4 March 2014
Last year the health department gazetted changes to the Medicines Act which, over about five years, will require complementary and alternative medicines (CAMs) to be registered with the Medicines Control Council (MCC).
CAMs includes a range of products, from weight-loss products to aphrodisiacs.
The new regulations require products to be tested for quality and safety, but remain rather lenient on proving claims that the products are effective. In other words, a product that claims it is snake oil must contain harmless snake oil - and every vial, tablet or sachet must contain exactly the same amount of the same snake oil. But if it claims it will cure your halitosis, don’t be surprised if your friends still keep an arm’s length from you.
Tamar Kahn explained in Business Day last week how that the “complementary medicines industry is blatantly resisting the government’s attempts at regulation”. Kahn mentioned that the industry was “ignoring a February 15 deadline to put disclaimers on its products, and continuing to sell many goods the regulator says are now illegal.”
One company’s CEO took the time to explain how and why he plans to resist the new regulations.
Last Wednesday Eddie Bisset, the founder and CEO of Herbex, held centre stage at a public meeting. The event organiser claims that Herbex is “one of the fastest growing, independent Complementary Health and Lifestyle product companies in South Africa”. Bisset told an audience of lay persons that the new (MCC) regulations on Complementary and Alternative Medicines are “draconian and onerous, to say the least.”
Claims about Herbex products have been debunked. The website CAMcheck explains that the company has been selling “inadequately substantiated weight loss and other nonsense products for more than 15 years,” and that “they continue to roll out new products – with zero proof of efficacy.”
Bisset has the foresight to begin by asking, “Is there anyone from the ASA [Advertising Standards Agency] here? The MCC? Health Professions’ Council?”
He scans the audience playfully, albeit carefully, and probably decides that the coast is clear. “Good. What we will be doing in this regulatory environment, is smuggling donkeys”.
He tells this story, “There was this smuggler, and the authorities knew he was a smuggler. And he would come by the officials, year after year with his donkey and they searched them both thoroughly, without ever finding anything.
“And years later, when he was retired, they asked him, ‘What were you smuggling?’, and he laughed as he said, ‘I was smuggling donkeys’.”
“We need to find a way to treat herbals not like pharmaceuticals,” explains Eddie, laying out a few not-so-new strategies about just how Herbex plans on doing this. “We’re trying to trade [our products] off as food.”
“We are now the same as Aspen [and] GSK [pharmaceutical companies]. And we never meant to be there. We are herbalists.”
Bisset wants to get around the regulations by claiming his products are food, not medicines.
This is not a new idea. In fact, this move has been pre-empted by the MCC, explains Rene Doms, consultant pharmacist and lawyer. “There is no food safe harbour for these medicines.”
Doms, using quite a bit of legal jargon, explains that any product that makes claims to repair your health is seen as a medicine by the law. This is what Bisset’s products do, so they fall under the new regulations.
Doms writes, “Evasive or deceptive tactics are not acceptable… A product that has been used for years and promoted as a medicine to the public … does not become a foodstuff because it now suits the seller.”
Bisset says with a grin, “Customers are foolish enough to believe what you put on your label.” Then he pauses, maybe realising that he is saying too much, and adds, “but you have to tone it down.” He receives encouraging nods from the audience.
“We now have to comply with the regulations laid down but the Department of Health and MCC…” he complains. “The MCC is run by doctors and pharmacists,” he says as though the flaw with this arrangement is self-evident. But, perhaps sensing some confusion, he spells it out, “You are taking a person who develops aeroplanes, and trying to get them to build motorcars.”
What he means by this curious analogy is unclear, especially when you consider that both aeroplanes and motorcars are subject to very rigid safety and quality testing before hitting the market.
“The complementary medicines industry in South Africa is self-regulated,” Bisset continues, and once again, the audience seems to agree unquestioningly.
Bisset, like many others in the CAMs industry, is afraid of what the new regulations will do to what has become a very lucrative sector.
“It’s an R8 billion industry, and it’s probably going to shrink by about 80%,” says Bisset.
Bisset does not however think that the new regulations are all bad. He approves of the regulations that limit foreign import of similar products. “I don’t want a guy coming in from India bringing in a product at half the price, making the same claims as me and the product doesn’t work.”
Herbex has big plans. According to Bisset, it operates in the Middle East, where it has already established operations, and from there can manage markets in Nigeria and Australia.
He also predicts that the new regulations will have unintended consequences once companies with enough capital manage to register some of their products: “What will happen? Fully compliant, protected brands will have less competition on the shelf and better relationships with retailers… the little guys will close down, and we [Herbex] will have about 10 products left. And in 5 to 10 years we will have about 90% of the market.”
Eddie Bisset seems to switch between railing against and revelling in the new regulations. The new requirements have been designed to protect consumers from harm and exploitation. Bisset aims to continue abusing the public’s trust by side-stepping what he deems to be “draconian” laws which would merely hold him accountable for the products he sells and the claims he makes.
A correction was made to this article. It originally said that Bisset said that the CAMS industry was R80b [per year] instead of R8b.