Fix The Patent Laws

Patient groups welcome release of Draft Intellectual Property Policy

Posted on | August 14, 2017 | No Comments

JOHANNESBURG, 14th AUGUST 2017 – On 8 August 2017, the Department of Trade and Industry published the Draft Intellectual Property Policy of the Republic of South Africa, Phase I, 2017. The Fix the Patent Laws Campaign (FTPL) welcomes its publication for public comment.

The FTPL, a coalition of 34 patient advocacy groups, welcomes the clear statements concerning the critical importance of advancing the Constitutionally guaranteed right of access to healthcare services. The policy points the way towards ensuring everyone in South Africa can access the medicines they need. As pointed out in the draft policy, South Africa currently grants many poor quality patents that are rejected in both other developing countries and in developed countries such as the United States. The draft policy shows an encouraging awareness that it is ultimately people in need of medicines and the South African economy that pays the price for our free-for-all patent system.

The draft policy states that the final policy must “first and foremost engender the ethos of the South African Constitution” and that a developmental and rights centred approach to IP is “urgently necessary”. We welcome the government’s commitments to cooperate to achieve the advancement of Constitutional rights and developmental goals and to do so urgently. The inter-departmental coordination between key departments, including Trade and Industry (DTI), Health, Economic Development, International Relations and Cooperation, Science and Technology and Higher Education and Training will be critical to achieving these goals as multiple departments are responsible for the legislation in need of reform. The FTPL will hold all government stakeholders to these commitments.

The draft policy identifies public health as a priority on the basis of important public interest considerations. It indicates that the DTI, together with key government departments, intends to address substantively in the immediate term, access to medicines, vaccines and diagnostics and South Africa’s approach to international IP cooperation. This policy and law reform process could thus be an important constitutional measure “to achieve the progressive realisation” of the right to health.

We welcome the DTI’s engagement with the United Nations Secretary General’s High-Level Panel on Access to Medicines report, which makes important recommendations about what states can do to ensure greater access to medicines, particularly through patent law reform.

We thank the DTI for taking account of the submissions made in respect of the IP Consultative Framework and for the substantive detail contained in this draft policy. The FTPL will study the draft policy and make comprehensive comments to assist the DTI and its government partners to implement the reforms in line with their constitutional obligations.

The following are preliminary views on the draft policy:

  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.
  1. 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.
  1. 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.
  1. 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.

Unlike countries like Argentina, Brazil and India, South Africa has to date not taken sufficient advantage of the public health flexibilities available to it in international law in order to promote public health. This draft policy provides an opportunity that should not be squandered. It has taken 20 years of stalled policy processes to get to this point. If South Africa wishes to lead on this issue, as is expressed in the policy, the policy must be finalised with the necessary urgency and draft bills must be published with equal urgency so that the people can directly benefit from greater access to medicines for cancer, tuberculosis, HIV, mental health conditions, hepatitis, epilepsy, and many other diseases.

Many people in South Africa continue to die and suffer because they cannot access the medicines that they need. This policy provides hope to those people. It is now up to government to deliver on this promise by swiftly implementing wide-ranging law reform in line with this policy.

The FTPL will publicly share its submission and its full views on the draft policy. We encourage other stakeholders to publicly state their positions on the proposals in the draft policy. Comments are open for 60 days from the date of publication of the draft policy in the Government Gazette.

 

For more information and interviews please contact:

Angela Makamure

Press Officer (MSF)

Phone: 011 403 4440

Mobile: 084 977 7553

angela.makamure@joburg.msf.org

 

About the Fix the Patent Laws Campaign:

