DOCSLIB.ORG

Pricing & Reimbursement

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Pricing & Reimbursement Pricing & Reimbursement 2020 Third Edition Contributing Editor: Grant Castle CONTENTS Preface Grant Castle, Covington & Burling LLP General chapter Reimbursement and Funding of Hospital-Based Drug Therapies Stephen Hull, Robert Reidy & Kaytlyn Oliver, Hull Associates LLC 1 Country chapters Australia Greg Williams, Colin Loveday & Sheena McKie, Clayton Utz 16 Belgium Pieter Wyckmans & Michiel D’herde, Quinz 31 Brazil Rodrigo Augusto Oliveira Rocci, Dannemann, Siemsen Advogados 46 Canada Teresa Reguly, Eileen McMahon & Manpreet Singh, Torys LLP 59 China Nicolas Zhu, CMS China 72 France Catherine Mateu, Armengaud Guerlain 80 Germany Dr. Ulrich Reese & Carolin Kemmner, Clifford Chance 98 India Archana Sahadeva, Sahadeva Law Chambers 113 Ireland Marie Doyle-Rossi & Maree Gallagher, Covington & Burling LLP 125 Italy Sonia Selletti & Mauro Putignano, Astolfi e Associati, Studio Legale 135 Japan Kazuhiro Kobayashi, Oh-Ebashi LPC & Partners 150 Korea Kyungsun Kyle Choi & Yunjoh Lee, Kim & Chang 161 Netherlands Koosje van Lessen Kloeke, Leijnse Artz 167 Poland Agata Zalewska-Gawrych & Marta Jagodzińska, Food & Pharma Legal Wawrzyniak Zalewska Radcy Prawni sp.j. 182 Spain Jordi Faus, Lluís Alcover & Joan Carles Bailach, Faus & Moliner 188 Sweden Camilla Appelgren, Mannheimer Swartling Advokatbyrå 207 Odd Swarting, Cirio Advokatbyrå Switzerland Dr. Oliver Künzler, Dr. Carlo Conti & Dr. Martina Braun, Wenger Plattner 218 United Kingdom Grant Castle, Brian Kelly & Raj Gathani, Covington & Burling LLP 227 USA Rujul Desai, Anna Kraus & Kristie Gurley, Covington & Burling LLP 240 Ireland Marie Doyle-Rossi & Maree Gallagher Covington & Burling LLP Abstract In Ireland, State expenditure on medicines is approximately €2.7 billion per annum. For most medicines, other than medicines restricted to hospital or medical specialist use, the only route to State reimbursement is to appear on a positive reimbursement list. Other than for cancer drugs, there is a uniform application procedure to have a product added to the reimbursement list. There currently is no distinct approval pathway for rare disease medicines or hi-tech products. Ireland has an ageing population and therefore demand for medicines, especially for chronic diseases, is increasing. In recent years, the State has reformed the Irish pricing and reimbursement system and introduced a number of measures to reduce healthcare expenditure. Suppliers are also entering into novel contractual arrangements to add value and demonstrate the cost-effectiveness of their products. Despite this, suppliers face significant challenges in securing reimbursement of new medicinal products in Ireland, especially hi- tech medicines and those for rare ‘orphan’ diseases. Market introduction/overview The Irish healthcare system is a two-tier one, comprising the public healthcare system and the private healthcare system. The public healthcare system is funded by the State through taxation and social security contributions. Any person ordinarily resident in Ireland is entitled to receive healthcare through the public healthcare system. The private healthcare system is funded by private insurance and private funds. Private healthcare remains a popular option in Ireland, with around 40% of residents taking out private insurance. In Ireland, healthcare policy and expenditure are determined by the Department of Health and Children, and administered through the Health Services Executive (HSE). The HSE operates a positive reimbursement list and HSE expenditure on medicines is approximately €2.7 billion per annum. Over the past decade, the population of Ireland has increased by nearly 7% to approximately 4.8 million. The demographic ageing of the population means demand for medicines, especially for chronic diseases, is increasing. As a result, pharmaceutical expenditure is expected to grow, with key drivers for increased spending being hi-tech drugs and new hospital drugs. The pricing and reimbursement landscape in Ireland has undergone significant change in recent years. New legislation introduced a number of measures to reduce healthcare expenditure, primarily a system of generic substitution and reference pricing. The State also entered into a four-year framework agreement with industry in 2016 for the supply and pricing of medicines to help contain pharmaceutical costs. The current framework agreement is due to end in July 2020. GLI – Pricing & Reimbursement 2020, Third Edition 125 www.globallegalinsights.com © Published and reproduced with kind