The Medicines and Related Substances Amendment Bill aims to change the way in which medicines are regulated.It is widely recognised that the Medicines Control Council (MCC) is not functioning very efficiently. Groups as diverse as the Democratic Alliance, the Health Products Association (HPA), and the Treatment Action Campaign have all been calling for reform for some time.
But rather than fixing the system, critics charge that the bill may deal the death knell to the scientific governance of medicine in South Africa.
Essence of the bill
In essence, the bill will dissolve the Medicines Control Council and replace it with the "health products regulatory authority" situated within the department of health. In addition, it will give the minister of health much greater powers in the regulatory process.
In a joint submission on the bill the Aids Law Project (ALP) and Treatment Action Campaign (TAC) charge that the amendments would "allow the Minister of Health to block the registration of medicines of proven quality, safety and efficacy, as well as to allow the sale and provision of untested 'treatments' and 'cures'."
Regarding the possibility that medicines of proven safety and efficacy may be refused registration, the pharmaceutical industry association Innovative Medicines South Africa told Health24 that "the entire industry is concerned about this aspect and greater clarity around the intentions is needed and how these provisions will be implemented".
Such anxieties seems largely to be based on Health Minister Manto Tshabalala-Msimang's record of questioning mainstream HIV/Aids science and her reluctance to introduce anti-retroviral treatments into the national health system.
Selling untested products
A second concern is that the amendments would allow the minister to give the green light for the sale and promotion of untested "treatments" and "cures".
In a worst case scenario, says Jonathan Berger of the ALP, this could result in the Minister giving the go-ahead for the sale and promotion of products like the fake Aids "cure" Ubhejane. He goes as far as suggesting that sections of the bill may have been designed with the express intension of allowing just this.
The minister's track record
And given the Minister's track record of not acting against fake cures, these fears would seem warranted.
For example, reacting to concerns raised by the Democratic Alliance (DA) concerning Ubhejane, Tshabalala-Msimang said in 2006 that, "It is disturbing to note that the DA continues to perpetuate racist stereotypes that African traditional medicines are inferior products manufactured by wizards."
Despite repeated calls to this effect, the Minister only distanced herself from the supposed cure after the Advertising Standards Authority (ASA) earlier this year ruled against claims made by Zeblon Gwala, the former truck driver who makes Ubhejane.
Whoever is in charge
Though many concerns relate to the current minister in particular, Berger says that the extended powers over the regulation of medicines would be inappropriate irrespective of who happens to be the Minister of Health.
In this regard Berger argues that:
- A political appointee is unlikely to have the relevant expertise to make the kinds of decisions required of the Minister in the bill.
- Locating such powers in a minister weakens the regulatory authority's role in retaining independence from political or commercial lobbying.
- The sheer volume of work such discretionary powers will generate makes it inappropriate for these decisions to be handled at this level.
- Where discretionary powers are given, the bill does not provide sufficient guidance on the exercise of those powers, arguably in conflict with the constitution.
- Registration should be based solely on the basis of quality, safety and efficacy. Other considerations do not come into the picture at all. Where these might be relevant is in relation to the funding of new drugs, whether by government or medical schemes - not in relation to registration.
Though not specifically concerned with the minister's increased powers, the HPA agrees that the measurement criteria outlined in the bill may be problematic. "These we believe are subjective and could compromise the integrity of the regulatory process," they told Health24.
All the sources we spoke to expressed concern over a general lack of clarity in the bill.
Another important concern is that a report from a ministerial task team asked to look into the restructuring of the regulation of medicines seems to have been ignored in the development of the bill.
"The report does not support the bill. If anything, many provisions in the bill undermine the report's recommendations," says Berger.
While Innovative Medicines SA reacted positively to the task team report, they also pointed out that "the bill itself does not give an indication of the extent of that reform and that is a concern".
At the earliest, hearings on the bill are expected to take place when parliament re-opens in late July.
The department of health has not responded to any of our requests for comment regarding the bill.
- Marcus Low, Health24, 11 June 2008