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The '''Health Impact Fund''' ('''HIF''') is a proposed pay-for-performance mechanism that would provide a market-based solution to problems concerning the development and distribution of medicines globally. It would incentivize the research and development of new pharmaceutical products that make substantial reductions in the global ]. The HIF is the creation of a team of researchers led by the ] philosopher ] and the ] economist ], and is promoted by the non-profit organization ] (IGH). The '''Health Impact Fund''' is a proposed pay-for-performance mechanism that would provide a market-based solution to problems concerning the development and distribution of medicines globally. It would incentivize the research and development of new pharmaceutical products that make substantial reductions in the global ]. The Health Impact Fund is the creation of a team of researchers led by the ] philosopher ] and the ] economist ], and is promoted by the non-profit organization ] (IGH).


==Motivation== ==Motivation==
In the current system of development and distribution of medicines, millions of people in poor countries die from diseases because the patented medicines they need are unaffordable or because no medicine exists to cure their ailments. Little pharmaceutical research is concentrated on ] This is largely because it has been difficult for pharmaceutical companies to profit from ] directed at products needed by the poor. The cost of pharmaceutical research and development is high and unlikely to be recovered from those in poor countries who cannot afford the medicines. Therefore, "the Health Impact Fund would give companies incentives to develop new products targeting the diseases and conditions for which existing systems have failed to produce results, which would especially benefit the poor." <ref> S.J. Hoffman, T. Pogge. 2011. “Revitalizing Pharmaceutical Innovation for Global Health,” Health Affairs 30(2):367. doi:10.1377/hlthaff.2011.0103. </ref> In the current system of development and distribution of medicines, millions of people from developing countries die from diseases because the patented medicines they need are unaffordable or because no medicine exists to cure their ailments. Little pharmaceutical research is devoted to ] This is largely because it has been difficult for pharmaceutical companies to profit from ] directed at products needed by the poor. The cost of pharmaceutical research and development is high and unlikely to be recovered from those in poor countries who cannot afford the medicines. Therefore, "the Health Impact Fund would give companies incentives to develop new products targeting the diseases and conditions for which existing systems have failed to produce results, which would especially benefit the poor."<ref>S.J. Hoffman, T. Pogge. 2011. “Revitalizing Pharmaceutical Innovation for Global Health,” Health Affairs 30(2):367. doi:10.1377/hlthaff.2011.0103.</ref>


The distribution of pharmaceutical research and development is partly a result of the global patent regime established by the ] (TRIPS). Prior to TRIPS, countries were free to not enact intellectual property laws covering medicines, leading to flourishing generic drug industries in countries such as ]. Following TRIPS, all ] members were required to institute strict, American-style intellectual property rights. As a result, the supply of generic medicines to poor countries has been sharply diminished.<ref name="stiglitz">Joseph Stiglitz, "," ''British Medical Journal'' 333, no. 7582 (2006), pp. 1279.</ref> According to ] ], the pharmaceutical patent system needs an "alternative" that would "give large rewards for cures or vaccines for diseases like malaria that affect millions."<ref name="stiglitz" /> The allocation of pharmaceutical research and development effort is partly a result of the global patent regime established by the ] (TRIPS). Prior to TRIPS, countries were free to not enact intellectual property laws covering medicines, leading to flourishing generic drug industries in countries such as ]. Following TRIPS, all ] members were required to institute strict, American-style intellectual property rights. As a result, the supply of generic medicines to poor countries has been sharply diminished.<ref name="stiglitz">Joseph Stiglitz, "," ''British Medical Journal'' 333, no. 7582 (2006), pp. 1279.</ref> According to ] ], the pharmaceutical patent system needs an "alternative" that would "give large rewards for cures or vaccines for diseases like malaria that affect millions."<ref name="stiglitz" />


==Design of the Fund== ==Design of the Fund==
The HIF is intended to address the problems with an uncomplemented pharmaceutical patent system. The HIF uses market forces to create incentives to develop medicines for typically neglected diseases and to distribute these medicines at low prices all over the world.<ref>Aidan Hollis and Thomas Pogge, ''The Health Impact Fund: Making Medicines Available for All'' (New Haven, CT: Incentives for Global Health, 2008), p. 3.</ref> Pharmaceutical patent-holders would receive financial rewards by opting to register their new medicines, or new uses of existing medicines, with the Fund. By registering, a patent-holder agrees to distribute its medicine globally at ] and to cooperate in measuring the health impact of that medicine. In return, the firm receives an annual reward based on its measurable contribution to reducing the ].<ref>Aidan Hollis and Thomas Pogge, ''The Health Impact Fund: Making Medicines Available for All'' (New Haven, CT: Incentives for Global Health, 2008), ch. 2.</ref> The Health Impact Fund is intended to address the problems with an uncomplemented pharmaceutical patent system. The Health Impact Fund uses market forces to create incentives to develop medicines for typically neglected diseases and to distribute these medicines at low prices all over the world.<ref>Aidan Hollis and Thomas Pogge, ''The Health Impact Fund: Making Medicines Available for All'' (New Haven, CT: Incentives for Global Health, 2008), p. 3.</ref> Pharmaceutical patent-holders would receive financial rewards by opting to register their new medicines, or new uses of existing medicines, with the Fund. By registering, a patent-holder agrees to distribute its medicine globally at ] and to cooperate in measuring the health impact of that medicine. In return, the firm receives an annual reward based on its measurable contribution to reducing the ].<ref>Aidan Hollis and Thomas Pogge, ''The Health Impact Fund: Making Medicines Available for All'' (New Haven, CT: Incentives for Global Health, 2008), ch. 2.</ref> In order to achieve distribution at cost, the Health Impact Fund could require generic licensing, tendering, or price controls, depending on the nature of the product.<ref name=":0">{{Cite web|url=https://www.healthimpactfund.org/pdf/DP1_Hollis.pdf|title=The Health Impact Fund and Price Determination|last=Hollis|first=Aidan|date=April 23, 2009|website=Health Impact Fund|archive-url=|archive-date=|access-date=}}</ref>


