The Finnish Medicines Agency Fimea is in charge of regulating and developing the pharmaceutical sector to promote the health of Finland s population.

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1 1 (11) FIMEA S STRATEGY Mission The Finnish Medicines Agency Fimea is in charge of regulating and developing the pharmaceutical sector to promote the health of Finland s population. Fimea s tasks The Finnish Medicines Agency Fimea started its operations in November 2009 when its predecessor, the National Agency for Medicines, was closed down. Fimea s tasks and goals are based on national and EU legislation, the Government Programme, the strategy of the Ministry of Social Affairs and Health, the Medicines Policy 2020 programme, and performance- and resource-based management. Fimea is a centralised authority operating under the Ministry of Social Affairs and Health. It is a regulatory authority in charge of licensing, supervision and regulation activities related to human and veterinary medicines, blood and tissue products and the pharmaceutical sector in general. Being a national authority, Fimea is part of a the European Medicines Regulatory Network. By definition, it is also responsible for coordinating the national development of the pharmaceutical sector and for research into and assessment of pharmacotherapies. Fimea gathers and assesses data on clinical pharmacotherapies and develops pharmacotherapy practices by means of education and dissemination of information. Fimea is funded by its income from chargeable services and by the state budget. State funding is mainly used for the assessment of pharmacotherapies and related supporting activities. Income from the European Medicines Regulatory Network is an increasing source of funding. Values Effectiveness We play an active role in the pharmaceutical sector both nationally and internationally. We perform our tasks responsibly and effectively to promote the health of the population, drawing on our high level of expertise, experience and extensive networking. Innovation and development We develop our professional expertise to meet future challenges. We use our knowledge and skills we have gained to develop the pharmaceutical field in cooperation with the relevant stakeholder groups. We look for interesting new perspectives and introduce innovative working methods. Reliability Reliability is based on transparency, high ethical standards, expertise and consistency. The information we produce is unbiased and evidence-based; the decisions we make are predictable and soundly based. We keep our promises. Respect for collaboration and people We work together to meet our common goals respecting and supporting for each other. An encouraging and fair atmosphere builds a sense of community, promoting well-being and efficiency in the workplace.

2 2 (11) Vision 2020 Fimea is a nationally and internationally recognised authority in the pharmaceutical sector. Fimea s operations are based on the expertise of highly motivated personnel and on networking with other stakeholders and research institutions in the field, ensuring that pharmaceutical research, access to medicines and the safety and appropriateness of pharmacotherapies in Finland meet the highest European standards. Fimea is actively involved in the European Medicines Regulatory Network and takes into account the needs of the Finnish health care system. Fimea is a key player particularly within its selected strategic fields of excellence. CHALLENGES IN A CHANGING ENVIRONMENT Challenges in the health care system Finland s population is ageing, resulting in a greater use of pharmaceuticals and a poorer dependency ratio. The public sector is struggling to cope with the increasing workload and ever decreasing resources, requiring greater focus on key functions and efficiency. Working life in Finland is changing and now requires more and more collaboration, interaction and networking. Treatments which increase survival of patients subsequently increase also the lifetime healthcare costs. In order to maintain a sustainable health care system, the improved health of the population must also increase lifetime productivity, e.g. through longer working careers. The efficiency of the health care system must be stepped up to ensure that everyone has an equal access to adequate health care. Service structures, activities and funding models must be further developed. The role of pharmacotherapy among medical treatment will increase, as will its share of health care costs. New methods and medicines and personalised medicine will increase the efficacy and effectiveness of pharmacotherapies but also the associated costs. New pharmacotherapies will affect not just the development and regulation of medicines but also the health care structures and distribution of medicines. Developing pharmaceutical services Ensuring the safety of medicines remains a key area in regulation of the pharmaceutical sector. At the same time increasing importance is being attached to the access to medicines, medication safety, the appropriate use of medicines and their therapeutic value. Access to medicines depends on many factors, from the development and introduction of medicines to their distribution and reimbursement. Access to medicines needs particular attention in small markets and in certain areas of pharmacotherapy, including rare diseases, paediatric pharmacotherapies and veterinary medicines. The efficiency of marketing authorisation procedures and distribution channels (pharmaceutical wholesalers, pharmacies) must be constantly assessed. The pharmaceutical distribution system is the key in ensuring regional access to medicines. It is increasingly challenging to maintain a nationwide high-quality, cost-effective distribution chain that meets the requirements for pharmaceutical safety. Health care centralisation in increasingly larger units and continuing migration to regional growth centres impairs the economic business conditions required to maintain a good pharmacy network covering all parts of the country. The retail distribution

