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G10 medicines group sets out recommendations

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三月 8, 2002

Brussels, 07 March 2002

The creation of networks of virtual health institutes and improvements to the procedure for introducing innovative medicines to the market are among suggestions for stimulating innovation and improving the EU science base proposed by the G10 Medicines Group, established Enterprise and Information Society Commissioner Erkki Liikanen and Health and Consumer Protection Commissioner David Byrne.

The 'High level group on innovation and provision of medicines,' set up in March 2001, aims to review ways of encouraging innovation and competitiveness in the pharmaceutical industry while ensuring high public health standards. In addition to Commissioners Liikanen and Byrne, the group includes a number of European health and industry ministers, pharmaceutical and health industry leaders and patient representatives.

The G10 group's recommendations for action at European and national level, adopted on 26 February, include a call for the European institutions to consider ways of improving the current licensing system to aid the introduction of innovative medicines to the market. The group calls for the use of telematics to improve the operation of the Community regulatory system.

The group also states that 'the effective exploitation of the science base in the EU is hampered by relatively weak links between research centres in different Member States,' and says the creation of European virtual institutes of health, connecting existing centres for fundamental and clinical research in a European network of excellence, could help to remedy the problem.

In addition, the group recommends that the European Commission, Member States and industry 'should work together to adopt and implement policies that promote disclosure and public engagement in research.' It suggests that the Commission and Member States coordinate and support the conduct of clinical trials on a European scale and establish a database of trials and clinical research results. It also calls on the Commission and Member States to put in place effective incentives for researching, developing and marketing medicines for children.

The group also advocates support for the development of a biotechnology strategy in line with the recent EU biotechnology and life sciences strategy announced proposed by the European Commission.

The group presented a number of recommendations to improve the working of the pharmaceuticals market. It calls on the Commission to develop a comprehensive set of benchmarking indicators covering the industrial competitiveness of the pharmaceutical industry, the treatment of diseases and emerging health threats, and the relationship between EU and Member State regulatory structures and the uptake of pharmaceuticals. It recommended measures to reduce the time between the granting of a market authorisation and pricing and reimbursement decisions, develop a competitive generic market and tackle intellectual property issues linked to this and develop a health technology assessment (HTA) which includes clinical and cost effectiveness.

The recommendations put forward by the group to help improve patient information include a review of legislation on patient information and moves to boost post-marketing surveillance and fund European patient groups.

The G10 group's recommendations will be set out in a report to be presented to the European Commission President Romano Prodi in May.

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