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USA undermining generic pharma production

Germa-Russian President’s Programme extended

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Oil: World Bank and Chad reach agreement

Dispute over World Bank malaria programme

United Nations: Stalled reforms

International peacebuilding efforts inadequate

Liberia: UN negotiates timber embargo

Aid for more trade


06/2006
 

[ Bilateral trade talks ]

USA undermining generic pharma production

If it was up to the USA, its trade agreement with Thailand would have been signed and sealed a long time ago. Both countries have been in negotiations for exactly two years, but due to the governmental crisis in Thailand (see D+C/E+Z/ 5 2005, p. 218), the conclusion of the talks has been postponed indefinitely. Apart from recent protests against the Thai government, one reason for the talks stalling was an issue that also affects other bilateral trade talks, in which Washington is engaged. The USA is trying to establish, via bilateral free trade agreements, patent protection rules for pharma- ceuticals in developing countries which would be far more stricter than protection provided by intellectual property rules in the context of the World Trade Organisation (WTO).

According to the non-governmental organisation Médecins sans Frontières, the USA has already concluded bilateral trade agreements with a dozen countries including Morocco, Chile and six Central American nations. These agreements make it far more difficult – if not impossible – for manufacturers of cheap copycat drugs to market their products.

The WTO adopted the Doha Ministerial Declaration on Intellectual Property Rights and Public Health in 2001. It states that patent protection may not prevent any country from supplying its people with important medication. To this end, a government may grant compulsory licences, for instance, authorising a company to produce a drug without seeking approval from the patent holder. For countries without pharmaceutical industries, a regulation has been in force for three years, allowing them to thus authorise foreign companies under certain conditions.

The bilateral trade agreements, which the USA is striving for, virtually obliterate such options. According to Médecins sans Frontières, these agreements contain clauses, according to which drug administrations may only grant generic medication approval for marketing if the original version is not patented. Médecins sans Frontières views such clauses as unreasonable self-restraint by the governments concerned. After all, drug administrations are meant to decide on the effectiveness and safety of a drug, but not to check intellectual property rights. Normally, the companies concerned would have to sue anyone they believe to have breached their patents.

According to another much-criticised provision, pharma producers are allowed to patent new versions of already established (and patented) active agents. The Patent Office in the Indian capital of Delhi is currently working on such a case. Gilead Sciences, a US-based corporation, has applied for patent protection for a supposedly new AIDS drug in India. AIDS activists, however, object, arguing that the medication is merely a modified version of an existing one. Cipla, an Indian generics manufacturer, is supporting the NGOs.

Moreover, US negotiators are pressing for clauses to extend patents beyond the 20-year protection required by the WTO. Similarly, they want to impose much stricter conditions for compulsory licences. Washington’s diplomats are negotiating trade agreements with many other countries besides Thailand.

However, some of the talks – for example those on a Free Trade Area of the Americas – have ground to a halt in a similar manner to Thailand’s case, or have been broken off indefinitely. Many countries affected have reservations about the US ideas on patent protection. In April, the USA gave up on negotiations with the countries of the Southern African Customs Union (SACU). Critics such as Ärzte ohne Grenzen would also like to see talks with Thailand end that way – as soon as the country has an operational government again. (ell)