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Public health authorities regulate in the public interest to protect health, ensure patient access to safe medicines, stimulate innovation and encourage a competitive market.1 Pharmaceutical regulation supports various components of a national pharmaceutical policy, including research and development (through regulation of clinical trials and provision of scientific advice), authorisation of medicinal products, regulation of the supply chain (manufacturers, wholesale dealers and pharmacies), pharmacovigilance and the rational use of medicinal products (through information about medicinal products and the use of medicines). The tangible public health outcomes of these processes are access, availability and affordability of medicinal products which are of good quality, and safe and efficacious when used rationally. ; peer-reviewed

Introduction: The Pharmaceutical Strategy for Europe (2020) proposes actions related to intellectual property (IP) rights as a means of ensuring patients' access to medicines. This review aims to describe and discuss the European IP framework and its impact on accessibility of biological medicines and makes some recommendations. ; Methods: A non-systematic literature review on IP for biological medicines was conducted. Data on authorizations and patent and exclusivity expiry dates of biological medicines obtained from the European Medicines Agency's (EMA) website and literature was analysed quantitatively and qualitatively. ; Results: The analysis showed that as at end July 2021, 1,238 medicines were authorized in Europe, of which 332 (26.8%) were biological medicines. There were only 55 biosimilars for 17 unique biologicals. There is an increasing trend in biological authorizations but significant delays in submission of applications for marketing authorization of biosimilars, with no significant differences in the time for assessment for marketing authorization between originator biologicals and biosimilars. For some of the more recent biosimilars, applications for authorization were submitted prior to patent and exclusivity expiry. COVID vaccines confirmed the impact of knowledge transfer on accessibility, especially when linked to joint procurement. ; Discussion: IP protects originator products and impacts the development of biosimilars. Strategies to improve competition in the EU biological market are discussed. Pricing policies alone do not increase biosimilar uptake since patients are switched to second generation products. Evergreening strategies might be abusing the IP framework, and together with trade secrets and disproportionate prices compared to R & D and manufacturing costs lead to an imbalance between market access and innovation. Conclusion: The European Pharmaceutical Strategy should focus on IP initiatives that support earlier authorization of biosimilars of new biologicals. Recommendations include knowledge sharing, simplification of the regulatory framework and transparency of prices and R & D costs. ; peer-reviewed

In 2018/2019 there were a number of initiatives for collaboration between Member States in the European Economic Area (EEA) and the European Commission published a Proposal for a Regulation on Health Technology Assessment. In view of the perceived benefits from collaboration, the experiences and challenges of these collaborative initiatives and the possible implications of the proposed legislation, a study of the evidence on attitudes, perceived impacts and the motivational factors towards European Member State collaboration regarding the pricing and reimbursement of medicines was conducted. This study adopted an evidence–based management approach by Barends and Rousseau. The main findings showed that Member States differed in their motivation for collaboration for different pharmaceutical activities. Member States favoured voluntary co-operation for all activities of pricing and reimbursement except for relative effectiveness assessments where Member State authorities had divergent attitudes and prioritised activities related to the sustainability of their healthcare systems and access to medicines. Contrastingly pharmaceutical companies strongly favoured mandatory cooperation for evaluation. Member States motivation for collaboration was highly dependent on the purpose, political will, implementation climate and cultural factors. Currently, with the experiences of ongoing collaborations, following the progress of the discussion at Council, and with a number of inititatives for new pharmaceutical strategy and policy, it is proposed that Member States use their trust, expertise and knowledge of application of evidence-based decision making for pricing and reimbursement of medicines and apply it to decide the future model for Member State collaboration. The applicability of principles of evidence-based management to pharmaceutical policy can be used as a starting point. ; peer-reviewed

