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Decision Makers and Decision-Making Processes Diagram 
Model description and Symbols:
The ultimate decision maker is listed at the top of the model Boxes: Decision-making bodies Solid Arrows: Required step in decision-making process Broken Arrows: May or may not impact decision BACKGROUND The Danish healthcare services are primarily public and are governed by a combination of national state institutions, regions and municipalities. All three levels have democratically elected assemblies and there is a tradition of decentralization of management and planning to the regions and local municipalities. National-level institutions include the Parliament, the Government and various state bureaucratic institutions. The state level is responsible for the overall legal framework for health care, and for coordinating and supervising the regional and municipal delivery of services. Five regions are responsible for delivering both primary and secondary sector health services. Most hospitals are owned and operated by the regions, and hospital doctors are salaried employees of the regions. Practising doctors are private, rather than state practitioners, but receive almost all of their income from services paid by the regions. The 98 municipalities at the local level have the responsibility regarding general prevention and health promotion as well as rehabilitation care outside hospitals. The public expenditures for healthcare are financed through taxes, primarily by a special national healthcare tax. According to the National Health Act the regions offers totally or partially coverage of the expenditures for treatment by general practitioners, specialists, dentists, and physiotherapists etc., as well as reimbursement of pharmaceutical treatment. All inhabitants in Denmark are covered by the Healthcare Act’s provisions. More than 98% of citizens have chosen to be “Group 1 members”, who are attached to one general practitioner and need a reference from this GP in order to visit a practicing specialist. Both visits to GP’s and practicing specialists are free of charge for those patients. A minority less than 2% have chosen to be “Group 2 members”, who are free to choose any GP and may visit a practising specialist without reference from a GP. The regions only cover part of the costs for Group 2 members. There is no difference between the two groups with regard to the reimbursement of pharmaceuticals. Citizens may take out insurance with private insurance companies and thus obtain further reimbursement of e.g. pharmaceutical expenditures and dental care. Health Insurance “Denmark” is the only major private (non-profit) health insurance company in Denmark (1.8 million members) but the private sector is growing especially due to collective arrangements within the labour market. DECISION-MAKERS AND INFLUENCERS At national level the main players are the Ministry of Health and Prevention, the Danish Medicines Agency and the Danish Parliament setting the framework of the pharmaceutical system. At regional level the five regions finance the reimbursement of pharmaceuticals through nationally paid taxes, and at local level the municipalities run a supplementary reimbursement system based on social indications. The main actors in the Danish pharmaceutical system are, beside these central actors the doctors, the patients, the industry and the pharmacies. Most patient associations are organised within the umbrella organisation “Danske Patienter” (Danish Patients) which represents more than 700,000 members and covers practically all patient interests. Also the Danish Consumer Council (Forbrugerrådet) – a body independent of public authorities and commercial interests – represents the interests of patients (and consumers in general). Please find a detailed description of the most important decision-makers and influencers below: The Ministry of Health and Prevention is in charge of setting the overall framework for the pharmaceutical system, the administrative functions related to the organisation and financing of the health care system, as well as the approval of pharmaceuticals and the pharmacy sector. Prevention and health promotion are also part of the Ministry’s remit. The Danish Medicines Agency's main duties are to authorise and control pharmaceuticals and companies, including pharmacies, and to monitor the economic use and consumption of pharmaceuticals. The Agency has four professional divisions, detailed below.
