Commercialisation of healthcare in South Africa: overview

A Q&A guide to the commercialisation of healthcare in South Africa.

This Q&A provides an overview of the regulatory framework for the commercialisation of medical products in South Africa. It covers the key requirements for manufacturing, advertising and selling drugs, medical devices, biological products and natural health products.

To compare answers across multiple jurisdictions, visit the commercialisation of healthcare Country Q&A tool.

This Q&A is part of the Commercialisation of Healthcare Global Guide. For a full list of jurisdictional Q&As visit www.practicallaw.com/healthcare-guide.

Kerry Williams, Webber Wentzel
Contents

Regulatory overview

1. What is the regulatory framework for medical products?

Legislation

The main laws regulating medical products are the:

  • Medicines and Related Substances Act 101 of 1965 (Medicines Act).

  • Hazardous Substances Act 15 of 1973 (Hazardous Substances Act).

  • Foodstuffs, Cosmetics and Disinfectants Act 54 of 1972 (Cosmetics Act).

  • National Health Act 61 of 2003 (Health Act).

Regulatory authorities

The regulatory authorities responsible for medical products are the:

  • Medicines Control Council (MCC).

  • Department of Health (DoH).

For more information on the MCC and the DoH see box: The regulatory authorities.

Private parties

Private parties are responsible for registering medical products (if registration is required) and ensure that, once registered, such products are put on the market.

 
2. What types of medical products are regulated?

Both medicines and medical devices are regulated. However, the provisions of the Medicines and Related Substances Act 101 of 1965 (Medicines Act) relating to medical devices are not currently enforced.

Most drugs, biological products, natural health products, traditional medicines and homeopathic medicines would constitute medicines as defined in the Medicines Act. Medicines are defined in the Medicines Act as any substance or mixture of substances used or purporting to be suitable for use, or manufactured or sold for use in either:

  • The diagnosis, treatment, mitigation, modification or prevention of disease, abnormal physical or mental state or the symptoms thereof in man.

  • Resorting, correcting or modifying any somatic or psychic or organic function in man.

Medicines also include any veterinary medicines.

A medical device is defined in the Medicines Act as any instrument, appliance, material, machine, apparatus, implant or diagnostic reagent that is either:

  • Used or purporting to be suitable for use, or manufactured or sold for use in:

    • the diagnosis, treatment, mitigation, modification, monitoring or prevention of disease, abnormal physical or mental states or the symptoms thereof;

    • restoring, correcting or modifying any somatic of psychic or organic function; or

    • the diagnosis or prevention of pregnancy.

    Such device must not achieve its purpose through chemical, pharmacological, immunological or metabolic means in or on the human body, but can be assisted in its function by such means.

  • Declared by the Minister of Health by notice in the Government Gazette to be a medical device.

Medical devices also include any part or accessory of a medical device.

The Minister of Health has recently published draft General Regulations Relating to Medical Devices and In Vitro Diagnostic Medical Devices (IVDs) (draft Medical Device Regulations) (published in the Government Gazette 38990 on 14 July 2015 for comment). If these regulations (or similar regulations) are promulgated, then medical devices will be subject to a comprehensive regulatory framework.

 

Drugs

3. What are the general requirements for a drug to be manufactured, advertised and sold?

Manufacturing

A medicine that is subject to registration cannot be sold in South Africa unless it is registered by the Medicines Control Council (MCC) (section 14(1), Medicines and Related Substances Act 101 of 1965 (Medicines Act)). Because manufacturers of medicines are required to sell such medicines into the market, a medicine subject to registration cannot be manufactured unless it is registered in South Africa by the MCC.

A medicine must be registered when it is "called up" for registration by the MCC as part of a category or class of medicines (section 14(2), Medicines Act). Most drugs have been called up for registration in South Africa through numerous notices published in the Government Gazette. The widest notice classifies as medicines all products purporting to be a medicine through use of the terms "medicated", "medicinal", "for medical use" or any other similar connotation (see Government Gazette 6029, GNR 1029, 26 May 1978).

Once a drug is called up for registration, an application for registration must be submitted to the Registrar of Medicines, who then submits the application to the MCC. An application can be made by any person residing and doing business in South Africa and must include particulars of a person with appropriate knowledge of all aspects of the medicine, who is responsible for communication with the MCC. Applications are made on the prescribed form and must include (regulation 22(3), General Regulations made in terms of the Medicines and Related Substances Act, 2003 (General Medicines Regulations)):

  • A screening form.

  • A proposed label.

  • A manufacturing licence for the medicine.

  • A good manufacturing practice (GMP) certificate from the regulatory authority of the medicine's country of origin.

  • Data on the safety, efficacy and quality of the medicine as determined by the MCC.

  • Proof of existence of a manufacturing site.

  • Any other information that the MCC may require.

A medicine for which an application is made must comply with the "technical requirements as determined by the MCC", and an application must be made for each individual dosage form and strength of medicine (regulation 22(6) and (7) , General Medicines Regulations).