In 2018/2019 there were a number of initiatives for collaboration between Member States in the European Economic Area (EEA) and the European Commission published a Proposal for a Regulation on health technology assessment. In view of the perceived benefits from collaboration, the experiences and challenges of these collaborative initiatives and the possible implications of the proposed legislation, a study of the evidence on attitudes, perceived impacts and the motivational factors towards European Member State collaboration regarding the pricing and reimbursement of medicines was conducted. This study adopted an evidence–based management approach by Barends and Rousseau. The main findings showed that Member States differed in their motivation for collaboration for different pharmaceutical activities. Member States favoured voluntary co-operation for all activities of pricing and reimbursement except for relative effectiveness assessments where Member State authorities had divergent attitudes and prioritised activities related to the sustainability of their healthcare systems and access to medicines. Contrastingly pharmaceutical companies strongly favoured mandatory cooperation for evaluation. Member States motivation for collaboration was highly dependent on the purpose, political will, implementation climate and cultural factors. Currently, with the experiences of ongoing collaborations, following the progress of the discussion at Council, and with a number of inititatives for new pharmaceutical strategy and policy, it is proposed that Member States use their trust, expertise and knowledge of application of evidence-based decision making for pricing and reimbursement of medicines and apply it to decide the future model for Member State collaboration. The applicability of principles of evidence-based management to pharmaceutical policy can be used as a starting point.

In 2018/2019 there were a number of initiatives for collaboration between Member States in the European Economic Area (EEA) and the European Commission published a Proposal for a Regulation on Health Technology Assessment. In view of the perceived benefits from collaboration, the experiences and challenges of these collaborative initiatives and the possible implications of the proposed legislation, a study of the evidence on attitudes, perceived impacts and the motivational factors towards European Member State collaboration regarding the pricing and reimbursement of medicines was conducted. This study adopted an evidence–based management approach by Barends and Rousseau. The main findings showed that Member States differed in their motivation for collaboration for different pharmaceutical activities. Member States favoured voluntary co-operation for all activities of pricing and reimbursement except for relative effectiveness assessments where Member State authorities had divergent attitudes and prioritised activities related to the sustainability of their healthcare systems and access to medicines. Contrastingly pharmaceutical companies strongly favoured mandatory cooperation for evaluation. Member States motivation for collaboration was highly dependent on the purpose, political will, implementation climate and cultural factors. Currently, with the experiences of ongoing collaborations, following the progress of the discussion at Council, and with a number of inititatives for new pharmaceutical strategy and policy, it is proposed that Member States use their trust, expertise and knowledge of application of evidence-based decision making for pricing and reimbursement of medicines and apply it to decide the future model for Member State collaboration. The applicability of principles of evidence-based management to pharmaceutical policy can be used as a starting point.

The mission of the Medicines Authority (MA) in Malta is to contribute to protection of public health through regulation of the safety, quality and efficacy of medicines for human use on the local market and to ensure that healthcare professionals and patients have access to accurate and up to date information about medicines. In order to disseminate information regarding safety of medicines, the MA publishes guidance notes for healthcare professionals and the pharmaceutical industry. The MA also publishes information on its website: http://www.health.gov.mt/mru/ On the 4th of May, 2004 the MA held a seminar to launch a national adverse drug reaction (ADR) reporting system involving the co-operation of doctors, dentists and pharmacists, as well as the pharmaceutical industry. The ADR reporting system will form part of an overall pharmacovigilance system within the Authority and this will be the primary means of collecting information useful in the surveillance of medicinal products. ; peer-reviewed

The proliferation of new drugs challenges clinicians to keep abreast of new developments and to integrate clinical expertise with the best available clinical evidence. Pressures of the introduction (and cost) of new drugs and technologies, an aging population and the increasing expectations of patients are forcing policy makers in developed countries to look at how they are to control the increasing cost of health care. The pharmaceutical industry is keen to recover the costs spent on research and development of new pharmaceuticals. Increasingly economic analyses are being used to justify policies and the use of resources, by introducing measures of cost and quality as well as effectiveness. Moreover decisions on what should and should not be funded from public funds will be influenced by the overall framework of national aims and objectives, by professional opinion and public values. Linking clinical and financial aspects of drug use requires expanded skills for clinicians, policy makers and for those who make decisions to include drugs on formulary. Moreover, formulary management activities are increasingly being evaluated in terms of their impact on overall disease management not just acquisition costs. A model of the practice is being developed to provide a discipline in understanding the nature of the local practice and in exploring options for future policy and action. The development of the model will lead to a concurrent progress of the practice. The project is at the stage of assessment and situation analysis. A concerted effort will be indispensable for the realisation of this project. This conference groups together all the parties involved including policy makers, clinicians and representatives of the pharmaceutical industry. The opportunity is being taken to introduce the project, to obtain feedback for its implementation and to encourage cooperation from all concerned and the objectives of the project will be used to motivate contribution. ; peer-reviewed

