SAAHIP Submission Medicines and Related Substances Control Amendment Bill

S.A. Association of Hospital and Institutional Pharmacists
S.A. Vereniging van Hospitaal en Inrigtings Aptekers

Address for correspondence regarding this submission

PO Box 70451, Overport, 4067

Submission to the National Assembly Portfolio Committee on Health regarding the Medicines and Related Substances Control Amendment Bill (B72-97)

A: Introduction

Chairperson, members of the Portfolio Committee, thank you once again for the opportunity to present the views of the South African Association of Hospital and Institutional Pharmacists (SAAHIP) regarding the Medicines and Related Substances Amendment Bill (B72-97) currently before your committee. May I also, once more introduce the association on whose behalf I speak today. We represent some 800 pharmacist who practise in the hospital and institutional setting, in both the public and private sectors. Thus in addition to bringing you the views of a substantial sector of the private health market, we can also say with some certainty that we represent the views of those pharmacists who cater directly for the drug-related needs of the majority of the people of this country. This is clear when consideration is given to the fact that the public health sector accounts for between 60 and 70% of the total volume of drugs consumed in this country, while catering for the approximately 80% of the population who have little or no access to private health care.

In making this submission we would like to record the following:

Our difficulty in interpreting the implications of many of the proposed changes, given that the Bill is often worded in enabling language, leaving much of the detail for Regulations. This applies in particular to the sections dealing with the handling of scheduled medicines, as the Schedules to the Act are as yet unseen. Nevertheless, it is SAAHIP’s view that this construction of the Bill is correct, and that a needlessly precriptive and inflexible piece of legislation is not desirable. We further believe that we will be given a chance to contribute to the framing of the Regulations, provided an appropriate process is assured by the wording of this legislation.

That in preparing this submission we have been guided by the following simple heuristic devices: where an object of the Council was specified, we wished to determine whether the general powers of the Council or a specific section of the Bill were in concert with such object. However, given that the description of the objects of the MCC is fairly broad, a more precise indication of the objects of this legislation was taken to be the Cabinet-approved National Drug Policy (NDP). In addition, specific aspects were also measured against the requirements of the Constitution, or emergent legislation in this sphere. Where possible we approached the impacts of the legislation from a public health perspective, but we would have failed our constituency had we not also considered its impact on the material well-being of our members, and in particular their job security and their need for a fulfilling, independent professional life. We wish to reiterate that SAAHIP is committed to the effective implementation of the National Drug Policy, a policy which has been hailed as one of the best examples of its type in the world.

This submission will follow the section numbering of the Amendment Bill.

B: Substantive submission

Section 1

We welcome the change in certain definitions, particularly those for "approved name", and the replacement of the term "generic equivalent" with "interchangeable multi-source medicine", despite its cumbersome nature. However, in the latter definition the concept of "therapeutic equivalence" is introduced. Given the sensitivity of this issue, and the need for council to prescribe standards for attainment of such status, this term perhaps deserves definition in its own right. Further, a number of terms used in the Bill, and mentioned in our previous submission, are still not defined. These include the term "wholesaler" used in the new section 22H. The term manufacture is defined in the General Regulations to the current Act (albeit in a very wide fashion, including for example the act of packing as being analogous to manufacturing), but the term manufacturer could well be defined in the Bill itself, especially as a number of terms are used to describe this entity (see the new section 18C which refers to "pharmaceutical companies"). Potential changes to the Pharmacy Act (as tabled in Bill 69-97) might also complicate the definition of applicant (as included in General Regulation 2 to the principal Act).

