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Asian Bioethics Review

, Volume 9, Issue 1–2, pp 87–101 | Cite as

Selling pharmaceuticals ethically in resource-limited settings: the case of Sofosbuvir

Original Paper
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Abstract

In countries without universal health insurance systems, is it ethically acceptable for pharmaceutical companies to sell their products only to the relatively small segment of the population that can afford private insurance coverage or to pay for medications out of pocket? Are there certain drugs that companies should be expected to sell in these economies even if they are unable to do so profitably? Within a human rights framework, this paper identifies these and related ethical challenges and proposes some responses. The paper begins by considering general ethical responsibilities that arise from commitment to the Universal Health Coverage initiative as a Sustainable Development Goal. It then discusses ethical responsibilities on the part of pharmaceutical companies as distinct from those of national governments or the broader international community. Some proposals follow for thinking through specific ethical challenges that arise when making decisions about whether, and on what terms, to introduce a new drug into a particular setting. Finally, the paper considers a number of these issues and responses in the context of the sale of sofosbuvir in the Asia-Pacific region.

Keywords

Pharmaceuticals Developing economies Emerging markets Equity Access to medicines Corporate social responsibility 

Introduction

Universal Health Coverage (UHC) is an initiative of the World Health Organization (WHO) that was endorsed by the World Health Assembly in 2005 and elaborated on in the World Health Report in 2010.(World Health Organization 2010) It commits all countries to work towards ensuring that all people have access to healthcare that they need without suffering financial hardship. In working towards UHC, all governments are encouraged to work on ensuring (1) a strong, efficient, well-run health system that meets priority needs through people-centred integrated care; (2) affordable health services; (3) access to essential medicines and technologies; and (4) a sufficient capacity of well-trained, motivated health workers. Essentially, all countries should expand priority services, include more people, and reduce out-of-pocket payments. From an ethical viewpoint, UHC is deeply rooted in the principle of fairness, which is taken to be synonymous with equity in a WHO report (World Health Organization 2014, 7).1 Policies that are enacted to achieve UHC should be optimal both from the perspectives of fairness and benefit maximization. Fair distribution and fair contribution, along with cost-effectiveness, are set out by WHO as three concrete guiding considerations for making policy decisions on the path to UHC (World Health Organization 2014, 8).2

Where medicines are concerned, WHO’s model essential medicines list has served as a model for national formularies since it was first published in 1977. It is also widely regarded as one of WHO’s most influential public health achievement, particularly in inspiring civil society movements and many governments to move towards practical implementation of their right-to-health commitments, which include an obligation to provide access to essential medicines. (Hogerzeil 2012) Essential medicines are defined as medicines that (World Health Organization 2017a, b, c)

satisfy the priority healthcare needs of the population, [and are] selected with due regard to disease prevalence and public health relevance, evidence of clinical efficacy and safety, and comparative costs and cost-effectiveness. Essential medicines are intended to be available within the context of functioning health systems at all times in adequate amounts, in the appropriate dosage forms, with assured quality, and at a price the individual and the community can afford.

While WHO’s model list is not designed as a global standard, its ethical goal is – like UHC – intended to promote health equity. Most of the medicines on the model list are not patented and relatively low cost, but the 2017 model list includes high-cost medicines for hepatitis C and cancer. (WHO 2017d).

A health system that is directed at UHC will need to consider what extent of access is ethically sufficient, and how such access can practically be provided. In health systems with UHC, constraints on healthcare spending are clearly necessary to ensure that UHC remains viable and sustainable. For instance, payers, reimbursement authorities and health insurers in these health systems increasingly require evidence of cost-effectiveness and other evidence of value (such as clinical benefit or improvement to quality of life) in assessing product price and/or reimbursement levels. To be sure, cost-effectiveness is but one of many other considerations, particularly when deciding if a high-cost medicine is to be added to the national formulary. As Urrutia, Porteny and Daniels observe: (Urrutia et al. 2016)

Cost effectiveness may be an important criterion for inclusion on the list, but it is not a sufficient condition for national selection by countries. To decide whether an allocation is reasonable one must take into account its full opportunity cost, which requires balancing concerns about cost effectiveness, priority to the worst off, and financial risk protection, among other considerations that may be relevant in a particular context.