Registrants of new drugs are eligible for reward payments for ten years starting at the date of ] of their product. New uses receive rewards for five years. Following the reward period, registrants agree to allow ] manufacturing of their medicines, in order to prevent price spikes.<ref>Aidan Hollis and Thomas Pogge, ''The Health Impact Fund: Making Medicines Available for All'' (New Haven, CT: Incentives for Global Health, 2008), pp. 13-14.</ref> Registrants retain their rights to control follow-on innovation.<ref>Aidan Hollis and Thomas Pogge, ''The Health Impact Fund: Making Medicines Available for All'' (New Haven, CT: Incentives for Global Health, 2008), p. 17.</ref> Registrants of new drugs are eligible for reward payments for ten years starting at the date of ] of their product. New uses receive rewards for five years. Following the reward period, registrants agree to allow ] manufacturing of their medicines, in order to prevent price spikes.<ref>Aidan Hollis and Thomas Pogge, ''The Health Impact Fund: Making Medicines Available for All'' (New Haven, CT: Incentives for Global Health, 2008), pp. 13-14.</ref> Registrants retain their rights to control follow-on innovation.<ref>Aidan Hollis and Thomas Pogge, ''The Health Impact Fund: Making Medicines Available for All'' (New Haven, CT: Incentives for Global Health, 2008), p. 17.</ref>


==Assessing the Health Impact of a Registered Product== ==Assessing the health impact of a registered product==
When assessing the health impact of a registered product, “the HIF would essentially estimate the difference between (1) the actual health status of people who consumed the registered product and (2) the estimated health status of those people, had they not had access to the registered product.”<ref>Aidan Hollis and Thomas Pogge, ''The Health Impact Fund: Making Medicines Available for All'' (New Haven, CT: Incentives for Global Health, 2008), p. 9.</ref> When assessing the health impact of a registered product, “the Health Impact Fund would essentially estimate the difference between
(1) the actual health status of people who consumed the registered product and
(2) the estimated health status of those people, had they not had access to the registered product.”<ref>Aidan Hollis and Thomas Pogge, ''The Health Impact Fund: Making Medicines Available for All'' (New Haven, CT: Incentives for Global Health, 2008), p. 9.</ref>


The standard measure of health impact is the ] (QALY). For example, if all registered products were in conjunction estimated to have saved 10 million QALYs, then a registered product that saved 1 million of those QALYS would receive ten percent of the available reward funds for that year.<ref>Aidan Hollis and Thomas Pogge, ''The Health Impact Fund: Making Medicines Available for All'' (New Haven, CT: Incentives for Global Health, 2008), pp. 3-4.</ref> The health impact assessment of a registered product would be conducted for each year of its registration with the HIF, and payments would be disbursed annually. The standard measure of health impact is the ] (QALY). For example, if all registered products were in conjunction estimated to have saved 10 million QALYs, then a registered product that saved 1 million of those QALYs would receive ten percent of the available reward funds for that year.<ref>Aidan Hollis and Thomas Pogge, ''The Health Impact Fund: Making Medicines Available for All'' (New Haven, CT: Incentives for Global Health, 2008), pp. 3-4.</ref> The health impact assessment of a registered product would be conducted for each year of its registration with the Health Impact Fund, and payments would be disbursed annually.


==Funding== ==Funding==
The HIF is to be financed by governments. Ideally, countries will commit a fixed amount of their ] (GNI) to the HIF (0.03 percent of a country’s GNI is the suggested minimum).<ref>Aidan Hollis and Thomas Pogge, ''The Health Impact Fund: Making Medicines Available for All'' (New Haven, CT: Incentives for Global Health, 2008), pp. 10-11.</ref> The Health Impact Fund might be financed by governments, with countries committing a fixed fraction of their ] (GNI) to the Health Impact Fund (0.03 percent of a country's GNI is the suggested minimum).<ref>Aidan Hollis and Thomas Pogge, ''The Health Impact Fund: Making Medicines Available for All'' (New Haven, CT: Incentives for Global Health, 2008), pp. 10-11.</ref> Alternatively, the Health Impact Fund might also be funded through an international tax on carbon emissions, say, or on disruptive financial speculations.


