Natural Medicines Part 2: Storm brewing in the medicine pot

Will the complementary medicines which practitioners currently use for their patients continue to be available after the new government regulations have become law? This is an issue which many are wrestling with – and something which concerns users and dispensers alike, as we are all likely to be affected.

Last week the Registrar of The Allied Health Professions Council of South Africa AHPCSA) Dr Louis Mullinder, announced that his council supported the new regulations on Complementary Medicines and said they were a “positive measure which would improve standards of quality, safety and efficacy.”

The AHPCSA regulates professions such as homeopathy, naturopathy, phytotherapy, Chinese Medicine, Unani Tibb and Ayurveda.

Intention to protect the public

“Where appropriate, regulations should allow the Medicines Control Council to restrict access to certain Complementary Medicines through appropriate complementary medicine-specific scheduling,” he said. This was “primarily in order to protect the public, by limiting the use of certain Complementary Medicines to appropriately trained and registered practitioners.”

There are however many Allied Health Practitioners who are not convinced the regulations are a good thing. They have concerns such as:

• Will they be limited to using only the medicines and remedies set down for their profession?
• If so, will all of these be available? For example, Silymarin (a flavonoid found in the herb Milk Thistle) has been made a schedule 3 substance (prescription only), even in homeopathic form (Carduus Marianus), according to one source (who preferred not to be named) as there is no lower limit of the substance stipulated in the scheduling document. Homeopaths don’t have access to schedule 3 products.
• Will they still be able to get other products they currently use in their practices?

65% of natural products to be categorized as general medicines

According to the Health Products Association, an estimated 65% of natural products on the market will not be registered in ‘Category D’, Complementary Medicines, but will fall into ‘Category A’, General Medicines, the same category as allopathic drugs.

Companies, which asked not to be named, have indicated that the registration process is both onerous and costly, especially for medicines falling into ‘Category A’ which includes almost all ‘mixed’ medicines containing herbs, extracts, tinctures, vitamins and minerals.

The Council is the body under which natural health practitioners and therapist are registered; this includes naturopaths, homeopaths, phytotherapists and Ayurvedic, Unani Tibb and Chinese Medicine practitioners. Many of these practitioners use these products alongside the medicines of their particular discipline. So for example, a homeopath may use nutritional supplements and herbal tinctures.

Those without specialized education ‘should not prescribe’

Dr Craig Wright, chairperson of the AHPCSA, was questioned about the issue of only being able to use products falling under their own modality.

In response he said:

“All diagnostic practitioners have the ability to prescribe vitamins and minerals as part of their current scope of practice. However, why should a homeopath, for example, be entitled to prescribe Unani medicines without the proper education and training? The same could be said of all other healthcare professionals using discipline-specific medicines that are not from their discipline, as they would not have the requisite education and training to do so. And if they did, they could then most certainly register in that profession and make use of them.”

“Not all of the medicines that our practitioners use would be subject to registration,” said Wright. “Many prescriptions could be extemporaneously compounded by practitioners with a valid compounding and dispensing licence.”

Whether the medicines practitioners currently use will continue to be available is a vexed issue, with many questions unanswered. While the regulations appear to protect the remedies used by the AHCPSA professionals, as most fall into Category D (Complementary Medicines), these products are also difficult to register, said an industry insider who is well-acquainted with the registration process.

For example, the Common Technical Document (CTD) is just as difficult to complete for Category D as for Category A. Consultants helping companies register their products are charging high fees, with no guarantees their products will be registered. One company is considering closing down. Others are downscaling as they wait for clarity.

Pay R160,000.00 to register one product

To illustrate the difficulty: One company was quoted R160 000.00 by a consultant to help register one product. They estimated it would take 55 000 hours to complete the forms. The company would be looking at R40-million just to attempt to register products, most of which fall into ‘Category A’, with no one able to say what chances they have at success. These are products that are registered in Australia.

“Practitioners are beginning to realize there is a big problem,” said one industry source “and are unsure where they stand.”
They are also reluctant to speak out, said one practitioner, who is also afraid to use his name, as Dr Mullinder has, in a letter to practitioners, said “registered practitioners and therapists should be aware that any support for contrary positions would be in direct contradiction to the AHPCSA’s position”.

Despite the concern expressed by the industry and practitioners, Dr Wright says: “I am sure that our practitioners would like guaranteed high quality, safe and effective medicines. We would urge companies to comply with the Regulations in order for the professions and the public to have better CMs in SA.”

Dr Wright differs with others on how combination products (which make up about 65% of the natural products market) will be registered. These are products containing, for example, herbs, vitamins and minerals together. Some may include Chinese herbs, with probiotics and an extract such as Curcumin. “It has become very clear to us that many, many people have not read the QSE Guideline that was published alongside the Regulations by the MCC,” he said.

Make medical claims – into the drug category you go

The QSE Guidelines he refers to, (clauses not relevant have been omitted) state that in the case of combination products:

• applicants will need to demonstrate explicit, cogent philosophies of use amongst all ingredients or will be referred for Category A registration;
• where vitamins, minerals or other substances of food origin are included in a combination product … and where such items fall below prescribed maximum food levels and provided that no medicinal claim is made, CM registration will be permitted, and
• where classified foods further purport to make medical claims or are above prescribed maximum food levels, these products will be referred for Category A registration.

However, companies trying to register combination products point out that most of them do in effect fall into ‘Category A’. For example, a product formulated to support liver function is considered to be making a “medicinal claim”, and would therefore be a ‘Category A’ medicine. Combining a Chinese herb with an extract such as Curcumin, would not fall under “cogent philosophies of use.”

Should these products not be registered by the MCC (because of the onerous and costly requirements for registration), many products Allied practitioners need for their patients will not be available.

Combination products remain a mystery

There are some important questions around regulations on combination products: The relevant section on combination products was added to the 2011 regulations and QSE (Quality, Safety and Efficacy) document, without any public or industry input. The AHPCSA did not comment on them before they were passed.

“I believe that the AHPCSA made comment during the 2011 public commentary period,” says Dr Wright. “We have not been specially consulted otherwise, except subsequent to promulgation of the Regulations. We are currently seeking clarifications from the MCC on a number of points, but this is not the forum to raise them. Any further detail you may require on Combination Medicines should be addressed to the MCC.”

The new regulations raise complex issues, not only for the Allied Health Practitioners, but also consumers, doctors and the wider health industry.

The regulations themselves are not the only issue and the devil seems to be in the detail: It is what is done with them, and at this stage, there are more questions than answers.

• Download the full regulations here.

Definition of a Complementary Medicine, from the Government Gazette November 15 2013:

“Complementary medicine” means any substance or mixture of substances that-
(a) originates from plants, minerals or animals;
(b) is used or intended to be used for, or manufactured or sold for use in assisting the innate healing power of a human being or animal to mitigate, modify, alleviate or prevent illness or the symptoms thereof or abnormal physical or mental state; and
(c) is used in accordance with the practice of the professions regulated under the Allied Health Professions Act, 1982 (Act No. 63 of 1982).”

If you did not see our previous story on this, here is the link.

By Jeanne Viall