The production of vaccines for COVID-19 has been far from ideal in terms of meeting world demand, thereby mitigating the infections and deaths caused by the pandemic. Part of the reason production has been inefficient is that those pharmaceutical companies that own the vaccine do not have sufficient productive capacity to meet demand. Resultantly, many have advocated for waiving patent rights to the vaccine so it can be massively produced worldwide. Pharmaceutical companies and their advocates have opposed this (...) waiving of patent rights. In this article, I respond to the arguments that oppose waiving patents and contend that there is a case for temporarily waiving them. Mainly, I present a negative argumentative strategy that upholds the view that patents ought to be waived. However, in light of my arguments, the absence of positive reasons to withhold the patents implies that there are positive views for temporarily waiving them. (shrink)

The attitudes of physicians and drug manufacturers in the US toward patenting pharmaceuticals changed dramatically from the mid-nineteenth century to the mid-twentieth. Formerly, physicians and reputable manufacturers argued that pharmaceutical patents prioritized profit over the advancement of medical science. Reputable manufactures refused to patent their goods and most physicians shunned patented products. However, moving into the early twentieth century, physicians and drug manufacturers grew increasingly comfortable with the idea of pharmaceutical patents. In 1912, for example, the (...) American Medical Association dropped the prohibition on physicians holding medical patents. Shifts in wider patenting cultures therefore transformed the ethical sensibilities of physicians. (shrink)

The International Bill of Rights enshrines a right to health, which includes a right to access essential medicines. This right frequently appears to conflict with the intellectual property regime that governs pharmaceutical patents. However, there is also a human right that protects creative works, including scientific productions. Does this right support intellectual property protections, even when they may negatively affect health? -/- This article examines the recent attempt by the Committee on Economic, Social and Cultural Rights to resolve (...) this issue and argues that it fails. This is problematic because it means defenders of the present patent regime can continue using human rights documents to support their position. I offer a new framework for resolving the problem by examining the values that underlie human rights. (shrink)

Neodevelopmental patent regimes aim to facilitate local actors’ access to knowledge and also encourage incremental innovations. The case of pharmaceutical patent examination in Brazil illustrates political contradictions between these objectives. Brazil’s patent law includes the Ministry of Health in the examination of pharmaceutical patent applications. Though widely celebrated as a health-oriented policy, the Brazilian experience has become fraught with tensions and subject to decreasing levels of both stability and enforcement. I show how one pillar of the neodevelopmental regime, (...) the array of initiatives to encourage incremental innovations, has fostered the acquisition of innovative capabilities in the Brazilian pharmaceutical sector, and how these new capabilities have altered actors’ policy preferences and thus contributed to the erosion of the coalition in support of the other pillar of the neodevelopmental regime, the health-oriented approach to examining pharmaceutical patents. The analysis of capability-derived preference formation points to an endogenous process of coalitional change. (shrink)

Only 19 new molecular entities and 3 biologics were approved by the Food and Drug Administration in 2007, the lowest rate in 24 years. This disappointing output occurred despite steady clinical trial and regulatory review times, the FDA maintaining high approval rates, and the pharmaceutical industry consistently reporting increasing revenues. A government report suggests that fewer new drug applications have been submitted to the FDA by the pharmaceutical industry in recent years. These data have rekindled the debate as (...) to the origins of pharmaceutical innovation and the comparative importance of public and private sources in contributing to drug discovery. The pharmaceutical industry contends that its research is responsible for most new medicines, and that the primary public institution supporting U.S. biomedical research, the National Institutes of Health, supports medical innovation “distinct from the process of drug development.”. (shrink)

The decade-long debate over ownership of living human materials has recently intensified with the ability of biomedical research to isolate, purify, and use human genes and gene products as therapeutics, factories for the production of therapeutics, and targets for the identification of therapeutic pharmaceuticals. Indeed, advances in genomic research have resulted in the identification of hundreds of thousands of DNA fragments and hundreds of genes. Many within the scientific and business communities believe genes and gene fragments have commercial value and (...) have filed patent applications on the nucleic acid sequences. This commercialization has amplified the discussion surrounding the ethics of patenting genes and the ownership of the human genome. (shrink)

It is generally recognised that public health problems in the developing world are dire and that the rest of the world has a moral commitment to provide assistance. Yet many of the world’s poor are unable to access essential pharmaceuticals simply because products that are under patent are too expensive and cheaper generics are not available. One of the proposed solutions to this problem is to allow domestic manufacture of generic products in response to public health crises. However, this solution (...) will provide no assistance in countries that lack the capacity to manufacture pharmaceuticals. This article discusses the extensive international negotiations occurring during the last couple of years that seek to provide an appropriate balance between access rights and patent rights. (shrink)