The Fix the Patent Laws is a joint coalition of 34 patient groups, including: Advocates for Breast Cancer,  AmaBele Belles’ Project Flamingo, Breast Course 4 Nurses, Breast Health Foundation, Cancer Alliance, Cancer Association of South Africa (CANSA), Can-Sir, CanSurvive Cancer Support, Cape Mental Health (CMH), Care for Cancer Foundation, Childhood Cancer Foundation of South Africa (CHOC), Community Technology Enablement and Collateral Harnessing (Community TECH), DiabetesSA, Doctors without Borders (MSF), EpilepsySA, Hospice Palliative Care Association (HPCA), Igazi Foundation, Look Good Feel Better, Marie Stopes South Africa, Movember, National Council Against Smoking, Oncology Nursing Association of SA, Pancreatic Cancer Network of SA, People Living With Cancer (PLWC), Pink Trees, Pocket Cancer Support, Reach for Recovery, Schizophrenia and Bipolar Disorders Alliance (SABDA), SECTION27, South African Depression and Anxiety Group (SADAG), South African Federation of Mental Health (SAFMH), South African Non-Communicable Diseases Alliance (SANCD Alliance), South African Oncology Social Workers Forum (SAOSWF), Stop Stock Outs Project (SSP), The Sunflower Fund, Treatment Action Campaign, Vrede Foundation, and Wings of Hope.

 

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Letter to Cabinet Ministers: FTPL requests urgent finalisation of the draft intellectual property policy

Posted on | July 20, 2017 | No Comments

On 7 June 2017, the FTPL coalition sent letters to all government ministers who form part of South Africa’s cabinet asking them to urgently finalise the draft intellectual property policy. The draft policy has been delayed in cabinet for more than 2 months, while people living in South Africa still struggle to access the medicines they need affordably, as a result of existing archaic patent laws. Enough is enough!

An example of the letter sent can be seen below:

Coalition welcomes landmark Competition Commission probe into prices of cancer medicines

Posted on | June 13, 2017 | No Comments

JOHANNESBURG, 13 JUNE 2017: The Fix the Patent Laws coalition welcomes the Competition Commission’s announcement earlier today that they will investigate the pricing of several cancer medicines in South Africa. This is a major victory in our struggle to ensure that all people in South Africa can access the medicines they need to stay healthy and alive.

Earlier this year our coalition launched the Tobeka Daki Campaign for Access to Trastuzumab during a global day of action. The campaign was named after Tobeka Daki – a fearless comrade and cancer activist who died of breast cancer in November 2016. Even though Tobeka’s doctor thought she should be provided trastuzumab, Tobeka could never access the medicine due to its high price – over half a million rand per treatment course in the private sector.

The Competition Commission probe announced today will investigate the price of cancer medicines of three pharmaceutical companies. One of these companies is Roche Holdings AG, which will be investigated for the excessive pricing of trastuzumab (the medicine Tobeka never had the chance to try). The investigation specifically relates to “excessive pricing”, “exclusionary conduct”, and “price discrimination”. While Tobeka was unable to access this medicine, Roche made USD 8.9 billion profit in 2015.

The Commission will also investigate local pharmaceutical company Aspen Pharmacare for alleged “abuse of dominance”. Reports in April this year indicated that the Spanish Markets and Competition Commission initiated anti-trust proceedings against Aspen. In October 2016, Aspen was fined over EUR 5 million by the Italian Competition Authority for having abused its dominant position by increasing prices of four of its anti-cancer medicines by up to 1,500%.

The Commission also initiated an investigation against pharmaceutical company Pfizer Inc. for “suspected excessive pricing of lung cancer medication”.

We are encouraged by the Commission’s undertaking to investigate manufacturers of excessively priced cancer medicines. We will be monitoring the Commission’s progress for the duration of these investigations. We are committed to assisting the Commission in their investigation and to ensure that cancer survivors and people who have lost loved ones to cancer have a place at the table. These investigations give hope that more people living with cancer will in future be able to access the medicines that will give them a chance at life.

