COMMENTS ON THE MEDICINES AND RELATED SUBSTANCES
CONTROL AMENDMENT BILL, 2002, PUBLISHED INITIALLY AS
GENERAL NOTICE NO.763 ON 22 MAY 2002 AND SUBSEQUENTLY
PUBLISHED AS GOVERNMENT NOTICE
NO.23684 ON 29 JULY 2002 IN THE GOVERNMENT GAZETTE


In view of the invitation by the Parliamentary Portfolio Committee on Health to submit comments and representations on the Medicines and Related Substances Control Amendment Bill, 2002, the Medical and Dental Professions Board of the Health Professions Council, established in terms of the Health Professions Act, 1974 (Act No.56 of 1974) wishes to comment as set out herein.

COMMENTS

1. SECTION 1 OF THE PRINCIPAL ACT
a. Definition: "medical Act" : The Health Professions Act, 1974 (Act No.
56 of 1974), covers a wide range of health professions and is not
limited to "medical" or "medicine" or "medical practitioners" only. It is
recommended, therefore, that the definition be changed to refer to the
relevant Act by means of its official short title in order to prevent any
possible interpretation problems, i.e. the Health Professions Act, 1974.
b. Definition: "medical devices": According to the Bill of 29 July 2002,
the definition of "medical devices" is to be deleted. Although the Board
may not be fully informed of the reasons for the proposed deletion of
that definition, the Board, nevertheless, believes that -

I. the said definition is essential to ensure that medical devices which are on sale to the public on the open market are appropriately tested, approved and controlled;

ii.such testing, approval and control of medical devices is essential for the protection of patients who, in their physical and emotional plight, may be exposed and fall prey to low quality, unwarranted or exceptionally high costs, unreliable and even dangerous devices which are said or alleged to assist in their cure or the relief of their condition or the symptoms thereof.


In view of the above, it is recommended that -

aa. that definition be retained somewhere in the relevant health care legislation;
bb. the control function over medical devices be retained by an appropriately qualified authority;
c. Definition: "medical practitioner": In the definition referred to in Act No.90 of 1997, reference is also made to an "intern registered under the Act". The Act and some Regulations made under Act No.56 of 1974, in fact, refer to interns in different professions, such as in psychology, biomedical engineering, genetic counselling and medical physics. It is recommended, therefore, that the definition should specifically refer to "interns in medicine".
d. Definition: "practitioner": Given the fact that various pieces of legislation refer to a practitioner in a much more wider sense than a specific professional category, it is proposed that the expression "practitioner" be utilized in its wider context to include all other health care practitioners whose regulation may and does fall beyond the jurisdiction of the Allied Health Professions Act, in order to avoid such definition unduly limiting the intended scope of application of the Act.

2. SECTION 3 OF THE PRINCIPAL ACT

In Act No. 90 of 1997 provision is made for replacement of the provision which specifies the composition of the Medicines Control Council. It is the Board's submission that the said Council needs to be constituted by experts in different professions and fields of practice relevant to the issues regulated by the envisaged Amendments in order for such experts to consider vital matters and issues which have or may have a profound impact on the health and health care of the total population of South Africa. It is recommended, therefore, that the membership of the Council be specifically incorporated to include such categories of experts as may be relevant to advance the interests of health care and safety of the population. It is indeed the submission of the MedicaI and Dental Professions Board, that such categories of experts may include, but not be limited to, pharmacology, pharmacy and medicine.

3. SECTION 6 OF THE PRINCIPAL ACT

In line with the recommendation in (2) above, it is recommended that a similar principle be applied in terms of filling vacancies that may occur during the course of the term of office

4. PROPOSED SECTION 22C OF THE PRINCIPAL ACT

a. Although not specifically mentioned in the Bill, the Board is aware that the principles listed hereunder may be a subject of regulations flowing from this Bill and in this regard, the Board wishes to submit its support of the said principles, namely, that -the medical practitioners and dentists should, only be entitled to
dispensing medicines and relevant substances, subject to specified conditions;

there is a need for the licensing of persons to dispense medicines and related substances;

III. dispensing persons (practitioners) should be appropriately recorded in a "register" and that such registration should be subject to specific conditions;

iv. one of the conditions for licensing and registration should be possession of sufficient knowledge base of medicines and of dispensing practices;

v. the issued license and registration should be withdrawn or suspended if the person concerned does not or no longer complies with the prescribed conditions or makes himself or herself guilty of unprofessional conduct in executing his or her dispensing responsibilities; and

vii.
if a licensed and registered person becomes impaired (as defined in Act No.56 of 1974), as a result of the abuse of or dependence on scheduled medicines or related substances, his or her license or registration might have to be withdrawn or suspended.
b. While supporting the issues and views raised above, the Board wishes to submit to the honourable members of the Portfolio Committee that -

i. the Health Professions Act, 1974, already provides in section 52 for the dispensing of medicines by medical practitioners and dentists and equally provides that dispensing medical practitioners and dentists be recorded and registered. That section reads as follows:

"52. (1) (a) Every medical practitioner or dentist whose name has been entered in the register contemplated in subsection (2) shall, on such conditions as the council (the Health Professions Council of South Africa or its Medical and Dental Professions Board) may determine in general or in a particular case, be entitled to personally compound or dispense medicines prescribed by himself or by any other medical practitioner or dentist with whom he is in partnership or with whom he is associated as principal or assistant or locum tenens, for use by a patient under treatment of such medical practitioner or dentist or of such other medical practitioner or dentist: Provided that he shall not be entitled to keep an open shop or pharmacy.

