Rights expert recommends new IP regime for pharmaceuticals

Pointing to concerns that intellectual property laws may undermine the enjoyment of human rights, including the right to science and culture, a UN rights expert has called, among others, for a new intellectual property regime for pharmaceutical products that is consistent with rights law and public health needs.

by K.M. Gopakumar

GENEVA: The United Nations Special Rapporteur in the field of right to culture, Fareeda Shaheed, has recommended a new intellectual property (IP) regime for pharmaceutical products, stressing that there is no human right to patent protection.

This recommendation was made in her report to the current 70th session of the UN General Assembly.

The Special Rapporteur recommends that “the United Nations should convene a neutral, high-level body to review and assess proposals and recommend a new intellectual property regime for pharmaceutical products that is consistent with international human rights law and public health requirements, and simultaneously safeguards the justifiable rights of inventors”.

This is drawn from the recommendation of the Global Commission on HIV and the Law appointed by the UN Development Programme (UNDP).

[The Global Commission made the following recommendation with regard to patents and access to medicines: “The UN Secretary-General must convene a neutral, high-level body to review and assess proposals and recommend a new intellectual property regime for pharmaceutical products. Such a regime should be consistent with international human rights law and public health requirements, while safeguarding the justifiable rights of inventors. ... Pending this review, the WTO [World Trade Organization] Members must suspend TRIPS [Trade-Related Aspects of Intellectual Property Rights Agreement] as it relates to essential pharmaceutical products for low- and middle-income countries.”]

Two other important recommendations by the Special Rapporteur are:

l     States have a positive obligation to provide for a robust and flexible system of patent exclusions, exceptions and flexibilities based on domestic circumstances, including through the establishment of compulsory and government use licences when needed.

l     States have a human rights obligation not to support, adopt or accept intellectual property rules, such as TRIPS-plus provisions, that would impede them from using exclusions, exceptions and flexibilities and thus from reconciling patent protection with human rights. International agreements that do not provide sufficient flexibility should be renounced or modified.

The report focuses on patent policy for the enjoyment of the right to science as provided in Article 15.1(b) of the International Covenant on Economic, Social and Cultural Rights (ICESCR), which establishes that State Parties recognize the right of every one “to enjoy the benefits of scientific progress and its applications”.

The report in its conclusion states: “A model of access to technology based on individual ability to pay is rational and legitimate from a purely commercial perspective. From a human rights perspective, however, deprivations through patent exclusivity may be deemed as arbitrary, discriminatory or disproportionate, depending on the extent to which human rights interests are implicated by the specific technologies at stake, and the degree to which patent exclusivity, rather than production costs, create the high prices.

“The obligations of States under intellectual property treaties must not jeopardize the implementation of their obligations under human rights treaties. Implementing unreasonably strong patent protection may constitute a violation of human rights.

“The human right to science and culture, as enshrined in Article 27 of the Universal Declaration of Human Rights and Article 15 of the International Covenant on Economic, Social and Cultural Rights, requires measures to ensure the affordability of and accessibility to technologies that are essential for a life with dignity and supporting the realization of other human rights.”

The Special Rapporteur’s report examines the following issues prior to making the conclusions and recommendations:

l     international and national legal framework of the right to science as well as patent policy;

l     inventors under Article 15.1(c) of the ICESCR, i.e., the moral and material interests of inventors and discoverers and the rights of indigenous peoples and local communities;

l     tensions between patent policy and the right to science and culture, such as the impact of patent policy on ensuring access to essential technologies and on the direction of scientific research;

l     asserting the right to science and culture in patent policy by promoting the right through exclusions and use of exceptions and flexibilities, and the importance of public participation.

The report is part of the Special Rapporteur’s examination of the impact of IP regimes on the right to science and culture. Earlier, the Special Rapporteur had submitted a report to the 28th session of the UN Human Rights Council titled “Copyright policy and the right to science and culture”.

Normative framework of the right to science

In the introduction, the Special Rapporteur recognizes the relationship between human rights and IP as “important and complex”. The report states, “The last decades have witnessed growing concern that the design and implementation of intellectual property laws may undermine the enjoyment of human rights.”

