These comments are submitted by the National Convention on Dispensing ("the NCD") representing the following organisations:

The Dispensing Family Practitioners Association ("DFPA");
The East Cape Medical Guild ("ECMG");
The Family Practitioners Association ("FPA");
The South African Medical Association ("SAMA");
The National General Practitioners Group ("NGPG");
The South African Managed Care Coalition ("SAMCC");
The South African Medical and Dental Practitioners ("SAMDP");
The Society of Dispensing Family Practitioners ("SDFP");
The National Association of Independent Practitioner Associations ("NAIPA");
The Society of General/Family Practitioners ("SGFP")
GPNet Managed Health Care ("GPNet")
Resmin Doctor's Group ("Resmin")
EXECUTIVE SUMMARY
These submissions are made on behalf of the NCD. The NCD was established during the course of 1996 and represents the following organisations:
The Dispensing Family Practitioners Association ("DFPA");
The East Cape Medical Guild ("ECMG");
The Family Practitioners Association ("FPA");
The South African Medical Association ("SAMA");
The National General Practitioners Group ("NGPG");
The South African Managed Care Coalition ("SAMCC");
The South African Medical and Dental Practitioners ("SAMDP");
The Society of Dispensing Family Practitioners ("SDFP");
The National Association of Independent Practitioner Associations ("NAIPA");
The Society of General & Family Practitioners ("SGFP");
GPNet Managed Health Care ("GPNet")
Resmin Doctor's Group ("Resmin").
Collectively the NCD represents the views of approximately 8000 dispensing doctors. Since 1996 the NCD has been actively engaging with the Department of Health and making submissions in regard to proposed amendments to the Medicines and Related Substances Act and proposed Regulations in terms of the Act. This is in fact the third presentation to the Portfolio Committee. Throughout this period the NCD has consistently submitted that the requirement that medical practitioners obtain a licence to dispense medicines:
is unnecessary having regard to the existing Legislative provisions and powers of the State;
will adversely limit the access to health care by persons who have limited financial means rather than enhance the delivery of health care services;
will lead to an infringement of the Constitutional rights of medical practitioners.
will place an unwanted and excessive burden on the already strained global health budget.
may well serve to increase the prices of medicines as a result of the elimination of competition currently provided by dispensing medical practitioners.
will have an adverse impact on managed care.
The NCD has further consistently submitted that if a licensing requirement is introduced (the necessity for which is challenged and not conceded) then the manner in which this is intended to be done as reflected in the Bill and the earlier draft regulations and will also lead to the results referred to in 1.2 above. In addition this will result in extended litigation arising from constitutional challenges.
It is premature for final comment to be delivered on the Bill before any amended draft of the Regulations has been issued for consideration together with the amended draft of the Bill.
The imposition of a licensing requirement on the basis envisaged in the Bill and the Regulations will limit the freedom of choice of patients as to where they will obtain medicines. This will be an infringement of the patients' constitutional rights. Dispensing doctors make medicines more accessible and readily available to patients. The controls envisaged must be rejected.
The Bill fails to spell out what criteria the Director General will have to take into account in assessing whether an application for a licence envisaged in Section 22C is to be granted or refused. This is a fatal flaw in the Bill. Regulations published for comment indicate certain criteria that are to be considered. In the first place such criteria should be contained in the Act itself. In the second place the criteria mentioned give rise to serious concern. By way of example reference is made to certain geographical criteria such as "in the area" and "in the vicinity of the premises". Any geographical considerations that may lead to pharmacists becoming preferred providers (by limiting the number of dispensing doctors) will be detrimental to patients and health care delivery in the country. Distortions in the supply and distribution of medicines will be created by such legislation and will prevent the formation of, or damage existing, Group practices and other integrated systems of managed care that would provide, and currently do provide, cost-effective care of high quality to patients.
By way of summary the NCD proposes that:
There should be no requirement for medical practitioners to obtain a licence in order to continue dispensing medicine, as they are at present entitled to do in terms of existing legislation.
The existing legislation effectively implemented is adequate to regulate dispensing doctors.
Medical practitioners who are registered in terms of Section 52 of the Health Professions Act 56 of 1974 ("Section 52") be required to successfully complete a relevant course prescribed by the Health Professions Council of South Africa ("HPCSA") in consultation with the Pharmacy Council. This can easily be incorporated as an addition to the existing Continuing Professional development ("CPD") requirements for (in this case) dispensing doctors.
