Chairperson, members of the Portfolio Committee, thank you for the opportunity to present the views of the South African Association of Hospital and Institutional Pharmacists (SAAHIP) regarding the South African Medicines and Medical Devices Regulatory Authority (SAMMDRA) Bill (B72-97) currently before your committee. May I also, once more introduce the association on whose behalf I speak today. We represent more than 800 pharmacists who practise in the hospital and institutional setting, in both the public and private sectors. We feel that we are able to bring to your attention the potential effects of the legislation under consideration, not only in the private sector, but perhaps more critically in the public sector. The fact remains that the vast majority of the population relies directly and solely on the state for the provision of health care. We particularly wish to bring to your attention the effects of such legislation on the professional activities of the pharmacists who cater for the drug-related needs of this majority of our citizens. In making this submission we would like to record the following:

1. Our difficulty in interpreting the implications of many of the proposed legislation, given that the Bill is directly linked to the Medicines and Related Substances Control Amendment Act, No 90 of 1997. This Act, which shares many clauses with the SAMMDRA Bill, has been held up by a court action of which you are no doubt aware. However, given that the SAMMDRA Bill repeals the substantive Act which Act 90 was designed to amend, we have sought guidance from the Department of Health on its impact on the legislative programme which sought to give effect to many of the policy directives of the National Drug Policy. To date we have not been able to obtain such clarity. It is therefore hoped that between submission of this written comment and the public hearings, such clarity can be provided by the State.
2. That we have restricted our submission largely to the issue of orthodox medicines or the effect of sections on the control of such medicines. As a group we have limited contact with and knowledge of other forms of medicine and medical devices. However, we also noted with concern that the Review Panel Report (of which this legislation is the logical conclusion) did not give clear guidance on the regulation of medical devices.
3. That in preparing this submission we have been guided by the following documentation; it is our belief that this documentation forms a unit, and should be considered as such:

• The National Drug Policy
• The Report of the Review Panel on Medicines Regulation, presented to the Minister of Health on 24 March 1998, entitled "The Medicines Regulatory System in South Africa: Review and Proposals for Reform" (this will be referred to as the Review Panel Report)
• The Report of the Medicines Regulatory Authority Transformation Task Team, presented to the Minister of Health on 17 July 1998, which served as part of the brief to the drafters of this Bill (referred to as the TTT Report)
• The Pharmacy Amendment Act (Act No 88 of 1997)
• The draft Regulations to accompany Act 88 of 1997, submitted to the Minister of Health by the Interim Pharmacy Council of South Africa on 20 July 1998, but as yet not published for comment in the Government Gazette
• The Medicines and Related Substances Control Amendment Act (Act No 90 of 1997)

This submission will follow the section numbering of the Bill.

As will be more fully motivated elsewhere in our submission, we feel that the list of definitions is incomplete. Some of the definitions are identical to those that we accepted in Act 90 of 1997. However, we would argue that definitions are needed for the terms:

• "policy"
• "manufacture" (defined in a very broad sense in the General Regulations to the current Act)
• "administer"
• "issue" (as opposed to "sell")
• "dispense"
• "substantial financial interest"
• "business partner"

The definition of "adverse drug events" is clear, but the second sentence of this sub-section does not make scientific sense. It is an indication of the managerial arrangement (as per the TTT Report) for the activities listed, and should not be taken to imply the broadening of the term to include such aspects as drug utilisation studies.

A basic requirement for the operation of this piece of legislation will be the ability to differentiate between an orthodox, a complementary and a veterinary medicine. While the last term is self-explanatory, the exact nature of complementary medicine is not clear. We note that orthodox medicine is, in essence, defined as being "not complementary". It would appear that a claim to complementary status would depend on listing in some other unstated schedule. The TTT Report mentions a Listing prepared by the Complementary Medicines Committee of the MCC. The status of this system is not defined in the Bill, nor is the process for allocation of an application to one or other category. The TTT Report also mentions the possibility of there being applications for registration of complementary veterinary medicines. It also distinguishes between the areas on the basis of the whether or not the applicant makes a medicinal claim for the substance or product. If this is to be the defining characteristic, then the exact nature of "medicinal claim" needs definition. We would refer the Committee to the recent Supreme Court ruling of Justice de Villiers, which dealt with the definition of a "medicine", and which supported the definition as included in the current Act 101.

