Once again the health minister is at war. This time, in defence of her medicines pricing regulations, she recognises the need to garner public support. Billed as a struggle between the right of access to medicines and corporate greed, the battle for hearts and minds is not letting the facts get in the way. Contrary to what is asserted in “Medicine pricing: A mandate to make quality medicine accessible and affordable” (ANC Today, January 21), the fight is largely about the process by and the manner in which the pharmaceutical sector should be regulated. The need for regulation remains undisputed.
The Medicines Act correctly targets the entire medicines supply chain for regulation. Dealing with all role-players from manufacturers through to retail pharmacists, it seeks to eliminate practices that limit access to medicines. Issued in terms of the Act, regulations were needed to give full effect to the law by providing detail. Attacked as a whole, the regulations are most problematic in setting an “appropriate dispensing fee” to be charged by pharmacists.
In evaluating the appropriateness of the fee, the Supreme Court of Appeal considered its impact on the viability of pharmacies. It drew attention to the need for an appropriate balance to be struck between the interest of the public in being able to purchase affordable medicines and the interests of pharmacists as suppliers of medicines.
The court held that access requires affordability and availability. Low prices do not necessarily guarantee access. Medicines also need to be available. Therefore a dispensing fee that is so low that it threatens the viability of pharmacies cannot be considered appropriate, because its effect is to limit access by ensuring that medicines are only available for purchase from a “few large dispensers located in relatively affluent areas”. The evidence before the court supported this conclusion.
The correctness of this decision will be considered by the Constitutional Court when it convenes on March 15 to consider the government’s application for leave to appeal. If the court agrees that the regulations are bad, it will have to consider what relief to grant. If, and when, it does, it will be asked to consider the broader context informed by the government’s wavering commitment to medicines access.
A strong commitment to access characterised the initial process of pharmaceutical sector reform, which began in earnest after the 1994 elections. It gave rise to the National Drug Policy of 1996 and a substantial amendment to the Medicines Act in 1997. But before the Medicines Amendment Act could be promulgated, the Pharmaceutical Manufacturers’ Association sought an interdict preventing Nelson Mandela from bringing it into effect.
When the matter finally came to court in March 2001, the Treatment Action Campaign (TAC) obtained permission to intervene as amicus curiae, or friend of the court. Six weeks later the association withdrew its lawsuit. It took three more years before the amended Medicines Act became fully operational, on May 2 last year.
Having directed all its attention to the Medicines Act, the Department of Health’s response to the attack on its regulations is understandable, albeit unhelpful. But this focus has clouded the issues, allowing for manufacturers to escape relatively unscathed. Instead of taking all reasonable steps to discharge its constitutional obligations, the department has backed away from tackling the manufacturers in any meaningful way, leaving organisations such as the TAC to do the hard work.
The TAC has sought to increase access in two key ways. First, it has actively made use of the existing statutory framework to reduce the price of HIV-related medicines. For example, its campaign against pharmaceutical giant Pfizer in 2000 resulted in the Diflucan Partnership Programme, in which the antifungal drug fluconazole is donated to and dispensed in the public sector. The TAC’s complaint to the Competition Commission against GlaxoSmithKline and Boehringer Ingelheim resulted in settlement agreements in 2003 that obliged the companies to license the local production and importation of more affordable generic anti-retrovirals.
Second, the TAC has consistently advocated the development and implementation of a comprehensive framework for medicines access. In its view, the Medicines Act and regulations are but a part of the constitutionally required framework. The TAC has sought to develop an understanding within the government of the various regulatory mechanisms available to the state. Having repeatedly alerted the government to its failure to make use of existing powers to increase access, the TAC continues to raise concerns about the existence of provisions in our law that unreasonably and unjustifiably limit the right of access to medicines.
The minister proclaims that her department “will continue to provide stewardship in the process of transforming the health sector … and will not compromise … [its] mandate to make medicines accessible and affordable to our people”. For this to happen, she will have to provide the type of leadership that — to date — has been lacking. Now is the time to work with those who are committed to ensuring access. That includes the TAC.
Jonathan Berger is head of the Aids Law Project’s law and treatment access unit