==Next Step: An Innovative Pilot== ==Next step: an innovative pilot==
{{More citations needed section|date=July 2016}}
As performance measurement is a core component of the HIF, it needs to be robust across different products and in diverse settings. Working with leading health care assessment organizations such as The George Institute for International Health, NICE International, and the Institute for Health Metrics and Evaluation, IGH will perform evaluations of the health impact of different products in a variety of countries. The HIF would expand assessment beyond pre-approval clinical trials, using epidemiological data from actual usage, practical trials, physician surveys, and patient demographics, as modifiers to the core health impact assessment. IGH aims to pilot the proposed HIF mechanism by rewarding a pharmaceutical manufacturer on the basis of measured health impact in a region. This will allow the pay-for-performance approach to be field-tested and refined before it is implemented on a wider scale. As performance measurement is a core component of the Health Impact Fund, it needs to be robust across diverse products, patient demographics, and social and natural environments. Working with leading health care assessment organizations such as The George Institute for International Health, NICE International, the Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG) and the Institute for Health Metrics and Evaluation, the Health Impact Fund would perform evaluations of the health impact of different products in a variety of countries. Such assessments would go beyond pre-approval clinical trials, using epidemiological data from actual usage, practical trials, physician surveys, and patient demographics, as modifiers to the core health impact assessment. IGH aims to pilot the proposed Health Impact Fund mechanism by rewarding a pharmaceutical manufacturer on the basis of measured health impact in a region. This will allow the pay-for-performance approach to be field-tested and refined before it is implemented on a wider scale.


Outcomes and Benefits of the Pilot: Outcomes and Benefits of the Pilot:
(1.) Create a comprehensive metric to evaluate the health impact of medicines based on the actual reductions in mortality and morbidity each achieves. (1.) Create a comprehensive metric to evaluate the health impact of medicines based on the actual reductions in mortality and morbidity each achieves.
(2.) Determine how to apply this metric reliably through a field-test that focuses on a new drug’s introduction into a specific area. No attempt has ever been made to measure the health impact of a newly introduced medicine. (2.) Determine how to apply this metric reliably through a field-test that focuses on a new drug's introduction into a specific area. No attempt has ever been made to measure the health impact of a newly introduced medicine.
(3.) Benefit people in the field-test area by giving them access to an important new product at an affordable price and by rewarding the innovator promoting its wide and effective use by those who can benefit from it. (3.) Benefit people in the field-test area by giving them access to an important new product at an affordable price and by rewarding the innovator promoting its wide and effective use by those who can benefit from it. This pilot would break new ground by being the first-ever effort to measure the health impact of a newly introduced medicine.


IGH is currently{{when|date=March 2014}} exploring opportunities for potential pilots. IGH is currently{{when|date=December 2019}} exploring opportunities for a potential pilot.


==Relationship to Other Proposals== ==Relationship to other proposals==
The HIF can be seen as a kind of comprehensive ], since it essentially is a way of incentivizing new research while ensuring access at low prices. However, compared to the Advanced Market Commitment, it is comprehensive because it could apply to any drug or vaccine, and it would operate in all countries. Alternatively, one can put it in the context of prizes, since it has prize-like characteristics in terms of incentivizing research while not enabling high prices. A third way of viewing it is as a supplementary global ], in which the ] made by consumers is equal to the cost of production. The Health Impact Fund can be seen as a development of ], which also incentivizes new research while ensuring access at low prices. Compared to the Advanced Market Commitment, the Health Impact Fund is comprehensive by offering to reward any new drug or vaccine. Moreover, the Health Impact Fund would not guarantee a market: how much an innovator would earn from its registered products would depend on how much health impact it achieves with them as well as on the reward rate, which in turn depends on the aggregate health gains achieved by all registered products. A third way of viewing it is as a supplementary global ], in which the ] made by consumers is equal to the cost of production.


The HIF staff has prepared a memo setting out their view of the intellectual history of the HIF.<ref></ref> The Health Impact Fund staff has prepared a memo setting out their view of the intellectual history of the Health Impact Fund.<ref></ref>


==Reception== ==Reception==


=== Criticisms === === Criticisms ===
⚫ When the HIF was proposed in 2008, it attracted criticism from Professor Brook Baker and Knowledge Ecology International for not requiring open licensing of registered drugs.<ref></ref><ref></ref> Instead, it allowed drug manufacturers to maintain a monopoly, subject to regulated prices. The proponents modified the proposal in response, suggesting greater flexibility about this aspect of the HIF,<ref></ref> but this remains a controversial feature of the proposal, when compared to other prize fund proposals that feature open licensing of patents to generic manufacturers.


⚫ When the Health Impact Fund was proposed in 2008, it attracted criticism from Professor Brook Baker and Knowledge Ecology International for not requiring open licensing of registered drugs.<ref></ref><ref></ref> Instead, it allowed drug manufacturers to maintain a monopoly, subject to regulated prices. The proponents modified the proposal in response, suggesting greater flexibility about this aspect of the Health Impact Fund.<ref name=":0" />
⚫ Brita Pekarsky (2010) has argued that the cost of the HIF may be too high, if it is taking money away from other valuable development aid or health related activities.<ref>Brita Pekarsky, “Should Financial Incentives be Used to Differentially Reward ‘Me-Too’ and Innovative Drugs,” ''Pharmacoeconomics'' 28.1(2010): 1-17.</ref>


⚫ Brita Pekarsky (2010) has argued that the cost of the Health Impact Fund may be too high, if it is taking money away from other valuable development or health related activities.<ref>Brita Pekarsky, “Should Financial Incentives be Used to Differentially Reward ‘Me-Too’ and Innovative Drugs,” ''Pharmacoeconomics'' 28.1(2010): 1-17.</ref> She does not, however, identify what ] is relevant.
⚫ Paul Grootendorst (2009) states that the primary drawback of the HIF is the difficulty of measuring health impact accurately.<ref>Paul Grootendorst, “How Should We Support Pharmaceutical Innovation?,” ''Expert. Rev. Pharmacoeconomics Outcomes Res.'' 2009: 9(4) – 313-320.</ref> He notes particularly the problems of trying to attribute health impact to drugs that have long latency periods in their effectiveness (such as vaccines and anti-hypertensives); the problems of consistency across different therapeutic areas; and the technical difficulty of disentangling the effect of the drug from confounding factors.


