Posted 23 October 2011
Law in Practice: Complementary and Alternative Medicines Regulations: Are All Medicines Now Equal?
By Elsabe Klink: Medical Chronicle
October 10, 2011
In July 2011, the Minister of Health published, on the advice of the Medicines Control Council (MCC), draft regulations on complementary and alternative medicines (CAMs). Unlike previous versions of drafts aiming to regulate CAMs, this draft version is an amendment to the 2003 General Regulations on Medicines, thereby bringing complementary medicine into the realm of the general definition of ‘medicines’. Amendments other than those relating to complementary medicines are also proposed in the draft.
A month later, the MCC released the guideline that will be used during the evaluation process prior to registration of a complementary medicine, with a deadline for comment a month earlier than that of the regulations. This means that the implementation guideline would be considered prior to the empowering legislative changes.
The inclusion of complementary medicine within the ambit of the Medicines and Related Substances Act, Act No 101 of 1965 (Medicines Act) and the General Regulations mean that CAMs are, in general, to be dealt with in the same manner as allopathic medicine, i.e. the same -criteria as found in the Medicines Act apply in terms of registration, labeling, manufacturer -licensing, pricing, the prohibitions on ‘bonusing’, sampling, etc.
Who can prescribe?
One major difference between allopathic and complementary medicines in the proposed new regulatory framework is that the latter appears to be linked intrinsically to the practice of professions governed by the Allied Health Professions Act, Act No 63 of 1982. This appears to indicate that complementary medicine can only be prescribed by, or recommended by, such healthcare professionals, and within the scope of such professionals. Professionals registered under the Allied Health Professionals Act include the professions of -ayurveda, Chinese medicine and acupuncture, chiropractic, homeopathy, naturopathy, os-te-o-pathy, phytotherapy, therapeutic aroma-therapy, massage therapy or therapeutic reflexology. The reality is, however, that many complementary medicines are prescribed or recommended by healthcare professionals registered under the Health Professions Act, Act No 56 of 1974, and the Pharmacy Act, Act No 53 of 1974. A further implication appears to be that traditional medicines are excluded, as traditional health practitioners are to be registered under the Traditional Health Practitioners Act, Act No 35 of 2004.
Some herbal medicines may not be used by any of the listed disciplines, and could then, unless an allied profession is so designated, not be regarded as a complementary medicine. As far as the disciplines are concerned, draft regulation 25A proposes that these be established by the MCC after consultation with the Allied Health Professions Council of SA. This means that the disciplines may go beyond those listed in the Allied Health Professions Act, or could even be added by the MCC in their own view – the only criteria would be that the MCC would have had to consult with the Allied Health Professions Council before subdividing into any new discipline.
Label information and package inserts
Pursuant to this link with the allied professions, the proposed amendment to Regulation 8, labeling, requires that a label include, in the case of complementary medicine, the discipline of the medicine and the phrase ‘use according to the principles of the discipline’.
Complementary medicines sold in patient-ready packs by a pharmacist, a person authorised to compound and dispense, or in a hospital pharmacy, also have to state the discipline of the medicine.
Similar amendments are proposed for package inserts (Regulation 9).
This means that the package insert of a complementary medicine has to contain exactly the same information as that of an allopathic medicine and add the discipline and ‘use according to’ statement.
Similar amendments (on the allied health disciplines) are proposed for Regulations 22 (registration application), 23 (information on the medicines register), 26 (certificate of registration) and 48 (labeling of veterinary medicine).
Regulation 10 deals with the patient information leaflet (PIL) and could be amended to harmonise with the Consumer Protection Act’s requirements of plain language information (including risk information).
The amendment proposes that the PIL should also include the following statements:
- Patients should advise their healthcare professionals if they are taking any other medication.
- Patients should consult their doctor, pharmacist or other healthcare professional if they are pregnant or breastfeeding.
- Not all side effects are listed on the PIL, and if a patient’s general health worsens or if they experience any ‘untoward’ effects while taking the medicine, they should consult their healthcare professional.
Scope of practice
Regulation 18 (on dispensing by non-pharmacists) is proposed to be amended to add the following phrase: ‘to dispense or compound and dispense medicine within his or her scope of practice’. This may open the dispensing licence arena to scopes of practice where such dispensing is ordinarily part of the person’s scope of practice. Not only would it cover dispensing by allied health practitioners – possibly occupational health practitioners and clinical trial investigators might now also be included.
Regulation 25 is to be amended to include a new category of medicines:
‘Category D, complementary medicines intended for use in humans and animals which are, without further manipulation, ready for administration, including packaged preparations where only a vehicle is added to the effective medicine’.
Complementary medicines therefore include both those used in humans and in animals. These products would have to fit within the previously listed pharmacological classifications, as found in the General Regulations.
Regulation 32 is amended to include the right of inspectors to seize medicines that are misbranded or ‘adulterated’.
What is absent in the draft regulations on complementary medicine is a mechanism whereby consumers can differentiate between the levels of evidence that underpin such medicines. For example, not all complementary medicines are only underpinned by principles of established use through tradition for example, while others have undergone clinical tests and have proven efficacy. Once again, the requirements of the Consumer Protection Act in terms of honesty on ingredients, the nature or purpose of the medicine, that it is generally intended to fulfill a specified purpose, etc. can be used to ensure alignment between the two legislative regimens.
Advertising of CAMs
The draft regulations are also silent on the claims that can be made in relation to the various levels of scientific evidence that underpin a particular product. Related to this, the advertisement of complementary medicines is also not properly regulated, i.e. what can a product claim to be, and to do. This has been identified as an area of concern and has been the subject of numerous advertising complaints at bodies such as the Advertising Standards Authority. Guidance through regulatory reform would be have been extremely helpful in ensuring that consumers are informed, as is required by the Consumer Protection Act.
It is also not clear how complementary medicines will be scheduled. The draft guideline (issued by the MCC on complementary medicine) states that complementary medicine can be scheduled as zero, one, two or three, i.e. it will be dealt with exactly as allopathic medicines.
Amendments proposed, and not related to complementary medicines include, among others, provisions on prescriptions or schedule 6 medicines, record-keeping of schedules two to five, register of importation, exportation and manufacture of specified schedules five and six, etc.
Two new regulations are also proposed, one on the acquisition and use of medicine on ships and aircraft and one on the use of medicine for exhibition purposes, which is now permitted, provided that it is not given out to healthcare providers or the public. It is not clear what the difference is between ‘healthcare providers’ and ‘healthcare professionals’, but the use of a different phrase may be indicative of a different meaning to be attributed to ‘healthcare provider’.
In general, the proposals to regulate complementary medicines are to be welcomed. Dealing with it in a similar fashion to allopathic medicine may however be problematic, and may also raise concerns as to the duration of registration. The application of aspects such as pricing policy to such products is also of concern. The main challenge in relation to complementary medicines, i.e. its promotion and advertisement, appear to also not be adequately regulated.