Fix The Patent Laws

Tuberculosis innovation approaches in South Africa and strategies to secure public returns

Posted on | April 24, 2019 | No Comments

Today, Fix the Patent Laws is launching a report of findings from an analysis of tuberculosis research and development (R&D) underway in South Africa. The analysis was conducted to gain greater insight into the TB innovation landscape in South Africa, the role of public financing in driving and supporting innovation, as well as expectations of public returns (I.e. affordable, user friendly health technologies) from R&D efforts and expenditure, and strategies employed to promote public returns. The analysis also sought to gain greater insight into opportunities and challenges to employing alternative innovation models in South Africa that do not result in access inhibiting patent monopolies. Data included in the analysis was collected through reviewing relevant academic and grey literature, surveying TB research groups in South Africa, and conducting in-depth interviews with biomedical researchers, technology transfer officers and policy makers.

The analysis was undertaken by Fix the Patent Laws steering committee members, Catherine Tomlinson and Marcus Low, with financial support from Open Society Foundations. The authors provide recommendations informed by the analysis to improve TB R&D financing and strengthen public interest safeguards as a condition of public R&D financing in South Africa. The authors also note South Africa’s leadership in promoting greater use of alternative innovation models that delink R&D financing from medicine prices and call for ongoing leadership and diplomacy to overcome financing challenges facing these models (see section 9 of the report for a full set of recommendations.)

Executive summary

Background

TB is the leading reported cause of death in South Africa[i], and the leading cause of death by a single infectious agent globally[ii]. While South Africa has experienced significant declines in TB incidence over the past decade largely due to the broad roll-out of antiretroviral therapy, new TB cases and TB mortality remain extremely high. South Africa is one of only five countries globally that experiences over 500 TB cases per 100 000 people.[iii] According to the World Health Organisation’s best estimates, South Africa had 322 000 new TB cases in 2017 alone. In that year, 15 986 and 747 patients were diagnosed with multi-drug resistant and extremely drug resistant TB respectively.[iv] These patients have fewer treatment options with longer treatment durations, more severe treatment side effects and lower treatment success and survival rates.

South Africa’s public sector provides diagnostic and treatment services for TB with no out-of-pocket costs. However, health facility access barriers including transport costs, health systems challenges and inadequate diagnostics often impede the diagnosis of TB and initiation of treatment. The World Health Organisation estimates that only around 68% of people with TB in South Africa are diagnosed and initiated on treatment.  Among these patients, it is estimated that 82% of drug susceptible patients, 55% of multi-drug resistant patients and 48% of extremely drug resistant patients are successfully treated.[v]

While inadequate investment has significantly impeded the development of new diagnostics and treatments for TB, South Africa has spearheaded the use of the few new important health technologies that have entered the market in recent years. South Africa was one of the first countries to implement the GeneXpert TB diagnostic following recommendations by the WHO.[vi] GeneXpert significantly reduced the turn-around times for diagnosing both drug-susceptible TB and rifampicin resistant TB. South Africa has also spearheaded the use of bedaquiline, announcing that the drug will be used as part of standard MDR TB treatment regimens in the country and expanding the use of this medicine beyond what is currently recommended by the WHO. Bedaquiline has replaced painful injectables with severe side-effects and low treatment success rates.[vii]

In addition to pioneering new health technologies, South Africa has demonstrated significant political will and leadership in pushing for global action and investment to address TB. South Africa’s President Cyril Ramaphosa was the only head of state from a BRICS country to attend the 2018 UN High-Level Meeting on TB during which he called for greater TB R&D investment, affordable drugs and the adoption of intellectual property laws that promote public health.[viii] South Africa’s Minister of Health Dr Aaron Motsoaledi chairs the Stop TB Partnership and the country’s Director General for Health Precious Matsoso chairs the Life Prize steering committee. South Africa has also demonstrated political will by significantly increasing domestic investment in TB R&D in recent years (see table 2), becoming the largest funder of TB R&D as a percentage of government expenditure on R&D.[ix] In 2016, South Africa committed more to TB R&D as a percentage of GDP than any other country.[x] Despite this, South Africa’s share of global TB research investment remains much lower than its share of the global TB burden and South African funding for TB research pales in comparison to countries with far greater GDPs such as the United States.[xi]

Recognising the urgent need for new health technologies to address TB in South Africa and the strong political will to address TB needs in this country, we undertook this analysis to gain greater understanding of the TB innovation landscape in South Africa. We also sought to understand whether adequate safeguards are in place to ensure that public financing for TB R&D serves public interest – for example by ensuring that health technologies developed with public financing are affordable and accessible. We conducted an online survey and various in-depth, in-person interviews with researchers, policy makers and technology transfer officers in South Africa between June and December 2018. Interviewees included officials from the Department of Science and Technology, the Department of Health, the South African Medical Research Council, two university technology transfer offices, and researchers from various South African universities and research organisations. We also consulted various reports and other relevant policy documents and publications. Below is a summary of our findings.

