Dysfunctional MCC under legal threat

Abstract

The dysfunctional Medicines Control Council (MCC) which has registered less than half of all medicine applications to it over the past seven years has become a life threatening risk to patients and is now under legal threat from stakeholders.
This emerged from an urgent letter sent to Health minister, Dr Aaron Matosoaledi and copied to MCC Registrar, Ms Mandisa Hela and all key government officials by the Southern African HIV Clinicians Society last month.
Ironically it comes just as the special task team headed by Benguela Health’s Dr Nicholas Crisp, has completed a full audit of the 4000-medicine backlog and put in place urgent measures to fast track critically needed registrations.
Crisp told Izindaba that by June all the administrative paperwork would be completed and 12 full time evaluators would begin working on prioritized HIV, TB, cancer and cardio vascular medicines.
‘Once the multi-year backlogs are cleared, we need to set a timeframe of what (in future) is a reasonable timeframe for approval or denial of a medicine so we can define what a backlog is,’ he said, stressing that any future political interference in the MCC would soon be almost impossible.
HIV Clinicians Society president, Dr Francois Venter, said in his letter that he’d been ‘repeatedly approached’ by HIV researchers, government health officials, international aid agencies, donors, pharmaceutical companies and activists expressing ‘intense frustration,’ with the MCC’s slow registration, especially of antiretrovirals (ARV’s).
‘Several of these individuals have indicated to me that they are considering resorting to legal action, as all other remedies, including repeated correspondence, have failed to draw a response or an explanation from the MCC’.