Health Impact Fund Research Articles

Just Rules for Innovative Pharmaceuticals

Globalized in 1995 through the TRIPs Agreement, humanity’s dominant mechanism for encouraging innovations involves 20-year product patents, whose monopoly features enable innovators to reap large markups or licensing fees from early users. Exclusive reliance on this reward mechanism in the pharmaceutical sector is morally problematic for two main reasons. First, it imposes a great burden on poor people who cannot afford to buy patented treatments at monopoly prices and whose specific health problems are therefore neglected by pharmacological research. Second, it discourages pharmaceutical firms from fighting diseases at the population level with the aim of slashing their incidence. These problems can be alleviated by establishing a supplementary alternative reward mechanism that would enable pharmaceutical innovators to exchange their monopoly privileges on a patented product for impact rewards based on the actual health gains achieved with this product. As such, an international Health Impact Fund (HIF) would create powerful new incentives to rapidly develop remedies against diseases concentrated among the poor, provide such remedies with ample care at very low prices, and deploy them strategically to contain, suppress, and ideally eradicate the target disease. By promoting innovations and their diffusion together, the HIF would greatly enlarge the benefits, and thereby also the cost-effectiveness, of the pharmaceutical sector, especially in favor of the world’s poor.

Avoiding Global Pandemic Injustice

Abstract COVID-19 has highlighted the failure of the current monopoly market system of pharmaceutical industries to efficiently and equitably distribute lifesaving health commodities in a pandemic. The pre-purchasing of COVID-19 vaccines in 2021 by high income countries (outside of the global coordinated effort called the COVAX facility) has led to inequitable access to vaccines globally. This may have contributed to the development of new COVID-19 variants of concern such as ‘Omicron’. Further, vaccine inequity has resulted in the poor suffering the worst health and economic outcomes of the pandemic. COVID-19 has deepened inequalities and increased global poverty. While high income countries are on a path to recovery with pre-pandemic growth rates forecast for 2022, low and middle income countries are still in economic recession, with growth rates forecast to remain at 5.5 percentage points below pre-pandemic levels by 2024. The Health Impact Fund approach offers an alternative, whereby pharmaceutical firms profit in proportion to their contribution to reducing the disease burden rather than through monopoly rents from product sales.

The Health Impact Fund: making the case for engagement with pharmaceutical laboratories in Brazil, Russia, India, and China

Despite progress in global health, the general disease burden still disproportionately falls on low- and middle-income countries. The health needs of these countries’ populations are unmet because there is a shortage in drug research and development, as well as a lack of access to essential drugs. This health disparity is especially problematic for diseases associated with poverty, namely neglected tropical diseases and microbial infections. Currently, the pharmaceutical landscape focuses on innovations determined by profit margins and intellectual property protection. To expand drug accessibility and catalyze research and development for neglected diseases, a team of researchers proposed the Health Impact Fund as a potential solution. However, the fund is predominantly considering partnerships with pharmaceutical giants in high-income countries. This commentary explores the limitations and benefits in partnering with pharmaceutical companies based in Brazil, Russia, India, and China (BRIC), with the goal of expanding the Health Impact Fund’s vision to incorporate long-term, local partnerships. Identified limitations to a BRIC country partnership include lower levels of drug development expertise compared to their high-income pharmaceutical counterparts, and whether the Health Impact Fund and the participating stakeholders have the financial capability to assist in bringing a new drug to market. However, potential benefits include the creation of new incentives to fuel competitive local innovation, more equitable routes to drug discovery and development, and a product pipeline that could involve stakeholders in lower- and middle-income countries. Our commentary explores how partnership with pharmaceutical firms in BRIC countries might be advantageous for all: The Health Impact Fund, pharmaceutical companies in BRIC economies, and stakeholders in low- and middle- income countries.

