låst DECEMBER 2016 The Danish Medicines Agency s availability strategy 2017 2021
Danish Medicines Agency, 2016 This publication may be freely quoted with appropriate acknowledgement of the source. Images from this publication must not be reused. Danish Medicines Agency Axel Heides Gade 1 2300 Copenhagen S Denmark dkma.dk Language English Version 1.0 Version date December 2016
Contents 1 Introduction 4 2 Delimitation of the strategy 4 3 Strategic challenges and focus areas 6 3.1 Reliability of supply 6 3.2 Delivery failure and uncertainty over substitution 3.3 New and expensive medicinal products 7 8 3.4 Increased availability via online sale and the risk of buying medicines from illegal online retailers 3.5 New dynamics in the medicinal product supply structure 8 9 3.6 The need for medicinal products in emergency situations 10 4 Efforts in the strategy period 10 The Danish Medicines Agency s availability strategy 3
1 Introduction Our mission is to secure effective, safe and accessible medicines and safe medical devices that benefit society. Our vision is to make the Danish Medicines Agency one of Europe s best in class. This means Active dialogue and collaboration value to citizens Quality and on-time delivery Professional expertise and commitment a fantastic place to work! Help boost Denmark as a leading life science nation Driver of European collaboration and a strong international position Our overall strategy for 2017-2021 describes how we will become part of Europe s best in class. Specific and cross-functional strategies unfold and clarify the work required to become one of Europe's best in class. We have prepared specific strategies for licensing, pharmacovigilance, availability, control and medical devices. We have also developed crossfunctional strategies for competency, quality, IT and communications. During the first years of the strategy period, we will primarily consolidate our organisation, with a strong focus on day-to-day operations. At the same time, we will take the steps required to realise our vision of reaching a European best-in-class level. The availability strategy contributes to this work. 2 Delimitation of the strategy The availability strategy has two overall objectives 1. Citizens must have continuous access to medicinal products of a good quality. 2. Pharmacies and pharmacy branches must be placed in all parts of the country so that citizens have easy access to prescription-only medicines, and it must be easy to identify legal online retailers of medicinal products. In addition, the price of medicines is of great importance to the individual citizen and to society. The reimbursement granted to the individual citizens when they buy medicinal products is also a significant factor. Thanks to the reimbursement system, citizens do not have to reject relevant treatment with medicinal products for financial reasons. The Danish Medicines Agency s availability strategy 4
The availability and prices of medicinal products are generally market-driven. The Danish Ministry of Health, the Danish Medicines Agency and Danish Regions have different areas of responsibility in relation to the prices of medicinal products see factbox 1. FACTBOX 1: THE AUTHORITIES ROLE IN RELATION TO THE PRICES OF MEDICINAL PRODUCTS Danish Medicines Agency Responsible for publishing consumer prices every fortnight and decisions on reimbursement for medicinal products dispensed at pharmacies in Denmark. Danish Regions Responsible for the procurement of medicinal products for Danish hospitals. Dispensing of medicinal products to patients at hospitals is free of charge. Danish Ministry of Health Responsible for price agreements with the pharmaceutical industry and markup agreements with pharmacies. The Danish Medicines Agency cannot instruct a pharmaceutical company to market a medicinal product in Denmark and cannot fix a price for the medicinal product. The companies decide whether they want to market medicinal products in Denmark and at what price. It is important to citizens that medicinal products are widely available and sold from physical sales outlets in all parts of the country as well as online. With the proliferation of the internet, the possibility of buying medicines from all parts of the world has increased significantly, and thus the risk of buying illegal medicines has also become more significant. In addition, it is important to have a ready supply of medicines that meet citizens' needs for medicines in special crisis situations. The special roles of companies and the Danish Medicines Agency in connection with the availability of medicinal products as well as the strategic challenges described in part 3 are illustrated in figure 1. The Danish Medicines Agency s availability strategy 5
Figure 1 3 Strategic challenges and focus areas 3.1 Reliability of supply Citizens must have continuous access to medicines of a good quality. The Danish market for medicines is small seen in a global perspective. Compared with certain other countries, Denmark has experienced relatively few supply problems with limited serious consequences for patients, but supply failure is an increasing problem in Europe. It is widely acknowledged that the causes of supply failure are complex and cannot be handled at a national level alone. It is essential for medicine users to have access to the medicinal products required for therapeutic purposes. Supply failure cannot be avoided completely, but when it occurs, it is important to quickly identify any alternatives to meet medicine users needs and inform them about it. The Danish Medicines Agency will strengthen its focus on reducing the impact of any future serious supply problems to initiate possible solution initiatives and minimise potential problems for medicine users as early as possible. In addition, we will assess the need for preparing targeted information to healthcare professionals, pharmacies and regions in connection with any supply failure. The Danish Medicines Agency s availability strategy 6