3 3 (11) of medicines is an important aspect of the health care system and requires not only pharmaceutical logistics but also a responsible approach to promote successful pharmacotherapy. The conditions under which the pharmaceutical industry operates pay a major role with respect to the access to medicines and ensuring an emergency supply of medicines in Finland. The safety of pharmacotherapies depends both on the product safety and on medication safety, e.g. the ways in which medicines are prescribed, handled and used in the treatment-related processes. The majority of adverse events related to medicines involve preventable deviations within these processes. Appropriate pharmacotherapy depends on the processes extending from the prescribing physician via other health care personnel all the way to the patient and the patient s relatives. Improvement of these processes, therefore, requires extensive collaboration between all the parties involved. More attention is being given to the appropriate use of medicines. Both health care professionals and medicine users need independent, balanced information on medicines and pharmacotherapies to ensure evidence-based treatment and to encourage patients to take more responsibility for their treatment. Finding a rational balance between pharmacotherapies and non-pharmacological therapies is important to ensure that pharmacotherapy is not used as a substitute for more effective or ethically more appropriate treatments. This is particularly important with regard to self-care medicines and geriatric pharmacotherapies. From the population health perspective, the use of medicines must be as effective as possible. The use of new medicines requires information on their therapeutic and economic value compared to existing treatments, something that must be taken into consideration in the development of pharmaceuticals. The authorities must collaborate to match the needs of regulation and pharmacotherapy assessment so that overlaps and unnecessary delays in introducing new medicines are avoided. This also reduces the cost of developing pharmaceuticals, directs development activities and promotes the development of products with added therapeutic value. Reliable information on the relative therapeutic and economic value of medicines allows the reimbursement system to promote the use of effective therapies and thus ensure equal access to them across the population. The increase in pharmaceutical costs must also be restricted, which underlines the importance of lower-cost pharmacotherapies such as generics and biosimilars. People are taking more and more responsibility for their health, and the health care system must support them in self-care. In self-care, medicines only serve as a support for other treatments. While pharmaceutical industry stakeholders strive to increase the use of over-the-counter (OTC) medicines, but an increase in the use and range of OTC medicines and the range of their distribution channels is subject to controversy. An increase is supported by hopes to reduce the workload of the health care system and reimbursement costs for pharmaceuticals and to improve access to medicines. Factors against it include the risk of increasing adverse effects, delays in diagnosing and treating serious diseases and underuse of non-pharmacological therapies. The increasing size of animal husbandry units is leading to greater morbidity and disease pressure among production animals. Global warming, animal transfers and tourism are increasing the spread of vector-borne and infectious diseases. Treatments for pets are being further developed and their demand is increasing. All this is increasing the need for veterinary medicines, which may result in inappropriate medicine use. This, in turn, may result in increased resistance to antimicrobials and a greater risk of pharmaceutical residues in animal-source foods.