Health Impact Fund

Health Impact Fund

Combating Antibiotic Resistance Through the Health Impact Fund

The Health Impact Fund (Hollis & Pogge 2008) is an innovative financing mechanism for global drug discovery and dissemination, separating the reward for successful R&D from the market price of the drug, also known as de-linkage. Aaron Kesselheim and Kevin Outterson have recently proposed a mechanism to reimburse companies for antibiotics according to their social value, but conditioned on achieving conservation goals to limit resistance (Kesselheim & Outterson 2010, 2011). This paper will explore whether this antibiotic resistance conservation proposal can be adapted to the framework of the Health Impact Fund. If these proposals can be meshed, then antibiotics might be an interesting therapeutic class for a test of the Health Impact Fund.

Improving access to medicines via the Health Impact Fund in India: a stakeholder analysis

ABSTRACTBackground: In India, 50–65% of the population face difficulties in accessing medicines. The Health Impact Fund (HIF) is a novel proposal whereby pharmaceutical companies would be paid based on the measured global health impact of their drugs. We conducted a key stakeholder analysis to explore access to medicines in India, acceptability of the HIF and potential barriers and facilitators at policy level.Objectives: To conduct a stakeholder analysis of the HIF in India: to determine key stakeholder views regarding access to medicines in India; to evaluate acceptability of the HIF; and to assess potential barriers and facilitators to the HIF as a policy.Methods: In New Delhi, we conducted semi-structured interviews. There was purposive recruitment of participants with snowball sampling. Transcribed data were analysed using stakeholder analysis frameworks and directed content analysis.Results: Participation rate was 29% (14/49). 14 semi-structured interviews were conducted among stakeholders in New Delhi. All participants highlighted access to medicines as a problem in India. There were mixed views about the HIF in terms of relevance and scaleability. Stakeholders felt it should focus on diseases with limited or no market and potentially incorporate direct investment in research.Conclusions: First, access to medicines is perceived to be a major problem in India by all stakeholders, but affordability is just one factor. Second, stakeholders despite considerable support for the idea of the HIF, there are major concerns about scaleability, generalisability and impact on access to medicines. Third, the HIF and other novel drug-related health policies can afford to be more radical, e.g. working outside the existing intellectual property rights regime, targeting generic as well as branded drugs, or extending to research and development. Further innovations in access to medicines must involve country-specific key stakeholders in order to increase the likelihood of their success.

International Patent Regimes and Access to Medicines: Is the Health Impact Fund an Effective Solution?

International Patent Regimes and Access to Medicines: Is the Health Impact Fund an Effective Solution?

Ebola, R&D on Neglected Diseases and the Health Impact Fund

The gravity of the Ebola virus pandemic in 2014 and the fact that no effective vaccine or antibiotic treatment exists against the disease has re-opened the debate on neglected diseases, public health, R&D and Intellectual Property. Neglected diseases are those having a major impact in the developing world or exclusively affecting developing countries. Patients suffering from this type of diseases are in need of life-saving treatments – e.g. drugs and vaccines – that either do not exist or require further development. However, there is a lack of incentives for pharmaceutical corporations to invest in R&D on these illnesses, which leads to a context of market failure. Despite the fact that there is an extensive demand for new and improved pharmaceutical products to treat this type of maladies, the market is too small to incentivize investment on R&D as the purchasing power of developing countries and their impoverished populations is very limited. Further, international IP laws are hindering the access to existing medicines by the world's poor.Yale University philosophy professor Thomas Pogge and University of Calgary economist Aidan Hollis propose the creation of the Health Impact Fund, as a feasible alternative to the existing IP system to address the issue of the unavailability of medicines for treating neglected diseases as well as the inaccessibility of available medicines to the poor.

Ebola and the need for restructuring pharmaceutical incentives.

Ebola and the need for restructuring pharmaceutical incentives.

Promoting public health research in BRICS through a multinational public health prize fund

This article proposes the establishment of a prize fund to incentivise public health research within the BRICS association, which comprises the five major emerging world economies: Brazil, Russia, India, China and South Africa. This would stimulate cooperative healthcare research within the group and, on the proviso that the benefits of the research are made freely available within the association, would be rewarding for researchers. The results of the research stimulated by the prize would provide beneficial new healthcare technologies, targeting the most vulnerable and needy groups. The proposed fund is consistent with current international patent law and would not only avoid some of the problems associated with the "Health Impact Fund", but also create a new model for healthcare research.

