Drug companies sue South African government over generics

More than 40 pharmaceutical companies, many of them the world's largest and most powerful companies, will be taking the South African government to court to try to stop it enacting legislation aimed at reducing the price of medicines for South Africans.

The Medicines and Related Substances Act of 1997 was fought strenuously by the multinational drug companies during its passage through parliament. As it was passed, the industry gave notice of its intention to have the law overturned, and in so doing effectively prevented the act coming into force.

Although the law also seeks to regulate the marketing and distribution of medicines in South Africa, it is seen largely as a test case, with international implications, for the use of parallel importing of cheaper drugs and generic substitution for brand name drugs.

The South African government is currently exploring changes to its Patents Act as a vehicle to import cheap generic drugs from countries such as Brazil and India. The major issue in the minds of millions watching the trial will be the HIV/AIDS epidemic, with at least 4.2 million people in South Africa carrying the virus. It is common knowledge, and not contested, that the drugs needed for South Africa's HIV/AIDS epidemic—to treat its opportunistic infections, as well as to attack the replication of the virus with antiretrovirals— are too expensive.

The issues, however, extend to many other medicines supplied at higher cost to South Africa than to many other countries. The rising demand for cheaper generic drugs—and the refusal of many drug companies to contemplate any major concessions to it—is rising up the international political agenda. Through the forum of the World Trade Organisation, the United States has attacked Brazil's programme of manufacturing generic drugs to treat HIV and AIDS. At the same time, an Indian generics manufacturer, Cipla, has offered to sell a generic version of the triple combination antiretroviral therapy to Médecins Sans Frontiàres and to governments in developing countries with a significant HIV/AIDS problem.

Last year, responding to some of the pressure building up against the larger companies, five multinationals made offers through UNAIDS to cut the price of their drugs or provide other services to help to make their medicines more accessible to poorer people. Miryeena Deeb, the chief executive officer of the Pharmaceutical Manufacturers Association, to which most of the multinational pharmaceutical companies belong, said that the trial is not about “denying accessibility” of the medicines to those who need it. She said it is about the rule of law and constitutionality. The government and an activist group see the issue, however, as fighting for the right to provide the much needed drugs less expensively to more people.

The case comes before the courts in the second week of March and will draw on all these issues. The AIDS activist group known as the Treatment Action Campaign has petitioned the court to participate in the trial after being turned down by the Pharmaceutical Manufacturers Association. Its views effectively summarise the government's case. “The ability of many persons with HIV to purchase and take medicines that treat HIV and its attendant illnesses, has a profound and inseparable bearing on the constitutional rights to human dignity and life, and access to health care,” the campaign's affidavit stated. “In this respect people with HIV are directly dependent on the State's ability to fulfill its constitutional duty to bring about the progressive realization of their rights to health care services.”

The campaign said that it acts on behalf of the children, healthcare workers, and people living with HIV and AIDS who cannot petition the courts for various reasons; most, for example, cannot afford the drugs. The campaign is interested in the section of the law relating to parallel imports and generic substitution and on the section that would seek to create a pricing committee for medicines. The case will deal with several other sections, many of which would address other problems in South Africa that tend to keep the prices of medicines high. But the world's eye will be on the issues that are currently in the spotlight: parallel imports, generic substitution, and the possible compulsory licensing of needed drugs.

Protesters demanding affordable access to AIDS drugs march through Durban, South Africa. Thousands of protesters gathered there last July to lobby the 13th international AIDS conference against pharmaceutical companies, high drug prices, and government inaction over high prices

(Credit: AP PHOTO/OBED ZILWA)