The Rapporteur ad int. was assigned to examine how to develop the duties and operations related to the field of medicines of the Ministry of Social Affairs and Health and the agencies and institutions under it and how to make the operations more efficient.

According to the Rapporteur the central administration of pharmaceutical service should be reformed starting from the national pharmaceuticals strategy. The strategy should define the principles and actors for the development of pharmaceutical service and the division of duties between the actors, the responsibilities for development and supervision of the implementation of pharmacotherapies and for assessment of the effectiveness of pharmacotherapies and treatment processes.

The most crucial problem related to the central administration of pharmaceutical service is the incoherent planning and decision-making system of the Ministry of Social Affairs and Health. The coordination of pharmaceutical service and pharmaceutical policy should be assigned to the Department for Social and Health Services of the Ministry.

The transparency of operation of the Pharmaceuticals Pricing Board linked to the Ministry should be improved by clarifying the criteria used in the assessment of medicinal products and the criteria for decisions. The medical and clinical-pharmacological expertise of the Pharmaceuticals Pricing Board and its secretariat should be enhanced. As regards the different operational alternatives it would be best to transfer the Board within the Ministry to the Department for Social and Health Services.

The National Agency for Medicines should be strengthened in regard to duties related to supervision and licence administration, but the research and development duties in the field should be assigned to the new research and development institute for welfare and health to be established.

The Centre for Pharmacotherapy Development (ROHTO) should be incorporated into the new research and development institute for welfare and health. Part of the present resources of the Centre should be used for promotion of rational pharmacotherapy in primary health care and evaluation of the therapeutic and economic value of medicinal products.

The evaluations of the therapeutic and economic value of medicinal products should be produced within an expert network. The unit coordinating the evaluations should be placed in conjunction with the new research and development institute for welfare and health.

The problems related to interfaces between the National Agency for Medicines and the new licence and supervision authority to be established based on the present National Authority for Medicolegal Affairs and the National Product Control Agency for Welfare and Health should be surveyed, and the division of duties should be determined thereafter.

Key words : medicinal products, social and health care administration