______________________________________________________________

For more information and to arrange interviews contact:

Luvo Nelani | nelani@section27.org.za | 079 381 8521

The Fix the Patent Laws coalition was founded in November 2011 by the Treatment Action Campaign (TAC), Doctors without Borders (MSF) and SECTION27. Today the coalition has 34 member organisations – including the Cancer Alliance and its various member groups working on cancer-related issues. The coalition has for several years now called on the Department of Trade and Industry to finalise a policy on intellectual property that would ensure that the right to access healthcare is prioritised over the private interests of pharmaceutical companies – as required by the Constitution of South Africa. You can read more about the campaign at www.FixThePatentLaws.org

In South Africa, the annual price charged by Roche for trastuzumab in the private sector is around USD 38 365 (ZAR 516,700). The few public facilities which can access trastuzumab do so at a lower price of around USD 15 735 (ZAR 211,920) per year. But, health economists have shown that a year’s worth of trastuzumab can be produced and sold for only USD 240, a price that includes a 50% increase above the cost of production for profit.

eNCA Checkpoint documentary explores trastuzumab access challenges

Posted on | March 16, 2017 | No Comments

On 14 March 2017, Checkpoint on eNCA aired a documentary exploring the access challenges faced by women in South Africa seeking trastuzumab – a WHO recommended essential medicine for HER2+ breast cancer. The documentary features the story of Tobeka Daki, in whose memory the Tobeka Daki Campaign for Access to Trastuzumab was launched. Watch the documentary at: http://www.enca.com/media/video/checkpoint-out-of-reach-part-1

 

Tobeka Daki Campaign writes to the UN Human Rights Council on Women’s Day

Posted on | March 8, 2017 | No Comments

This letter was issued by the Tobeka Daki Campaign for Access to Trastuzumab to the Human Rights Council today – on International Women’s Day – as they convene a panel discussion on access to medicines in the context of the right to health. The letter can be accessed here.

——

Dear High Commissioner Zeid Ra’ad Al Hussein,

ACCESS TO MEDICINES IS A BASIC HUMAN RIGHT

We are writing to you from the Tobeka Daki Campaign for Access to Trastuzumab in South Africa on the occasion of International Women’s Day to highlight the gross injustice faced by women across the globe in many low and middle income countries who cannot access lifesaving cancer treatments due to the exorbitant pricing of the pharmaceutical industry.

The Tobeka Daki Campaign launched a month ago on 7th February 2017. The campaign is in loving memory of a fearless activist who lead the struggle to ensure access to breast cancer treatment for women in South Africa. Despite being prescribed trastuzumab, a WHO essential medicine for the treatment of HER2+ breast cancer, Tobeka was never able to access the treatment due to its high cost. In South Africa, the annual price charged by Swiss multinational company Roche in the private sector is around US$ 38,365. The few public facilities which can access trastuzumab do so at a lower price of around US$ 15,735 per year. But, health economists have shown that a year’s worth of trastuzumab can be produced and sold for only US$ 240, a price that includes a 50% increase above the cost of production for profit.

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Global Day of Action Against Roche’s Inhumanity #RocheGreedKills

Posted on | February 7, 2017 | No Comments

 

ACTIVISTS AROUND THE WORLD MARCH #ForTobeka

 – Demonstrations held at Roche & pharma associations in South Africa, Malaysia, UK, France, Zambia, Brazil, US

108 organisations endorse a letter to Roche                              

Tuesday, 7th February 2017 – Swiss multinational company Roche faced global condemnation today from women living with cancer, families of people with cancer, activists, scientists, researchers and health professionals from across the world. They highlighted the immoral and unconscionable tactics employed by Roche across the developed and developing world. Roche’s greed is preventing women from accessing affordable versions of trastuzumab, an essential medicine used in the treatment of breast cancer.

The global day of action was led by women living with cancer in South Africa who gathered outside Roche’s office in Johannesburg demanding justice for Tobeka Daki – a leading cancer activist from South Africa whose own struggle against cancer ended last year.

“In South Africa today, we launched the Tobeka Daki Campaign for Access to Trastuzumab. In loving memory of a fearless activist who lead our struggle to ensure women could get this medicine,” said Salomé Meyer of the Cancer Alliance in South Africa. “Even as the likelihood of her being able to get trastuzumab diminished, Tobeka’s determination to ensure other women could access the medicine only grew stronger.”