Payers are a major stakeholder in any considerations and initiatives concerning adaptive licensing of new medicinal products, also referred to as Medicines Adaptive Pathways to patients (MAPPs). Firstly, the scope and necessity of MAPPs need further scrutiny, especially with regard to the definition of unmet need. Conditional approval pathways already exist for new medicines for seriously debilitating or life-threatening diseases and only a limited number of new medicines are innovative. Secondly, MAPPs will result in new medicines on the market with limited evidence about their effectiveness and safety. Additional data are to be collected after approval. Consequently, adaptive pathways may increase the risk of exposing patients to ineffective or unsafe medicines. We have already seen medicines approved conventionally that subsequently proved ineffective or unsafe amongst a wider, more co-morbid population as well as medicines that could have been considered for approval under MAPPs but subsequently proved ineffective or unsafe in Phase III trials and were never licensed. Thirdly, MAPPs also put high demands on payers. Routine collection of patient level data is difficult with high transaction costs. It is not clear who will fund these. Other challenges for payers include shifts in the risk governance framework, implications for evaluation and HTA, increased complexity of setting prices, difficulty with ensuring equity in the allocation of resources, definition of responsibility and liability and implementation of stratified use. Exit strategies also need to be agreed in advance, including price reductions, rebates, or reimbursement withdrawals when price premiums are not justified. These issues and concerns will be discussed in detail including potential ways forward ; peer-reviewed

Sales of medicines continue to grow world-wide driven in part by increasing expenditures on biological medicines leading to concerns with the long-term sustainability of European healthcare systems. The increasing use of biosimilars at lower costs can potentially address this. However, there can be concerns with their prescribing. There are also concerns with biosimilar insulin glargine including concerns with different devices despite increasing sales of longacting insulin analogues worldwide. Consequently, a need to appraise the European biosimilar market incorporating measures to enhance their use including potential ways to increase the prescribing of biosimilars of insulin glargine at lower costs. Multiple approaches were used to undertake the study including researching measures to enhance biosimilar use and their impact across Europe. In addition, undertake cross national research on the utilization and expenditure of long-acting insulin analogues, which includes biosimilars, principally among Central and Eastern European countries. Multiple demand-side measures across the countries have enhanced the use of biosimilars. There was variable use of biosimilar insulin glargine 100 IU/ml driven by increasing use of patented 300 IU/ml formulations and small price differences between the originator and biosimilars in practice. Overall, multiple demand-side initiatives can appreciably increase biosimilar use benefiting all groups. Additional measures are needed to enhance future prescribing of long-acting biosimilar insulin analogues. ; peer-reviewed

Background: Across European countries, differences exist in biosimilar policies, leading to variations in uptake of biosimilars and divergences in savings all over Europe. Objectives: The aim of this article is to provide an overview of different initiatives and policies that may influence the uptake of biosimilars in different European countries. Recommendations will be formulated on how to create sustainable uptake. Methods: An overview of policies on biosimilars was obtained via a questionnaire, supplemented with relevant articles. Topics were organized in five themes: availability, pricing, reimbursement, demand-side policies, and recommendations to enhance uptake. Results: In all countries studied, biological medicines are available. Restrictions are mainly dependent on local organization of the healthcare system. Countries are willing to include biosimilars for reimbursement, but for commercial reasons they are not always marketed. In two thirds of countries, originator and biosimilar products may be subjected to internal reference pricing systems. Few countries have implemented specific incentives targeting physicians. Several countries are implementing pharmacist substitution; however, the scope and rules governing such substitution tend to vary between these countries. Reported educational policies tend to target primarily physicians, whereas fewer initiatives were reported for patients. Recommendations as proposed by the different country experts ranged from the need for information and communication on biosimilars to competitive pricing, more support for switching and guidance on substitution. Conclusions: Most countries have put in place specific supply-side policies for promoting access to biosimilars. To supplement these measures, we propose that investments should be made to clearly communicate on biosimilars and educate stakeholders. Especially physicians need to be informed on the entry and use of biosimilars in order to create trust. When physicians are well-informed on the treatment options, further incentives should be offered to prescribe biosimilars. Gainsharing can be used as an incentive to prescribe, dispense or use biosimilars. This approach, in combination with binding quota, may support a sustainable biosimilar market. ; peer-reviewed

