2 August 2016 – Cabinet recently approved a new Intellectual Property (IP) Consultative Framework for South Africa. This follows a Draft National IP Policy published for comment in 2013 – on which we and many other groups commented. The 2013 Draft National IP Policy committed to reforming South Africa’s patent law to address shortcomings that impede medicine access. The Consultative Framework now presents a process for finalisation of the Draft Policy.

We welcome progress by the Department of Trade and Industry (DTI) in moving towards reforming South Africa’s laws in line with commitments made in the 2013 Draft IP Policy, and are encouraged to see public health safeguards as a priority, as well as by the cooperation between different ministries evident in the Framework. However, we are deeply concerned by the three years of delay between documents, as well as potential for ongoing delays in reforming the country’s laws (See a history of South Africa’s patent law reform process here).

The three years of delay between the documents benefits the multinational pharmaceutical industry which set out to delay or prevent the finalisation of the Draft IP Policy in what became known as the ‘Pharmagate’ scandal.

The slow pace of reform means that South Africa’s patent laws remain out-dated and in the foreseeable future South Africa will remain unable to utilise a number of public health safeguards available under international law. Ultimately it is patients who will pay the price.

In the three years since the release of the Draft National IP Policy, we estimate that over 7,000 patents have been granted on pharmaceuticals in South Africa[1], of which 80% should have been rejected for failing to meet patentability criteria[2]. Each new patent granted receives 20 years of monopoly protection, during which people living in South Africa are prevented from using more affordable products that are often available outside of the country.

Over the past three years, people with extensively drug-resistant tuberculosis struggled to pay for one of the medications they need, called linezolid, which cost over R700 per pill until more affordable products finally became available through the public sector this year. Women with HER2-positive breast cancer have been denied access to trastuzumab, which costs over R500,000 per year. The hepatitis B medication entecavir remains inaccessible to most due to its high price, while generic products are available outside of South Africa at 84% lower prices.

Patent barriers have also contributed to medicine shortages in the country, including months-long national shortages of patented versions of lopinavir/ritonavir during 2015 that threatened access to treatment for over 160,000 people living with HIV.

This is only the tip of the iceberg in terms of unavailable medicines resulting from South Africa’s outdated patent laws.

Fix the Patent Laws will submit detailed comments on the new IP Consultative Framework before the end-August deadline. For the time being, we are sharing the following initial reactions:

1. We are deeply concerned by the document’s lack of emphasis on fundamental rights, guaranteed in international human rights law and the Constitution of South Africa, particularly, the right to access healthcare services. Although creators are entitled to remuneration for research and development, monopolies that transform into high prices are not required for the realisation of this. The UN Special Rapporteur in the Field of Cultural Rights recently affirmed that there is no human right to patent protection, stating, “where patents and human rights are in conflict, human rights must prevail.’’ Similarly, the UN Human Rights Council and the Special Rapporteur on the Right to Health have both affirmed that the right to health supersedes intellectual property protections.

2. The Consultative Framework appears to place the Constitution at the same level as policy plans such as the National Development Plan and various industrial development policies. This is incorrect. The Constitution places legal obligations on the state and all policy interventions must be consistent with these obligations.

3. The Consultative Framework specifically outlines the role of the right in section 25 of the Constitution, mistakenly suggesting that the “Constitution guarantees the right to property”. Rather, the Constitution guarantees that “no one may be deprived of property except in terms of a law of general application”. Disappointingly, having dealt with the right not to be arbitrarily deprived of property, the Framework fails to balance it against the Constitutional right “to have access to health care services, and the state’s obligations to take steps to progressively realise that right.

4. On a more positive note, we welcome the identification in the IP Consultative Framework of a number of important issues for “immediate domestic review”. These issues include: compulsory licenses, patentability criteria, patent opposition procedures, substantive search and examination of patents, parallel importation, and disclosure requirements. These are all issues relating to the health safeguards provided under international law for which FTPL has been advocating. If these issues are successfully integrated into the policy and then promulgated into law, South Africa could be a world role model in prioritising people’s health over profit. However it is concerning that specific pro-health recommendations made in the Draft IP Policy are not reiterated in the IP Consultative Framework. Rather, these issues are merely identified as priority areas for consideration. It is crucial that government fulfils its legal and moral obligation to reform South Africa’s patent laws to fully utilise health safeguards as committed to in the Draft IP Policy, and other statements and declarations.[3] [4] [5] [6] [7]

5. We remain concerned about ongoing delays and the lack of clarity regarding the process of law reform going forward. It is unclear whether the issues for “immediate review” will first be collated into a policy – or whether the policy will only be formulated once both immediate and medium term issues have been addressed. The extensive public consultations on the 2013 Draft National IP Policy and subsequent inter-departmental discussions by government have provided sufficient opportunity for the views of all parties to be aired on the same issues that are identified in the new IP Consultative Framework. The process of reviewing evidence must not be repeated and delayed further. The DTI must draft bills and regulations on issues cited for immediate review, and table these bills in parliament, where a further public consultation process will take place. It is notable that in relation to copyright, another area of intellectual property, government did not wait for the policy process to conclude before submitting a far-reaching bill to parliament.

We urge the Department of Trade and Industry and all ministries involved in the inter-ministerial committee on IP reform to be cognisant of the urgency of these issues, to provide concrete timelines and actions for the process going forward, and to continue to prioritise the public’s health in doing so. We remain committed to engaging with this process.

For media enquiries, please contact:

Angela Makamure – Doctors Without Borders (MSF) – 011 403 4440

Lotti Rutter – Treatment Action Campaign (TAC) – 081 818 8493

[1] A study published in 2011, revealed that SA granted 2,442 pharmaceutical patents in 2008. If similar numbers were granted in subsequent years, then it is likely more than 7,000 pharmaceutical patents have been granted since 2013, See the 2011 study at: http://apps.who.int/medicinedocs/documents/s21395en/s21395en.pdf

[2] Another 2011 study, revealed that 80% of patents granted in South Africa fail to meet the country patentability criteria and would be rejected if South Africa substantively examined patent applications: http://reference.sabinet.co.za/document/EJC97100

[3] http://www1.chr.up.ac.za/undp/regional/docs/audeclaration7.pdf

[4] http://brics5.co.za/about-brics/sectorial-declaration/health-ministers-meeting/beijing-declaration/

[5] https://www.fixthepatentlaws.org/?p=79

[6] http://www.thepresidency.gov.za/pebble.asp?relid=5053

[7] https://www.fixthepatentlaws.org/?p=1051