Pat Sidley: Business Report,

THERE has been a good deal of celebrating over the Cape high court judgment stopping Matthias Rath from doing business in this country by selling drugs claimed to be a cure for AIDS.

The Treatment Action Campaign (TAC), with the SA Medical Association (Sama), has good reason to be delighted with the findings for the time being. It is just as well Health Minister Manto Tshabalala-Msimang is studying the judgment.

Apart from potentially making her feel a bit liverish (pun intended) where it knocks her specifically, it also has some problem areas that are likely to muddy the water in the medicines registration process - as well as the intended amended process.

She may not see this as a problem as, once again, her powers in the proposed amendment to the Medicines Act have been strengthened. The loopholes and gaps in the judgment present her with an opportunity to wield power one would rather not have vested in the hands of one politician.

Unfortunately, this particular administration has provided enough evidence of the fact that political interference in how medicines get to market and how people are treated can do great harm to the vulnerable.

The TAC had accused Rath of selling medication by using claims which could not be backed up for people with HIV/AIDS. The TAC was also worried about the use of the drugs in clinics in what looked like ethically and legally dubious clinical trials.

It was concerned, too, that a substance found in one of the products was scheduled, as this should have meant the drug had to be approved by the Medicines Control Council before finding its way onto the market.

The activists' biggest beef was that Tshabalala-Msimang was required to give effect to the law to ensure that false claims could not be made about medication; that safe and efficacious drugs made it onto the market; and that potentially harmful substances could not be sold without undergoing this process.

The process also involves checking that clinical trials (when humans are part of the testing process) are done in an ethical and legal way.

It is worth looking back at why most countries have a system of laws and bodies that ensure some kind of process to prevent unscrupulous players from making a quick buck at the expense of the health of the more vulnerable.

The landmark case that forced countries to put many of these measures in place was over a drug called Thalidomide, which was prescribed for pregnant women suffering from nausea. The unmentioned side effect of this drug was birth defects that destroyed many lives for several generations. Inevitably, the scrutiny fell on whether any clinical trial processes had been undertaken and if this catastrophe could have been anticipated.

As a result of the many court cases about the use of the drug, most countries beefed up their processes to prevent a recurrence, minimise a potential occurrence involving new drugs and ensure that the culprits would be found.

The US toughened the laws that control food and drug administration. These days the EU's very tough approval regime is being implemented, and in 1998 the South African government passed a new and hotly contested Medicines and Controlled Substances Act, aimed at making the processes rational.

Then the AIDS pandemic struck - but the government decided that the real problem was poverty. The government made many decisions and indecisions according to batty theories, and enormous pressure was brought to bear on regulatory authorities all over the world by AIDS activists and pharmaceutical companies to speed up the process that Thalidomide had slowed, in order to get new medication onto the market more quickly.

In the middle of the confused and confusing atmosphere of government battiness and activist and pharmaceutical company pressure, two snake oil salesmen tried to get Virodene - a lethal industrial solvent - onto the market by circumventing the process that would have stopped them and using politicians who should have known better.

Various heads rolled among those appointed to protect us from Thalidomide and snake oil salesmen, and registration of antiretroviral medication for treating AIDS became an intensely political issue with safety and efficacy further down the list of priorities. Various rules and regulations were changed to an extent that made health supplements the flavour of the week.

Virodene, Rath's vitamins (with added extras) and the Minister's beetroot and garlic gained a prominence and near-respectability in the treatment of HIV/AIDS.

That is the truncated background that prompted the TAC and the Sama to ask the court to force Tshabalala-Msimang to do her job of ensuring that only safe and efficacious medicine got into the market; stop illegal and unethical clinical trials; and stop the sale and distribution of the products that had caused concern to the TAC and Sama. This was done.

The judgment, however, has sections dealing with the registration of medication and the sale of scheduled substances, which some experts fear may confuse things if push should come to shove and court action becomes necessary again.

The judgment points to two "call-up notices", one in 1985 and one superseding it in 2002, that are apparently aimed at dealing with a potential requirement to register.

The judgment also mentions areas found to be contradictory in the 2002 notice. The differences involve how complementary medicines and similar substances are to be treated and how to determine what needs to be registered and what does not. They are not easy for a lay person to understand and, given some of the remarks made, experts are finding singular difficulty in dealing with these parts of the judgment.

To complicate this further, the amendments now before parliament will make a much larger and more complicated process out of registration, vest more power in the Health Minister and may be more complicated than intended when seen against the judgment.

According to the TAC's advocate, Geoff Budlender, the judgment has been very useful in stopping Rath from doing business in this country. But he says the parts of the judgment dealing with scheduled substances and registration may have made it more difficult to distinguish between processes in the future.

Andy Gray, a pharmacological expert from the University of KwaZulu-Natal, points to the powers of the Minister and questions whether the confusion in the judgment, along with the proposed new law, will cause the law to be less effective than it should.

An obvious question is whether this will all be used to keep particular medications off the market as and when a political need arises, or whether it will be used to force a substance onto the market for political reasons.

It needs to be cleared up and fought where necessary. This country does not need Virodene or Thalidomide.

Sick people should not be forced to drag themselves to court each time a politician decides a proven medicine should not be given - as was the case for Nevirapine, used to prevent HIV transmission from HIV-positive pregnant women to their soon-to-be-born babies.