The Health Impact Fund: a new paradigm in pharmaceutical innovation

We have learned that the speed and quality of innovation can be substantially raised by granting innovators temporary monopolies, such as patents or copyrights, which enable them to profi t by charging high mark-ups. But such temporary monopolies promote innovation at the expense of diff usion. In other words, the better we innovate, or incentivize innovation, the more we pay a price in terms of the diff usion of those same innovations. Rewarding innovation in the wrong way in the areas of pharmaceu ticals, food production, and environmental innovation has especially serious eff ects on the poor. The current system does poorly with regard to access targeting and cost-eff ectiveness. The Health Impact Fund proposes a new way of paying for pharmaceutical innovation by incentivizing the development and delivery of new drugs through pay-for-performance mechanisms. Furthermore, the same idea could be applied to agricultural and environmental innovation. Keywords: Health Impact Fund; healthcare · pharmaceutical industry; innovation; patents; agriculture; environment; population growth

Synthetic biology: ensuring the greatest global value.

Synthetic biology (SynBio) has tremendous, transformative potential. Like other technologies, it can be used for good or ill. Currently, the structure of the allocation of potential benefits and risks is biased in favor of richer countries. The underlying problem is simple: most risks from SynBio are universal and affect both the rich and the poor with equal force; but benefits from SynBio can be expected to accrue chiefly to the rich. The risk/benefit balance is therefore skewed in a way that may lead to inefficient and unfair decisions. One potential solution is presented in this paper, using the principles that underlie the Health Impact Fund (HIF). The HIF is designed to reward companies based on assessed health impact, no matter where it occurs in the world, so that extending the life of a poor person is as profitable as extending the life of a rich person. This paper considers both the potential benefits and costs of SynBio; examines how the current global pharmaceutical industry is structured; introduces the HIF proposal; and finally explores how the principles underlying the HIF could be used productively with SynBio for global health.

Special issue editorial: synthetic biology, global health, and its global governance

Special issue editorial: synthetic biology, global health, and its global governance

Patents for Humanity

This article evaluates two policy initiatives by the United States Government to address access to essential medicines -- Priority Review vouchers and “Patents for Humanity. Such proposals are aimed at speeding up the regulatory review of inventions with humanitarian uses and applications by the United States Food and Drug Administration, and the United States Patent and Trademark Office. It is argued that such measures fall short of international standards and norms established by the World Intellectual Property Organization Development Agenda 2007; the World Trade Organization’s Doha Declaration on the TRIPS Agreement and Public Health 2001 and the WTO General Council Decision of August 30, 2003; and the World Health Organization’s declarations on intellectual property and public health. This article concludes that there is a need for broader patent law reform in the United States to address matters of patent law and public health. Moreover, there is a need to experiment with other, more promising alternative models of research and development -- such as medical innovation prizes, a Health Impact Fund, the Medicines Patent Pool, and Open Source Drug Discovery.

The Health Impact Fund: Enhancing Justice and Efficiency in Global Health

Some 18 million people die annually from poverty-related causes. Many more are suffering grievously from treatable medical conditions. These burdens can be substantially reduced by supplementing the rules governing pharmaceutical innovation. Established by the World Trade Organization's TRIPS Agreement, these rules cause advanced medicines to be priced beyond the reach of the poor and steer medical research away from diseases concentrated among them. We should complement these rules with the Health Impact Fund (HIF). Financed by many governments, the HIF would offer any new pharmaceutical product the opportunity to participate, during its first 10 years, in the HIF's annual reward pools, receiving a share equal to its share of the assessed health impact of all HIF-registered products. In exchange, the innovator would have to agree to make this product available worldwide at the lowest feasible cost of manufacture. Fully consistent with TRIPS, the HIF achieves three key advances. It directs some pharmaceutical innovation toward the most serious diseases, including those concentrated among the poor. It makes all HIF-registered medicines cheaply available to all. And it incentivizes innovators to promote the optimal use of their HIF-registered medicines. Magnifying one another's effects, these advances would engender large global health gains.