Even then, many health systems in general, and low-resource ones in particular, struggle with serious informational, distributional and broader systemic limitations. For instance, lack of pharmacoeconomic data have contributed to delays in the availability of new medicines, even in advanced health systems in Europe and the US (Evens and Kaitin 2015, 216).3 Where a pharmaceutical company intends to sell high-cost medicines in a region like the Asia-Pacific, what are its ethical responsibilities? While some Asia-Pacific countries have implemented UHC, all have committed to it. Does a pharmaceutical company have an ethical duty to provide its products, especially those that are highly priced, in a manner that does not contribute to social inequity?

In the section that follows,4 we discuss how these ethical challenges could be identified and evaluated within a human rights framework. We then consider how these challenges could be responded to from the standpoint of an international research-based pharmaceutical company selling its products in less economically developed countries. Finally, we consider these issues and responses in the context of the sale of sofosbuvir in the Asia-Pacific region.

Human rights as source of ethical obligations

The Constitution of the World Health Organization (WHO) states that “[t]he enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being” (World Health Organization 2006).5 Numerous international agreements reinforce this position by expressly affirming the existence of a human right to health (See, e.g., United Nations 1948, Art. 25; United Nations 1976, Art. 12; United Nations 1979, Art. 12; United Nations 1990, Art. 24; United Nations 1965, Art. 5; Organisation of African Unity 1981, Art. 16; Organization of American States 1988, Art. 10).6 The United Nations (UN) Committee on Economic, Social and Cultural Rights has explicitly recognized that a core component of the human right to health is equitable access to essential medicines, (World Health Organization 2011) which WHO has defined as “those drugs that satisfy the health care needs of the majority of the population.”(World Health Organization 2017a, b, c) WHO calls on countries to make these drugs “available within the context of functioning health care systems at all times in adequate amounts, in the appropriate dosage forms, with assured quality, and at a price the individual and the community can afford.”(WHO 2002).

Although governments have the primary responsibility for “respecting, protecting, and fulfilling” human rights, (United Nations Global Compact 2017) non-state actors, including for-profit businesses, also bear certain human rights obligations. (United Nations Human Rights Office of the High Commissioner 2011) A pair of publications by the UN Special Rapporteur on the Right to Health, Paul Hunt (the ‘Hunt Guidelines’), offers guidance on how human rights principles apply specifically to the pharmaceutical sector. First, a 2008 report, titled Human Rights Guidelines for Pharmaceutical Companies, set forth 47 guidelines for pharmaceutical companies, including a duty to give “particular attention to the very poorest in all markets” (United Nations Secretary-General 2008, paragraph 5).7 Second, a 2009 Annex to the report observed that companies that develop “life-saving medicines” are engaged in a “public function” that triggers additional responsibilities (United Nations Secretary-General 2009, paragraph 41),8 including a duty “to take all reasonable steps to make the medicine as accessible as possible, as soon as possible, to all those in need, within a viable business model” (United Nations Secretary-General 2009, paragraph 39).9 According to the Annex, these obligations stem in part from the “express and implied terms” of the patent system, which both rewards companies “for fulfilling this critically important social function” and, in exchange, “places important right-to-health responsibilities on the patent holder” (United Nations Secretary-General 2009, paragraph 35).10

Some commentators have suggested that the Hunt guidelines might go too far in ascribing responsibilities to businesses that more properly belong to national governments (See, e.g., Moon 2013).11 In contrast, in a presentation delivered at a meeting held at Seton Hall Law School in October 2016,12 Professor Alex John London13 suggested that the duties of state and non-state actors are not necessarily distinct. He argued that states may seek to satisfy some of their human rights obligations — including the duty to provide access to essential medicines — by relying on the market, subject to a system of regulation designed to align private interests with human rights goals. Pharmaceutical companies that produce essential medicines can therefore be seen as a critical component of the government’s strategy for fulfilling its own human rights obligations. According to London, these companies should be free to aggressively pursue profits only insofar as doing so does not undermine the human rights functions the state relies on them to perform.

