Over 70 organisations globally have called on the Department of Trade and Industry (DTI) to urgently finalise South Africa's National Intellectual Property (IP) Policy in an open letter delivered today (June 17). You can find a PDF of the open letter here. The Fix the Patent Law campaign thanks all signatories for their support for improving access to medicines in South Africa!
Open letter from Civil Society groups to Minister Rob Davies and the Newly Appointed Cabinet on the Urgent Need to Finalise and Adopt South Africa’s National IP Policy.
We the undersigned, call on Minister Rob Davies and the newly appointed Cabinet to urgently reform South Africa’s patent system in line with the Constitutional obligation to take legislative steps to realise the right to health.
Under the leadership of Minister Rob Davies, the Department of Trade and Industry published South Africa’s draft National Policy on Intellectual Property (IP) in September 2013. The draft policy proposes a number of critical and long overdue reforms that dramatically increase affordability of medicines and brighten the future of healthcare in South Africa. Minister Davies and the wider Cabinet must now act urgently to finalise and adopt a policy that fulfils Constitutional requirements and makes full use of public health related flexibilities available under international intellectual property law.
South Africa grants an excessive number of pharmaceutical patents – making the country an outlier by international standards. In 2008 alone, South Africa granted 2442 medicine patents, while from 2003-2008 Brazil only granted 273. One of the reasons for excess patenting is that South Africa grants medicine patents without examining them to determine if they meet the country’s (already low) standard for what is patentable.
The multinational pharmaceutical industry takes full advantage of this lack of review. By continuously making obvious, minor modifications to existing medicines, or filing patents for new uses of old medicines, pharmaceutical companies are able to continually extend their 20-year patent monopolies. This has lead to South Africans paying unnecessarily high prices for a number of medicines because there is no competition from cost-effective generic suppliers. This is costing the government millions of Rands and is contributing to South Africa’s worryingly large pharmaceutical trade deficit. Most importantly it is denying people access to life-saving medicines.
The international legal framework on patents provides countries with various tools to strike a better balance between the private interests of patent holders and the right to affordable access to medicines. South Africa could examine patent applications, set higher criteria for what is deserving of a patent, allow third party oppositions to applications, and ensure flexibility in accessing entirely new drugs that offer a public health benefit. By allowing fewer poor quality patents to be granted through higher standards, opposition procedures, and rigorous examination, South Africa could ensure that generic competitors are able to enter the market sooner. Generic competition has proven to be the most effective way to push prices down to truly affordable levels. Generic competition was the key factor in the massive drop from around R100,000 in 2000 to R1080 today in annual per person costs for year of standard first-line ARV treatment.
The South African government has started to address this issue but continued delays are threatening the fundamental changes needed. South Africa’s National IP Policy has been in development for over six years at the Department of Trade and Industry (DTI). This is the third South African administration that has presided over the process. There has been extensive consultation on the draft policy that was released last September – we understand that the DTI received more than 200 submissions on the draft policy. This has not been a rushed process, and no party can claim not to have had an opportunity to provide input.
We cannot afford to wait any longer. Given South Africa’s extremely high burden of both communicable and non-communicable diseases, and the continuing rise in healthcare costs, there is a pressing need to take urgent steps to address access to many important medicines.
The reforms proposed in the draft policy are not radical. Each reform is entirely lawful. Each reform is sanctioned by the World Trade Organization, the World Intellectual Property Organization, and the World Health Organization. Each reform is in accordance with international intellectual property law (the TRIPS Agreement). Similar reforms have already been implemented in other countries such as Argentina, Brazil and India. The reforms do not seek to break the patent system and will not remove the incentive to invest in researching truly new and innovative medicines. There is no legal reason to delay the policy and correlative patent law reform any longer. To the contrary, the Constitution demands that reasonable legislative measures that increase access to healthcare must be implemented promptly.
South Africa’s ruling party, the African National Congress (ANC), and the main opposition party, the Democratic Alliance (DA), both expressed strong support for reform of South Africa’s patent laws before the election. The parties were responding to a question on pro-public health reform of South Africa’s patent laws in the Treatment Action Campaign’s (TAC) People’s Health Manifesto. Furthermore both parties expressed urgency in response to this question.
While we are critical of the length of time this process has taken to date, we hope that the continuity in the Ministry means no further delays will occur. Without major reform of the existing patent system and further investment in critical R&D, many medicines will remain unaffordable, unavailable, and unsuitable across South Africa. Healthcare is not a privilege for the few. The South African government must do all in its power to actively realise the right to health in line with their Constitutional obligations by rapidly finalising and adopting South Africa’s National IP Policy without further delay.