Dispensing doctors undergo updates of this course at stipulated intervals – every five years – in order to maintain their registration. These updates should be part of the continuing professional development programme.
Dispensing doctors should be required to comply with a Code of Good Dispensing Practice. The NCD commits itself to take part in drawing up such code in consultation with other stakeholders under the auspices of the HPCSA.
In addition to these written submissions the NCD requests that it be given the opportunity to address the Parliamentary Portfolio Committee on Health in regard to these representations.

INTRODUCTION
Before dealing with the specific provisions of the Bill, the NCD wishes to make some introductory comments.
The NCD shares the State's commitment to meet its constitutional obligations to broaden access to quality health care for all South Africans.
The NCD is committed to co-operate with the health authorities to ensure that all persons, including medical practitioners, who are registered to dispense, maintain high standards and are adequately trained in good dispensing practices.
Subject to what is set out herein the NCD is of the opinion that the existing legislative powers adequately deal with the registration of dispensing doctors, and adequately address potential transgressions by dispensing doctors. It is submitted that additional controls will be superfluous, costly and limit the delivery of health care services currently provided by dispensing doctors especially to persons in the lower income groups.
There are over 8 000 dispensing doctors already registered in terms of Section 52. The additional administrative requirements necessary to set up a system and infrastructure to deal with the applications, appeals, registration and renewal of licences will involve the State in costs which could better be directed to the provision of health care services.
The NCD believes that the requirement for dispensing doctors to submit to an additional licensing process in order to continue dispensing is unnecessary having regard to the existing legislative powers of the State.
To the extent that the requirement for the envisaged licence is based on factors such as those set out in the proposed Regulation 18(4) and not solely on competency, the requirement is unconstitutional being unlawful, arbitrary and administratively unfair. It is also contrary to the achievement of the provision of health care services to all people as envisaged in Section 27 of the Bill of Rights in the Constitution. This is particularly important for those with limited financial resources.
The HPCSA is the regulatory authority that should determine whether additional qualifications are necessary for the medical profession to dispense.
The convoluted nature of the licensing process and the wide range of variable criteria which may be applied by the Director-General in the granting, refusal, renewal or revocation of a licence creates unnecessary impediments instead of facilitating the process.
It is of extreme concern that the Bill published for comment on the 22^nd May, 2002 envisaged that the "Department" (under the control of the Minister) would be the decision maker in regard to the granting, refusing, renewal and revoking of licences with the Minister being the sole person to hear Appeals in regard to any such decisions. This would clearly be unconstitutional.
In the present Bill this line of approach is continued. Decisions in respect of licences will be taken by the Director General. However in respect of decisions by the Director General the Minister remains the only avenue for appeal. This reflects the continued intention of the Department to control the licencing process without any recourse to an independently, and properly qualified Appeal committee as constituted in the existing Section 24. This is of even more concern when regard is had to the fact that it is proposed that the existing provision allowing an appeal to the High Court from a decision of the Appeal Committee be removed.
In addition to this the Appeal Committee is at present chaired by a person appointed on account of his or her knowledge of the law with at least 10 years experience thereof. In terms of the Bill the requirement that the chairperson have at least ten years experience of the law is deleted. The matters to be dealt with by the Appeal Committee will be of a technical nature and will require a good knowledge and experience of the law. There is no basis upon which the requirement that the chairperson should have at least 10 years experience of the law should be deleted.
This legislation places barriers to the attainment of increased access to cost-effective dispensing services especially by the under-privileged, which is contrary to the obligation of the government to provide basic health care to every citizen in South Africa. (Section 27 & 28 of the Constitution).
It is submitted that in the event of the representations contained herein by the NCD not being accepted, the effect of the implementation of the Bill and the proposed Regulations ("the Regulations") read together with the amendment of Section 52 of the Health Professions Act and Section 22C of Act 101 of 1965 will:
limit the access to health care of persons who have limited financial resources rather than enhance this;
increase the prices of medicines to the patient as a result of the elimination of competition currently provided by dispensing doctors - this may well be anti-competitive and encourage cartel formation and collusion in the medicine-manufacture and supply chain, notwithstanding the establishment of a "Medicine-Pricing Committee" as part of the Bill;
lead to the infringement of the rights of medical practitioners; and
will place an unwanted and excessive burden on the already strained global health budget.

