Public and MPs must keep health authority on toes
September 22, 2008
P at Sidley's column ("When medicines law fails, the public can still complain", September 18) refers.
South Africa has missed a golden opportunity to lead the world with its restructuring of the body that registers medicines, from one dealing only with conventional medicines to one dealing with all products that make medical claims or purport to be medicines.
This is a difficult task worldwide, as the boundary between foods for survival and foods used as medicines becomes more blurred. To ensure all medicines made for sale to the public are checked for safety, quality and efficacy, a new authority, the South African Health Products Authority (Sahpra), will form. It will evaluate devices and products purporting to be medicines for safety, quality and efficacy. It will monitor advertising and work with the director-general for health to ensure that facilities employ good manufacturing practices.
This is a priority for the department of health. Recent experiences have been stark reminders of the need for a strong regulator to protect the public. But the authority that will be ushered in by a law already approved by the portfolio committee on health will not provide the protection we need. It will be managed by a chief executive appointed by and accountable only to the minister. The executive will appoint full-time committees to do what he or she decides.
There is no guidance in the legislation about qualifications, transparency, or how to co-ordinate the sections. All is left to trial and error. Licensing of facilities will be done by the director-general on behalf of the minister, but all the work on safety will be managed by the executive. Hence, the executive and the minister have unfettered power over a multibillion-rand industry and the authority will lack accountability.
Sahpra will have a complex task involving advanced science, huge finances and the management of many units. The treasury made the same request for a board as opposition members and members of the public, criticising the lack transparency and accountability of the proposed authority.
The argument was advanced that if the executive is incompetent, he or she must be fired by the minister. But the executive will bid for the minister and won't be sacked unless the minister is crossed. This is worrying, as the onus will be on the firm making a product to apply to have it registered.
Someone making a magic potion for sale will not want the expense and trouble of having it registered. This places the onus on stores selling products for use as medicines to ensure they are registered, or on inspectors to check. If a class of medicine is called up by the executive, the people who make it will be obliged to send it for registration. But it's up to the executive to decide what classes and products to call up. Only then do provisions apply for advertising and licensing of the premises to ensure safety.
In spite of the bill's failings, the committee introduced vital changes to this law. We insisted there should be no financial conflict of interest for the executive who heads the authority, or for people on the appeal committee - the body to which people can appeal a decision of the executive if they refuse to register their medicine.
We removed provisions that enabled the minister to decide, on the basis of public interest, whether a certified medicine should be registered. The minister will now have to use his or her influence over the essential drugs list and over state tenders to develop a local medicine industry and support disadvantaged groups. The private sector will be free to make state-of-the-art medicines, provided they are shown to be safe and provided the executive runs an efficient authority.
Initially this bill lacked provisions for medical devices. We changed the two-tier process to no-conflict-of-interest provisions. We showed how much effect the legislature can have when it is free to do so and doesn't have to rubber-stamp the executive. The split in the ANC gave us this freedom.
But both the old and new ANC favour a regulating authority that gives vast discretionary powers to ministers. Hence, the public must be trained to look after its own interests. The authority will have a website that lists substances to be registered. These should have a registration number on the pack. If a listed product has no registration number, it must be reported, not bought.
If an item makes a medical claim and is not called up for registration, it must be exposed. Reputable dealers are the best bet for purchases, and problems with the authority must not be tolerated. Sadly, poor and ignorant people will be most subject to exploitation. It is the role of alert individuals and an active industry, together with MPs, to keep this authority on its toes.
Dr Ruth Rabinowitz
Johannesburg
Lehman Brothers deserves its demise
I am pleased about the demise of Lehman Brothers. These clever boys were responsible for talking up the oil price to $150 (R1 195 at Friday's exchange rate) when it was only $70.
This gave speculators a target they previously never had and they drove up the price relentlessly.
It is clear from the recent drop below $100 that the peak of $145 was a speculative bubble created by remarks first made by Lehman.
The high oil price was in no small measure responsible for Lehman's collapse. It should serve as a warning to others about making irresponsible comments.
Richard Gruning
Jetpark
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