The new section 1(2) is clearly in concert with the proposals of the National Drug Policy, as far as allowing parallel imports is concerned (see sections 3.2 and 6.2.of the NDP). How this will be applied to the issue of international tendering and to the acceptance of donated drugs is however not clear, although mention is made in the new section 1(4) of "prescribed manner and on the prescribed conditions". We can only assume that such medicines will have to comply with all current registration requirements, with the understanding that if they are regarded as Essential Medicines they will have access to the fast track mechanisms proposed previously. We note with some satisfaction that our previous concern regarding the new section 1(4) suggested by B30-97 has been dealt with by the new section 15C. Further argument will be provided when considering that section of the Bill. It is however worth repeating here SAAHIP’s considered view that the security of the drug distribution chain cannot be assured only by a licensing process, but by making bodies and persons which operate in this area subject to the full sanction of both the Pharmacy Council (by registration of all bodies corporate and their key employees involved in the pharmaceutical industry in its widest sense) and the Medicines Control Council. Issue is not taken with the ownership of the importer, but rather with the ability to control the actions of the importer and to hold those responsible to professional codes of conduct.

Section 2

Supported.

Section 3

As we have indicated our support for an enabling wording to the Act per se, SAAHIP acknowledges that the precise qualifications of the members of Council need not be specified here, but can instead be specified in Regulations. This would allow for a less rigid composition than is currently the case, but we believe strongly that some indication of the scientific credentials and size of this important body must be assured by the Act. The current wording would allow the Minister to dramatically curtail the ability of the Council by reducing its size and intellectual weight. Although that is clearly not her intention, the law should not be in a position to provide political figures with such wide ranging powers. We note the fact that the composition of Council shall be determined from time to time, but feel that this should be more explicitly stated - the composition should be prescribed by the Minister (in consultation with the Council of the time).

Section 4

Given the level of expertise required to effectively contribute to the affairs of the council, the change to a term of office of 5 years is welcomed, as is the provision for re-appointment of the Council to give effect to this Amendment Act.

Section 5

We note that the new section 6(1)(b) has not been worded so as to include all of the health related Acts,; specifically the Nursing Act, No 50 of 1978 should be included. Given that the composition of Council is left fairly open in terms of the new section 3, the retention of section 6(2)(b) is also problematic, if no such qualifications are required for eligibility. The major problem with this section lies with the requirement that all employees of the "pharmaceutical industry" should be excluded. If this is to applied, a definition of what constitutes the industry should be attempted first. Perhaps this should be reworded to exclude all those in the full-time employee of manufacturers (as defined in the Act). This suggestion, of course, presupposes that such manufacturers will in fact be so registered. In addition, section 6(4) calls for all members who have commercial interests of any sort in the industry to recuse themselves from decisions possibly relating to such interests. SAAHIP wishes to signal its full support for the attempt to rid the Council and its decisions of any chance of conflicts of interest and holds that such a provision will be sufficient to remove the need to disqualify all employees of the pharmaceutical industry from serving on the Council.

Section 6

This is supported, as it merely brings the election of the executive committee in line with the appointment of expert and other committees, as dealt with in section 9(1)(b) of the principal Act.

Section 7

Supported.

Section 8

This section has been substantially altered since the tabling of Bill 30-97. Specifically we welcome the retention of the right of a pharmacist to compound medicines extemporaneously. We acknowledge the right of other health professionals to perform similar acts, provided they have received adequate training, as is contemplated in the new section 22C(1)(a). We further note that current realities support a different approach to the handling of medicines by veterinarians, but would direct the attention of the committee to the Veterinary Drug Policy, which aims to deal with veterinary medicines in a manner analogous to the National Drug Policy, and which therefore entrenches the role of the pharmacist with respect to such medicines. The addition of nurses and other permit holders as prescribers is also welcomed. Pharmacy staff in primary care settings are particularly constrained by the current understanding of what constitutes an authorised prescriber. However, we would argue that the category of nurse intended here , as well as her registration in terms of the Nursing Act, No 50 of 1978, should be stated. Finally, we welcome the addition wording to the final paragraph of section 14(4)(b), as this clearly and fully defines what substances may be included in a prescribed or pharmacist-initiated extemporaneously compounded (and hence unregistered) product.

