Belinda Beresford
One of the largest manufacturers of copycat drugs in the world kicked the issue of generic drugs into play this week by applying for a compulsory licence to import eight Aids drugs into South Africa.
Cipla, a company based in India, on Wednesday formally requested compulsory licences on the anti-retrovirals in a letter to the Registrar of Patents. Compulsory licences force a company to share the patent, for example by allowing other manufacturers to produce or import the drugs. The letter requested non-exclusive licences under South Africa’s intellectual property laws, on the grounds that the patent-holding manufacturers were abusing their copyright. The request will now be heard by a special patents court.
Dr Yusuf Hamied, head of Cipla, said the eight drugs had been chosen because they were either already in production or would be by the year end. Cipla has already offered to make the “Cameron cocktail” (named after appeal court Judge Edwin Cameron) of stavudine, 3TC and Nevirapine available for $350 a year to aid organisation Mdcins sans Frontires and $600 to governments in developing countries.
The eight drugs include indinavir and efavirenz, both manufactured by United States-based multinational Merck. The same day, Merck announced that it would reduce the prices of the two drugs to $600 and $500 a year in developing countries, which it claims give it no room for profit.
A significant part of the battle between the Pharmaceutical Manufacturers’ Association of South Africa (PMA) and the government over the Medicines and Related Substances Control Amendment Act is whether section 15C of the legislation gives the minister of health excessive ability to issue compulsory licences.
A PMA representative said it welcomed the use of the Patents Act, but questioned whether Cipla was following due process. The issue was between Cipla and the individual companies, and the PMA would not interfere, she said.
The Department of Health said: “The Cipla application will certainly move matters forward by testing the notion that the PMA and the companies it represents would be prepared to see compulsory licensing effected through the Patents Act.”
Meanwhile, the South African government may come under renewed pressure in the international arena, after the Pharmaceutical Research and Manufacturers of American (PhRMA) confirmed that it has requested South Africa be put back on a United States watchlist for possible trade sanctions.
PhRMA representative Mark Grayson said the request was triggered by the belief that South Africa’s laws were not compliant with international trade treaties. In particular this meant section 15C of the legislation being fought over by the PMA and the government. Pharmaceutical companies claim this section would allow the minister of health to issue a compulsory licence without following due process.
Grayson said the decision on whether to put South Africa on the list would be made by the end of April, and therefore would be unaffected by the PMA court case, which he did not expect would be completed before the end of the year.