Academics & Allies Call for a Better Return on Public Investments in Biomedical R&D
Public outrage over pharmaceutical corporation price-gouging for lifesaving medicines has been burgeoning for months. The very real threat of antimicrobial resistance (AMR) is well known and still, the United States (U.S.) government has yet to introduce any tangible and time-bound solutions to address this reality and it is unclear what measures, if any, the new administration will introduce.
As members and supporters of the international academic and scientific community, we recognize the U.S. National Institutes of Health’s (NIH) leadership in working to address this challenge, including its $20 million prize fund for AMR and support of the CARB-X initiative. However, in both of these promising initiatives to tackle AMR, the NIH has yet to take any decisive steps to ensure that subsequent discoveries will be accessible to the public. Therefore we are calling on the NIH to take action to ensure that lifesaving medicines and health technologies invented using U.S. taxpayer-funded research grants are priced to promote affordable access worldwide.
There is an urgent need to increase investment in innovations for neglected areas of health like AMR, which pose a growing threat to global health. The impacts of AMR are already a reality for millions of people around the world and, if we do not address AMR soon, the death toll will rise from 700,000 AMR-related deaths per annum today to a staggering 10 million deaths per a year by 2050.
Further, the NIH must ensure increased affordability of any new publicly-funded medical treatment or technology. Take for example the prostate cancer drug Xtandi, which is currently sold at $129,000 per-patient in the U.S., while the same product is sold at $29,000 in Canada. The NIH, which contributes approximately $31 billion USD each year to global public health research in many important areas including AMR, has a responsibility to change its funding guidelines to ensure that the medical discoveries made through research the NIH funds with taxpayer dollars at American universities and public research institutions is accessible to the public at affordable prices.
As was recommended in the United Nations High Level Panel Report on Access to Medicines, the NIH should safeguard innovation funded by the American public so that the American people can reap the benefits of the research they already pay for. The NIH and many U.S. universities previously endorsed the use of access licensing, signing onto the Statement of Principles and Strategies (SPS) in 2009, a “concrete statement of goals as well as licensing practices [to] help to promote further progress in advancing health in developing countries” signed by the Association of University Technology Managers (AUTM), Boston University, Brown University, Harvard University, Oregon Health & Science University, University of Pennsylvania, and Yale University as well as many additional academic and research institutions.
Now more than ever, the NIH must take steps to ensure that the U.S. government and the many universities they fund are in fact implementing the access principles laid out in the SPS.
The proposals set out require existing laws and policies to be enforced. We believe it is past time to act to foster real change already legislated at the national level.
We support the proposals made by Universities Allied for Essential Medicines (UAEM) set out in the annex below. These proposals seek to preempt and rectify situations where U.S. taxpayer-funded inventions are sold for exorbitant and often unaffordable prices.
Now more than ever, we call on the NIH to act. As students, staff, and affiliates of institutions that work with and receive funding from the NIH, we urge the NIH to adopt these next steps towards a fair and just public return on public investment.
UAEM licensing proposals endorsed in the letter:
1. New, federally funded biomedical research and development (R&D) grants should include terms and conditions that require affordability and availability of products in low- and middle-income countries, and affordable pricing requirements for the U.S.
(a) Government biomedical R&D grants should include affirmative global access contractual obligations for biomedical products, including those that include subsequent follow-on patents for grant recipients. For all low- and middle-income countries (LMICs), affordability will be accomplished by requiring non-exclusive licenses with terms that ensure wide availability, enabling generic drug manufacturers to provide a competitive supply for lifesaving treatments in LMICs.
(b) When publicly funded research is licensed, the licenses can include terms to address the access to follow-on IP in order to ensure that there will be competition for the manufacture, sale, and use of publicly funded medical technologies in LMICs.
(c) Domestically, taxpayer-funded biomedical R&D grants should require affordable pricing mechanisms, such as stipulating that drugs will be priced no higher in the U.S. than the median price charged in the 7 largest foreign economies (that have per capita incomes at least 50 percent of U.S.), as measured by GNP.
2. For products already on the market, or that are already in development that were developed entirely or significantly due to public R&D funding, specific conditions should be established that trigger the government’s exercise of existing “march-in rights”, royalty-free rights for federally funded patents, and other remedies such as government use under 28 U.S.C. sec. 1498.
(a) Trigger criteria for march-in rights, royalty-free rights or government use under sec. 1498 should include exorbitant pricing, and anticompetitive, abusive or unfair practices by a patent holder or licensee. Examples of conditions for march-in or other remedy should include, but are not limited to: tying arrangements, sudden and arbitrary price increases unrelated to increased costs (exclusive of advertising), price setting disproportionate to drugs in the same class and similar therapeutic value, or 11th hour filings for rarely used new indications to gain orphan drug protection. In developing countries, all of the above would constitute a trigger. Additionally, conditions would also include the failure to register product patents with national drug regulatory authorities.
Fair-pricing determinations should be made with a clear formula, such as 1(c) above. These rights should apply also for inventions whose co-formulation, co-administration or concomitant use includes additional or follow-on patents.