Findings

There was wide agreement among interviewees that TB research is underfunded in South Africa. South African government investment in medical research increased significantly from 2012 to 2014, after which it stagnated and then declined from the 2016/2017 to the 2017/2018 fiscal year. However, funding specifically for TB research increased significantly in 2016 and 2017, suggesting increased prioritisation of TB research in this period. Even though South Africa invests more than most countries in TB research measured as a percentage of GDP or GERD, absolute investment is low compared to wealthy countries such as the United States. Arguably, South African government investment in TB research is insufficient given the country’s severe TB burden.

Government funding for TB research is channelled through several government entities, including the South African Medical Research Council (SAMRC), the Department of Science and Technology (DST), the National Research Foundation (NRF) and the Technology Innovation Agency (TIA). These various entities have differing mandates and differing funding priorities. The Strategic Health Innovation Partnerships (SHIP) within the MRC is the key entity tasked with funding TB innovation in South Africa.

Much TB research in South Africa is funded or co-funded by foreign donors such as the United States National Institutes for Health (NIH) or the Bill and Melinda Gates Foundation (BMGF). Almost half of the MRC’s budget is derived from foreign donors. The high level of dependence on these foreign donors is a key feature of the TB research landscape in South Africa.

A wide variety of TB research is conducted in South Africa. The country has substantial clinical trial capacity and trials of TB drugs or TB vaccines receive significant funding from foreign donors. There is also significant basic TB research being conducted in the country, particularly in relation to identifying better diagnostic and prognostic biomarkers or sets of biomarkers. Work on TB diagnostics has led to three diagnostic products being spun-off into companies – with one diagnostic product used to calibrate Gene Xpert machines already in wide use. There is some drug discovery work being done – both as part of the TB Drug Accelerator (an international project) and independently. There is also substantial investment in operational or implementation TB research in South Africa. 

Decision-making regarding what research to fund appears generally to be made in a relatively open and consultative manner. SHIP, the key grant-making entity for TB innovation, has a steering committee with wide representation from different government departments and donors. The work of SHIP is supplemented by the TB Think Tank, a Department of Health initiated, and BMGF funded group, with wide participation from researchers and policy makers. Interviewees report that research priorities are relatively well-aligned with those of foreign donors and that foreign donors tend to consult with local experts when setting research priorities.

There are multiple examples of South African researchers participating in international networks or projects. One such example is RePORT, a project that aims to standardise sample collection and data capturing across clinical trial sites in multiple countries to allow for better pooled analysis and better comparisons between clinical trials. Participation in RePORT is symptomatic of a wider trend toward greater data sharing and data standardisation in South Africa. In line with ambitions set out in the recently published draft White Paper on Science, Technology and Innovation, the South African government is investing in improving domestic data collection and management capacity. In building new TB data repositories government is drawing on expertise and capacity developed on the Square Kilometre Array – a major international astronomy project with a large footprint in South Africa. 

A key focus of our research was ownership of intellectual property generated from publicly funded research and access conditions placed on products resulting from publicly funded research. While funders and research entities in South Africa have some flexibility to negotiate terms on a case-by-case basis, these negotiations take place within parameters set by predominantly the Intellectual Property from Publicly Financed Research and Development Act (IPR Act), but also other key documents depending on the specific donor – examples include the SAMRC’s Socially Responsible licensing guidelines and the Grand Challenges Canada Global Access Policy. Between these various laws, policies and guidelines, and considering the nature of the TB market, most interviewees are satisfied that products resulting from publicly funded TB research in South Africa will be affordable and available in the areas where it is most needed – put another way, the perception is that there is no incentive for companies to develop TB products that are unaffordable. However, while funding agreements typically include provisions on access and affordability, these provisions are not always clear and may turn out to be hard to enforce should the need arise given the ambiguity around key terms and limited capacity for oversight of industry behaviour across low- and middle-income countries (LMICs).

South Africa’s Bayh-Dole-style IPR Act seeks to ensure that IP falling under the Act is identified, protected, utilised and commercialised for ‘the benefit of the people of the Republic’. It does not include any specific guidance on how to deliver or measure public benefit when commercialising technologies, nor on how to ensure that technologies are affordable and accessible. The Act recommends that IP holders use non-exclusive licensing approaches but does not require them. The Act also provides walk-in rights to government to address the state’s health, security and emergency needs. The only research excluded from the IPR Act is research that is funded in full by non-public sources – with full-cost including all direct and indirect costs incurred during the research, including staff and overhead costs at institutions. The Act is currently under review.

None of the interviewees expressed ideological opposition to non-exclusive licensing, however they raised practical challenges to its implementation. Additionally, they raised concerns that requirements for non-exclusive licensing approaches as a condition for receipt of public financing could impede their efforts to deliver new health technologies. Technology transfer officers and policy makers viewed their IP and ability to make exclusive deals as critical leverage tools for raising research funding and generating commercialisation investment from local and international funders and investors. Interviewees were generally of the view that, in the context of publicly funded TB research in South Africa, exclusive licensing would not lead to excessive pricing or limited access to resulting products. Testing whether this assumption is correct is an important area of future research. Presently it is hard to assess given that very few products have reached the market. Either way, in this regard, the incentive and market dynamics surrounding TB research in South Africa are perceived to be fundamentally different to, for example, the dynamics surrounding cancer research conducted in the United States. In addition, while South African government objectives such as job creation and economic development may at times conflict with public health objectives, most interviewees felt that these various objectives were in fact quite well balanced at present.

