The Minister of Health of South Africa, Manto Tshabalala-Msimang, is trying her luck. She has put forward a bill apparently intended to improve the process surrounding the registration and certification of new medicines.
I have to put in my disclaimer here: I'm not an attorney, advocate or judge. I'm not a legal expert at all, and the sum total of my legal training was a course in copyright law at college. What follows is my reasonably well-informed lay interpretation of this piece of proposed legislation. I welcome any opinions or insights more enlightened than my own.
This bill is a pretty detailed document, encompassing a number of seemingly subtle changes to the existing legislation... some of which are potentially beneficial, many of which are very troubling.
I'll start with the good news.
The bill begins by redefining the substances that should be regulated as medicines. The definition has been expanded from only commercial pharmaceuticals to include just about anything about which medical claims are made, including foodstuffs and diagnostic machines.
This is good news because under this bill all quacks are subject to regulation just like real medicine is. Homeopaths, naturopaths, acupuncturists, sangomas, electrodiagnosticians, chiropractors, Danie Krugel, Matthias Rath and all other quacks will need to satisfy the same burden of proof as Adcock Ingram and GSK.
More good news is that efficacy is one of the items specifically listed by which any and all such interventions will be measured. In other words, the person seeking certification for their specific intervention will have to show, to the satisfaction of the registering body, that their gadget or pill does what it claims to do. If their product fails to be certified, they may not advertise it along with those medical claims.
I think this represents a remarkable step forward in consumer protection in our country. The same processes designed to protect the public from dishonest peddlers of pharmaceuticals is to be expanded to encompass anyone who claims that their magic product can cure a rainy day.
But as far as I see it, that's where the good news ends.
One of the primary aims of the bill is to change the whole process by which these products are regulated. It effectively dissolves the Medicines Control Council, and establishes a new office called the South African Health Products Regulatory Authority. This in itself isn't necessarily a bad thing. The problem comes in with how it's organized.
The Chief Executive Officer of the Authority is appointed by, and serves at the pleasure of the Minister of Health. There doesn't appear to be any formal selection process defined, other than an interview between the applicant and the Minister herself. This means that Manto gets to decide, all by herself, who she thinks is the best person for the job. That CEO is then responsible for appointing all staff and committees within the Authority, which means we have a single point of failure for the organization: the CEO. The CEO is accountable only to the Minister, and not to the general public or the scientific community.
It gets worse.
Assuming that by some fluke, Manto appoints a scientifically-minded and intelligent person to the position of Authority CEO, that person is still not the only one to decide if any given intervention should be certified or not. Once the CEO and his minions are ready to certify a given intervention, he must submit it to the Minister who has the right to exercise veto power over the application.
On the surface this may not seem like such a bad thing. Rather err on the side of fewer interventions making it through the process than getting false positives, right? Not so much.
Take this hypothetical situation as an example:
Big Pharma develops an HIV vaccine that has passed a great many clinical trials. The vaccine has demonstrated that it is safe (to within acceptable levels) and effective (also to within acceptable levels). It renders 95% of patients immune to HIV infection with minimal side effects. In other words, it's been proven to be a safe and effective intervention.
The CEO of the Authority is satisfied with the evidence presented along with the application, and approves it, sending it off to the Minister for certification. The Minister, being an ideologically motivated idiot with genocidal tendencies who believes that vegetables are a better treatment for HIV than anti-retrovirals, decides that she doesn't like the idea of an HIV vaccine, and rejects the application - thus sentencing millions of South Africans to a slow and painful death.
One need only run a Google News search on Manto to see that this hypothetical situation is far from unlikely. The fate of South African lives should not be left in the hands of any one person, least of all a stupid politician. (Not all politicians are stupid, but this one is)
The only way of making this approval process even close to effective is by employing a panel of qualified experts from a variety of medical and scientific disciplines, and submitting every request to a consensus-vote by them, not unlike the referee process employed by scientific journals.
Science, and particularly scientific medicine is not a matter of policy, politics or ideology - it is a matter of life and death. Can we, as a developing nation suffering under the weight of this deadly pandemic, stand by and allow these incompetent politicians continue to make decisions about whether our children live or die?
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