THE REQUIREMENT THAT MEDICAL PRACTITIONERS WHO WISH TO REMAIN REGISTERED AS DISPENSING DOCTORS SHOULD SUCCESSFULLY COMPLETE A PRESCRIBED COURSE
The NCD supports the requirement that medical practitioners wishing to remain registered as dispensing doctors should successfully complete a prescribed dispensing course. This requirement arises not from the fact that medical practitioners are not properly qualified to undertake such dispensing, but in order to ensure uniformity and to promote good practice amongst dispensing doctors.
The prescribed supplementary pharmaceutical course should be devised under the auspices of the HPCSA, which Council should be the sole controlling body in respect of the medical profession. The preparation, implementation and control of this course should be done in consultation with the Pharmacy Council.
The dispensing course should be incorporated into the undergraduate curriculum, which will ensure that every medical practitioner qualifying at any SA University would be competent to dispense.
Existing dispensing doctors on the HPCSA register should complete the prescribed course as part of the CPD Programme within a specified number of years. The NCD recommends five years.
In the meanwhile all medical practitioners registered with the HPCSA as dispensing doctors should continue dispensing thus maintaining continuity of services to existing patients.
Any medical practitioner found guilty of contravening good dispensing practice or any other ethical provision by a disciplinary committee of the HPCSA will face a sanction determined by that council which could include the removal of that medical practitioner's name from the register of medical practitioners allowed to dispense.
All medical practitioners registered in terms of Section 52 as a dispensing doctor should attain a certain number of points per year as part of the Continuing Professional Development ("CPD") Programme of the HPCSA. Provision can be made for those doctors who are registered dispensers to acquire a stated number of the CPD points in every five year cycle to remain on the dispensing register.
There is also a necessity to distinguish between "compounding" and "dispensing". This has been partially recognised in the Regulations that were published for comment, and in particular Regulation 18(8) which states:
"For the purposes of this regulation, "compounding and dispensing" does not refer to medicines compounded and used for the purposes of administration or injection thereof to a patient in the consulting rooms."
Dispensing doctors are involved with dispensing and not with compounding. Any course that is introduced for medical practitioners should accordingly be directed at dispensing and should be distinguished from a course in regard to compounding and dispensing which might be required for pharmacists.
Of note is the fact that medical practitioners are allowed to dispense/administer injections as well as stat medicine doses to patients under their care even in terms of the envisaged legislation without any additional formal licensing or training requirements. This is totally inconsistent and with respect, puts the logic of imposing different legislative conditions on dispensing where the patient takes any medication home seriously in doubt.

CODE OF GOOD DISPENSING PRACTICE
The NCD submits that a Code of Good Dispensing Practice should be prepared under the auspices of the HPCSA. This Code would include matters which are contained in the proposed Regulation 18(7). Codes of Good Practice have been successful implemented in Acts such as the Labour Relations Act. The Code should be drawn up in consultation with the professions concerned. The relevant legislation should be amended to include a reference to the Code of Good Dispensing Practice.
Provision should be made for a positive obligation upon dispensing doctors to comply with the requirements as set out in the latest edition of the Code of Good Dispensing Practice as issued from time to time. This approach has been proposed, for example, in Regulation 19(4)(a) in respect of licences to manufacture. A failure to comply will expose the medical practitioner to disciplinary steps and the potential loss of the right to dispense.

THE RIGHT TO DISPENSE TO DEPEND UPON COMPETENCY ALONE
It is submitted by the NCD that the right to dispense by medical practitioners should be based on competency alone and not on any other conditions or decision by the Director-General the Department, or any other body. The criteria to be considered by the Director-General must be contained in the Act and not merely be dealt with in regulations which can be amended from time to time.
There are at present over 8 000 medical practitioners (specialists, general practitioners, district surgeons, factory/ industrial doctors) registered in terms of Section 52 who are entitled in terms of that Act of Parliament to dispense medicine and have had the right for many years to do so.
The obligation that these practitioners must now apply for a licence which may be granted, refused, or revoked and which may or may not be renewed on grounds such as those contained in Regulation 18(4) is unconstitutional.