Interviewees expressed support for the principles of delinkage as well as for specific examples such as the Life Prize (a delinkage-based TB drug regimen development initiative previously known as the 3P Project). There was however wide scepticism about the likelihood of getting such projects funded. While South Africa’s Director General of Health Precious Matsoso chairs the Life Prize steering committee, no prize funds have yet been funded through the Life Prize mechanism. According to interviewees, the scale of investment required makes it extremely unlikely that the South African government could fund any major delinkage-based projects on its own.

While also supportive in principle, interviewees were generally sceptical about the prospects of international collaboration in funding delinkage-based projects, a R&D convention, or research collaborations such as the BRICS TB Research Network. In negotiations toward such agreements the perception among interviewees is that countries’ short to medium-term national economic interests holds sway over common longer-term interests, including health benefits. In addition, the imperative for economic development in low- or middle-income countries with relatively small budgets, such as South Africa, arguably makes it irrational to enter into such agreements without at least reciprocal commitments from other, hopefully wealthier, countries.

In conclusion, a compelling argument can be made that the South African government must increase its funding for TB and other medical research – something that will have both health and economic benefits.  The existing research infrastructure, funding mechanisms, and the legal and regulatory framework in South Africa appear to function well, although benefit may be derived from increased coordination in some areas and further guidance regarding socially responsible licensing and affordability and access, including through the development of an enforceable access policy for publicly funded research. South Africa has, and should continue to play, an important role in promoting delinkage-based drug-development and to support greater international collaboration on TB research. Such international collaboration will be critical to funding and properly testing alternative innovation models. (See section 9 for a full set of recommendations).

No fair prices for medicine without access and transparency

Posted on | April 16, 2019 | No Comments

Statement from 64 civil society organisations and coalitions ahead of the second meeting of the Fair Pricing Forum, hosted by the World Health Organization and South African government April 11-13th in Johannesburg.

The Fair Pricing Forum will ask what is a fair price for a medicine? We accept that different stakeholders will have different understandings of what is ‘fair’ but the WHO’s current definition of a fair price is concerning.  At a minimum, a definition of fairness must prioritize affordability and transparency of Research and Development (R&D) outlays, manufacturing costs, and pricing decisions.

The issue of excessive medicine prices is global, inextricably linked to a lack of pro-patient medical innovation and affects all diseases, all technologies, and all countries, especially low and middle-income countries. 100 million people around the world each year are being pushed into poverty because of healthcare expenses. High prices cause avoidable human suffering, inequality and poverty.

It is notable that this meeting is taking place in South Africa. Hundreds of thousands of people died from AIDS in South Africa because they could not afford excessively priced antiretroviral medicines in the late 90s and early 2000s. Today, many medicines, particularly cancer treatments, are unavailable to the majority of the South African population due to the high price, despite being available for a fraction of the price in other countries. This is partially because South Africa’s industry-friendly patent laws impede the introduction of low-cost generics, but also because there is no effective price regulation capping launch prices in the country.  

Our view of fair pricing:

  1. A medicine price cannot be considered fair if people or the government cannot afford it. This would compromise human rights including the right to life, the right to enjoy the benefits of scientific progress and its applications and the right to health. Currently the excessive prices of many cancer drugs results in people either dying because they cannot access the medicines or spending their life savings on co-payments for these medicines. We do not accept that this is fair.
  2. A medicine price cannot be considered fair without full transparency of all R&D expenditure, of manufacturing costs, and of how the price is decided.  Transparency is required throughout the R&D process from the start of basic research to the final delivery of medical products to patients. Some governments and most pharmaceutical corporations try to justify high prices by citing the need to recoup R&D outlays. Yet, pharmaceutical companies refuse to provide details of these R&D outlays and of related support from public and charitable entities. Some governments and pharmaceutical companies are actively opposing various efforts at enforcing greater transparency (as per various bills in the United States and a transparency proposal from the Italian government to be considered at the World Health Assembly). Transparency is essential so that governments or other payers negotiating with pharmaceutical companies can have an informed understanding of the real investments made by the public and private sector in their various forms (including in-kind contributions from health institutions involving patients, doctors and infrastructure).

Concern about current WHO definition

We are concerned about the WHO’s current definition of a fair price that appears in the WHO’s Roadmap for Access to Medicines, vaccines and other health products (EB 144/17); a “Fair price is one that is affordable for health systems and patients and that at the same time provides sufficient market incentive for industry to invest in innovation.”. We are not aware of any formal process that led to the adoption of this definition, nor of the status of the definition.

This definition has three critical flaws:

  1. It does not require transparency of R&D costs and price setting decisions. This means that the public will still have to trust pharmaceutical companies’ price-setting.
  2. It does not account for the substantial role of the public sector in funding R&D. This must be considered in defining fair prices to ensure the public does not pay twice and receives a public return on public investments.
  3. It pre-supposes that R&D is always to be paid for through end prices of medicines. The definition thus excludes development models based on the principles of delinkage, in which R&D would be incentivized through grants, subsidies and innovation inducement prizes, rather than monopoly-based high prices.

