Fix The Patent Laws

New IP consultative framework for SA: three years’ delay is three too many

Posted on | August 2, 2016 | No Comments

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.
  1. 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.
  1. 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.
  1. 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]
  1. 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] http://www.fixthepatentlaws.org/?p=79

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

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

Health Minister takes strong stand on cancer drug costs

Posted on | May 10, 2016 | No Comments

The Fix the Patent Laws coalition applauds the speech given by the South African Minister of Health, Dr Aaron Motsoaledi, today as he presented the budget for his Department to Parliament. We welcome his strong stance taken on the costs of cancer drugs, specifically trastuzumab (marketed as Herceptin), around which the Fix the Patent Laws coalition has been campaigning for some time due to its total unaffordability in South Africa. We hope this speech heralds the beginning of an era of more affordable cancer drugs for South Africans and that Parliament recognises the damaging role that patents play in causing these medicines to remain out of reach.

Read the Minister’s full speech below:

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SA government takes promising stand on patents

Posted on | April 28, 2016 | No Comments

  • But public remains in the dark regarding stalled policy process

The Fix the Patent Laws (FTPL) coalition welcomes recent public comments made by Minister of Trade and Industry Rob Davies and Minister of Health Dr Aaron Motsoaledi about patents and patent law in South Africa and in other developing countries.

Earlier this month Minister Davies delivered a landmark keynote address at the World Intellectual Property Organisation’s (WIPO) International Conference on Intellectual Property and Development in Geneva. In his speech Minister Davies dispelled a number of commonly held myths about the role of intellectual property in development. He said that “there is no unambiguous evidence that stronger IPRs (intellectual property rights) foster industrial development and countries may require different approaches and policies dependent on their level of industrial development.”

Davies confirmed: “The role of patent protection in promoting innovation has also been controversial. There are arguments that patents are unlikely to foster innovation in developing countries at early stages of industrialization. The evidence on the extent to which patent protection, which is of particular relevance in the context of industrial policies, contributes to encouraging innovation is, at best, inconclusive. Some studies contend that other factors, notably ‘first mover’ advantages, are more decisive in promoting innovation.”

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Activists demand Roche drops cost of vital breast cancer medicine

Posted on | March 31, 2016 | No Comments

THURSDAY 31st MARCH 2015, JOHANNESBURG – Today, members of the Fix the Patent Laws campaign, including Advocates for Breast Cancer, the Cancer Alliance, the Cancer Association of South Africa (CANSA), Doctors without Borders, People Living with Cancer, SECTION27, the South African Non-Communicable Diseases Alliance, the Treatment Action Campaign, and Wings of Hope are picketing outside pharmaceutical company Roche to highlight the excessive price of a life-saving breast cancer medicine.

Women with a specific form of breast cancer, HER2 positive, require a medicine called trastuzumab (marketed in South Africa as Herceptin). Many women in South Africa who need trastuzumab cannot access it due to the high price charged by Roche. In the private sector, a 12-month course of Herceptin costs approximately R485,800, or more if higher dosing is required. Roche is able to charge such a high price as it holds multiple patents on the drug, which may block cheaper biosimilars from being sold in South Africa until 2033.

“I was diagnosed with HER2 breast cancer in 2013,” explains Tobeka Daki. “Despite it being recommended by my doctor, my medical aid declined to cover Herceptin claiming that it was too expensive. There’s no way I could afford the half a million-rand price tag. Without access to Herceptin my cancer has spread and last year I was diagnosed with bone cancer of the spine. This medicine is a last hope for patients like me. Chemo alone isn’t enough.”

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Problematic patent laws block access to critical breast cancer medicine

Posted on | February 3, 2016 | No Comments

3 February 2016 – Leading up to World Cancer Day (4 February 2016), the Fix the Patent Laws coalition released a short video highlighting how shortcomings in South Africa’s patent laws contribute to barriers to access for critical breast cancer medicine trastuzumab. The Fix the Patent Laws coalition is a coalition of 18 patient groups, including the Cancer Alliance, and Alliance members: the Cancer Association of Southern Africa and People Living with Cancer.

Watch the video here.

This briefing document provides background on trastuzumab and patent-related barriers to access.