The Health Impact Fund: More Justice and Efficiency in Global Health

Some 18 million people die annually from poverty-related causes. Many more are suffering grievously from treatable medical conditions. These burdens can be substantially reduced by supplementing the rules governing pharmaceutical innovation. Established by the World Trade Organization’s TRIPS Agreement, these rules cause advanced medicines to be priced beyond the reach of the poor and steer medical research away from diseases concentrated among them. We should complement these rules with the Health Impact Fund. Financed by many governments, the HIF would offer any new pharmaceutical product the opportunity to participate, during its first ten years, in the HIF’s annual reward pools, receiving a share equal to its share of the assessed global health impact of all HIF-registered products. In exchange, the innovator would have to agree to make this product available worldwide at the lowest feasible cost of manufacture. Fully consistent with TRIPS, the HIF achieves three key advances. It directs some pharmaceutical innovation toward the most serious diseases, including those concentrated among the poor. It makes all HIF-registered medicines cheaply available to all. And it incentivizes innovators to promote the optimal use of their HIF-registered medicines. Magnifying one another’s effects, these advances would engender large global health gains.

P1-9 The health impact fund-meeting the challenge of health impact assessment

IntroductionThe Health Impact Fund (HIF) is a publicly funded international agency proposed to enable pharmaceutical innovators to register a product for health impact rewards in exchange for selling it worldwide...

Encouraging pharmaceutical innovation to meet the needs of both developed and developing countries

PurposeCurrent pharmaceutical global pricing strategies functionally exclude developing countries from the market for drugs to treat many diseases. The purpose of this paper is to evaluate some of the proposed patent reward models to determine their feasibility in the current environment.Design/methodology/approachA review of a variety of proposals including special financing or tax arrangements, public‐private partnerships, and government‐funded patent purchases are briefly reviewed. A more in‐depth examination of the recently proposed health impact fund (HIF) is undertaken.FindingsIn brief, the HIF requires developed countries to donate to a fund that finances the release of pharmaceutical patents. The pharmaceutical companies would be reimbursed over a ten‐year period from the government donation pool based on the medicine's health impact. The expected consequence of this policy would be affordable medicines for developed and developing countries. This examination highlights deficiencies in the current HIF strategy and offers a number of suggestions mostly focused on a more balanced sharing of the inherent risks in pharmaceutical product development to improve the strategies viability.Practical implicationsAlthough among the proposed strategies, the HIF offers the most promise, the suggested changes would result in a program viewed more favourably by the pharmaceutical industry and participating countries.Originality/valueAlthough it is recognized that pricing challenges are limiting the availability to essential medications in developing countries, current strategies often ignore many of the market dynamics for pharmaceuticals. This critique, focused on the HIF strategy, is presented in an effort to improve the likely success of the most promising of these strategies.

The Health Impact Fund: a potential solution to inequity in global drug access

Global health inequities persist despite significant increases in funding and a growing number of global health initiatives. Especially vulnerable to disease, the poor majority of the world's population currently cannot afford advanced medicines, and the diseases confined to the poor receive little attention from pharmaceutical research. As a complement to the existing intellectual property regime, we have proposed the Health Impact Fund (HIF) as a mechanism that would create incentives for the development and optimal promotion of new high-impact medicines sold at the cost of manufacture. In this article, we outline the HIF and its ethical significance.

Fund proposed to pay for drugs with greater global impact

A global fund proposed by a Canadian economist would see drug companies rewarded for the health impact of medicines they commit to sell at cost. The Health Impact Fund, proposed by Aidan Hollis, professor of economics at the University of Calgary in Alberta, and Thomas Pogge, professor of