Signed:

AIDS and Rights Alliance for southern Africa (ARASA) (Regional)

Associação Brasileira Interdisciplinar de AIDS (ABIA) (Brazil)

Alianza LAC – Global por el Acceso a Medicamentos (Regional)

Campaign for Affordable Trastuzumab (India)

Cancer Alliance South Africa

Fix the Patent Laws Campaign (South Africa)

Global Justice Now (UK)

Health Action International (Global)

Heart to Heart Foundation (Thailand)

Health GAP (Global Access Project)

IFARMA Foundation (Colombia)

Interfaith Center on Corporate Responsibility (USA)

International Treatment Preparedness Coalition (ITPC) (Global)

Knowledge Ecology International (Global)

Misión Salud (Colombia)

Positive Malaysian Treatment Access & Advocacy Group (MTAAG+) (Malaysia)

Public Eye (Switzerland)

Salud por Derecho (Spain)

Southern African Programme on Access to Medicines and Diagnostics (Regional)

STOPAIDS (UK)

Third World Network (Global)

Universities Allied for Essential Medicines Brazil (UAEM Brazil)

Women’s Coalition Against Cancer (Malawi)

Yolse (Switzerland)

The Fix the Patent Laws campaign consists of 42 South African civil society organisations, including the Treatment Action Campaign, SECTION27, Doctors without Borders (MSF), and various mental health, NCD, sexual and reproductive health, and cancer organisations including those that make up the Cancer Alliance.

WIPO conference an insult to people who died of AIDS

Posted on | October 24, 2018 | No Comments

Johannesburg, 24 October 2018 – This week South Africa is hosting a World Intellectual Property Organization (WIPO) conference titled “Respect for IP – Growing from the Tip of Africa. Amongst others this conference will discuss “how intellectual property crime can be treated with higher priority by police authorities to ensure the safety of the public.”

We are disturbed by the insensitivity and tone-deafness of hosting such a meeting in South Africa, a country where excessive respect for intellectual property (IP) meant that HIV medicines remained excessively priced at a time when people were dying of the disease in large numbers. A country infamously sued by 39 international drug companies for attempting to improve access to affordable medicines in 1999.

There is ample evidence that South Africa’s legal framework currently provides too much respect for intellectual property. A 2011 University of Pretoria paper found that as many as 80% of patents granted in South Africa do not meet the country’s legal criteria for patentability. A 2012 research report found that when presented with the same set of patent applications, South Africa typically grants around 66% more patents than the United States or European Union.

We have so much respect for intellectual property in South Africa that at present we grant patents without examining whether the patents are merited. Government has finally started a process to institute a patent examination system, but this will take time to get off the ground. For now, we continue to give away patents without scrutiny.

A recent report released by the Fix the Patent Laws campaign and the Cancer Alliance exposed the excessive patenting of cancer medicines. 92 secondary patents were found on just 24 cancer medicines in South Africa, 39 of which had been rejected or withdrawn in at least one other country. This impacts on both affordability and availability in the country. 15 out of the 24 medicines were found to be available in India for half the price than South Africa – and in some far less. In the most extreme case, a year’s supply of lenalidomide is priced at ZAR 882,000 in South Africa and less than ZAR 32,000 in India. These high prices mean that out of the 24 medicines, only 7 are available in the public sector. This excessive respect for intellectual property has real-world consequences for normal people like Sue Johnson and Tobeka Daki, leaders in our campaign who passed away without access to certain lifesaving cancer medicines.

South Africa has also never issued a compulsory license on a medicine, not even at the height of the AIDS epidemic in the mid-2000s, despite the fact that we could legally have done so under World Trade Organisation (WTO) rules.

With Cabinet’s recent adoption of Phase I of the National Intellectual Property Policy, there is finally reason to hope that government will find a better balance between respect for human life and the private interests of pharmaceutical companies. Finding this better and more humane balance within the framework of current WTO rules is possible, as has been shown in countries like India and Argentina. In practical terms this better balance involves: Introducing a patent examination system, raising the bar for what deserves a patent to ensure only true inventions are rewarded, introducing more workable compulsory licensing procedures, and providing simple procedures for any interested party to challenge the grant of a patent. South Africa urgently needs to reform its Patents Act to introduce these changes.

We urge the South African government, and all other governments, to place respect for human life and the right to healthcare services ahead of the WIPO agenda that prioritises the enforcement of IP held by multinational companies. This is in line with the rights and obligations enshrined in our Constitution, which requires the state to respect, protect, promote and fulfil the Bill of Rights. It is also in line with common human decency.

For more information contact:

Ntsiki Mpulo (SECTION27) | mpulo@section27.org.za | +27 82 782 7143

The Fix the Patent Laws Coalition is a coalition of 40 patient groups and civil society organisations representing most major diseases areas in South Africa. The coalition was founded in 2011 by the Treatment Action Campaign (TAC), SECTION27 and Doctors without Borders (MSF). We advocate for reform to South Africa’s patent laws that will ensure wider and more affordable access to medicines.

New laws needed now to save lives: FTPL statement on new IP policy

Posted on | May 31, 2018 | 2 Comments

Intellectual property policy welcomed after nine years of development

JOHANNESBURG, 31 MAY 2018 – Yesterday, after nine years of development, the Department of Trade and Industry (the dti) finally published the Intellectual Property Policy of the Republic of South Africa, Phase I. The policy has been adopted by cabinet and as such represents official government policy, and has the potential to herald a new era in access to medicines for South Africa.

