While the patents on many older, first-line ARVs have expired, leaving generic manufacturers free to produce them, newer, less toxic and more effective drugs are patented and priced out of reach of less developed nations.
The main way generics manufacturers can produce newer drugs is to obtain a "voluntary licence" from the patent holder. This usually sets quality requirements and defines the markets in which the licensee can sell the product. For example, pharmaceutical giant Gilead has allowed the South African firm, Aspen Pharmacare, to manufacture and distribute branded and generic versions of tenofovir, one of the newer first-line ARV drugs.
However, civil society activists say voluntary licences skew the balance of power too far in favour of patent-holders. "This is a way to control generic competition by creating dependency on the innovator companies," Manmohan Amonkar, from the HIV/AIDS unit of India's Lawyers Collective, said at the recent International AIDS Conference in Vienna.
The US and the European Union have been accused of pressuring countries to implement stricter intellectual property regulations.
Special 301
"The United States is using trade threats to coerce countries into adopting intellectual property laws that will increase the cost of medicines," Matthew Kavanagh, director of US advocacy at the NGO, Health Global Access Project (GAP), told IRIN/PlusNews. "By jeopardizing generics, especially those from India, they are effectively putting millions of lives at risk."
Shifting away from generic competition would put the power of price-fixing back in the hands of 'big phrama' and make ARVs unaffordable again |
Health GAP recently joined several other NGOs in putting an official complaint on the use of Special 301 to the UN Special Rapporteur on the Right to Health, stating that it is "in violation of the international right to health".
TRIPS-plus
The trade-related aspects of intellectual property (TRIPS) laid out by the World Trade Organization contain minimum standards of protection for pharmaceutical intellectual property, but also accommodate developing countries. For example, it gives countries the right, under specific situations such as public health emergencies, to issue compulsory licences - an authorization given by a government to a third party to produce a patented invention without the permission of the patent-holder.
Through Free Trade Agreements (FTAs) and Economic Partnership Agreements, the US and European Union (EU) may circumvent the TRIPS agreement by making provisions that, for instance, limit the circumstances under which compulsory licences may be issued or extend the life of patents beyond 20 years - a practice known as TRIPS-plus.
Of particular concern are negotiations around a "Broad-based Trade and Investment Agreement" between India and the EU, due to be completed by December 2010. Activists fear such an agreement may impose TRIPS-plus-type conditions on India's manufacture and export of generic medicines.
"Shifting away from generic competition would put the power of price-fixing back into the hands of 'big pharma' and make ARVs unaffordable again," said Gilles van Cutsem, project coordinator for Médecins Sans Frontières in the South African township of Khayelitsha.
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Patent pool
A new patent pool, in which it is hoped patent holders will place their patents for use by generic companies in exchange for royalties, is expected to help lower the prices for life-saving medicines. UNITAID, the funding mechanism that runs the patent pool, has already negotiated a two-thirds cut in the price of paediatric ARV formulations.
"If we manage to get this [patent pool] off the ground, we will be able to solve many, many problems," Ellen 't Hoen, UNITAID's senior adviser for intellectual property and medicines patent pool, said in Vienna.
However, she warned that it meant financing for HIV had to remain strong, as even the lowest-cost drugs needed an assured market.
While the pool remains empty for the moment, she said UNITAID had held talks with several drug developers, including the US's National Institutes for Health, Tibotec, Gilead and Merck, all of whom had shown "considerable interest".
"Access to treatment is a fundamental human right; this puts the obligation on all of us to do all we can to make sure that it happens right here, right now," she said.
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This article was produced by IRIN News while it was part of the United Nations Office for the Coordination of Humanitarian Affairs. Please send queries on copyright or liability to the UN. For more information: https://shop.un.org/rights-permissions