REPORT NEW AND AFFORDABLE MEDICINES IN THE NETHERLANDS Tracing the Dutch Government’s Policy Commitments and Actions HEALTH ACTION INTERNATIONAL ACTION HEALTH REPORT NEW AND AFFORDABLE MEDICINES IN THE NETHERLANDS Tracing the Dutch Government’s Policy Commitments and Actions Prepared for Health Action International by Medicines Law & Policy: Katrina Perehudoff LLM PhD Sabrina Wimmer MSc Jacquelyn Veraldi LLM Ellen ’t Hoen LLM PhD Acknowledgements The authors are grateful to Ella Weggen (Wemos), Jaume Vidal (HAI), Tim Reed (HAI) and Yannis Natsis (EPHA) for their review of this report. The authors also appreciate the participation of representatives of the Ministries of Health, Welfare and Sport, and Economic Affairs and Climate in the interviews. Conflicts of Interest Statement None of the authors receive or have received funding from the pharmaceutical industry. Katrina Perehudoff is a member of Health Action International and a Board Member of the Pharmaceutical Accountability Foundation. Sabrina Wimmer is a member of Universities Allied for Essential Medicines. Jacquelyn Veraldi has no interests to declare. Ellen ’t Hoen is a member of Health Action International and a member of the Advisory Council of the Pharmaceutical Accountability Foundation. She has been a consultant to the Fair Medicine Initiative. Publisher Copyright Health Action International This report is licensed under a Creative Commons Overtoom 60 (2) | 1054 HK Amsterdam Attribution-NonCommercial 4.0 International Licence. The Netherlands View a copy of this licence at www.creativecommons.org/ +31 (0) 20 412 4523 licenses/by-nc/4.0. HAIWEB.ORG HEALTH ACTION INTERNATIONAL ACTION HEALTH CONTENTS INTRODUCTION 4 METHODS 5 RESULTS 6 Overview of Policy Commitments 6 Areas of Policy Action 8 Reflections on Policy Actions 13 CONCLUSIONS AND RECOMMENDATIONS 18 APPENDICES 20 Annex 1. Detailed Methodology for Document Review 20 Annex 2. List of Source Documents 23 Annex 3. Semi-structured Interview Guide 25 REFERENCES 27 NEW AND AFFORDABLE MEDICINES IN THE NETHERLANDS 3 HEALTH ACTION INTERNATIONAL ACTION HEALTH INTRODUCTION “We cannot achieve any real progress without acknowledging that the current patent-based business model and the way we apply international patent rules need to change. The system is broken.” - Former Dutch Ministers, Lilianne Ploumen and Edith Schippers, November, 2016 These bold words from the former Ministers of Since then, the Netherlands has been among the Foreign Trade and Development Cooperation, few EU Member States to resolutely and vocally and Health, Welfare and Sport about achieving commit to addressing the systemic problems that access to essential medicines for all set the Dutch permit and sustain high medicines prices. The government apart from most other European Dutch government has openly questioned the countries. Similar to its European Union (EU) business model for pharmaceutical innovation neighbours, the Netherlands struggles to afford and its reliance on patent and other intellectual the ever-increasing prices for new medicines. property (IP) and regulatory exclusivities.⁴ One of the first signals of a turning tide came in Recently, the government made strong statements 2015 when nivolumab was marketed at a total about safeguards for the flexible implementation projected cost of €200 million per year to treat of patent rules for public health.5 In doing so, patients in the Netherlands with advanced stage, the government effectively broke ranks with non-small-cell lung cancer.¹ This exorbitant other EU countries in multilateral fora; instead, cost, roughly equivalent to an eighth of the the Netherlands seems to try to find new paths Netherlands' total expenditure on inpatient synonymous with its changing domestic policies pharmaceuticals, triggered a landmark decision for drug development and pricing. by the Dutch government to stop automatically reimbursing new, expensive medicines used in Towards the end of her term, then Minister of hospitals and, instead, negotiate better prices.² Health, Welfare and Sport (from 2010–2017, Edith Schippers called for urgent and far-reaching This momentum continued during the Dutch revisions to Dutch medicines policy. Some of Presidency of the Council of the EU from these policy initiatives are now being continued January to June, 2016. The official programme by the current Minister for Medical Care and of the Presidency committed to examining how Sport, Bruno Bruins. Both Ministers are members medical innovations can reach patients faster ‘at of the People’s Party for Freedom and Democracy a socially acceptable cost’.