Once registered, a medicine is issued with a "certificate of registration", which is commonly known in South Africa as a "marketing authorisation". The applicant for registration accordingly becomes known as the marketing authorisation holder. Marketing authorisation holders have a competitive advantage in South Africa as no one except the holder can sell the medicine to the market, and, because of delays in the registration process, the "first to market" often has a competitive advantage.

In addition, when a medicine is manufactured in South Africa, the manufacturer must comply with certain prescribed conditions (section 22A(1), Medicines Act). The manufacturer must apply to the MCC for a licence to manufacture medicines on the prescribed form and specifying the relevant medicines to be manufactured, along with documentary proof of the following information:

  • Particulars of the owner of the business.

  • Registration of the responsible pharmacist.

  • Qualification of the staff to manufacture medicines in accordance with the Medicines Act.

  • Ability to comply with good manufacturing or distribution practices as determined by the MCC.

The manufacturer must also appoint and designate:

  • A pharmacist who will control the manufacturing of medicines.

  • A natural person residing in South Africa, who is responsible to the MCC for compliance with the Medicines Act.

The manufacturer must pay the prescribed application and inspection fees, and submit to an inspection by the MCC of the business premises specified in the application.

Unregistered medicines can be manufactured in South Africa for clinical trials. However, this is unlikely to occur as the cost of establishing a manufacturing site would not be justified if the manufacturer can only supply the unregistered medicine to trial participants. In practice, unregistered medicines are imported into South Africa for clinical trials. In addition, the General Medicines Regulations provide that a person wishing to initiate or conduct a clinical trial in respect of an unregistered medicine (and a new indication or new dosage regimen of a registered medicine) must apply to the MCC for authority to conduct a clinical trial. If such authority is granted, then the unregistered medicine used in the clinical trial must be properly labelled and the package must sufficiently identify the:

  • Clinical trial to be carried out.

  • Unregistered medicine to be used.

  • Person to whom the medicine is to be administered.

  • Name and address of the premises where the clinical trial is to be carried out.

Advertising

The advertising of medicines is strictly regulated in South Africa. Advertisement and advertising is defined widely in section 1 of the Medicines Act as any written, pictorial, visual or other descriptive matter or verbal statement or reference that is:

  • Appearing in any newspaper, magazine, pamphlet or other publication.

  • Distributed to members of the public.

  • Brought to the notice of members of the public in any manner that is intended to promote the sale of that medicine.

Any form of marketing activity directed at the public or a section of the public is likely to fall within this definition.

Any advertising relating to a medicine cannot be false or misleading (section 20(1)(i), Medicines Act) or make any claim that (section 20(1)(ii), Medicines Act):

  • The therapeutic efficacy and effect of the medicine is other than that stated by the MCC.

  • The medicine should be used for a purpose or under circumstances other than those stated by the MCC.

No person can advertise a medicine unless such advertisement complies with certain prescribed requirements referred to in section 18(2) of the Medicines Act and contained in regulation 45 of the General Medicines Regulations. Medicines that do not contain a scheduled substance or contain a schedule 0 or 1 substance can be advertised to the public (regulation 45(2)(a) , General Medicines Regulations). Medicines that contain schedule 2 to 6 substances can only be advertised either (regulation 45(2)(b), General Medicines Regulations):

  • To medical practitioners, dentists, veterinarians, pharmacists and other persons authorised to prescribe medicines.

  • In a publication that is normally available to such persons.

However, the public can be informed of the prices, names, pack sizes and strengths of schedule 2 to 6 medicines (regulation 45(2)(c), General Medicines Regulations).

Sale

A medicine cannot be sold in South Africa unless it is registered by the MCC. There are limited exceptions to this requirement. The MCC can authorise in writing any person to sell a specified quantity of a medicine during a specified period and to a specified person or institution (section 21(1), Medicines Act). These authorisations are known as "section 21 authorisations", and are often applied for where a new medicine is available internationally but has not yet been registered in South Africa (and the medicine provides compassionate relief). Section 21 authorisations are not used for the provision of medicines in clinical trials, as medicines used in clinical trials are provided free of charge.

There is also an expedited registration process for medicines that are included in the Essential Drug List (EDL) or for medicines that cannot be included on the EDL but which are essential for national health in the opinion of the Minister of Health (section 15(2)(b), Medicines Act). The applicant for registration will be notified within 30 days of the date of the receipt of the application whether the medicine will be subject to an expedited registration process. The MCC must make a decision regarding the registration of the medicine within nine months from the date of receiving an application.

 
4. Are there different requirements for patented and generic drugs?

Generic and patented medicines are generally regulated in the same manner. To be sold, generic medicines must be registered by the Medicines Control Council (MCC). They can only be manufactured in South Africa if they have been registered by the MCC and comply with the prescribed conditions, and can only be advertised in accordance with the provisions of the Medicines and Related Substances Act 101 of 1965 (Medicines Act). There is no process for the expedited registration of generic medicines.

The only expedited registration process for medicines in South Africa concerns the registration of medicines that appear on the Essential Drug List (EDL) (see Question 3, Sale).

