Mandela ‘Castigates’ Drug Companies, Criticizes Government Efforts on Eve of Resumption of Patent Trial
Speaking Sunday to the South African Broadcasting Company, former South African President Nelson Mandela "castigated" the Pharmaceutical Manufacturers' Association of South Africa and the 39 drug firms it represents in the lawsuit against South Africa's 1997 Medicines and Related Substances Control Act, Reuters reports. Mandela's comments come days before the trial is set to resume in Pretoria's High Court. In the hour-long interview, Mandela accused the pharmaceutical industry of "exploiting" the situation in South Africa and other developing nations by charging "exorbitant" prices for AIDS medications. The pricing policies are "completely wrong and must be condemned," he said. But he also said that the South African government had "failed to engage adequately" with the drug companies to negotiate "affordable" prices. Regarding the court case, which resumes tomorrow after a five-week postponement, Mandela said, "The government is perfectly entitled, in facing [the HIV/AIDS epidemic], to resort to generic drugs, and it is a gross error for the companies, for the pharmaceuticals, to take the government to court." Mandela added, "[W]e must also take responsibility for not doing sufficient work to persuade these pharmaceuticals to change their approach." In an "apparent message" to his successor, Thabo Mbeki, whose government has been accused of "ignor[ing] repeated offers" of donations and price cuts, Mandela said, "There is nothing as important as a dialogue in trying to resolve problems. If we have a clear and connected plan to persuade the pharmaceuticals to settle and to charge prices which are affordable to the masses of the people, I am sure that the result would be positive" (Boyle, Reuters, 4/15).
The 1997 Medicines and Related Substances Act, which would allow the government to override patent laws and "import, license and produce" lower-cost generic versions of medications, is in the middle of the controversy. After the law's passage in 1997, the PMA, representing 39 pharmaceutical companies, filed suit to block the measure's implementation, claiming it would "put the very future of the pharmaceutical industry at risk by threatening profits that accrue from the protection of intellectual property rights" and that support further research and development (Agence France-Presse, 4/15). However, the government claims that the law is not about patents, but about making medicines more affordable. Zweli Mkhize, health minister of KwaZulu-Natal province, said competition is one way to lower prices. "We want to be independent in those types of decisions and let the industry be competitive and therefore offer us the best deal that is available in the market. But the market must be open and allow that possibility to happen," Mkhize said. Mark Heywood, national secretary of the Treatment Action Campaign, said that drug affordability will "free up" funds for improving the medical infrastructure needed to deliver complicated AIDS treatments. The lack of medical resources has been cited by drug companies as one reason price cuts would not make much of a difference in AIDS treatment in sub-Saharan Africa. "Availability would provide an incentive for people to get tested and seek treatment," he added (Brown, Hartford Courant, 4/15). The PMA says that the law is making the pharmaceutical industry a "scapegoa[t] for South Africa's inaction" on HIV/AIDS, adding that infrastructure problems, hunger and contaminated water are widespread in sub-Saharan Africa. "When people are angry and dying out there, the government mustn't accuse us of delaying their treatment," PMA head Mirryena Deeb said (Picard, Globe and Mail, 4/16).
Legal Maneuverings and Briefs
The resumption of the "landmark court battle" will include the presentation of a friend-of-the-court brief filed by the Treatment Action Campaign, an AIDS advocacy group and "fierce" critic of the government's failure to provide antiretroviral medications (Agence France-Presse, 4/15). TAC's brief is expected to say that the drug firms have earned "excessive profits" on AIDS medications, especially in light of tax breaks they received on their research and the fact that "key" compounds in many of the drugs were discovered by publicly funded researchers. "It will be argued ... that the alleged violations of intellectual property can in no way be said to threaten the viability of profitability of the research-based pharmaceutical industry," TAC wrote in papers submitted to the court and obtained by Reuters. In an affidavit, the PMA counters that the law would give the health minister "unfettered power" over importing generic medications in violation of intellectual property laws, without any "real" savings on cost. If the law were implemented, it would "lead to generic substitutes" for medicines still under patent protection, "in violation of the [drug manufacturers'] patent rights, trademark rights and copyright," the document continues (Swindells, Reuters, 4/16). The affidavit, filed last week, also states that the South African government "ignor[ed]" offers of price reductions by the companies. "(There is) a general unresponsiveness on the part of the government to utilize the offered assistance," the PMA wrote. Boehringer-Ingelheim, one of the claimants in the case, said last week that it offered the government a donation of Viramune, an antiretroviral drug used to reduce the risk of vertical transmission from mother to child, but the Medicines Control Council has "dragged its feet" on the offer for more than a year. The affidavit includes examples of offers made by several companies to South African Health Minister Manto Tshabalala-Msimang, but speaking before parliament she denied that she ever received those offers and declined to comment on the case because it was still pending. She also declined to say whether the government would freely distribute antiretroviral drugs if it were to win the case (Agence France-Presse, 4/15). Since the postponement of the trial in March, Merck and Bristol-Myers Squibb, along with Abbott Laboratories, which is not partaking in the lawsuit, have announced further price reductions (Hartford Courant, 4/15). The hearings are slated to continue until April 25 and a ruling is not expected for two to three months after that time. An appeal by the losing party to the Constitutional Court, South Africa's highest court, is expected (Reuters, 4/16).