MSF urges South Africa to stand strong, move ahead on patent law reforms, in defiance of aggressive pharma opposition to delay change and keep drug prices high

Johannesburg/Geneva, 20 January 2014 – Médecins Sans Frontières (MSF) is encouraged that the South African government is standing strong against a broad multinational pharmaceutical industry effort to undermine and delay the country’s effort to reform its patent laws and improve access to affordable medicines.

Documents leaked on 17 January (see more here) reveal plans for a covert, large-scale public relations campaign with a US$600,000 (R6 million) budget, financed largely by the US-based pharmaceutical lobby. The goal of the proposed strategy is to disrupt the country’s long-awaited plans to bring into force public health safeguards absent in its patent system. These changes would, among other initiatives, ensure that companies cannot unfairly extend monopolies by simply changing a formulation or combining two medicines into a single tablet, and registering a new patent for this obvious change. This practice of patent ‘evergreening’ unfairly blocks generic competition and keeps drug prices high, limiting patients’ ability to access the life-saving medicines they need.

Countries such as Brazil and India have struck the right balance between promoting public health and access to medicines, while also protecting companies’ intellectual property rights by granting patents for innovative developments. South Africa’s new IP policy would modernise South Africa’s laws in line with other middle income countries and international norms, and set a positive example for other countries in Africa who are also involved in patent law reform processes, but also want to ensure patients have the medicines they need.

“Thanks to leaked documents, we know that South Africa represents ‘ground zero’ for the looming legal battles on intellectual property between pharmaceutical companies and middle-income countries seeking access to affordable medicines for their people,” said Dr. Manica Balasegaram, executive director of MSF’s Access Campaign. “Big pharma doesn’t want South Africa to reform its patent system and laws because they know other countries will follow suit.”

Because South Africa blindly hands out patents without examining their quality—granting more patents on medicines than even the U.S. and Europe—the country often cannot access generics available in other countries. Multiple patents on medicines in South Africa lead to some of the longest delays in the developing world for the introduction of generic competition. In some cases, such as for cancer medicine imatinib, South Africa pays up to 35 times more for originator products than other countries pay where robust generic competition is available.

The pharmaceutical companies’ tactics to delay reform are a bid to evergreen as many drugs as possible before changes to the law go into effect. This will allow them to continue capitalizing on the market monopolies and increased profits evergreening of patents offers.

“The effort by big pharma to undermine national patent law reform comes as little surprise, since these are the same companies that tried to deny South Africans affordable antiretroviral medicines over a decade ago in the face of an exploding HIV epidemic,” said Andrew Mews, Head of Mission for MSF operations in South Africa. “History is repeating itself, with medicines to treat drug-resistant tuberculosis, cancer, and other diseases patented and priced out of reach for people and the health department.”

“We have seen outstanding results since pressuring companies into allowing generic ARVs into South Africa—lower prices improve access and have not harmed research and development into new HIV treatments. The government is now well-positioned to speed up necessary changes by passing the new policy, and improving implementation of existing patent rules as soon as possible.”

Background

In September 2013, South Africa’s Department of Trade and Industry (DTI) proposed reform of the intellectual property system and published the Draft National Policy on Intellectual Property (DNPIP) for public comment.

Chapter 1 of the DNPIP recommends the use of a substantive search and examination system to determine whether applications, especially in the pharmaceutical sector, are valid or not.

Chapter 2 of the DNPIP notes that South African legislation should enact stricter criteria for granting a patent. Chapter 1 of the DNPIP notes that South Africa should provide for a pre- and post-grant opposition mechanism within national law to enable third parties to oppose weaker patents that fail to meet patentability standards.

Chapters 1 and 2 of the DNPIP acknowledges the need to modify existing legislation and regulations to address the difficulties in using both compulsory licensing and parallel importation measures, as neither provision has been successfully used to date on a pharmaceutical product.

Since November 2011, MSF, along with local partners, Treatment Action Campaign (TAC) and SECTION27 (S27), have run the “Fix the Patent Laws” (www.fixthepatentlaws.org) campaign in support of the DTI’s intention to reform the intellectual property system. A joint submission from MSF/TAC/S27 commenting on the DNPIP can be accessed here.