While we welcome the finalisation and adoption of this policy, we stress that it has not yet changed anything in the lives of people in South Africa who right now need medicines that remain unaffordable, and that it will not do so until key elements of the policy become law. As a matter of urgency, the dti must produce a thorough and far-reaching bill to amend the relevant Acts and parliament must prioritise the passing of this bill. Those aspects of the policy that can be implemented without legislative changes must be implemented right away. Whether the state can deliver the required legislative changes will be a key test of its commitment to the health of the people.

The harsh reality is that this law reform process in South Africa has already taken too long. It has taken too long for two of our comrades who have passed away in recent years, Tobeka Daki and Sue Johnson. At critical times in their illnesses, both Tobeka and Sue could not access the medicines they needed due to high prices. We will remember these comrades as we continue to advocate for more just and humane patent laws.

Comment on the content of the policy

As the Fix the Patent Laws coalition, we welcome the publication of the new policy and we are broadly in agreement with its content. The policy addresses most of the critical health-related policy and legislative changes that we have been campaigning for since 2011. We are disappointed though that certain critical sections of the policy are lacking in detail – in particular the sections on patentability criteria and on compulsory licensing.

That said, we welcome the policy’s framing in terms of the Constitution of South Africa and its acknowledgement of the importance of considering the public health impact of economic policy. We also welcome the policy’s acknowledgement that South Africa requires an intellectual property framework appropriate to its phase of development and that a patent maximalist approach is not in the best interest of our economy. In this regard, the policy implicitly rejects the incorrect view that trade-offs have to be made between the right to health and economic development.

We make the following specific comments:

  1. We support the introduction of a substantive patent search and examination system for patents in South Africa – something we have been advocating for, for years. The policy recognises that the current depositary system, in which patent applications are granted if they meet procedural formalities (paperwork and filing fee), leads to an excessive number of poor quality patents being granted in comparison to other countries. Patent examination guidelines must now be published for public input and the examination of patent applications for pharmaceutical products must start as soon as possible.
  1. We welcome the commitment to develop patentability criteria to “promote genuine innovation” – although we are disappointed that the policy does not go further to discourage specific evergreening practices. Ideally, the policy would have explicitly stated that South Africa will no longer grant patents for new uses, new forms, new formulations, combinations and other minor modifications of existing medicines. To improve the system, it is vital that South Africa develop rigorous patentability criteria and examination guidelines, following international best practices in countries of a similar developmental status, such as Argentina and India. By ensuring that only patents that meet rigorous criteria for novelty and inventiveness are granted, the government can curb excessive and secondary patenting, and ensure that only genuine innovation is rewarded. This will facilitate earlier introduction of more affordable generic medicines, ensuring that more people can access medicines earlier. Raising the bar for patentability is also necessary to incentivise R&D expenditure and efforts towards the development of meaningful health innovations that address unmet health needs, rather than perpetuating the pursuit of minor modifications and me-too versions of existing profitable products.
  1. We welcome the long-term commitment to introducing pre- and post-grant patent opposition procedures that could help ensure that only those inventions that represent genuine innovation are granted patent protection. This has been another key ask of our campaign. However, we are concerned that the interim solution proposed by the policy—a third-party observation system and administrative law procedures—will not permit sufficient participation by third-parties. We instead encourage the rapid introduction of simplified opposition procedures, and greater transparency concerning patent applications to allow third parties, such as civil society groups and other pharmaceutical companies, to intervene.
  1. We support the commitment to introduce a “more effective and efficient” system to obtain compulsory licenses for medicines – another key ask of our campaign in recent years. Compulsory licenses are a vital tool to ensure medicine access and must be available on a wide variety of grounds and in such a way that they can be granted quickly and effectively when needed for public health purposes. We urge government to withstand the industry pressure that will no doubt oppose this policy commitment, even though this commitment is entirely in line with World Trade Organisation rules.

We remain committed to engaging constructively with the DTI, the inter-ministerial committee on IP, and wider government to ensure rapid reforms to our patent laws to improve access to medicines in line with the state’s Constitutional obligations. We cannot wait another nine years for this policy to be turned into law.

 

_____________________________________________________________________________________________

For more information and to arrange interviews please contact:

Angela Makamure | Doctors Without Borders (MSF) | 079 872 2950 | angela.makamure@joburg.msf.org

Ntsiki Mpulo | SECTION27 | 082 782 7143 | mpulo@section27.org.za

Lotti Rutter | Treatment Action Campaign (TAC) | 072 225 9675 | lotti.rutter@tac.org.za

 

Notes

The policy references the Fix the Patent Laws report that outlines key medicines that people have struggled to access as a result of patent barriers in South Africa: “Patent Barriers to Medicine Access in South Africa: A Case for Patent Law Reform”.

The report is available at https://www.fixthepatentlaws.org/wp-content/uploads/2016/09/MSF-FTPL-report-FINAL-VERSION.pdf

The Fix the Patent Laws Coalition, made up of 40 patient groups and civil society organisations representing most major diseases in South Africa was launched on 11 November 2011 (on the 10-year anniversary of the WTO Doha Declaration) to advocate for changes to South Africa’s Patent Laws.

