Activists Urge a Change in Patent Laws in South Africa

via PlusNews Global

Ten years ago, the Doha Declaration allowed countries to circumvent patent rights to access life-saving medicines, particularly those used to treat HIV/AIDS, tuberculosis and malaria. However, the South African government has failed to take advantage of these provisions, and increasingly important TB medication and second- and third-line antiretrovirals (ARVs) remain out of reach, activists warn.

"Pre-Doha, treating [HIV] without generics... meant HIV was a death sentence," said Gilles van Cutsem, medical coordinator for Médecins Sans Frontières (MSF).

In South Africa, with the world's highest HIV infection rate, the availability of generic first-line ARVs meant a drop from an annual cost of more than US$10,000 per patient to $60. Now, with more than one million people on treatment, the country will need to put more HIV-positive people on second- and third-line regimens.

Right to health

The Doha Declaration, or the Declaration on the TRIPS Agreement (Agreement on Trade-related Aspects of Intellectual Property Rights), was signed by members of the World Trade Organization (WTO) in response to concerns that patent protection granted by the TRIPS Agreement would undermine the ability of countries to protect their right to health and access to medicines.

The 1995 TRIPS Agreement made all WTO members beholden to a pharmaceutical patent period of 20 years, during which time no generic could be produced. Before TRIPS, countries such as Brazil and India did not respect patent periods at all, and many other nations observed shorter time-spans (16 years in South Africa).

With the 2001 Doha Declaration, provisions within the TRIPS agreement to protect public health were reaffirmed, as were the rights of member countries to "use, to the full, the provisions in the TRIPS Agreement, which provide flexibility for this purpose".

This included the granting of compulsory licences, which allow a government to formulate or import generic versions of medicines essential to public health but still under the 20-year patent period.

To take advantage of public health flexibilities such as compulsory licensing, however, it must be enacted into national legislation. Unfortunately, few countries, including South Africa, have taken advantage of their rights.

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Kenyan government grapples with counterfeit ARVs

via PlusNews Global

Kenya's government is scrambling to remove thousands of batches of counterfeit antiretrovirals (ARVs) from circulation after patients and health workers reported irregularities in the appearance and texture of a widely used drug.

In September, nurses working with the medical NGO, Médecins Sans Frontières - which runs HIV and tuberculosis clinics in the capital, Nairobi, and western Kenya - reported irregularities in the appearance of the antiretroviral Zidolam-N, a combination treatment containing the ARVs zidovudine, lamivudine and nevirapine.

The ARVs were found to be falsified versions of a World Health Organization (WHO)-certified generic drug purchased through a distributor endorsed by the Kenya Pharmacy and Poisons Board (KPPB), the country's drug regulatory authority.

According to the KPPB, one batch of the fake Zidolam-N, with the number E100766, is marked as manufactured in 2009 and set to expire in May 2013, while a second carries the batch number A9366 with manufacture and expiry dates of June 2009 and May 2012 respectively. The main irregularities included discolouration, mould and crumbliness; the packaging is also of varying quality and the text differs in font and colour from the genuine drug.

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[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

A Trade Barrier to Defeating AIDS

Via the New York Times, by Tina Rosenberg.

Earlier this month, [the Medicines Patent Pool, a new organization trying to make AIDS drugs better, cheaper and available sooner to people who need them in poor countries] received its first donation of rights from a pharmaceutical manufacturer, Gilead Sciences.   It is an important step  — but the terms Gilead negotiated are also confirmation of a dangerous new trend: middle income countries as a target market for drug makers.  In the past, pharmaceutical companies have lowered prices in these countries to increase sales.  The new strategy is to treat people in Egypt, Paraguay, Turkmenistan or China — middle-income countries, all — as if they or their governments could pay hundreds or even thousands of dollars a year each for AIDS drugs.   This low-volume high-profit strategy might make  business sense.   But in terms of the war against AIDS, it means surrender.