London further argued that, in the absence of regulatory frameworks that adequately align companies’ commercial interests with human rights objectives, companies that produce essential medicines assume some responsibility for promoting human rights themselves. He suggested that pharmaceutical companies would fail to respect their role as instruments in the state’s pursuit of human rights if they exploit public systems for their own private benefit. For example, because states have a human rights obligation to create health systems that meet the health needs of all persons equitably, companies can be criticized if they exploit such systems to selectively favour the interests of certain subgroups, such as the wealthy.

Implications for selling medicines in emerging economies

As the Hunt Guidelines emphasize, patents are rewards for discovery that come with implicit conditions (United Nations Secretary-General 2009, paragraph 41).14 In light of the state’s own human rights obligation to promote access to essential medicines, it is reasonable to view one of these conditions as a commitment to take steps to make such medicines available on an equitable basis. As London argues, one way that countries fulfil their human rights obligations is, in essence, by delegating certain functions to market participants. In the case of pharmaceuticals, the award of a patent can be seen as the mechanism by which this delegation of responsibilities occurs.

The case for requiring patent-holders to provide equitable access to essential medicines is strongest as applied to persons within the borders of the patent-granting jurisdiction. However, we do not believe that companies’ ethical obligations should be defined in such a limited way. Instead, the award of patent protection for an essential medicine in the industry’s primary markets should be seen as triggering a duty to make reasonable efforts to make the product equitably available wherever it is needed, even outside the borders of the patent-granting jurisdictions. Such an approach is justified by the principle of global solidarity that underlies the entire system of international human rights (Office of the United Nations High Commissioner for Human Rights and World Health Organization 2008; see also United Nations 1945, articles 55–56).15 For example, the UN Committee on Economic, Social and Cultural Rights states that, “[d]epending on the availability of resources, States should facilitate access to essential health facilities, goods and services in other countries, wherever possible, and provide the necessary aid when required.”(United Nations Committee on Economic 2000) This international perspective is also reflected in the 1994 Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS), which incorporates a variety of flexibilities that permit less economically developed countries to limit or even override pharmaceutical patents for public health purposes (World Trade Organization 1994; see also World Trade Organization 2001).16 In accepting these flexibilities, the international community has implicitly recognized that the benefits companies receive from patent protection in high-income countries justify limitations on their ability to pursue profits in other parts of the world.

A duty to make reasonable efforts to make an essential medicine available wherever it is needed does not entail an absolute obligation to register the medicines regardless of the circumstances. As the Hunt Guidelines state, pharmaceutical companies have a duty to provide reasonable access to essential medicines “within a viable business model” (United Nations Secretary-General 2009, paragraphs 37 and 41; see also Luna 2016).17 If it will be impossible to sell a drug in a particular country at a business-viable price, registering the drug in that country should be considered a discretionary act of philanthropy, rather than fulfilment of a minimum ethical expectation.

The difficult question is determining what constitutes a “business viable price” for an essential medicine in the context of a less economically developed country. In general, businesses set their prices at a level higher than the actual costs of production, in order to earn a return on their investment. Pharmaceutical companies typically characterize this return as a “reward for innovation” and argue that it compensates them for the high risks inherent in the drug discovery process (Saadj and White 2014).18 While the appropriate amount of this reward is a matter of substantial debate, it seems clear that asking companies to forego the reward entirely would not represent a “viable business model,” as it would remove any incentive for companies to invest resources in the development of new drugs.