According to the Special Rapporteur, apart from the tension between patents and the right to health, the patent policy in the areas of agriculture, energy-saving and climate change technologies is feared to threaten enjoyment of the right to food and the right to a safe and sustainable environment.

The Special Rapporteur states that Article 15.1 of the ICESCR provides a framework for “reconciling the tensions between human rights and intellectual property laws”. She defines the normative content of the right to science as:

“(a)   access to the benefits of science by everyone without discrimination;

“(b)   opportunities for all to contribute to the scientific enterprise and freedom indispensable for scientific research;

“(c)   participation of individuals and communities in decision-making;

“(d) an enabling environment fostering the conservation, development and diffusion of science and technology”.

Further, the Special Rapporteur stated that “the spirit of the human right to science and culture recognizes human knowledge as a global public good and recommended that States guard against promoting the privatization of knowledge to an extent that deprives individuals of opportunities to take part in cultural life and enjoy the fruits of scientific progress”.

The Special Rapporteur notes the shift in the international patent regime from the 1970s to the TRIPS Agreement, which ignores the diversity of national needs. She also notes that in response to flexibilities in the TRIPS Agreement, corporations and some developed states “have pushed since its inception for a wider and stronger set of standards through add-on agreements, often called TRIPS-Plus treaties or provisions”.

Conveying clearly a sceptical view on the so-called benefits of the TRIPS Agreement such as increase in research and development investment, rewarding human creativity, disclosure of invention and development of new technologies, the Special Rapporteur states: “These claims need to be carefully weighed, taking into consideration the various interests at stake and the technologies in question (for example, some require expensive research, some do not). The effects of intellectual property rights are strongly context-dependent. It is not possible to expect the same outcomes in countries with very different levels of technological capacity and industrial profile.”

Aggressive patenting practices exploit such administrative weaknesses. The practice of patent “trolling” and the proliferation of patent thickets – where the right-holder’s aim is not to manufacture any product or use the process but to launch frivolous lawsuits and collect fees based on ambiguous patent claims or exclude others from developing competing technologies – obstruct further development and dissemination of technology. High numbers of low-quality patents hinder research, legitimate competition and access to technology.

The Special Rapporteur also points out that the patenting of new uses or evergreening of patents would result in the extension of the patent life beyond the 20 years set out in the TRIPS Agreement.

She further expresses concern over the “appropriation of scientific knowledge through patents (such as patents on genes) and the patenting of discoveries (that is, pre-existing information versus inventions); of frivolous innovations; and the practice of misappropriation of indigenous and local communities’ innovations through patents”.

Inventors under Article 15.1(c) of the ICESCR

Even acknowledging the fact that the UN Committee on Economic, Social and Cultural Rights considers the term “author” to also include the creator of scientific innovations, the Special Rapporteur refutes the claim that Article 15.1(c) of the ICESCR recognizes intellectual property rights as a human right.

[Article 15.1(c) reads: “The States Parties to the [ICESCR] recognize the right of everyone … to benefit from the protection of the moral and material interests resulting from any scientific, literary or artistic production of which he is the author.”]

According to the Special Rapporteur, “The equation of intellectual property regimes with the human right to protection of the moral and material interests of authors is false and misleading”.

Further, she stresses that “intellectual property rights primarily protect business and corporate interests and investments”. Even though the report recognizes the use of the term “author” in Article 15.1(c) to include inventors and scientific discoveries, the right is limited to the moral and material rights of the inventions “with which they have a strong personal link similar to the link between an author in the traditional sense and their creative work of authorship”.

The report states: “This right does not provide patent holders’ grounds to challenge patent rules as providing inadequate protection of their financial or commercial interests. Nor can the right to protection of moral and material interests be used by States to defend patent laws that inadequately respect the right to science and culture.”

In the context of indigenous peoples, the report states: “International and national intellectual property regimes have historically failed to adequately take into account the concerns of indigenous peoples and local communities. The interests in maintaining control over non-commercial, communally created and historically rooted cultural assets tend to fall through the cracks of intellectual property regimes.”

