Campaigning for pro-public health reform of South Africa’s Patents Act
A Treatment Action Campaign briefing document: The Agreement on Trade Related Aspects of Intellectual Property (“the TRIPS agreement”), effective from 1 January 1995, set standards of intellectual property protection that member states of the World Trade Organisation (WTO) are required to uphold in their own national laws.
The TRIPS agreement requires WTO member countries to provide 20 years of patent protection on pharmaceuticals and all other products that meet patentability criteria (previously South Africa provided 16 years of patent protection). During this period the patent holder has exclusive rights to market the medicine – although it typically takes a few years before a medicine can be brought to market.
Given that pharmaceutical companies face no competition during the patent period, they often charge extremely high prices in order to maximise profits. During this period medicines will often remain unavailable through the public sector or to those whose medical schemes do not cover the full cost of medicines and cannot afford to pay the full or partial cost out of pocket.
Given valid concerns by WTO members that the TRIPS agreement would undermine countries’ ability to achieve the right to health, the Doha Declaration on the TRIPS agreement and public health (“the Doha Declaration”) was made on 14 November 2001. The Doha Declaration was important because it clarified the rights of members to use flexibilities contained in the TRIPS agreement to protect health and states that the TRIPS agreement “should not prevent Members from taking measures to protect public health... and should be interpreted in a manner supportive of WTO Members’ right to protect public health and, in particular, to promote access to medicine for all.”
On 16 November 2011, TAC and Médecins Sans Frontières held a press conference in which we explained that, more than a decade after the Doha Declaration, South Africa has not utilised the pro-public health flexibilities contained in the TRIPS agreement. In order to utilise the flexibilities existing in international trade law to protect health, they first need to be written into South Africa’s national legislation. We argue that the state has a constitutional obligation to make these legislative changes in terms of section 27 of the South African Constitution.
There is a pressing need for South Africa to take urgent steps to address the lack of access to many important, life-saving medicines and curb the rising costs of medicines. Through activism, complaints at the competition commission, the entry of generic medicines and successful tenders we are now able to access a number of affordable 1st line antiretroviral medicines for HIV. However, some important 1st and 2nd line medicines remain unavailable because of patent protection. Currently, there are no 3rd line antiretroviral treatments provided through the public sector, despite the growing number of patients in need of these medicines.
The barrier of cost created by the current patent system in South Africa extends beyond HIV. Many important cancer medicines are simply not provided in the public sector due to their high costs. The private sector also sometimes pays medicine prices far higher than charged even in some developed countries – this is partly due to the extremely high number of patents granted in South Africa.
Amending our laws to include public health safeguards will reduce the cost of key medicines for government, private medical schemes, and for patients and their families.
Overview of flexibilities
There are a number of legal flexibilities available to South Africa that would ensure that the patents office only reward real innovation and prevent ‘evergreening’ or abusive patenting. If fewer patents are granted, then more generic versions of medicines will be able to enter the market, which will drive down prices.
South Africa can limit the number of pharmaceutical patents granted by tightening patentability criteria, ensuring that all pharmaceutical patent applications are properly examined, and by allowing third parties to oppose the granting of patents.
South Africa also has the flexibility under the TRIPS agreement to access generic versions of patented medicines in cases where medicines remain inaccessible, due to high cost or inadequate supply, by issuing compulsory licenses. Even though the Patents Act already provides for compulsory licenses, these provisions have not been used - in part due to sub-optimal terms and procedures for issuing compulsory licenses.
This briefing paper details the legislative amendments that South Africa can make (within its rights under the TRIPS agreement) to its Patents Act 57 of 1978 (“the Patents Act”). These amendments will facilitate the use of flexibilities within TRIPS to protect health. (2012)
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