Advocates, activists, and academics have criticized pharmaceutical intellectual property ("pharma IP") rights as obstacles to access to medicines for the global poor. These criticisms of pharma IP holders are frequently exceptionalist: they focus on pharma IP holders while ignoring whether others also bear obligations to assist patients in need. These others include holders of other lucrative IP rights, such as music copyrights or technology patents; firms, such as energy companies and banks, that do not rely on IP; and (...) wealthy private individuals. Their resources could be used to aid patients by providing direct medical assistance, funding prizes or biomedical research, or purchasing pharmaceutical patents and granting rights to the disadvantaged. -/- After identifying this exceptionalism, this Article evaluates several arguments in its defense. These are that pharma IP holders are unique in (1) owning what poor patients need, (2) being in special proximity to these patients, (3) being able to assist at low cost to themselves, (4) having a professional duty to help these patients, or (5) being implicated by their past conduct in these patients' plight. It concludes that none of these arguments are compelling: while IP holders have a duty to help, this duty is not fundamentally different from the duties others owe. -/- Even though this project criticizes exceptionalism, it does not absolve pharma IP holders of duties to help the sick. Rather, it argues that spreading the costs of aiding patients in need across a greater number of market actors, via publicly funded "pull" programs like prizes and patent buyouts or "push" programs like grants, would be preferable. So would allowing pharmaceutical firms to seek contribution from others who are able to help. However, if others cannot be held to account, imposing burdens on pharma IP holders can be justified in order to promote global health: treating wealthy firms arbitrarily is preferable to ignoring the urgent needs of the global poor. (shrink)

Instead of impeding access to essential medicines in developing countries, the essay explores why and how patents can serve as a source of funding for the much needed access to medicine. Instead of a weakening of patents, prolonged protection periods are suggested in circumstances where there is widespread lack of access. The revenues from extended patents are seen as a source of funding for drug donations to the least developed countries.

In response to the great crises of the COVID-19 coronavirus, virtually all new technologies protected by patent rights have been used in practice from diagnostics, therapeutic, medical equipment, and vaccine to prevention, tracking, and containment of COVID-19. However, the moral justification of patent rights is questioned when pharmaceutical patents conflict with public health. This paper proposes a revised approach of deciding on how to address the conflicts between business ethics and patent protections and then compares the different mechanisms (...) of clearing patent thickets. Our findings highlight that patent pledges may not only contribute to achieving the maximized substantive justice of the public but also help patent pledgors fulfill procedural justice. The advantages of patent pledges have attracted many patent holders to make public statements during the COVID-19 pandemic. In contrast, the disadvantages of a free license may make patent pledges not sustainable for a long time without the related supporting measures. Our findings will be helpful for policymakers or company managers to make an appropriate decision on rationally utilizing patent portfolios for fighting against public health crises. (shrink)

The moral justification of intellectual property is often called into question when placed in the context of pharmaceutical patents and global health concerns. The theoretical accounts of both John Rawls and Robert Nozick provide an excellent ethical framework from which such questions can be clarified. While Nozick upholds an individuals right to intellectual property, based upon its conformation with Lockean notions of property and Nozicks ideas of just acquisition and transfer, Rawls emphasizes the importance of basic liberties, such (...) as an individuals right to health, superceding such secondary rights as intellectual property rights. From a policy perspective, patent protection for pharmaceutical products necessarily entails the balancing of corporate intellectual property interests and public interests in healthcare. The moral dilemma that occurs when these two interests clash is not easily resolved. Aside from corporate and public interests, the state maintains an interest in creating and preserving policies that regulate the moral dilemma itself. This paper analyzes the economic and ethical factors surrounding the production and distribution of the anti-HIV medication, AZT. Potential policy implications and recommendations are also discussed. (shrink)

Few topics in international intellectual property law have been as controversial in recent years as the one we are about to examine. In the 1980s and early 1990s, a Diplomatic Conference attempted to revise the oldest international convention providing some protection for patented inventions outside of the domestic laws. Those efforts broke down, largely because developed and developing countries could not agree on the powers that governments should retain to issue compulsory licenses or on the grounds for which these powers (...) could be exercised. The failure of this Conference, held under the auspices of the World Intellectual Property Organization (WIPO), persuaded the technology-exporting countries to link future negotiations concerning international intellectual property protection to the Multilateral Trade Negotiations, known as the Uruguay Round, which got underway in 1986. The end result was Annex IC of the Agreement Establishing the World Trade Organization of 1994, which incorporated a new, comprehensive and relatively elevated set of international minimum standards of patent protection into the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement). (shrink)