Institute for Rational Pharmacotherapy (IRF) – the aim of IRF is to promote the most rational use of current and future pharmaceuticals with respect to both pharmacological and economical aspects and directed towards both primary and hospital care. The Institute publishes the monthly medical journal "Rational Pharmacotherapy" and arranges courses on the use of pharmaceuticals, reviews new pharmaceuticals on the web site and supports regional medical advisers on pharmaceuticals. The Institute for Rational Pharmacotherapy (IRF) provides well balanced information to all medical doctors in Denmark. Secondary target groups are other professionals in the health sector and consumers of pharmaceuticals. The National Board of Health (SST) is the central professional authority in the health care field with the main task of monitoring the health care system and its actors and activities, authorising health professionals, and providing professional advice on health issues to the Minister of Health and Prevention, the regions and other authorities, as well as to the population. The Danish Centre for Health Technology Assessment (DACEHTA) carries out health technology assessments (HTA) with the aim of improving quality, standards and value for money. It is also an objective to integrate health technology assessment (HTA) principles into the running and planning of the public health service at all levels. The five regions/the Regional Councils decide on which pharmaceuticals to use and which (expensive) new medical treatments to implement in the hospital sector. The regions buy pharmaceuticals via public procurement. They are also in charge of funding the reimbursement of pharmaceuticals eligible for reimbursement in the primary care sector and thereby act as a third-party payer. The regions are drawn together in the Association of Regional Councils. The Reimbursement Committee's (MTN) task is to advise the Danish Medicines Agency in cases concerning health insurance reimbursement of pharmaceuticals (both general reimbursement and individual reimbursements). The Reimbursement Committee consists of a maximum of seven people, two of whom must be general practitioners. Members are appointed by the Minister of Health and Prevention after recommendation by the Danish Medicines Agency. One member represents the regions (the third-party payer). The members of the Committee are appointed for a 4-year term and collectively possess a broad range of professional expertise. As a rule the Committee is consulted when deciding on the reimbursement status of new pharmaceuticals for which the company has applied for general reimbursement and the Committee also recommends on criteria for the various types of individual reimbursement. However, the reimbursement decisions themselves are the responsibility of the Danish Medicines Agency alone. The Reimbursement Committee meets once a month and the Danish Medicines Agency provides a secretariat for the work of the Committee. The Council for Adverse Drug Reactions offers general guidance to the Danish Medicines Agency on adverse reaction matters and makes recommendations to the Agency for improving the prevention and monitoring of adverse reactions, thereby encouraging safer use of pharmaceuticals. The main tasks of the Council are to monitor and assess adverse reaction reporting in practice, and to propose recommendations and give inspiration to the Danish Medicines Agency’s information and communication tasks on adverse reactions for consumers, patients and health care professionals. The council is appointed by the Danish Medicines Agency and it consists of nine members representing the industry, therapists, pharmacists, patients and consumers. Meetings are held 4-6 times per year, and the Danish Medicines Agency provides a secretariat for the work of the Committee. The Licensing Committee - the main task of the Licencing Committee is to advise the Danish Medicines Agency on cases concerning applications for – and annulment of – market authorisations for pharmaceuticals and clinical testing of pharmaceuticals. The Licensing Committee consists of a maximum of 13 people appointed by the Minister of Health and Prevention, on the recommendation of the Danish Medicines Agency. Members of the Committee are appointed for four years at a time and, collectively, possess a broad range of professional expertise. The Committee meets once or twice per month, and the Danish Medicines Agency provides a secretariat for the work of the Committee. The Danish Association of the Pharmaceutical Industry (LIF), the Danish Generic Medicines Industry Association (IGL) and the Danish Association of Parallel Importers of Pharmaceuticals (PFL) are sometimes used by the Ministry of Health and Prevention and the Danish Medicines Agency as experts and advisory bodies for the authorities in matters related to the industry. The Danish Association of the Pharmaceutical Industry (Lif), the Danish Generic Medicines Industry Association (IGL) and the PFL are sometimes represented in official committees and working parties. The industry is consulted by the Ministry of Health and Prevention and the Danish Medicines Agency in connection with preparing new bills and governing orders that affect the industry. DECISION-MAKING PROCESS The Danish Medicines Agency decides on the reimbursement status of each pharmaceutical product. It is a parallel board to the National Board of Health under the Ministry of Health and Prevention. It is responsible for legislation concerning pharmaceuticals and medical devices, the approval of new products, clinical trials, deciding which drugs should be reimbursed; and licensing companies that produce and distribute pharmaceuticals. The regional health authorities advise the Danish Medicines Agency before they make any decision on whether or not to reimburse a particular drug. According to S. 143 of the National Health Act, the regions are required to provide reimbursement for the purchase of medicinal products for which the Danish Medicines Agency has granted reimbursement. The handling of an application for national market authorisation is divided into four phases: start-up phase, assessment phase, follow-up phase and closing phase, which are displayed in detail (e.g. regarding guidelines and forms, case handling times, etc.) on the Danish Medicines Agency’s web site. Denmark follows the specified time limits set out in the European Community legislation, i.e. the handling of an application takes a maximum of 210 days for national market authorisation. The duration for the follow-up phase for new applications is 90/60 days, as shown in the graphic illustration: 90 days for new full applications, and 60 days for abridged applications. The handling of market authorisation cases and the case handling times have been discussed with industry branch organisations, because the Danish Medicines Agency has had a backlog of national applications for market authorisations. The Danish Medicines Agency has a contract with the Ministry of Health