permission by Global Legal Group Ltd, London Covington & Burling LLP Ireland Despite the savings provided by these measures, there has been relatively little growth in the HSE budget for new medicines. Consequently, suppliers face significant challenges in securing reimbursement of new medicinal products, in particular hi-tech medicines and those for rare orphan diseases. This is compounded by the fact that there currently is no separate approval process for these products, which inevitably are deemed cost-ineffective when assessed on standard pharmacoeconomic criteria. However, even those products that are deemed to be cost-effective are facing reimbursement delays due to the lack of overall affordability for the Irish healthcare system. It remains to be seen what effect the COVID-19 pandemic will have on healthcare expenditure for innovative medicines. The high cost of new innovative drugs and delays in reimbursement are among the key challenges for market access in Ireland. Pharmaceutical pricing and reimbursement Regulatory classification There are two main supply categories of medicinal products in Ireland: (i) prescription-only; and (ii) non-prescription products. Prescription-only medicines are those which require medical supervision and are available only with a doctor’s or dentist’s prescription, and dispensed through pharmacies. Prescription-only medicines tend to be dispensed to patients by community pharmacists and are reimbursed by the State. Non-prescription medicines consist of two classes: (i) pharmacy-only products that are available under the supervision of a pharmacist; and (ii) general sale products that can, with reasonable safety, be sold without the supervision of a pharmacist. In general, non- prescription medicines are not reimbursed by the State, but certain non-prescription items are reimbursable where a doctor prescribes them. The Medicinal Products (Control of Placing on the Market) Regulations 2007 (SI 540/2007), as amended, set out the criteria for determining the legal supply status of medicinal products. Generally, new medicines may only be supplied on prescription. After several years of use of the medicine, sufficient information may be available to justify a change in its legal supply status to non-prescription supply by a pharmacist. It may also be possible for medicines previously supplied only by a pharmacist to be supplied on general sale, if appropriate. Who is/are the payors? In Ireland, the State pays for nearly 80% of all medicines through reimbursement of community pharmacists. The cost to the State of medicines dispensed in the community depends on the different reimbursement schemes an eligible patient may use. The HSE Primary Care Reimbursement Service (PCRS) operates four principal reimbursement schemes: • General Medical Services Scheme (GMS): a patient receives their medicines after paying a €2.00 per item prescription charge (up to a maximum charge of €20.00 per person or family per month) or for a patient aged over 70, the prescription charge is €1.50 per item (up to a maximum charge of €15.00 per person or family per month). The prescription charge per item for all patients is due to be reduced by €0.50 in September 2020. The pharmacist receives a dispensing fee. The GMS scheme applies to those who do not have sufficient means to pay for their medicine, while prescription charges for people in emergency accommodation are to be phased out. • Drug Payment Scheme (DPS): a patient pays a maximum of €124 per month for medicines supplied to them and their family, which is set to reduce by €10 to €114 per GLI – Pricing & Reimbursement 2020, Third Edition 126 www.globallegalinsights.com © Published and reproduced with kind permission by Global Legal Group Ltd, London Covington & Burling LLP Ireland month from September 2020. If an interchangeable medicine is supplied, the reference price is used to calculate the monthly cost. The pharmacist receives a dispensing fee. • Long Term Illness Scheme (LTI): provides medicines to patients with specific long-term medical conditions, such as diabetes, epilepsy, multiple sclerosis and cystic fibrosis, free of charge. The LTI scheme is not means-tested and therefore does not depend on a patient’s income or other circumstances. Similar to the DPS, the pharmacist receives a dispensing fee. • Hi-Tech Scheme: a patient receives expensive medicines required for long-term care and either pays the first €124 a month of the cost in accordance with the rules of the DPS, or receives the medicines free of charge, if they hold a medical card or the medicine is for a specific condition covered by the LTI. Under the hi-tech scheme, pharmacists receive a patient care fee of €62.03 per patient in the month when an item is dispensed, and €31.02 in the months where no item is dispensed. The non-dispensed patient care fee may only be paid for a maximum of three consecutive months in respect of a particular patient between each dispensing. Payments to pharmacists are regulated by the Public Services Pay