The author critiques the expedient application of market valuation principles by the transnational corporations and other large firms in the Indian pharmaceutical industry on a number of issues like patents, pricing, irrational drugs, clinical trials, etc. He contends that ethics in business is chiseled and etched within the confines of particular social structures of accumulation. An ascendant neo-liberal social structure of accumulation has basically shaped these firms' sharp opposition to the Indian Patents Act, 1970, government administered pricing, (...) etc. The author contends that the practice of neo-liberal economics is strongly associated with a "one dimensional" ethics that privileges market valuation principles over all others. This seems to inevitably generate a social counter-movement that struggles for social protections. He critiques neo-liberal business practices from a perspective that derives from the work of the economic anthropologist Karl Polanyi. Before the present phase of liberalization in India, markets were "managed", but without a "welfare state" in place. Moving toward deregulation of the markets without a welfare state in place is unethical. Keeping the debilities of the institutional framework of public policy in mind, the author adopts a Polanyian perspective that places its trust and hope in the growing social legitimacy of the counter-movement in opposition to both neo-liberal business practices and the degenerate behavior of state agencies. (shrink)

This paper uses John Rawls' theory of justice to defend the patent system against charges that it has an unfair effect on access to medications, from the perspective of national and international justice. The paper argues that the patent system is fair in a national context because it respects intellectual property rights and it benefits the least advantaged members of society by providing incentives for inventors, investors, and entrepreneurs. The paper also argues that the patent system is fair in an (...) international context, provided that developed nations take steps to help disease-stricken countries secure internal justice. Fairness in a national or international context also requires that the patent system should include emergency exceptions to deal with short-term inequities. (shrink)

The pharmaceutical industry has in recent years come under attack from an ethical point of view concerning its patents and thenon-accessibility of life-saving drugs for many of the poor both in less developed countries and in the United States. The industry has replied with economic and legal justifications for its actions. The result has been a communication gap between the industry on the one hand and poor nations and American critics on the other. This paper attempts to present (...) and evaluate the arguments on all sides and suggests a possible way out of the current impasse. It attempts to determine the ethical responsibility of the drug industry in making drugs available to the needy, while at the same time developing the parallel responsibilities of individuals, governments, and NGOs. It concludes with the suggestion that the industry develop an international code for its self-regulation. (shrink)

New and highly effective treatments against hepatitis C have come on the market in recent years. Their high cost has sparked vociferous debate concerning drug price control, the state’s responsibility towards infected populations and the power of multinational pharmaceutical companies. One possible way to understand these debates is to take into account the particular effects of pharmaceutical capitalism upon the circulation of commodities. Recent protests related to access to treatment identify circulation of medicines as an increasing site of (...) capital accumulation and conflicts. This article defines the notion of ‘logistic regimes’ and shows how such regimes are contested. It analyzes critical ways of engaging with contemporary pharmaceutical logistics, through variations on medical tourism, critiques of patenting and pricing practices, and organization of alternative supply routes. It further proposes to deepen the notion of diversion as a political concept describing specific forms of opposition to the management practices of logistical capitalism. (shrink)

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. (shrink)

This study assesses Latin America and Caribbean countries’ capacity to innovate new pharmaceuticals, defined as developing new drugs and vaccines, repurposing existing drugs, and inventing around patents to produce new drug variations. Vaccine innovation includes reengineering existing vaccines, developing new manufacturing methods, and the clinical development of unapproved vaccine candidates initiated elsewhere.

This article argues that effective corporate social responsibility (CSR) of multinational pharmaceutical companies in developing countries should reflect context, opportunity, proximity, time and impact in accordance with the social integration and ethical approaches to CSR. It proposes a CSR model expressed as CSR=COPTI+SI+E, which acknowledges access-to-medicines as a matter in the global public domain, a public choice problem and a moral responsibility issue for multinational pharmaceutical companies. This model recognises the globalisation of the principle of humanity in communities (...) of place and communities of interest as highlighted by the Global Economic Ethic Manifesto 2009 as an integral part of the responsibilities of multinational pharmaceutical companies. The model reflects a global application of the concept of disadvantaged consumer already known to some national laws. The article suggests an access-to-medicines CSR framework for pharmaceutical companies which may include pricing, patents, testing and clinical trials, research and development, joint public private initiative and appropriate use of drugs. (shrink)

Among American adults 20 years and older, 59 percent take at least one prescription drug on a regular basis. Unlike most branded drugs, which are generally drugs that have a trade name and are protected by a patent, off‐patent generic drugs make up approximately 90 percent of prescriptions annually filled in the United States; yet in 2017, generic drugs made up only 23 percent of total drug costs in the U.S. The U.S. Food and Drug Administration has taken the lead (...) in encouraging increased competition in the nation's prescription drug marketplace, most recently with its release of the agency's Drug Competition Action Plan, but also with its regulatory guidance and enforcement efforts to eliminate “gaming” of the regulatory process by both branded and generic pharmaceutical manufacturers. Such “gaming” activities include “pay‐for‐delay” agreements involving financial compensation between branded and generic pharmaceutical manufacturers to forestall the emergence into the market of generic pharmaceuticals to compete against a formerly patent‐protected branded drug. A combination of new enabling legislation, federal judicial guidance, and agency regulatory activities show promise in encouraging increased competition in the prescription drug marketplace, with the American consumer the ultimate beneficiary of lower health care costs and improved overall personal health. (shrink)

