Fix The Patent Laws

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.

No more delays Minister Davies – we need medicines

Posted on | September 27, 2016 | No Comments

– 1000 activists march to DTI to demand urgent reform of outdated patent laws

– Fix the Patent Laws campaign now comprises 31 patient groups

– New medicine report shows how patents stop people accessing nine important medicines

27 September 2016 – PRETORIA: Today, more than 1000 activists from the Fix the Patent Laws campaign will march to the Department of Trade and Industry (DTI) in Pretoria. They are demanding that the DTI take urgent steps to fix South Africa’s outdated patent laws so that everyone can get the medicines they need.

“Currently people are suffering and dying because medicines for cancer, hepatitis, tuberculosis, mental health and many other diseases are too expensive,” said Nkhensani Mavasa, National Chairperson of the Treatment Action Campaign. “While we won the fight for first line HIV medicines, we lost the battle for almost all other medicines.”

Almost 15 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. By contrast to the chronic delays in South Africa, countries like Argentina, Brazil and India have actively used these WTO-sanctioned health safeguards to protect the health of their citizens. In addition, a major United Nations report published last week strongly recommended that countries make full use of these health safeguards available under international law.

After years of advocacy, the South African government finally committed to reforming South Africa’s patent laws in a draft National Policy on Intellectual Property published in 2013. Yet three years later, nothing has changed and many people still suffer unnecessarily. In July 2016, Cabinet approved a new Intellectual Property (IP) Consultative Framework for South Africa. The framework now presents a new process for reforming our patent laws. At today’s march to the DTI, the Fix the Patent Laws campaign will hand over a detailed submission of recommendations on this consultative framework.

“The government has a moral, legal and Constitutional obligation to ensure that everyone can access the medicines they need – yet 15 years down the line and we are still putting the profits of industry before the lives of the people,” says Cassey Chambers, from the South African Depression and Anxiety Group (SADAG).

Without these reforms, many medicines in South Africa will remain unaffordable or unavailable. 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 over 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 per cent more expensive in South Africa than India.

“The Fix the Patent Laws campaign is launching a ground breaking report (“Patent barriers to medicine access in South Africa: A case for patent law reform”) that illustrates nine medicines in South Africa, including entecavir and celecoxib, that are either priced out of reach, or have faced shortages as a result of patents. The government must understand the effect that delays in reform have on people’s lives,” said Claire Waterhouse from Doctors Without Borders (MSF).

Coalition grows to include 31 patient groups

Today’s march marks the expansion of the Fix the Patent Laws coalition to include 14 further member organisations from the Cancer Alliance. The expanded coalition of 31 organisations represents public and private sector patients in South Africa seeking treatment and care for a range of cancers, mental illnesses, diabetes, and other non-communicable diseases – as well as tuberculosis, HIV and sexual and reproductive health.

“Medicines for cancer are exorbitantly priced. Many aren’t available in the public sector and even private medical aid schemes don’t want to pay for them,” said Salomé Meyer from the Cancer Alliance. “We joined the campaign because we think it is reprehensible that people cannot access life-saving medicines. The South African government must stand up to the pressure of the multinational pharmaceutical industry and urgently amend these laws.”

 

For media enquiries, please contact:

Lotti Rutter | TAC | lotti.rutter@tac.org.za | 081 818 8493
Angela Makamure | Doctors Without Borders (MSF)| 084 977 7553

 

Notes:

  1. REPORT LAUNCH:

“Patent barriers to medicine access in South Africa: A case for patent law reform”

The report is available here.

The Fix the Patent Laws today launched a new medicines report that outlines nine specific medicines that people have struggled to access as a result of patent barriers. Two of the people in the report will be on the march and available for interview – Tobeka Daki who is living with HER2+ breast cancer and Thandi Shabangu who is living with HIV.

  1. SUBMISSION TO DTI:

The submission of the Fix the Patent Laws campaign is available here.

 

  1. TIMELINE OF PATENT LAW REFORM IN SOUTH AFRICA

The timeline is available here.

 

About the Fix the Patent Laws Campaign:

The Fix the Patent Laws is a joint coalition of 31 patient groups, including: Advocates for Breast Cancer,  AmaBele Belles’ Project Flamingo, Breast Course 4 Nurses, Breast Health Foundation, Can-Sir,  Cancer Association of South Africa (CANSA), Cape Mental Health (CMH), Childhood Cancer Foundation of South Africa (CHOC), DiabetesSA, Doctors without Borders (MSF), EpilepsySA, Hospice Palliative Care Association (HPCA), Igazi Foundation, Look Good Feel Better, Marie Stopes South Africa, National Council Against Smoking, Oncology Nursing Association of SA, Pancreatic Cancer Network of SA, People Living With Cancer (PLWC), Pink Trees, 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), Stop Stock Outs Project (SSP), The Sunflower Fund, Treatment Action Campaign, Vrede Foundation, and Wings of Hope.

 

#FixPatentLaw
@FixPatentLaw
www.fixthepatentlaws.org

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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  • 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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