Load more

Recommended publications
  • Annex 2 Case Studies
    EUnetHTA WP7 research and analysis activity 1: Annex 2 Case studies An analysis of HTA and reimbursement procedures in EUnetHTA partner countries: Annex 2 Case studies Disclaimer: EUnetHTA is supported by a grant from the European Commission. The sole responsibility for the content of this document lies with the authors and neither the European Commission nor EUnetHTA are responsible for any use that may be made of the information contained therein. 1 of 43 EUnetHTA WP7 research and analysis activity 1: Annex 2 Case studies Contents Contents ..................................................................................................................... 2 Case study 1: Collaborative HTA by the Spanish Network of HTA agencies, Spain .. 4 Context ................................................................................................................... 4 The Spanish Network .......................................................................................... 4 Working Practices ................................................................................................... 5 Coordination functions ........................................................................................ 5 Topic selection .................................................................................................... 6 Allocation of work ................................................................................................ 6 Production of Assessments ................................................................................
    [Show full text]
  • Joint Clinical Assessment and HTA 1
    Regulamento sobre Avaliação das Tecnologias de Saúde e Grupo La Valetta Heitor Costa, Director Executivo da APIFARMA 1 Cross-Country collaborations • Historical ties (except Valetta) ⚑ Iceland BeneluxA • Countries move… Finland Valetta Declaration ⚑ IE and LT belong to 2 CCC’s Norway ▼ Iberia partnership Sweden Estonia Visegrad+ • Not part of any CCC: Latvia Denmark⚑ FR, UK, DE and… BU, CH Baltic Partnership Lithuania Ireland Poland Nordic Council Netherlands • North vs South/East Nordic Tendering pilot ⚑ Belgium Czech led by AMGROS Luxembourg Republic Slovakia FINOSE Austria Hungary Slovenia Romania Italy Croatia ▼ ▼ Portugal Spain Greece Cyprus Malta 2 Cross-Country collaborations Nordic collaborations ⚑ Nordic tendering pilot (Denmark, Norway, Iceland) led by AMGROS ⚑ • September 2018: call for 2 off-patent Iceland products BeneluxA • Innovative medicines as a second iteration Finland not excluded Valetta Declaration ⚑ Norway • Combination of strong political will and ▼ Iberia partnership Sweden expertise Estonia Visegrad+ • Industry has been very active already Latvia locally (engagement, legal analysis…) Denmark⚑ Baltic Partnership Lithuania Ireland Poland Nordic Council Netherlands Nordic Tendering pilot ⚑ Belgium Czech ● FINOSE (Finland, Norway, Sweden) led by AMGROS Luxembourg Republic Slovakia FINOSE • Collaboration on HTA/REA Austria Hungary Slovenia Romania • High-level meeting on 27 March 2018 Italy Croatia • Evaluation of the initiative planned late 2020 ▼ ▼ • Actively reaching out to companies Portugal Spain Greece Cyprus
    [Show full text]
  • Current Status of Health Intervention and Technology Assessment in the Balkan Region
    CURRENT STATUS OF HEALTH INTERVENTION AND TECHNOLOGY ASSESSMENT IN THE BALKAN REGION CURRENT STATUS OF HEALTH INTERVENTION AND TECHNOLOGY ASSESSMENT IN THE BALKAN REGION Abstract This report outlines the status of health technology assessment (HTA) in the Balkan region, including facilitators and barriers. It is based on the discussions during a WHO workshop on health intervention and technology assessment in support of universal health coverage held in Ljubljana, Slovenia, in February 2020, as well as a survey and a desktop review of relevant literature. Participants from public institutions working in the field of HTA from eight Balkan countries and areas attended the workshop, along with international technical experts and staff from WHO and WHO partners. The developmental status of HTA varies across countries. Facilitators of HTA identified include