In this regard it is submitted that in order to achieve the Department’s objective of regulating the dispensing of medicines and maintaining good dispensing standards the proposed legislation/ regulations should enable the large number of existing dispensing doctors to provide health care rather than impose severe limitations upon their ability to do so.
The most effective and least disruptive process must be adopted. The NCD respectfully suggests that the Bill and the last draft Regulations do not achieve this goal. Refusal of a licence, even to a few dispensing doctors (which will undoubtedly happen), will deny several thousands of patients an essential dispensing service. In a free and democratic society such as ours the profession, especially in the private sector, must be fully utilised to assist the government in meeting its constitutional obligation to provide health care to a larger number of the SA population.
Reference has been made above to the fact that it is premature to consider the Bill without the amended draft of the proposed regulations. The requirements contained in the last draft of the Regulations indicate that the Director-General will be required to determine or have regard to:
Whether there is a need for the licence in a particular area (Regulation 18(3)(vii);
The existence of other licenced health facilities in the vicinity of the premises of the medical practitioner applying for the licence (Regulation 18(4)(a); and
The geographic area and number of health care users in that area (Regulation 18(4)(c) and (d).
These Regulations indicate that the Director-General may refuse a licence if the Director-General is of the view that there are a sufficient number of licenced health facilities in the area and/or if the Director-General disagrees with the motivation for the need for a licence in that area.
The variability of the above three criteria, and the arbitrary nature thereof will lead to uncertainty and arbitrary decisions. Furthermore the geographic and demographic information called for in the Regulations is not available, nor determinable. For example, who will determine what "in a particular area" means or what "in the vicinity of the premises" means. Inadequate data is available from the census figures to provide a satisfactory motivation. Hence any patient data provided would be unscientific and impossible to verify and assess. All these criteria must be removed from the legislation. The sole test of whether a license should be granted must depend on competency alone.
It is submitted by the NCD that there is no requirement in the Pharmacy Act to the effect that the Pharmacy Council must take into account, when considering an application for a pharmacy licence, the number of other pharmacies in the vicinity of the premises that are the subject of the application before them. The requirement of a supplementary professional competency serves to "level the playing fields". Therefore discrimination based on other criteria with respect to dispensing is considered to be unconstitutional, administratively unjust, and not in the interest of the patients or the medical profession.
The approach envisaged in the Bill and the Regulations will not only deprive the dispensing doctors of the right to dispense (a statutory right which they have had for many years) but would also deprive the patients who obtain their health care services through such doctors of these services. Patients regard the dispensing of medicines as an integral part of the visit to a doctor. They rely on the dispensing doctor to provide a one stop service. This involves a consultation, diagnosis and the dispensing of medicines for an affordable fee. In this regard it must be remembered that disadvantaged communities and indigent persons are not restricted to rural areas or areas with no pharmacy in the nearby vicinity. It is submitted that many patients will stop visiting doctors altogether if they are unable to receive medicines at the conclusion of the consultation.
It is submitted that many of these patients will be compelled to attend the State facilities due to the overall increase in the cost of healthcare, which the Regulations will invariably cause. The overcrowded state of State health services at present, will result in these State facilities not being able to cope with this increased load.
It is submitted that the State's ability to provide access to health care for all, will be greatly reduced if the new measures are implemented. The net effect of the implementation will be a significant restriction on the number of dispensing doctors resulting in a severe limitation of access to health care.
It cannot be denied that dispensing doctors currently provide a large degree of support and services that are auxiliary to those provided by the State. Currently dispensing doctors countrywide service at least seven million patients per month i.e. 8000 x 30 patients per day x 30 days per month (7.2 million). Any further restriction of these auxiliary services would severely limit access to health care services to the most indigent of the South African society. The patients served are a mix of insured, uninsured, employed and unemployed and many are seen free of charge.
The impact on managed care must also be highlighted. At present there are many medical practitioners who are contractually bound by managed care contracts to provide services to the lower income groups and their families. Mainly generic medicines are dispensed and the basic costs are covered. Dispensing under these circumstances is only possible if medicines can be acquired at bulk discount rates. The service providers are sharing risk with the managed care companies. The managed care contracts are largely for lower income groups
These capitation systems are an attempt by the medical practitioners to extend quality care to more people who cannot afford the conventional medical schemes. The introduction of licensing and the one exit price will have serious negative consequences for the patients as well as the service providers. In this context the term "one exit price" will have to be clearly defined and understood. The NCD believes that cost of services will increase and many contracts will have to be terminated with its own set of legal and ethical consequences.
