Fix The Patent Laws

WORLD HEPATITUS DAY: TAC Joins Organisations Calling for Improved Access to HepB Vaccines & Medicines

Posted on | July 28, 2014 | No Comments

On World Hepatitis Day, organisations call on SA government: protect infants with HepB jab at birth & reduce patent barriers to HepB therapies

July 28, 2014, JOHANNESBURG—On World Hepatitis Day, 26 organisations and individuals from around the world have called on the South African Department of Health (DOH) and Department of Trade and Industry (DTI) to address the public health threat of hepatitis, by implementing hepatitis B immunisation at birth, and reforming national patent laws to promote access to more affordable hepatitis therapies.

Hepatitis B is highly endemic in South Africa and across sub-Saharan Africa, where around 8% of people are chronically infected, and the rates of hepatitis B-related liver cancer are some of the highest in the world. Globally, viral hepatitis causes approximately 1.3 million deaths every year—more than either malaria or tuberculosis—with around 240 million people chronically infected with hepatitis B virus (HBV), and 140 million people with hepatitis C virus (HCV). Either of these viruses can result in liver failure and liver cancer.

“Preventing infant infection is undoubtedly the most important way to reduce the prevalence of the hepatitis B virus,” said Dr. Monique Andersson, a virologist at Stellenbosch University. “A safe, effective, and affordable hepatitis B vaccine has been available for over two decades, and remains the backbone of prevention strategies. Yet infants continue to be infected across sub- Saharan Africa because they don’t receive the immunisation early enough.” Read more

South Africa’s Statement on Access to Essential Medicines at WHA

Posted on | May 26, 2014 | No Comments

This statement was originally published on the Knowledge Ecology International website by Thiru Balasubramaniam:

On Friday, 23 May 2014, the World Health Assembly is currently discussing access to essential medicines in the context of resolution EB134.R16, tabled China in January 2014. The following statement was delivered by South Africa on behalf of the 47 members of the African region. South Africa highlighted the point that “vaccines and anti-cancer drugs remain out of reach of millions of people in both developed and developing countries.”

With respect to the concept of “essentiality” and the high cost of medicines, the WHO African region noted,

The high price of medicines, particularly in the private sector, is a key barrier to affordable essential medicines in developing countries. While affordable prices are a key determinant in improving access to medicines, we should not forget that adequate, sustainable and equitable financing of medicines is also required. The WHO essential medicines committee may consider producing a list of medicines that are essential for public health however they are at an unaffordable price. This would direct other low cost manufacturers to focus on their product portfolio.

The full statement follows.

Statement by South Africa
Item 15.5 Access to Essential Medicines

Chairperson, Honourable Representatives of Member States, distinguished delegates, South Africa is pleased to a speak on behalf of the 47 members of the African region.

We thank the secretariat for preparing this report on Access to Essential Medicines and the WHO Medicines Strategy as reflected in the Twelfth general Programme of Work: 2014-2019.

Progress towards achieving the MDGs will not be realised if there are still barriers to access medicines. While countries have made considerable progress in achieving MDGs, particularly with respect to accessing medicines to fight HIV, malaria and TB. Access to other drugs such as vaccines and anti-cancer drugs remain out of reach of millions of people in both developed and developing countries.

Access to medicines implies continuously available and affordable medicines at health facilities which are close to where people live. Barriers to access can be due to several factors such as inadequate financing, high-priced products, procurement of originator brands, and inefficiencies in the supply and distribution chain.

The high price of medicines, particularly in the private sector, is a key barrier to affordable essential medicines in developing countries. While affordable prices are a key determinant in improving access to medicines, we should not forget that adequate, sustainable and equitable financing of medicines is also required. The WHO essential medicines committee may consider producing a list of medicines that are essential for public health however they are at an unaffordable price. This would direct other low cost manufacturers to focus on their product portfolio.

Chair, public sector availability of medicines is low in many developing countries. In a survey of 27 developing countries found the average public sector availability was only 35 per cent. When medicines are not available in the public sector, patients will have to purchase these medicines from the higher-priced private sector, or forgo treatment altogether. Low availability of medicines is therefore another barrier to access.

Generically equivalent products are usually priced at a substantially lower level than the originator brand. Increasing the use of quality-assured generic medicines through competition is therefore a key strategy for improving the affordability of medicine. A range of policy options is available to promote the use of generics.

Patents also have a dramatic impact on access to medicines when they are used to prevent competition. When life-saving treatments for diseases such as HIV/AIDS, cancer and Hepatitis become unaffordable to those that need them, the consequences can be – and are – devastating. Yesterday we were discussing limited access to Hepatitis treatment at the Assembly. In developing countries, where people pay for drugs out of their own pockets and very seldom have health insurance, the high price of medicines becomes a question of life and death.