political will, networks, structured health systems, legal frameworks and relevant examples of gain. Barriers include political instability, small economies and human resources. Recommendations for future action include mapping needs and options, strengthening collaborative initiatives, involving stakeholders and develop roadmaps towards transparent and sustainable HTA frameworks. All participants recognized the need for increased transparency. Keywords HEALTH TECHNOLOGY ASSESSMENT HEALTHCARE DECISION MAKING HEALTH POLICY TRANSPARENCY COST-EFFECTIVENESS ANALYSIS Document number: WHO/EURO:2020-1303-41053-55733 © World Health Organization 2020 Some rights reserved. This work is available under the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/igo). Under the terms of this licence, you may copy, redistribute and adapt the work for non-commercial purposes, provided the work is appropriately cited, as indicated below.
    [Show full text]
  • Presentation
    Patient registries in the BeNeLuxA member countries – A mapping exercise Background • Orientation Meeting on Patient Registries on 28 November 2017 • Policy makers and national patient registry experts from BeNeLuxA countries, Hungary and the United Kingdom met in Vienna on 28 November 2017 to explore a possible collaboration in the field of patient registries in order to increase efficiency, and enhance evidence generation and information sharing. • Mapping of patient registries • As a supportive exercise, a preliminary mapping of patient registries in the member countries of the BeNeLuxA collaboration was done and shared. Patient Registries 2 Disclaimer and citation policy • The mapping exercise was conducted for internal BeNeLuxA purposes, • however, the BeNeLuxA is pleased to make findings publically available. • Precautions have been taken to verify the information • but the mapping exercise does not pretend to be comprehensive. • Interested researchers and experts are allowed to use information compiled in the mapping exercise, • however, the BeNeLuxA collaboration shall be acknowledged as author. • Cite as follows: • BeNeLuxA Collaboration. Patient registries in the BeNeLuxA member countries – A mapping exercise. Available from: http://www.beneluxa.org Patient Registries 3 Purpose of registries • Research and evidence • Scientific publication • Statistics • Surveillance • Quality assurance and quality improvement • Overview and recruit patients for clinical trials • Cost containment • Looking for donors • Monitoring • Other (funding,
    [Show full text]
  • Intentions on Collaboration on Pharmaceutical Policy Between The
    Intentions on collaboration on pharmaceutical policy between the Kingdom of Belgium, the Kingdom of the Netherlands, the Grand Duchy of Luxembourg, the Republic of Austria and the Republic of Ireland (The Beneluxa Initiative on Pharmaceutical Policy) Shared views on the benefits of voluntary collaboration There are imbalances in the current pharmaceutical market which have been caused, to some extent, by the limitations of national policies on pricing, reimbursement and on the use of pharmaceuticals. At the same time, disproportionate stress is put on capabilities of individual authorities. Both elements could ultimately hamper timely access to medicines for patients. Joining forces and taking action on a voluntary basis to face common challenges resulting from these imbalances should support participating countries in fostering the sustainability of national healthcare systems and the affordability of medicinal products challenged by high prices, adverse consequences of incentives and the unfulfilled leverage potential of individual countries in negotiations with industry. The countries co‐signing this document agree that policies on pricing and reimbursement of pharmaceuticals benefit from collaboration between those countries. Objectives of the collaboration initiative Based on the current Beneluxa collaboration, four areas for potential collaboration were defined: 1. Horizon Scanning; 2. Health Technology Assessment; 3. Information sharing and policy exchange; 4. Joint price negotiations. The initiative aims to further investigate how collaboration on these topics can be formalized, to determine the possible extent of cooperation and to define the desired outcomes, with due respect to current confidentiality agreements. Pilot projects are conducted in order to test and optimize collaboration methods. Jointly composed Terms of Reference serve as a basis for execution and development of the current ongoing collaboration initiative, as well as for expansion to other countries.