In this regard, the Special Rapporteur acknowledges the work of the World Intellectual Property Organization’s Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore but remarks that the “progress seems uncertain”.

Tensions between patent policy

and the right to science

According to the Special Rapporteur, the right to science in Article 15.1(b) of the ICESCR clearly includes patented technologies.

The report clearly states: “The human rights perspective demands that patents do not extend so far as to interfere with individuals’ dignity and well-being. This may be the case, for example, when the patent-holder’s property right is so strong as to make compulsory licensing of medicines impracticable or unduly cumbersome.”

The Special Rapporteur highlights the adverse impact of patenting in the areas of pharmaceuticals, food, energy, information and communication technologies, nanotechnologies and synthetic biology. Further, the report says that lack of access to technology affects the enjoyment of the right to participate in the political, social, economic and cultural life of society.

According to the Special Rapporteur, “Interrogating the impact of patent policy on the right to science cannot be dissociated from interrogating its impact on the right to participate in cultural life and to pursue specific ways of life, such as in the case of small farmers”.

Asserting the right to science

According to the Special Rapporteur, “States must ensure that their patent laws are well-designed to promote the right of the public to participate in scientific progress, both through universal access to essential technologies and by eliminating or overcoming barriers to scientific research and technological development”.

Towards this purpose, the report calls upon governments to use flexibilities. It states: “It is crucial that international legal regimes on patents continue to leave room for countries to adopt and implement policies to abide by their human rights obligations.”

On flexibilities, the report emphasizes: “Although exclusions, exceptions and flexibilities are fully part of international intellectual property law, such as the TRIPS Agreement, they remain optional from the perspective of trade law. From the perspective of human rights, however, they are often to be considered as obligations.”

Recommendations

The report makes recommendations in the following areas: ensuring transparency and public participation in law-making; ensuring the compatibility of patent laws, policies and practices with human rights; exclusions, exceptions and flexibilities; adopting policies fostering the right to science and culture, including the right to scientific freedom; and indigenous peoples and local communities.

Some of the important recommendations are:

l     International patent instruments should be subject to human rights impact assessments and contain safeguards for human rights, including the right to health, food, science and culture.

l     The WTO bodies should take into account human rights standards and obligations when interpreting WTO rules on intellectual property. They should review rules that have a negative impact on the realization of human rights.

l     States should refrain from pressuring other states to adopt TRIPS-plus provisions or to otherwise forego the use of TRIPS-compliant flexibilities.

l     At the domestic level, judicial or administrative procedures should enable members of the public to request the implementation and expansion of exclusions, exceptions and flexibilities to assure their constitutional and human rights.

l     States should invest in science, ensure independence for researchers, guarantee their freedom to publish results and their ability to continue to undertake research, to improve existing technologies and processes, and to be innovators in their own context for their survival needs, regardless of patents.

l     Plant variety rules should not impede the right of small farmers to continue to use, save, exchange and sell farm-saved seeds and to continue to engage in experimentation, especially in situ.

l     Universities and other public research institutions should ensure that their licensing approaches are compatible with their primary mission to explore and develop technological innovations for the benefit of society.

l     States should do more to distinguish between generic medications and counterfeit medications. States through which generic medications transit have a responsibility to treat the generics in accordance with the law of the destination country.

l     As suggested by the Global Commission on HIV and the Law, the United Nations should convene a neutral, high-level body to review and assess proposals and recommend a new intellectual property regime for pharmaceutical products that is consistent with international human rights law and public health requirements, and simultaneously safeguards the justifiable rights of inventors.

l     Enhanced disclosure requirements in intellectual property legislation, such as sources, should be adopted to protect the right of attribution of communities whose traditional knowledge contributed to a patent application.

l     Companies benefiting from patents in the pharmaceutical sector should disclose information about the costs for developing drugs, the items included in such costs and the sums they reinvest in research and development. (SUNS8111)                          

Third World Economics, Issue No. 601/602, 16 September -15 October 2015, pp14-16