The regulation, registration and control of medicines in South Africa is (still) chaotic. A What's New DOC (WND) investigation uncovered an MCC trying to pick up the pieces amid a fractured past which includes massive backlogs, political meddling, allegations of bribes and vested commercial interests, lack of control over complementary medicines and quack remedies flooding the country
By ANSO THOM, (award-winning journalist, Health-e News Service)
SA's beleaguered Medicines Control Council (MCC) is slowly starting to make inroads into its massive backlog, but it will take a long time to repair the havoc wreaked by years of political meddling and incompetence.
Since the 1998 purge of MCC chairperson Peter Folb, registrar Johan Schlebusch and his deputy Christel Bruckner, the quality of the MCC’s work has declined dramatically, said Treatment Action Campaign treasurer Nathan Geffen.
Unhappiness with the MCC culminated during the 2009/2010 Christmas break when there was a deluge of media reports about the seven-year backlog. Since then some progress has been made, and according to a spokesperson from the Pharmaceutical Industry Association of SA, communication between the MCC and the pharmaceutical industry has improved. Other industry sources say current registrar Mandisa Hela is working tirelessly to fix the situation and that she has already made great strides.
In March this year, she was part of a delegation that presented the health department’s strategic plan and budget to Parliament’s portfolio committee.
Full attention to the registration of new meds
According to minutes from the Parliamentary Monitoring Group, Hela acknowledged the ‘slowness in the registration’ of new medicines and said she was giving the matter her full attention and was working towards speeding up registration, especially of antiretrovirals.
But the backlog is still huge and there are still no clear results following recommendations by a task team set up two years ago by then health minister Barbara Hogan, Geffen said.
The task team had to examine the legislation and problems linked to drug regulation, transform the MCC and start clearing the backlog.
Geffen is the author of Debunking Denialism, which chronicles how the MCC’s poor functioning has opened the floodgates for all kinds of quack remedies and questionable drugs.
This includes complete chaos surrounding legislation for complementary drugs. New, life-saving drugs, especially for ICU and cardiovascular patients, are also unavailable as they await registration, in spite of the fact that many of these drugs have already been approved by respected agencies such as the US Food and Drug Administration and the European Medicines Agency.
In addition, pharmaceutical companies have complained that at times their patent rights have almost expired by the time they receive registration, dramatically reducing their window period to make a profit.
Allegations of bribery and vested interests have added to the MCC’s woes.
It is difficult to establish exactly what the current situation is because of a lack of communication. What’s New DOC has been trying to interview current Hela since January this year. Countless emails, messages on her cellphone and messages left with her assistant in Pretoria have remained unanswered.
In April, she finally agreed to reply to our list of questions – some of which touched on very sensitive issues – but never did.
'The MCC is an important institution, but it does not have the resources to do its work. It needs more money and competent people,' Geffen said.
Corridors overflowing with unprocessed applications
So while inroads have been made, many challenges remain. Several sources spoke of a time when the corridors on the MCC’s second-floor offices in the Hallmark building in Pretoria were clogged with overflowing cardboard boxes containing thousands of applications for registration, many of them for so-called complementary medicines.
At one time there were about 20 000 alternative medicine applications sitting with the MCC unprocessed and there was no plan to process them, Geffen said.
Some of this mess has now been cleared and on the surface order has been restored. Insiders said the new sense of urgency was also due to the involvement of Hogan’s former special adviser Dr Nicholas Crisp, who is now overseeing the establishment of a Medicines Regulatory Authority (MRA), expected to eventually replace the MCC.
Quantifying the backlog
The extent of the current backlog is unclear. In a 2008 briefing to Parliament’s portfolio committee on health, Hela said the backlog for registration in 2003 (the number of applications received but not registered in that year) was 28%. Those not registered for 2004 came to 31%, not registered for 2005 53%, not registered for 2006 80% and 98% were not registered for 2007 (see the graph on the opposite page).
It has also been reported that of the 748 applications received in 2008, only five were registered and of 2009’s 281 applications, only two had been registered by January 2010.
