The Government proposes establishing a new national Medicines Agency
The main duties of the Finnish Medicines Agency that is to be established are proposed authorisation and supervision tasks in the pharmaceuticals field, research and development, and production and dissemination of information on medicinal products with a view to improve the effectiveness of pharmaceutical service and pharmacotherapy.
The aim of concentrating the duties associated with pharmaceutical service in the new Agency as well as of its new tasks is to improve the pharmaceutical service for the population and the safety, appropriateness and economy of pharmacotherapy. The reform will contribute to integrating the skills and knowledge related to medicinal products better than today into the social and health care service system. In addition, the population can be provided impartial information on medicinal products.
The most important reasons for the need to reorganise the pharmaceutical service in Finland are the improved medicinal therapies, the ageing of the population, and the increased costs of pharmacotherapy.
The Government decided on the content of the government bill regarding the Agency on 13 May. The President of the Republic submitted the bill to Parliament on Friday 15 May. According to it, the Finnish Medicines Agency will start work on 1 November 2009 in Kuopio.
The tasks of the new Agency include the present tasks of the NationalAgency for Medicines associated with medicinal products. The National Agency for Medicines has actively contributed to the supervision of medicinal products within the EU. The Government bill wants to stress and expand the EU level and international cooperation of the new Agency.
The new Agency is to promote the health and safety of the population by supervising medicinal products and human tissues used for medical purposes, and by developing the pharmaceuticals field. Its research and development will support, among others, the societal decision-making regarding medicinal products. The purpose is to carry out pharmacopolitical and pharmacoeconomic research and to enhance R&D cooperation in the pharmaceuticals field.
The new Agency will also be in charge of the supervision and development of pharmacy operations. The objective is to secure the availability of medicinal products throughout the country. The Agency is to secure, besides safe medicinal products, also the safety of tissues used for medical purposes. On the other hand, the intention is to assign the tasks related to medical devices to the National Supervisory Authority for Welfare and Health (Valvira).
The Finnish Medicines Agency is to network with and operate in a close cooperation with actors and stakeholders in the pharmaceuticals field. The tasks of the Agency will be organised so that they will serve the pharmaceuticals field and health care as efficiently and effectively as possible. By building cooperation between various actors and engaging in the development of the pharmaceuticals field the Finnish Medicines Agency could vitally improve the functioning of the chain of pharmaceutical services and pharmacotherapy processes.
The Ministry of Social Affairs and Health and the National Agency for Medicines have prepared a plan to ensure the optimal functioning of operations during the transition. The regionalisation will be carried out during a transition period of five years. The most important tasks of thepresent National Agency for Medicines, EU level and other international commitments included, will be prioritised. The Agency has also undertaken measures to retain skills and expertise. Electronic official communication and automated case management are being developed, processing of marketing authorisations included.For further information contact
Päivi Sillanaukee, Director-General, tel. +358 9 160 73313
Marja-Liisa Partanen, Director-General, tel. +358 9 4733 4200
Anne Koskela, Ministerial Counsellor, Legal Affairs, tel. +358 9 160 74340, +358 50 5011908
Ulla Närhi, Ministerial Adviser, tel. +358 9 160 74 146
Vesa Jormanainen, Project Manager, tel. +358 50 430 1732