Background: From October 2018, adalimumab biosimilars could enter the European market. However, in some countries, such as Netherlands, high discounts reported for the originator product may have influenced biosimilar entry. Objectives: The aim of this paper is to provide a European overview of (list) prices of originator adalimumab, before and after loss of exclusivity; to report changes in the reimbursement status of adalimumab products; and discuss relevant policy measures. Methods: Experts in European countries received a survey consisting of three parts: 1) general financing/co-payment of medicines, 2) reimbursement status and prices of originator adalimumab, and availability of biosimilars, and 3) policy measures related to the use of adalimumab. Results: In May 2019, adalimumab biosimilars were available in 24 of the 30 countries surveyed. Following introduction of adalimumab biosimilars, a number of countries have made changes in relation to the reimbursement status of adalimumab products. Originator adalimumab list prices varied between countries by a factor of 2.8 before and 4.1 after loss of exclusivity. Overall, list prices of originator adalimumab decreased after loss of exclusivity, although for 13 countries list prices were unchanged. When reported, discounts/rebates on originator adalimumab after loss of exclusivity ranged from 0% to approximately 26% (Romania), 60% (Poland), 80% (Denmark, Italy, Norway), and 80–90% (Netherlands), leading to actual prices per pen or syringe between €412 (Finland) and €50 – €99 (Netherlands). To leverage competition following entry of biosimilar adalimumab, only a few countries adopted measures specifically for adalimumab in addition to general policies regarding biosimilars. In some countries, a strategy was implemented even before loss of exclusivity (Denmark, Scotland), while others did not report specific measures. Conclusion: Even though originator adalimumab is the highest selling product in the world, few countries have implemented specific policies and practices for (biosimilar) adalimumab. Countries with biosimilars on the market seem to have competition lowering list or actual prices. Reported discounts varied widely between countries. ; peer-reviewed

Drug shortages have been identified as a public health problem in an increasing number of countries. This can negatively impact on the quality and efficiency of patient care, as well as contribute to increases in the cost of treatment and the workload of health care providers. Shortages also raise ethical and political issues. The scientific evidence on drug shortages is still scarce, but many lessons can be drawn from cross-country analyses. The objective of this study was to characterize, compare, and evaluate the current systemic measures and legislative and organizational frameworks aimed at preventing or mitigating drug shortages within health care systems across a range of European and Western Asian countries. The study design was retrospective, cross-sectional, descriptive and observational. Information was gathered through a survey distributed among senior personnel from ministries of health, state medicines agencies, local health authorities, other health or pharmaceutical pricing and reimbursement authorities, health insurance companies and academic institutions, with knowledge of the pharmaceutical markets in the 28 countries studied. Our study found that formal definitions of drug shortages currently exist in only a few countries. The characteristics of drug shortages, including their assortment, duration, frequency and dynamics, were found to be variable and sometimes difficult to assess. Numerous information hubs were identified. Providing public access to information on drug shortages to the maximum possible extent is a prerequisite for performing more advanced studies on the problem and identifying solutions. Imposing public service obligations, providing the formal possibility to prescribe unlicensed medicines, and temporary bans on parallel exports are widespread measures. A positive finding of our study was the identification of numerous bottom-up initiatives and organizational frameworks aimed at preventing or mitigating drug shortages. The experiences and lessons drawn from these initiatives should be carefully evaluated, monitored and presented to a wider international audience for careful appraisal. To be able to find solutions to the problem of drug shortages, there is an urgent need to develop a set of agreed definitions for drug shortages, as well as methodologies for their evaluation and monitoring. This is being progressed.

