Whenever a new infectious outbreak threatens global health, pharmaceutical companies, governments, international organizations, and philanthropies scramble to develop new vaccines. But intellectual property, price, and other access provisions can get in the way.
Building on the lessons of the 2014 Ebola outbreak in West Africa and propelled by the urgent need for Covid-19 vaccines, the private and public sectors have made enormous progress in responding to pressing public health needs. New partnerships such as the Coalition for Epidemic Preparedness Innovations and COVAX have advanced the development and procurement of vaccines for the greater global good.
But for public-private partnerships (PPPs) to maximize the social benefit of health security investments, it is essential to identify and disseminate best practices around ownership of intellectual property, price, and access, which lie at the heart of why the public-private partnership model exists in the first place.
The private sector has the ability to develop essential vaccines and other medications for global public health purposes, but markets often fail to adequately reward this activity. The public sector often lacks the in-house expertise to conduct development and manufacturing, but it can provide funding and direction to incentivize private sector activity. Together, both parties can pursue research and development to serve the greater public good.
Nation states, charitable organizations such as the Bill and Melinda Gates Foundation and the Wellcome Trust, and intergovernmental organizations such as the World Health Organization have increasingly turned to public-private partnerships to conduct research and development and to provide services required to meet global health security objectives.
The race to develop Covid-19 vaccines represents a historic level of collaboration between the public and private sectors. While the degree of cooperation between sectors has varied from project to project, almost every vaccine that has been authorized to date was developed according to the terms of a PPP agreement.
Public-private partnerships depend on contracts that address inherent tensions around issues such as the magnitude of public subsidies, allowable profit, price, ownership of intellectual property, and equitable distribution to low and middle-income countries. As with any contract, clearly defined terms allow projects to be manageable, traceable, and enforceable. Unfortunately, these agreements are often drafted with little understanding of how well certain strategies for intellectual property, price, access provisions, and the like have worked before.
Public-private partnership agreements are difficult to study because they are negotiated under confidentiality to protect intellectual property and business strategy. While limited confidentiality around truly proprietary contract elements is necessary, not all aspects of these agreements should remain shrouded in secrecy. The resulting lack of transparency around the terms of these deals thwarts efforts to understand what has worked well in the past and to identify best practices.
Poor transparency also makes it harder for watchdog groups to ensure that contracts contain appropriate safeguards against price gouging, and that terms ensure responsible use of public funds. Improving transparency wherever possible is essential to any effort to accelerate and improve the translation of policies into agreements.
Inconsistent use of key terms in public-private partnership agreements further complicates negotiations. For example, funders often use “step in” and “humanitarian license” to describe the process by which they intend to secure rights necessary to maintain the continuity of the projects they fund. Yet companies worry that these terms will restrain their ability to conduct a for-profit business. The reality is that these terms do not diverge significantly from business as usual. Back-up manufacturers (trusted partners) are often required in commercial contracts and access to background intellectual property is frequently provided to trusted commercial partners.
Precious time is wasted as negotiators use different terms to address a recurring set of issues. Harmonizing key terms in advance can improve the speed and quality of negotiations.
To address the need for assessment, transparency, and harmonization, the Global Health Innovation Access Accelerator, which one of us (J.B.W.) directs, launched the global health Master Alliance Provisions Guide (MAPGuide) with the support of the Wellcome Trust. The MAPGuide provides a freely available curated collection of agreement provisions in public-private partnership agreements for key issues, such as equitable access, transparency, alliance management, and ownership of intellectual property. This online tool is searchable by issue, therapeutic category, type of partner, and stage of development. The MAPGuide also provides a platform for sharing new terms and practices as they evolve.
All parties benefit from a shareable repository of contracts to address key issues in global health research, development, and purchasing. A glossary informs stakeholders about alternate definitions of key terms to prepare parties for negotiations and to give them a common language for discussion. This makes it easier for policy makers to consider how their policies are drafted and how they are implemented. In particular, this tool can be used to reach provisional agreements before an outbreak so higher-quality agreements can be reached faster in the event of an outbreak.
Looking ahead, researchers can use the MAPGuide to track the outcomes of individual public-private partnership agreements and assess the effectiveness of terms and strategies across agreements to identify best practices. Funders can then better pair investments with optimal provisions to ensure desired outcomes, such as ensuring that the end product is sustainably available through technology transfer.
The need for tools to guide partnership agreements has never been more evident. As countries scramble to obtain Covid-19 vaccines, the fate of populations and economies depend to a large degree on the terms of public-private partnership agreements. Developing an understanding of what works well in them will ensure that the urgent need for safe and effective vaccines is met in a timely and sustainable fashion, not just for this pandemic, but for all future health threats. The MAPGuide helps ease and improve this important work.
Julia Barnes-Weise is executive director of the Global Healthcare Innovation Alliance Accelerator and a senior consultant to the Coalition for Epidemic Preparedness Innovations. Kendall Hoyt, is a biosecurity expert, an assistant professor of medicine at the Geisel School of Medicine, and a lecturer at the Thayer School of Engineering, all at Dartmouth University.
For the original article, please click here.