Legal battle over anti-AIDS drugs

The South African government said it has not bowed to legal pressure by multinational pharmaceutical companies in reviewing provisions of its new medical act which enables the supply of affordable AIDS-therapy drugs.

"The decision to review the South African Medicines and Medical Devices Regulatory Act of 1998 was attributable to internal discussions with the department of health and was not due to any existing litigation against the government of South Africa," a health department statement received by IRIN on Monday said.

The Pharmaceutical Manufacturers Association (PMA) of South Africa, mostly multinational subsidiaries, last week reportedly said that because of the review they had suspended a lawsuit against the government over the 1998 legislation, especially a section which authorises compulsory licensing and parallel importing to increase accessibility and affordability of essential medicines.

Compulsory licensing enables governments to instruct a patent holder to license the right to use its patent to a company or government agency. Parallel importing allows importers to shop around for the cheapest source of drugs for resale without authorisation of the original seller. Both mechanisms are permitted under the General Agreement on Trade and
Tariffs, according to a report by the Washington-based Africa Policy Information Centre (APIC).

A department of health official said he was "confused" by the PMA's suspension of the lawsuit. He told IRIN on Monday "there was no relationship" between the review of the legislation and the dispute with the pharmaceutical industry. A US public health policy official was reported by the news agency IPS at the weekend as saying he doubted the pharmeceutical companies were giving up the fight against cheaper generic drugs and this was a "lull before the storm".

According APIC, compulsory licensing can lower the price of medicines by 75 percent or more. "Life-saving HIV/AIDS drug cocktails cost about US $12,000 a year in many African countries - vastly out of the reach of all but a small handful of the growing African population with HIV/AIDS," the report notes.

But in defence of the pharmaceutical companies' interpretation of
intellectual property rights, and as part of a concerted effort to persuade Pretoria to repeal the 1998 legislation, the US government has put South Africa on the "Special 301 Watch List" of countries receiving heightened trade scrutiny.

Because of the lawsuit the medicines act has not been enforced.
According to the health official, "it was a very broad act which covered many areas that needed transforming from the apartheid days." The litigation has prevented change "in one very important sector of health care in South Africa which is medicines policy."