Section 9

Considerable problems are currently being experienced with the implementation of the primary EDL, as many of the products suggested are as yet not available on the South African market. SAAHIP can therefore only support a well-designed and rigorous fast-track mechanism for the registration of essential drugs. That this already exists, de facto, and has in fact been used in expediting the registration of drugs such as the anti-retroviral agents, is also acknowledged. The proposed section 15(2)(b) is therefore merely regularising what already occurs, and making explicit to all applicants the conditions for and processes inherent in fast-track registration. The definition of essential medicines has also been corrected.

SAAHIP must reiterate its doubts regarding the ability of the MCC, in its present form, to truly re-evaluate all drug registrations every 5 years. Thus while laudable, this section places too great a burden on an already stretched service. In addition, no indication of the cost implications has been given.

Section 10

Section 10 of this Bill will no doubt be the subject of intense debate during these hearings. Many of the issues at hand are beyond the ken of the average practising health professional and, we would be so bold as to suggest, most parliamentarians, and it is therefore incumbent on the portfolio committee to obtain expert advice on this area before coming to any conclusions. As an opening gambit, SAAHIP would bring to the attention of the committee the following points:

This area is a locus of struggle between groups with widely divergent world views. On the one hand, those who benefit from the changes wrought by the Uruguay Round of GATT, and in particular from the agreements reached in terms of Trade-Related Intellectual Property Rights (TRIPs), applaud and welcome this brave new era of globalisation and trade liberalisation. Such parties are in this context, by virtue of the concentration of economic power in the metaphorical North, mostly represented by the multinational pharmaceutical manufacturers whose principal owners are based in North America and Europe. On the other hand, activists and health workers from the metaphorical South, who have seen the potentially deleterious effects of making developing countries comply with the aforementioned agreements, point to the marked North-South inequalities in the negotiation process.

As a result, both sides in this debate have mustered what forces they could to influence decision makers such as this very committee. SAAHIP would direct the committee to a publication prepared by the Dutch-based group Health Action International, entitled "Power, Patents and Pills". This publication records the presentations by both proponents and opponents of the TRIPs and other WTO agreements at a meeting held in October 1996. Some of the thoughts expressed bear repeating. Dr Zafar Mirza, co-ordinator of The Association for Rational Use of Medication in Pakistan, encapsulated the problem thus: "WTO patent agreements will delay the introduction of generic drugs. This means consumers will have to pay higher drug prices for a longer time. Strong patent protection will lead to further monopolisation in the pharmaceutical industry. As many developing countries are just beginning to establish a national pharmaceutical industry, they are likely to be seriously affected by patent issues and international competition." Dr James Love, from the Centre for the Study of Responsive Law in the US, recently co-authored an open letter to US Vice-President Al Gore on this topic. The letter was widely distributed in electronic form. The basic message was clear, and echoed his statement at the HAI meeting: "International trade agreements limit national sovereignty on pharmaceutical policies". The letter further points out that many of the policies included in the NDP against which the transnational manufacturers were mobilising sentiment in the US, ahead of the meeting of the Gore-Mbeki Commission, are standard WHO-supported measures and have been implemented in other settings, notably in Europe. This is particularly true of parallel importation. At the HAI meeting it was stated by Mr Adrian Otten, from the WTO Secretariat, that the TRIPs agreement would cover the two areas contemplated here, stating that: "patent owners must also have the right to prevent importation by third parties without their consent", and "the right to prevent sale or use of a drug on the market without consent in another country".

Substantial resources have been expended by those with vested interests to bring pressure to bear on South African regulatory and legislative bodies, for example by lobbying the US Food and Drug Administration. This and attempts to influence US Government opinion provided the impetus for the aforementioned letter from Ralph Nader and James Love to Vice-President Gore. It is interesting to note that despite this level of effort from both sides, the issue of South Africa’s Drug Action Programme did not appear in the minutes of the second meeting of the Health Working Group of the Sciences and Technology Committee of the Gore-Mbeki Commission, which met in Washington in July 1997.