However, the viability of the pharmaceutical business model does not depend on companies’ ability to earn a reward for innovation each and every time they sell one of their products. As long as companies can earn a reasonable return on investment when they sell their products in the high-income countries that make up their primary markets, there is nothing preventing them from also selling their products in less economically developed countries at a price closer to their costs. Thus, the fact that it might not be possible to earn a profit on an essential medicine in a particular country does not absolve patent-holding companies of their ethical responsibility to enter that market. Rather, companies should be expected to register a new drug in all countries in which the drug meets the definition of an essential medicines unless the company cannot reasonably expect to sell the drug at a price sufficient to recover their actual costs.

Whether or not a drug falls under the definition of an essential medicine, once a company has made a decision to sell the drug in a particular market, it must ensure that the manner in which it does so respects human rights principles. One way that introducing a new medicine could undermine these principles is by placing burdens on limited resources, including health care facilities, equipment, or trained medical personnel. For example, resources needed to administer a new drug safely and effectively might be taken from other existing uses that provide greater public health benefits. Similarly, a drug might lead to iatrogenic injuries for which patients seek treatment in already overburdened public health facilities (see generally, Mouton et al. 2016).19 More generally, making a drug available only to certain groups, such as the wealthy or politically connected, can contribute to the general problem of social inequality, which has been correlated with a wide range of problems independent of a country’s absolute level of wealth (Pickett and Wilkinson 2009).20 In the next section, some suggestions for actions companies can take to mitigate these unintended consequences are presented.

Breadth of market access

In general, if a country has a public health system that provides medicines to patients, either directly or through reimbursement programs, companies should make every effort to sell their products through that system. Doing so is the best way to provide broad access to the medication throughout the country in a sustainable manner. This is especially important for essential medicines, but it is also desirable for other medicines that satisfy important health care needs for particular segments of the population.

In negotiating sales prices with public health systems, companies should take into account the country’s level of economic development, as well as the burden of disease and the expected value of the medication. In addition to being ethically relevant, companies have an economic incentive to consider these factors, as they provide evidence of the country’s ability and willingness to pay particular prices. When feasible, companies should explore alternative payment arrangements with public health systems, including price-volume arrangements (Organisation for Economic Co-operation and Development 2008) and/or pricing mechanisms that tie the level of reimbursement to the medical benefits produced (see generally, Adamski et al. 2010).21

If a drug will not be made broadly available through a public health system (whether because such a system does not exist or because it is unable or unwilling to purchase the drug at a business-viable price), companies may seek to market the drug to self-pay or privately insured patients. In some cases, this may be the only realistic option for selling a product, particularly in countries without well-developed public health systems. While such an approach is not ideal, it should not be considered inherently unethical. Precluding such practices would mean that drugs not provided through a country’s public health system would not be made available to anyone in the country, an outcome that could deprive private-pay patients of access to important drugs. In general, medicines that have been proven to be safe and effective should not be withheld from patients who could benefit from them solely because it may not be possible to benefit all patients in need.

Nevertheless, selling medicines exclusively to self-pay or privately insured patients presents significant ethical challenges. By increasing the treatment options available to the wealthy without also increasing the options available to the poor, such an approach will necessarily exacerbate existing inequalities in access to health care. Moreover, as noted above, new drugs can give rise to iatrogenic injuries that may require treatment in the public health system, which would cause further harm by taking away resources that could have been devoted to other public health purposes (see generally, Mouton et al. 2016).22 At some point, the availability of lucrative drug-based treatments may even lead some health care professionals to abandon the public system entirely, so that they can devote more of their energies to private-pay patients.

In light of these risks, companies that choose to market their products to self-pay or private-pay patients, without also making them broadly available through a country’s public health system, assume a responsibility to undertake affirmative mechanisms to mitigate these potential negative consequences. One way they might do this is to institute programs to provide the drug to less wealthy segments of the population at an affordable price. For example, companies might provide means-tested subsidies that patients can use to obtain the drug for reduced or no cost, with the amount of the subsidy based on patients’ ability to pay.

