A court battle looms over new regulations for the sector that will require testing and approval of all products.
The complementary medicines industry is taking the government to court over new regulations that require complementary products to be tested and proven to be effective before registration, bringing them in line with existing requirements for allopathic medicines.
The outcome of the legal battle will decide how complementary medicine (See What is “complementary medicine”) is managed in the future and, according to some companies in the complementary sector, will decide their fate.
The Health Products Association of South Africa (HPASA), which represents 114 companies that produce complementary medicines, has applied in the Pretoria High Court for new department of health regulations to be set aside, saying the regulations are “a threat to the sector”, “vague” and “contradictory”.
The battle is over regulations that require some 155 000 complementary medicines — from slimming tablets to herbal supplements and vitamins — to go through a registration process and trials to prove that they are effective.
The regulations subject complementary products to formal controls, bringing them in line with similar long standing requirements for allopathic medicines. The chairman of HPASA, Normal Fels, says the association is legally challenging the department because the regulations place a “costly and onerous burden” on the sector that is “akin to requiring Fiat 500 vehicles to go through the same registration process as an Airbus 380”.
The industry could not afford the additional costs he said, because research had to be provided to back up each claim for each ingredient in a complementary product. The internationally acceptable practice of listing ingredients for the products would resolve the impasse and allow contra-indications to be looked up, Fels said.
Werksmans director Neil Kirby, who represents HPASA, said the regulations are “vague and contradictory”. Kirby said the regulations are “inconsistent with the Medicines & Related Substances Act” because “the Act does not contain provisions that support the way the regulations were drafted”. The new registration process requires clinical trials, among other requirements, and that most businesses in the sector “cannot afford these costs”.
There was a need for regulation, but “it must be proper, appropriate, reasonable and lawful”.
“I do not think that one can treat the registration process of a product containing ibuprofen the same way as for a product containing sandalwood oil or witch hazel,” said Kirby.
Fels said there were “already mechanisms in place that allow for the Medicines Control Council (MCC), the Consumer Protection Act and the Advertising Standards Authority (ASA) to take action”.
The government is opposing the application but the department of health has declined to comment on the matter, saying the matter was sub judice.
Fels says the association is asking to find a “workable way forward”. The regulations “do not provide for 60% of products on the market and may lead to the loss of companies which it may turn out, sells safe, quality products for which they can provide research”, he said.
The Allied Health Professions Council of South Africa (AHPCSA) said the regulations are “needed when so many people use complementary medicines in South Africa with no education and training”.
Specialist clinical pharmacologist Roy Jobson, speaking in his personal capacity, welcomed the regulations.
Jobson alleged that several companies sell complementary medicines that contain ingredients that are scheduled substances (which legally require a prescription) such as milk thistle, a Schedule 3 drug. He added that some complementary medicines contain so-called “banned” substances. He said “freedom of choice” does not exist “if you cannot even be sure of what is in a medicine”.
Fels said the health department and the MCC already had power through the Medicines and Related Substances Control Act to remove unsafe or undesirable products from shelves. Kirby said current laws provide protection to consumers, while the costs of complying with the new regulations to provide detailed research would be a substantial outlay for many of the companies.
He said the new law came into effect when it was gazetted in the middle of last November, but it had taken the sector, characterised by many stakeholders and lots of politicking, “a while to absorb the impact of the new rules”, and that there “was a degree of fear over launching an action”.
Until the outcome is heard, companies cannot put new products on the shelf without registering them with the MCC. Existing products are subject to the timelines detailed in the regulations and need to go through the registration process.
Jobson said consumers have to some degree been protected by the ASA, which has in many ways “been a substitute MCC for over 10 years” and has played an important role in protecting the public. “But the ASA can only act if complaints are received.”