The appointment of a top Department of Health official as acting registrar of the Medicines Control Council (MCC) has raised alarm about a potential conflict of interest.
Humphrey Zokufa, a chief director whose tasks included the implementation of the new medicine pricing regulations, has been named temporarily to fill the post vacated by Precious Matsoso, who has left to work for the World Health Organisation in Geneva.
Reactions to Zokufa’s appointment vary from those claims that he is Minister of Health Manto Tshabalala-Msimang’s ”yes-man”, not willing to ”stick his neck out” or ”rock the boat”, to the response of both the pharmaceutical society and manufacturers, who have welcomed his appointment, describing him as ”fair and willing to build bridges”.
The politically charged role of registrar was highlighted last year at the Bangkok Aids conference when Motsoso told the assembly that because of problems around the original study used to test nevirapine, the MCC did not recommend use of the drug, employed in South Africa as single-dose therapy to protect unborn babies from contracting HIV.
Motsoso’s announcement bolstered the minister’s contention that the drug should not have been provided in the public sector. It also reinforced suspicions that the MCC — which is expected to be independent, although it is housed in the department — is susceptible to political pressure.
Health department spokesperson Sibane Mngadi said it was decided last week that Mandisa Hela, the department’s director for access to affordable medicines, will take over from Zokufa as acting chief director of the pharmaceutical policy and planning cluster in charge of Aids drug procurement, while Anban Pillay, director of the pharmaceutical economic evaluation unit, will now report to Hela.
Mngadi said the MCC registrar’s position will be advertised but the position could not be left vacant because of a backlog in medicine registrations.
He described Zokufa as most qualified to step into the interim position, saying there is no conflict of interest as the MCC’s role ”has nothing to do with the price of drugs”.
But industry experts warn that Zokufa, as the former head of procurement and pricing regulations, was privy to the department’s plans concerning international reference drug prices and the sourcing of generics. ”We have to monitor his objectivity around generics that will be registered,” said an industry expert.
He added that Zokufa needs to focus on quality rather than cost. And he raised the concern that Zokufa will not be independent of the influence of Tshabalala-Msimang, in the light of the council’s regulatory role in making sure all drugs sold are efficacious, safe and of the highest quality, while also standing up to the pharmaceutical industry.
Jonathan Berger, an attorney at the Aids Law Project, said Zokufa’s failure for more than a year to procure anti-retroviral drugs for the national treatment plan has not inspired confidence in his abilities. ”The person appointed [as registrar] needs to stand up to [the] government and all [stakeholders] with vested interest to protect the public.”
Asked to comment, Zokufa said: ”Politics are integral in the very creation of the MCC, with the minister appointing the council and registrar.”
But, he added, ”there is no conflict of interests ” rather a complementary role.
”The MCC has to make technical and scientific decisions … In no way is our government or our minister trying to interfere with this process.” ÂÂ
Political interference is not the issue, Zokufa said, but rather interference from those who have commercial vested interests and may try to influence decisions.