In the definition of the word "sell", we note the misspelling of the word "consign".

It is noted that section 1(2) of Act 101 is not repeated in the Bill. While it could be argued that section 26(1) of the Bill, which prohibits the sale of non-registered medicines, is sufficient to prevent the entry of such products into the South African market, the inclusion of section 1(2) in 1979 was precisely to prevent parallel importation. This was amended by section 1(j) of Act 90 of 1997, by the addition of the words "subject to section 15C". While this cannot, for obvious reasons, be included here, the omission of section 1(2) might be construed as allowing unfettered access to parallel importation. The 1979 ruling of Justice Kriegler in the Cape Division of the Supreme Court should be consulted in this regard.

Section 26(1) introduces a number of terms that need definition if their various meanings are to be subject to effective control. These are:

• "manufacture"
• "package"
• "distribute"
• "market"
• "sell"

While the import of "distribute" and "market" may not be apparent from this Bill, their meaning is crucial if the restrictions of wholesale activity and the marketing code of conduct which were introduced in Act 90 of 1997 are to take effect.

As with section 26, this section seems to introduce a list of terms that beg definition. These are:

• "manufacture"
• "sell"
• "administer"
• "prescribe"
• "dispense"

The entire construct used in this section is problematic. In our submission to this Committee late last year we used the term "dog’s breakfast" to describe what was then to be section 22A of Act 101. It would seem that little of the constructive advice given in those hearings has been heeded, and we therefore find ourselves again pointing out the same problems in this section.

In providing comment on this section we would like to repeat the general comments we offered in 1997. We stated:

Different schedules are dealt with in haphazard order and no indication has been given in the Memorandum of Objects of the Bill as to the logic which has guided the specific restrictions placed on the handling of the schedules. SAAHIP wishes first to restate some of the basic approaches we would like to see guide this area of the Act:

• SAAHIP believes that a category of medicines (unscheduled at present, perhaps the envisaged Schedule 0) should be available in open shops. This group should however preclude medicines with potentially harmful effects, for example in the event of inadvertent overdose. This logic informed the recent rescheduling of certain paracetamol formulations and pack sizes.
• SAAHIP believes that a further category of medicines should be available without prescription, but only from a pharmacist (not a pharmacy). This presupposes the right of the pharmacist to prescribe such medicines (and this terminology is important if such pharmacist-initiated or pharmacist-assisted therapy is to be covered by Medical Aids). This category should include at least all the medicines currently listed in Schedule 2 of the Act. Considerable effort has been expended in recent years in the rescheduling of medicines such as the anti-ulcer agents (H2-blockers), certain antifungals, and certain anti-inflammatories to allow non-prescription access for or under specified conditions. This process should not be scuppered unnecessarily by this Bill
• SAAHIP accepts that a gradation of control over the prescribed medicines should occur. This gradation should take the form of increasing control over quantities, over the ease of obtaining repeat prescriptions, over the details specified on the prescription, and over the time the prescription remains valid. The number of gradations required deserves some close attention. Far simpler systems seem adequate in countries such as Britain, yet we persist with a myriad of regulations and fine distinctions.
• Finally, SAAHIP concedes that certain circumstances would permit the supply of medicines usually denied to the public under particularly strict conditions (as in the present Schedule 9).

Having made those points, SAAHIP wishes to express the following opinions, always tempered by the fact that no indication has been given of how the proposed schedules will differ from those presently in force. In addition, while mention is made in section 32(1) of the application of this section to all categories of medicine (orthodox, complementary and veterinary), how these relate to the concept of a "scheduled substance" is not stated. In the TTT Report, mention is made of only three gradations of control over complementary medicines (these being "open sale", "pharmacy only" and "practitioner only"). However, in section 32(2) and onward, the impression is given that the system will apply only to orthodox and veterinary medicines. The balance of our comment will assume this to be the case.

