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Home » EU PARLIAMENT BACKS NEW DRUG PATENT EXTENSION PLAN
EU PARLIAMENT BACKS NEW DRUG PATENT EXTENSION PLAN
September 14, 2005
The European Parliament has unanimously approved the Regulation on Medicinal Products for Paediatric Use. The draft law will require drug firms to test the suitability of their products for children, in return for a six-month patent extension.
Within six months of its final approval, the regulation is expected to encourage European Union (EU) drug agency EMEA to create a new Paediatric Committee. The Parliament has also approved amendments to streamline procedures for any resulting paediatric trial activity, simplifying communication channels in an effort to avoid duplicating clinical trial work.
The measure has created some controversy among European legislators, with some left-wing parties arguing that the extension period should be made more flexible, possibly depending on the size of the company in question. Their opponents reply that such plans are simply a gesture to national generic drug firms. In Eastern Europe, generics makers could be hit by the regulation, adding to problems with incorporating the EU's so-called "8+2+1" patent legislation.
The European Generic medicines Association (EGA) has expressed disappointment with the regulation, but the EU's central bureaucracy -- the European Commission -- has supported the proposals for a full six-month extension.
KEYWORDS Daily International Pharma Alert
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