⚫ Paul Grootendorst (2009) states that the primary challenge for the Health Impact Fund is the difficulty of measuring health impact accurately.<ref>Paul Grootendorst, “How Should We Support Pharmaceutical Innovation?,” ''Expert. Rev. Pharmacoeconomics Outcomes Res.'' 2009: 9(4) – 313-320.</ref> He notes particularly the problems of trying to attribute health impact to drugs that have long latency periods in their effectiveness (such as vaccines and anti-hypertensives); the problems of consistency across different therapeutic areas; and the technical difficulty of disentangling the effect of the drug from confounding factors.
⚫ Jorn Sonderholm (2009) argues that there is a lack of evidence that patents create a barrier to access, so that the HIF may fail to address a real problem.<ref>Jorn Sonderholm, “A Reform Proposal in Need of Reform: A Critique of Thomas Pogge’s Proposal for How to Incentivize Research and Development of Essential Drugs,” ''Public Health Ethics'' 0.0 (2009): 1-11.</ref>


⚫ Jorn Sonderholm (2009) argues that there is a lack of evidence that patents create a barrier to access, so that the Health Impact Fund may fail to address a real problem.<ref>Jorn Sonderholm, “A Reform Proposal in Need of Reform: A Critique of Thomas Pogge’s Proposal for How to Incentivize Research and Development of Essential Drugs,” ''Public Health Ethics'' 0.0 (2009): 1-11.</ref> This is due to a misunderstanding about the nature of the Health Impact Fund, which addresses the problem that there are insufficient incentives to invest in vaccines and treatments for diseases that lack effective market demand.
⚫ Sakiko Fukuda-Parr and Proochista Ariana (2011) criticized the HIF on a variety of grounds, including its approach to the distribution of benefits and costs, the impact on generic competition and the role of the HIF in strategic negotiations on intellectual property rights,<ref>Sakiko Fukuda-Parr and Proochista Ariana, "Health Impact Fund – Raising Issues Of Distribution, IP Rights And Alliances," ''IP-Watch.Org'', September 26, 2011.</ref> leading to a response from IGH.<ref></ref>

⚫ Sakiko Fukuda-Parr and Proochista Ariana (2011) criticized the Health Impact Fund on a variety of grounds, including its approach to the distribution of benefits and costs, the impact on generic competition and the role of the Health Impact Fund in strategic negotiations on intellectual property rights,<ref>Sakiko Fukuda-Parr and Proochista Ariana, "Health Impact Fund – Raising Issues Of Distribution, IP Rights And Alliances," ''IP-Watch.Org'', September 26, 2011.</ref> leading to a response from IGH.<ref></ref>

Afschin Gandjour and Nadja Chernyak state that the Health Impact Fund does not have a rational basis for the underlying willingness to pay per health gain. They propose a system in which the reward for innovative drugs would be based on "willingness to pay."<ref>{{cite journal|last1=Gandjour|first1=Afschin|last2=Chernyak|first2=Nadja|title=A new prize system for drug innovation|journal=Health Policy|date=October 2011|volume=102|issue=2–3|pages=170–177|doi=10.1016/j.healthpol.2011.06.001|pmid=21724290}}</ref> Since willingness to pay is quite low in low-income countries, their approach requires altruistic motivation by high-income countries to address existing global health inequities.


===Support=== ===Support===
The Health Impact Fund is supported by a distinguished Advisory Board. The Health Impact Fund is supported by a distinguished advisory board.