The definition of "authorised prescriber" (in section 32(17)(a)) is needlessly firm, and ignores the express injunction of the National Drug Policy to accommodate extremes of need. For example, the NDP envisages that prescribing by pharmacists of drugs above Schedule 2 (the current schedule 2 that is) will be permitted in terms of specific regulations. While SAAHIP does not believe that the current manner in which section 22A(12) permits are issued is defendable, we would argue for the retention of an exclusion clause such as the proposed section 32(15). Cognisance must be taken of innovative access-enhancing distribution strategies employed in other countries, such as community-based distribution of contraceptives, community health worker-led vaccination campaigns and, in this country, the pilot studies involving pharmacist-prescribed oral contraceptives and vaccines. Further it is noted that the manner in which assessment of the competence of those members of the professions being added to the list is done is left unstated, and is in fact delegated entirely to the professional councils involved (vide section 32(14)(b)). This section is in fact a good example of the problems of applying a construct designed exclusively for orthodox medicines to the entire gamut of scheduled substances. In effect, it gives all medical practitioners and dentists unfettered access to all complementary medicines, despite their patent lack of training in the philosophies underpinning the use of these products. We would call for a separate section to control access to these products, along the lines suggested in the TTT Report.

We note the return of the age limit on the sale of over-the-counter medicines (Schedule 1 and 2), as suggested in our prior submission and welcome the need for adequate documentation of their sale.

We welcome the limit placed on the number of repeats allowable in terms of Schedule 2 to 4 prescriptions, and would argue that this is clinically defensible. Equally the retention of the restriction on the intervals between repeats of Schedule 5 medicines is also supported. In section 32(5)(f)(ii) we note that the word "only" has been omitted after the phrase "in subparagraph (i)". Section 32(6)(h) provides some interesting problems. While the need to exercise greater control over the misuse and abuse of centrally-acting substances (particularly those with anxiolytic, hypnotic or analgesic properties, but not those intended for antidepressant use) is well recognised, we doubt whether the provisions of this section are implementable. In order to be workable, these provisions presupppose that all patients visit only one prescriber or alternatively only one pharmacy. While well-meaning and ambitious, the fact that a simple avoidance manoeuvre such as changing pharmacy after 6 months or visiting another prescriber and then taking the prescription to another pharmacy, makes a total mockery of this piece of legislation. That is but one of the practical problems - we have yet to consider the cost implications, whether a telephonic consultation is allowed, how that consultation will be made "visible" to the pharmacist who dispenses the prescription, or who bears the responsibility if a patient is found to have obtained a supply of such agents in contravention of the section. We would argue that an educational campaign, aimed at rational use of these agents by both prescribers and patients would be more effective than this sadly flawed attempt at legislative control. Perhaps the answer lies in a mechanism to enforce the restrictions on use of any substance for other than a "medicinal purpose".

We welcome the provision made in section 32(6)(l) for emergency supply by a pharmacist of all Schedule 2 to 4 medicines previously prescribed.

