Home > IP Topics Index > The Policy and Legal Environment for Innovation > Global Health: Lessons from Bayh-Dole > Editor's Summary, Implications and Best Practices

Are public research institutions delivering public health goods? The question itself might appear foolish. In the past fifty years, the intensity of research and the pace of discovery in the biomedical and health fields have accelerated dramatically in the U.S. As a result, the number of safe and effective drugs, vaccines, and medical devices for a broad range of illnesses and conditions has skyrocketed. And so have sales in developed countries. But in an increasingly global world—where the risk of disease and the benefits of research can come from any corner—the society that benefits from public sector health investment should be the global society. Keusch and Nugent therefore argue that the “public benefit” aspect of U.S. federal research investments should include the poor in societies outside of the U.S.

Most everyone agrees that the government should fund health research. After all, publicly supported research fills knowledge gaps that private industry ignores—though public sector inventions are usually brought to market by private sector product development. Indeed, the choice of whether to develop new ideas into products is largely left up to the private sector: technology development from public research by and large gets rationed according to private sector priorities. So what role do public agencies have in ensuring that the public benefits from its investments in health research? The answer is not obvious. Under current arrangements in the U.S., the public sector has limited capacity and experience in the downstream steps of developing and delivering biomedical products to consumer markets. These steps are costly. They are also not aligned with the public sector’s comparative advantages.

The public sector, therefore, needs to get creative, and Keusch and Nugent offer several ways that public institutions can increase the resources and tools devoted to the public health needs of the developing world. At the “upstream” end they can direct funds toward research in developing countries and their diseases; they can also partner with private and non-profit entities wishing to do the same. At the “downstream” end they can directly provide products to users in poor countries, reduce barriers to the transfer of technology that benefits developing countries, or partner with industry and academia to expedite the development of products from research. Aimed at those in the public health and biomedical fields, though some recommendations apply more broadly, this chapter outlines several ways that public and university decision-makers can re-orient their IP strategies to expand the ability of the poor to access the benefits derived from public research investments.

As an illustrative example, this chapter points out how the Bayh-Dole Act successfully created a large body of intellectual property from publicly funded research. Absent a strong profit motive for the private sector, however, the Act has been much less successful at producing public goods for health. Current practice undervalues the public benefit aspect of the mandate, especially for the poor. Furthermore, in an increasingly global world, where the risk of disease and the benefits of research can come from any corner, the society that benefits from public sector health investment should be the global society. The public benefit aspect of U.S. federal research investments should thus include the poor in societies inside as well as outside the U.S., and the IP laws and practices should be changed to enhance the benefit of our investments.

The intent of Bayh-Dole was not to produce supplemental revenue streams to universities. Rather, it was to engender innovation and increase the use of technology for economic development. Although intellectual property has clearly spurred the development of technologies that promote the public health of wealthier nations, the impact of intellectual property in promoting global health goods is mixed at best. Although the fundamental premise of IP protection, that it acts as a spur to innovation and a reward to risk taking, applies equally to all industries, some characteristics of the health care industry set it apart form other fields where intellectual property is important. This chapter builds upon the truth of the insight that IP rights play a broad role in trade and economic relations. Indeed, if Bayh-Dole were being debated today, then surely economic development objectives at the core of the legislation would take on a much broader meaning.

Key Implications and Best Practices

Given that IP management is heavily context specific, these Key Implications and Best Practices are intended as starting points to be adapted to specific needs and circumstances.

For Government Policymakers

• Establish an open, transparent government policy regarding the ownership of publicly-funded research, and implement it with well-trained people.
• Economic development, drugs for the poor, breakthrough technologies for the world’s most common diseases, and investing in scientific advances for tropical diseases are hoped for goals for all nations. Policymakers should ensure that investment in research is returned as a public benefit, possibly via a system that spurs economic development and creative innovation along the lines of the Bayh-Dole Act.
• Policymakers should retain the government’s right to exercise a license for the technology on behalf of the public, as well as (under extreme circumstances) full “march-in rights” to force a compulsory license. The possibility of such government action is likely to provide strong incentive to companies to make products available in the market. In this way, the government accepts ensures that the public investment pays returns.
• Require that recipients of government grants state a public benefit from the planned research (the purpose can be a scientific benefit to the public, but should be explicitly stated)
• By all means, adapt provisions of the U.S. Bayh-Dole Act to your country’s circumstances if desired. But one major provision (which is not included in the Bayh-Dole Act) should be included in any such legislation: Require that products developed and marketed commercially from publicly-funded research have some provision for delivery to the poor. In other words, whereas it is important to promote public-private collaborations for the development of publicly funded R&D, it should be balanced with humanitarian access provisions.

For Senior Management (university president, R&D manager, etc)

• In developing countries, Public Private Partnerships (PPPs) or Product-Development Partnerships (PDPs) are becoming more and more common. These newly created, tightly focused organizations are dedicated to developing products for neglected diseases in developing countries. PDPs will require that scientists put a priority on delivering global benefits and that university officials fully embrace the larger role of universities in society and in the global community.
• Many universities prominent in health research are also seeking to establish the right balance among their financial objectives, achieving scientific discovery, and disseminating benefit to the public through use of the discovery. A major policy objective should be to find the balance between public benefit and economic returns. This is the central challenge.
• Universities can include public benefit clauses in their licenses to the private sector, invest part of their royalty stream in a foundation, establish an “ethical” investment fund, license technologies to non-profits or others who would develop and manufacture for poor countries, and bundle technologies to encourage development of medicines aimed at diseases of the poor.

For Scientists

• Individual researchers in the U.S. have established product development companies in large numbers – and developing country research scientists and their institutions can do the same.
• When considering research collaboration with scientists from the U.S., developing country scientists should be certain that they receive equitable treatment in whatever IP ownership arrangements are made.
• As IP systems arise, developing country scientists should be cautious about delaying, or even preventing, research discovery from being published. It is critical to get the professional exposure and opportunities that scientific publication can offer, and excessive, and possibly misled, emphasis on securing property rights can inhibit those benefits.

For Technology Transfer Officers

• Traditionally, the mission of technology transfer offices was to bring university-generated intellectual property into public use as rapidly as possible. But over the years, academic technology transfer has evolved to serve a broader purpose: to enhance the reputation of the academic institutions we serve and help them achieve their missions of education, research, and community outreach.
• It is the job of the technology transfer office to create the incentives needed to move discovery into the product development arena, motivating academic researchers not by the promise of high profits (which rarely appear) but by the satisfaction of seeing their work applied to achieve public benefit. This will involve creating opportunities for various forms of licensing – including exclusive where appropriate, but also non-exclusive if that is likely to move a promising technology towards product development and commercialization.