EGA Press Release

Monday, 24 January 2002

EGA supportive of “G10 on Medicines”

“G10 on Medicines is making good progress and the series of G10 Workshops are providing an important avenue for increased participation and transparency,” says Andrew Kay, President of the EGA (European Generic medicines Association) and a Member of the G10 group on Medicines.

According to the EGA President, the G10 consultation paper last year was a good basis for developing a final document and hoped that all sides could set aside certain differences to allow a common position to be adopted. It is also important that the final paper reflect both the need to improve competitiveness of all sectors of industry as well as the need for improved provision and public health.

The European Commission services and G10 “sherpas” are now working on a final paper. “It will not provide all the answers for either the generic or innovative industry but it should provide agreed common polices that can be pursued both at national and European levels. The European Commission have set themselves an almost impossible task to get all stake holders to agree a paper and they should be congratulated for the progress made so far”, said Andrew Kay. In the area of generic medicines the final paper is expected to endorse the need for increased generic competition as part of an overall policy to increase competitiveness and provision.

Andrew Kay, who participated in the G10 Workshop on Competitiveness, held in London on 16th January, stated, “in many respects the Workshops are proving to be as important as the final paper”. In the G10 Workshop on Competitiveness, Andrew Kay stressed the importance of a European Bolar provision as a means of improving the competitiveness of the EU generic industry vis-à-vis US, Asian and Canadian competitors. He also stressed that such a provision in the EU cannot be seen as a trade-off for increasing data exclusivity. A G10 Workshop on Generic Medicines held in France last December 2001 and hosted by Bernard Kouchner, French Minister of Health, identified 3 key hurdles for generic medicines: increased data exclusivity, lack of SmPC harmonisation, and increased use of usage patents. This Workshop also identified generic prescribing and dispensing as key areas for generic promotion.

It is hoped that G10 will have a document ready for publication in the spring. “Once the document has been finalised it is important that we can monitor to what extent national governments and the EU implement the findings of G10,” said Andrew Kay.

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