The Fix the Patent Laws campaign calls on the Department of Trade, Industry, and Competition (dtic) to urgently release the Patent Bill for public comment. Despite repeated promises the long-awaited Bill – that could pave the way for a new era in access to medicines in South Africa – remains unpublished.
“The dtic must urgently publish the Patent Amendment Bill for public comment. Nearly two decades have now passed since the government began the law reform process, and South Africa’s patent laws remain unchanged. What remains the same is that people do not have access to life saving medicines because they are too expensive. Despite the government having a constitutional obligation to prioritise the right to health, the profits of the multinational pharmaceutical industry continue to be protected. We remind the dtic that people’s lives depend on the rapid conclusion of this process. The dtic must urgently finalise the Bill and publish it for public comment as is required by the Constitution,” said Tendai Mafuma from SECTION27.
The Intellectual Property Policy of South Africa was adopted by Cabinet in May 2018. Yet to date no Bills to give effect to the policy have been published for public comment. 25 years after the signing of a critical international agreement (the Doha Declaration on Public Health) that gave countries the ability to change their laws to incorporate public health safeguards, South Africa has yet to write these safeguards into our national laws.
Reports from a recent Parliamentary briefing by the dtic and Companies and Intellectual Property Commission (CIPC) suggest that the Patent Amendment Bill will contain the following provisions:
- Incorporation of TRIPS flexibilities to bring South African patent law in line with international best practice and improving accessibility of the patent system;
- Introduction of substantive search and examination at the CIPC to ensure that patents are granted only when they meet the standard of genuine invention;
- Introduction of a pre-grant third party observation process to assist the evaluation of patent applications;
- Provision for the implementation of a post-grant patent opposition process when CIPC has established requisite capacity;
- Bringing compulsory licensing and government use provisions of South Africa in line with the TRIPS Agreement and international best practice.
The scope and manner in which these provisions will appear in the Bill require public comment and consultation due to the often direct, adverse impact of pharmaceutical patents on access to affordable generic medicines.
“The law reform process in South Africa has already taken far too long. Just imagine, we have been campaigning to Fix the Patent Laws since 2011! It is time that South Africa learns the valuable lessons from other countries already using their laws to protect public health. From Argentina’s strict definitions of what deserves a patent drastically reducing the number of patents they grant, to India’s system allowing people to successfully oppose dubious patent applications, or even Colombia’s recent compulsory license on a critical HIV medicine. Other countries are walking the walk, actually getting important and lifesaving medicines into the hands of people who need them. When will South Africa follow?” said Salomé Meyer from the Cancer Alliance.
The Parliament report suggests that a substantive search and examination (SSE) system will be introduced in South Africa – a longstanding demand of the Fix the Patent Laws campaign. While patent examination is already allowed for in the Patent Act, currently any patent for which the paperwork is filed and fees paid is granted. On top of this, South Africa currently has low standards for what deserves a patent. Because of this South Africa grants many patents that have been rejected in other countries – granting more pharmaceutical patents than even the United States or European patent offices.
Pharmaceutical companies exploit this, by making minor changes to their medicines and medical products, extending patent monopolies well beyond the 20 years required, blocking more affordable generics from coming to market for longer. This is known as “evergreening”.
How SSE is introduced and how the bill proposes to tighten patentability standards requires public comment, scrutiny, and consultation. The government must seek assistance from key development partners such as the United National Development Programme (UNDP) and the South Centre, to ensure that patent examination prioritises the right to health and is modelled on countries with similar socio-economic positions and health burdens.
Strict patentability standards are essential to the success of SSE and must be applied to curb secondary patenting, ensuring that only genuine innovation is rewarded. For example, in Argentina, patent examination regulations adopted in 2012 detailed how new use, new forms, and new formulation patents did not meet patentability criteria. Given the constitutional requirement to realise the right to health, South Africa’s Patent Bill too can design criteria that ensure that patents for new uses, new forms, new formulations, combinations, and other minor modifications of existing medicines are rejected.
This together with simplified pre- and post-grant patent opposition procedures – that allow third parties, such as civil society groups and generic pharmaceutical companies to intervene – will help ensure that only those inventions that represent genuine innovation will be granted patent protection.
Broad grounds for when a patent can be opposed must be adopted in the law as well as clear timeframes. Pre-grant oppositions should be allowed any time up to the grant of the patent – a system that has effectively helped patent offices in other countries by providing research, evidence, and support in patent examination. Post-grant oppositions should be allowed for at least a year after their granting as in India, where patent opposition have successfully secured access to many generic HIV and cancer treatments. Crucially there must not be limits set on who can file an opposition – any person including community groups or individuals must be allowed to object. Administrative procedures must also be adopted to ensure the system is workable and accessible, and fees should not be prohibitive. Access to patent data will also be critical. While South Africa has an online searchable patent database, it needs reworking to fully allow pharmaceutical patent monitoring and oppositions to take place. This requires robust disclosure requirements of both the patent office and patent applicants to help identify the pharmaceutical product related to a patent application.
The report to Parliament however suggests a diluted system of pre-grant observation may instead be included in the Bill, and post-grant opposition will be introduced at a much later stage. This suggests that the government is failing to confront the crisis in access to affordable generic medicines for people in South Africa with the urgency that is required.