Treatment Action Campaign, South Africa
SECTION27, South Africa
Doctors Without Borders, South Africa
Equal Education, South Africa
Lawyers for Human Rights, South Africa
Budget Expenditure Monitoring Forum (BEMF), South Africa
People’s Health Movement, South Africa
UKZN IP & Access to Medicines Programme, School of Law, University of KwaZulu-Natal, South Africa
Médecins Sans Frontières (MSF) Khayelitsha, South Africa
AIDS & Rights Alliance for Southern Africa (ARASA), Southern Africa
National Association of People Living with HIV and AIDS (NAPWA), South Africa
HIV Clinicians Society, South Africa
Diamond Life, South Africa
Stop Stockouts Project, South Africa
Social Justice Coalition, South Africa
Ndifuna Ukwazi (Dare to Know), South Africa
Global TB Community Advisory Board (TB CAB), South Africa
Artists for a New South Africa
Pan-African Treatment Access Movement, Africa
Swaziland Positive Living (SWAPOL), Swaziland
International Community of Women Living With HIV Zimbabwe Chapter, Zimbabwe
Pan-African Positive Women’s Coalition (PAPWC), Zimbabwe
AIDS Law Project, Kenya
National Empowerment Network of PLHAs in Kenya (NEPHAK), Kenya
RAP+ Afique Centrale
Working Group on Intellectual Property (GTPI/Rebrip), Brazil
Associação Brasileira Interdisciplinar de AIDS (Brazilian Interdisciplinary AIDS Association) (ABIA), Brazil
Conectas Direitos Humanos (Conectas Human Rights), Brazil
Federação Nacional dos Farmacêuticos (National Federation of Pharmacists) (FENAFAR), Brazil
Grupo de Apoio à Prevenção à AIDS de São Paulo (Support Group for AIDS Prevention in São Paulo) (GAPA/SP), Brazil
Grupo de Apoio à Prevenção à AIDS do Rio Grande do Sul (Support Group for AIDS Prevention in Rio Grande do Sul) (GAPA/RS), Brazil
Soropositividade, Comunicação e Gênero (GESTOS - HIV+, Communication and Gender), Brazil
Grupo de Incentivo à Vida (Incentive to Life Group) (GIV), Brazil
GrupoPela Vidda/SP (Group for Life in São Paulo), Brazil
Grupo Pela Vidda/RJ (Group for Life in Rio de Janeiro), Brazil
Grupo de Resistência Asa Branca (Resistance Group Asa Branca) (GRAB), Brazil
Instituto Brasileiro de Defesa do Consumidor (Brazilian Institute for Consumers Protection) (IDEC), Brazil
Network of People Living with HIV/AIDS Maranhão (RNP+/MA), Brazil
Fundación GEP, Argentina
Red Argentina de Personas Positivas (REDAR Positiva), Argentina
Red Latinoamericana por el Acceso a Medicamentos (RedLAM), Latin America
Positive Malaysian Treatment Access & Advocacy Group (MTAAG+), Malaysia
Delhi Network of Positive People (DNP+), India
Lawyers Collective, India
Asia Pacific Network of People Living with HIV (APN+), Asia
East Europe and Central Asia Union of People Living with HIV
International Treatment Preparedness Coalition (ITPC), International
Médecins Sans Frontières (MSF) Access Campaign, International
Coalition PLUS, International
International AIDS Society, International
Third World Network, International
Restless Development, International
People’s Health Movement, Global
Knowledge Ecology International
American Medical Student Association (AMSA), USA
Universities Allied for Essential Medicines, USA
Open Society Foundations, USA
Health GAP (Global Access Project), USA, Uganda, Kenya
Act-Up Philadelphia, USA
I-MAK – Initiative for Medicines, Access & Knowledge, USA
Student Global AIDS Campaign (SGAC), USA
Treatment Action Group (TAG), USA
Student Stop AIDS Campaign, UK
HIV i-Base, UK
Health Poverty Action, UK
Friends of Treatment Action Campaign (FoTAC), UK
Universities Allied for Essential Medicines (UAEM), UK
SHAFTED?! Building the HIV Army, UK
Act-Up Basel, Switzerland
Act Up-Paris, France
All-Ukrainian Network of PLWH, Ukraine
Australian Federation of AIDS Organisations, Australia