Reforming the law in Europe
One of the most comprehensive revisions ever undertaken of the pharmaceutical legislation in Europe made significant progress during 2003. The ABPI worked hard to ensure that the key players involved in the review of the pharmaceutical legislation were aware of industry’s position including UK Ministers, EU Council representatives, MPs, UK MEPs and the Commission, through participation in the committees within its European counterpart, the European Federation of Pharmaceutical Industry Associations.

Although the outcome was not totally as industry would have wanted, it can be judged as positive and representing a balanced compromise, considering industry’s major objective of completion of the review before EU enlargement on 1 May 2004, which would have severely delayed decisions still further.

Under the new legislation, the centralised procedure for the authorisation of new medicines will be compulsory for biotech products and those developed for orphan indications, AIDs, cancer, neurodegenerative disorders and diabetes. After four years, products for autoimmune disease, other immune dysfunctions and viral diseases will also have to use the centralised procedure. At the same time, the scope of the centralised procedure will be reviewed for all other products.

All products, independent of the route of authorisation that they have been through, will receive 10 years, market exclusivity. A generic manufacturer can apply for permission to manufacture after eight years, but cannot place the generic on the market until 10 years. It is possible to extend the data exclusivity period to 11 years for a new therapeutic indication if a medicine can be shown to have a significant clinical benefit in comparison with existing therapies.

The ABPI will continue to work with the Medicines and Healthcare products Regulatory Agency, the government body in the UK that authorises new medicines, on the national implementation of the revised EU legislation. Some operational changes will be made at the European Medicines Evaluation Agency, which is the European body which authorises new medicines, to facilitate EU enlargement in 2004, but the rest of the legislation is likely to become effective in early 2006. Such streamlining of authorisation procedures should help to ensure that new medicines reach patients more quickly, not only in the UK, but in every state in the European Union and beyond.

G10 promotes further change
An important meeting of the G10 Group of pharmaceutical industry and Government representatives from leading industrial nations was held in Rome in July to consolidate the agreements reached by the Group over the period of its activity.

Importantly, the Group reaffirmed its commitment to provide adequate data exclusivity for pharmaceutical innovation and to resolve the issues relating to competition for medicines not purchased by individual member states for their health systems.

In addition, the G10 Group provided a further impetus to the introduction of new incentives for the development of children’s medicines, albeit against a background of slow progress in regard to enabling legislation.

The importance of monitoring the impact of EU enlargement to ensure the continuing competitiveness of the pharmaceutical industry in Europe was also underlined. On a more negative note, the Council Working Party proposed the introduction of the concept of ‘affordability of medicines’ as a criterion for market entry, i.e. in effect a ‘fourth hurdle’, where, in addition to the accepted criteria of safety, quality and efficacy, a new medicine would be assessed for its cost-effectiveness as well. Such a move might deprive patients of some of the innovative medicines that are now in the pipeline.

One final meeting of the G10 Group will be held in spring 2004, following which it will be for individual EU member states to implement the agreements reached.