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FTPL support ratification of December 6 Decision but reiterate need for urgent reform of national laws

Posted on | December 7, 2015 | No Comments

On 23 November 2015, the Fix the Patent Laws coalition sent a letter to Members of Parliament considering the ratification of the December 6 Decision on Doha on TRIPS. In the letter the coalition noted that they supported the ratification of the December 6 Decision by South Africa – but noted that

“While the FTPL coalition supports the ratification of the December 6 Decision, we stress that its ratification and formal adoption by WTO member countries is not a pre-requisite for the full adoption of TRIPS safeguards to protect health in South Africa… [further] we re-iterate that this ratification alone will not improve access to affordable medicines for people living in South Africa and that reform of the country’s intellectual property laws to fully adopt TRIPS safeguards must remain an urgent priority both for the DTI and Members of Parliament.”

No decision was taken by Members of Parliament on the ratification of the December 6 Decision as the proceedings were interrupted by striking parliamentary workers.

Minister Davies responds to the Fix the Patent Laws coalition

Posted on | November 5, 2015 | No Comments

In response to the letter sent to Minister Davies from the Fix the Patent Laws coalition, Minister Davies sent a letter to the coalition recommitting to the adoption of TRIPS safeguards to protect health but noting ongoing delays. The coalition welcomed Minister Davies confirmation that the DTI remains committed to the adoption of TRIPS safeguards to protect health, but called for an urgent end to delays to ensure people in South Africa are able to access the medicines that they need.

Stalled policy will cost lives: Patient groups appeal to Minister Davies

Posted on | October 29, 2015 | No Comments

29 October 2015

Cape Town/ Johannesburg – The Fix the Patent Laws (FTPL) Campaign, today called on the Department of Trade and Industry (DTI) to end years of pharmaceutical company price gouging and broken promises for patent law reform and produce a final intellectual property (IP) policy and bill to amend the Patents Act.

The coalition released a detailed timeline revealing how broken promises by the DTI, and push back by the pharmaceutical industry have contributed to government’s delays in finalising reform of South Africa’s patent laws. [1]

“It is now more than two years since the period for public comment on the draft Intellectual Property Policy ended and the policy appears to have been shelved,” said Anele Yawa, General Secretary at the TAC. “Minister Davies has repeatedly ignored requests from the Fix the Patent Laws coalition for clarification on when the policy will be finalised and a bill to amend the Patents Act will be brought before Parliament.”  

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A Timeline of Intellectual Property Reform in South Africa 1994 – 2015

Posted on | October 29, 2015 | No Comments

See brief timeline at: FTPL timeline web infographic

April 1994:                            The Bill of Rights comes into force in South Africa outlining the new democratic government’s constitutional obligations.  The Bill of Rights states that “the state must take reasonable legislative and other measures, within its available resources, to achieve the progressive realisation of [the right to have access to health care services].” Source:http://www.justice.gov.za/legislation/constitution/SAConstitution-web-eng-02.pdf

April 1994:                            As a member of the World Trade Organisation (WTO), South Africa signs the international agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS), agreeing to provide 20-years of patent protection on products and processes that are new, innovative and capable to industrial application. The agreement contains safeguards to allow countries to protect health over patents. Source:https://www.wto.org/english/tratop_e/trips_e/t_agm0_e.htm

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Open letter to Minister Davies calling for urgent action to adopt TRIPS safeguards into law

Posted on | October 29, 2015 | No Comments

29 October 2015

Dear Honourable Minister Davies

RE: Request for urgent update on the status of the IP Policy and introduction of a bill to fully incorporate TRIPS safeguards to protect health into the Patents Act 57 of 1978

October 2015 marks the two year anniversary of the close of the public comment period on the Draft National Policy on Intellectual Property (IP). The draft policy – released by the DTI in September 2013 – committed to reforming South Africa’s patent laws to fully adopt safeguards to protect health and access to medicines allowed under the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS). To date no finalised policy has been released, despite multiple promises and commitments by the DTI to do so over the past two years. See Annex 3

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  • About the Campaign

    fix the patent laws
    Fix the Patent Laws is a campaign of the Treatment Action Campaign (TAC). TAC is a non-profit organisation that seeks to ensure that every person living with HIV has access to quality, comprehensive prevention and treatment services to live a healthy life. Through this blog we will highlight how amending South Africa’s Patents Act 57 of 1978 will reduce the cost of medicines, improving the health and saving the lives of millions of South Africans.

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