The Fix the Patent Laws campaign has also repeatedly called for a more effective and efficient system to obtain compulsory licenses. Compulsory licenses are a vital tool – fully legal and in line with World Trade Organization (WTO) rules – to ensure access to medicines and other health products. They must be available on a wide variety of grounds, and in such a way that they can be granted quickly and effectively when needed for public health purposes. An efficient compulsory licensing system, for example, could have allowed us to gain rapid access to lifesaving Covid-19 vaccines during the height of the pandemic, while rich countries hoarded stocks.
While the South African government led endorsement of compulsory licensing on the international stage, our domestic laws remain unworkable. The current judicial process for granting licences is time consuming and costly, and the grounds and process for issuing compulsory licences are underspecified and unclear, creating a substantial barrier. According to UNDP it could take up to 3 years and cost over a million rand to undergo court proceedings to issue a compulsory license currently.
The Patent Bill must introduce specific grounds for compulsory licensing related to availability, affordability and accessibility of pharmaceutical products and processes – and simplify compulsory licensing processes and procedures. The public interest must also be prioritised by allowing community groups to be able to initiate compulsory licensing proceedings. With optimal terms and procedures, competitors and generic companies could also be encouraged to file for compulsory licences, especially for medicines not available in the public sector.
The incorporation of these public health safeguards into our national laws is critical to ensuring access to more affordable medicines, lowering the cost of key medicines to the public purse, and ensuring access to newer and better health products. The process must be infused in the public interest, and the role of community must not be overlooked as laws are being rewritten. Lessons from other countries reveal how the technical expertise of communities has ensured that patents are monitored, patent standards are upheld, dubious applications are rejected, and compulsory licenses have been supported. Ensuring that communities can engage in the implementation of these public health safeguards will be integral to their success.
Ensuring that the Patent Amendment Bill addresses these and many other concerns regarding the full use of TRIPS flexibilities in South Africa raised by the Fix the Patent Laws campaign requires urgent publication and consultation on the bill. The presentation of the dtic suggests that even the introduction of parallel imports may be limited to essential medicines or emergency products while no such restrictions are required under TRIPS.
After years of underfunding and austerity spending in the health system, and following the loss of significant resources from the United States to South Africa’s HIV and TB programme, ensuring the availability of more affordable medicines is even more critical to the overall public health system.
“We need a well-functioning healthcare system, where the dignity of all is respected and nobody is excluded – but the reality is that our clinics and hospitals are often in shambles. Every year we fail to fix our patent laws, increases the time we must pay inflated prices for medicines that do not even deserve a patent. That is money that could be paying for more healthcare workers, buying medical supplies, or improving conditions in our clinics. There is no more time to lose. Until the relevant Acts are amended, people in South Africa will continue to suffer and die because affordable medicines are not available, and because the public healthcare system is broken. Whether government can deliver the required legislative changes will be a key test of its commitment to the health of the people,” said Sibongile Tshabalala from the Treatment Action Campaign (TAC).
#FixPatentLaw
For more information or to arrange interviews contact:
Gillian Pillay | pillay@section27.org.za | 082 772 0052
Ndivhuwo Rambau | media@tac.org.za | 066 161 1048
The Treatment Action Campaign (TAC), SECTION27, and Médecins Sans Frontières (MSF) launched the Fix the Patent Laws campaign in November 2011 (on the 10-year anniversary of the Doha Declaration). Since then, the campaign has grown to include more than 40 organisations representing a range of disease areas including HIV, TB, cancer, sexual health, non-communicable diseases and mental health.
The Fix the Patent Laws is a joint coalition of the Treatment Action Campaign (TAC), Doctors Without Borders (MSF), SECTION27, Cape Mental Health (CMH), Diabetes SA, Epilepsy SA, Health GAP, Marie Stopes South Africa, the Stop Stock Outs Project (SSP), the Schizophrenia and Bipolar Disorders Alliance (SABDA), the South African Depression and Anxiety Group (SADAG), the South African Federation of Mental Health (SAFMH), the South African Non-Communicable Diseases Alliance (SANCD Alliance) and the Cancer Alliance including Association for Palliative Care Centres (APCC), Breast Course 4 Nurses (BC4N), Breast Health Foundation (BHF), Cancer Association of South Africa (CANSA), Cancer Heroes, Cancervive, Care for Cancer Foundation, Check Know Prevent, Childhood Cancer Foundation of South Africa (CHOC), Global Colon Cancer Association, Glynnis Gale Foundation, Look Good Feel Better (LGFB), Love Your Nuts (LYN), Lymphoedema Association of South Africa (LAOSA), Matchi Filotimo Cancer Project, Men’s Foundation, National Council Against Smoking, National Oncology Nursing Society of SA (NONSA), Neuro Endocrine Tumor Southern Africa Support Group, the Pink Parasol Project, Pink Trees for Pauline (Pink Trees), Project Flamingo, Project Peacock, The Prostate Cancer Foundation, Purple Project, Reach for Recovery (R4R), South African Animal Cancer Association (SAACA), South African Oncology Social Workers’ Forum (SAOSWF), South African Bone Marrow Registry (SABMR), South African Society for Ostomates (SASS), South Africa United Again (SAUAC), Soweto Cancer Society, and Wings of Hope (WoH).
0 Comments