Brussels, 18/07/2001 (Agence Europe) - As we announced earlier (see EUROPE of 18 July, p.10), the European Commission approved the package proposed by Commissioner Erkki Liikanen for revising European pharmaceutical legislation and the procedures of the European Agency for the Evaluation of Medicinal Products (EMEA). It comprises a proposal of regulation and two draft directives that will be submitted to the European Parliament and to the Council according to codecision procedure.
Presenting the package to the press, Commissioner Liikanen said that this reform would allow all patients in Europe to obtain new and better medicines than is the case at present. He said this is a major step in the construction of a more innovative and competitive European industry, that will be to everyone's advantage. Mr Liikanen insisted on the contribution that his reform must make to the competitiveness of the pharmaceutical industry and to the acceleration of marketing authorisation procedures. He pointed out that this should no longer take more than one year: between 150 days (fast-track approval) and 210 days for centralised procedure. While acknowledging that this point had been the most controversial, Mr Liikanen defended bringing in the possibility for patients to be informed by the industry but, at the same time, he said it was in no way a matter of authorising direct advertising. He went on to specify that the proposal provides for a pilot project, lasting five years, for three pathologies (AIDs, diabetes and asthma) with assessment of the results after this period. The Commission will adopt a code of conduct for providing a framework for information that will be diffused by companies, which, in turn, should submit their projects to the Agency on Medicinal Products before it is passed on to the public if the Agency does not voice opposition to this within one month. Mr Liikanen also recalled that, as long as they understand English and have access to the Internet, European citizens may already find information and advertising about medicinal products on the web.