Despite being a good candidate for trastuzumab, Tobeka was never able to access the treatment due to its high cost. In South Africa the annual price charged by Roche in the private sector is around US$ 38 365 (ZAR 516,700). The few public facilities which can access trastuzumab do so at a lower price of around US$ 15 735 (ZAR 211,920) per year. But, health economists have shown that a year’s worth of trastuzumab can be produced and sold for only US$ 240, a price that includes a 50% increase above the cost of production for profit.

Roche maintains its high prices in every way possible. Roche holds multiple evergreened patents on trastuzumab in certain countries across the world. In South Africa, for example, multiple patents extend Roche’s monopoly until 2033. In countries where the patents expired or do not exist, Roche is using other means to block potentially more affordable biosimilar versions coming to market.

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Statement by South Africa on its experiences related to access to medicines

Posted on | December 15, 2016 | No Comments

On the heels of the statement by South Africa earlier this week on patents and health, the Fix the Patent Laws campaign is again very encouraged to see the second statement from the South African government, made on 14 December 2016. This time, a comprehensive account of South Africa’s experience related to access to medicines was given to the Standing Committee on the Laws of Patents (SCP) at the World Intellectual Property Organisation (WIPO).

The statement makes specific mention of the Fix the Patent Laws campaign and the changes being proposed for South Africa’s laws. While the coalition applauds these latest statements, we urge the government to remember that we need these reforms urgently. We know that people will continue to suffer until actual legal change is brought to South Africa’s patent laws, allowing better access to affordable medicines.

The latest statement is below:

South Africa Access to Medicines: South Africa’s Experience Related to the Topic of Access to Medicines at the Standing Committee on the Laws of Patents

Background

Madam Vice Chair,

South Africa is pleased to be afforded the opportunity to share its journey in the quest to provide access to essential medicines through the patent system.

As some of you would be aware, South Africa has a proud history of robustly engaging with issues that concern intersection between Intellectual Property (IP) rights and public health. Indeed the South African government’s stance in the case between the Pharmaceutical Manufacturers Association versus the President of South Africa (the late President Nelson Mandela) in 1998, was a key factor leading to global dialogue around the potential negative impacts of intellectual property rights on public health, culminating in the Doha declaration on TRIPS and Public Health.

South Africa has been a key player in the global recognition that the duty owed by States to safeguard public health is not inconsistent with the responsibility to honor international treaty obligations.

In the late nineties, for countries such as South Africa, the affordability of antiretroviral medicines was the main barrier to them being listed as essential medicines, and provided to patients. In 1998 the National Essential Medicines Lists Committee recommended to the Minister of Health that antiretroviral therapy (ART) be approved for provision to persons living with HIV/AIDS, provided that the price of the medicine could be reduced. It was within this context that the interpretation of TRIPS and IP protection and their impact on pricing and affordability of medicines became salient.

Measures to ensure affordability in South Africa

To address some of the challenges associated with patent-related pricing monopoly, South Africa amended its Medicines and Related Substances Control Act, (Act 101 1965) introducing Section 15C, titled “Measures to ensure supply of more affordable medicines.” This section was introduced to provide for parallel importation and compulsory licensing.

The pharmaceutical industry, backed by some governments, vigorously opposed the enactment of Section 15C, arguing that it was tantamount to a complete annulment of patent rights and that it violated the TRIPS agreement. In spite of vociferous opposition, Section 15C was signed into law by the late President Nelson Mandela on 12 December 1997.

In an attempt to block the implementation of Section 15C, over 40 of the World’s largest and most powerful pharmaceutical companies initiated a court action, challenging the constitutionality of Section 15C before the High Court of South Africa in February 1998. Section 15C was also put on the agenda for high-level bilateral trade discussions between South Africa and some countries which resulted in South Africa being placed on a special ‘watch list’ in 1998 and 1999 relating to international trade relations.

These tensions escalated, and ultimately created significant public awareness and controversy regarding the conflict between the pharmaceutical industry and developing countries. As this pressure increased the narrative emerged that pharmaceutical companies were putting ‘profit before the people’. The lawsuit against the South African government was ultimately withdrawn unconditionally in May of 2001, with costs. Civil society treatment access activists cite the successful media campaigns as central to achieving this victory.