We recognize that intra-country price tiering raises challenging logistical issues (Williams et al. 2015, 1292)23 and is likely to prove unfeasible without assistance from the government. Moreover, subsidies may not reach all segments of the population, particularly patients in geographically remote areas. Systems would need to be developed to assess relative need fairly and accurately, and distribution channels would need to be carefully managed to ensure that subsidies are not diverted from their intended recipients to other beneficiaries. Measures to prevent abuse of such systems are particularly important in countries with high levels of corruption.

Another strategy for making drugs more broadly available would be to enter into a licencing arrangement with a local manufacturer that permits the manufacturer to market the same drug in a generic version at a significantly lower price (Moon 2013, 10).24 (In countries that lack local manufacturing capacity, an alternative might be for the company to market a lower-cost version of the drug itself under a different brand name.) However, the effectiveness of this strategy depends on the disease type and market size. It is most likely to work for drugs that can be sold in high volumes at low profit margins. It is least likely to work for drugs that have significant non-price barriers, limited markets, or are difficult to manufacture, where the introduction of a generic alternative might not lead to a substantial reduction in price.

For some drugs, neither of these strategies may be a viable option, due to structural, non-price barriers that prevent safe and effective use of the medicines in certain segments of the population. For example, in rural areas that lack access to basic health facilities, it might not be possible to ensure the ongoing monitoring necessary for the safe use of some products, even if they are provided at an affordable price. Wherever possible, companies should work with governments and local stakeholders to explore the feasibility of overcoming these barriers. For example, in some situations, it may be possible to rely on non-physician providers to monitor patients, or to monitor patients remotely through mobile technology. Companies should also use their negotiating power with governments to lobby for measures to address infrastructure gaps that inhibit access to medicines, such as the absence of roads in remote rural areas. However, even with these efforts, it must be recognized that, in some cases, companies may have no realistic means to make certain products equitably available to the entire population, even if they are willing to make substantial concessions on price.

Programmes designed to make medicines available to all segments of the population at an affordable price are not the only way that companies can reduce the inequities resulting from selling drugs to self-pay and privately insured patients. Another option would be to use some of the proceeds from sales of the product to support other public health initiatives. For example, companies might dedicate a portion of a drug’s sales revenue to efforts to provide access to essential medicines in low-income communities. Alternatively, they might choose to fund other public health initiatives, such as the construction of health facilities or the purchase of needed diagnostic equipment. Such programs might be instituted in addition to, or in some cases instead of, mechanisms to make the drug more broadly available.

In choosing a strategy for mitigating the potential negative consequences of selling drugs primarily to a country’s wealthy population, companies should work collaboratively with governments and other local stakeholders. The choice of strategy should also be guided by the nature of the particular drug. For essential medicines, particularly those that are insufficiently supported by the country’s public health system, it will generally be preferable to make efforts to ensure that the drug is made broadly available to all segments of the population, through the use of means-tested subsidies, licencing arrangements, or other mechanisms. Using some of the proceeds from sales of the drug to support other public health initiatives can complement these efforts but should not replace them entirely.

By contrast, for drugs that do not have a major public health impact, efforts to promote broad population access may not be the best use of resources. For example, consider a company that seeks to market a new antidepressant that contains the same active ingredient as a medication already available in generic form but that is available in a more convenient once-a-week dosage. While such a drug might provide a meaningful benefit to certain individuals, it cannot reasonably be characterized as filling a pressing public health need. Therefore, rather than seeking to ensure broad access to the medication among all segments of the population, it might be preferable to use some of the proceeds from sales of the product to finance programs to provide essential health care services.

Companies can demonstrate their commitment to addressing the ethical implications of their marketing practices by being transparent about their choice of strategy and their rationale for choosing it. For example, before launching a new product in a particular country, companies might undertake a formal social impact assessment that details which segments of the population are likely to face barriers to access and the steps the company intends to take to respond to these barriers.

