Discussions on access to essential medicines yesterday at the World Health Organization were in some ways overshadowed by the recent leak of a global pharmaceutical campaign aimed at derailing efforts by the South African government to revise its intellectual property policy. WHO Director General Margaret Chan strongly supported South Africa, as did several developing countries, while developed countries remained silent on the subject.

On the agenda of the 134th session of the WHO Executive Board (EB), meeting from 20-25 January, was an item on access to essential medicines. The secretariat submitted a report [pdf], on activities, such as supporting universal health coverage, monitoring and the use of information, rational use of medicines, antimicrobial resistance, innovation and the local production of medicines, and access to medicines for noncommunicable diseases. The report was commended by member states.

However, feeding the discussion was the recent effort by some pharmaceutical companies to undermine efforts of the South African government to amend its IP laws, revealed through a leaked document bluntly titled, “Campaign to Prevent Damage to Innovation from the Proposed Draft National IP Policy in South Africa,” (IPW, Public Health, 22 January 2014).

South Africa received support from many developing countries, such as Namibia, Brazil, Cuba, India, Argentina, Nigeria, Bolivia, and Zimbabwe, which qualified the incident as an “unfortunate attack on a sovereign state and an attack on the right to life in the interest of profit.” The delegate called on WHO to be diligent in its approach with dealing with non-state actors (IPW, WHO, 24 January 2014).

Precious Matsoso, director-general of health of the South African Ministry of Health, and former head of the WHO programme on Public Health, Innovation and Intellectual Property, delivered an emotional statement [pdf]. She said one of the objectives of the new South African IP policy is to contribute towards the protection and promotion of public health, and access to medicines in particular.”

“This is not the first time that South Africa has been under such an attack, even in the face of the most devastating HIV/Aids and TB co-morbidities,” in 2000, she said. “We’ve seen this attack whereby Nelson Mandela was the first respondent,” she added.

The cost of combination antiretroviral therapy per person per annum was brought down from US$ 10,000 to US$ 1,000 since 2000, she said. “This would not have been possible without generic competition,” she said, adding that South Africa has been able to put 2.4 million people on treatment. However, only 4 percent of South Africans are on second line antiretroviral therapy and that number must be increased to 14 percent, she insisted. This increase will not be possible at current costs for South Africa, she said.

“Generic competition has been the main driver of affordable medicines,” Matsoso said, noting that Canada, through its Bolar provision is “such an example” for having introduced early generic entry. The new South African policy that is under discussion will promote competition and ensure the levelling of the playing field, she said, adding, “We’ve seen IP reforms can really make a difference.”

The IP reform includes patent examination, said Matsoso, which is common practice in Europe, the United States, India and Brazil. “In all these countries poor quality patents are rejected. For instance, both the US and European Patent Office have rejected 40 percent of these applications when in South Africa, we actually approved all of them,” she remarked. She also said South Africa welcomed WHO technical support on policy reforms proposals in defence of public health. She ended her statement under a sustained round of applause.

Chan supported South Africa. She reminded delegates of the WHO 12th general programme of work, approved by member states, and its paragraphs 97, 98 and 99 on increasing access to essential, high-quality, effective and affordable medical products.

“I have been following the event in South Africa and I was very struck by what is happening and I have said so in other contexts and I will repeat again: no government should be intimidated by interested parties for doing the right thing in public health” she said. WHO, at the request of the South African government has commented on the draft policy. Chan thanked governments for their solidarity with South Africa and stated that “nobody should be denied access to life-saving intervention or medical products.”

Nicoletta Dentico, co-director of Health Innovation in Practice (HIP) said, “I found it politically embarrassing, and disquieting that, during the EB discussion, not one single delegate from the industrialised North took the floor to express a word of solidarity towards the government of South Africa.”

[Update:] Universities Allied for Essential Medicines (UAEM) issued a statement in support of South Africa at the EB.

[Update:] A delegate from India quoted the WTO Doha Declaration on TRIPS and Public Heath and its purpose. “Here it basically means to protect public health and in particular to promote access to medicines for all. It does not mention essential medicines.”

Draft Resolution on Access

A draft resolution [pdf] on access to essential medicines, not yet adopted, was put forward by China, Libya, South Korea and South Africa.

The draft resolution calls on the WHO to “provide, as appropriate, upon request, in collaboration with other competent international organizations, technical support, including, where appropriate, to policy processes, to Member States that intend to make use of the provisions contained in the TRIPS agreement, including the flexibilities recognized by the Doha Ministerial Declaration on the TRIPS agreement and Public Health and other WTO instruments related to TRIPS agreement, in order to promote access to essential medicines, in accordance with the Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property.”

Shortages, Affordability: Barriers to Access

Other concerns on access to essential medicines were voiced by developing countries who said that it is a pressing issue, citing affordability, shortages of medical products, and rational use of medicines.

Namibia, on behalf of the African region, said the most important barrier to access to essential medicines is affordability. The delegate called on WHO to support member states’ efforts to use of the flexibilities included in the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).

Brazil also underlined the use of TRIPS flexibilities. TRIPS should not prevent member states from taking measures to protect public health and guarantee access, the delegate said.

Qatar underlined that shortage of medicines as a dire problem. The delegate said market changes can affect generic medicines as generic companies do not have incentive to produce them.

NGOs, Pharma Focus on Use, Civil Society on IP

The International Pharmaceutical Federation underlined [pdf] the shortage of medicines and said that an independent report found that US$500 billion could be saved annually if responsible use of medicines were achieved.

Médecins Sans Frontières (MSF, Doctors without Borders), in its statement said it is “concerned by the lack of attention in the Secretariat’s report on the impact intellectual property has on the affordability and accessibility of medicines, and how this affects the inclusion of new treatments in essential medicines lists.”

“The intersection between intellectual property, innovation and public health is recognized in a number of WHO resolutions and in the TRIPS Agreement. Yet it remains a challenge for WHO member states, especially developing countries, to use these flexibilities when drafting intellectual property policies that aim to promote access to affordable essential medicines,” said the MSF representative. MSF also underlined IP clauses included in trade negotiations initiated by the United States and the EU.

Medicus Mundi International, a network of organisations working in the field of international health cooperation and advocacy, underlined the underfunding of the WHO programme on essential medicines.

A group of NGOs published a suggested draft resolution [pdf] on access to essential medicines.

Chan noted the points made by the NGO community, and told member states, “if these works is so important to you why are they left unfunded. This is a question you need to reflect on.”

Julia Fraser, an intern with Intellectual Property Watch, contributed to this story.