Pharmaceutical expertise to be consolidated into new centre in Finland

The reorganisation concerns the National Agency for Medicines, the National Authority for Medicolegal Affairs (TEO), the National Product Control Agency (STTV) and the Centre for Pharmacotherapy Development ROHTO as well as the National Research and Development Centre for Welfare and Health (STAKES) and the Social Insurance Institution of Finland in respect of the duties relating to pharmaceutical supply of the latter two. The role of the Ministry of Social Affairs and Health as coordinator will be strengthened and the status of the Pharmaceuticals Pricing Board (Hila) will be determined during the autumn.

“The premise is for all tasks relating to pharmaceutical supply to be concentrated to the new pharmaceutical centre. The location of the new centre will be subject to a regional decentralisation study in which the alternatives are Kuopio and Oulu. Both cities feature solid pharmaceutical expertise and according to the Government’s guidelines, the focus in regional decentralisation shall be on eastern and northern Finland. The aim is for the new centre to open in autumn 2009,” said Ms Liisa Hyssälä, Minister of Social Affairs and Health, in a briefing on the reorganisation.

Key elements of the reorganisation

Research and development in pharmaceutical supply and drug therapy processes as well as the dissemination of best practices in pharmaceutical supply will be concentrated to the new centre. The pharmaceutical centre will also assume responsibility for evaluating the overall effectiveness and cost-effectiveness of drug therapy and evaluating the adverse effects of medicinal products and the safety of drug therapy, and also for the national register of adverse drug reactions.

Marketing authorisations for medicinal products will fall within the ambit of the licensing and supervisory duties of the new pharmaceutical centre. The intention is to transfer all other licensing matters, such as pharmacy licences, blood establishment licences, tissue licences and marketing authorisations for medical devices, to the Authorisation and Supervisory Authority for Welfare and Health that will commence operations at the beginning of 2009.

The aim is to conduct the regional decentralisation study on as expedited a schedule as possible. The Ministry of Social Affairs and Health has commissioned the study from Ms Liisa Turakka, professor emerita, who will submit a proposal on the main points of the report in mid-October. The location of the new pharmaceutical centre will be decided by the end of November, which is the reporting deadline for the study. The Ministry has set up a project organisation to make preparations for the establishment of the new centre together with the agencies currently responsible for pharmaceutical supply and their employees.

“Drug therapy is an essential component of healthcare. The importance of drug therapy and drug safety is only growing. This reorganisation will allow us to ensure that the standard of pharmaceutical supply will remain high in the future as well. We must also discover new means of ensuring that society can afford new medicinal products, and in such a way that patients have access to these at a reasonable cost,” Minister Hyssälä said.

Further information:

State Secretary Terttu Savolainen, tel. +358 9 160 74099, +358 50 583 9912