South Africans have been denied the “biggest advance” in antiretroviral therapy over the last few years because of a lack of urgency in the drug registration process in South Africa, according to the Treatment Action Campaign.
The TAC is calling for the urgent registration of Tenofovir, which is considered one of the safest antiretro-viral (ARV) drugs and needs only to be taken once a day. Tenofovir was submitted for registration to the Medicines Control Council (MCC) in 2005. More than a year later, there is no sign of a decision.
The TAC is planning a campaign of action against the MCC and the pharmaceutical company Aspen Pharmacare, which holds the South African licence for Tenofovir. The Aids Law Project has, on behalf of the TAC, sent letters to the MCC and Aspen demanding that they explain the delay by February 2. The TAC has planned a day of worldwide demonstrations on February 22.
The TAC is also turning its attention to the potential registration of Atripla, a three-in-one combination pill that also needs only to be taken once a day.
Tenofovir, which was registered by the US Food and Drug Administration in 2001, is already being used in the private sector in South Africa under an exemption clause that allows the use of unregistered drugs on a “named patient, named doctor” basis. However, Tenofovir cannot be considered for inclusion in the government’s national HIV treatment guidelines until it is registered.
Aspen chief executive Stephen Saad says his company has no problem with the speed of the Tenofovir registration process, and that he is confident it is being fast tracked in the registration process. The fast track process generally allows the drug to be assessed within nine months after application for registration. However, the Tenofovir registration was submitted more than a year ago, and as yet Aspen has no idea when registration will be complete. The company has already started manufacturing the drug, and currently has almost a quarter of a million pills ready for sale.
The MCC said it could not answer many of the Mail & Guardian’s questions. However, the Registrar of Medicines, Mandisa Hela, said the national guidelines for ARV treatment “are reviewed when there is a necessity to do so”. She said 1 130 applications for registration were received by the MCC in 2006.
AIDS Law Project senior researcher Jonathan Berger says his organisation is acting for the TAC because it is concerned about barriers to appropriate health care interventions. “The delayed registration of Tenofovir is symptomatic of the broader problem of drug registration, which is agonisingly slow and non-transparent, putting the public’s health and welfare at risk. We need access to newer and better medicines -- we should not be held hostage by bureaucratic bungling and inaction,” says Berger.
“There are probably many reasons for the slow registration process, but if one is a shortage of resources at the MCC, then government has a duty to ensure that the MCC is able to do its job.”
“The consensus among HIV clinicians is that Tenofovir is an excellent product. Sure, it might make ARV treatment slightly more expensive in the short term, but it will reduce costs associated with the monitoring and treatment of side effects. More importantly, its use will improve the quality of life for many people on ARV treatment. We have no financial interest in this matter. Neither the ALP nor the TAC will accept money from either the brand-name or generic pharmaceutical industry.”
Tenofovir is a nucleotide reverse transcriptase inhibitor (NtRTI) which blocks the replication of HIV, but it does so at a different point to all other inhibitors. As a result it can be used as a substitute for other classes of ARVs, and is particularly useful for patients who have already developed drug resistance.
In South Africa, doctors would particularly like to use Tenofovir as a substitute for d4T, which is widely used because of its cost and efficacy, but which is associated with higher levels of side effects, and particularly a potentially fatal condition in overweight women, lactic acidosis.
The head of the Southern Africa HIV Clinicians Society, Dr Francois Venter, is enthusiastic about the drug: “Tenofovir has been the biggest stride forward in antiretroviral drug development for the last few years. If we could get this drug registered fast, it would be of huge benefit to many South Africans needing or on treatment. People with side effects could substitute with Tenofovir. People starting antiretrovirals could even commence on Tenofovir, in conjunction with other antiretrovirals, and avoid the risk of the side effects we see with the other drugs.”
The rights to Tenofovir are owned by US company Gilead Sciences, but Aspen has been given the licence in South Africa. Aspen already distributes many ARVs, especially cheaper generic versions of drugs for which it received licences from the patent owners. The granting of these licences was in part the result of lobbying by the TAC and other activist groups.
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