 

Members include: Treatment Action Campaign (TAC), Doctors Without Borders (MSF), SECTION27, the South African Non-Communicable Diseases Alliance (SANCD Alliance), DiabetesSA, EpilepsySA, Marie Stopes South Africa, Stop Stock Outs Project (SSP), South African Depression and Anxiety Group (SADAG), Cape Mental Health (CMH), the South African Federation of Mental Health (SAFMH), Schizophrenia and Bipolar Disorders Alliance (SABDA), as well as the following members of the Cancer Alliance and Advocates for Breast Cancer: Breast Course 4 Nurses, Breast Health Foundation, Cancer Association of South Africa (CANSA), Cancer Heroes, Can-Sir, CanSurvive, Care for Cancer Foundation, Childhood Cancer Foundation of South Africa (CHOC), Hospice Palliative Care Association (HPCA), Igazi Foundation, Look Good Feel Better, Love your Nuts, Lymphoedema Association of South Africa (LAOSA), Men’s Foundation, National Council Against Smoking, National Oncology Nursing Association of SA, Pancreatic Cancer Network of SA (PanCan), People Living With Cancer (PLWC), Pink Trees for Pauline, Pink Phoenix Cancer Foundation, Pocket Cancer Support, Project Flamingo, Rainbows and Smiles, Reach for Recovery, South African Oncology Social Work Forum (SAOSWF), The Pink Parasol Project, The Sunflower Fund, Vrede Foundation and Wings of Hope.

 

 

 

South African Cabinet Approves New Intellectual Property Policy

Posted on | May 24, 2018 | 3 Comments

 

fix-the-patent-laws3The Fix the Patent Laws Coalition (FTPL) welcomes the news today that the Cabinet of the Government of South Africa has approved the new Intellectual Property (IP) Policy. After nine years of policy development, two different draft policies and various rounds of public consultation, we now finally have an agreed-upon government policy that can guide much-needed law reform. Though we await seeing the final policy until it is gazetted by government, we are optimistic that the policy will herald a new era for access to medicines in South Africa by prioritising people’ lives over the profits of pharmaceutical corporations.

While the finalisation and adoption of a policy is an important milestone, the hard work of developing and passing legislative amendments is still ahead of us. We urge the Department of Trade and Industry to prioritise the development of bills that will bring a more humane and Constitutionally sound balance to our legal framework.

The approval of the new IP policy is particularly poignant given that it comes just days after the loss of one of our members and brave patient activists, Sue Johnson, on 16 May 2018, to Multiple Myeloma, for which she was unable to access the recommended treatment (a medicine called lenalidomide) due to its exhorbitant cost of R75,000 per month. This same medicine is available in India for just R5,000 per month. We remember at this time also our dear colleague Tobeka Daki, who passed away in November 2016 from HER2+ Breast Cancer, and who too was unable to afford the medicine she needed – trastuzumab, which cost approximately R500,000 per course at the time. We salute these brave comrades and the many others who have not been able to get the medicines they needed as a result of South Africa’s regressive patent system.

Though we celebrate today as an important step in the right direction, we will continue the fight to fix South Africa’s patent laws until all who need affordable medicines can access them. We remain committed to a world where no-one is denied life-saving or suffering preventing treatment simply because they cannot afford it.

FTPL will release a full statement after having read and analysed the new policy in detail.

In loving memory of Sue Johnson (04/04/1954 – 16/05/2018)

Posted on | May 17, 2018 | No Comments

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It is with immense sadness that the Fix the Patent Laws (FTPL) Coalition shares the news of the passing of a dear friend and brave patient advocate, Sue Johnson. Sue was a mother of two children and grandmother to two girls. She was born in the UK and moved to South Africa in 1983, where she spent her life working for the UN and Habitat for Humanity in Cape Town until her retirement in 2017.

Sue was also a prominent patient advocate for access to lenalidomide – a medicine prescribed for multiple myeloma – for the Cancer Alliance and FTPL. She spoke bravely and passionately of the struggles she face in accessing the medicine she needed at an affordable price, most memorably at the stakeholder meetings hosted by the Department of Trade and Industry on Intellectual Property Reform in October 2017 and at the Cancer Alliance launch of the Access to Medicine campaign in January 2018..

Sue was diagnosed with Breast Cancer in 2008 and with Multiple Myeloma in 2014. While she was initially able to access a generic lenalidomide treatment from India on a Section 21 authorisation from the Medicines Control Council at a price of about R5000 per month, this was revoked in 2016 when the originator product from Celgene, Revlimid, was registered in South Africa, at a cost of R882,000 per year. Sue’s medical insurer agreed to cover the increased cost of nearly R75,000 per month – but only for four months. After that, Sue and her family had to struggle to get the rest from their own pockets.

Secondary patents will block more affordable generics from entering the South African market until at least 2028. This means that equitable access for patients like Sue is a long way off.

“I remember that day very well, when everything changed: one day I had the support of the MCC and was able to import my medication from India. The next day the MCC took away my authorisation and my right to access generic medication. The registration of the patented product changed everything for me with just the stroke of a pen. Overnight I could no longer afford the treatment I needed to live.”

