The vacuum left by the transition from the old Medicines Control Council to the new regulator is bad news for consumers of complementary medicine. Aaron Nicodemus reports
In warehouses, on loading docks and on natural food store shelves, a pitched battle is being fought over dietary supplements, vitamins and herbal remedies.
The battle over “complementary medicine” revolves around the South African Medicines and Medical Devices Regulatory Authority, established in December last year to regulate on these products.
The regulations to be enforced by the new authority have yet to be made public. This lack of information – decried as a shroud of secrecy by its detractors, labelled simple inefficiency by those in favour – has exacerbated tensions on all sides.
And in the years it has taken the authority to replace the outgoing Medicines Control Council, companies attempting to enter South Africa’s lucrative complementary medicine market are finding the path blocked.
The regulatory process requires that any new products must be registered with the Medicines Control Council, a process that in practice takes up to three years.
In the meantime, the “big three” South African companies in the market – Pharma Natura, Bioforce International and Natura Homeopathic Company – operate under a loophole in an old law, Act 101 of 1965, which allows them to continue selling their products without undergoing the lengthy regulatory procedure.
In 1980, the “big three” and several other South African companies applied for product registration during a six-month grace period, paid a small fee and have since been allowed to sell their products. Few of the products have actually gone through a full-blown registration process, but no matter: the products are considered legal until the new regulatory authority is enacted.
Rene Doms, managing director of Pharma Natura, says the purpose of the new authority is to protect the general public against the pharmaceutical industry, and that the barriers of entry into the field are necessarily stringent.
“It’s going to place a burden on the manufacturer, perhaps more heavily on the smaller ones,” Doms said.
“The sort of johnny-come-lately just coming on to the scene will only be allowed to enter the market through government control. In the end, the balance will fall to the consumer.”
He points out that if Pharma Natura created a new product, it would be forced to undergo the same regulatory procedure.
But companies on the outside complain that the current situation creates an uneven playing field that excludes competition – one that uses government regulators to prevent new players from entering the market.
A good example is Solgar of South Africa, a United States-based company that sells dietary supplements, vitamins and herbal remedies. Solgar has 530 different product lines. While it’s free to sell them all around the world, the company can only sell about 140 of its products in South Africa.
“It’s a ludicrous state of affairs,” says Denise Maidment, managing director of Solgar. “We lost about R1-million in products last year [that were confiscated and destroyed by government regulators], and we’re losing about R2-million in [potential] sales each month.”
Solgar had been selling its products in South Africa freely until about two-and-a-half years ago, Maidment says, when government regulators began to clamp down.
She says the government’s intrusion into the market is “creating barriers of unfair trading”. Worse, she says, South African companies who are receiving the protection of the loophole are reporting other companies’ infractions to the council, who then swoop in to confiscate “illegal” goods.
“It’s not the consumers who are reporting infractions to the Medicines Control Council,” Maidment complains, “it’s the competition.”
In an interview with Health Independent, a monthly newsletter, council chair Dr Helen Rees rebuts the charges made by Solgar: “Unsubstantiated claims are being made in respect of a number of imported products and our fear is that they may constitute a potential health hazard.
“The council has tried to accommodate Solgar within the legal framework, but as mentioned, if any company persists in acting outside Act 101, the inspectorate is legally obligated to act against them.”
Many of the companies frozen out of the market say the government crackdown on complementary medicines was forced by Pharma Natura. The company allegedly threatened to sue the Medicines Control Council if it did not begin enforcing the regulations against companies attempting to import complementary medicines into South Africa without proper approvals.
Both Pharma Natura and the council deny this, but for the past several years, companies selling such products without the 1980 exemption have felt the pinch.
The regulatory mess caused by the gap between Act 101 and the new regulatory authority could have been cleared up by Minister of Health Nkosazana Zuma. She could approve a list of complementary medicines deemed to be “safe”, and a moratorium on enforcement would be implemented.
Companies like Solgar have repeatedly provided sample lists to the Medicines Control Council, but each time they have been set aside.
Rees responds: “We are truly sympathetic. We have been advised that we have to run with the old Act 101 while it remains in force and apply it equally to all.
“The legal position is that we cannot call a moratorium on any one part of the Act; neither can there be a temporary moratorium.”
In the interim, there are simply fewer choices for consumers. “The bottom line is that consumers are going into the health shops and they can’t get the medicines they want,” says Richard Mathias, owner of the Nutri-Balance Centre in a Johannesburg shopping centre. “Drug companies love it, but consumers are getting a bad deal.”