Medical Law – Requirements for dispensing doctors

Prior to 01 April 1966 the authority of medical practitioners to dispense or compound medicines was governed by section 52 of the Health Professions Act.

Under this act, a medical practitioner who desired to dispense medicines simply had to inform the HPCSA of his intention to dispense medicines. The HPCSA had a discretion to then enter the name of such medical practitioner in the register of medical practitioners who were allowed to dispense medicines. A medical practitioner whose name had been entered in the register then became entitled personally to dispense medicines prescribed by him or her or by any medical practitioner with whom he was in partnership or with whom he was “associated as principal or associate or locum tenens”.

When the Medicines and Related Substances Act 101 of 1965 (“the Act”) came into operation on 01 April 1966, the position was changed dramatically. Section 22C of the Act now required a doctor wishing to dispense medicine to patients to apply to the Department of Health for a dispensing licence. Certain conditions for the granting of a dispensing licence were prescribed in the regulations to the Act. It also became a requirement that the applicant complete a supplementary dispensing course.

The conditions for the granting of a dispensing licence are set out in regulation 18 to the Act. The application has to be submitted to the Director-General of the Department of Health (“the Director-General”) and regulation 18 requires the application to contain at least the following information:

• The name, residential and business addresses (both physical and postal) of the applicant;

• The exact location of the premises where the dispensing will be carried out;

• Proof of completion of the prescribed supplementary course;

• Telephone and fax numbers of the applicant;

• Proof of registration with a statutory council such as the Health Professions Council of South Africa;

• A copy of the required notice to other health facilities in terms of sub-regulation 4;

• Motivation as to the need for a dispensing licence in a particular area; and

• Any other information that the Director-General may require.

Sub-regulation 18(4) has been the subject of much debate in the medical community since the Regulations came into effect. It directs that the Director-General is obliged to consider the existence of other licensed health facilities in the vicinity of the premises from where the applicant intends to carry out the dispensing. The Department of Health (with reference to this regulation) adopted a self-made rule that doctors not be allowed to dispense within a 5 km radius of any pharmacy. This position was obviously met with extreme opposition from the medical community as a whole.

The matter finally got the attention of the Constitutional Court in the matter of The Affordable Medicines Trust and Others v Minister of Health and Another (CCT27/04) [2005] ZACC 3. The matter was heard on 11 November 2004 and decided on 11 March 2005.

The Applicants challenged inter alia the powers of the Director-General to prescribe conditions upon which dispensing licences may be issued, the “coupling” of a licence to dispense medicines to particular premises and the factors which the Director-General is required to consider when reviewing an application for a licence.

The arguments put forth by the Applicants were, in broad terms, the following:

 • The power given to the Director-General to prescribe conditions upon which dispensing licences may be issued is too broad and may have the effect of giving the Director-General arbitrary legislative powers.

• The “coupling” of a licence to dispense medicines with specified premises is not authorised by the Act and therefore the Minister exceeded her powers when making the regulation giving the Director-General this right. In the alternative, the requirement of this “coupling” falls outside the authority to regulate the practice of the medical profession.

• The regulations, in their entirety, are vague and as such gives the Director General powers to make arbitrary decisions.

The Constitutional Court held that the provisions of the Act and its Regulations had to be considered in the light of the government’s stated objective to increase the public’s access to safe medicines. When considered with this objective in mind, the provisions of both the Act and the Regulations, although conferring many powers on the Minister and the Director-General, could not be regarded as unconstitutional.

The Court also held that the statutory framework giving rise to the Regulations provided sufficient guidance to enable the Director-General to adequately determine conditions upon which to issue licences and also limited the power of the Director-General to prescribe conditions by the context in which these powers are to be exercised.

Regarding the “coupling” of the dispensing licence to particular premises, the Constitutional Court (in agreement with the High Court) found that the “coupling” facilitates regular inspection and held that if the public is to have access to safe medicines, the dispensing of medicines cannot be separate from the premises where dispensing takes place.

It was held that Regulation 18 does not expressly require the licence to dispense medicines to be linked to specific premises. However, the Regulation contemplates that health-care providers who wish to dispense medicines will do so from the premises where the medical practitioner practises from (as principal or as associate, assistant or locum tenens with another practitioner).

The Court held that in the case of a medical practitioner who practices as an assistant, the licence will reflect the premises of the principal, these being the premises from which such medical practitioner will dispense medicines. Similarly, a locum tenens will dispense medicines from the premises of the principal who holds a dispensing licence. Since a locum tenens may work under various principals, the licence may be issued subject to the condition that he may only dispense medicines from premises of principals who have been issued with dispensing licences.

The Court further held that a medical practitioner with satellite practices will be issued with a single licence listing all the premises from which medicines will be dispensed. Whenever a medical practitioner wishes to expand his practice to other premises, application has to be made for the addition of the new premises to the licence.

The Constitutional Court also held that the Regulations providing that medical practitioners are not permitted to dispense where there is a pharmacy within a 5 km radius had the effect of protecting pharmacies from competition with medical practitioners. The Court held that was not the purpose of the Act and Regulations 18(5)(a), (c), (d) and (e) were declared unconstitutional and invalid.

Medical practitioners who fail to comply with the provisions of the Act may face removal from the HPCSA’s register, effectively suspending them from practice. It seems that there are still practitioners who are unaware of the current requirements relating to dispensing licences and these practitioners are putting their careers at stake.