Sue will be remembered by all for her bravery and unselfish desire to fight for equitable and affordable access for all – despite knowing that she might not be able to benefit from it.

FTPL salutes Sue and will continue the fight for equitable and affordable access to lifesaving medicines for all in South Africa in her memory.

 

More information on lenalidomide and the battle for equitable access

With the FTPL and Cancer Alliance, Sue’s doctor, Dr Mike du Toit, appealed the MCC’s decision to deny the importation of generic lenalidomide into South Africa on the basis that the patented product was unaffordable and thereby inhibited access to patients in need of the life-saving medicine. In his appeal, Dr du Toit highlighted previous precedent of the MCC authorising the use of unregistered products on the basis of affordability concerns. The MCC’s 1 November 2017 decision to authorise importation of generic lenalidomide in response to Dr du Toit’s appeal ‘based on the previous use of the medicine and to allow for continuation of treatment’ further establishes precedent for the use of Section 21 to address affordability concerns.

A recent report by the Cancer Alliance and Fix the Patent Laws demonstrated that many important cancer medicines remain inaccessible to the majority of people that could benefit from them in South Africa while under patent due to their excessive costs. The report further highlighted that South Africa commonly grants patents that are rejected, withdrawn or overturned in other countries – blocking access to more affordable generic products already available outside of the country.

While Section 21 authorisations can improve access to generic products and should be applied more broadly for this use, the mechanism has limitations, including requiring detailed individual patient information, limiting patient numbers and, in some cases, dragging on for months or years through multiple appeal phases.

The lenalidomide case therefore further highlights the urgent need for expedited, administrative compulsory license provisions to license the use of generic products in South Africa when patents inhibit access.

 

US civil society sends letter to US government in support of patent law reform in South Africa

Posted on | November 9, 2017 | No Comments

On 6 November 2017, a group of US civil society organisations sent a letter urging the US government and industry not to interfere with South Africa’s efforts to promote access to lifesaving medicines. The group wrote they were “gravely concerned that the US government and industry representatives will try to undermine the South African government’s plan to reform patent laws over the next few months.” The letter notes that the draft intellectual property policy is both “consistent with South Africa’s international obligations” and “morally necessary.” It also highlights similar, existing policies in US law. The full text of the letter can be read below.

Patient groups march for access to medicines in South Africa

Posted on | October 24, 2017 | No Comments

Finalise the draft policy and amend laws to save lives, activists tell dti

24-10-2017

PRETORIA – Today, more than 1,000 members of the Fix the Patent Laws Coalition (FTPL) will march to the Department of Trade and Industry (dti) in support of the government’s efforts to fix our patent laws and ensure everyone has access to the medicines they need.

Made up of 36 patient groups and civil society organisations representing people affected by most major diseases in South Africa, the FTPL Coalition will hand over its in-depth submission in support of the draft Intellectual Property Policy, and a new report documenting the dire inaccessibility of many cancer medicines due to patent barriers. The draft policy was released by the dti in August 2017.

The draft policy paves the way for a new, progressive intellectual property regime in South Africa, sixteen years after the signing of the Doha Declaration on Public Health – a critical international agreement confirming countries’ ability to amend their laws to incorporate public health safeguards. Notably, for the first time, the draft policy is clear in its prioritising people’s Constitutionally guaranteed right of access to healthcare services, stating that the final policy must “first and foremost engender the ethos of the South African Constitution”.

“This reform process has been ongoing since 2009. We are encouraged that a final policy and actual changes to the law finally seem to be imminent. We march today to support the steps taken by the dti to protect public health, but also to remind the dti that people’s lives depend on the rapid conclusion of this law reform process. Until the relevant Acts are amended, people will continue to suffer and die in South Africa because they can’t access affordable medicines,” says Claire Waterhouse, Access Campaign Advocacy Adviser for Doctors Without Borders Southern Africa.

Sibongile Tshabalala, Chairperson of the Treatment Action Campaign says: “We march in solidarity with all people who cannot access the medicines they need to give them a chance at life, or to ease their suffering. We have lost comrades and friends simply because they couldn’t access the medicines they needed due to high prices driven by unwarranted patent monopolies.”

The march comes almost a year after the tragic passing of prominent FTPL activist, Tobeka Daki – a mother of two fighting HER2+ breast cancer. Daki could not access the medicine she needed, trastuzumab, due to the exorbitant price tag of almost R500,000 per year charged by pharmaceutical corporation Roche because of a protected patent monopoly.

The cancer medicines report launched today highlights that the case of trastuzumab is not unique. Of the 24 cancer medicines examined in the report, 15 are available in India for less than half of the price offered in the South African private sector.

In the most extreme case, a year’s supply of lenalidomide is priced at R882,000 in South Africa compared to less than R32,000 in India. The report confirms earlier research showing that South Africa grants large numbers of secondary patents on medicines that are often rejected in other countries – a critical factor driving the vast price differences on the same medicines in South Africa and India.

While the new medicines report highlights the serious issues in accessing many cancer treatments as a result of South Africa’s current patent laws, this is only one disease among many facing these problems. People across the country suffering from diseases ranging from HIV and TB, to epilepsy, to mental illness are all affected by similar access problems as a result of patent barriers, and it is the widespread nature of this issue that makes the finalising of patent law reforms all the more urgent.