4 4 (11) Development of pharmaceuticals In Finland, globalisation is influencing both the business structure and the activities of authorities. This provides an opportunity for the promotion of the Finnish health care system, provided that the stakeholders in the field have sufficient courage, expertise and innovation. Pharmaceutical companies grow by acquiring smaller companies. Product development and manufacture are increasingly outsourced, giving rise to both small, innovative development companies and contract manufacturers specialising in good manufacturing practice. Innovationoriented Finnish companies sometimes struggle to find partners specialising in manufacturing of pharmaceuticals in Finland. The development of pharmaceuticals often starts in an innovative company backed by public funding. Investors and major companies only take an interest in new molecules once the development process has passed the most critical stage. The early stages of development must therefore be supported both financially and with the help of authorities to ensure that investments yield good results. The emphasis in the development and manufacture of pharmaceuticals and the manufacture of finished medicinal products is moving away from Europe and North America to third countries, particularly India and China. Stakeholders from outside the EU also need extensive scientific advice and guidance on official requirements and guidelines. Both the industry and health care authorities are concerned about the low number of innovative pharmaceuticals despite significant scientific and technological progress and about spiralling development costs. New research methods such as bioinformatics, phase 0 studies, use of biomarkers and adaptive study designs will probably be introduced to enhance the development of pharmaceuticals. The range of pharmacotherapies is growing with an increasing number of biological agents being introduced alongside the conventional chemical ones. Advanced therapies (cell and gene therapy, tissue engineering) are creating new opportunities in areas previously devoid of effective pharmacotherapy. Pharmacogenetics allows treatment to be directed at patient populations with a more favourable product risk-benefit ratio. Imaging, molecular diagnostics and other novel methods result in many medical conditions being divided into several subgroups on the basis of the stage or aetiology of the disease. This increases the need for the interaction between diagnostics and pharmaceutical development. Medicines are increasingly being integrated into various devices, and the use of new biomaterials is increasing. This is strengthening the ties between the regulation of pharmaceuticals and the regulation of medical devices. Control of the manufacturing procedure of pharmaceuticals is increasingly being supported by a profound understanding of the critical stages of the process and their interrelations. The introduction of new technologies and manufacturing methods requires constant dialogue between the research community, the pharmaceutical industry and the authorities, as well as re-evaluation of working methods. International nature of regulatory activities Within the EU, the regulation of pharmaceuticals is becoming more centralised. The role of the European Medicines Agency (EMA) is growing in relation to that of the national authorities. The EU is likely to expand even further, and the use of medicines will then have to be adjusted to meet an even wider spectrum of national health care systems. The importance of the EMA is increasing both in marketing authorisation activities and in the coordination of pharmacovigilance and inspection activities. Collaboration between the EU (EMA, EDQM 1, PIC/S 2 and the United States Food and Drug 1 European Directorate for the Quality of Medicines, Council of Europe 2 Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme

5 5 (11) Administration (FDA) is broadening, and progress is being made in the global harmonisation of official guidelines. With regard to the marketing authorisation processes, the centralised and decentralised/referral procedures are gaining ground over national procedures. This is forcing national authorities to assess their activities and position in the European Medicines Regulatory Network. The effective regulation of pharmaceuticals can be enhanced at the EU level by promoting smooth processing of common marketing authorisation procedures and by avoiding overlapping work. In addition to the collaboration, national authorities also compete for opportunities to participate in the decision-making and for the maximum expertise in the field of developing pharmacotherapies. This will improve the quality and effectiveness of the regulatory agencies.