Doha Declaration & TRIPS flexibilities

As the global narrative in favor of access to medicines continued to strengthen, in 2001 developing countries raised concerns about the possible negative impact that a narrow interpretation of TRIPS could have on certain policy objectives, particularly public health outcomes relating to access to medicines. These concerns culminated in the Doha Declaration on 14 November 2001, which clarifies that the TRIPS agreement should be interpreted in a way that support public health objectives, by stimulating the creation of new medicines whilst also promoting access to existing medicines. Thus, 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.”

This declaration clarifies TRIPS flexibilities, including compulsory and voluntary licensing, the Bolar exception, non-commercial use and the parallel importation of medicines. These mechanisms have been incorporated into our law through the amendment of our Patents Act of 1979, the Medicines and Related Substances Control Act and other relevant legislation, to circumvent limited access to medicines due to market exclusivity. However, providing access to essential medicines still remains a challenge because of the delicate exercise of balancing interests of both innovators i.e. (pharmaceutical companies) and the public at large.

Activist pressure, competition law & use of voluntary licenses

Since 2001 many Generic manufactures have secured voluntary licenses to produce medicines in South Africa, including over 20 licenses for medicines in the antiretroviral category. The increase in voluntary licensing (VL) agreements for ARV drugs was often a result of civil society pressure, and the use of competition law. For example, in 2002 activist initiatives of the Anti-Retroviral Therapy (ART) treatment campaign, resulted in some multinational companies being found guilty of excessive pricing by the South African Competition Commission. At this time the prices of patent holders were between 3 and 10 times higher than the least expensive generic version of the same medicines.

In 2004, the prices of ARV dropped to a level where the South African department of health introduced them as essential medicines. However, prices remained relatively high and there were concerns regarding financial sustainability. Over time, however, often as a result of ongoing civil society pressure, increasing numbers of voluntary licenses were issued, resulting in steady price decreases. In one example, in 2006 a license for the drug tenofovir (TDF), was granted to a generic manufacture and as a result the price for the drug decreased by 64%.

Similarly in 2007, activist pressure resulted in complaints to the Competition Commission regarding more multinational companies for excessive pricing. As a result, these companies issued voluntary licenses, after which competition increased and prices for the medicines concerned decreased in state tendering processes. Licenses for generic manufacturing of APIs in other parts of the world have also contributed to cheaper APIs, and thus cheaper medicine formulation since APIs accounts for approximately 70% of the cost of manufacturing for ARVs.

The current activist initiative ‘Fix the Patent Laws’ has resulted in a number of media battles and ongoing pressure towards multinational pharmaceutical companies regarding pricing and affordability for patented medicines. This activist campaign aims to strengthen Intellectual Property laws in South Africa in the interests of stimulating medicine price competition. This is an ongoing process with multiple stakeholder involvement including the Department of Trade and Industry, the Department of Health and the Department of Science and Technology.

Intellectual Property Law in South Africa

South Africa has never issued a compulsory license but those manufacturers who have actively courted multinational pharmaceutical companies have acquired lucrative voluntary license agreements where pressure exists to improve generic manufacturing. These companies are careful to maintain IP regulations and good relationships with pharmaceutical firms, in favour of potential of local voluntary patent pools for innovation, rather than supporting a compulsory licensing approach.

Way Forward

As a way forward, in July 2016, the South African cabinet approved a new IP Policy Consultative Framework, which aims to promote competition and ensure the levelling of the playing field in the area of public health and intellectual property rights. The new IP policy framework takes a consultative approach that seeks to include all relevant stakeholders, which includes government, the pharmaceutical industry, NGOs and the general public.

This framework will consider the amendment of current IP laws, to ensure that a balance is struck between IP rights and the rights of every citizen to access to medicines. It will also consider simplifying the processes of providing access to medicines and fast-tracking the approval processes required to access such medicines. In South Africa, the current process to obtain a compulsory licence requires a judicial process which is a lengthy process and because it involves litigation, it is an expensive process. The policy will therefore consider a more streamlined and accessible administrative process as opposed to a judicial process for obtaining a compulsory licence.