The rising cost of the opioid antagonist and overdose reversal agent naloxone is an urgent public health problem. The recent and dramatic price increase of Evzio, a naloxone auto-injector produced by Kaléo, shows how pharmaceutical manufacturers entering the naloxone marketplace rely on market exclusivity guaranteed by the patent system to charge prices at what the market can bear, which can restrict access to life-saving medication. We argue that 28 U.S.C. § 1498, a section of the federal code that allows (...) the government to use patent-protected products for its own purposes in exchange for reasonable compensation, could be used to procure generic naloxone auto-injectors, or at least bring Kaléo to the negotiating table. Precedent exists for the use of § 1498 to procure pharmaceuticals, and it could give meaning to the federal government's recent declaration of a public health emergency around the opioid epidemic, discourage new market entrants from charging exorbitant prices, and yield important public health benefits. (shrink)

The Health Impact Fund (HIF) is a project aimed at expanding access to life-saving drugs worldwide and incentivizing pharmaceutical companies to invest in research and development for neglected diseases. The HIF would invert the existing patent framework by rewarding ideas through their diffusion rather than protecting against this diffusion, by encouraging a collective rather than privatized wealth scheme. The basic idea behind the HIF is the creation of a new competitive market that centers on individuals who, under normal circumstances, (...) exert very little force on the tide of market demand. The HIF does not operate on standard market measures of demand, but instead measures demand as a product of needs, while in conventional market scenarios, private citizens and national welfare states pay for needs. The idea is that the HIF would create a functional, competitive market in which pharmaceutical profit is determined by the actual health impact of each new drug, a measure born from pharmacological and distributive efficacy. In this article, the basic features of and main challenges to the HIF are addressed. (shrink)

Current debates about the roles of the public and private sectors in pharmaceutical innovation have a long history. The extent to which, and ways in which, the public sector supports drug innovation has implications for assessments of the returns to public research funding, taxpayer rights in drugs, the argument the high prices are needed to support drug innovation, and the desirability of patenting publicly funded research.

This chapter contains sections titled: Introduction The Shipwreck of the Richmond and the Duty to Rescue The Ethics of Global Access to Essential Medicines Conclusion References.

Data exclusivity is a temporary exclusive user right on the clinical data that need to be submitted to the regulatory authorities to prove that a new drug is safe and effective. For the pharmaceutical industry, data exclusivity is an important addition to the patent system, as data exclusivity will de facto delay the market entry of generic drugs until after the exclusive user rights on the clinical data have expired. In order to assess the normative legitimacy of the industry’s (...) demand to include minimum standards for data exclusivity in international agreements, this chapter evaluates the three justifications that have frequently been advanced, depicting data exclusivity as an essential policy tool to promote innovation, a mechanism to prevent the generic industry from ‘free-riding,’ and a legal instrument to protect the industry’s property rights in clinical data. (shrink)

Recently I reported in this journal1 how it became necessary for a judge to settle a dispute between the pharmaceutical industry and certain Dutch pharmacists. It considered the question of whether a pharmacist is permitted, without prior consultation, to give a patient a generic drug instead of the patent drug mentioned on the prescription.Another dispute has now arisen after the pharmaceutical industry discovered that healthcare insurers were paying general practitioners a bonus if they prescribed generic drugs, such as (...) simvastatin or omeprazol (which reduces the …. (shrink)

The current regulatory regime for pharmaceuticals is criticized from a libertarian perspective for imposing the same risk–benefit analysis on all patients. The critics call for the abandonment of market access regulations. But the regulatory regime is also criticized by philosophers of science for applying too low epistemic standards, who call for stricter regulation. This article aims to engage the debate in a less polarized way, first by advancing the libertarian alternative to the current regime through an approach I call Certified (...) Capitalism for Pharmaceuticals (CCP), without endorsing this view in the end; second, by developing an argument against all regulatory regimes without market access regulations, including CCP, based on the possibility that the pharmaceutical industry could bend pharmaceutical science to its interests in such a regime. Whether this argument is successful, or whether CCP is able to circumvent it, cannot be decided on the basis of the empirical information currently available. Third, these arguments lead to two further insights for a philosophy of science that takes the social embeddedness of science seriously: Market access regulations limit the bending of research by industry by limiting epistemic diversity. The patent system can be seen as the thread of a well-functioning scientific system because it can give some agents enough resources to bend science through industrial selection. (shrink)

