MEPs approve regulation to boost research into children's medicines
Following some intense lobbying and a heated Parliamentary debate, MEPs adopted a regulation by an overwhelming majority on 7 September aimed at stimulating the research and development of medicines for children. A number of amendments to the Commission's original proposal were adopted before the vote was taken, aimed, for example, at improving the exchange of information to prevent unnecessary trials, and creating a research programme known as medicines investigation for the children of Europe (MICE) to adapt for children existing treatments that are no longer covered by patents. The most contentious issue during the debate related to the types of incentives that should be offered to pharmaceutical companies to invest more in children's medicines - given the relatively small size of the market and the difficulty of conducting clinical trials. The Commission proposed that companies should be granted an extra six months of protection under the patent system during which time they can generate higher revenues. However, a number of MEPs argued for a shorter period of protection or one that depends on the size of the company. Some members felt that the disagreements reflected the special interests of generic pharmaceuticals producers in certain countries, and the French rapporteur Françoise Grossetête deplored the way the debate on this point had been reduced to 'arguments of carpet salesmen'. Introducing proportionality into the patent extensions would, she said 'lead us from the logic of health to the logic of the market. Research is unpredictable. We should not add to that by introducing an unstable regulatory framework.' Commissioner for Enterprise and Industry, Günter Verheugen, told MEPs that the six-month fixed period was essential: 'This system would be simple to use, is predictable, will produce less bureaucracy and is compatible with existing patent law. The Commission is not prepared to accept and compromise on this point [...] I ask Members to think of the interests of children, which are far more important that one lobby or another. In the end, the plenary supported the line of the Commission and rapporteur and adopted the fixed six-month extension, and the proposal will now be forwarded to the Council where it is expected to receive final approval under the UK Presidency.