* ], Professor of Economics and Operations Research, Stanford University; Nobel Prize Winner in Economics * ], (deceased in 2017) Professor of Economics and Operations Research, Stanford University; Nobel Prize Winner in Economics
* ], Institute Professor, Department of Linguistics & Philosophy, MIT * ], Institute Professor, Department of Linguistics & Philosophy, MIT <ref></ref>
* ], director of the Institute of Human Virology at the ], co-discoverer of the ] * ], director of the Institute of Human Virology at the ], co-discoverer of the ]
* ], President of Georgetown University * ], President of Georgetown University
* ], Chairman of the National Institute for Health and Care Excellence (NICE) * ], Chairman of the National Institute for Health and Care Excellence (NICE)
* ], Director of the Berman Institute of Bioethics, Johns Hopkins University * ], Director of the Berman Institute of Bioethics, Johns Hopkins University
* ], Chair of the Department of Global Health and Social Medicine at Harvard Medical School; Co-Founder, Partners in Health * ], Chair of the Department of Global Health and Social Medicine at Harvard Medical School; Co-founder, Partners in Health
* ], twenty-first Prime Minister of Canada * ], twenty-first Prime Minister of Canada
* ], Institute Director, Institute for Health Metrics and Evaluation (IHME) * ], Institute Director, Institute for Health Metrics and Evaluation (IHME)
* ], Research Biologist, Australian of the Year in 2000. * ], Research Biologist, Australian of the Year in 2000.
* Baroness ], Member of the UK House of Lords; former President of the British Academy * Baroness ], Member of the UK House of Lords; former President of the British Academy
* ], Associate Professor of Medicine and Political Science, University of Toronto; Former International President of MSF * ], Director of Dahdaleh Institute for Global Health Research, York University; Former International President of MSF
* ], Chairman of the UK National Institute of Health & Clinical Excellence (NICE) * ], former Chairman of the UK National Institute of Health & Clinical Excellence (NICE)
*Jan Rosier, Elan Professor of Biotech Business at University College Dublin; Former Vice President of Janssen Drug Development
* ], German Parliament member, speaker of the SPD-faction in the Subcommittee on Health in Developing Countries * ], German Parliament member, speaker of the SPD-faction in the Subcommittee on Health in Developing Countries
* ], Professor of Economics and Philosophy, Harvard University; Nobel Prize Winner in Economics <ref name="yalealumnimagazine" ></ref> * ], Professor of Economics and Philosophy, Harvard University; Nobel Prize Winner in Economics <ref name="yalealumnimagazine" ></ref>
* ], Ira W. DeCamp Professor of Bioethics, Princeton University <ref name="yalealumnimagazine" /> * ], Ira W. DeCamp Professor of Bioethics, Princeton University <ref name="yalealumnimagazine" />
* Judith Whitworth, Chair of WHO's Global Advisory Committee on Health Research * ], Chair of WHO's Global Advisory Committee on Health Research
* ], Member of the German Bundestag for Wiesbaden; German Federal Minister for Economic Cooperation and Development, 1998 to 2009 * ], Member of the German Bundestag for Wiesbaden; German Federal Minister for Economic Cooperation and Development, 1998 to 2009
* Richard Wilder, Associate General Counsel of the Bill & Melinda Gates Foundation * Richard Wilder, Associate General Counsel of the Bill & Melinda Gates Foundation
⚫ * ], President of Dartmouth College; Co-founder, Partners in Health was on the advisory board but resigned following his appointment as President of the World Bank in 2012.


⚫ In June 2010, the Social Democratic Party of Germany officially endorsed the Health Impact Fund and called on the German government to actively support a Health Impact Fund pilot.<ref>German Social Democratic Party, "," Drucksache 17/2135, June 6, 2010.</ref>
⚫ * ], President of Dartmouth College; Co-Founder, Partners in Health was on the Advisory Board but resigned following his appointment as President of the World Bank in 2012.

⚫ In June 2010, the Social Democratic Party of Germany officially endorsed the HIF and called on the German government to actively support a HIF pilot.<ref>German Social Democratic Party, "," Drucksache 17/2135, June 6, 2010.</ref>


The World Health Organization Expert Working Group on Research and Development Financing (related to Public health, innovation and intellectual property) described the HIF as one of a few "promising" proposals deserving further examination.<ref>, Incentives for Global Health. 17 January 2010.</ref> A new WHO Consultative Expert Working Group (CEWG) has noted that the HIF proposal would benefit from a pilot to demonstrate feasibility. The World Health Organization Expert Working Group on Research and Development Financing (related to Public health, innovation and intellectual property) described the Health Impact Fund as one of a few "promising" proposals deserving further examination.<ref>, Incentives for Global Health. 17 January 2010.</ref> A new WHO Consultative Expert Working Group (CEWG) has noted that the Health Impact Fund proposal would benefit from a pilot to demonstrate feasibility.


Carl Nathan (2009) suggests that the HIF could help to overcome obstacles to the control of tuberculosis such as development and distribution of vaccines and medicines to the poor.<ref>Carl Nathan, “Taming Tuberculosis: A Challenge for Science and Society,” ''Cell Host and Microbe'' 5(2009): 222.</ref> Carl Nathan (2009) suggests that the Health Impact Fund could help to overcome obstacles to the control of tuberculosis such as development and distribution of vaccines and medicines to the poor.<ref>Carl Nathan, “Taming Tuberculosis: A Challenge for Science and Society,” ''Cell Host and Microbe'' 5(2009): 222.</ref>


John J. DeGioia, President of Georgetown University, has complimented the HIF for bringing moral imperatives and pragmatic market principles together. He states, "that this is the beauty of the Health Impact Fund . . . it translates idealism into innovation."<ref>John J. DeGioia, Georgetown University, Gonda Theater. 1 December 2008.</ref> John J. DeGioia, President of Georgetown University, has complimented the Health Impact Fund for bringing moral imperatives and pragmatic market principles together. He states, "that this is the beauty of the Health Impact Fund . . . it translates idealism into innovation."<ref>John J. DeGioia, {{Webarchive|url=https://web.archive.org/web/20100609052328/http://president.georgetown.edu/sections/speeches/61659.html |date=2010-06-09 }} Georgetown University, Gonda Theater. 1 December 2008.</ref>


Christian Barry and Matt Peterson favour the HIF as a mechanism for providing innovators with incentives to develop new medicines that have significant health impacts rather than significant sales impacts.<ref>Christian Barry and Matt Peterson, “Shallow Cuts: GSK’s Voluntary Price Reductions and Patent Pooling Are Not Enough,” ''Public Ethics Media'', 4 March 2009.</ref> Christian Barry and Matt Peterson favour the Health Impact Fund as a mechanism for providing innovators with incentives to develop new medicines that have significant health impacts rather than significant sales impacts.<ref>Christian Barry and Matt Peterson, “Shallow Cuts: GSK’s Voluntary Price Reductions and Patent Pooling Are Not Enough,” ''Public Ethics Media'', 4 March 2009.</ref>


