Abstract

Concerns about affordable access to medicines reflect the emergence of new, high-priced medicines, as well as expectations regarding the cost of precision therapies coming to market. Compared with a decade ago, novel medicines are subject to longer delays between global launch and market access, even in wealthier countries. Various paths forward offer potential policy solutions to address problems with access to high-priced pharmaceuticals. This technical report considers four categories of policies - demand pooling, formal tiered pricing, risk-sharing agreements and policies to harness competition - with potential to ameliorate issues in ensuring timely, affordable and equitable access to effective medicines in the WHO European Region. Each approach offers the potential to address a different dimension of the affordability problem. The most promising strategies to tackle affordability of high-priced medicines are likely to entail a combination approach - for example, a test pilot of a single-buyer agreement using a combination of managed-entry agreements and tiered pricing for agreement signatories under an agreed formula. To facilitate policy development, stakeholder commitment to three underlying principles - solidarity, transparency and sustainability - is essential.

Contents

• Abbreviations
• Acknowledgements
• Executive summary
• 1 Introduction
  • 1.1. Background and context
  • 1.2. Objective and aims
• 2 Challenges in achieving equitable, affordable and prompt access to medicines
  • 2.1. Nature and extent of problems driving reform
  • 2.2. Role of current policies in contributing to problems
  • 2.3. Guiding principles proposed as underpinnings for new social contract
• 3 Potential policy solutions for examination and exploration
  • 3.1. Demand pooling and other collective initiatives
  • 3.2. Tiered pricing
  • 3.3. Performance-based managed-entry (shared-risk) agreements
  • 3.4. Harnessing the power of competition
• 4 Conclusion: guiding principles essential to drive progress
• References
• ANNEX 1 Recent regulatory initiatives in the EU and the United States

Suggested citation:

Docteur E. Towards a new vision for shared responsibility in pharmaceutical pricing, coverage and reimbursement. Policy approaches building on principles of solidarity, transparency and sustainability. 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 WHA72.8 on improving the transparency of markets for medicines, vaccines, and other health products.

ISBN: 97-892-890-5819-3

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Suggested citation: Docteur E. Towards a new vision for shared responsibility in pharmaceutical pricing, coverage and reimbursement. Policy approaches building on principles of solidarity, transparency and sustainability. Oslo Medicines Initiative technical report. Copenhagen: WHO Regional Office for Europe; 2022. Licence: CC BY-NC-SA 3.0 IGO.

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