Case consideration: Selling Sofosbuvir in Asia and the Pacific region

Clinical management practices for HCV depend on a number of conditions, particularly the viral genotype and its prevalence, disease severity, previous treatment status, comorbidity and coinfection. (World Health Organization 2016) All-oral direct-acting antivirals (DAA) are generally the first-line of treatment, and a mixture of different classes of compound (which may also include pegylated interferon and ribavirin) is necessary in order for the treatment to be successful (or for sustained virologic response to be achieved). In late 2013, four new treatment regimens (see Table 1 below) (The Foundation for AIDS Research 2015) involving DAA drugs were approved by the US Food and Drug Administration for the treatment of Hepatitis C virus (HCV). When used in combination with existing HCV drugs, the treatment duration was halved, from 24 to 48 weeks to 12–24 weeks, with decreased side effects. Successful outcomes across all patient populations also increased from 50 to 80%, to 85–95% (Moon 2013, 10).25 However, the exorbitant prices of the new HCV medications drew immediate criticisms, most of which were directed at Gilead for the pricing of sofosbuvir at roughly US$1000 per pill. It was estimated that, even after taking into account all available discounts, it would cost approximately US$110 billion to treat approximately 3.2 million individuals in the U.S. with chronic HCV infection.
Table 1

HCV Treatment Regimens

Active Ingredient

Brand Name

Treatment Formulation

Geno-type

Treatment Duration

Pharmaceutical Company

List Price* (US$)

Total Regimen Cost* (US$)

simeprevir

Olysio

simeprevir + peginterferon alfa + ribavirin

1

12 weeks (simeprevir); 24–48 weeks (total)

Medivir & Janssen Pharmaceutical

$66,360

$85,960

sofosbuvir

Sovaldi

sofosbuvir + pegylated interferon + ribavirin

1, 4

12 weeks

Gilead Sciences

$84,000

$103,600

  

sofosbuvir + ribavirin

2 (3)

12 weeks (24 weeks)

 

$84,000 ($168,000)

$85,100 ($169,100)

ledipasvir/ sofosbuvir

Harvoni

ledipasvir + sofosbuvir

1

12 weeks

Gilead Sciences

$94,500

$94,500

ombitasvir/ paritaprevir/ ritonavir

Viekira Pak

ombitasivir + paritaprevir + ritonavir + dasabuvir

1

12–24 weeks

AbbVie Inc.

$83,319

$83,319

*Prices indicative of the total list price for a treatment regimen

Globally, WHO estimates that there are about 185 million people living with hepatitis C, with up to 350,000 deaths annually due to HCV-related liver diseases. About half of these people with HCV live in the Asia-Pacific Region, (Mohd Hanafiah et al. Mohd Hanafiah et al. 2013) with Pakistan and Taiwan having the highest prevalence. (European Society for the Study of Liver 2015) However, managing HCV in this region is challenging for a variety of reasons, including the following: (Lim et al. 2017)
  1. 1)

    Considerable difference in the prevalence and genotypes from one country to the next, with some genotypes that are only common to certain sub-regions. In East Asia (China, Japan, South Korea and Taiwan), genotypes 1b and 2 are the most common. While there is a high prevalence of genotypes 1 and 6 in Vietnam, only genotype 6 is prevalent in Cambodia and Laos. In contrast to the East Asian and Indochina sub-regions, genotype 3 is prevalent in South and Southeast Asia (Thailand, India and Pakistan). Treatment for genotype 3 HCV is more challenging because many of the oral DAA drugs are less effective and a modified treatment plan may be required.

     
  2. 2)

    Only a handful of jurisdictions (Australia, Japan, Malaysia, New Zealand, South Korea, Singapore, Thailand and Taiwan) have implemented UHC, with high-cost medicines continuing to be a heavy contributor to financial burden for patients in jurisdictions that have not done so.

     
  3. 3)

    Regulatory approval requirements and processes for direct-acting antiviral therapy vary greatly, with some countries requiring local clinical trial data for drug licencing approval. While a DAA drug like sofosbuvir will have received drug licencing approval from all countries in the Asia-Pacific region by 2018, another DAA drug like asuneprevir has only been approved in a handful of jurisdictions (these being Japan, Macau, the Philippines, Singapore, South Korea and Taiwan).