Since the 1970s, the United States has adopted a trade policy agenda that has forced countries to trade away flexible patent provisions for access to US markets. While pharmaceutical companies have argued that the recognition of patent rights is essential for recovering investments in research and development of pharmaceuticals and incentivizing future innovation, the lack of competition has had damaging consequences for public health, as companies tend to set the prices of treatments beyond the reach of consumers and government (...) programs. Thailand and Brazil are bound by law to provide universal access to anti-retroviral treatment (ART) to People Living with HIV/AIDS (PLWHA). This has been made possible in part due to the universal health care systems in each country and the countries' local technical and industrial capacities that provide the government with affordable generic medicines. The introduction of stronger intellectual property protection laws however, has limited possibilities for procuring generic medicines and inflated the cost of treatment. Between 2006–2008, Thailand and Brazil used compulsory licensing to authorize generic competition against the consent of the pharmaceutical companies in order to guarantee the right to health and ensure the viability of government health budgets. This paper will demonstrate how the interaction between individual / collective action and structural and institutional elements in Thailand and Brazil produced propitious conditions for each country to assert the primacy of health over patent rights. (shrink)

The prevailing model for encouraging innovation based on patents and market-oriented raises at least two economic and ethical issues: it imposes barriers on individuals and developing countries governments' access to medicines by defining prices that do not match their income, and the unavailability of new or appropriate products to address the health problems of these populations. In the last decade, this scenario has undergone some changes due to the emergence of new actors, the contribution of aid resources, the introduction (...) to the market of new products against neglected diseases, the development of new governmental healthcare policies and research programs, etc. One example of such initiatives is the Fixed-Dose Artesunate Combination Therapy (FACT) project consortium, which brought together institutions with different natures from both the North and the South, for the development of two antimalarial fixed-dose combinations recommended by the WHO – artesunate-amodiaquine (ASAQ) and artesunate-mefloquine (ASMQ). This paper proposes to describe and analyze the ASMQ consortium, which is the result of a new pharmaceutical development approach, based on a different paradigm – needs-driven instead of market-driven –, collaborative, with strategic participation of institutions from the South, funded by alternative resources (public and philanthropic). Thus, it represents an interesting object of study for bioethical debates on intellectual property and innovation, and its analysis is justified in light of the current debate on ways of stimulating needs-driven pharmaceutical innovation. (shrink)

In May 2011, the Brazilian Ministry of Health announced the distribution of the first batch of locally produced generic tenofovir disoproxil fumarate (TDF) to support its program of universal and free access for the treatment of HIV/AIDS. The inclusion of TDF in the public health program illustrates what has been considered the ‘Brazilian model’ of HIV/AIDS response, as it illustrates the current phase of the Brazilian pharmaceutical economy. Brazil is known for having managed to control the expansion of HIV/AIDS (...) through a unique initiative combining the public health and the industrial production of generics. But, if at first local manufacturers could freely copy ARVs and produce cheaper generic versions that were delivered to the Ministry of Health, since the country started to grant patents on drugs in 1996, the sustainability of this policy has been challenged by the high cost of patented second-line HIV/AIDS treatments. In order to assure continuity of the local production of ARVs, and keep the program of public health alive, Brazilians are now forced to deal with conflicts of drugs' intellectual property rights in order to open the path to generic production. This article aims to describe the experiences surrounding TDF in Brazil and the unprecedented conflicts and challenges it has brought for our different interviewees. Blurring the frontier between the public and the private, the TDF case was driven at the same time by an ethic of drug access and regulation of drug quality, which has inspired Brazilians to intervene and transform the world they live in. (shrink)

The federal government indirectly subsidizes the pharmaceutical industry by funding basic research, various tax credits and deductions, patent rules, grants of market exclusivity, and other means, in order to spur drug development, promote public health, and improve medical care. But today, the pharmaceutical industry often neglects these goals and sometimes even undermines them, due to what Lawrence Lessig refers to as institutional corruption — that is, widespread or systemic practices, usually legal, that undermine an institution’s objectives or integrity. (...) A key source of institutional corruption is improper dependence by the institution or its key actors on the actions of third parties that have fundamentally different interests. It is the health care system’s improper dependency on pharmaceutical firms that allows them to displace some public policy goals and to compromise the attainment of others. (shrink)

Just as tariffs lead to economic distortions and provide incentives for corruption, so do patent monopolies on prescription drugs, except the impact is often an order of magnitude larger.