    [Show full text]
  • Joint HTA and Drug Pricing Collaborations in EU: by Whom and When to Be Pursued? Eline Middelburg, Rachel Rowbottom, Dr
    Joint HTA and Drug Pricing Collaborations in EU: By whom and when to be pursued? Eline Middelburg, Rachel Rowbottom, Dr. Marc Matar | 1 Plough Place, EC4A 1DE, London, UK INTRODUCTION OBJECTIVES METHODS Over the past years, several cross-country joint Health Tech- This topic will remain relevant in the future, as new The purpose of this research is to: We conducted a qualitative in-depth nology Assessments (HTA) and drug pricing collabora- initiatives are introduced, and the existing bodies evolve analysis of publicly available information to Gain an understanding of pricing and market access im- tions have been developed in the EU with the aim of: analyze the P&MA implications for pharma- For example, a recent proposal was made for steps plications of existing joint HTA and drug price collaborations ceutical companies of joint HTA and drug Improving efficiency of evaluations, and avoiding towards allowing confidential net prices to be shared Identify and share Simon-Kucher’s future outlook on joint pricing collaborations duplication of decisions between members of the Valetta Declaration group HTA and drug price collaborations Based on these insights, we defined the Accelerating patient access Cross-country collaboration remains politically Share Simon-Kucher’s view on next steps pharmaceutical expected future outlook for joint HTA and Making use of combined payer negotiation power attractive, as an indicator of actions to address time to companies should consider when evaluating whether to drug price collaborations, assessing
    [Show full text]
  • Presentation
    Making the case for Horizon Scanning Facing the challenges: Equity, Sustainability and Access Aldo Golja, Beneluxa Coordinator Ministry of Health, The Netherlands 1 Introduction Samuel Becket bridge, Dublin 2 A question to payers How well do we know the impact of Spinraza (nusinersen)? Targeted population Expert opinions Impact on care pathway Expected price & budget-impact Competitors expected to enter the market Facing the challenges: Equity, Sustainability & Access - Lisbon, November 28-29, 2018 3 2 Horizon Scanning defined Graslei, Gent (B) Horizon Scanning •A HSS aims at identifying, filtering, and prioritising new and emerging health technologies with a considerable predicted impact on health, costs, society and the health care system in order to inform policymakers, purchasers, and health care providers or facilitate early access” (KCE report 2017) •Performed in some countries e.g. UK, Italy, Denmark, Sweden, Austria and the Netherlands •Universal need for predictive data: potential to enhance data collection internationally Facing the challenges: Equity, Sustainability & Access - Lisbon, November 28-29, 2018 5 The potential of Horizon Scanning •Improvement of Access Prioritisation (policies & capacity planning) Earlier planning for guidelines and registries Efficiency gains streamlining procedures from MA -> Prescription (e.g. early access schemes) •Potential for savings Budget planning Creating a level playing field – negotiations •Early identification – enables collaboration Facing the challenges: Equity, Sustainability
    [Show full text]
  • Patient Access to Innovative Medicines in Europe a Collaborative and Value Based Approach January 2019 Contents
    Patient access to innovative medicines in Europe A collaborative and value based approach January 2019 Contents Foreword 01 Executive summary 02 Infographic 04 Part 1. Payer challenges to pharma innovation 06 Part 2. Innovating in a more challenging environment 11 Part 3. New approaches to access and pricing 16 Part 4. Succeeding in the new value-based environment 23 Part 5. Next generation market access 31 Abbreviations 36 Appendix 37 Endnotes 38 Contacts 41 The Deloitte Centre for Health Solutions is the research arm of Deloitte LLP’s Life Sciences and Health Care practices. Our goal is to identify emerging trends, challenges, opportunities and examples of good practice, based on primary and secondary research and rigorous analysis. The UK Centre’s team of researchers seeks to be a trusted source of relevant, timely and reliable insights that encourage collaboration across the health value chain, connecting the public and private sectors, health providers and purchasers, patients and suppliers. Our aim is to bring you unique perspectives to support you in the role you play in driving better health outcomes, sustaining a strong health economy and enhancing the reputation of our industry. In this publication, references to Deloitte are references to Deloitte LLP, the UK affiliate of Deloitte NWE LLP, a member firm of Deloitte Touche Tohmatsu Limited. Patient access to innovative medicines in Europe | A collaborative and value based approach Foreword The European environment for pharmaceutical (pharma) market access and pricing is changing rapidly. European payers are struggling to meet the health demands of their populations. Consequently, health care providers are looking for ways to optimise their expenditure on health care services, and pharma products represent a clearly visible cost payers can attempt to control.