Perhaps it is fitting to end this section with a quote from an activist in this arena, Dr K Balasubramaniam (HAI co-ordinator for Asia and the Pacific): "Is it unreasonable for developing countries to ask for the same standards of intellectual property rights that were enjoyed by developed, industrialised countries during a period in their development when they had not reached international competitiveness?". Although he goes on to claim that the three provisions set up by TRIPs which can be used to avoid the most dire consequences of the agreement, exhaustion of rights, compulsory licensing and the transition period, might not be effective in all developing country contexts, it behoves this committee to access expert opinion on whether the proposed wording of this section is in accordance or goes beyond the limits set by the agreement. They should however be mindful of the very real vested interests involved in this area of international trade when considering the import of the many submissions on this topic.

With particular reference to section 10 of the Bill, SAAHIP would welcome any measure which will reduce the cost of medicine in South Africa. It would welcome measures which would enable the DoH, with the help of the Council, to determine that the use of a medicine for a particular purpose is safe and effective, and can be allowed without such an indication being specifically sought in the registration of the product by the manufacturer. Pointedly, we would argue that South African citizens should not be denied access to safe and effective medicines in order to placate the moral or political views of citizens of another country. Finally we would welcome any attempt to make parallel imports subject to some form of registration process, so that the safety of South African patients can be assured, regardless of the route the medicine has taken or the price that has been paid. Thus while the international legal implications of sections 15C(a), (b) and (c) are beyond the scope of our expertise, we acknowledge the earnest attempt by the government to give effect to the NDP, and note that similar provisions have been instituted in other countries of the North as well as the South, without the grievous damage to the health of the public which some would have us believe follows hard on the heels of such action.

Section 11

The proposed section 18(3) will require that all minor changes in label appearance be approved in advance by Council. It could also be argued that amendment of section 18(1) to include reference to a Council-approved label, bearing all required particulars, would be more elegant, and avoid the insertion of a separate section. From the point of view of advancing the aim of the NDP to encourage rational, generic prescribing, SAAHIP supported the previous attempt to require generically-labelled medicines for State supply. Whether or not the approach actually incorporated in the policy, which expresses a preference for generically-labelled products, but allows for the trade name to appear (if of the same size and type face as the generic) is truly in conflict with the TRIPs agreement is a moot point.

Section 12

Supported.

Section 13

It would not be overstating the case to describe this section as a "dog’s breakfast". 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 by section 22A.However, the attempt to draw together what currently resides in section 22A and in diverse General Regulations is welcomed. 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 amendment.

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 indication has been given of how the proposed schedules will differ from those presently in force.

The definition of "authorised prescriber" is needlessly firm, and ignores the express injunction of the NDP 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 22A(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 22A(14)(b)).

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. Section 22A(5)(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) 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 22A(5)(l) for emergency supply 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 22A 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.

We also welcome the return of the definition of "medicinal purpose".

Section 14

The proposed sections 22C, 22D and 22E are supported wholeheartedly. We would submit that arguments advanced in the previous hearings regarding the desirability of placing the training and assessment of licence holders under the Health Professions or Nursing Councils are fatuous, particularly in the light of the demonstrated inability or unwillingness of the Medical and Dental Council to play the role contemplated by section 52(1)(a) of their current Act. The principle is clear: the area of competence desired belongs squarely within that prescribed for control by the Pharmacy Council, and they should be the final arbiters. The same should apply for any analogous situation in which any other health professional seeks registration to perform tasks falling within the exclusive competence of any group controlled by the Health Professions Act or Nursing Act.

