SAAHIP Submission Pharmacy 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 Pharmacy Amendment Bill (B69-97)

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 Pharmacy Amendment Bill (B69-97) currently before your committee. May I also once more place on record some measure of introduction of the association on whose behalf I speak today. We represent some 800 pharmacists 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.

This submission will follow the section numbering of the Amendment Bill, adding where necessary (in order of appearance in the principal Act) sections which are not addressed as yet. These will be indicated in bold type.

The definition of "body corporate" is supported, as this will deal with the wider variety of business forms now available than is currently the case. The definition of "pharmacy" is also welcomed, as this will allow for control over mobile services. Th definition of "pharmacy practice" is however problematic. The definition introduces a common confusion which permeates this piece of legislation - that of the difference between a "scope of practice" and "acts specially pertaining to the profession". The first can be termed a maximalist approach, describing the total range of actions which may be performed by a person holding a particular registration. This list may and most probably will include acts which are performed by persons holding registrations other than that for which the "scope" is prescribed. For example, a person registered as a pharmacist will perform acts which may also be performed by a pharmacist assistant, or a nurse holding a permit to dispense. In stark contrast, "acts specially pertaining" are those acts which may only be performed by a person holding a registration in terms of which the acts are prescribed. It is therefore a minimalist approach and is far more difficult to describe in a truly exclusive manner. This is particularly true of all the health professions where, for good reason, a large degree of multiskilling has evolved. This argument will be developed further in dealing with section 29(2) of the principal Act. In short, for the purpose of this definition, the maximalist approach should be used: pharmacy practice means the sum total of all those acts described in the scope of practice of a pharmacist. We note with some satisfaction the inclusion of the definition of a "responsible pharmacist", in a form clearly derived from the IPCSA draft. However, we would argue that the portion of that definition omitted in this Bill be replaced. This deals with the need to ensure that where the pharmacy is owned by an entity other than the pharmacist in question (a body corporate for example), then the "responsible pharmacist" must be a part of the executive management of the business entity. SAAHIP members who practise in the private hospital sector would attest to the necessity for such a provision, as all too often decisions taken at executive level have professional implications for which the pharmacist must answer, and for which this provision will hold the pharmacist (and not any member of the management) responsible. This raises another definition included in the IPCSA draft which has not seen the light of day in this or the previous Bill - that of a "public officer". SAAHIP argued in June, and we reiterate our view now, that the designation of such a person is necessary to fully hold accountable pharmacies which are owned by bodies corporate. We would go further and argue that such a designation is in concert with the provisions of section 60 of the draft National Health Bill (draft 9), which makes allowance for a designated "head of establishment" for all health establishments. Finally, we draw the committee’s attention to the definition of "unprofessional conduct". We fail to see why the definition in this Bill should be different from that used in the Medical, Dental and Supplementary Health Service Professions Amendment Bill (B62-97), and would urge the committee to substitute the definition used in the latter Bill for that in Bill 69-97.

In general the objects of Council are supported. However, we would suggest, as we did in June, that section 3(e)(ii) of the Bill should be amended to read "for the registration of both a person who provides and the premises from which, one or more…". This is crucial if effective control over standards and practice is to be ensured (as is required of Council in the first paragraph of s3(e) and in s3(c,d)). This argument will be developed in greater depth in the consideration of section 13 of the Amendment Bill.

The following sections are strongly supported as being practical and enabling: new sections 4(o), (q ), (s), (t), (u), (v), and in particular (zJ). However, section 4(p) should be reconsidered in line with the proposed representation of professional boards on the Health Professions Council (in terms of the Medical, Dental and Supplementary Health Professions Amendment Bill), in that the representatives of such boards should have voting rights on the Council. A number of sections not amended need attention to give meaning to the new objects enshrined in s3(e)(ii) and (iii): sections 4(i) and (j) should be amended to refer to all categories of persons registered in terms of the Act (and not only to pharmacists). A particular need was noted in our previous submission, and has still not been adequately addressed. That is the need for the power to exempt persons from the provisions of the Act. This was dealt with in the proposed section 4(jj) of the IPCSA draft which reads: "to grant any person not registered in terms of the Act authority to perform an act forming part of the scope of pharmacy practice, or in writing exempt any person from the provisions of this Act, on such conditions as it may determine".