6 6 (11) STRATEGIC PRINCIPLES Incorporating pharmaceuticals as part of the social and health service system Several bodies are involved in regulating and developing the pharmaceutical field, and Fimea is in charge of coordinating the activities of this network in Finland. The future Pharmaceutical policy decisions until the year 2020 (the Medicines Policy 2020 programme) have been defined in various working group with the extensive stakeholder group participation. Under the leadership of the Ministry of Social Affairs and Health Fimea is committed to promoting the goals of the Medicines Policy 2020 programme. Critical success factors: o Networking within the pharmaceutical sector creates added value for societal decision-making o Societal investment in medicines creates real and measurable health benefits o Further development of the management systems of medication safety. Developing EU pharmaceutical policy The Finnish health care system is Fimea s main client. However, pharmaceutical policy decisions affecting Finland are increasingly being made internationally, since many tasks, particularly the regulatory ones, are based on the EU guidelines. Fimea is actively involved in developing pharmaceuticals policies and regulations of pharmaceuticals in EU. Fimea s ability to influence the EU-level decisions is based on the high level of expertise of its personnel. Fimea plans to increase its influence within the EU regulatory activities by specialising in selected fields of EU-level collaboration, specifically biological and generic medicines. This will further promote the safety of medicines and pharmacotherapies and access to them in Finland. Access to medicines The development of pharmaceuticals is international business, and the EU is striving to bring the focus back to Europe through its innovation policy. Regulatory authorities are in a position to make the working environment more favourable for this development. The development of pharmaceuticals is being increasingly strictly regulated, and the associated costs are rising. The situation poses particular challenges for small companies and those from outside the EU and North America. Fimea is developing its administrative and scientific guidance on pharmaceuticals development to make it more attractive, interactive, proactive and inclusive. By influencing official requirements, Fimea seeks to strike a balance between the access to medicines and the safety issues. The development and licensing of pharmaceuticals is gathering pace, and Fimea is responding by developing methods for post-authorisation surveillance. There is an intense pressure to further develop the distribution system for medicines, and distribution channels are becoming more diverse. Fimea strives to ensure a high level of medicine safety and to guarantee reliable and appropriately timed pharmaceutical information irrespective of the distribution channel. Access is a particular challenge in the case of veterinary medicines. Being a small market, Finland is unattractive to those applying for a marketing authorisation. The regulation of veterinary medicines by Fimea mainly focuses on products used for the production animals and their influence on food safety. Particular attention is given to the controlled use of antimicrobials. Finland remains free from many animal diseases that are common in Europe, and the current situation must be maintained, for example by ensuring the proper quality of veterinary vaccines and sufficient access to them.

7 7 (11) Appropriate use of medicines The amount, quality and comprehensibility of information on medicines and pharmacotherapies need to be improved to ensure the safe and appropriate use of medicines. This can be achieved through collaboration between all those working in this field. Fimea will draw up a national pharmaceutical information strategy and coordinate its implementation. Fimea encourages patients to participate actively in their treatment by increasing the amount of reliable, easy-to-understand pharmaceutical information available in user-friendly information sources and by helping patients to better utilise information and information sources. In the future, pharmacotherapies will be increasingly personalised which emphasises the need for detailed information. Fimea supports research on self-care medication in order to ensure safe and appropriate use of OTC medicines. Fimea will compile a national self-care programme with guidelines on the OTC medication use in a self-care context. Information on medicines and pharmacotherapies will also be disseminated directly to the public via appropriate distribution channels. The social media will allow interactive communication on medicines and immediate input by medicine users. Health care professionals play a key role in disseminating easy-to-understand information on medicines, particularly on new, innovative products. Fimea publishes pharmaceutical information on all new innovative medicines being put on the market. It also uses its expertise to support education on medicines and pharmacotherapies on a number of levels. Existing systems supporting decisionmaking are utilised to meet the need for pharmaceutical information in social and health care services. From medicine safety to medication safety The development of medicine safety is based on the earlier recognition of risks by means of risk management plans and independent epidemiological studies. Fimea promotes the development of Finnish health care registers to improve their usability for this purpose. However, the main safety issue in the use of medicines is medication safety, consisting of processes related to the appropriate prescription, handling and usage of medicines. Fimea is in charge of coordinating collaboration between the bodies regulating these processes. Good supervision of medication usage also improves the efficiency of pharmacotherapies and reduces costs. Pharmaceutical costs A well-functioning pharmaceuticals market is a prerequisite for healthy competition and for controlling the increase in pharmaceutical costs. Cost reductions achieved through price competition also spare financial resources that can then be used for new medicines. Fimea promotes the access to highquality generics and seeks to facilitate generic substitution. Fimea is actively involved in developing regulative guidelines on the use of biosimilars. The therapeutic value of a medicine must be in an adequate relation to its costs. Assessing the therapeutic and economic value of medicines is an important part of the treatment process. Assessment of pharmacotherapies guarantees optimum health benefits in relation to the available resources. A comparative assessment of pharmacotherapies also facilitates the identification of unmet therapeutic needs, which promotes the development of new pharmacotherapies and improves access to new therapies with added value.