³ It emphasised the (Volkspartij voor Vrijheid en Democratie or importance of safeguarding access to innovative VVD), a conservative liberal political party. Now, and affordable medicines, therefore committing one year into the term of the Rutte III Cabinet, to strengthening Member State voluntary this report collects the Dutch government’s cooperation on issues of pricing and market commitments to the development and marketing access. of new, affordable medicines and, where possible, assesses their implementation. NEW AND AFFORDABLE MEDICINES IN THE NETHERLANDS 4 HEALTH ACTION INTERNATIONAL ACTION HEALTH METHODS This report aims to collect the Dutch specifically related to the pricing and/or government’s policy commitments for the affordability of medicines in the Netherlands, was development and marketing of new, affordable published after 1 January, 2016, and was the most medicines in the Netherlands. It also aims to recent version available in full text. assess the degree to which the Dutch government has implemented these commitments through Three experienced researchers with backgrounds concrete policy measures to date. Commitments in law and pharmaceutical policy analysis of interest relate to pharmaceuticals and (1) IP and independently selected text from the retrieved Trade-related Aspects of Intellectual Property material into a data extraction sheet. A descriptive (TRIPS) flexibilities, (2) alternative innovation analysis was generated by summarising the models, (3) competition policy, and (4) pricing commitments and actions taken within each policy. of the four domains. Although it is relatively early to judge the achievements of these policy This is a mixed-methods policy tracing study, actions, we considered them in relation to three based on a document review validated through overarching objectives that can advance access to two expert interviews. Data are the written and new medicines: oral commitments made by representatives of the Dutch government in political fora and print • Does the government build political media between 1 January, 2016, and 1 October, consensus for a new narrative and policy 2018. We included commitments and actions measures to lower medicines prices? made one year before the most recent general • Does the government enhance the election (2016) to the present day. Data was transparency of research and development cross-checked against available literature, policy (R&D) costs, medicines prices, and profits? documents, grey literature, and the interview • How is the government facilitating the results. The commitments in the four domains implementation of its policy commitments? are the reference against which policy action is judged. Interviews Two semi-structured interviews were conducted Document Review with representatives of the Dutch Ministries of A detailed methodology for this document review Health, Welfare and Sport, and Economic Affairs is available in Annex 2 of this report. A systematic and Climate. Interviewees were selected based online search strategy was used to locate material on their expertise in relation to this report. from policy sources (i.e., the Dutch government, They were provided with a draft of this report multilateral institutions), academic literature (including the results of the document review) in (i.e., PubMed search, articles published in the advance of the interview. At the outset of each Dutch medical journal, Nederlands Tijdschrjft meeting, informed consent was sought in line voor Geneeskunde) and grey literature (i.e., the IP with the ‘Ethical Guidelines for Interviewing Health and EU Alliance listservs). Public Personalities’, published by the University of Toronto’s Social Sciences and Humanities The online search was executed in August, 2018, Research Ethics Board. The interviews followed a and updated in October, 2018, using search terms semi-structured guide (Annex 3). These interviews in English and Dutch. In addition to this online aimed to complement the document review by search, information was crowdsourced from clarifying uncertain commitments, as well as experts by requesting a list of pharmaceutical the status and preliminary outcomes of their policy initiatives from national health advocates. implementation. Therefore, the interviews served Material was included if it expressed a to validate the results of the document review. government commitment or policy action NEW AND AFFORDABLE MEDICINES IN THE NETHERLANDS 5 HEALTH ACTION INTERNATIONAL ACTION HEALTH RESULTS Overview of Policy Commitments Nineteen policy documents were included in this study (see Annex 2 for a complete list of the source documents). Nine core policy commitments to access to medicines in the Netherlands were distilled from those policy documents (see below). Intellectual Property and TRIPS Flexibilities Determine the positive and negative • Examining if the existing EU protection mechanisms effects of current