The current model of pharmaceutical research and development (R&D), which rewards innovators with extensive patent periods and high prices, is neglecting health needs of people in low- and middle-income countries. It is also increasing the financial burden of already overstretched health budgets in the European Union (EU). Considering that most new drugs entering the market offer little or no added therapeutic value, new models of pharmaceutical R&D are needed—quickly. Health Action International is working at the European Union and global levels to make this a reality.
Improving Pharmaceutical R&D in the European Union
The EU has committed to exploring alternative models of R&D through its development and health policy objectives. We urge the European Commission and Member States to ensure that innovation and biomedical knowledge that is derived in whole or in part from publicly-funded health R&D results in public goods and medical products that are appropriate, affordable and accessible. This includes Horizon 2020 and, under it, the European and Developing Countries Clinical Trials Partnership and the Innovative Medicines Initiative.
We also encourage the Commission and Member States to explore new incentive mechanisms—like innovation inducement prices, patent pools, open-source research and product development partnerships—that de-link the costs of R&D from the final price of medicines.
The Innovative Medicines Initiative
The European Union’s Innovative Medicines Initiative 2 (IMI 2) is a public-private partnership that aims to finance pre-competitive pharmaceutical R&D.
Although it is primarily funded by EU taxpayers and intended to ensure that public money contributes to more efficient and needs-driven R&D, the programme is disappointing. Clear conditions have not been set to allow for public access to the research, or affordable access to the end products. In fact, benefits from IMI 2 research are mostly privatised.
Health Action International advocates for open access to all research data to enhance its transparency, accountability and reliability. We also call for intellectual property that is dervived from IMI2-funded research to be licensed on non-exclusive terms. This will ensure that this publicly-funded health R&D results in public goods and medical products that are suitable, more affordable and accessible.
Global Efforts to Improve Pharmaceutical R&D
Debates about alternative biomedical innovation incentive models have taken place at the World Health Organization (WHO) for a decade. In 2008, WHO Member States approved a Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property. The plan promotes measures to increase access to medicines while exploring new approaches to innovation.
The WHO also established the Consultative Expert Working Group on Co-ordination and Financing of Biomedical R&D (CEWG) to develop recommendations for financing and coordinating new R&D incentives. The expert group has emphasised the importance of open knowledge innovation and de-linking the cost of R&D from the price of a medicine, which we support. In addition, the group strongly recommends that WHO Member States begin to negotiation a multilateral global health R&D convention.
The progress of WHO Member States is disappointing. Although they have commissioned new demonstration projects that are intended to show the effectiveness of new R&D incentive models, the selected projects offer little progress on exploring such new models. And despite mandating the WHO secretariat to create a new voluntary pooled funding mechanism for health R&D, more ambitious discussions on global norms to govern global health R&D funding are needed. Without this, the pooled fund will be reduced to a weak mechanism that puts money into an existing system that is broken.
Health Action International urges Member States to start negotiations on a global biomedical R&D framework covering all type I, II and III diseases where there is a market failure in attracting R&D funding.
WEBSITE: Private Patents & Public Health: Changing intellectual property rules for access to medicines
Read and share infographics from our easy-to-understand website that explains how the out-of-balance patent system is impacting access to new medicines for millions around the world.