As highlighted above, parallel importation of medicines in South Africa is governed by section 15C of the Medicines and Related Substances Act and it is also dealt with in the South African Patents Act of 1979 as amended, which provides for exhaustion of rights. However there is some uncertainty over whether Section 15C applies not withstanding any rights conferred in terms of the South African Patents. The policy will also clarify maters on exhaustion of rights where parallel importation is concerned.

The policy will also consider amendments to the Patent Act to provide for substantive examination of patent applications and introduction of opposition proceedings in the grants of patent rights. We have already heard the story of Thobeka, who required a cancer drug in the treatment of breast cancer. However, due to the high price of this drug, it was inaccessible to most patients who have been diagnosed with breast cancer, resulting in the unnecessary deaths of patients even though suitable treatment was available. Interestingly, the patent had expired in most countries where patent protection had been obtained. But because South Africa has a depository system, this patent continued to remain in force on the patent Register. In terms of South African law, it would have required protracted and expensive litigation to challenge the validity of this patent. Hence it is a policy position of the South African government to introduce substantive search and examination and opposition proceedings to ensure that only quality patents remain on our registers.

In conclusion, South Africa is embarking and consultative and inclusive process to address issues of IP rights and access to essential medicines. We recognize the importance of striking a balance between the needs of indigent people who require access to medicines but because of their status are unable to afford and access essential medicines and on the other hand, the need to incentivize pharmaceutical companies to continue in investing in research and development of new medicines to address future needs.

In all these efforts, we would want to be in a position to continue to call on WIPO, to support us to craft IP policies that support our objectives of balancing the rights of innovations and needs of the public.

I thank you Madam Chair

Statement by South Africa on Patents and Health

Posted on | December 14, 2016 | No Comments

The Fix the Patent Laws Campaign is heartened by the statement delivered yesterday, 13 December 2016, at the World Intellectual Property Organisation (WIPO) Standing Committee on the Law of Patents (SCP) during discussions on patents and health.

We remind the South African government that it is crucial to turn these words into actions by reforming South Africa’s outdated patent laws without delay. We need a pro-public health IP policy that prioritises people over profits, so that every person living in South Africa is able to access the medicines they need.

Statement by the Republic of South Africa:

WIPO Standing Committee on the Law of Patents (SCP) 13 December 2016Madam Chair

South Africa aligns itself with the statement delivered by Nigeria on behalf of the Africa Group.

Please allow me Madam Chair to preface my statement by following other delegations and reminding this august gathering that through the adoption of the United Nations 2030 Agenda for Sustainable Development, all countries committed themselves to achieving universal health care where everybody is supposed to receive their required health services not hindered by their financial status. In this regard, SDG Goal 3 states:

“Ensure healthy lives and promote well-being for all at all ages” and SDG target 3.8 requires that the international community should strive to “Achieve universal health coverage, including financial risk protection, access to quality essential health care services and access to safe, effective, quality and affordable essential medicines and vaccines for all” .

Madam Chair,

A paper on Universal Health Coverage published in May 2016 by the Elders, a group of independent international leaders convened by former South African president Nelson Mandela in 2007 to use their collective experience and influence for peace, justice and human rights worldwide, paints a very dire picture. It notes that although universal health coverage is a commitment of every UN Member State, the realities on the ground do not reflect this commitment.

“However, across the world, hundreds of millions of people are currently denied lifesaving health services or are plunged into poverty because they are forced to pay unfordable fees for their care. This burden is particularly felt by women, children and adolescents, who often have high needs for health but least access to financial resources. In some instances, women and babies are even being imprisoned in health units because they cannot pay their medical bills. This represents a cross violation of their basic human rights”.