The Danish Medicines Agency will also strengthen and focus its efforts in relation to international activities and initiatives to reduce supply failure and ensure the availability of authorised medicines of a good quality. This applies to our efforts at a European level and the Nordic cooperation. We will contribute to the analysis of the pros and cons of joint initiatives, e.g. common Nordic packages, so that companies can generally provide the same package for the entire Nordic market. When there is a need for alternative methods to give patients access to medicines, for example because a medicinal product is not marketed in Denmark, it is important that these mechanisms operate as smoothly and efficiently as possible. This applies to our work with compassionate use permits, exemptions from the labelling rules and permissions for magistral preparation of medicinal products. The Danish Medicines Agency will continuously review the administration of compassionate use permits and permissions for magistral preparation of medicinal products to assess the opportunities to maximise flexibility and efficiency of these for the benefit of doctors and medicine users. 3.2 Delivery failure and uncertainty over substitution In Denmark, suppliers of medicinal products must notify the Danish Medicines Agency of prices every fortnight. As a general rule, the medicinal product with the lowest price wins the market for two weeks as pharmacies must offer medicine users the least expensive medicinal product of a substitution group. This means that the company must be able to supply the medicinal product to the market in the first of the two weeks when the medicinal product has the lowest price. Over the years, the Danish Medicines Agency has found an increasing number of delivery failures during a 14-day price period, which means that medicine users must be offered a different and more expensive medicinal product. At the same time, there are other challenges in the system, which means that not all delivery failures can be announced. With the involvement of relevant stakeholders experience, the Danish Medicines Agency will give rules and practices an overhaul to ensure that the system is as smooth, user-friendly and efficient as possible. This overhaul will also include an assessment of adequate sanctions on any violation of the rules. The Danish Medicines Agency's classification of medicinal products in package substitution groups is an important element in ensuring low prices of medicines in Denmark. Pharmacies must offer medicine users the least expensive medicinal product of a substitution group, which means that medicine users must have a certain knowledge about medicinal products and be familiar with the reason why pharmacies switch between different medicinal products. It may be difficult to understand the many changes in medicinal products caused by the rules on substitution, and some medicine users may feel uncomfortable. In cooperation with the relevant stakeholders in this field, the Danish Medicines Agency will prepare targeted information about substitution, which can make medicine users more comfortable when they switch to another medicine because of substitution. In addition, the Danish Medicines Agency will assess the opportunities to widen the span in package size to ensure that patients have access to the least expensive medicinal products. The Danish Medicines Agency s availability strategy 7
3.3 New and expensive medicinal products The development of new and more expensive medicinal products, including personalised medicine, means that the assessments of efficacy in relation to price become more and more complex. Overall, this increases the interest and need for the involvement of health economic analyses in the assessments about reimbursements. In 2017, Danish Regions has established a medicine council that will assess the application of new medicinal products in the hospital sector, where health economic analyses form an integral part of the assessments. The Danish reimbursement system for medicines in the primary healthcare sector is based on needs, which means that the more reimbursable medicine a medicine user needs, the greater the reimbursement will be. The purpose of the system is that no medicine users should reject appropriate medical treatment for financial reasons. In addition to the benefits for medicine users, reimbursement also matters to companies opportunities for selling their medicinal products. At the same time, society has a strong focus on public expenditure, including expenditure on medicine. The price of a medicinal product is included in the Danish Medicines Agency's reimbursement assessment as it is assessed whether the price is proportionate with the therapeutic value compared with other relevant treatment. The Danish Medicines Agency will ensure that the administration of the reimbursement system is up to date and future-oriented, including the use of adequate methodology and ensuring continued short assessment times for the processing of applications for individual and general reimbursement for the benefit of both medicine users and businesses. The Danish Medicines Agency will continue to focus on targeted information for healthcare professionals, proprietary pharmacists and medicine users about changes in the reimbursement status and cooperation in relevant areas with the new medicine council. In addition, the Danish Medicines Agency will work actively internationally to exchange experience in efficient administration and initiatives in relation to the increasing medicine expenditure. 