Brian Citro and Mihir Mankad, INTERNATIONAL HUMAN RIGHTS CLINIC, UNIVERSITY OF CHICAGO LAW SCHOOL

Lead Author: Brian Citro and Mihir Mankad
Additional Author(s): Kiran Raj Pandey, Evan Lyon, Stop TB Partnership, Treatment Action Group, Kenya Legal and Ethical Issues Network on HIV and AIDS (KELIN)
Organization(s): International Human Rights Clinic, University of Chicago Law School; Department of Medicine, University of Chicago; Stop TB Partnership;Treatment Action Group; Kenya Legal and Ethical Issues Network on HIV and AIDS (KELIN)
Country: USA

Abstract

Innovation of and Access to Health Technologies and the Right to Health

Health technologies, including medicines, vaccines and diagnostics, are often unaffordable to those who need them, or simply unavailable—i.e., nonexistent—due to a lack of research and development. In this submission, we examine what is required of States and the international community pursuant to the right to health to ensure innovation of and access to health technologies.

At the core, there exists a legal and policy incoherence wherein the rights of inventors are prioritized over the rights of people who need medicines and other health technologies. However, States have a legal obligation under international law to respect, protect, and fulfil the right to health. Among other things, this requires States to ensure health goods, services, and information are available and accessible, without discrimination, especially for vulnerable or marginalized groups.

To meet these obligations, State must intervene when markets alone do not facilitate access to health technologies for people who need them or spur research and development of new technologies for conditions primarily affecting the poor. State interventions to ensure affordability include, among others, use of TRIPS flexibilities, development of mechanisms for pre- and post-grant challenges to patents for health technologies based on international human rights law, and creation of independent government bodies to review health technology patent applications in light of the right to health. State interventions to ensure health technologies are available, particularly for neglected diseases and conditions primarily affecting the poor, include development of a treaty-based system of mandatory resource pooling and coordination for research and development of new health technologies, and increasing investments in alternative incentive models based on the principles of delinkage, open innovation, and licensing for access.

Submission

Innovation of and Access to Health Technologies and the Right to Health

The Problem

The access to medicines crisis first came to global attention as the result of the efforts of health and human rights activists in response to the global HIV epidemic in the late 1990s and early 2000s. Since then, the global community has sought to address the crisis in various, largely ad hoc, ways. Nonetheless, due to structural factors, such as increasing economic inequality, the globalization of intellectual property laws, and an innovation system in which profit motivations outweigh public health considerations, the problem persists. The current situation is one in which health technologies, including medicines, vaccines and diagnostics, are often unaffordable to those who need them or simply unavailable—i.e., nonexistent—due to a lack of research and development. At the core, there exists a legal and policy incoherence wherein the rights of inventors are prioritized over the rights of people who need medicines and other health technologies.

Unaffordability

Many health conditions affect high, middle, and low income countries alike. New health technologies developed for these conditions receive patents, and producers target populations who can afford to pay high prices. Since the globalization of intellectual property rights through the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), these populations have included both people in wealthy countries and wealthy people in poorer countries, because patents can now be obtained in all World Trade Organization (WTO) Member States. The intellectual property system operates on the premise that a grant of market exclusivity through a patent for a limited period of time incentivizes innovation and commercialization of new discoveries. By its very nature, the regime encourages patentholders to maximize profits during the life of their patent. The standard 20 year grant of market exclusivity for pharmaceutical patents allows developers to both recoup the costs of investments in research and development and generate profits. This may not be a concern for luxury goods and other non-essential items, but for medicines, vaccines, and diagnostics it has led to a global health crisis.

As a result, we have repeatedly seen medicines developed and brought to market for diseases such as cancer, HIV, hepatitis, TB, and others and that are unaffordable for many who need them, including for governments of poor countries. The consequence of restricting or eliminating patents and allowing generic competition for new medicines, on the other hand, is dramatic. For example, before generic competition, prices for patent-protected HIV medicines were approximately $12,000/year in 2000. Once generic competition entered the market, prices reduced by nearly 99% within two years, to about $150 year.

Unavailability

For many health conditions, including neglected diseases and conditions primarily affecting the poor, medicines, vaccines, and diagnostics simply do not exist. They are unavailable because the research and development needed to create them has not been undertaken due to a lack of financial incentives. In other words, there is market failure: innovation does not occur for these conditions because profitable markets for related health technologies do not exist under the current regime. For example, in 2014 the private pharmaceutical sector contributed only 16% of the total funding for research and development for neglected diseases—a mere 534 million dollars. By comparison, the industry claims it costs $1.5 billion on average to develop a single new medicine. Funding for all neglected diseases in 2014 thus amounted to just a third of what the industry claims it costs to develop a single drug. Compounding this problem, the current incentive model rewards incremental innovation, whereby it is more profitable to slightly modify a patent and earn additional market exclusivity, rather than to produce wholly new compounds that require much greater investment. The result is that innovation of health technologies is driven primarily by market forces rather than global health needs.

