EGA Press Release

Wednesday, 13 July 2005

PAEDIATRIC MEDICINES:
EP COMMITTEE VOTES FOR COSTLY PATENT EXTENSIONS, REDUCES PHARMA INDUSTRY OBLIGATIONS TO PROVIDE CHILD MEDICINES

Today, only one week after European Parliament rejected industry demands for patents on software, the Committee for Environment and Public Health narrowly voted to adopt a 6-month patent/SPC extension for pharmaceuticals as proposed by the European Commission in its draft Regulation on paediatric medicines. This move will generate up to €2 billion each year in unnecessary additional costs to Europe’s financially overburdened healthcare systems.

The actual voting, however, appears to have been the object of some confusion. The all inclusive “compromise” amendment proposed by the Rapporteur in favour of 6-months was soundly rejected early on, but the measure later prevailed when the vote on alternative 3+3-month or 4-month proposals were not adopted. It is not clear that the overall sentiment of the committee was fully reflected in the final outcome.

MEPs also voted to reduce the period between the end of an SPC and a company’s application for the extension. The six month notification period adopted creates a commercially impossible situation for manufacturers who have less expensive generic products under development for marketing immediately upon SPC expiry.

From a public health perspective, it is also concerning that the committee voted to remove obligations that the new paediatric product must be made available in all Member States in order to qualify for the reward. This will allow manufacturers to sell the new child formulations only in the more lucrative markets, thereby limiting the number of countries that will benefit from the better paediatric medicines.

On a more positive note, the EGA welcomes the committee’s vote to disallow the accumulation of several awards for a single investment, the committee’s refusal to further extend data and market exclusivity protection, and it’s adoption of a measure to allow 3rd companies to produce the paediatric formulation if the patent holder benefits from the reward but then does not market the product.

The committee agreed to review the new regulation within 6 years to determine its effectiveness in producing better medicines for children. This review will include an economic assessment to ensure that industry rewards are indeed commensurate with investments. The EGA, in line with all other interested parties, also welcomes the committee’s decision to call for the establishment of the so-called MICE programme to fund independent research into the development of paediatric uses for off-patent medicines. This fund will, for example, enable hospitals, universities and other research institutes to develop safe paediatric uses for medicines that are well-established and trusted in treating adults.

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