We wish to reiterate the strong support of SAAHIP for the proposed composition of the Council. In stark contrast to other submission the committee will no doubt hear, we wish in particular to point out that the provisions of section 5(1)(b) are seen by us as giving expression to the provisions of concurrent powers as listed in Schedule 4 to the Constitution. This section will also ensure that the inputs of those members of the profession who cater for the majority of the population are heard at and influence the decisions of Council. We note further that no provision is made for cross-membership of this and other statutory councils, and would argue that this is correct, given the establishment and apparent success of the Liaison Forum for Statutory Health Councils.

As was explained in respect of the definition of "pharmacy practice", the use of the term "specially pertaining to the scope of practice" is considered to be a non sequitur, and should be amended in this section (subsections 13(1) and 13(3)) to refer to the minimalist meaning - that of the acts which are exclusively reserved for a particular class of registered person. SAAHIP notes with pleasure the addition of section 13(4), which addresses a problem noted in the previous Bill by all constituencies.

Some of the points made in our previous submission (in respect of what was then considered to be a replacement only for section 22 of the principal Act) bear repeating:

SAAHIP therefore supports the construction used in the IPCSA draft, in terms of section 13 and 14 of Chapter III. This allows for Council to give expression to its obligation to control practice by registering bodies corporate and by using the concept of a "responsible pharmacist" and a "public officer" (analogous to the "head of the establishment" provided for in the National Health Bill). Specifically, section 14 allows for the logical ownership of the pharmacy within a hospital by the owner of the hospital itself (as already happens de facto in many cases). However, in order to ensure continuity of care, we would argue against the restrictions placed on such establishments in terms of being able to service only in-patients and those leaving with medication to take home after discharge. This restriction, while it applies in Germany and the Netherlands, has been vehemently opposed in Britain for this very reason.

While so-called "open" ownership is hotly debated in many countries, recent converts include all but one of the Canadian provinces and Iceland. No doubt opponents of this change will present evidence from around the globe, gathered at the behest of those with an entrenched interest. SAAHIP wishes to restate that, when looked at coldly and logically, little justification for discriminating between retail, hospital, wholesale and manufacturing pharmacies appears to exist. Nonetheless, we recognise the desirability of separating the prescriber of drugs from a financial interest in the dispenser of the same.

We would submit that one of the key problems with these sections is the confusion which appears to exist between the process of registration of facilities and the concept of licensing "health establishments". We acknowledge the need for the DoH to regulate the establishment of all health facilities so as to ensure an equitable and efficient health service for all. We are also all too cognisant of the effect that untrammelled growth of the private sector can have on the public sector, in the form of an internal "brain drain". We would therefore suggest that, while the suggested section 22(1) might be necessary, it could be dealt with equally well in the National Health Bill. The problem lies with section 22(2), as this appears to remove the right of Council to refuse registration of the premises in order to control the practice of the profession and protect the right of the public to a service of acceptable standard. This is not adequately covered in the suggested section 22(6), as the issue is not the "right" of Council to inspect a new facility, but its obligation to do so. It is clear that, although Council may in terms of section 22(6) have the right to inspect and submit a report to both the applicant and the Director-General, this need not necessarily be binding on the latter. Equally, the suggested section 14(h) gives the Council the right to refuse recordal, but the impact of such refusal is not clear, given that the act of licensing would precede an application for recordal. We would argue that the order in which such "permission" to practise is obtained is not critical, provided that what is needed is both licensing by the National Health Authority (DoH) and registration as a body corporate with the Pharmacy Council. The former exercise will allow the DoH to control the retail trade in drugs by means of licensing, as is provided for in the National Drug Policy; the latter will enable the Council to fulfil its obligations in terms of section 3 of the Act. The two processes must not be seen in opposition to one another, but rather as complementary. Neither the DoH nor the Council can fulfil both roles by virtue of one mechanism, both are required if the National Drug Policy is to be implemented successfully.