    [Show full text]
  • BENELUXA Et Al.: the BEST IS YET to COME
    UNIVERSAL ACCESS AND AFFORDABLE MEDICINES BENELUXA et al.: THE BEST IS YET TO COME ANALYSIS About EPHA EPHA is a change agent – Europe’s leading NGO alliance advocating for better health. We are a dynamic member-led organisation, made up of public health civil society, patient groups, health professionals, and disease groups working together to improve health and strengthen the voice of public health in Europe. About EPHA’s Universal Access and Affordable Medicines advocacy EPHA’s Universal Access and Affordable Medicines advocacy promotes transparency, accountability and the public interest in the field of pharmaceuticals in line with the priorities of our members most active in this field. We aim to guarantee better and affordable medicines for Europe by questioning and calling for reforms to the current pharmaceutical business model to ensure better access to medicines for all. See more at https://epha.org/universal-access-and-affordable-medicines/ BY Yannis Natsis • Policy Manager, Universal Access and Affordable Medicines Co-funded by Health Programme of The European Union The European Public Health Alliance has received funding under anoperating grant from the European Union’s Health Programme (2014-2020). The content of this document represents the views of the authoronly and is his/her sole responsibility; it cannot be considered to relectthe views of the European Commission and/or the Consumers, Health, Agriculture and Food Executive Agency or any other body of theEuropean Union. The European Commission and the Agency do notaccept any responsibility for use that may be made of the informationit contains. Transparency Register Number: 18941013532-08 UNIVERSAL ACCESS AND AFFORDABLE MEDICINES | EPHA Contents Executive Summary 5 Preface 7 1.
    [Show full text]
  • First Results of Multi-Country Cooperation on Medicine Price Negotiations
    BENELUXA: First results of multi-country cooperation on medicine price negotiations Reflection Paper September 2017 The European Public Health Alliance (AISBL) has received funding from the European Union, in the framework of the Health Programme. Sole responsibility for the content displayed within this document lies with EPHA and the Executive Agency is not responsible for any use that may be made of the information contained therein. Transparency Register Number: 18941013532-08 By Yannis Natsis, Policy Manager for Universal Access and Afordable Medicines UNIVERSAL ACCESS AND AFFORDABLE MEDICINES | EPHA 1 BENELUXA: FIRST RESULTS OF MULTI-COUNTRY COOPERATION ON MEDICINE PRICE NEGOTIATIONS Executive summary In 2015, the Dutch and Belgian Ministers of Health signed a historic declaration of intent to jointly negotiate with the pharmaceutical sector on the price and reimbursement of some medicines. Since then, the cooperation has been joined by Luxembourg and Austria, with several more governments expressing an interest. This intergovernmental cooperation on medicines is unprecedented in Europe. Until now, each national government negotiated with pharmaceutical companies on a bilateral basis. The European Public Health Alliance (EPHA) has followed this development with great interest. The information asymmetry between the pharmaceutical industry as the vendor and national governments as buyers is assumed to have contributed to the rise in medicine prices to today’s unsustainable levels. As a consequence, access to medicines is no longer only an issue for developing countries. High prices are now also a barrier to accessing medicines for patients and health systems in some of the richest countries in the world. Could the new cooperations between national governments - not only “Beneluxa” but also the Valletta Declaration and other country groupings - go some way to redressing the balance? This paper tells the story so far of this innovative cooperation and summarises the irst results announced by the participating governments.