The extension of intellectual property rights into the realm of biology has emerged as an increasing focus of controversy in relation to science,2 biodiversity,3 agriculture,4 health,5 development,6 human rights7 and trade.8 This paper presents the results of a review of international trends in activity for patent protection between 1990-2000 and provisional data to 2004 and 2005 from over 70 national patent offices, four regional patent offices and the World Intellectual Property Organisation using the European Patent Office esp@cenet worldwide database.9 The (...) review employed patent publication counts as an indicator of activity for traditional medicines, pharmaceuticals, agriculture, and biotechnology. The research provides insights into the internationalisation of patent activity in multiple areas of biology. The review emphasises the need to combine the further development of quantitative methods with qualitative analysis of the implications of international patent activity in relation to biological and genetic material for science, society and policy. (shrink)

On September 15, 2003, the US. Court of Appeals for the Eleventh Circuit held that agreements between pharmaceutical and generic companies not to compete are not per se unlawful if these agreements do not expand the existing exclusionary right of a patent. The Valley DrugCo.v.Geneva Pharmaceuticals decision emphasizes that the nature of a patent gives the patent holder exclusive rights, and if an agreement merely confirms that exclusivity, then it is not per se unlawful. With this holding, the appeals (...) court reversed the decision of the trial court, which held that agreements under which competitors are paid to stay out of the market are per se violations of the antitrust laws. An examination of the Valley Drugtrial and appeals court decisions sheds light on the two sides of an emerging legal debate concerning the validity of pay-not-to-compete agreements, and more broadly, on the appropriate balance between the seemingly competing interests of patent and antitrust laws. (shrink)

This paper attempts to better define the areas of conflict and agreement between value ethics and the theoretical ethics of the market processes at work in the biotechnology industry. Despite the apparent lack of ethics in an oligopolistically competitive pharmaceuticals industry, the paper concludes that the current stage of development of the medical biotechnology subindustry offers unparalleled opportunities for ethical systems to influence the market-based development of biotechnology. Ethical conversations between doctors and biologists with ethicists can help the market absorb (...) more of the reflective wisdom that ethics brings when discussing such issue areas as justice, patents of the human genome, and modifications of the human genome. If conversations between ethicists and biotechnological managers and doctors are successful the metaphors of market-based financing may be refined and the knowledge base of the good increased. (shrink)

Although some have argued that COVID-19 vaccine patents are morally justified, a broader argument on the morality of breaching contracts is necessary. This article explores the ethics of breaching unfair contracts and argues that it is morally justified to breach contracts with pharmaceutical companies concerning vaccine patents. I offer two arguments to support this view. Firstly, contracts may be breachable in some situations. The ones I point out are that contracts can be broken when the costs of (...) not violating vaccine patents are too high or when the process for agreement is not fair, or when an urgent ethical issue needs to be addressed and it is possible to compensate the other party for their loss. Secondly, I argue that because the contracts with the pharmaceutical companies do not treat people as ends in themselves, there is no moral obligation to respect them. (shrink)

The genetic component of variations in human responses to pharmacological agents is called pharmacogenetics while the molecular basis for these variations are most often identified as pharmacogenomics. Pharmacogenomics as a field of scientific endeavor is so new that in the scientific literature the two terms are often used interchangeably. In fact, the search for new drugs at the molecular level start with the identification of variations in DNA sequences whose products produce alterations in the amino acid structure of the active (...) portion of a protein which are then identified with the clinical disorder in question. This process is just the reverse of standard pharmaceutical approaches which begin with exploration of the physiological and potentially the biochemical basis of the specific disorder under study. The completion of the first draft of the human genome in the first months of the new millenium has increased expectations that molecular genetic approaches to drug disovery and development will significantly shorten the time-frame of new drug testing, significantly reduce the level of adverse events and anable the design of drugs to treat those with unique disorders.Based on such rosy expectations and the potential economic opportunities afforded by those who obtain such patents, there has been a rush of patent applications both in the United States and in Europe by private industry and university laboratories conducting genomic research to secure the rights to specific DNA sequences and federal agencies attempting to place the control of such information in the public domaine. This paper will document and discuss from a historic prospective the public policy and bioethical issues associated with the availability of patents for drug development. (shrink)

The facilitation of tight regulatory frameworks necessary to ensure that new drugs are safe and effective have yet to be effectively applied within the paediatric population. Utilization of unlicensed and off-label drugs in children results in a variety of problems ranging from inefficacy, adverse reactions and in some cases death. This ethically questionable behaviour has led the European government to legally force pharmaceutical companies to propose paediatric applications and carry out clinical studies at early stages of drug development. The (...) new European Paediatric Regulation implemented in 2007 opens a new era of paediatric drug development and will offer the opportunity to vastly improve children's health. However, this brighter outlook for the paediatric community might encourage potentially unethical behaviour in a pharmaceutical industry that finds itself in economically unstable times. The article records the gradual evolution of the US Paediatric Exclusivity Plan and the underlying principle of the newly introduced European Paediatric Regulation. It discusses some of the potential drawbacks and detrimental consequences of implementing the new European regulation, and the prospects of avoiding these by critically evaluating the difficulties experienced by the US. (shrink)