"(b) The council may, on such conditions as it may determine, exempt any medical practitioner or dentist from the requirement of registration contemplated in paragraph (a), and may, after an investigation, withdraw such exemption.

"(2) The registrar shall keep a register in which he shall enter, at the direction of the council, the name and such other particulars as the council may determine of a medical practitioner or dentist -

"(a) ; or

"(b) who informs the registrar in the prescribed manner of his intention to compound or dispense medicine in the practice of his profession as contemplated in subsection (1) (a).

"(3) The council may, after an investigation, direct that the name of any person be removed from the register contemplated in subsection (2), or prohibit him for a specified period from making use of the right contemplated in subsection (1).

"(4).".

the Health Professions Act, 1974, provides in section 18 for the establishment of registers of medical practitioners and dentists, as well as for a large number of registers for other professions (i.e. a total of some 85 separate registers are being kept under the said Act);

iii. details of registered and dispensing medical practitioners and dentists are already recorded and have been so recorded since 1984 when the compulsory registration of dispensing medical practitioners and dentists was first provided for;

iv. as specified above, the said section of the Act also provides in subsection (3) for the possibility of the withdrawal of such license and registration after due investigation;

v. the prescribing of conditions regarded by the Board to be a as section 52 of Act No.56 of Council or Board established to profession(s) (in this case the Board);
for licensing and registration is strictly professional matter which, 1974 provides, belongs with the regulate and control the relevant Medical and Dental Professions

vi. the medical and dental professions, in particular, has over many years been involved in and responsible for managing ill to critically ill patients which, amongst others, was and is based on knowledge of the use, effects, side effects and dosages, etc. of medicines and related substances;

vii the study of Pharmacology is part and parcel of the education and training of medical practitioners and dentists and will become even more so in the new and integrated curricula which are in the process of being implemented by all schools of medicine and dentistry;

c. In view of the above considerations, it is recommended that :-

the possible interpretation problems that could arise from the provisions of S52 of the Health Professions Act, 1974 read with the envisaged propositions in the Bill, be addressed by the Portfo!io Committee in order to eliminate any possible contradictions;

ii .the determination of the supplementary course and the regulation of its completion be made the responsibility of the Board and/or Council in relation to medical and dental practitioners which structures already have that responsibility and expertise. It is recommended, contrary to the proposed amendment, that the South African Pharmacy Council rather be consulted by the Board in the determination of the supplementary course and its management than the other way round.

5. PROPOSED SECTION 22E OF THE PRINCIPAL ACT

In view of the comments made in regard to the proposed section 22C, the Board submits that it should follow that the provisions of the proposed section 22E be revised in order to eliminate any possible conflict or contradiction between the powers already vested with the Board in terms of Chapter IV of the Health Professions Act, 1974 (for dealing with any form of unprofessional conduct) and the powers vested in the Director-General in terms of S22E.


6. PROPOSED SECTION 22F OF THE PRINCIPAL ACT

a. The contents of the proposed section 22F is being noted, especially also the contents of subsection (4). It should be recorded, however, that the person prescribing any medicines or related substances, is doing so on the basis of a clinical examination of the patient, based on his or her scientific and professional knowledge, observations and clinical findings. Furthermore, the person issuing the prescription in question personally accepts professional responsibility for his or her actions which he or she would have to defend should such actions -including the prescription of medicine - be found to be inappropriate or professionally unjustified.

b. By making provision for substitution of a branded medicine by an interchangeable multi-source medicine, the issues of professional responsibility and legal liability must be raised as essential elements in assuming such responsibility on the part of a pharmacist, unless proper consultation between the prescriber and the pharmacist has taken place. Obviously, such consultations could and should take place, while adhering to the principle of professional responsibility and legal liability.
c. Thus the Medical and Dental Professions Board acknowledges the role of the pharmacist to assist the medical practitioner or dentist with advice, by recommending substitution or even recommending on a proposed different approach to medication. Such advice or recommendation should, in the Board's view, however, always be discussed with the prescriber who should retain the professional right and responsibility to accept or reject such advice or recommendation.

d. The provision that the patient himself or herself may forbid such substitution, does not at all safeguard the public in general as very few patients would have any or sufficient knowledge to justifiably make a decision to forbid substitution.

e. The fact that the patient's forbidding of substitution is to be recorded on the prescription, certainly will have specific implications for him or her, especially in relation to his or her own legal liability in the case of unforeseen results and in terms of medical aid payments. The responsibility for such a decision cannot justly be placed at the door of more than a very select few of the total population.

f. It is recommended, therefore, that a pharmacist only be permitted to substitute after consultation and agreement with and by the prescriber.


DrC M Kruger
Dr S M Dhlomo
Adv. B M Mkhize
Mr H L Rode

16 September 2002