European health ministers have backed a plan to increase the level of clinical testing of new medicines to ensure that they are safe and effective for use in children. The proposal can now proceed to the second reading in the European Parliament, and should become law in 2007.
More than half the medicines taken by children in Europe have never clinical testing or been specifically approved for use in that age group. The proposal would oblige companies to submit a paediatric investigation plan when they apply to market new drugs in the European Union, including new formulations or uses for already-marketed products, in return for a six-month extension in patent protection, rising to two years for ‘orphan’ drugs with a limited patient population.
The news will disappoint the European generics industry, which had argued that the extended protection delays the entry of copycat drugs, inflating the cost to healthcare payers.
A system of waivers will be adopted to allow companies to bypass the requirement in those cases where testing in children would not be appropriate. Support measures such as an EU-wide network of investigators and trial centres, and funds to support clinical testing in children, will also be set up.
The regulation also establishes a new type of marketing approval, the Paediatric Use Marketing Authorisation (PUMA), which allows 10 years of data protection for innovative uses of off-patent products.
The European Commission welcomed the endorsement of the plan. “This regulation will improve the health of children by ensuring innovation in the development of medicines for their use," commented Commission vice president Guenter Verheugen.