The laudable goal of the Government to attain access for patients to quality medicines at "best" prices, especially in the private sector can best be achieved through dispensing doctors. This submission is made on the basis that the dispensing medical practitioner is more aware of costing and price issues, thus being able to be a value adding ally in the quest to achieve the stated goal.


IMPACT OF THE PROPOSED ADDITIONAL ADMINISTRATIVE INFRASTRUCTURE AND PROCESSES
It is submitted that the information which is called for in terms of Regulation 18(3) is already available at the HPCSA. To the extent that this has not already been supplied to the Council in terms of Section 52, provision could be made in the Regulations for such additional information that may be required to be submitted to the Council.
Section 52 already makes provision for the Council to remove from the register compiled in terms of Section 52 the name of any practitioner, or to prohibit such practitioner for a specified period from making use of the right to dispense. The infrastructure is accordingly established for the termination or curtailing of the right to dispense after investigation.
Reference has been made above to the fact that a positive obligation shall be stipulated to the effect that dispensing doctors must comply with the Code of Good Dispensing Practice.
It is submitted that when, in 1997, representations were made by the State in respect of complaints relating to dispensing doctors, these complaints were not directed at the competency of dispensing doctors but to the fact that certain dispensing doctors had not complied with good practice. This alone does not warrant the requirement that dispensing doctors should obtain a licence on the basis envisaged in the Bill and the Regulations.
The requirement that applications be submitted by the over 8 000 doctors alone, excluding all the other health care practitioners working in the public or private sector who wish to apply for licences, will, in itself create the necessity for a major administrative infrastructure capable of dealing with over 8 000 applications in a period of less than twelve months (the period referred to in Section 22C(5) and (7)).
The Regulations envisage the fact that "any person may support or oppose an application referred to …" by making representations to the Director-General." (Regulation 18(6)).
Having regard to the provisions of the Constitution and Administrative Law a fair process will require that the applicant and any opponent be heard before a decision be made.
It must also be remembered that provision is made for the lodging of an appeal. These processes will have to be completed within the twelve month period failing which the existing rights of dispensing doctors will be removed even though their application and/or their appeal has not yet been finalised. This will not be administrative action that is lawful, reasonable and procedurally fair as entrenched in Section 33 of the Constitution.
The processing of the applications will not only be extremely time consuming but expensive. There is no doubt that any refusal of an application will be carefully scrutinised and that the result of such refusal of the application and/or appeal will result in legal challenges to the decision. The legal challenges will not be limited to a review of, or appeal against, a decision of the Director-General but will also involve questions of Constitutional law which will have to be determined by the Constitutional Court.
The NCD submits that the impact of the costs of the proposed additional administrative infrastructure (including those costs associated with the receiving of applications, the approval and/or rejection of applications, the dealing with appeals, applications for renewal of licences and legal challenges made in regard to the refusal of licences and/or renewals) on the already strained global health budget will be excessive and unwarranted. The limited budget could better be applied to the provision of the access to health care services to all citizens as entrenched in Section 27 of the Constitution.
The licence requirement will mean that the actions of dispensing doctors in certain aspects will be subject to disciplinary action through the office of the Director-General, through the HPCSA and through the Medicines Control Council. It is submitted that this would be unfair and administratively difficult. It is clearly desirable that this function in respect of medical practitioners be centralised solely through the HPCSA.
To the extent that the submission by the NCD that there should be no requirement for dispensing doctors to apply for a licence is not accepted, it is submitted that the sole criteria for the dispensing licence should be the competency of the dispensing doctor as reflected by the successful completion of a prescribed dispensing course.