The proposed section 22(4) would appear to address the concerns of those who practise in the hospital sector, but could be more explicitly stated. It must be borne in mind that the State plans to deliver health care services via a district-based primary health care model. This involves the provision of first-contact services at clinic or mobile clinic level. The number of such facilities already in existence or planned clearly exceeds the number of pharmacists in the public sector. While the amendments to Act 101 of 1965 aim to empower nurses to provide a prescribing and dispensing function, there will still be a need for a clinic-level pharmacy. This would be best served by pharmacy support personnel under periodic supervision of a district pharmacist. Given that the Pharmacy Act will become, albeit in a staggered fashion, applicable to the State, it is important that either an exclusion clause be allowed (exclusion of specified facilities for a specified period, under specified conditions) or the applicability of periodic supervision by a pharmacist be enabled under prescribed conditions (in both the private and public sectors). The proposed wording would suggest that these matters will be dealt with by Regulation.

Finally we would suggest the addition of the words "in consultation with the Council" after the word "Minster" in section 22A of the Act. This would allay the fears of those who perceive sinister intentions in the wish of the Minister to alone decide the conditions for "open" ownership of retail pharmacies.

SAAHIP applauds the attempt to place all matters relating to education under a coherent chapter, but (as will be argued later) suggests that much work is needed in this regard.

While not addressed by this Amendment Bill, these sections would appear to have superseded by the new section 14, which would deal with the issue of registers, registration and removal by means of Regulation (as indicated by the use of the phrase "in the prescribed manner"). The issue of appeal against a decision by the Council would also appear to have been dealt with by the new section 22(11). Specialists are dealt with in section 13(2).

This section again brings into sharp focus the apparent confusion between a "scope of practice" and "acts specially pertaining to the profession". Before considering the detail of this section, we refer the committee to the argument presented in our prior submission and in our original submission to the IPCSA, which read: "The ideal of each recognised profession having sole access to a specialised body of knowledge and hence a well described and exclusive set of "acts specially pertaining to the profession" is probably unattainable. This is particularly so in the health professions, where considerable overlap occurs. Such overlap is, in fact, desirable if the health professions are to contribute meaningfully to holistic care. That any list of actions, therefore, can be prescribed in law, and be used to ensure exclusive rights of the registered members of the profession is a pipe dream. Some definition of the accepted range of actions of the profession is required, but this entire list cannot be regarded as exclusive to that profession".

We further noted that this viewpoint appeared to have been shared by a number of constituents, as the IPCSA draft Bill dealt with the issues currently contemplated by section 29(2) of the principal Act in a an innovative manner. Chapter III deals with registration requirements, and section 17(1) restricts performance for gain of certain acts (unspecified) as in the current section 29(1). Chapter IV deals with the powers of Council to control the practice of pharmacy, and in sections 19(a)(i) and (ii) is given the right to prescribe a "scope of practice" for each category of person and premises registered in terms of the Act.

The proposed amendment in this Bill has replaced the entire list in the current section 29(2) with a statement of the ‘scope of practice" (the list prescribed by regulation in terms of section 35A(a)(i)) - this would mean that any person who performs any act forming part of the scope of practice of a pharmacist while not so registered would be in contravention of this Act and hence liable to a fine. As indicated before, a scope of practice describes the full range of possible functions which may be performed by a particular class of registered person. Acts included in this list might also be included in the scopes of practice of other classes registered under the same or different Acts. That such persons would then be liable to prosecution is clearly not the intention of the legislation. What is required is a minimal list, a list of actions which can only be performed by the persons holding that particular registration and no other. It is our submission that such a list cannot be defined closely enough to be of use in law. Section 29(3) attempts to provide escape clauses for some of these groups (auxiliary staff and other health professionals who hold permits to dispense for example). With the proviso that the confusion regarding acts "specially pertaining to the scope of practice" be ironed out, we welcome the rewording of section 29(4).

This section, while admirable in its intent to bring all issues relating to pharmaceutical education under one heading, deserves closer attention and considerable tidying. What is not at all clear is whether the Minister wishes to be involved in almost all aspects of this function, by means of being the agent which issues Regulations, or whether the legislation aims to empower Council to administer this area by means of Rules. The difference between these two instruments is shown in the new sections 49(4) and (5). In contrast the proposed section 33 suggests that the "Minister may, in consultation with the council, make regulations to make rules" (vide s33(1)(d)) - obviously an oversight. Clarity should be sought with the two parties as to which aspects are so fundamental as to be dealt with by Regulations (in which case the provisions of section 49(5) would apply, with the crucial proviso dealt with later in regard to that entire section). The balance would therefore be dealt with by Council directly, in terms of a delegated authority to regulate by means of Rules (issued in terms of section 49(4)).