Centre for Applied Philosophy and Public Ethics (CAPPE), Menzies Centre for Health Policy, The Australian National University, LPO Box 8260, ANU Canberra ACT 2601, Australia. Tel.: +61 (0)2 6125 4355; Mobile: +61 (0)431 124 286; Fax: +61 (0)2 6125 6579; Email: michael.selgelid{at}anu.edu.au ' + u + '@' + d + ' '//--> Abstract Thomas Pogge has proposed a supplement to the standard patent regime whereby innovating companies would be rewarded in proportion to the extent to which their innovations lead to (...) reduction of the global burden of disease (GBD). This paper argues that an expansion of this proposal—whereby provision of already existing medicines are incentivised in a similar way—would provide a more comprehensive solution to the healthcare situation in developing countries. It then considers the practical challenges that the implementation of such a proposal (expanded or otherwise) would entail. Though these include difficulties associated with disease burden metric, I argue that the most serious difficulties are associated with the problem of causal attribution. A basic idea underlying Pogge's proposal is that the disease burden reduction attributable to particular interventions can be determined. Theoretically speaking, in cases involving multiple interacting causal factors, there may be no fact of the matter regarding the extent to which disease burden reduction should be attributed to one intervention as opposed to another; and (even if workable practical solutions to this theoretical challenge can be met) the data requirements for implementation would be daunting. CiteULike Connotea Del.icio.us What's this? (shrink)

Policies that shape the market for science-based goods have ramifications for the commercialization of scientific findings. This study illustrates how subsidy policies in Sweden have evaluated prescription drugs. These have created incentives for scientific research and development that differ from those encouraged by patents, which do not primarily consider how products are used when granting protection.

Most bioethicists who address questions to which global justice matters have not considered the significance of the disputes over the correct theory of global justice. Consequently, the significance of the differences between theories of global justice for bioethics has been obscured. In this paper, I consider when and how these differences are important. I argue that certain bioethical problems can be resolved without addressing disagreements about global justice. People with very different views about global justice can converge on the existence (...) of a duty to aid the very badly off — those in absolute poverty — wherever they may be. However, despite agreement on extreme cases, there should be disagreement over the extent of international obligations to those who are only relatively poor. Consequently, different theories of justice will diverge in their implications for a number of important problems in contemporary bioethics. I close by sketching in more detail two contemporary bioethical issues —concerning pharmaceutical patents and the health worker brain drain —and show how responses to them might be developed by cosmopolitan and statist liberals. (shrink)

Since the adoption of the WTO-TRIPS Agreement in 1994, there has been significant controversy over the impact of pharmaceutical patent protection on the access to medicines in the developing world. In addition to the market exclusivity provided by patents, the pharmaceutical industry has also sought to further extend their monopolies by advocating the need for additional ‘regulatory’ protection for new medicines, known as data exclusivity. Data exclusivity limits the use of clinical trial data that need to be (...) submitted to the regulatory authorities before a new drug can enter the market. For a specified period, generic competitors cannot apply for regulatory approval for equivalent drugs relying on the originator's data. As a consequence, data exclusivity lengthens the monopoly for the original drug, impairing the availability of generic drugs. This article illustrates how the pharmaceutical industry has convinced the US and the EU to impose data exclusivity on their trade partners, many of them developing countries. The key arguments formulated by the pharmaceutical industry in favor of adopting data exclusivity and their underlying ethical assumptions are described in this article, analyzed, and found to be unconvincing. Contrary to industry's arguments, it is unlikely that data exclusivity will promote innovation, especially in developing countries. Moreover, the industry's appeal to a property rights claim over clinical test data and the idea that data exclusivity can prevent the generic competitors from ‘free-riding’ encounters some important problems: Neither legitimize excluding all others. (shrink)

Michael Ravvin, Department of Political Science, Columbia University, 420 W. 118th Street, New York, NY 10027 Email: mer2133{at}columbia.edu ' + u + '@' + d + ' '//--> Abstract The existing intellectual property regime discourages the innovation of, and access to, essential medicines for the poor in developing countries. A successful proposal to reform the existing system must address these challenges of access and innovation. This essay will survey the problems in the existing pharmaceutical patent system and offer critical (...) analysis of some reform proposals. I will argue that existing mechanisms that are intended to mitigate the harms of the current pharmaceutical patent system, such as bulk buying, differential pricing and compulsory licenses, are inadequate and perhaps even counter-productive over the long-term. Other incentive mechanisms based on push funding, such as government research grants, are inefficient and limited in scope. Pull mechanisms, which offer some reward for successful pharmaceutical innovations, offer a more promising incentive mechanism. I will evaluate three pull mechanisms -- Priority Review Vouchers, Advance Market Commitment (AMC) and the Health Impact Fund -- on the basis of their capacity to incentivize access and innovation, as well as their efficiency and political feasibility. Though the Health Impact Fund appears to be the most promising proposal, more work must be done to overcome challenges of its implementation. CiteULike Connotea Del.icio.us What's this? (shrink)