James Orbinski states that the HIF is an innovative policy proposal that "should be implemented."<ref>James Orbinski, “Are Patents Impeding Medical Care and Innovation?”, 7.1(2009): 3.</ref> James Orbinski states that the Health Impact Fund is an innovative policy proposal that "should be implemented."<ref>James Orbinski, “Are Patents Impeding Medical Care and Innovation?”, {{Webarchive|url=https://web.archive.org/web/20100322185416/http://www.plosmedicine.org/home.action |date=2010-03-22 }} 7.1(2009): 3.</ref>


==References== ==References==
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==Further reading== ==Further reading==
*Peter Singer, , ]. 16 Sept. 2008. *Peter Singer, , ]. 16 Sept. 2008.
* Amitava Banerjee, Aidan Hollis, Thomas Pogge, ''Lancet'' 375.9709 (2010): 166–69. * Amitava Banerjee, Aidan Hollis, Thomas Pogge, ''Lancet'' 375.9709 (2010): 166–69.


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* *


] ]
] ]

Latest revision as of 23:32, 26 September 2023

The Health Impact Fund is a proposed pay-for-performance mechanism that would provide a market-based solution to problems concerning the development and distribution of medicines globally. It would incentivize the research and development of new pharmaceutical products that make substantial reductions in the global burden of disease. The Health Impact Fund is the creation of a team of researchers led by the Yale philosopher Thomas Pogge and the University of Calgary economist Aidan Hollis, and is promoted by the non-profit organization Incentives for Global Health (IGH).

Motivation

In the current system of development and distribution of medicines, millions of people from developing countries die from diseases because the patented medicines they need are unaffordable or because no medicine exists to cure their ailments. Little pharmaceutical research is devoted to diseases specific to the poor. This is largely because it has been difficult for pharmaceutical companies to profit from research and development directed at products needed by the poor. The cost of pharmaceutical research and development is high and unlikely to be recovered from those in poor countries who cannot afford the medicines. Therefore, "the Health Impact Fund would give companies incentives to develop new products targeting the diseases and conditions for which existing systems have failed to produce results, which would especially benefit the poor."

The allocation of pharmaceutical research and development effort is partly a result of the global patent regime established by the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). Prior to TRIPS, countries were free to not enact intellectual property laws covering medicines, leading to flourishing generic drug industries in countries such as India. Following TRIPS, all World Trade Organization members were required to institute strict, American-style intellectual property rights. As a result, the supply of generic medicines to poor countries has been sharply diminished. According to Nobel Laureate Joseph Stiglitz, the pharmaceutical patent system needs an "alternative" that would "give large rewards for cures or vaccines for diseases like malaria that affect millions."

Design of the Fund

The Health Impact Fund is intended to address the problems with an uncomplemented pharmaceutical patent system. The Health Impact Fund uses market forces to create incentives to develop medicines for typically neglected diseases and to distribute these medicines at low prices all over the world. Pharmaceutical patent-holders would receive financial rewards by opting to register their new medicines, or new uses of existing medicines, with the Fund. By registering, a patent-holder agrees to distribute its medicine globally at cost and to cooperate in measuring the health impact of that medicine. In return, the firm receives an annual reward based on its measurable contribution to reducing the global burden of disease. In order to achieve distribution at cost, the Health Impact Fund could require generic licensing, tendering, or price controls, depending on the nature of the product.

Registrants of new drugs are eligible for reward payments for ten years starting at the date of marketing approval of their product. New uses receive rewards for five years. Following the reward period, registrants agree to allow generic manufacturing of their medicines, in order to prevent price spikes. Registrants retain their rights to control follow-on innovation.

Assessing the health impact of a registered product

When assessing the health impact of a registered product, “the Health Impact Fund would essentially estimate the difference between (1) the actual health status of people who consumed the registered product and (2) the estimated health status of those people, had they not had access to the registered product.”

The standard measure of health impact is the Quality-Adjusted Life Year (QALY). For example, if all registered products were in conjunction estimated to have saved 10 million QALYs, then a registered product that saved 1 million of those QALYs would receive ten percent of the available reward funds for that year. The health impact assessment of a registered product would be conducted for each year of its registration with the Health Impact Fund, and payments would be disbursed annually.

Funding

The Health Impact Fund might be financed by governments, with countries committing a fixed fraction of their gross national income (GNI) to the Health Impact Fund (0.03 percent of a country's GNI is the suggested minimum). Alternatively, the Health Impact Fund might also be funded through an international tax on carbon emissions, say, or on disruptive financial speculations.

Next step: an innovative pilot

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As performance measurement is a core component of the Health Impact Fund, it needs to be robust across diverse products, patient demographics, and social and natural environments. Working with leading health care assessment organizations such as The George Institute for International Health, NICE International, the Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG) and the Institute for Health Metrics and Evaluation, the Health Impact Fund would perform evaluations of the health impact of different products in a variety of countries. Such assessments would go beyond pre-approval clinical trials, using epidemiological data from actual usage, practical trials, physician surveys, and patient demographics, as modifiers to the core health impact assessment. IGH aims to pilot the proposed Health Impact Fund mechanism by rewarding a pharmaceutical manufacturer on the basis of measured health impact in a region. This will allow the pay-for-performance approach to be field-tested and refined before it is implemented on a wider scale.

