IHS Global Insight Perspective | |
Significance | Established in the context of a large reorganisation of the Finnish pharmaceutical administration planned by the Ministry of Social Affairs and Health in 2008, the new Finnish Medicines Agency Fimea's main role includes the regulation and authorisation procedures of pharmaceutical products as well as the pharmacotherapy assessment. |
Implications | The new independent body replaced two former bodies: the National Agency of Medicines and the Centre for Pharmacotherapy Development in an attempt to rationalise the regulation environment. |
Outlook | The new organisational structure is met with much interest by the Finnish pharmaceutical industry, which expects faster introduction of new medicines in the market and calls for further collaboration and dialogue. |
Established at the beginning of November according to the bill submitted to Finnish parliament on 15 May 2009, the Finnish Medicines Agency Fimea replaced two former regulatory bodies: the National Agency for Medicines (NAM) and the Centre for Pharmacotherapy Development (ROHTO). The new independent body's main responsibilities include market authorisations and regulations of pharmaceuticals, research and development, and the production and dissemination of information in order to improve supply of pharmaceuticals and effectiveness of pharmacotherapy.
Marketing Approval
In terms of marketing authorisation, the Finnish Medicines Agency Fimea inherited the former National Agency for Medicines' (NAM) main duties. As a consequence, since the beginning of November, national marketing authorisations for pharmaceuticals have been handled by the Fimea. In addition to its national role, the Fimea also plays an EU-wide regulatory role and will gradually develop co-operation with European institutions. Medicines falling outside the scope of the European centralised procedure, which grants marketing authorisation in all 27 countries, can be approved via two possible options: the decentralised procedure (DCP) and the mutual-recognition procedure (MRP). In both cases, the Fimea plays a regulatory role if an approval procedure is filed in Finland. The 2008 data of the Co-ordination Group for Mutual Recognition and Decentralised Procedures—Human (CMDh) revealed that Finland completed 6% of all approved European MRPs and 4% of all approved European DCPs in 2008. In total, 23 marketing authorisation applications were evaluated under the MRP and 27 applications under the DCP.
Pharmacotherapy Evaluation
In terms of pharmacotherapy, the Fimea inherited Finland's Centre for Pharmacotherapy Development (ROHTO)'s responsibilities, namely the collection and dissemination of information to promote rational, evidence-based and cost-effective pharmacotherapy. The pharmacotherapy assessment is achieved via Drug Information Packages (DIPs) produced on selected products (e.g. medicines with unclear benefits and status or widely used medicines). Finnish pharmacotherapy evaluation is also based on assessments published by other organisations including Denmark's Institute for Rational Pharmacotherapy (IRF), the U.K. National Institute for Health and Clinical Excellence (NICE), Sweden's Nepi (network for Pharmacoepidemiology), the EMEA and the U.S. FDA. Statements and recommendations are published using levels of evidence classified between A and D, level A representing "strong research-based evidence" and level D representing "no evidence" of clinical benefit.
Outlook and Implications
The establishment of the Fimea was announced by the Finnish Ministry of Health following a review of the performance of the four agencies involved in the supply and distribution of medicines in Finland: the National Medicines Agency (NAM), the National Research and Development Centre for Welfare and Health (STAKES), the Centre for Pharmacotherapy Development (Rohto) and the Social Insurance Institution (KELA). The Fimea establishment represents an important milestone for the Finnish Health Ministry which seeks to improve efficiency and productivity in the supply and distribution of medicines. The Finnish Pharmaceutical Trade Body, PIF, has great hope that a boost in efficiency will help drugs enter the market more quickly than before as the new medicines agency offers greater centralisation in authorisation procedure and supervision of the pharmaceutical market. As reported in the review, a drug can sometimes enter the Finnish market two years after its introduction in Sweden. In the context of the reorganisation, the place of the Pharmaceuticals Pricing Board (PPB), responsible for pricing and reimbursement, still needs to be confirmed.
The establishment of the Finnish Medicines Agency was met with much interest by the pharmaceutical industry as it aims at increasing access to medicines and at bringing new medicines faster to the market through collaboration in research and development and improved approval procedures. If a greater collaboration is initiated between the agency and EU institutions, European marketing approval procedures in Finland could become more attractive for pharmaceutical companies seeking to enter the European market via a decentralised or a mutual-recognition procedure.