The Right to Health

In this submission, we examine what is required of States and the international community pursuant to the right to health to ensure innovation of and access to health technologies. States that have ratified international human rights treaties have committed themselves to incorporating human rights, including the right to health, into their domestic law and ensuring existing laws comply with human rights. This includes laws and regulations related to intellectual property, research and development of health technologies, and trade. These laws must comply with States’ obligations under the right to health—at the very least they must not violate the right.

The right to health is enshrined in the Universal Declaration of Human Rights, the WHO Constitution, the International Covenant on Economic, Social and Cultural Rights, the Convention on the Elimination of Discrimination Against Women, the Convention on the Rights of the Child, and other major international human rights treaties. The right to health is also enshrined in more than 130 constitutions around the world.

States have a legal obligation under international law to respect, protect, and fulfil the right to health. Among other things, this requires States to ensure health goods, services, and information are available, accessible, acceptable, and of good quality, without discrimination, especially for vulnerable or marginalized groups. States also have an obligation to ensure adequate, equitable, and sustainable financing of their health systems to this end, including for health technologies, and to promote medical research. While many States may have limited resources, they must take necessary steps to the maximum of their available resources to meet these obligations. At the international level, States should cooperate to take joint and separate action to fully realize the right to health. Finally, the right to health requires the participation of affected populations in all health-related decision-making at the community, national, and international levels.

State obligations to ensure affordability

The obligation to fulfill the right to health requires States to take all necessary steps to ensure health technologies are financially accessible, i.e., affordable, on a nondiscriminatory basis. When markets alone do not facilitate access to health technologies for people who need them, States must intervene in order to fulfill the right to health, particularly for vulnerable or marginalized groups. In most cases, this will require States to both (1) enact effective laws and regulations in the private health sector and (2) engage directly in procurement and distribution of health technologies.

The obligation to protect the right to health requires States to prevent non-state actors from interfering with individuals’ enjoyment of the right to health. This includes an obligation to implement effective laws and regulations in the private health sector, in order to prevent infringements on the right to health by private entities, such as through prohibitively high pricing of health technologies.

The obligation to respect the right to health requires States to refrain from enacting laws or regulations that violate the right to health, including those that restrict access to health technologies. This includes an obligation to refrain from entering into bilateral or multilateral agreements that result in infringements of the right to health, such as those that impose strict requirements in the area of intellectual property rights for health technologies, resulting in unaffordable prices.

State obligations to ensure availability

The obligation to fulfil the right to health requires States to ensure health technologies are available for those who need them, on a nondiscriminatory basis, especially for vulnerable or marginalized groups. When health technologies do not exist because of the structure of incentive systems for research and development, States must intervene, including through promotion of medical research. As with efforts to address unaffordability, in most cases, this will require States to both (1) enact effective laws and regulations in the private health sector and (2) engage directly in the funding, research, and development of health technologies. That is, in order to ensure health technologies are available for those who need them, States must act to create an enabling environment that spurs research and development in the private sector that meets public health needs, as well as fund and conduct public research and development of their own.

The obligation to protect the right to health requires States to ensure innovation of health technologies in the private sector does not infringe the right to health. This includes an obligation to ensure research and development priorities do not result in de facto discrimination, such as when medicines are not available for conditions affecting certain groups, and that special attention is paid to the needs of vulnerable or marginalized groups. The State must intervene in either case to guide private research and development through laws and regulations aimed at protecting the right to health.

The obligation to respect the right to health requires States to refrain from acting in ways that make health technologies unavailable. This includes, as with unaffordability, an obligation to refrain from enacting laws or policies that make health technologies unavailable, including those imposed through bilateral and multilateral agreements.

Solutions to Ensure Affordability and Availability of Health Technologies as Required by the Right to Health

In this section, we consider specific ways States can meet their obligations to respect, protect, and fulfill the right to health, as outlined above, to ensure affordability and availability of health technologies. We discuss both fixes to the current system and solutions that contribute to the development of new incentive mechanisms to promote innovation that meets global health needs.

Solutions to ensure affordability of health technologies

The global system of research and development of health technologies must ensure access to the fruits of innovation—most importantly, that health technologies are affordable to those who need them. This is especially true in the case of publically funded health technologies. In some cases, in order to ensure health technologies are available, States must engage directly in funding and research, as noted above. In the current system, publicly funded research is often used by private developers to produce health technologies that are later sold at prohibitively high prices. Such practices contravene the right to health. To ensure this does not occur, private use of public funds and publicly funded research must be strictly conditioned upon ensuring access to the resulting health technologies, particularly for vulnerable or marginalized groups. Ideally, this will involve ex ante negotiations to set affordable prices prior to the allocation of public funds or use of public research, but it may also involve compulsory price reductions after production. To facilitate this, information about public contributions to research and development should be made transparent and easily accessible, in line with States’ obligation under the right to health to ensure access to health information.