     
  4. 4)

    Public health infrastructure is highly sophisticated in some countries (or urbanized areas within countries) but relatively basic in others. Many countries with high HCV prevalence do not have a sufficiently developed public health screening and surveillance system. For this reason, a large number of people infected with HCV remain undiagnosed. In addition, point-of-care testing for HCV is hampered by the need for confirmatory testing and other follow-up procedures including genotyping, viral load assay and fibrosis assessment.

     
  5. 5)

    Cost-effectiveness data for oral direct-acting antivirals may not be available. And even if antivirals are cost effective, they may not be affordable to the health system.

     

Dramatic price reductions have been achieved by some countries through negotiation with Gilead. (Gilead 2017) Eleven generic drug companies in India have also been authorized by Gilead through a voluntary licence agreement to sell generic sofosbuvir formulations in 101 developing countries, with varying proportions of royalty. In addition, three generic manufacturers in Egypt and Pakistan were chosen for in-country production and distribution of the drug. It is unclear how these 101 countries were chosen, why other countries have been excluded, and how production and distribution arrangements on a global scale have been devised. Perhaps an even more crucial question should be the ethical propriety of a pharmaceutical company (or its licensees) unilaterally deciding which health systems should get access to medicines, at what cost, and what form access and distribution should take. A more accountable, inclusive and transparent approach ought to apply to decisions that have clear global health and equity implications.

Currently, international organizations have at best a supportive role in facilitating access to high-cost medicines. For instance, WHO is working with countries on assessing and promoting policy options for increasing access to new medicines that are unaffordable, even for high-income countries. Where the new HCV medicines are concerned, WHO has conducted an analysis of the patent situation for seven new hepatitis treatments in order to provide clarity on whether the medicines are patent protected or not in individual countries. (World Health Organization 2017a, b, c) The most updated information includes the patent status of sofosbuvir in about 20 countries. (World Health Organization 2015) Some over-simplification admitted, the fact remains that it is a pharmaceutical company that has ultimate discretion on how much access a particular health system will have to sofosbuvir, if any at all.

Taking ethical responsibility seriously

As we have argued earlier on in this paper, a pharmaceutical company should lower the price of essential medicines that it produces as much as needed to make the drug equitably available, as long as it is still possible for the company to recover its costs assessed from a long-term perspective. Companies should also consider using some of the profits they earn on non-essential medicines in these countries to subsidize the costs of providing sofosbuvir to those who cannot afford it. Overall, companies should seek to remain fully embedded in and firmly engaged with the communities that purchase their products.

A more equitable and accountable framework is needed for the production and distribution of high-cost medicines like sofosbuvir, taking into account what is reasonably affordable to health systems based on a holistic assessment. The problem of high-cost medicines is fundamentally a systemic failure at a global level in satisfying ethical principles that underscore UHC. Where pharmaceutical companies (or their shareholders) are concerned, a “whole system” viewpoint should be adopted in which industry sees itself not as outside of a country’s health system, but rather as a crucial component within it. Whenever practicable, medicines proven to be safe and effective should be accessible to patients who could most benefit from them, even if they are not yet equally available to all health systems. In working towards equal access, whether within the Asia Pacific region or elsewhere, pharmaceutical companies should not undermine health systems in the pursuit of short term gains. Particularly in systems that are working towards implementing UHC, the provision and distribution of high-cost medicines should be planned in a manner that is most likely to support the ethical goals that UHC is directed at realizing. This could include infrastructural and professional developments, as well as other initiatives that support capacity building and more broadly a culture of trust and collaborative partnership.

The ethical mandate of UHC will also require an organization like the WHO to assume a greater role in negotiating access to new drugs and in facilitating their distribution to all countries. There is at present little incentive for a drug producer to enable generic licensees to manufacture a new drug for all countries. Companies also may not have the resources and capabilities needed to devise and manage varying royalties charged to different countries, through a process that is transparent, accountable and legitimate. These are admittedly tall orders, but if drug development and production is to be a socially valued enterprise, redressing the current failings is a worthwhile and necessary undertaking.