This dissertation is informed by the general project of applying ethics to intellectual property, and focuses on a matter of particular concern within the field of applied bioethics, in conjunction with business ethics. Ensuring access to life-saving medical treatments for those in need of them is of crucial contemporary relevance. This line of enquiry led me to a specific question, which provides a conceptual framework for this work. That question is the following: should patents on pharmaceuticals be prohibited or (...) restricted in order to achieve that objective? ;To address that question, I use a very old and familiar example of a thought experiment, namely the Heinz dilemma, to make the case for paying attention to intellectual property issues. The Heinz dilemma is the focus of Chapter One. In Chapter Two, I endorse the application of mid-level principles in applied ethics. I elaborate on the mid-level principle of "economic efficiency" in Chapter Three, and then examine the "social responsibility of business" principle in Chapter Four. ;I recommend a relatively anti-theoretical approach to applying ethics to intellectual property issues. It is easier, I suggest, to appreciate the merits of such approaches if one first acquires an appreciation for the wonders and perplexities of intellectual property jurisprudence. To that end, Chapter Five contains background material on the particulars of intellectual property jurisprudence, especially patent law. In it, I contrast patents with trade secrecy protection, and briefly discuss compulsory licensing, stockpiling provisions, infringement exemptions. In Chapter Six, I survey the economic literature on patents and the debates over increased innovation as a desirable social goal. I propose several concepts---namely, technique, proportional property rights and the enhancement effect---which can contribute to a clearer understanding of what is at stake in the debates. ;The next three chapters, Seven to Nine, each deal with a different objection to patent protection in the context of biotechnology. Chapter Seven addresses the objections to bioprospecting. Chapter Eight deals with the objections to the increasing commercialization of medical research. Then Chapter Nine explicitly tackles the objections to unreasonable pricing practices, the ones so frequently charged against pharmaceutical patents, in particular. Lastly, I explore a range of policy options, alternatives to altering the scope or availability of patent protection, which may more effectively address the specific problem of ensuring access to innovative medical treatments. (shrink)

Most new drugs are protected by pharmaceutical patents, which give the patent holder exclusive control over that drug’s supply for 20 years. When the patent term expires, the drug becomes available for generic production by any company. The resulting competition typically leads to dramatic reductions in price. In Brazil, generic drugs are on average 40% cheaper than reference or brand-name drugs. In the United States, the Federal Drug Administration reports up to 85% price differences. Consumers in India have (...) witnessed more than 100-fold price reduction for antiretroviral drugs due to generic production. Generics thus play a key role in broadening access to health care, mostly by driving costs down, both in the developing and developed world. (shrink)

A free world is one in which human beings can live free, self-directed lives. A great obstacle to such a world is severe poverty, still blighting the lives of half of humankind. We have the resources, technologies, and administrative capacities to eradicate severe poverty, but doing so requires some restructuring of existing social arrangements. We might begin with the current regime governing innovation, which has monopoly markups as its key funding source. Such monopoly rents encourage the quest for innovations, but (...) also greatly impede their diffusion. This headwind harms the poor, who cannot afford monopoly prices and whose specific needs innovators thus tend to ignore. It also works against potential innovations whose benefits would mostly go to third parties whom buyers care little about. Both problems can be much alleviated through a supplementary alternative reward mechanism that would enable innovators to exchange their monopoly privileges on any patentable technology for impact rewards based on the social benefits achieved with it. By promoting innovations and their diffusion together, international impact funds would bring substantial gains in justice and cost-effectiveness, especially in the pharmaceutical and green-technology sectors. (shrink)

In recent months, pharmaceutical manufacturers have brought legal challenges to a provision of the 2022 Inflation Reduction Act (IRA) empowering the federal government to negotiate the prices Medicare pays for certain prescription medications. One key argument made in these filings is that price negotiation is a “taking” of property and violates the Takings Clause of the US Constitution. Through original case law and health policy analysis, we show that government price negotiation and even price regulation of goods and services, (...) including patented goods, are constitutional under the Takings Clause. Finding that the IRA violates the Takings Clause would radically upend settled constitutional law and jeopardize the US’s most important state and federal health care programs. (shrink)

One-third of all human lives end in early death from poverty-related causes. Most of these premature deaths are avoidable through global institutional reforms that would eradicate extreme poverty. Many are also avoidable through global health-system reform that would make medical knowledge freely available as a global public good. The rules should be redesigned so that the development of any new drug is rewarded in proportion to its impact on the global disease burden (not through monopoly rents). This reform would bring (...) drug prices down worldwide close to their marginal cost of production and would powerfully stimulate pharmaceutical research into currently neglected diseases concentrated among the poor. Its feasibility shows that the existing medical-patent regime (trade-related aspects of intellectual property rights—TRIPS—as supplemented by bilateral agreements) is severely unjust—and its imposition a human-rights violation on account of the avoidable mortality and morbidity it foreseeably produces. (shrink)