8 8 (11) Promises to the clients The immediate clients of Fimea s regulatory and licensing services are license holders that submit their applications to Fimea for licences and other statutory permits. Medicine safety regulation, pharmacotherapy assessment, production of pharmaceutical information and development of the pharmaceutical industry benefit the social and health care service system as a whole, the health care professionals involved and, finally, those who use medicines. Critical success factors: o Regulatory activities are based on risk assessment o Fimea s regulatory decisions are of a high standard and issued on time. Regulation of medicines and license holders The number of Fimea s licensing procedures will probably increase during the period covered by this strategy. Fimea s limited resources will be used as effectively as possible by focusing on those areas considered to have the highest risks. Fimea puts particular emphasis on new medicines and medicines considered to involve particular risks. The regulation of pharmaceuticals within the EU is based on the network of national regulatory authorities. This network model ensures that optimum use is made of the expertise of the member states and takes into consideration the differences between health care systems in the different member states, as well as the differences in the prevalence of various medical conditions. Fimea supports the EU s regulatory network model through its active participation and its confidence in the other national authorities involved. Fimea will develop its operations on the basis of requirements emerging during benchmarking of the regulatory authorities. The majority of new medicines introduced in the Finnish market are processed using either the centralised or the decentralised marketing authorisation procedures. Fimea will increasingly act as the reference member state in the decentralised procedure and handles reporting tasks for the centralised procedure within the agreed timelines. The quality of assessment reports is ensured with both local and the EU-level procedures. Both the reference member state and rapporteur s responsibilities create a continuous chain of tasks. An electronic data management system will be developed to support the process, while calculation models will be introduced to facilitate financial and resource planning. Fimea s inspection and laboratory activities focus on the most critical operations and actors on the basis of risk assessments. The priorities of surveillance is decided according to the trust that the license holder has built through its own actions and on the historical regulatory data. Pre- and postauthorisation regulation by authorities is complemented with the self-regulation by the marketing authorisation holders. The manufacturing of active pharmaceutical ingredients and finished medicinal products has moved away from Europe to rapidly growing economies such as India and China, subsequently an increasing proportion of Fimea s inspections will target these countries. Collaboration in the international and national network of authorities, a clear definition of responsibilities and promotion of harmonisation will ensure more effective use of regulatory resources in the current situation, which is characterised by increasing risks associated with counterfeit medicines and the safety risks and responsibility issues arising from the increasingly longer outsourcing chains.

9 9 (11) Assessment of pharmacotherapies Fimea will assemble and coordinate a national network of expertise to perform pharmacoepidemiological, pharmacoeconomic and pharmacopolitical research. This research will focus primarily on nationally defined issues, but Fimea will also be active in international research projects. Assessment of the therapeutic and economic value of medicines is based on comparative safety and efficacy data, which is assessed during the marketing authorisation procedure and gathered continuously afterwards. For the assessment purposes, Fimea will develop a national procedure and coordinate the work of the national stakeholders in this area. As pharmacotherapy study designs become more complex, Fimea will pay particular attention to the quality and appropriateness of the methods used. Promises of Fimea for each client group Medicine users Pharmaceutical innovations with added therapeutic value and low-cost pharmaceutical options are rapidly accessible. Medicines are safe when used appropriately. The distribution system for medicines is reliable and extensive. Reliable, unbiased and easy-to-understand information on medicines, their effects and their appropriate use will be available from a range of sources. We will inform the public of the risks associated with counterfeit medicines and medicines obtained from outside the controlled distribution system. Health care professionals Reliable, appropriate and user-friendly pharmaceutical information is available from a range of sources. We will promote education on pharmacotherapies and pharmacoeconomy in collaboration with universities, higher education institutes and other educational institutes. We will participate in the development of the regulation, monitoring and management of the medicine and medication safety to improve patient safety. We will enhance research on medication safety to identify high-risk medicines and processes. Pharmaceutical industry and the license holders Medicines and the licence holders will be competently regulated based on risk assessments and with guidance offered. Our activities will continue to be even more interactive, effective and transparent. We will process applications within the set timelines, provided they meet all requirements and are of high quality. We will inform companies about the regulatory guidelines of the pharmaceutical development. We will promote the application of the latest scientific and technological information in the pharmaceutical development. We will ensure that patients needs and unmet medical needs receive more attention in the pharmaceutical development. Social and health care services system We will continue to develop the pharmaceutical sector in Finland in collaboration with stakeholder groups and in line with goals of the Medicines Policy 2020 programme. We will promote the introduction of a multidisciplinary model of pharmaceutical services in collaboration with other stakeholders with the client s best interests in mind. We will continue to promote the appropriate use of medicines.

