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.”

The World Health Organisation recommends infants be administered an initial vaccination against hepatitis B within 24 hours of birth to prevent HBV infection in the initial weeks of life. This “birth dose” reduces mother-to-child transmission of HBV. Studies in Africa suggest transmission is currently between 2-30% of infants born to HBV-infected mothers. However, in much of sub-Saharan Africa the birth dose has not been implemented and HBV vaccine coverage remains low. “The DOH needs to set an example for the region,” said Andersson. “It’s time South Africa and other countries add a hepatitis B birth dose to the national immunisation agenda.”

For individuals already infected with hepatitis, there is also a critical need for key hepatitis treatments to be available at more affordable prices. Entecavir, for example, is an effective treatment for hepatitis B for those with kidney impairment, but the drug is only available in South Africa from multi-national pharmaceutical company, Bristol-Myers Squibb (BMS), which charges monopoly prices. Entecavir is not readily available through the public sector, and drug costs in the private sector for treating a hepatitis B patient range from R4,700-R5,500 per month. In India, by contrast, where generics are available, the costs of treating a hepatitis B patient with entecavir are much lower—between R400-R800 per month.

The initial patent on entecavir expired in South Africa in 2011, which should have permitted lower-cost generic competitors to enter the market. However, BMS holds additional patents on entecavir in South Africa that do not expire until 2022, at the earliest. While the price remains high, the product remains out of reach for those who need it.

“South Africa doesn’t examine patent applications, so we grant monopolies to companies for things that aren’t new or innovative—patents that other countries wouldn’t grant,” said Anele Yawa, General Secretary of the Treatment Action Campaign. “An entecavir patent was recently overturned in the United States, but if it is filed in South Africa, it is likely to be granted to BMS. Examples like entecavir show how urgently the DTI needs to finalise a national policy on patent laws that prioritises public health needs, so the Patents Office rejects frivolous applications.”

The following organisations and individuals have endorsed this statement for World Hepatitis Day, calling on governments in South Africa and across the region to prioritise strategies that will support the eradication of hepatitis B mother-to-child transmission, and develop intellectual property policies that prioritise public health needs and promote medical innovation for affordable and adapted products:

 

Organisations:

Africa Partners Medical

Association Sauvons l’Afrique Des Hépatites (ASADH)—Togo

Doctors Without Borders (MSF) South Africa—South Africa

Ghana Coalition of NGOs in Health—Ghana

HepCBC Hepatitis C Education and Prevention Society—Canada

Latin American Association for the Study of the Liver (ALEH)

Les Club des Amis du Monde—Guinea (Conakry)

Médecins Sans Frontières Access Campaign

Réseau Accès aux Médicaments Essentiels (RAME)—Burkina Faso

Southern African HIV Clinicians Society

Treatment Action Campaign—South Africa

Treatment Action Group—USA

 

Individuals & Affiliations:

Monique Andersson

Division of Medical Virology, Dept of Pathology, Stellenbosch University, South Africa

Joan Awunyo-Akaba

Executive Director, Future Generations International (FUGI), Ghana

CSO Board Member, GAVI Alliance Board

Francsca Cainelli

Senior Lecturer in Internal Medicine, University of Botswana and Head, Department of Medicine, Princess Marina Hospital, Gaborone, Botswana

Prof. Mark Cotton

Director FamCRU, Stellenbosch University, South Africa

Chris Kassianides

Chairman, Gastroenterology Foundation of South Africa

Stephen Korsman

Medical Virologist, University of Cape Town/Groote Schuur NHLS, South Africa

Jean Nachega

Professor, Director Centre of Infection, Stellenbosch University, South Africa

Theobald Owusu-Ansah
President, Theobald Hepatitis B Foundation/ Hepatitis Coalition of Ghana
Board Member, National Association of Hepatitis Taskforce, United States

Wolfgang Preiser

Professor and Head: Division of Medical Virology, Department of Pathology, Stellenbosch University and NHLS Tygerberg, South Africa

Christo van Rensburg

Professor and Head: Division of Gastroenterology, University of Stellenbosch, South Africa

Naveen Thacker

M.D. (Ped), F.I.A.P., Consultant Pediatrician

Gerhard Theron

Departmental Chairman, Dept. of Obstetrics and Gynaecology, Stellenbosch University, South Africa

Sandro Vento

Professor of Internal Medicine and Dean, Faculty of Medicine, University of Botswana, Gaborone, Botswana

Charles Wiysonge

Professor, Centre for Evidence-based Health Care, Stellenbosch University, South Africa

 

For further information, or to be added to this list of individuals and organisations calling for an improved response to Hepatitis B and C, please contact:

DR MONIQUE ANDERSSON

Division of Medical Virology, Department of Pathology, Stellenbosch University, South Africa

tel:  +27 (0)21 9389354

mobile: +27 (0) 82 709 6152

email:  andersson_m@sun.ac.za

 

Media Requests

KATE RIBET

Media Liaison Officer, Doctors Without Borders South Africa

tel: +27 (0) 11 403 4440

mobile: +27 (0) 79 872 2950

email: kate.ribet@joburg.msf.org

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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.

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