    [Show full text]
  • Beneluxa Pilots on Joint
    BeNeLuxA Pilots on joint HTA (Health Technology Assessment) and joint negotiations 1 Pilot requirements Bread house, Brussels Pilot requirements – HTA and negotiatons • A joint pilot is entered on a voluntary basis by all parties; • A joint pilot can include two or more BeNeLuxA partners; • In general, Luxembourg does not actively participate in any joint HTA & negotiations pilot. Luxembourg can act as an observer and will receive the joint HTA report. • A pilot will start with a joint HTA and if applicable, a joint negotiation can follow; • Joint price negotiation without a joint HTA will not be possible, as the joint negotiation will be based on a joint view on the (added) value of the pharmaceutical. • In a joint procedure all the steps will be handled as one by the participating countries; • At this moment, no formal joint ‘BeNeLuxA’ reimbursement regulation is put in place; • All formal separate national reimbursement procedures according to national legislation will run in parallel; • One of the participating countries will be designated as the primary contact for the company in the pilot. • Separate formal reimbursement decisions will be made in each participating country. BeNeLuxA guidance joint assessment & joint negotiations 3 2 Selection and eligibility of products Keizersgracht, Amsterdam Eligibility for a joint procedure • Selection of pilots case-by-case. • Focus on pharmaceuticals with (high) unmet medical need, expected added value and satisfactory degree of evidence. • A candidate for a pilot must comply with national legislations, for example: • in the Netherlands only hospital pharmaceuticals that enter the “lock procedure” • in Belgium only pharmaceuticals submitted as Class 1 or orphan application • in Austria only pharmaceuticals that are classified as outpatient products in the Austrian health system • A pilot candidate is only eligible if a reimbursement procedure has not yet started in any of the participating countries.
    [Show full text]
  • CROSS-COUNTRY COLLABORATIONS to Improve Access to Medicines and Vaccines in the WHO European Region
    CROSS-COUNTRY COLLABORATIONS to improve access to medicines and vaccines in the WHO European Region CROSS-COUNTRY COLLABORATIONS to improve access to medicines and vaccines in the WHO European Region ABSTRACT This report assesses five government-led, voluntary cross-country collaborations in the WHO European Region that aim to improve access to essential medicines through joint activities: the Baltic Procurement Initiative, Beneluxa Initiative, Fair and Affordable Pricing, Nordic Pharmaceutical Forum and Valletta Declaration. These cover activities including information sharing, health technology assessment, horizon scanning, joint pricing/reimbursement negotiations and joint procurement of medicines. The research shows that tangible results are only seen after months or years of cooperation. Challenges include the resources required, different languages of participants, dissimilar organizational and legal frameworks, the reluctance of industry to engage in negotiations with a collaboration and pressure to produce results. Nevertheless, interviewees considered the collaborations beneficial. Facilitating factors identified include political support, trust within the collaboration, commitment of the technical experts involved, similarities between health care systems and leadership of a dedicated person. The report concludes with a checklist of prerequisites for successful cross-country collaborations. Keywords PHARMACEUTICAL POLICY, INTERNATIONAL COLLABORATION, HEALTH, ACCESS TO MEDICINES, PHARMACEUTICALS, PRICING, REIMBURSEMENT, PROCUREMENT, EUROPE Address requests about publications of the WHO Regional Office for Europe to: Publications WHO Regional Office for Europe UN City, Marmorvej 51 DK-2100 Copenhagen Ø, Denmark Alternatively, complete an online request form for documentation, health information, or for permission to quote or translate, on the Regional Office website (http://www.euro.who.int/pubrequest). ISBN 978 92 890 55031 © World Health Organization 2020 Some rights reserved.
    [Show full text]