Footnotes

  1. 1.

    (World Health Organization 2014), at 7.

  2. 2.

    Ibid, at 8.

  3. 3.

    (Evens and Kaitin 2015), at 216.

  4. 4.

    The sections on “Human Rights as Source of Ethical Obligations” and “Breadth of Market Access” are excerpted from a report that was prepared by one of the authors: (Coleman 2017)

  5. 5.

    Constitution of the World Health Organization, 45th edition, Oct 2006.

  6. 6.

    See, e.g., Universal Declaration of Human Rights, G.A. Res. 217 (III) A, Art. 25 U.N. Doc. A/RES/217(III) (10 Dec 1948); International Covenant on Economic, Social and Cultural Rights, G.A. Res. 2200 (XXI) A, Art. 12, U.N. Doc. A/RES/2200(XI) (3 Jan 1976); Convention on the Elimination of All Forms of Discrimination Against Women G.A. Res. 34/180, Art. 12, U.N. Doc. 34/180 (18 Dec 1979); Convention on Rights of the Child, G.A. Res. 44/25, Art. 24, U.N. Doc. 44/25 (2 Sep 1990); International Convention on the Elimination of All Forms of Racial Discrimination, G.A. Res. 2106 (XX), Art. 5, U.N. Doc. 2106 (21 Dec 1965); African Charter on Human and Peoples’ Rights, Art. 16 (June 1981); Additional Protocol to the American Convention on Human Rights in the Area of Economic, Social and Cultural Rights, Art. 10 (17 Nov 1988).

  7. 7.

    (United Nations Secretary-General 2008) (by Paul Hunt).

  8. 8.

    (United Nations Secretary-General 2009) (by Paul Hunt).

  9. 9.

    See id. at paragraph 39.

  10. 10.

    Id. at paragraph 35.

  11. 11.

    See, e.g., (Moon 2013)

  12. 12.

    A meeting on ethical considerations in selling pharmaceuticals in emerging economies was organized by one of the authors (Carl H Coleman) on 6 and 7 October 2016 at the Center for Health & Pharmaceutical Law & Policy, Seton Hall Law School, New Jersey, USA.

  13. 13.

    Professor of Philosophy and Director of the Center for Ethics and Policy, Carnegie Mellon University.

  14. 14.

    See Hunt, supra note 17, at paragraph 41.

  15. 15.

    (Office of the United Nations High Commissioner for Human Rights and World Health Organization 2008) see also U.N. Charter arts. 55–56.

  16. 16.

    Agreement on Trade-Related Aspects of Intellectual Property Rights, 15 Apr 1994, Marrakesh Agreement Establishing the World Trade Organization, Annex 1C, 1869 U.N.T.S. 299; see also World Trade Organization, Declaration on the TRIPS Agreement and Public Health, 14 Nov 2001, WT/MIN(01)/DEC/2, 41 I.L.M. (2002) (the ‘Doha Declaration’).

  17. 17.

    Hunt, supra note 17, at paragraph 37, 41; see also: (Luna 2016)

  18. 18.

    See (Saadj and White 2014)

  19. 19.

    See generally (Mouton et al. 2016)

  20. 20.

    See (Pickett and Wilkinson 2009)

  21. 21.

    See generally (Adamski et al. 2010)

  22. 22.

    See generally Mouton et al., supra note 30.

  23. 23.

    See (Williams et al. 2015), at 1292.

  24. 24.

    See Moon, supra note 21, at 10.

  25. 25.

    Ibid.

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Copyright information

© National University of Singapore and Springer Nature Singapore Pte Ltd. 2017

Authors and Affiliations

  1. 1.Seton Hall University School of LawNewarkUSA
  2. 2.Centre for Biomedical Ethics, Yong Loo Lin School of MedicineNational University of SingaporeSingaporeSingapore
  3. 3.WHO Collaborating Centre for Bioethics (Singapore)SingaporeSingapore

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