A number of fixes to the current global intellectual property system are available for use by States to ensure health technologies are affordable pursuant to the right to health:

First, flexibilities allowed under the TRIPS Agreement must be fully utilized in order to ensure intellectual property protections do not result in unaffordable health technologies. These include: use of compulsory licenses for production of patented health technologies; limitations on the scope of patentability for health technologies; and prohibition of data exclusivity, especially for technologies developed through use of public funds or research. For example, in India, Section 3(d) of The Patents Act, 1970 limits the scope of patentability for pharmaceutical products by requiring producers to demonstrate an “enhancement of the known efficacy” of new forms of known substances.

Second, the TRIPS Agreement should be amended to make clear that it is subject to international human rights law. While the Doha Declaration on the TRIPS Agreement and Public Health makes explicit that TRIPS must not prevent Member States from taking steps to protect public health, the WTO must go further and explicitly allow States to consider their obligations under the right to health during TRIPS implementation. The WTO Dispute Settlement Body (DSB) should also explicitly consider the requirements of international human rights law, and the right to health in particular, during disputes involving health technologies. International human rights experts, including the UN Committee on Economic, Social and Cultural Rights and the UN Special Rapporteur on the right to health, should provide guidance and analysis to Member States and the DSB on States’ obligations under the right to health in relation to the TRIPS Agreement.

Third, States should develop mechanisms that allow for pre- and post-grant challenges to patents for health technologies based on international human rights law. In particular, such mechanisms should allow interested parties, including civil society and patients groups, to oppose patent applications and recent patent grants that threaten to make health technologies unaffordable in violation of the right to health. Similar mechanisms exist and have been used with success in some States, including India. In addition to denying or invalidating patents, successful pre- or post-grant challenges based on the right to health could result in the granting of a compulsory license or other forms of relief. In order to ensure such challenges are adjudicated properly, the capacity of domestic intellectual property tribunals to consider human rights grounds must be strengthened through training and inclusion of judges with appropriate expertise.

Fourth, States should consider creating an independent government body that reviews all health technology patent applications in light of the right to health and the obligation to ensure health technologies are affordable for all who need them. Such a body should be comprised of public health and human rights experts and representatives from affected communities, patients groups, and civil society. The body should have the authority to reject or modify patents that threaten to infringe the right to health and to condition the grant of a patent on ensuring affordability, such as through voluntary licensing or pre-negotiated prices. The Brazilian Health Surveillance Agency (ANVISA) represents a body with similar authority that may serve as a model.

Fifth, when public funds or public research are used by private producers to develop health technologies, States must ensure there is complete transparency and that all commercialization is contingent upon on ensuring access to people who need the technologies. This could entail a number of things, including publishing the terms of contracts between the State and private developers, ensuring all contracts explicitly provide for post-clinical trial access, and providing for public comment and participation in the development of public research agendas.

Solutions to ensure availability of health technologies

In order to satisfy the demands of the right to health, the global system of research and development must ensure health technologies are available to those who need them, without discrimination and with special attention paid to vulnerable or marginalized groups. Systems must be developed that promote innovation tailored to meet public health needs, particularly for neglected diseases and other conditions primarily affecting the poor. This requires States to act to overcome the primary obstacle to such innovation—market failure.

A treaty-based system of mandatory resource pooling and coordination for research and development of new health technologies founded on States’ obligations under the right to health presents one option toward this end. The UN Consultative Expert Working Group (CEWG) on Research and Development: Financing and Coordination has recommended that steps be taken to develop a global framework convention based on articles 19, 21, and 23 of the WHO Constitution under which global financial resources would be pooled and coordinated to promote research and development. Contributions would be mandatory and based on States’ ability to pay, as negotiated under the terms of a treaty. The CEWG proposes the framework not to replace the current global intellectual property system, but to function as a “supplementary instrument”; however, the framework could be the primary mechanism for research and development of health technologies for neglected diseases and conditions primarily affecting the poor. Given the WHO’s global remit and role as standard setter, it is best situated to take on the role of coordinator. However, in accordance with the right to health, the framework must establish a central role for affected communities, patients groups, and civil society in all its processes.

It is not sufficient, however, only to overcome market failure. The design of the global system for research and development must also ensure the affordability of new health technologies pursuant to States’ obligations under the right to health. As discussed, the current incentive system based on intellectual property rights and patents results in prohibitively high prices for new technologies, due to producers’ ability to exclude competition and charge monopolist prices. In order to both overcome market failure and ensure affordability, States should increase investments in alternative incentive models based on three principles: (1) delinkage (2) open innovation, and (3) licensing for access. This can be done unilaterally by individual States and through the targeted use of funds pooled and coordinated under the treaty-based system discussed above.

Each principle serves a specific function in either reducing the price of new health technologies or promoting development of technologies that meet public health needs. Delinkage disconnects the price of new technologies from investments in their research and development in order to ensure they are affordable. Open innovation facilitates the sharing of critical technical expertise, manufacturing know-how, and other information essential to developing safe and effective health technologies. Licensing for access, through voluntary and compulsory licenses, allows producers, including generic manufacturers, to make use of existing patents to create new products, therapeutic combinations, or reformulations, and to sell existing patented products at lower prices. Alternative development models in use now, including prize funds, open laboratories, and advanced market commitments, make use of some or all of these principles.

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