In the world’s most impoverished countries, AIDS drugs are cheap.   It wasn’t always that way.  Until well into the Clinton administration, the United States government pressured even the poorest countries shamelessly if they tried to bring down the prices of medicine.   Even newly democratic, AIDS-ravaged South Africa became the object of an all-out assault by the Clinton administration to get the country to repeal a law allowing it to break medical patents, a step that was perfectly legal under world trade rules.  Washington was not interested in the health consequences.   (A U.S. trade negotiator who worked on South Africa at the time told me that he had been unaware that AIDS was a major problem there.)    Public outrage over South Africa ended Washington’s pressure on poor countries.   In 2000, President Clinton issued an executive order pledging that sub-Saharan African countries would not face trade sanctions for laws promoting access to AIDS medicines.

The order continues to be largely respected, and the group of countries who are generally able to get access to the cheapest drugs has grown to include the poorest countries from around the world — Afghanistan, Tajikistan, Bangladesh, Burma.    Gilead’s agreement with the Medicines Patent Pool covers these countries.

But countries just above this cutoff line are on their own.  “There are countries that are considered to be “middle income” that will never be able to afford the high prices charged by innovative pharma companies,” said reader A. Grant of New York.  These nations are also losing the discounts that major manufacturers of AIDS drugs used to offer them.  According to Médecins Sans Frontières, which tracks drug prices, prominent manufacturers of AIDS drugs have stopped offering discounts to middle-income countries, or now require that countries negotiate those discounts one by one.

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[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

India says 'no' to policy that would block access to affordable medicines

Via Médecins Sans Frontières.

India formally announced at the UN High Level Meeting on HIV and AIDS that it will not accept data exclusivity, a provision harmful to access to affordable medicines, as part of a free trade agreement (FTA) currently being negotiated with the European Union (EU). 

Although this is an important victory for the global mobilisation against the potential negative impact of the FTA on access to medicines, further harmful measures remain on the negotiating table, the international medical humanitarian organisation Médecins Sans Frontières (MSF) said today.

“MSF and other treatment providers depend on a sustainable flow of affordable generics from India to treat people across the developing world. Saying ‘no’ to data exclusivity will reach far beyond India’s borders in terms of ensuring access to affordable medicines in developing countries”, said Dr Tido von Schoen-Angerer, Executive Director of MSF’s Campaign for Access to Essential Medicines.  “This is a big victory, but we’re not letting up until we see all the potentially harmful policies off the table”.

By delaying the registration of generic versions of a medicine by up to ten years, data exclusivity would effectively have given a backdoor monopoly status to companies, even for drugs that do not deserve a patent under India’s law. The clause, which was criticised by global health actors including the Global Fund, WHO, UNAIDS, and UNITAID, threatened to further limit price-busting generic competition in India, thanks to which the price of HIV medicines has fallen by 99 per cent over the last 10 years.

The announcement by India at the AIDS Summit now means both the EU and India have officially confirmed data exclusivity will not be part of the FTA text. MSF is now calling on Europe to remove other harmful clauses from the EU-India FTA negotiations.

“Europe is still pushing provisions on the enforcement of intellectual property that are of great concern for procurers and suppliers of medicines, like MSF, as they put us at risk of litigation or court orders that prevent us from delivering medicines to patients,” said Michelle Childs, Director of Policy/Advocacy of MSF’s Access Campaign.

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[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

South Africa Marks AIDS Treatment Milestone

Via Forbes, by Thandisizwe Mgudlwa.

AIDS patients and government officials on Friday celebrated the 10th anniversary of a pioneering program that brought AIDS drugs to impoverished South Africans, a program patients credited for saving their lives.

Patients and officials danced and sang in Cape Town's gritty Khayelitsha area to mark the establishment of a Medecins Sans Frontieres program that showed sophisticated treatment could work and people would stick to schedules for taking a cocktail of drugs in impoverished areas. International experts had questioned that at the time.

"Medecins Sans Frontieres, I would call them activist doctors," said Vuyiseka Dubula of the Treatment Action Campaign, South Africa's best known AIDS activist organization. "The West or the northern world said we were too poor to treat, they said, 'They can't even tell the time.' To their surprise, we beat them on adherence. We adhere better than they do."

Khayelitsha resident Thobani Ncapai was losing weight, vomiting and sick with diarrhea in 2001.

"I'm happy to have MSF coming to Khayelitsha," said 40-year-old Ncapai, one of the clinic' first AIDS patients. "Otherwise I would not have received this treatment and I would not have survived."

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[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]