The South African Pharmacy Council
Die Suid-Afrikaanse Aptekersraad
The Chairman
Parliamentary Portfolio Committee of Health
Parliament CAPE TOWN
Dear Sir
COMMENT ON MEDICINES AND RELATED SUBSTANCES AMENDMENT BILL, 2002 [B40-2002]
The Minister of Health is congratulated and supported in her efforts to ensure better medicines control and more affordable medicine in South Africa. The publication of this Bill (B40-2002) will go a long way towards supporting these efforts to the benefit of the general public, health institutions, as well as health care professionals. One piece of legislation dealing with all matters relating to medicine is long overdue and the South African Pharmacy Council as the governing body for all pharmacists, pharmacist's assistants and pharmacies will in line with its vision, namely to ensure that pharmaceutical services are the best to meet the health care needs of the people, support all appropriate actions to bring about safe systems relating to medicines control, the availability of medicine which is safe, of good quality and efficacious and to ensure safety for patients in the use of such medicine.
Comment is provided as deemed necessary for purposes of inter a/ia the execution of the activities of the South African Pharmacy Council. Comment has thus not been provided on all sections of the Bill in question, but only with reference to the following Sections of the Bill, 2002 [B40-2002].
Section 1
(a) It is proposed that the term "pharmaceutical industry" also be defined as this term (concept) is used often in the contents of the Bill and could have different meaning(s) to different stakeholders. For example, does "pharmaceutical industry" refer to pharmaceutical manufacturers only or does it include pharmaceutical wholesalers/distributors and/or other categories of pharmacies registered in terms of the Pharmacy Act 53 of 1974, as amended?
(b) It is proposed further that the terms "manufacturer", "wholesale dealer" and "distributor" be defined. One way of doing this is to, for example,
define a "manufacturer" as a manufacturing pharmacy registered as such under the Pharmacy Act, 1974. The same could apply to "wholesale dealer" and "distributor". Refer, for example, the definitions of pharmacist intern and pharmacist in Act 10111965, as amended. This approach would prevent any ambiguities in the future.
(c) The terms "compounding" and "dispensing" must also be defined. Draft definitions can be provided, if required. Definitions should, however, be in line with the provisions of the Pharmacy Act 53 of 1974, as amended.
Section 5(i)
A pharmacist must retain a prescription after the dispensing of any Schedule 3, Schedule 4, Schedule 5 or Schedule 6 substance. The patient will be in possession of the medicines concerned but not the prescription. This subsection thus needs to be redrafted to make provision for medicines which are in the possession of patients, after such medicines have been dispensed by pharmacists or other authorised persons in accordance with a prescription issued to the patient.
It is thus proposed that the new Section 5(i) should rather read: 'any person may possess a Schedule 3, Schedule 4, Schedule 5 [,] or Schedule 6 [or Schedule 7] substance if supplied to him or her upon a prescription issued by an authorised prescriber".
Section 6
Section 6(b): Dispensing course
The two acts of "compounding" and "dispensing" which both specially pertain to the profession of a pharmacist are very different in nature, requiring different skills and knowledge, as well as supplementary courses. In terms of the amended Section 22C(2), a supplementary course must be determined by the South African Pharmacy Council. The section fails, however, to say WHAT "supplementary course" should be determined, and leaves it to the reader to assume that it should be a supplementary course in "compounding" and/or "dispensing". In a worse case scenario, it could be any supplementary course, as long as it was "determined" by the South African Pharmacy Council (SAPC) (refer also Annexure 3).
The section in question also fails to describe HOW compliance with minimum standards will be ensured. Once the SAPC has determined a supplementary course, WHO will provide such a course(s) and WHO will assure quality of the contents of the course?
The following amendment to remedy the situation could thus be proposed, viz:
(2) A licence referred to in subsection (1) (a) shall not be issued unless the applicant has successfully comDleted a suDDlementarv course [prescribed under the Pharmacy Act, 1974 (Act No.53 of 1974), by the Interim Pharmacy Council of South Africa] in compounding ordisensing basedon unitstandards as determined by the South African Pharmacy Councilafterconsultation with the Health Professions Council ofSouth Africa, the Allied Health Professions Council of South Africa and the South African Nursing Council. and such supplementary course complies with the minimum criteria for the approval of providers and courses as determinedand publishedbythe South African Pharmacy Council"
The above-mentioned amendment will bring the section in line with SAQA requirements and provide for quality assurance of the courses in question.
Section 6(e): Commencement of Section
Act 90/1997 does not make provision for different sections of the Act to come into operation on different dates.
Section 8
The matter of a Pricing Committee determining a fixed appropriate (what is appropriate?) dispensing fee for pharmacists and/or wholesalers, needs to be reconsidered. The SAPC is authorised in terms of Section 35A of the Pharmacy Act 53 of 1974, as amended, to make rules as to the services for which a pharmacist may levy a fee and guidelines for levying such a fee or fees. There could thus be a conflict between the two pieces of legislation. Furthermore, the Competition Commission has thus far been adamant that dispensing/professional fees may not be determined by way of regulations, but should be a negotiated fee. - Is Section 22G thus in line with the provisions of the Competitions Act? (refer also Annexure 2).
Section 9 (f)
It is unclear and not advisable that the Director-General and the Minister as the persons responsible for policy and the ensuing drafting and publication of the appropriate legislation should also sit in sole judgement of an appeal against a decision taken in terms of the same legislation. Will such a situation promote administrative justice? There is also no further remedy available to any aggrieved person other than to take the Minister or the Director-General to court.
The following annexures are included for further information, viz:
Annexure 1: Minutes of meeting with Medical and Dental Professions Board;
Annexure 2: Report on a meeting with the Competition Commission;
Annexure 3: Unit standards for entry level pharmacists regarding manufacturing, compounding and pre-packing of pharmaceutical products
The opportunity to comment on this very important Bill is appreciated.