CONCLUSION IN RESPECT OF LICENCE REQUIREMENT
For, inter alia, the reasons set out above the NCD submits that:
It supports the requirement that dispensing doctors should undergo additional dispensing training devised and administered by the HPCSA;
Dispensing doctors complete this course successfully within a period of five years from a stipulated date in order to maintain their registration as dispensing doctors in terms of Section 52;
Dispensing doctors be required to update this knowledge as part of the HPCSA’s Continuing Professional Development programme in order to maintain their registration on the Register of Dispensing Doctors;
A Code of Good Dispensing Practice be established and that it be a requirement that dispensing doctors comply with that Code in order to maintain their registration;
The HPCSA should continue to be the only body that will have the right to remove, permanently, or for a specified period, the name of any dispensing doctor from the Register of dispensing doctors;
There should, accordingly be no requirement for dispensing doctors to apply for a licence on the basis envisaged in the Bill and the Regulations or at all.
To the extent that the registration process be altered to one of a licence (and the NCD submits that there is no requirement for this) that the determination of whether or not a licence be granted should be determined solely upon the competency of the dispensing doctor and not upon arbitrary and variable criteria such as those referred to in the proposed Regulations 18(3)(vii) and/or 18(4).

SPECIFIC COMMENTS IN REGARD TO THE BILL
Clause 1.
The definition of "justice" should be replaced with "Judge of the High Court". See further paragraph 0 below.
Clause 2. Amendment of Section 6(3)
It is inappropriate to remove the words "subject to the provisions of Section 3". At present where a vacancy must be filled the Minister must have regard to the provisions of Section 3 which, inter alia, set out the composition of the Council. By deleting the reference "subject to the provisions of Section 3" the Minister may replace persons who were appointed to be representative of a particular discipline, such as a pharmacist, with a person who is not representative of that discipline. This requirement should remain to ensure that effect is given to Section 3 where vacancies are filled.
Clause 4. Amendment of Section 18C
The word "after" before the word "consultation" in the envisaged 18C(1) should be replaced with the word "in". It is essential that this be a meaningful consultation on an ongoing basis. The reference in this proposed sub-section to "other stakeholders" is too vague. Reference should be made to identified stakeholders including health care providers in the private sector.

Amendment of Sub-section 16(b) of Section 22A.
The wording used is not clear. If it is intended that the person must physically have the prescription on his or her person, then this is too restrictive. The wording should rather indicate that the person may possess the substance provided the person can prove that the substance was obtained in accordance with a fully issued prescription.
Clause 6. Section 22C
Reference is made to the submissions of the NCD above to the fact that there is no necessity for the introduction of a licence system to entitle doctors to dispense medicines and that on the basis envisaged in the Bill read with the relevant legislation and the Regulations the requirement is unconstitutional. The NCD must record that the rights of its members to challenge the constitutionality of the Bill, the Regulations and the implementation thereof are fully reserved.
It is reiterated that the NCD submits that no licensing dispensation need be introduced. Without detracting in any way from this standpoint the NCD is of the opinion that the dispensation envisaged will be impractical, administratively difficult, expensive to the State and will limit access to health care services to the most indigent of the South African society.
Any licensing dispensation that is introduced should:
Recognise the existing rights of medical practitioners who are already entitled to dispense by allowing them to continue to dispense without a licence subject only to the comments made in paragraph 0 to 0 above.
Where a licensing dispensation is to be introduced for medical practitioners who do not at present have the right to dispense then such dispensation should allow a lead time of 24 months coupled with an application procedure for a licence based solely on competency and not upon other arbitrary and extraneous circumstances.
In regard to the proposed supplementary course as envisaged in 22C(2) the submissions are repeated that:
A distinction should be drawn between "compounding" and "dispensing";
Any such course should be devised, implemented and controlled under the auspices of the HPCSA; and
A licence, once granted, should not lapse after a period of three years (as envisaged in the Regulations) but should continue provided that the medical practitioner maintains his/her competency on the basis referred to above.
In regard to the proposed Section 22C(3) the submission is that the existing Section is framed too widely. The information required should be limited to objective information that is accessible to the medical practitioner and which relates to the conduct of the dispensing undertaken by the medical practitioner and/or the competency of the medical practitioner.
In regard to the existing Section 22C(4) and in regard to the provisions of Section 22E the submission is made that any licence ought not merely to be summarily revoked or suspended by the Director-General. Such suspension or revocation should only take place in the event of there having been found in a court of law that the medical practitioner has been guilty of criminal conduct directly relevant to the suitability of the medical practitioner to continue dispensing and/or the medical practitioner has been found guilty of conduct by the HPCSA of such a nature that the HPCSA concludes that the registration of the medical practitioner a dispensing doctor should be suspended or revoked. This is particularly so in view of the proposal that any appeal against administrative decisions by the Director-General, must be decided on appeal by the Minister alone.
