Compulsory licensing struggles continue: Cambodia loses rights as Brazil seeks new rights

Keith Alcorn, Keith Alcorn
Published: 13 September 2003

Further evidence came to light this week of US-led attempts to pressurise developing world nations into accepting restrictions on access to essential medicines in return for future promises of liberalised trade with the US, the EU and Japan.

Reuters Cambodia has reported that the Cambodian government has been forced to introduce a restriction on imports of generic versions of newer HIV drugs as a condition of joining the World Trade Organisation.

Ellen T'Hoen of MSF Access to Medicines campaign said yesterday that the restriction would work by preventing generic manufacturers from using data generated by branded manufacturers for five years after its submission. The provision would mean that a generic manufacturer could not draw on information about the safety of a product generated in the branded manufacturer's trials to support an application for registration of a generic version for five years, for example.

However, Cambodia will still be able to take advantage of public health provisions to import generics already registered.

Cambodia’s decision comes just days after the WTO agreed a policy that would allow nations like Cambodia to import generic versions of medicines after the TRIPS agreement comes into force in 2005 by using compulsory licensing.

Advocates warn that Cambodia’s capitulation to US pressure on intellectual property restrictions is just the latest example of a systematic US camapign to offer free tade concessions at a price, and to restrict opportunities for compulsory licensing.

In Latin America, says MSF, the United States is attempting to negotiate highly restrictive intellectual property restrictions as part of the establishment of a Free Trade Area of the Americas. These restrictions would prevent countries from using compulsory licensing provisions in most circumstances, and would restrict the ability of Brazil to export cheap generic antirerovirals to other countries in the region.

In particular, the US is trying to insist that countries can only use compulsory licensing for drugs when the patent on a product has expired. This would put all antiretrovirals out of the reach of compulsory licensing for the rest of the decade, with the exception of AZT.

The US is also seeking to narrow the circumstances in which compulsory licensing can take place, permitting its use for FTAA states only in a national emergency. The WTO agreement reached at the end of August places no restriction on the circumstances in which compulsory licensing can take place, leaving it up to the WTO to decide whether the compulsory license is appropriate. In Latin America, the US wants to set up an additional review body to police intellectual property disputes over and above the WTO.

The restrictions are particularly threatening in Latin America, because ten governments in the region recently carried out a tendering process with generic antiretroviral manufacturers that achieved price reductions of between 30% and 92% on components of the typical first-line treatment regimen. In Brazil, the risk is especially high, because the country is already treating more than 100,000 people with a mixture of branded and generic products. The Brazilian government is currently engaged in a struggle with Abbott, Merck and Roche (manufacturers of lopinavir, indinavir, nelfinavir and saquinavir respectively) to bring down the prices of these drugs, which account for 63% of Brazilian antiretroviral expenditure. Following the refusal of a demand for a 40% price reduction, the Brazilian government has announced that it will seek to import generic versions from India or China to fill the gap until it can increase its own capacity to produce generic versions of these drugs.

Ellen T’Hoen of MSF told the Wall Street Journal that she sees the Brazilian move as `extremely good news`. “Brazil is taking the lead again in ensuring universal access to antiretroviral drugs," she said last week. "It is showing the political will to implement WTO flexibility.”

On Wednesday, advocacy groups gathered in Cancun, Mexico, for the WTO summit issued an appeal to developing country governments to start using the August 30 provisions to import medicines.

In an analysis published by the advocacy group Health Gap, Professor Brook Baker of Northeastern University School of Law, Boston, highlighted the leeway that developing country governments currently have to issue compulsory licenses:

  • non-WTO members can produce and export medicines without WTO

    complications because of their non-membership (though they might have

    national legislation protecting patents which would forestall their rights to produce and export generic versions of patented medicines),

  • least developed countries do not have to provide patent

    protection for pharmaceutical products or processes until 2016, although many do so prematurely or under pressure from the U.S. in regional trade agreements),

  • countries like Brazil (which did not start granting patents on medicines until compelled to do so by the TRIPS Agreement) can make generic versions of pre-1995 drugs legally even without a compulsory license),
  • countries like India (which did not have patent production for pharmaceutical "products" but only for pharmaceutical "processes" and thus have until 2005 to become fully TRIPS-compliant) can continue to make lawful copies of medicines not yet patented as products, and will be permitted to continue production of generic products alreday registered after 2005
  • other countries where for one reason or another the patent-holder has not filed a patent application (d4T (stavudine), for example, is not registered in many African countries).

Community Consensus Statement on Access to HIV Treatment and its Use for Prevention

Together, we can make it happen

We can end HIV soon if people have equal access to HIV drugs as treatment and as PrEP, and have free choice over whether to take them.

Launched today, the Community Consensus Statement is a basic set of principles aimed at making sure that happens.

The Community Consensus Statement is a joint initiative of AVAC, EATG, MSMGF, GNP+, HIV i-Base, the International HIV/AIDS Alliance, ITPC and NAM/aidsmap

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