“Luckily, it seems that the dti has woken up to the fact that it’s time to put people’s health over pharmaceutical corporation profits. The cancer report indicates just how urgent this is, which is why we want to show our support for this draft IP policy. This is South Africa’s opportunity to be a global role model in this area and we are ready to push Parliament next year to make this a reality,” says Salomé Meyer of the Cancer Alliance.

SECTION27’s Umunyana Rugege concludes: “The FTPL submission to the dti highlights areas of encouraging progress while continuing to provide recommendations for improvement, to ensure that a pro-public health policy that advances human rights is finalised.”

——————————————————————————————————————————————

For media enquiries, please contact:

Lotti Rutter | TAC | lotti.rutter@tac.org.za | 072 225 9675

Angela Makamure | Doctors Without Borders (MSF)| 079 872 2950

Notes:

  1. REPORT LAUNCH:

“Exploring patent barriers to cancer treatment access in South Africa: 24 medicine case studies”

The report is available here.

The Cancer Alliance and Fix the Patent Laws today launched a new medicines report that outlines 24 specific cancer medicines that people have struggled to access as a result of patent barriers in South Africa.

  1. SUBMISSION TO DTI:

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

Submissions remain open for any organisation or member of the public to submit their comments on the draft IP policy until November 17 2017. More information can be found at www.dti.gov.za

  1. TIMELINE OF PATENT LAW REFORM IN SOUTH AFRICA:

The timeline is available here.

ABOUT THE FIX THE PATEN LAWS CAMPAIGN:

The Fix the Patent Laws campaign is a joint coalition of 36 patient groups, including: AmaBele Belles’ Project Flamingo, Breast Course 4 Nurses, Breast Health Foundation (BHF),  Cancer Association of South Africa (CANSA), Can-Sir, CanSurvive Cancer Support, Cape Mental Health (CMH), Childhood Cancer Foundation of South Africa (CHOC), DiabetesSA, Doctors without Borders (MSF), EpilepsySA, Hospice Palliative Care Association (HPCA), Igazi Foundation, Lymphoedema Association of South Africa (LAOSA), Look Good Feel Better, Marie Stopes South Africa, Men’s Foundation, National Council Against Smoking, Oncology Nursing Association of SA, Pancreatic Cancer Network of SA, People Living With Cancer (PLWC), Pink Trees for Pauline, Pocket Cancer Support, Rainbows and Smiles, 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 Pink Parasol Project, The Sunflower Fund, Treatment Action Campaign (TAC), Vrede Foundation, and Wings of Hope.

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@FixPatentLaw

www.fixthepatentlaws.org

Submission by University of KwaZulu-Natal-Affiliated Academics on SA Draft Intellectual Property Policy

Posted on | October 23, 2017 | No Comments

The Union for Affordable Cancer Treatment comments on SA’s Draft IP Policy

Posted on | October 10, 2017 | No Comments

UACT-300dpi-300pxOn October 10, 2017, the Union for Affordable Cancer Treatment (UACT) and 22 NGOs working on cancer in South Africa and members of the Cancer Alliance, submitted comments to the South Africa on the Draft South Africa IP Policy.

The text of the submission can be read here and below.


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  • About the Campaign

    fix the patent laws
    Fix the Patent Laws is a campaign co-founded by SECTION27, Treatment Action Campaign (TAC) and Doctors Without Borders (MSF) in 2011. Since then, the coalition has grown to include 38 other organisations fighting together to push South Africa to amend its patent laws to prioritise public health. 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.

    The members of the Fix the Patent Laws Campaign are as follows: Treatment Action Campaign (TAC), Doctors Without Borders (MSF), SECTION27, the South African Non-Communicable Diseases Alliance (SANCD Alliance), DiabetesSA, EpilepsySA, Marie Stopes South Africa, Stop Stock Outs Project (SSP), South African Depression and Anxiety Group (SADAG), Cape Mental Health (CMH), the South African Federation of Mental Health (SAFMH), Schizophrenia and Bipolar Disorders Alliance (SABDA), as well as the following members of the Cancer Alliance and Advocates for Breast Cancer: Breast Course 4 Nurses, Breast Health Foundation, Cancer Association of South Africa (CANSA), Cancer Heroes, Can-Sir, CanSurvive, Care for Cancer Foundation, Childhood Cancer Foundation of South Africa (CHOC), Hospice Palliative Care Association (HPCA), Igazi Foundation, Look Good Feel Better, Love your Nuts, Lymphoedema Association of South Africa (LAOSA), Men’s Foundation, National Council Against Smoking, National Oncology Nursing Association of SA, Pancreatic Cancer Network of SA (PanCan), People Living With Cancer (PLWC), Pink Trees for Pauline, Pink Phoenix Cancer Foundation, Pocket Cancer Support, Project Flamingo, Rainbows and Smiles, Reach for Recovery, South African Oncology Social Work Forum (SAOSWF), The Pink Parasol Project, The Sunflower Fund, Vrede Foundation and Wings of Hope.

  • Read the TAC and MSF campaign pamphlet

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