AIDS in China is most commonly associated with the trouble-hit villages of central Henan province, where unsafe blood collection systems led to 250,000 infected HIV people in the 1990s. But the bulk of the country’s HIV-infected population is in southern and western China – home to two-thirds of the approximately 650,000 people in China living with HIV/AIDS, according to the UN AIDS agency (UNAIDS) and World Health Organization (WHO) figures from late 2005.
The disease was first reported in China in 1985 but making treatments available to patients has been a difficult process.
In 2001, China became fully compliant with the WTO’s Trade-Related Aspects of Intellectual Property Rights (TRIPS) regulations, which meant it had to observe international patents on pharmaceuticals. Patented ARV drugs used to treat HIV, which are generally not registered or marketed in China because the manufacturers don’t want to chase slim profit margins, therefore became out of bounds.
Going without
Like many developing countries, China has no second- and third-line ARV treatments for HIV and is restricted to producing first-line products that are no longer under patent.
At present, at least six types of generic ARV drugs are produced by the likes of Shanghai Desano Biopharmaceutical, Northeast General Pharmaceutical, and Xiamen Mchem Pharma Group. But most of the drugs are made largely for export to Africa and developed countries.
According to Philip Tavernier, head of mission in China for international aid organization Doctors Without Borders/Medecins Sans Frontieres, China’s first-line treatments began with ARV generics didanosine (ddI), stavudine (d4t) and nevirapine (nvp). But d4t has dangerous side effects if taken long-term. It is neurotoxic and can also cause lactic acidosis, which can result in a potentially fatal spike in the blood’s acid levels.
About a month ago, there was an unpublicized move by the Chinese government to replace d4t with zidovudine (AZT), which has less side effects. The new ARV first-line treatment would then be AZT, lamivudine (3TC) and nvp. But Tavernier noted that the national guidelines for the AZT replacement won’t be implemented for another six months.
Another difficulty to accessing ARV treatments in China are that fixed-dose medications are not readily available, resulting in resistance to the existing treatment regime.
A step forward
In response to the growing AIDS problem, the Ministry of Health launched a national program in 2003 which provided free ARV treatments and outreach to areas most hard-hit by the disease.
“All rural patients and the urban poor are eligible. Technically all rural patients should be getting free testing and ARV treatment. As of now first-line drugs are covered, but second-line drugs are not available,” said Dr Salil Panakadan, the monitoring and evaluation advisor for UNAIDS China.
More needs to be done. According to Tavernier, the national program is flawed because the government only offers US$130 in reimbursements for HIV infected patients requiring medical care but often this amount is not enough to cover costs. On top of that, there is insufficient counseling and monitoring provided for patients on life-long ARV treatments.
“Patients taking [the proper] ARV treatments do not have to die … they have built up a resistance to first-line drugs,” Travernier added.
But there is a solution. In 2001, the Doha Declaration was enacted to clarify Article 8 under the TRIPS Agreement, which would allow China to waive pharmaceutical patent rights and produce second- and third-line ARV generics through compulsory licensing by declaring a public health emergency.
But China has not yet done so, most likely to avoid patent infringement issues. Local AIDS drug manufacturers focus instead on the production and export of active pharmaceutical ingredients in ARV medicines. However, if the country is to make headway in its battle with AIDS/HIV, Beijing will have to pay more attention to the needs of its underserviced domestic market.