Fix the patent laws

The Fix the Patent Laws (FTPL) coalition was started in 2011 by the Treatment Action Campaign, Doctors Without Borders and SECTION27 to advocate for reform of South Africa’s outdated drug patent laws to improve medicine affordability and accessibility. 

During 2015, key cancer groups joined the Fix the Patent Laws coalition, including People Living With Cancer, Advocates for Breast Cancer, CHOC Childhood Cancer Foundation, CanSurvive, the Cancer Association of Southern Africa and the umbrella organisation, Cancer Alliance – sending a strong message to government and other stakeholders that patent law reform is a critical issue for people living with cancer.

Since its launch, the FTPL coalition has sought to draw attention to the negative impact of South Africa’s patent laws on health and how the adoption of international norms to protect health would help make medicines significantly more affordable and easier to access.

Patents are a form of commercial monopoly that are granted by governments to companies and individuals to reward them for innovation. International trade agreements require that these monopolies are granted for 20 years. Yet, companies routinely apply for multiple, secondary patents on individual medicines, which often extends their monopoly on the drug well over 20 years.

Outside South Africa, many pharmaceutical patent applications are rejected or overturned for not meeting the innovation standards required for patent protection or inhibiting medicine access. Yet in South Africa, these same patents are almost always granted and rarely overturned as a result of systemic shortcomings and the lack of health safeguards in the country’s patent laws. This impacts most severely on users of both the public and private health system in South Africa who don’t have access to more affordable generic and biosimilar products available outside of the country.

During the period that a medicine is under patent, only the patent holder is allowed to market the medicine in the country. Without competition, companies commonly charge extremely high prices for their products that far exceed the initial costs of development and production. When the patent period ends or is overturned, generic or biosimilar versions of these medicines are able to enter the market causing prices to topple.

This was most clearly seen with the introduction of generic antiretroviral drugs (ARVs) in South Africa during the 2000s, following significant public pressure and patent challenges by patient groups. The price of a first line ARV regimen in South Africa fell by 94% after generic products were introduced and today more than 3.2 million people in the country are receiving lifesaving ARVs – a remarkable achievement that could not have been realised without access to affordable generics.

Nonetheless, despite this important victory, many newer ARVs and critical medicines to treat other illnesses, such as cancer, remain under patent and inaccessible to the majority of people that could benefit from them – as illustrated by trastuzumab and sorafenib.

Tratuzumab is a critical medicine used to treat HER2 positive breast cancer that is marketed by Roche in South Africa under the brand names Herceptin and Herclon. A recommended 12-month course of trastuzumab costs R485, 800 in the private sector. Due to its high cost, trastruzumab is not offered to the majority of public sector users that could benefit from it, nor is it fully covered by private insurers. As more competitor products are developed, the prices of trastuzumab will likely fall in countries where patent monopolies have expired – including the UK, India and South Korea. But South African patients may miss out on price reductions if patent barriers lasting until 2033 are not addressed.

Sorafenib is a critical medicine used to treat kidney, liver and thyroid cancer, that is marketed by Bayer in South Africa under the brand name Nexavar. Given the high cost of sorafenib, private insurers are not currently required to cover its full cost and it is not available in the public sector. Patent monopolies granted in South Africa could block the use of generic versions until 2027. Generic sorafenib is already available in India, where patent protection was overturned because it was deemed harmful to people’s health, at 94% lower prices than Bayer’s brand name version in South Africa.

To improve access to critical cancer medicines, including trastuzumab and sorafenib, South Africa must reform its outdated patent laws. This process must be initiated by the Department of Trade and Industry, which is the government department responsible for intellectual property policy and legislation.

Responding to pressure from the Fix the Patent Laws coalition, the Department of Trade and Industry committed in 2013 to undertake reform of South Africa’s patent laws to address the country’s health needs. Nevertheless three years later, aside from requests for public submissions from interested parties, little concrete action has been taken.

During 2016, the Fix the Patent Laws campaign will scale-up pressure on the Department of Trade and Industry to urgently embark on life-saving reform.

To learn more about Fix the Patent Laws and opportunities to support pro-public health reform of South Africa’s patent laws visit www.fixthepatentlaws.org

Written by Catherine Tomlinson and Claire Waterhouse.

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