For decades, South African patients have grappled with inaccessible health care services and affordable drugs - even while on medical aid.
Nearly eight years after the South African government committed to reforming the country’s patent laws in 2009, the Department of Trade and Industry (the dti), has finally released a new draft Intellectual Property Policy. The move has since been welcomed by 34 patient advocacy groups who make up The Fix the Patent Laws Coalition (FTPL).
The release of the policy has been described as a positive step towards advancing the constitutionally guaranteed right of access to health care services and access to affordable drugs.
“Many people in South Africa continue to die and suffer because they cannot access the medicines that they need,” says Claire Waterhouse, Doctors Without Borders (MSF) Access Campaign advocacy officer. “This policy provides hope to those people. It is up to the government to deliver on this promise by swiftly implementing wide-ranging law reform in line with this policy”.
Without these reforms, many medicines for cancer, hepatitis, tuberculosis and mental health in South Africa will remain unaffordable or unavailable in South Africa and people will continue to suffer and die, the Fix the patent LAWS campaign said in a statement.
Entecavir – a chronic medicine to treat hepatitis B – is unavailable in the public sector due to its cost. It is available in the private sector at more than R5 500 per month, while in comparison, it is available in India at R480. Celecoxib – which treats pain in patients with rheumatoid arthritis and osteoarthritis – is 80 percent more expensive in South Africa than India.
Although the FTPL will study in detail the draft policy and make comprehensive comments to assist the dti and partners to implement the reforms, the coalition has shared its preliminary views that strongly support the draft policy.
In particular, the coalition supports the following:
1. We support the implementation of a system of substantive search and examination of patent applications in order to ensure compliance with existing law and to ensure that only applications deserving of patent protection are granted. We agree with the proposed incremental approach, which we submit can be achieved by starting with the pharmaceutical sector and by considering outsourcing of the examination of applications for patents.
2. We support the recommendation to introduce pre- and post-grant opposition procedures in our law. We agree that such procedures are beneficial in that they ensure that the patent examiner has access to relevant information concerning the patent application. Third parties, which could include generic companies and civil society groups, will be able to assist the patent examiner in the decision-making process. We encourage an administratively cost-effective procedure and wide access to information concerning patent applications to enable third parties to intervene. We will make detailed submissions on potential interim procedures to enable such interventions as early as possible.
3. We welcome the commitment to develop patentability criteria in line with the state’s “constitutional obligations, developmental goals and public policy priorities” as well as the intention to utilise available flexibilities to strike the correct balance between promoting innovation and protecting the rights of IP holders and users (patients). We hope that this stated intention will lead to fewer poor quality or ever-greening patents being granted in South Africa and that instead only true innovations will be rewarded with patent protection.
4.We support the recommendations to introduce non-judicial, cost effective and expeditious mechanisms to obtain medicines through the issuance of compulsory licences. In this regard, we support the recommendation to remove the requirement that a government department first negotiate terms of a licence before approaching a court to seek a compulsory licence. This is not required by the TRIPS Agreement and should be removed through the necessary amendments to the Patents Act.