3.4 Increased availability via online sale and the risk of buying medicines from illegal online retailers With the increasing spread and use of the internet, the market for medicinal products and healthcare has become global. In general, it is positive that medicine users can buy medicines and healthcare online from many different outlets and that users are not dependent on the physical location of sales outlets. The availability of medicinal products and healthcare, both legal and illegal, is great. The risk of health damage when buying illegal medicinal products is also great. This increases the need for information on how to buy medicinal products and healthcare safely online. The proliferation of the internet and social media means that the debate about medicinal products and medicinal product safety also takes place on other platforms than the traditional news media, and there are many different views and opinions to take into account. This means that medicine users must have knowledge about how to buy medicines and healthcare safely online. In addition, myths are often spread on e.g. social media about the right treatment or alternative treatment without evidence. The Danish Medicines Agency will cooperate with other authorities on the organisation of targeted information campaigns involving social media about the risks of buying medicines and healthcare online, including how to avoid buying products from websites that are not The Danish Medicines Agency s availability strategy 8
under regulatory control. This includes information that can increase awareness of the European safety logo for websites under the regulatory control of a European country. The Danish Medicines Agency will actively follow debates and the like on social media and consider the need for providing neutral information and facts about the topics discussed to help disprove myths. 3.5 New dynamics in the medicinal product supply structure Only pharmacies have an obligation and a right to dispense prescription-only medicinal products to medicine users. Forming part of the Danish health service, the pharmacy sector plays an important role in the medicinal product supply structure in Denmark. At the same time, pharmacies can offer citizens a number of healthcare services. The modernisation of the pharmacy sector, which entered into force on 1 July 2015, gave proprietary pharmacists the opportunity to open up to seven branches within a radius of 75 km from their pharmacy. This resulted in more than 100 new outlets handling prescriptions or an increase of over 30% in the number of outlets handling prescriptions in less than eighteen months. This is positive for the physical availability as well as competition. The new outlets were mainly established in or close to the major cities in Denmark. At the same time, there is increasing competition for skilled staff, which is quite scarce especially in remote areas. Due to the many new outlets, there is a risk that the quality of the professional advice offered to medicine users is reduced, that is the extent to which pharmacies can meet medicine users requests immediately. The Danish Medicines Agency will monitor developments through the continuous control of pharmacies and we will intervene if we find any violations of the law. The medicines must be easily available, and generally the distance to the nearest outlet handling prescriptions should be no more than 15 km for any citizen. In the event of any gaps in the medicinal product supply structure, the Danish Medicines Agency is responsible for assessing potential solutions. For example, we may order a proprietary pharmacist to open a branch in the area concerned. In special situations, the Danish Medicines Agency must operate pharmacies without a licence holder for a short period until a new licence holder or other solution is found. The Danish Medicines Agency will develop the collaboration with the sector and continuously contribute to easy accessibility to outlets handling prescriptions in all parts of Denmark. The pharmacy is the only place in health service where citizens can contact healthcare professionals without prior agreement. At the same time, Danish pharmacies can offer some healthcare services, e.g. medicines review, smoking cessation and blood glucose measurement. In connection with the modernisation, it became mandatory for pharmacies to offer pharmacist-patient communication about medication to newly diagnosed chronic sufferers. Some municipalities have made agreements with pharmacies on citizen-oriented healthcare, and there is generally increased awareness of the healthcare that pharmacies can offer. The Danish Ministry of Health regularly asks the Danish Medicines Agency to provide analyses of the development in healthcare services at pharmacies in Denmark and abroad. The Danish Medicines Agency will continue to monitor the development in this field and contribute with analyses when requested. The Danish Medicines Agency s availability strategy 9
3.6 The need for medicinal products in emergency situations The Danish Medicines Agency forms part of the overall health preparedness, and in special circumstances we have a specific responsibility in relation to providing a ready supply of medicinal products and medical devices for human use that can meet changed requirements for consumption, supply and distribution in everyday life, in supply emergencies and in case of accidents and catastrophes. 4 Efforts in the strategy period In the strategy period from 2017 to 2021, we will focus on the following four efforts: Reduction of the impact of any potential occurrence of serious supply problems. Overhaul of rules and practices for the notification of prices and supply capacity. Review of the administration of the reimbursement system. Cooperation with other authorities on the organisation of targeted information campaigns about the risks of buying medicines and healthcare online, including information on how citizens can avoid buying products from websites that are not under regulatory control. The Danish Medicines Agency s availability strategy 10