Reference is made to the fact that the Department "or the Council" may make certain decisions and require certain actions to be undertaken by a medical practitioner. The legislation, as presently drafted, is inappropriate and will involve administrative action that will infringe upon a medical practitioner's right to administrative action that is lawful, reasonable and procedurally fair. Circumstances will arise where a medical practitioner will be accountable to the HPCSA, the Pharmacy Council, the Medicines Control Council and/or the Minister/Department/Director-General.
In Section 22C(7) it is welcomed that the period within which the intended provisions will come into operation is extended from six months to twelve months from the date of commencement of the Section. It is submitted however that the period of twelve months is still too short and that this period should be extended to a period of 24 months. It is further submitted that in the event of the licensing dispensation being implemented the existing rights of a medical practitioner to dispense should not terminate until such time as an application for a licence has been refused and until any appeal and/or court process in terms of which the medical practitioner challenges the refusal of a licence has been finally exhausted.
Section 22B indicates that a licence will be valid for a prescribed period. In terms of the Regulations this period has been indicated as a 3 year period. For the reasons set out above it is submitted that once a licence has been issued it should continue until termination without there being a requirement or a re-application. Continuation will be dependent upon the medical practitioner maintaining his/her competency and/or any criminal or disciplinary steps as referred to in paragraph 0 above.
Section 22E has been referred to above. A licence, once granted, should not be capable of suspension or revocation merely upon the taking of administrative steps. Where any conditions such as those envisaged in Section 22E(1)(a – d) are to be implemented any such revocation and/or suspension should only take place after due process which includes the audi alteram rule. This will mean that such revocation and/or suspension should not take place merely at the decision of the Department/Minister/Director-General but only after a finding in regard to any of the proposed factors. It is submitted, for the reasons mentioned above, that the possible revocation and/or suspension should only follow a criminal conviction and/or a finding by the HPCSA. To the extent that this submission is not upheld the suggestion that a suspension and/or revocation could take place after a period of only 20 days must be rejected. This period would be totally inadequate under the circumstances for a medical practitioner to obtain information as to the alleged complaints, to investigate the alleged complaints and/or to prepare submissions in response. This proposal creates a reverse onus on the medical practitioner which has been held to be unconstitutional.
Clause 7. Amendment of Section 22F
In the memorandum on the objects of the Bill the following is stated:
"Clause 7 provides that not only pharmacists, but also persons who dispense medicines must inform patients of the availability of generic substitutes".
It is submitted that the wording of the proposed sub-section 1(a) is not clear. As it is drafted at present, the provisions will apply to a member of the public who visits (one of the designated places) with a prescription for dispensing. It is unlikely that a patient will be visiting his/her doctor with a prescription. The wording is therefore unclear as to whether this will apply to a doctor who issues a prescription to his/ her patient as a result of the visit to the doctor. It is further unclear as to what is meant by informing the member of the public as to "the benefits of the substitution for a branded medicine by an interchangeable multi-source medicine". If, as it is stated in the memorandum, the obligation is to inform patients of the availability of generic substitutes, the wording should state this, and the NCD supports the imposition of such a duty, provided the obligations created are clearly defined. The reference to what the "benefits of the substitution are" is something that is far wider than indicating the availability of generic substitutes. Opinions both of pharmacists and medical practitioners are likely to vary as to the particular benefits of the substitution in regard to specific medicine. In this regard it must be remembered that a medical practitioner who prescribes any medicines (or related substances) does so after a clinical examination of the patient based upon his/her professional knowledge including the knowledge of the efficacy of the appropriate medicines and generic substitutes. In addition the proposal does not take into account the question of professional responsibility and legal liability to the patient.
Section 22G. In terms of the proposed Regulations, and more particularly Regulation 39, no provision is made for the appointment of persons to the Pricing Committee who would be representative of dispensing medical practitioners and/or pharmacists. While it is accepted that the Pricing Committee should not consist solely of such persons it is totally inappropriate that no representation is envisaged for such persons.
