "balance between the obligations for pharmaceutical companies to conduct complex, costly and lengthy paediatric research...with their support for a proven, simple and effective incentive mechanism".

But generic companies expressed disappointment at the move. Though it welcomed the creation of MICE, the European Generic Medicines Association said that the patent extension would "generate up to €2 billion each year in unnecessary additional costs to Europe's financially overburdened healthcare systems". It will also delay the marketing of generic versions of the adult formulae, as the patent covers all uses of the drug.

MEPs will vote on the draft text in plenary session in September before health ministers decide whether to formally approve it, or send it to second reading in the European Parliament.

Article reports that the European Parliament's Committee on the Environment, Public Health and Food Safety on 13 July 2005 adopted a report by French centre-right MEP Françoise Grossetête on a proposed law that would offer pharmaceutical companies that develop paediatric versions of their drugs a six-month patent extension. Deputies also backed an amendment to strengthen the creation of a programme for paediatric research called MICE (Medicines Investigation for the Children of Europe) that would group researchers and research centres.

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