The basic premise behind section 22F is also firmly supported. It is common knowledge that this system has been applied in some form for many years in the public sector. Given that only one generic form of a medicine is often available on State tender, the applicability of section 22F(1)(a) in the State hospitals/clinics would appear to be limited. This section should also take into account the situation should a patient not be personally present, or when a care-giver presents the prescription. As with the restriction on the repeat prescriptions of benzodiazepines, this section would appear well-intentioned but difficult to police effectively. The introduction of a new tariff structure in the private sector will complicate identification of the "retail price" referred to in section 22F(4)(b). We would also like to see a statement linking section 22G(4) to subsections (1), (2) and 3). At present the application of these restrictions on substitution is not clear as the sub-section stands in isolation without a linking statement, such as "notwithstanding anything to the contrary in this section". We question the removal of the section 22F(5) included in Bill 30-97. While at first glance it might have appeared contradictory, this section is necessary to avoid discouraging generic substitution by way of a threat of added liability. What is clear is that the pharmacist will always accept a degree of liability, merely by the act of dispensing the prescription (regardless of whether any substitution has occurred or not). It is logical that it is the MCC which accepts any additional liability (by virtue of declaring that medicine substitutable, in that it will have registered the generic form and not included that medicine on the so-called "negative" or non-substitutable list).

Two problem areas with respect to section 22G can be pointed to: the concept of a "single exit price", and the mention of a "dispensing fee", applicable to all licensed dispensers. In contrast, the recent tariff agreement is based on a pharmacist’s professional fee, which cannot be applied to prescribers who are licensed to dispense. Throughout this Bill, the exclusion (as in section 22G(4)) of persons employed by the State cannot be explained. In essence, the concept of a transparent pricing mechanism and the ability of the State to at least influence drug pricing is supported by SAAHIP.

Section 22H is also supported in its current formulation. However, if this is intended to allow for the introduction of the multi-dimensional mark system, then SAAHIP would urge far greater investigation of the physical feasibility and cost-implications of the process introduced in the July 12 Regulations last year. That the fundamental lesion in the "grey" market in drugs exists within the State apparatus was again demonstrated in May when increasingly effective measures to control shrinkage at the KwaZulu-Natal Provincial Medical Supply Stores resulted in a shooting which is being treated by police as an attempted murder. The target of this attempt was a pharmacist and a SAAHIP member. It is there that the efforts need to be directed, and not at an impossibly expensive and high-tech intervention which will complicate the movement of drugs in all sectors.

Sections 15 and 16

Supported.

Section 17

This change is supported, as the previous wording was far too general, and gave to the inspector powers beyond those required for execution of his or her duties. In fact, the powers of entry, search and seizure afforded a Medicines Control Officer were only exceeded by those enjoyed by security force personnel under the State of Emergency .

Sections 18 to 23

Supported.

Section 24

The change in section 35(1) to include the words "in consultation with" is welcomed. If the broad definition of "manufacture" in the General Regulations is to remain, then the legality of section 35(1)(xxxv) might be challenged. This is of particular importance in the State sector, where the provision of patient-ready packs is the basis of many mobile and clinic-level services. This aspect should be dealt with unambiguously. The reason for the deletion of the previous section 35(12)(xxxv) in Bill 30-97 (dealing with the pricing system and dispensing fee) is not clear, given that section 22G(2) mentions just such regulations, except that they would be made on the recommendation of the pricing committee and not in consultation with the Council.

Given the furore unleashed by the 12 July 1996 regulations, and in particular the attack on the use of "subordinate legislation", the utility of section 35(1)(x1) must be limited.

Sections 25 to 28

Supported.

Section 29

As was pointed out before, the long title introduces terms which are either not used elsewhere in the Bill or are not adequately defined, such as "distributors".

Sections 30 and 31

Supported.

Section 32 and 33

SAAHIP, while supportive of the ideal that all legislation be applicable in all areas, public and private, has serious reservations about this Bill having only one commencement date, applicable to all sections of the Act. In particular, the State sector will have problems complying with the documentation requirements of section 22A. Primary care facilities in general use patient-carried records, and will require the introduction of considerable resources to allow prescription records to be kept in compliance with this Act.

C: Conclusion

In conclusion therefore, Chairperson and members of the committee, SAAHIP wishes to thank you once again for the opportunity to point out the remaining 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 which will be suitable to submit to the National Assembly.

I thank you.

Andrew Lofts Gray
Vice-President
19 September 1997