Abstract

Lower-income countries (LICs) in the WHO European Region generally have poorer health status and more limited resources than higher-income countries. This creates pressing issues when making decisions on financing high-priced medicines. The market access strategies for innovative medicines in LICs usually follow the low-volume, high-price business model, which does not guarantee access for all potentially eligible patients. If the political will to make changes exists, however, several policy tools could be used that may improve patient access to these medicines.

This technical report describes specific constraints of LICs related to public financing of high-priced medicines, and summarizes policy considerations to improve access to high-priced medicines in LICs in three areas, including price-control mechanisms, tools to increase the negotiation power of health-care payers and tools to facilitate appropriate prescribing.

Contents

• Abbreviations
• Acknowledgements
• Executive summary
• 1 Introduction
  • 1.1. Scope of the report
• 2 Specific constraints of LICs
  • 2.1. Need for health-care services
  • 2.2. Limited purchasing power
  • 2.3. Political priorities
• 3 Price-control mechanisms
  • 3.1. Ex-factory price-setting mechanisms
  • 3.2. Conditional pricing and reimbursement
  • 3.3. Delayed-payment mechanisms
  • 3.4. Markup controls and taxation
• 4 Tools to increase the negotiation power of health-care payers
  • 4.1. Joint or pooled procurement
  • 4.2. Strengthening links between HTA bodies and health-care payers
  • 4.3. Inappropriate practices for pricing and reimbursement
• 5 Tools to facilitate appropriate prescribing
  • 5.1. Importance of off-patent pharmaceuticals
  • 5.2. Development and enforcement of treatment guidelines
  • 5.3. Inappropriate utilization practices
• 6 Summary of policy considerations
  • 6.1. Policy considerations for price-control mechanisms
  • 6.2. Policy considerations for tools to increase the negotiation power of health-care payers
  • 6.3. Policy considerations for tools to facilitate appropriate prescribing
• 7 Conclusions
• References
• Annex 1. Country groupings used in the report
• Annex 2. Overview of MEAs

Suggested citation:

Németh B, Csanádi M, Inotai A, Ameyaw D, Kaló Z. Access to high-priced medicines in lower-income countries in the WHO European Region. Oslo Medicines Initiative technical report. Copenhagen: WHO Regional Office for Europe; 2022. Licence: CC BY-NC-SA 3.0 IGO.

Oslo Medicines Initiative

Established in 2020, the Oslo Medicines Initiative (OMI) is a collaboration between the WHO Regional Office for Europe, the Norwegian Ministry of Health and Care Services and the Norwegian Medicines Agency. The OMI aims to provide a neutral platform for the public and the private sectors to jointly outline a vision for equitable and sustainable access to and affordability of effective, novel and high-priced medicines.

In line with the Regional Office's European Programme of Work 2020-2025 - “United Action for Better Health”, equitable and sustainable access to quality medicines is critical for universal health coverage and for achieving the Sustainable Development Goals. The OMI provides a strong focus on equity and on leaving no one behind, and is underpinned by three pillars; solidarity, transparency and sustainability.

The OMI has commissioned a series of technical reports to summarize relevant evidence and provide policy considerations as a basis for discussion to inform its work. These reports are also in line with the implementation of World Health Assembly resolutions, in particular, resolution WHA 72.8 on improving the transparency of markets for medicines, vaccines, and other health products.

ISBN: 978-92-890-5801-8

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Suggested citation: Németh B, Csanádi M, Inotai A, Ameyaw D, Kaló Z. Access to high-priced medicines in lower-income countries in the WHO European Region. Oslo Medicines Initiative technical report. Copenhagen: WHO Regional Office for Europe; 2022. Licence: CC BY-NC-SA 3.0 IGO.

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