UNDP Study Calls On South Africa To Use TRIPS Flexibilities For Medicines Access

A newly published study from the United Nations Development Programme (UNDP) outlines significant problems in accessing medicines in South Africa – which is said to have the highest number of people living with HIV in the world – and urges its government to use available tools under international trade law such as exceptions to patents on needed medicines.

The study, entitled, Using Law to Accelerate Treatment Access in South Africa, is available here [pdf].

It comes at a time when South Africa is drafting a national IP policy, and is under pressure to incorporate measures ensuring medicines access and local innovation.

According to a summary, the study “focuses on policy options available in three interrelated areas of patent, competition and medicines law affecting access to HIV treatment and other essential medicines.”

“The recommended reforms are aimed at safeguarding public health by optimizing the use of public health related TRIPS flexibilities and therefore, the policy space available to countries at the WTO,” it said. “Potential drawbacks and challenges are highlighted, as are strategies for adoption that draw on the experiences of other low- and middle-income countries.”

TRIPS refers to the 1994 World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights.

The study says: “Accelerating access to affordable, quality-assured treatment is an essential component of South Africa’s National Strategic Plan (NSP) on HIV, STIs and TB 2012–2016. Of note, the NSP recognizes that the cost of anti-retroviral medicines remains the single greatest expenditure in the NSP’s annual budget. The NSP also calls attention to ‘ensuring an enabling and accessible legal framework that protects and promotes human rights in order to support implementation of the NSP’.”

The study, authored by Chan Park, Achal Prabhala and Jonathan Berger, suggested that in order to boost innovation and local pharmaceutical industry growth, South Africa “could move towards an examination system, by initially implementing an opposition-based and/or partial examination system. This would reduce the number of patents currently being granted through its current registration system, which does not involve a substantive examination of patent applications.”

It contains discussion of the use of compulsory licensing, measures for addressing “evergreening” of patents, disclosure requirements, and anti-competitive measures. It also discusses enforcement mechanisms and counterfeits. The aim of the suggested steps is to streamline access and reduce delays, it said.

“The pursuit of the law reform recommendations found in this paper can contribute to the Government’s achievement of its policy objectives and Constitutional commitments to respect, protect, promote and fulfil the right to medicines not only for these diseases,” it said, “but also for other HIV co-infections and non-communicable diseases.”

Medicines Access and Draft National IP Policy

Meanwhile, several nongovernmental groups, including Médecins Sans Frontières (MSF, Doctors without Borders), have been working under the ‘Fix The Patent Laws’ campaign to call for reforms to the country’s IP laws to increase access to affordable drugs.

According to an MSF release, the desired reforms include:

–       “implementing an examination systems for all pharmaceutical patents
–       strengthening patentability criteria for drugs
–       enhancing transparency of the Patent office around patent applications
–       allowing for pre- and post-grant oppositions to patents
–       making compulsory licensing easier
–       allowing for research on new drugs under patent.”

The draft policy was published for public comment in early September, the release said, and was welcomed by the campaign, as “the principles outlined set the stage for changes that will increase competition in the pharmaceutical sector and lower the price of medicines in South Africa.”

Separately, a group of South African academics has submitted comments to the Department of Trade and Industry about the new draft national policy. Their comments are available here.

Despite errors in the text, they said, “the overall intention of the draft policy is in our view good: it is grounded in a developmental approach appropriate to our country, and seeks to eliminate the many negative outcomes of IP protection which are detrimental to the broader society.”