Outcomes and Benefits of the Pilot: (1.) Create a comprehensive metric to evaluate the health impact of medicines based on the actual reductions in mortality and morbidity each achieves. (2.) Determine how to apply this metric reliably through a field-test that focuses on a new drug's introduction into a specific area. No attempt has ever been made to measure the health impact of a newly introduced medicine. (3.) Benefit people in the field-test area by giving them access to an important new product at an affordable price and by rewarding the innovator promoting its wide and effective use by those who can benefit from it. This pilot would break new ground by being the first-ever effort to measure the health impact of a newly introduced medicine.

IGH is currently exploring opportunities for a potential pilot.

Relationship to other proposals

The Health Impact Fund can be seen as a development of Advanced Market Commitment, which also incentivizes new research while ensuring access at low prices. Compared to the Advanced Market Commitment, the Health Impact Fund is comprehensive by offering to reward any new drug or vaccine. Moreover, the Health Impact Fund would not guarantee a market: how much an innovator would earn from its registered products would depend on how much health impact it achieves with them as well as on the reward rate, which in turn depends on the aggregate health gains achieved by all registered products. A third way of viewing it is as a supplementary global drug insurance system, in which the copayment made by consumers is equal to the cost of production.

The Health Impact Fund staff has prepared a memo setting out their view of the intellectual history of the Health Impact Fund.

Reception

Criticisms

When the Health Impact Fund was proposed in 2008, it attracted criticism from Professor Brook Baker and Knowledge Ecology International for not requiring open licensing of registered drugs. Instead, it allowed drug manufacturers to maintain a monopoly, subject to regulated prices. The proponents modified the proposal in response, suggesting greater flexibility about this aspect of the Health Impact Fund.

Brita Pekarsky (2010) has argued that the cost of the Health Impact Fund may be too high, if it is taking money away from other valuable development or health related activities. She does not, however, identify what opportunity cost is relevant.

Paul Grootendorst (2009) states that the primary challenge for the Health Impact Fund is the difficulty of measuring health impact accurately. He notes particularly the problems of trying to attribute health impact to drugs that have long latency periods in their effectiveness (such as vaccines and anti-hypertensives); the problems of consistency across different therapeutic areas; and the technical difficulty of disentangling the effect of the drug from confounding factors.

Jorn Sonderholm (2009) argues that there is a lack of evidence that patents create a barrier to access, so that the Health Impact Fund may fail to address a real problem. This is due to a misunderstanding about the nature of the Health Impact Fund, which addresses the problem that there are insufficient incentives to invest in vaccines and treatments for diseases that lack effective market demand.

Sakiko Fukuda-Parr and Proochista Ariana (2011) criticized the Health Impact Fund on a variety of grounds, including its approach to the distribution of benefits and costs, the impact on generic competition and the role of the Health Impact Fund in strategic negotiations on intellectual property rights, leading to a response from IGH.

Afschin Gandjour and Nadja Chernyak state that the Health Impact Fund does not have a rational basis for the underlying willingness to pay per health gain. They propose a system in which the reward for innovative drugs would be based on "willingness to pay." Since willingness to pay is quite low in low-income countries, their approach requires altruistic motivation by high-income countries to address existing global health inequities.

Support

The Health Impact Fund is supported by a distinguished advisory board.

  • Kenneth J. Arrow, (deceased in 2017) Professor of Economics and Operations Research, Stanford University; Nobel Prize Winner in Economics
  • Noam Chomsky, Institute Professor, Department of Linguistics & Philosophy, MIT
  • Robert Gallo, director of the Institute of Human Virology at the University of Maryland School of Medicine, co-discoverer of the human immunodeficiency virus
  • John J. DeGioia, President of Georgetown University
  • Professor David Haslam, Chairman of the National Institute for Health and Care Excellence (NICE)
  • Ruth Faden, Director of the Berman Institute of Bioethics, Johns Hopkins University
  • Paul Farmer, Chair of the Department of Global Health and Social Medicine at Harvard Medical School; Co-founder, Partners in Health
  • Paul Martin, twenty-first Prime Minister of Canada
  • Christopher Murray, Institute Director, Institute for Health Metrics and Evaluation (IHME)
  • Gustav Nossal, Research Biologist, Australian of the Year in 2000.
  • Baroness Onora O'Neill, Member of the UK House of Lords; former President of the British Academy
  • James Orbinski, Director of Dahdaleh Institute for Global Health Research, York University; Former International President of MSF
  • Sir Michael Rawlins, former Chairman of the UK National Institute of Health & Clinical Excellence (NICE)
  • Jan Rosier, Elan Professor of Biotech Business at University College Dublin; Former Vice President of Janssen Drug Development
  • Karin Roth, German Parliament member, speaker of the SPD-faction in the Subcommittee on Health in Developing Countries
  • Amartya Sen, Professor of Economics and Philosophy, Harvard University; Nobel Prize Winner in Economics
  • Peter Singer, Ira W. DeCamp Professor of Bioethics, Princeton University
  • Judith Whitworth, Chair of WHO's Global Advisory Committee on Health Research
  • Heidemarie Wieczorek-Zeul, Member of the German Bundestag for Wiesbaden; German Federal Minister for Economic Cooperation and Development, 1998 to 2009
  • Richard Wilder, Associate General Counsel of the Bill & Melinda Gates Foundation
  • Jim Yong Kim, President of Dartmouth College; Co-founder, Partners in Health was on the advisory board but resigned following his appointment as President of the World Bank in 2012.

