China considers public health override of HIV drug patents

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A Chinese health official, Qi Xiaoqiu, head of the Department of Disease Control of the Ministry of Health, is reported by the BBC (here) to have said that China is prepared to override drug patents for antiretroviral drugs. This move, permitted by the World Trade Organisation if needed in the interests of public health, would happen if multinational drug companies are unable to agree further substantial reductions in their prices in the next few months.

However, Associated Press has since reported a 'clarification' by the same official, denying that China has any plans to override existing patent rights, while confirming that China is seeking deeper discounts and that a number of companies within China are planning to make antiretroviral drugs that are out of patent.

China now acknowledges that a million of its people may have HIV, although surveillance is not consistent and there have been efforts by local officials to suppress information about the epidemic.

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.

antibiotics

Antibiotics, also known as antibacterials, are medications that destroy or slow down the growth of bacteria. They are used to treat diseases caused by bacteria.

The state-owned Northeast Pharmaceutical Group, based in Shenyang (website here), recently launched a generic version of AZT (zidovudine) which is being supplied to healthcare facilities within the country, although its cost and pricing has not been reported. AZT is no longer covered by patents in China, but other drugs which would be needed for effective HAART treatment options are still under patent. China has reportedly been in negotiation with Bristol-Myers Squibb, GlaxoSmithKline and Merck, which all sell antiretrovirals in China, on this issue.

Chinese law has recently been revised to strengthen recognition of international patents, linked to Chinese entry into the World Trade Organisation. However, it has been widely reported that the production of fake medicines – usually with no active ingredients – remains a large-scale, often home-based industry in China, leading to many deaths from treatable or preventable diseases. Law enforcement is difficult, uneven, and depends heavily on funding from pharmaceutical companies.

Issues of quality control in the production of “generic” copies of antiretroviral drugs were raised at the recent International Conference on AIDS in Barcelona by activists from Argentina, critical of what they see as inadequate surveillance of local industrial versions of antiretroviral drugs.

WHO’s commitment to assist in the evaluation of medicines of public health importance, such as antiretrovirals, antibiotics and antifungals, regardless of who makes them, could be an increasingly important means to address such concerns. Further information on this initiative is available here.

The detention by the authorities of the Chinese activist Dr Wan Yanhai, as reported earlier here has apparently been confirmed by a state security official, although there is still no public explanation and he has not been allowed contact with his family, friends or lawyers.

References

Viñuela R. Lack of quality in treatments: Argentina's crisis or worldwide challenge (one investigation on legal procedures over quality control). XIV International AIDS Conference, Barcelona, abstract ThPeG8282, 2002.