Clause 9. Amendment of Section 24
The existing provisions contained in the present Section 24 are appropriate in law and equity to ensure that there is administrative action that is lawful, reasonable and procedurally fair. There is no need to draw a distinction between an appeal from decisions of the Council and appeals from a decision of the Director-General. In particular where decisions of the Director-General relate to the grant, refusal, renewal, refusal to renew and / or revoke a license granted to a medical practitioner to dispense medicines, an appeal should lie to the Appeal Committee and not to the Minister. In addition there can be no basis for removing the requirement that the chairperson of the Appeal Committee not only be appointed on account of his or her knowledge of the law, but also have at least 10 years experience thereof. By deleting this provision, there will be no certainty that the person appointed will have at least a minimum period of experience. It must be pointed out that the decisions that will have to be taken are important and will involve difficult and technical questions of law, including constitutional law. In addition the amendment to delete the existing clause 24(6) is opposed. In terms of this Section an Appeal will lie from the decision of the Appeal Committee to the High Court. This is an added measure of protection contained in the existing Act. This will of course be in addition to the right to review such decision, either in terms of the High Court Act or in terms of the Act dealing with the right to lawful, reasonable and procedurally fair administrative action as envisaged in Section 33 of the Constitution. The provisions of this Section also need to be expanded in order to indicate clearly what the nature of the appeal will be. Will this be in a form of a review of the decision taken by the Director-General or an appeal on the basis of de novo consideration of the matter.
Clause 11. Amendment of Section 28
The drafting of the new proposed Section is an improvement on that made available for comment on the 22^nd of May 2002. There are however still shortcomings. In the proposed wording published for comment on 22 May 2002, reference was made to the fact that any warrant issued would be a warrant issued by a Magistrate or a Judge of the High Court. It is submitted that this is the correct position. The amendment contained in Section 1 to insert a definition of "justice" is incorrect. "Justice" as defined in Section 1 of the Criminal Procedure Act is a "Justice of the Peace appointed under the provisions of the Justices of the Peace and Commissioner of Oaths Act". It would be quite inappropriate for such power to given to a Justice of the Peace. The reference should be to a Judge of the High Court.
It is submitted further that where a search and seizure clause section such as this is to be inserted the following principles should be followed.
An inspector who has reasonable grounds to believe that there has been non-compliance by any person with the Act or an offence in terms of the Act has been committed by any person then the inspector may apply to a Judge of the High Court for the issue of a warrant. An application for a warrant shall be supported by information supplied under oath or solemn declaration establishing the facts upon which the application is based.
A judge, who is satisfied that there are reasonable grounds based upon the application to believe that the issue of a warrant is justified may issue a warrant. A warrant so issued shall:
Refer to the alleged non-compliance or offence in relation to which it is issued;
Identify the premises to be searched;
Identify the person alleged to have failed to comply with the provisions of the Act, or to have committed the alleged offence;
Be specific as to any medicines, documents or things to be searched for, and/ or seized; and
Shall be accompanied by a copy of the application filed by the inspector before the Judge.
The reference to "at all reasonable times" is too widely stated in sub-section 1(a). This should either be on the basis of at ranged times or to indicate that this must be at reasonable times having regard to the conduct of the practice of the person in question. In addition it should be indicated that this must be done in such a manner as to limit any disruption to the conduct of the business or conduct of the practice in question.
The above is not intended as a final drafting of the provisions. What is important however is that the inspector should not be given arbitrary grounds to extend the provisions of the warrant. An Inspector should not be entitled to proceed without a warrant. An inspector may call in the assistance of the South African Police Services or revert to the relevant Magistrate or Judge in the event of there being reasonable grounds for more urgent action. The inspector and the Department should be liable for unlawful actions and/or any loss caused by the search and seizure in the event of it being held that the inspector and/or the Department act incorrectly and/or unlawfully.

8. CONCLUSION
The NCD submits that the Bill, in its present form, should not be proceeded with for the reasons set out herein. In the event of a decision being taken to proceed with the Bill, the NCD requests that an amended draft of the Bill be issued taking into account the submissions contained herein and that this be published together with an amended draft of the Regulations to be read with the Bill. Interested parties, including the NCD, should then be allowed a further period of time within which to make submissions in regard to the amended Bill and amended Regulations.


Pretoria
September 2002
The National Conventions on Dispensing