Madam Chair,

While the report identifies political commitment at the national level as one essential element for the implementation of universal health coverage as mandated by SDG 8, as a remedy to the problems articulated by the Elders above, the UN Secretary General’s High Level Panel on Innovation and Access to Health Technologies, which was convened by the outgoing UNSG and mandated “to review and assess proposals and recommend solutions for remedying the policy incoherence between the justifiable rights of inventors, international human rights law, trade rules and public health in the context of health technologies” points to serious impediments to achieving the noble goal of health for all, impediments which are brought about, in one way or another, by factors related to intellectual property, patents, in particular.

For example, the report notes that many governments have not used flexibilities available under the TRIPs Agreement for various reasons ranging from capacity constraints to undue political and economic pressure form states and corporations, both express and implied. The Panel concludes that political and economic pressure placed on governments to forgo the use of TRIPs flexibilities violates the integrity and legitimacy of the system of legal rights and duties created by the TRIPS Agreement and reaffirmed by the Doha Declaration. (We will elaborate further on how our own country was a victim of this pressure in our exchange of experience presentation).

The Panel recommends that:

Countries should make full use of the flexibilities enshrined in the TRIPS Agreement, and use the policy space available in Article 27 of TRIPS “by adopting and applying rigorous definitions of invention and patentability that are in the best interests of the public health of the country,” including amending laws to curtail the ever-greening of patents and awarding patents only when genuine invention has occurred.

The United Nations Conference on Trade and Development (UNCTAD), the United Nations Development Programme, (UNDP), the World Health Organisation (WHO), the World Intellectual Property Organisation (WIPO) and the World Trade Organisation (WTO) should cooperate with one another and with other relevant bodies with the requisite expertise to support governments to apply public health sensitive patentability criteria.

These multilateral organisations should strengthen the capacity of patent examiners at both national and regional levels to apply rigorous public health-sensitive standards of patentability taking into account public health needs.

Finally, Madam Chair,

The Report is a rich repository and reference document and we believe that the implementation of its recommendations and other intellectual property and health related recommendations, as articulated in the Africa Group’s proposal, document SCP/24/4 has the potential to minimize this unfortunate situation where women and babies are being imprisoned in health units, anywhere in the world, because they cannot pay their medical bills.

We welcome further dialogue and contributions from other Member States on how we can make this dream become a reality.
I thank you

In loving memory of Tobeka Daki

Posted on | November 15, 2016 | No Comments

tobeka-1It is with great sadness that the Fix the Patent Laws (FTPL) coalition shares news of Tobeka Daki’s death. Tobeka, was a single mother from Mdantsane in the Eastern Cape, a daughter, a friend, a woman living with HER2 positive breast cancer, a support group member and an advocate for equal and affordable access to medicines for all.

Tobeka was diagnosed with HER2 positive breast cancer in 2013. At this time, Tobeka was told by her oncologist that she needed trastuzumab – in addition to chemotherapy – which would increase her chances of beating cancer and living a long and healthy life. Trastuzumab is recommended by the World Health Organisation as an essential treatment for HER2 positive breast cancer – a more aggressive type of cancer, with higher recurrence and mortality rates than HER2 negative cancer.

Despite being a good candidate for trastuzumab, and being a member of a medical scheme, Tobeka was unable to access this treatment due to its extremely high cost and inaccessibility in most public sector facilities. The cancer spread to her spine and, on 14 November 2016, Tobeka died in her home.

As an advocate for medicine access, Tobeka spoke out about her inability to access trastuzumab in the FTPL campaign for affordable and equitable access to trastuzumab. On World Cancer Day (4 February) 2016, Tobeka was featured in a short video that highlighted the challenges facing women in South Africa seeking treatment for HER2 positive breast cancer. In March of 2016, Tobeka told her story in front of the United Nations High Level Panel on Access to Medicines, which pledged to remedy incoherence between patent rights and health rights. Later that month Tobeka led a picket in front of Roche’s offices in Pretoria to protest the high price charged by Roche, which prevented her from accessing the potentially life-saving treatment.

In July, Tobeka shared her story at the International AIDS Conference in Durban during a disruption of Roche’s conference display booth. And, as recently as September, Tobeka led a picket outside of the Department of Trade and Industry’s Pretoria offices to call on the South African government to end delays in undertaking reform of South Africa’s patent laws to improve medicine affordability and access.