What is not dealt with in this section is the impact of the proposals made by the National Commission on Higher Education. In view of the role envisaged for bodies such as the Pharmacy Council by the South African Qualifications Authority Act, No. 58 of 1995 (as a standards setting body and not a provider), it is noted that section 33(2) of the principal Act is to be repealed. However, section 33(1)(g) still makes mention of the ability of the Council to "conduct" supplementary training, as does section 33(1)(m). This is again evident in the retention of section 49(1)(k)(i).

Again, the problem of "a service which pertains specially to the scope of practice" is encountered.

The ability to provide for a scope of practice statement is welcome, as are provisions for a code of conduct, Good Pharmacy Practice documents and guidelines on fee structures.

This is supported. However, the construction used in section 20 of the IPCSA draft is clearer: "No person or body corporate shall conduct his or her pharmacy practice or its pharmacy business under a title or name not approved by the council". The details could be better covered in Regulations.

As was mentioned in our previous submission, this section is best moved to form part of Chapter V (Disciplinary Powers of the Council), as indicated by the fact that any inquiry of the circumstances contemplated here has to be held mutatis mutandis in terms of sections 40 and 49(1)(o). This has been elegantly accommodated in Chapter V of the IPCSA draft, in section 22(d). Of note is the provision for using a rule nisi mechanism if this is deemed to be in the public interest.

The addition of the words "brought to the attention of the council " is crucial if concern is had for the requirements of sections 3(c ), (d) and (g). In other words, the Council must be given the power to initiate an inquiry on its own, and not only in response to a complaint, charge or allegation.

In particular the addition of sections 40(3) and 45(1)(d) is welcomed. As was pointed out before, a major problem faced by the current Council is that of appropriate penalties. In our original submission to Council, SAAHIP put it thus: "The current set of penalties leaves too great a gap between the largely symbolic (caution, reprimand) and the dire (suspension, removal from the register). Too often, this gap is bridged by the expediency of imposition of a suspended sentence of the more dire penalties. …this does not provide for a visible and "felt" sense of justice, either in the profession or the public". This problem will be largely addressed by the imposition of fines and he awarding of cost orders. The placement of the onus to report prima facie evidence of misconduct on employers and educational institutions is also welcomed.

Crucially, an important amendment which was suggested by all parties in respect of the previous Bill, but did not form part of the agreement reached between the Council and the DoH in June, has again not been addressed adequately. This is the issue of the mechanism of consultation between the Council and DoH prior to the publication of Regulations by the Minister. SAAHIP again offers an argument for the inclusion of the wording "in consultation with the council" in section 49(1) of the Act, if this is taken to mean "in agreement with". We acknowledge the need to allow the Minister to initiate the process of issuing regulations in order to give effect to government policy. However, if left as it currently stands, the Minister would have to wait for Council to make a recommendation. Conversely, to entirely remove the contribution of council, as was contemplated in the previous Amendment Bill (B28-97), would negate its very role as a statutory body. We also note that the wording suggested above has been used in the Medical, Dental and Supplementary Health Service Professions Amendment Bill (B62-97) and the Medicines and Related Substances Control Amendment Bill (B72-97), and thus believe that its exclusion here is merely an oversight.

Further, given the arguments advanced in terms of Council’s perceived role vis-a-vis education, the need for provision to be made for a diploma in pharmacy and hence for its curriculum cannot be understood. This section (49(k)) should be repealed in its entirety.

We also note with satisfaction the provisions made with respect to the publication for comment of both rules and regulations.

Supported, with the proviso that every effort is made to not unduly extend the term of office of the Interim Council, as is provided for in the new section 52(2). SAAHIP wishes nonetheless to place on record its recognition of the simple elegance of this section, which has obviated the need for an overly hasty and perhaps ill-considered conclusion to this legislative process.

Again, these are supported. We trust, however, that the commencement dates set in terms of section 46(2) will take into account the realities of the State sector and the ability of current budgetary allocations to radically change those realities.

In conclusion therefore, Chairperson and members of the committee, SAAHIP wishes to thank you once again for the opportunity to point out the few remaining technical problems we have with this piece of legislation, and trusts that the inputs we have given will be considered favourably.