Nearly two billion people lack access to the medical care they need, and in the developing world those who do manage to have access are overwhelmingly paying out-of-pocket, often triggering a fall into poverty. The monopoly-making power of patents to drive the cost of medicines beyond affordability is a significant contributor to this disturbing trend, says a report of the United Nations rapporteur on the right to health presented at last week’s Human Rights Council.

The ultimate goal of developed countries “was and is the universal harmonisation of IP laws according to their standards,” the report asserts. They have tried to push such harmonisation through the World Trade Organization Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement as well as through free trade agreements. While flexibilities in TRIPS exist, developing nations often lack the capacity to or are the subject of political pressure not to use them.

“From a right to health perspective,” it adds, “developing countries and LDCs” need to use flexibilities that remain in the TRIPS agreement, in particular to create exceptions to patent rights, issue compulsory licences, and facilitate parallel importation.

Developing countries need to be particularly careful when negotiating free trade agreements on a bilateral or regional basis, the report says. Such agreements “have extensive implications for pharmaceutical patent protection” and “are usually negotiated with little transparency or participation from the public, and often establish TRIPS-plus provisions [that] undermine the safeguards and flexibilities that developing countries sought to preserve under TRIPS.”

TRIPS-plus measures include extension of patentability terms, the introduction of exclusivity of use on data gleaned from clinical trials, the linking of a patent status with a drug registration and approval (so generic versions of drugs under patent cannot be approved for market), and the creation of new enforcement mechanisms.

These free trade agreements can “severely impede access to medicines,” said report author special rapporteur Anand Grover, when he presented [pdf] at the Human Rights Council on 2-3 June. The Human Rights Council is meeting from 2 – 18 June; the report is available here [pdf].

The special rapporteur on the right to health is mandated [pdf] to submit an annual report to the Human Rights Council detailing information about, and recommendations for improving, the realisation of the right to the highest possible standards of physical and mental health.

Grover expressed the hope, according to a summary of the 2-3 June event, that the Human Rights Council would address these intellectual property issues in the form of a resolution.

But it is unclear that they will do so. A member of the HRC secretariat told Intellectual Property Watch that it is now up to the member states to decide what to do with the report.

The report recommends that developing countries introduce national laws incorporating TRIPS flexibilities, including procedures for issuing compulsory licences. Full use of a grace period in adopting all aspects of the TRIPS agreement afforded to least developed countries should be encouraged, and TRIPS-plus standards should not be introduced, it adds. And developing countries should seek – and receive – technical assistance from international agencies to help build their capacity in implementing TRIPS flexibilities, it concluded.

Anand Grover was appointed special rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health in the summer of 2008. As an attorney in India, he directs the HIV/AIDS unit of the Lawyers Collective, a human rights and public interest law firm. His full bio is available here.

States Respond to Report

The report received a mixed reception at the HRC, with the United States and Switzerland in particular saying that Grover’s report was attempting to weaken the TRIPS agreement, according to a press release summarising the council’s discussions.

Achamkulangare Gopinathan of India said that TRIPS does not undermine the rights of governments to take measures to protect public health, and that the 2001 Doha Declaration on Public Health affirmed that view, according to the press release.
Norway, Australia and others agreed that TRIPS flexibilities could be used to aid public health goals, and Grover said his report did not extend beyond encouraging the use of these flexibilities.

Jurg Lauber of Switzerland said that Grover’s report indicated the lack of market incentives was the main issue in explaining why research and development for neglected diseases is also insufficient, and needs be further explored, according to the release.

But “the protection of public health must prevail over private interests,” said Jean Feyder of Luxembourg. And Joelle Hivonnet of the European Commission said there are “growing difficulties” in getting medications under patent produced in generic form, and asked if Grover would look into the possibility of patent pools, in which rights owners agree to licence intellectual property relating to certain technologies as a collective, rather than as individual patents.

According to the summary, Victoria Romero of Mexico added that in the case of pandemics, such as the recent outbreak of H1N1 or swine flu, responses should take into account the “full respect of human rights and fundamental freedoms.”

And Muhammed Saeed Sarwar of Pakistan suggested technology transfer should be encouraged in order to help developing countries improve their capacity to manufacture medicines.

Access to and innovation of medicine is more complex than just IP rights, said Imad Zuhairi of Palestine, despite the fact that IP is an important incentive for innovation. Situations of poverty and occupation, such as exist in Gaza, may prevent access to health care no matter the IP regulation, added Zuhairi [name corrected], asking how the free flow of technology could be accomplished “for people whose movements were restricted.”

The Role of Pharmaceutical Companies

Others said that non-state actors, especially international pharmaceutical companies, have a key role in access to medicines that needed further consideration.

Pharmaceutical companies as well as states have a duty to respect the human right to health, said Grover. As a part of his role he visited the offices of brand drug producer GlaxoSmithKline in London, and found that they had made strides in aiding the goal of access to medicines by reducing the prices of their drugs in least developed countries and via patent pooling. Some still remain unaffordable, however, and the company had previously, for example, sued South Africa in an attempt to stop a law intended to make use of TRIPS flexibilities to create generic competition on drugs for HIV/AIDS. Grover encouraged GSK to publicly commit not to push for TRIPS-plus regulation.