(IRIN) VIENNA, 2 August 2010 (PlusNews) – Most of the estimated 5.2 million people worldwide on antiretroviral (ARV) treatment are taking generic versions manufactured primarily in India, but tighter global intellectual property rights and trade rules could shut down “the pharmacy of the developing world”.
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.
“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.”
“Special 301”, an annual review process led by the Office of the US Trade Representative, has placed several countries, including India, on a “priority watch list” for failure to properly enforce intellectual property rights. According to Kavanagh, this is “a warning of imminent trade sanctions” against a country, which could affect its exports to the US.
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”.
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.
Efforts to reduce the impact of TRIPS-plus have mainly involved negotiating with big pharmaceutical companies, many of which are prepared to make special provisions allowing for generic versions of their drugs to be produced in poor countries.
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.