Roche is currently the only company marketing trastuzumab in South Africa. Patents granted in South Africa could extend Roche’s monopoly until 2033 – long after it has ended in other parts of the world.  In the private sector a 440 mg vial of Herceptin costs ZAR 25,835 – or approximately ZAR 516,700 per 12-month course. Trastuzumab is unavailable to the vast majority of women seeking care in the public health care sector – except in rare cases where motivated oncologists have successfully advocated for facility level budgets to be allocated for trastuzumab.

The FTPL coalition has repeatedly called on Roche to lower the cost of trastuzumab to ensure it is accessible to all people that could benefit from the treatment, and to publicly disclose the price it has offered to the Department of Health. To date, they have failed to do so.

Today, the Cancer Alliance (20 cancer organisations that are members of FTPL) made a submission to the Department of Health motivating for the provision of trastuzumab in the public sector, and calling on the Department of Health to explore and utilize all available tools to secure an affordable price for its procurement.

We further reiterate our call to the Department of Trade and Industry to end delays and act with extreme urgency in reforming South Africa’s patent laws to improve medicine access in the country.

FTPL has set up a fundraiser to raise money to support Tobeka’s family with funeral costs, and in caring for the two sons that she left behind. All money donated will go directly to Tobeka’s family. See fundraiser at: https://www.generosity.com/medical-fundraising/in-loving-memory-of-tobeka-daki/x/15365025

 

 

Job advert: Consultant to the Cancer Alliance

Posted on | October 25, 2016 | No Comments

The Cancer Alliance is a national alliance of 18 cancer organisations in South Africa that undertake advocacy on issues related to cancer prevention, detection and treatment. The Cancer Alliance is committed to the achievement of equitable access to cancer treatment and services for all people living in South Africa. The Cancer Alliance is seeking a part-time consultant to conduct research, advocacy, communications and training related to overcoming patent-related barriers to cancer treatments.

During 2015, the Cancer Alliance joined the Fix the Patent Laws coalition, a national coalition of patient groups and organisations advocating for reform of South Africa’s patent laws to improve access to affordable medicines in the country. The Fix the Patent Laws coalition was founded by the Treatment Action Campaign, Doctors Without Borders and SECTION27 in 2011 and has subsequently grown to include 31 organisations.

Consultant responsibilities:

1.       Conducting research and developing evidence to inform advocacy of the Cancer Alliance related to achieving reform of South Africa’s patent laws and equitable access to cancer treatment.
2.       Developing patent and access landscapes for cancer medicines in South Africa.
3.       Developing training, advocacy and communications materials for the Cancer Alliance and the Fix the Patent Laws coalition.
4.       Arranging and conducting trainings on intellectual property, as well advocacy and social movements related to the achievement of equitable access to medicines.
5.       Liaising with members of the Cancer Alliance, cancer patients and the Fix the Patent Laws coalition to facilitate information sharing, communication and collaboration.
6.       Engaging with policy makers, the media and other stakeholders.

Experience and skills required:

–          Bachelor’s degree required
–          Advanced degree in Public Policy, Public Health, Pharmacy, Health Economics or a related field preferable
–          Previous work in research, advocacy and/or communications
–          Strong research and writing skills (writing samples will be requested)
–          Strong diplomatic, communication and public speaking skills
–          Commitment to social justice principles, including equitable access to health care
–          Knowledge of Microsoft Office (Word, Excel, Power Point)

Time-commitments:

The consultant will work two days per week between 28 November 2016 and 17 August 2017. (Ideal starting date 28 November 2016)

Location:

The consultant will be based at offices in Mowbray, Cape Town.

Conditions:

–          8.5 month contract (68 days)
–          South African citizen, permanent resident or valid South African work permit
–          Consultant must supply own laptop

Please forward your curriculum vitae accompanied by a 1-2 page cover letter to crtomlinson@gmail.com by 11 November 2016.  Late applications will not be considered and only shortlisted candidates will be contacted for an interview.

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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.

  • Read the TAC and MSF campaign pamphlet

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