Brussels, 10/11/2003 (Agence Europe) - The medical and pharmaceutical biotech industry has welcomed the proposed revision of EU pharmaceutical legislation, particularly the plan to protect patents for 10 years (extended by a year in the event of new indications) and keep the centralised procedures for launching products. The criteria determining equivalence between generic drugs and specialities (set out in the Council's common position) will be tightened up in order to ensure patient protection and avoid legal contradictions for bio-similar drugs.
Outlining the views of the biotech industry to reporters in Brussels, Hugo Schepens, General Secretary of EuropaBio (European Biotech Industry Association), said there were currently more than a hundred biotech drugs on the market, most of which provide innovative treatments for diseases like cancer, cardiovascular problems, degenerative neural diseases like Parkinson's or Alzheimer's, and rare genetic disorders. There are more diseases than treatments, added Schepens, pointing out that suitable treatment was available for only 10,000 of the 30,000 known diseases.
In July 2001, DG Enterprise of the European Commission suggested revising EU pharmaceutical legislation covering the European Medicines Agency and the EU human medicine and veterinary medicine codes with the aim of promoting public health, simplifying procedures for authorising the launch of new product, improving operations for the pharmaceutical industry and preparing for enlargement. On 29 September 2003, the Council adopted via qualified majority voting (Belgium and the Netherlands voting against and Germany abstaining) a common position on a regulation setting out EC procedures for the authorisation and surveillance of medicines for human and veterinary use, and establishing a European Medicines Agency. By unanimous voting, the Council adopted a common position on a directive amending Directive 2001/82/EC establishing an EC code on veterinary medicine. The proposal is currently before the EP for second reading. The EP's Environmen! t Committee is espected to vote on it on 26 and 27 November and the dossier will then be submitted to the EP plenary in Strasbourg on 15-18 December.
In 2002, the European biotech industry was made up of some 1800 companies with a total workforce of 80,000. The European biotech industry has to date spent more than EUR 7 billion on R&D into combatting diseases like AIDS and leucaemia.