Communities in Africa have insufficient access to essential medicines, a situation compounded by fragmented medicines regulatory systems. The medicines regulatory harmonisation was approved by the AU Conference of Ministers of Health in 2007 (under the pharmaceutical manufacturing plan for Africa and launched in 2009) and aims to enable African countries to fulfil their national obligations to provide all citizens with safe, quality and efficacious essential medicines.

Chair, in conclusion:

We would like to recognise that there are several factors that affect access to medicines. These include :
• The purchase price of the medicine from the manufacturer is a key factor that influences access. This can be best addressed through a price regulatory system.
• Utilisation of the TRIPS flexibilities to promote access to medicines that impact on public health.
• A system to track the availability of medicines through the medicine supply chain.
• A simplified, harmonised, efficient and transparent regulatory approval process particularly for generic medicines.
• A generic substitution policy that is effectively implemented.
All of these interventions must be implemented in a integrated system to improve access to essential medicines. The member states of Africa support the resolution on Access to Medicine as key to improving people’s lives and fundamental to realising the right to health.


Posted on | March 12, 2014 | No Comments


Activists demand rapid completion of intellectual property policy six years in the making; Without internationally recognised public health safeguards policy will be health disaster

2014/03/11, PRETORIA — Marching to the Department of Trade and Industry (DTI), the Treatment Action Campaign (TAC), Doctors Without Borders (MSF) and SECTION27 led 1,000 health activists to demand the finalisation of a National Intellectual Property (IP) Policy before the general elections, to provide South Africans better access to the drugs they need through legislative reforms.

“It’s been six years since the Department of Trade and Industry started work on the IP policy and we cannot wait any longer. DTI has to keep to its promise to complete it by April – before the elections on 7 May – so the laws can start to change. We cannot afford to keep lining the pockets of international pharmaceutical companies at the expense of South Africans who need vital drugs,” says Andrew Mosane of the Treatment Action Campaign.

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MEDIA INVITE: Photo opportunity as health activists take to the streets

Posted on | March 7, 2014 | No Comments



TUESDAY MARCH 11 – Department of Trade and Industry (DTI) offices, PRETORIA


Health activists to demand completion of South Africa’s Intellectual Property Policy outside DTI offices, Pretoria and Parliament, Cape Town.

Over 2,500 health activists across the Western Cape and Gauteng will march on the DTI offices in Pretoria and Parliament in Cape Town to demand that South Africa fix its intellectual property laws to improve access to affordable medicines in the country.

Activists are asking the DTI to resist pharmaceutical industry pressure and complete the National Policy on Intellectual Propertybefore the general elections, in line with the government’s Constitutional obligation to take legislative measures to realise the right to health.  Read more

Responding to PhRMA lies in the South African media

Posted on | March 7, 2014 | No Comments

Lotti Rutter from the Treatment Action Campaign responds to PhRMA opinion piece in BDLive on 26th February 2014

This Wednesday’s opinion piece – “Strong IP regime could boost FDI” – might have promised a simple solution for increasing foreign direct investment, but unfortunately the reality is much more complicated. Rather than strong intellectual property (IP) protection being the ‘dynamo of growth’ as suggested by PhRMA Vice President Rod Hunter, the available evidence from our developing country peers suggests the exact opposite.

A recent study by Mila Kashcheeva, of 103 countries from 1970 to 2009 found that strong IP protection has a negative correlation with FDI in developing countries. Instead countries with ‘lax’ levels of IP protection achieved higher growth in foreign investment. The actual drivers of FDI in the pharmaceutical sector prove to be labour and production costs and economic incentives.

If granting poor quality patents lead to increased FDI, one would expect South Africa to be awash in investment since virtually every patent applied for here is granted. Instead we have attracted far less FDI than countries with weaker IP protection. Since complying with international trade law, 35 pharmaceutical manufacturing plants have shut down. Read more

TAC paper responds to inaccurate industry claims following the pharmagate scandal

Posted on | February 13, 2014 | No Comments

“The Economic & Social Case for Patent Law Reform in South Africa”

Lotti Rutter and Catherine Tomlinson

This updated research paper from the Treatment Action Campaign seeks to respond with reasoned analysis to a number of inaccurate claims that have been made by the pharmaceutical industry, particularly following the PharmaGate scandal. The evidence highlights how South Africa’s current intellectual property system allows exploitation by foreign companies whilst impeding access to medicines and the growth of our local industry. Additionally, the paper demonstrates that there is little evidence to back up industry claims that the adoption of public health safeguards in South Africa will undermine the development of future medicines.