In June 2010, the Social Democratic Party of Germany officially endorsed the Health Impact Fund and called on the German government to actively support a Health Impact Fund pilot.

The World Health Organization Expert Working Group on Research and Development Financing (related to Public health, innovation and intellectual property) described the Health Impact Fund as one of a few "promising" proposals deserving further examination. A new WHO Consultative Expert Working Group (CEWG) has noted that the Health Impact Fund proposal would benefit from a pilot to demonstrate feasibility.

Carl Nathan (2009) suggests that the Health Impact Fund could help to overcome obstacles to the control of tuberculosis such as development and distribution of vaccines and medicines to the poor.

John J. DeGioia, President of Georgetown University, has complimented the Health Impact Fund for bringing moral imperatives and pragmatic market principles together. He states, "that this is the beauty of the Health Impact Fund . . . it translates idealism into innovation."

Christian Barry and Matt Peterson favour the Health Impact Fund as a mechanism for providing innovators with incentives to develop new medicines that have significant health impacts rather than significant sales impacts.

James Orbinski states that the Health Impact Fund is an innovative policy proposal that "should be implemented."

References

  1. S.J. Hoffman, T. Pogge. 2011. “Revitalizing Pharmaceutical Innovation for Global Health,” Health Affairs 30(2):367. doi:10.1377/hlthaff.2011.0103.
  2. ^ Joseph Stiglitz, "Scrooge and Intellectual Property Rights," British Medical Journal 333, no. 7582 (2006), pp. 1279.
  3. Aidan Hollis and Thomas Pogge, The Health Impact Fund: Making Medicines Available for All (New Haven, CT: Incentives for Global Health, 2008), p. 3.
  4. Aidan Hollis and Thomas Pogge, The Health Impact Fund: Making Medicines Available for All (New Haven, CT: Incentives for Global Health, 2008), ch. 2.
  5. ^ Hollis, Aidan (April 23, 2009). "The Health Impact Fund and Price Determination" (PDF). Health Impact Fund.
  6. Aidan Hollis and Thomas Pogge, The Health Impact Fund: Making Medicines Available for All (New Haven, CT: Incentives for Global Health, 2008), pp. 13-14.
  7. Aidan Hollis and Thomas Pogge, The Health Impact Fund: Making Medicines Available for All (New Haven, CT: Incentives for Global Health, 2008), p. 17.
  8. Aidan Hollis and Thomas Pogge, The Health Impact Fund: Making Medicines Available for All (New Haven, CT: Incentives for Global Health, 2008), p. 9.
  9. Aidan Hollis and Thomas Pogge, The Health Impact Fund: Making Medicines Available for All (New Haven, CT: Incentives for Global Health, 2008), pp. 3-4.
  10. Aidan Hollis and Thomas Pogge, The Health Impact Fund: Making Medicines Available for All (New Haven, CT: Incentives for Global Health, 2008), pp. 10-11.
  11. Health Impact Fund intellectual history memo
  12. Baker criticism
  13. Knowledge Ecology International criticism
  14. Brita Pekarsky, “Should Financial Incentives be Used to Differentially Reward ‘Me-Too’ and Innovative Drugs,” Pharmacoeconomics 28.1(2010): 1-17.
  15. Paul Grootendorst, “How Should We Support Pharmaceutical Innovation?,” Expert. Rev. Pharmacoeconomics Outcomes Res. 2009: 9(4) – 313-320.
  16. Jorn Sonderholm, “A Reform Proposal in Need of Reform: A Critique of Thomas Pogge’s Proposal for How to Incentivize Research and Development of Essential Drugs,” Public Health Ethics 0.0 (2009): 1-11.
  17. Sakiko Fukuda-Parr and Proochista Ariana, "Health Impact Fund – Raising Issues Of Distribution, IP Rights And Alliances," IP-Watch.Org, September 26, 2011.
  18. Response to criticism by Fukuda-Parr and Ariana
  19. Gandjour, Afschin; Chernyak, Nadja (October 2011). "A new prize system for drug innovation". Health Policy. 102 (2–3): 170–177. doi:10.1016/j.healthpol.2011.06.001. PMID 21724290.
  20. HIF Advisory Board
  21. ^ A philosopher with a plan
  22. German Social Democratic Party, "Germany's responsibility to fight for health in developing countries - neglected diseases, reduce child and maternal mortality and a strong Global Fund," Drucksache 17/2135, June 6, 2010.
  23. "WHO Working Group Endorses Health Impact Fund", Incentives for Global Health. 17 January 2010.
  24. Carl Nathan, “Taming Tuberculosis: A Challenge for Science and Society,” Cell Host and Microbe 5(2009): 222.
  25. John J. DeGioia, “Making New Medicines Available to All: The Health Impact Fund,” Archived 2010-06-09 at the Wayback Machine Georgetown University, Gonda Theater. 1 December 2008.
  26. Christian Barry and Matt Peterson, “Shallow Cuts: GSK’s Voluntary Price Reductions and Patent Pooling Are Not Enough,” Public Ethics Media, 4 March 2009.
  27. James Orbinski, “Are Patents Impeding Medical Care and Innovation?”, PLoS Medicine Archived 2010-03-22 at the Wayback Machine 7.1(2009): 3.

Further reading

External links

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