SOUTH Africa’s R8bn complementary medicines industry is blatantly resisting the government’s attempts at regulation, ignoring a February 15 deadline to put disclaimers on its products, and continuing to sell many goods the regulator says are now illegal.
Shelves of leading retailers, including Clicks and Dis-Chem, carry hundreds of products such as homeopathic pills and aromatherapy oils that should carry labels informing customers their claimed benefits have not been evaluated by the Medicines Control Council (MCC) and that they are not intended to diagnose, treat or cure any disease.
But to all intents and purposes it is business as usual for an industry that has flourished in the absence of regulatory oversight and surging consumer demand for alternatives to allopathic medicine.
"The industry isn’t progressive. Probably only 20% of our clients instructed us to change their labels before the February 15 deadline," says a contract manufacturer, who asks not to be named for fear of jeopardising future business deals.
"There are going to be casualties, but compliance is not nearly as difficult as the industry is making out," he says.
For now the Department of Health is adopting a soft line, saying it will give the industry time to get its house in order before it begins seizing products from shelves.
"The regulations were gazetted at a difficult time, just before Christmas, so you need to be practical," says the head of the MCC’s inspectorate, Joey Gouws. " We are starting to contact companies and asking them, what’s your plan? And if they don’t have a plan, they won’t leave us with any option but to remove them from the market," she says.
Health director-general Precious Matsoso says, "It’s a question of balance: on the one hand protecting the public from harm and on the other ensuring you have a vibrant, ethical and healthy industry."
She insists the government has no plan to regulate the complementary medicines industry out of existence.
That’s not how some industry players see it.
About 80% of the products that were on the market before the regulations came into effect, are now under threat, says consultant René Doms, predicting a sea-change in the nature of the industry once the new laws are fully implemented.
The Health Products Association, an industry body for complementary medicine businesses, agrees. "The ramifications will be absolutely horrendous," says its treasurer, Norman Fells. "We estimate the losses to the economy could be as much as R50bn, when you consider the advertisements, packaging, direct selling associations, manufacturers and distributors, which I’m sure neither the South African Revenue Service nor the Department of Trade and Industry would welcome."
Opinion is divided whether the changes will be a good thing: many players in the industry argue that the regulator is limiting consumer choice and threatening jobs, while the pro-regulation lobby says consumers need protection from ineffective, dangerous and contaminated products. Until now there has been no oversight of the manufacturing facilities for complementary medicines, leaving unscrupulous businesses free to adulterate their products with cheap fillers such as powdered rice, or spike them with registered medicines such as steroids.
New regulations to the Medicines and Related Substances Act were published on November 15, for the first time bringing oversight to the hundreds of thousands of complementary and alternative medicines on the South African market.
The regulations define complementary medicines (Category D) as products making medicinal claims that are linked to an allied healthcare profession such as Ayurveda or western herbal medicine. They may stay on the market until they are called up for assessment by the MCC.
The first such evaluation deadline is May 15, by which time manufacturers of complementary medicines for cancer, diabetes, heart diseases and HIV/AIDS will have to submit evidence of their safety and efficacy. Next will be products claiming to help with slimming, to boost libido, and to stimulate the immune system.
All products making medicinal claims that do not fall into Category D are now classified as Category A, or allopathic medicines. The registration rules for Category A medicines are more stringent than for Category D: they cannot be marketed until they have been registered by the MCC, based on an assessment of clinical safety and efficacy.
This means any alternative health product that the new regulations placed in Category A should already have been withdrawn from the market. And any product that does not fall into category A or D, and is not a foodstuff or a cosmetic, is now considered to be illegal, according to the registrar of medicines, Mandisa Hela.
The regulator has published a roadmap spelling out the way forward for the alternative medicines industry. It says goods containing banned substances such as yohimbine and damiana should be withdrawn immediately; products containing substances defined as scheduled should be recalled; and the sale of products that don’t fit the definition of a complementary medicine should cease, while those that do should submit registration documentation.