The reforms proposed by the Department of Trade and Industry in South Africa are not radical. They are moderate, legal, rationale reforms acknowledged by global institutions including the WTO, WHO and WIPO. Nothing in the proposed reforms to South Africa’s Patent Act will do a way with patents. Truly innovative new treatments will still be patentable. Instead, what the Fix the Patent Laws campaign seeks is a more rational patent regime that takes into account South Africa’s health, developmental, social and economic needs. A regime that is based on relevant evidence rather than ideology.

You can access the research paper here: The Economic and Social Case for Patent Law Reform in South Africa.

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Pharmagate and the economics of patent law reform

Posted on | January 28, 2014 | No Comments

A shortened version of this article was originally published in the Financial Mail of January 24-29. By Marcus Low, Treatment Action Campaign.

We are deeply perturbed by revelations in last Friday’s Mail & Guardian exposing what appears to be a very well-funded, covert plot by foreign pharmaceutical companies and their local subsidiaries to delay a democratic law reform process in South Africa. The law reform concerns the new draft intellectual property policy developed by the Department of Trade and Industry (DTI). This policy has already been delayed for many years. The leaked documents expose a secretive US$ 500,000 plot to delay the policy even further.

We do not dispute the right of the companies involved to argue against patent law reform. They have had ample opportunity to make their case during last year’s period of public consultation and during meetings they had with the DTI before that. What does concern us is the intent to deceive the South African public. The leaked documents indicate that this will be done through rigging research into the impact of policy changes and by setting up a front organization called Forward South Africa. Forward SA would have a prominent South African person as its public face, but would secretly be run from the U.S. It is the stuff of conspiracy theories, but set down in documents circulated between members of the Innovative Pharmaceutical Association of South Africa (IPASA) and endorsed by Michael Azrak, head of IPASA’s intellectual property committee.

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Statement of South Africa on Access to Essential Medicines (in the wake of Pharmagate)

Posted on | January 24, 2014 | No Comments

This statement was originally published on the Knowledge Ecology International website by Thiru Balasubramaniam:

On Thursday, 23 January 2014, Malebona Precious Matsoso (Director General of the South African National Department of Health) delivered the the following intervention at the 134th session of the World Health Organization’s Executive Board under agenda item 9.7 on Access to essential medicines in response to the recent Pharmagate imbroglio.



Chair, the recent leak by the multinational pharmaceutical industry of the strategy written by Public Affairs Engagement to undermine South Africa’s efforts to reform its Intellectual Property policies is unfortunate. One of the objectives of this policy is to contribute towards the protection and promotion of public health, and access to medicines in particular.

This is not the first time that South Africa has been under such an attack, even in the face of the most devastating HIV/AIDS and TB co-morbidities. The first time was when Nelson Mandela was the first respondent to the legal challenge.

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Patents: Reform or Lose

Posted on | January 22, 2014 | No Comments

Article originally published by the NSP Review here. By Lotti Rutter, Treatment Action Campaign

Achieving the National Strategic Plan (NSP) objectives depends on the effective use of the national health budget. But is there sufficient emphasis on value for money in the health sector at a time when South Africa is struggling to meet its targets of placing 80% of eligible patients on ART and reducing TB deaths by 50%? Or is money being wasted lining the pockets of the pharmaceutical industry that manipulates the system to make ever-increasing levels of profit?

According to the agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS), member countries of the World Trade Organization (WTO) must respect a period of patent protection lasting 20 years. During this time, a patent holder maintains exclusive rights to their product. This lack of a competitive market allows pharmaceutical companies to charge unaffordable prices in order to maximise profits – meaning life-saving medicines remain inaccessible.

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COSATU reacts to big pharma’s plot to derail patent law reform in SA

Posted on | January 20, 2014 | No Comments

On 18th January, the Congress of South African Trade Unions (COSATU) put out the following statement in response to the #PharmaGate scandal – pertaining to a leaked international pharmaceutical industry plot to derail national plans for patent law reform in South Africa:

“The Congress of South African Trade Unions condemns with the contempt it deserves the plot by greedy pharmaceutical companies to block the adoption of the National policy on Intellectual Property that would drive down prices for a range of medications, including antiretrovirals and tuberculosis treatment, and allow South Africans to have access to cheaper and more affordable medication. 

We support the Minister of Health, Minister Aaron Motsoaledi’s statement that the planned campaign by multinational pharmaceutical companies against these proposals is genocide. This plot is tantamount to treachery as it seeks to stop parliament from exercising its duty to pass legislation that improves the lives of South Africans.

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  • About the Campaign

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

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