We question the removal of the need for a retail or hospital pharmacist or other dispenser of schedule 6 medicines (as opposed to a manufacturer or wholesaler) to keep a register of all transactions, such register to be balanced as prescribed. This provision currently applies to Schedule 7 substances, and we assume from the details of the proposed section 32 that Schedules 6 and 7 will be combined. We would argue for the retention of this control measure, despite the fact that prescription records of all sales must be kept. The entire concept of prescription records needs careful regulation if the rendering of an effective service in rural and underserved areas is not to be needlessly compromised. For example, section 32(6)(a) makes mention of a "prescription book or other permanent record", required to be kept in the "prescribed manner". This may prove problematic in the case of some primary care facilities, if the narrow interpretation of the current Regulations, which define the "prescribed manner", are retained (Regulation 28 to the Medicines and Related Substances Control Act, Act No 101 of 1965). This Regulation states that certain details are to "entered" into a record, and that such record be retained "at the business premises of the seller for a period of at least three years after the date of the last entry made therein". This is clearly intended for the retail pharmacy arena. In such practices, either a photocopy of the original prescription or a computer record is maintained. However, in State facilities, the original prescription is usually written on either a facility-retained or a patient-retained medical record. In the former case, this record is stored in the Medical Records section, and is thus accessible to the pharmacy personnel. If a prescription needs to be traced, then the patient name and hospital number can be used to locate the file. In the case of a patient-retained record (as is used in many primary care clinics), the details are also recorded in a so-called "tick register", a statistical record of all patients seen, procedures performed and treatment issued. This record is retained in the clinic, but not in the pharmacy. This eventuality needs to be explicitly catered for in the legislation if unnecessary bureaucratic measures are to be avoided.

Section 32(16)(b) allows for the indirect supervision of pharmacy support personnel in primary care facilities. However, the section is incomplete, as the exact definition of what constitutes a "primary care clinic or facility" is not included. This has been defined in the draft Regulations to the Pharmacy Act as applicable in the public sector only. This definition should therefore be included in this Bill, or the nature of supervision defined as that given in the Regulations to the Pharmacy Act (once promulgated).

Firstly, it is noted that the Authority is given the right to issue such permits, and not the Director General of Health, as was the case in Act 90 of 1997. We support this change. However, we wish to draw the attention of the members of the Committee to the fact that, in the vast majority of primary care facilities around the country, dispensing of medicine to patients will be performed by nurses, at least for the foreseeable future. The application of section 34 will therefore entail the licensing of a large number of nursing staff. It might be profitable to draw a distinction between the act of dispensing in this arena and the complete act (of dispensing and compounding) which is perhaps envisaged in a private medical practitioner’s practice. In a state-operated primary care setting, medicines are restricted to the primary level Essential Drugs List. Central pharmaceutical stores may make such medicines available in patient-ready packs. If the nurse is to be trained to use the Standard Treatment Protocols which accompany the Essential Drugs List, then the additional skills needed to safely dispense such medication (when pre-packaged and labelled) will be largely restricted to effective counselling, storage and control, ancillary labelling and legal considerations (such as record keeping). This should be contrasted with the skills needed by a practitioner who wishes to keep a full range of medicines, might wish to compound extemporaneously, and needs to consider the rationality of a prescription without the assistance of a formulary. The feasibility of section 34(7) must therefore be questioned. The sheer number of nurses who will need to complete the dispensing course prescribed by the Pharmacy Council, the costs (in time and money), and the effect on service delivery in already underserved and understaffed areas needs to be taken into account.

Supported. The misgivings expressed under section 50 should be noted.

In conclusion therefore, Chairperson and members of the committee, SAAHIP wishes to thank you once again for the opportunity to point out the technical problems we have with this piece of legislation, and trusts that the inputs we have given will be considered favourably. We believe that the amendments suggested by SAAHIP offer a way forward for the portfolio committee in preparing a Bill that would be suitable to submit to the National Assembly. Each time we come to these hearings the question is posed: should this legislation be passed in amended form or rejected out of hand? We would submit that the Bill before you represents an attempt to put in practice many of the policy directives of the National Drug Policy. That the Review Panel on the MCC was constituted after Act 90 of 1997 was passed is perhaps unfortunate, but should not be used to further frustrate a process which has already been delayed inordinately. What we do seek, however, is the assurance that this Bill, if passed, will not unduly complicate the application of Act 90, as that Act contains even more of the legislative backing which the National Drug Policy demands. To mention but one, this Bill is silent on the question of generic substitution. Legislative measures such as this, already accepted by Parliament and signed into law by the President, are urgently needed if we are to make the advances so bravely signposted by the NDP.

I thank you.