In January the backlog was standing at nearly 3 000 medicines and it was estimated it would take two years to clear. An industry source said current delays continue for up to 40 months.
However, critical drugs are fast-tracked and registered within nine to 15 months, Hela said at the 2008 briefing.
The international average for the registration of drugs is between 20 and 22 months.
Explaining the problem
In 2008, Hela offered various reasons for the backlog, including that the MCC still had the same number of evaluators and committee members it had in 1965 in spite of an increase in the number of applications.
But the main culprit was what she called a 'tsunami' of generics. There are many duplicate applications of generics because a separate application is submitted for each different market targeted by the same product.
Very few of the dossiers in the system are New Chemical Entities (NCEs), in other words, many are simply versions of the original.
A 2008 report by Professor Ronald Green-Thompson, adviser for former health minister Dr Manto Tshabalala-Msimang, found the following: in 2003 there were 16 applications for NCEs and 508 for generics; in 2004, 27 were NCEs and 563 generics; in 2005, 18 were NCEs and 490 generics; in 2006 21 were NCEs and 801 generics; and in 2007 22 were NCEs and 765 were generics (see the graph on the opposite page).
The ARV issue
The MCC has also come under pressure from those who have an interest in seeing antiretrovirals registered. Earlier this year, HIV stakeholders called on the MCC to speed up the registration of the critical anti-HIV medication or face legal action.
The Southern African HIV Clinicians Society sent an appeal to the health minister to intervene and address the MCC registration process which they described as the single biggest obstacle to getting affordable access to medicines. They claimed that some drug dossiers had been in the MCC pipeline for years.
President of the society Dr Francois Venter warned at the time that the drugs on the list included all fixed-dose combinations, especially those that will be on the state’s first-line regimen.
Alternatives: a free-for-all
In March this year, the Parliamentary Committee grilled Hela on the impunity with which those peddling complementary medicines operate. She conceded that complementary medicines are not regulated, but said the MCC is looking into ways to strengthen the regulations.
The problem is historical. In February 2002, the health department issued a directive in which manufacturers and distributors of complementary medicines were asked to submit information on their products to the MCC. The aim was to audit the complementary medicines market over a period of six months and then formulate new regulations to better control the industry.
But it seems the audit never took place and eight years later manufacturers are still sending in applications for MCC approval, often claiming this means their products are 'registered'.
Sources say that the MCC is now trying to sort out the problem by cancelling the call-up and formulating regulations, but they find themselves in battle with role players with a stake in the complementary medicines market.
Earlier this year the Health Products Association of Southern Africa (HPA) lodged an official appeal to the decision to rescind the call-up. It fears that if recision is put into practice, it will have a major impact on the complementary medicines industry, effectively making about 15 000 products illegal.
An industry source said negotiations are taking place.
The Simply Slim debacle earlier this year showed why the matter is urgent. After being ordered by the MCC to remove Simply Slim from the market, the manufacturer simply revised it and returned it to the shelves.
Simply Slim, which claimed to be 100 percent herbal, contained more sibutramine that prescription medicines.
'There is no evidence before the MCC that any work has been done on this product; it's unbelievable,' a source said.
Last year, a group of South Africa’s top pharmacology experts and academics sent a five-page letter to the MCC warning that the market is being flooded with all kinds of quack remedies and dubious 'medicines'. Neither Eagles nor Hela acknowledged the letter.
The letter warned that the information submitted continues to be accepted by the Medicines Regulatory Affairs Cluster of the health department and as a consequence these products are freely marketed without any regulatory oversight.
They said that in the absence of independent assessment it is not known whether the products contain any active ingredients or toxic health metals, are possibly contaminated with bacteria or banned substances, contain scheduled substances or whether formulations are rational or safe.
Will these problems be solved by the MCC, or its envisaged successor, the MRA? It is clear a dramatic overhaul of medicine regulation is needed to ensure the public has prompt access to new, life-saving drugs – and that it’s protected against substandard products.
(This is an edited extract of an article first published in What’s New DOC, 10th issue, May 2010. What’s New Doc is a publication for medical doctors, produced in association with Health24.)