Abstract

Public concern has been increasing about the high prices of novel medicines, limits on availability and access, and the strain on health-care budgets across all countries. Addressing these challenges requires scrutinizing the underlying system of research and development (R&D) that produces these outcomes. Increasing policy attention has turned towards how to make the outputs of the innovation process accessible to all, and what changes to the current innovation model are needed. This report analyses the implications and challenges of transforming medicines - which have to date largely been treated as national private goods - into “global public goods” (GPGs). It describes the current model for pharmaceutical R&D and assesses how well it performs in producing GPGs along three dimensions: generation of pharmaceutical knowledge, its global availability and its global affordability. It then investigates alternative business models, including those implemented for COVID-19, and analyses how well they may be able to produce GPGs, concluding with proposals for consideration by public and private actors in the WHO European Region that could reorient the R&D system towards delivering GPGs.

Contents

• Acknowledgements
• Abbreviations
• Executive summary
• 1 Introduction
  • 1.1. Background, purpose and overview
  • 1.2. Methods
• 2 Medicines as GPGs
  • 2.1. GPGs: defining the concept
  • 2.2. Implications and challenges of pharmaceutical R&D as a GPG
• 3 Current business model for R&D: description and critique
  • 3.1. Actors and policies in the current R&D business model
  • 3.2. Outputs, costs and risks in the current business model
  • 3.3. How well does the current business model deliver GPGs?
  • 3.4. Investments and actors in pharmaceutical R&D in the WHO European Region
• 4 Alternative business models
  • 4.1. Neglected diseases of poverty
  • 4.2. Rare diseases and paediatric diseases and formulations
  • 4.3. Biosecurity R&D
  • 4.4. Antibiotics: emerging approaches
  • 4.5. Other approaches to alternative business models
  • 4.6. Common themes and approaches across alternative business models
• 5 COVID-19 R&D business models
  • 5.1. Push R&D investments: who is investing and how much
  • 5.2. Internationally pooled R&D grants with access conditions
  • 5.3. Pull R&D incentives
  • 5.4. Public support for manufacturing and technology transfer
  • 5.5. Pooling technology, IP and data
  • 5.6. Compulsory licensing and suspension of IP rights
  • 5.7. Conclusions on alternative COVID-19 R&D business models
• 6 Proposals for consideration
• 7 Conclusions
• References

Suggested citation:

Moon S, Vieira M, Ruiz AA, Navarro D. New business models for pharmaceutical research and development as a global public good: considerations for 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 to 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.