10 10 (11) Continuous improvement of operational effectiveness Critical success factors: o Management and decisions are based on extensive, factual information o Implementation of electronic services, communication and case management system Fimea seeks to improve the overall effectiveness of its operations by linking risk assessments more strongly with regulation and inspection, reducing overlapping activities and improving all internal processes and related systems. Development work currently focuses on a project to build and introduce a management system for electronic services, communication, case management and archiving. It also involves the renewal and integration of basic registers and document management. The purpose is to create interfaces that allow Fimea to communicate with both the marketing authorisation holders and the European pharmaceutical regulatory network in an entirely electronic manner, permitting a seamless exchange of information and interlinking of processes. Development resources are focused on these projects, which promote key operations. Support functions will be transferred to the state level service centres or will be outsourced. In terms of licensing and regulation activities, these changes will be reflected as changes in job structures and new job descriptions. Fimea is further developing its accounting system and promoting greater transparency in its operations and funding. The purpose is to use information as extensively as possible to improve operational effectiveness. Fimea is using data on resources, performance figures and service quality from a range of operational areas to compile a unified set of information, which can then be used to increase its economic and operational flexibility and predict the changes it will face in the future. Data reporting is seen as a process of creating, acquiring, storing, transferring, sharing and utilising data. Sources of fragmented and isolated data will be combined to produce accessible information to support decision-making and strategy implementation. Effectiveness reporting in support of our operations allows resources to be allocated more costeffectively. We aim to be able to demonstrate increases in productivity, which in turn allows the resourcing of the net budgeted operations to better meet the needs of the clients.

11 11 (11) Fimea s operations and service performance are based on expertise Critical success factors: o High level of expertise o Personnel resources are consistent with the expanding field of operations o Successful management of the regionalisation of the bureau Fimea and its personnel comply with the shared values, which they put into practice in Fimea s operations and in the working place. An adequate number of expert, well-motivated personnel and a high level of personnel well-being are prerequisites for Fimea s success. Within its net budgeted activities, Fimea strives to be able to perform its tasks with the number of personnel that meets clients needs. Fimea s success depends on a high level of professional expertise. Professional expertise is essential to gain trust among our stakeholder groups and to succeed in international competition for expert tasks. Professional expertise creates new demand for a range of tasks involving guidance and advice. During the period covered by this strategy, Fimea s field of operations in the pharmaceutical field will expand and the content of its previous tasks will change. Expertise must be developed to meet these challenges, and some new areas of expertise must be built from scratch. Fimea s services are produced in an interactive manner so that everyone s input counts. Fimea s success is not only based on a high level of scientific, administrative and procedural expertise but also requires skills in areas such as information technology, change management and communication. Fimea emphasises the importance of good collaboration between assessment teams and smooth regulatory processes throughout the lifespan of a medicinal product. Expertise also includes management skills and, for everyone, transferable skills. Management and leadership must be of high quality, and Fimea places a great emphasis on the development of management skills and change management. Personnel motivation and well-being are vital for Fimea to meet its targets. An individual s resources comprise health, the physical, psychological, mental and social ability to work, knowledge, practical skills, as well as motivation and commitment. Fimea s human resources strategy seeks to ensure personnel well-being and to give personnel a sense of performing an important and rewarding task. Fimea is the leader in location-independent work within the public administration of Finland. We utilise information and communication technology to create virtual working methods. We operate in several locations, including Kuopio and other university cities. By 2020, Fimea aims to be the best workplace in Finland s public administration. Interesting and socially important tasks, opportunities for continuous professional development, systematic career planning, rewards, good management, extensive networking and flexible working procedures encourage commitment and motivation among the personnel.