Abstract

This Oslo Medicines Initiative technical report presents existing policy options for payers that support innovation and access to medicines in the WHO European Region. It identifies innovation incentives, such as early assessment schemes, managed entry agreements and dedicated budgets (so-called innovation funds), across 48 countries in the Region. These incentives are supplemented by supporting assessment tools to generate evidence for informed decision-making (such as horizon scanning and health technology assessments) and access policies for innovation, such as value-based pricing, pooled procurement and subscription fee-based procurement. The report also points to possible limitations of the identified policies; some innovation policies can challenge the financial sustainability of health-care systems, and there are trade-offs between incentivizing innovation and principles of evidence generation, transparency and budget impact. Case studies demonstrate how two countries apply a mixture of policies to support innovation and access to medicines.

Contents

• Acknowledgements
• Abbreviations
• Executive summary
• 1. Introduction
  • 1.1. Background
  • 1.2. Key concepts
  • 1.3. Objective
• 2 Methods
• 3 Policies to support innovation and access to medicines
  • 3.1. Background
  • 3.2. Supporting preparedness of systems and early launch of innovation
  • 3.2.2. Early access schemes
  • 3.3. Value assessment
• 4. Case studies
  • 4.1. Case study on policies to support access and innovation in Italy
  • 4.2. Case study on policies to support innovation and access and to fight AMR in Germany
  • 4.3. Summary of application of identified innovation policies in the case study countries
• 5. Policy considerations
• References
• Annex 1. Definitions of innovation in national legislation
• Annex 2. Examples of cross-country collaboration on pricing and reimbursement

Suggested citation:

Vogler S. Payer policies to support innovation and access to medicines 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.

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Suggested citation: Vogler S. Payer policies to support innovation and access to medicines 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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