According to Mr Doms, the market is littered with "Category A misbranded, self-styled complementary medicines" — including multivitamin preparations and products claiming to affect a physiological function — which are modelled on the requirements of the US dietary supplement health and education act. Such products are unlikely to survive scrutiny from the MCC, as the regulations signed by the health minister are much tougher than those imposed across the Atlantic, he says.
Dis-Chem director Stan Goetsch says the regulations will affect many of the brands the company stocks, some of which may need to be recalled and registered by suppliers. Compliance with the new labelling regulations alone is likely to prove too costly for some suppliers and force them to close, and registering many of the new Category D products will push prices up to such an extent they will no longer be viable, he says.
"We share the concerns of most players in the industry about the effect these regulations will have on the viability and sustainability of many players, and fear many jobs will be lost."
Rhodes University pharmacologist Roy Jobson says it is illegal for a pharmacist or retailer to sell an unregistered medicine, and such products should have already been withdrawn.
"The numerous products on supermarket shelves containing glucosamine for joint pain and arthritis are deemed Schedule 3 medicines. They should be registered as medicines and should not be available without a prescription. The same is true for products containing milk thistle, which contains silymarin, used in liver remedies," he says.
"The complementary medicines lobby says people have the right to take responsibility for their own health, diagnose themselves and choose their medication. That might be true if you have the correct biological training, but across the board from rich to poor, people don’t. We need to be much more careful," says Prof Jobson.
Many complementary medicine manufacturers have applied for an extension to the labelling deadline last week but there is no scope for a stay of execution on the requirement to register Category A medicines, says Allison Vienings, executive director of the Self-Medication Association of SA. The new laws pose a huge headache for many of the smaller manufacturers and retailers, which, unlike the large pharmaceutical companies, have little or no in-house regulatory expertise, she says.
"We are scrambling, but we are doing our very best to comply with the new regulations," says Steve Parker, who imports complementary medicines from New Zealand’s Good Health Products. "For many years we have wanted regulation to chase away the industry cowboys.
"We were hoping for something less onerous, a different system with less paperwork that would still provide a way of assessing safety and efficacy.
"It is unfair to have to go through the same regulatory process for vitamin C as Prozac," he says.
"Down the track the consumer will be the loser, as prices will rise. Any manufacturer that is unable to comply with good manufacturing practices will struggle, and smaller companies will be the first to go. Business will slow and there will be retrenchments," he predicts.
Many of the JSE-listed companies with large complementary medicine portfolios are urgently reviewing their products, but they will not say which of their brands are being pulled from the market.
Health and beauty retailer Clicks says it is evaluating affected products, and has identified "a number" that will be withdrawn from its shelves, but declines to provide specifics.
"Should any product or substance not meet the requirements stipulated by the regulations as either a foodstuff or Category D complementary medicine, such products would be withdrawn from sale," says Clicks chief operating officer Keith Warburton.
Local pharmaceutical manufacturer Adcock Ingram is reviewing its portfolio but is unable yet to say whether it will need to withdraw any of its products, says CEO Jonathan Louw.
Newly listed Ascendis, which acquired supplement business Solal last year, declined to discuss the regulations. CEO Karsten Wellner says the company is in a closed period and unable to comment further until it releases its interim financial results early next month.
University of KwaZulu-Natal pharmacologist Andy Gray says the industry is hoping the regulations will not be enforced by the Department of Health, but warns they could face stiff penalties for transgressing the Medicines Act, including a jail term of up to 10 years.
"The teeth are there, and the evidence from Australia’s regulator is that it can be done," he says. The Australian Therapeutic Goods Agency successfully laid criminal charges against Pan Pharmaceuticals for manufacturing counterfeit medicines.
"They are hoping that if they do nothing so will the health department. It needs somebody big to be hit," says Mr Gray.