Drug shortages have been identified as a public health problem in an increasing number of countries. This can negatively impact on the quality and efficiency of patient care, as well as contribute to increases in the cost of treatment and the workload of health care providers. Shortages also raise ethical and political issues. The scientific evidence on drug shortages is still scarce, but many lessons can be drawn from cross-country analyses. The objective of this study was to characterize, compare, and evaluate the current systemic measures and legislative and organizational frameworks aimed at preventing or mitigating drug shortages within health care systems across a range of European and Western Asian countries. The study design was retrospective, cross-sectional, descriptive, and observational. Information was gathered through a survey distributed among senior personnel from ministries of health, state medicines agencies, local health authorities, other health or pharmaceutical pricing and reimbursement authorities, health insurance companies and academic institutions, with knowledge of the pharmaceutical markets in the 28 countries studied. Our study found that formal definitions of drug shortages currently exist in only a few countries. The characteristics of drug shortages, including their assortment, duration, frequency, and dynamics, were found to be variable and sometimes difficult to assess. Numerous information hubs were identified. Providing public access to information on drug shortages to the maximum possible extent is a prerequisite for performing more advanced studies on the problem and identifying solutions. Imposing public service obligations, providing the formal possibility to prescribe unlicensed medicines, and temporary bans on parallel exports are widespread measures. A positive finding of our study was the identification of numerous bottom-up initiatives and organizational frameworks aimed at preventing or mitigating drug shortages. The experiences and lessons drawn from these initiatives should be carefully evaluated, monitored, and presented to a wider international audience for careful appraisal. To be able to find solutions to the problem of drug shortages, there is an urgent need to develop a set of agreed definitions for drug shortages, as well as methodologies for their evaluation and monitoring. This is being progressed. ; peer-reviewed

Drug shortages have been identified as a public health problem in an increasing number of countries. This can negatively impact on the quality and efficiency of patient care, as well as contribute to increases in the cost of treatment and the workload of health care providers. Shortages also raise ethical and political issues. The scientific evidence on drug shortages is still scarce, but many lessons can be drawn from cross-country analyses. The objective of this study was to characterize, compare, and evaluate the current systemic measures and legislative and organizational frameworks aimed at preventing or mitigating drug shortages within health care systems across a range of European and Western Asian countries. The study design was retrospective, cross-sectional, descriptive, and observational. Information was gathered through a survey distributed among senior personnel from ministries of health, state medicines agencies, local health authorities, other health or pharmaceutical pricing and reimbursement authorities, health insurance companies and academic institutions, with knowledge of the pharmaceutical markets in the 28 countries studied. Our study found that formal definitions of drug shortages currently exist in only a few countries. The characteristics of drug shortages, including their assortment, duration, frequency, and dynamics, were found to be variable and sometimes difficult to assess. Numerous information hubs were identified. Providing public access to information on drug shortages to the maximum possible extent is a prerequisite for performing more advanced studies on the problem and identifying solutions. Imposing public service obligations, providing the formal possibility to prescribe unlicensed medicines, and temporary bans on parallel exports are widespread measures. A positive finding of our study was the identification of numerous bottom-up initiatives and organizational frameworks aimed at preventing or mitigating drug shortages. The experiences and lessons drawn from these ...

Drug shortages have been identified as a public health problem in an increasing number of countries. This can negatively impact on the quality and efficiency of patient care, as well as contribute to increases in the cost of treatment and the workload of health care providers. Shortages also raise ethical and political issues. The scientific evidence on drug shortages is still scarce, but many lessons can be drawn from cross-country analyses. The objective of this study was to characterize, compare, and evaluate the current systemic measures and legislative and organizational frameworks aimed at preventing or mitigating drug shortages within health care systems across a range of European and Western Asian countries. The study design was retrospective, cross-sectional, descriptive, and observational. Information was gathered through a survey distributed among senior personnel from ministries of health, state medicines agencies, local health authorities, other health or pharmaceutical pricing and reimbursement authorities, health insurance companies and academic institutions, with knowledge of the pharmaceutical markets in the 28 countries studied. Our study found that formal definitions of drug shortages currently exist in only a few countries. The characteristics of drug shortages, including their assortment, duration, frequency, and dynamics, were found to be variable and sometimes difficult to assess. Numerous information hubs were identified. Providing public access to information on drug shortages to the maximum possible extent is a prerequisite for performing more advanced studies on the problem and identifying solutions. Imposing public service obligations, providing the formal possibility to prescribe unlicensed medicines, and temporary bans on parallel exports are widespread measures. A positive finding of our study was the identification of numerous bottom-up initiatives and organizational frameworks aimed at preventing or mitigating drug shortages. The experiences and lessons drawn from these initiatives should be carefully evaluated, monitored, and presented to a wider international audience for careful appraisal. To be able to find solutions to the problem of drug shortages, there is an urgent need to develop a set of agreed definitions for drug shortages, as well as methodologies for their evaluation and monitoring. This is being progressed.