and Prevention that states the case handling times that must be adhered to for applications for market authorisations. Any delay in the case handling time is therefore placed in the initial validation phase i.e. prior to the four phases mentioned above. This means that once a case has been started, the case handling times are strictly followed. Delays in starting national applications are published on the Danish Medicines Agency web site allowing each applicant to follow the proceedings of the backlog through a unique and confidential case number. HEALTH TECHNOLOGY ASSESSMENT Staff at all levels of the health service is responsible for identifying and drawing attention to areas where HTA is needed. This responsibility includes the need for new technology assessments as well as the evaluation of existing technologies. In areas where an independent national intervention is necessary, HTA projects are to be undertaken as a basis for planning and operational decision-making. Implementation of independent national projects should take place in cooperation with research councils, health authorities and professional organizations. On 1 April 2001, the Danish Institute for Health Technology Assessment (DIHTA) and the Danish Hospital Evaluation Centre merged to form the Danish Centre for Evaluation and Health Technology Assessment (DACEHTA). The centre is situated as an entity within the The National Board of Health. DACEHTA is served by two boards: The Strategic Advisory Board and The Scientific Advisory Board. The key aims of the Danish Centre for Health Technology Assessment (DACEHTA) include carrying out health technology assessments (HTAs) with the aim of improving quality, standards and value for money. It is also an objective to integrate HTA-principles into the running and planning of the public health service at all levels. DACEHTA collaborates with the health authorities at regional level in evaluating and analysing medical equipment, pharmaceutical products, investigations, treatment and care methods, methods for rehabilitation, health education and prevention. The Centre initiates and carries out HTA in cooperation with clinical departments, GPs, health administrators, clinical scientists, health services researchers and representatives from the medical industry. DACEHTA primarily targets health professionals and decision-makers at all levels as well as related research communities. DACEHTA is charged with employing those activities and methods that will contribute most effectively to quality, efficiency and standards of care in the Danish health service. In terms of international collaboration DACEHTA is hosting the coordinating secretariat for the European HTA network - European Network of Health Technology Assessment (EUnetHTA). DACEHTA is also a member of the International Network of Agencies for Health Technology Assessment (INAHTA). There is no regulatory mechanism in the Danish health service requiring the use of HTA in policy decisions, planning or administrative procedures. At the national level, however, a number of comprehensive assessments of health technology have formed the basis for health policy decisions. However, the conclusions of HTAs are often disregarded due to political or an individual health professional’s priorities. A primary concern regarding HTAs is that assessments are time-consuming and thorough tasks, which can be difficult to fit into a short-term political process that often demands quick decisions. However, several of the reports published from DACEHTA have helped to create an ongoing and lively public debate on priorities in health care. REIMBURSEMENT AND PRICING APPROVAL PROCESS The pharmaceutical area is strictly regulated in Denmark as in other countries. Marketing authorization is regulated according to EU regulation and relies on effect, safety and quality issues. As a consequence marketing authorization regulation in Denmark does not differ significantly from that of other European countries. Pricing and reimbursement issues are however a matter of national competency. In Denmark, reimbursement for an individual medicine is based on its main indication; however, other secondary indications also warrant reimbursement. Some pharmaceutical products are only reimbursed for certain diseases. The medicine’s therapeutic effect, value added, and side-effects are also factors considered when deciding on reimbursement. Price comparisons and economic evaluations also form part of the decision-making process. In general, reimbursement is granted for drugs that have a definite and valuable therapeutic effect and when they are used for a well-defined indication. The reimbursement rate depends on the patient’s accumulated pharmaceutical expenses during 12 months. At expenses below 820 DKK the reimbursement rate is 0% (2009). At expenses between 820 DKK and 1340 DKK the reimbursement rate is 50%. Between 1340 DKK and 2885 DKK the rate is 75% and above 2885 DKK the reimbursement rate is 85%. If the patient’s payment exceeds 3370 DKK, the patient can apply for 100% reimbursement for the rest of the year. From April 2005 the reimbursement price is calculated according to the least expensive generic product. This means that patients who do not choose the cheapest generic product will be reimbursed for a lower price than the price they actually pay. Please note that the amounts apply from 1 January 2009 and are adjusted every year. For pharmaceutical products without general reimbursement, an individually based subsidy may be obtainable by submitting an application, through a patient’s own physician, to the Danish Medicines Agency. Non-prescription drugs may be included in the list of reimbursable pharmaceuticals, but in such cases reimbursement is only granted to pensioners and patients suffering from a chronic illness that requires continuous treatment with the drug. A prescription would have to be issued for the pharmaceutical in question as well. Even if a drug meets the criteria for reimbursement, certain characteristics of the pharmaceutical, its specific use or the way in which it is prescribed may lead to a non-reimbursement decision.
DATA REQUIREMENTS Normally, general reimbursement is granted by the Danish Medicines Agency (DKMA) on the recommendation of the Reimbursement Committee (MTN), if:
Unless very special circumstances exist, general reimbursement shall not be granted for a pharmaceutical if: a) There is a considerable risk of off-label use (i.e. that the pharmaceutical will be used beyond the authorised indication, as is often the case for bisphosphonates) These criteria are exclusively product specific, based on the therapeutic value of the pharmaceutical in relation to price and in comparison with other available treatment for the disease in question. To justify a high price and demonstrate cost-effectiveness, a health-economic analysis may be submitted by companies as part of the application for eligibility for reimbursement. ACRONYMS
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