Abbott offers Aluvia to Thailand in return for compulsory licensing halt

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Abbott Laboratories said this week that it is willing to proceed with the registration of a heat stable version of lopinavir/ritonavir called Aluvia in Thailand if the Thai government will halt its plans for a compulsory license to allow imports of a generic version from India, and will sell it to the Thai government for $1000 a year.

Abbott has been in dispute with the Thai government since January 2007, when plans for a compulsory license to import lopinavir/ritonavir were first announced by the Thais. Abbott retaliated by withdrawing seven products from drug registration processes in Thailand, including Aluvia.

In February Abbott offered a price cut to $167 a month for Kaletra, the soft-gel capsule version of lopinavir/ritonavir.

Glossary

generic

In relation to medicines, a drug manufactured and sold without a brand name, in situations where the original manufacturer’s patent has expired or is not enforced. Generic drugs contain the same active ingredients as branded drugs, and have comparable strength, safety, efficacy and quality.

middle income countries

The World Bank classifies countries according to their income: low, lower-middle, upper-middle and high. There are around 50 lower-middle income countries (mostly in Africa and Asia) and around 60 upper-middle income countries (in Africa, Eastern Europe, Asia, Latin America and the Caribbean).

Earlier in April Abbott announced that it was cutting the price of Kaletra and Aluvia when registered to $1000 a year in 40 lower middle-income countries following discussions with World Health Organization director-general Margaret Chan. But the company said that its offer would only apply where its patents are respected, a clear warning to the Thai government.

According to the Wall Street Journal, Abbott chief executive Miles White said that the decision to withdraw Aluvia from registration had been driven by “concern that compulsory licensing would be abused ever-more widely, using HIV as an excuse."

But last month Abbott public affairs staff insisted that the company’s action was not related to HIV drugs, but to a lack of respect for `numerous` patents.

Treatment advocates have urged the Thai government not to back down on its compulsory licensing policy.

“The fact that Thailand has been brave enough to issue a compulsory license means that 40 countries are now able to get Kaletra for $1000 a year,” said Paul Cawthorne, head of mission for Médecins sans Frontières in Thailand, speaking during a phone briefing for journalists earlier today.

The Thai government says that negotiations will continue.

A version of lopinavir/ritonavir alleged to be heat-stable was recently launched by the Indian company Emcure. However no data is available on the manufacturer’s website to explain the stablility of Emletra, and the product has not been prequalified by the World Health Organization.