However, under the Medicines Act, generics are treated differently to patented medicines as follows:

  • Generics are subject to compulsory substitution by pharmacists and dispensing doctors in certain circumstances. A pharmacist must dispense a generic medicine (referred to as an interchangeable multi-source medicine) instead of the medicine prescribed unless expressly forbidden by the patient or the prescriber (and on condition that the generic medicine is cheaper) (section 22F, Medicines Act).

  • The Minister of Health can make regulations on the parallel import of generic medicines into South Africa (despite the rights of a patent holder). A medicine can be imported in this way if the following conditions are met:

    • the medicine must be sold outside South Africa with the consent of the patent holder for such medicine;

    • the medicine must be imported from a person licensed by a regulatory authority recognised by the MCC;

    • the person wishing to import such medicine must be in possession of a permit issued by the Minister of Health; and

    • the medicine must be registered by the MCC.

 
5. What authority is responsible for regulating the manufacture, advertising and sale of drugs?

The Medicines Control Council (MCC) and the Department of Health (DoH) are the authorities responsible for regulating the manufacture, advertising and sale of medicines.

For more information on the MCC and the DoH see box: The regulatory authorities.

 
6. Are there fewer or different requirements for drugs that have already been licensed/approved in another jurisdiction?

Drugs that are licensed in other jurisdictions are subject to the Medicines and Related Substances Act 101 of 1965 (Medicines Act) and its regulations and must accordingly comply with all applicable registration requirements (see Question 3). However, the Medicines Control Council (MCC) can conduct an abbreviated medicine review process (AMRP) when requested to register medicines that have been licensed in other jurisdictions. The AMRP allows for an abbreviated evaluation process for drugs registered in other jurisdictions recognised by the MCC within the previous three years (although in practice this rarely leads to an expedited registration process for new medicines). To benefit from the AMRP, an applicant must provide the MCC with the following:

  • Expert reviewer's report on safety, quality and efficacy from the relevant registration authority.

  • Certificate of registration of the new chemical entity by one of the recognised registration authorities.

  • Written confirmation that the proposed package insert is based on the package insert and the complete dossier of the foreign registration authority.

  • Written confirmation that the data submitted to the MCC is identical to that submitted to the registration authority.

  • Expert reports on chemical-pharmaceutical, pharmaco-toxicological and clinical documentation.

  • Correspondence between the applicant and the foreign registration authority, both positive and negative (for example, queries, non-acceptance of certain claims/statements).

  • Written confirmation that the formulation applied for is identical to that approved by the registration authority.

 
7. Is it possible to sell drugs to or buy drugs from other jurisdictions?

It is possible to sell drugs to or buy drugs from other jurisdictions.

 
8. Is it permitted to advertise drugs to consumers? Are there restrictions on advertising?

Medicines that do not contain a scheduled substance or that contain a schedule 0 or 1 substance can be advertised to consumers (referred to as the public). Medicines that contain schedule 2 to 6 substances can only be advertised either (regulation 45(2)( b), General Medicines Regulations):

  • To medical practitioners, dentists, veterinarians, pharmacists and other persons authorised to prescribe medicines.

  • In a publication that is normally available to such persons.

However, the public can be informed of the prices, names, pack sizes and strengths of schedule 2 to 6 medicines (regulation 45(2)(c), General Medicines Regulations).

 

Medical devices

9. What are the general requirements for a medical device to be manufactured, advertised and sold?

Although the Medicines and Related Substances Act 101 of 1965 (Medicines Act) defines medical devices (see Question 2), it does not create a comprehensive system of regulation for medical devices. Medical devices do not need to be registered. In addition, manufacturers, distributors and wholesalers of devices are not in practice licensed by the Medicines Control Council (MCC) to conduct their respective activities (despite a requirement to do so in the Medicines Act). As a result, medical devices need not meet any requirements to be manufactured, sold and advertised in South Africa.

However, some medical devices are regulated under the Hazardous Substances Act of 1973 (Hazardous Substances Act) if they amount to group III hazardous substances (such as X-ray units, therapeutic lamps, intra-oral curing devices, blood warmers, various ultrasound appliances, electronically-controlled ventilators, cardiac pacemakers, infant incubators, high pressure injection devices and any pulmonary function analyser) (group III medical devices). Certain requirements must be met in order to manufacture, sell and advertise group III medical devices.

Manufacturing

Currently, in practice, manufacturers are not licensed to manufacture medical devices, although the Medicines Act requires the licensing of manufacturers of medical devices (section 22C(1)(b)).

However, the sale, lease, use, operation and application of group III medical devices requires a licence. This means that, to manufacture group III medical devices for sale, a manufacturer must be licensed.

The practice of not licensing manufacturers of medical devices in accordance with the Medicines Act is likely to change when the draft Medical Devices Regulations come into force. The draft Medical Devices Regulations provide that a medical device manufacturer must:

  • Apply for a licence before commencing business.

  • Appoint a natural person who resides in South Africa as its authorised representative (who is responsible for compliance with the Medicines Act and controlling the manufacturing of the medical device).

A manufacturer will be licensed for five years, and a licence will be renewable on application to the MCC.

Additionally, the draft Medical Device Regulations require the registration of medical devices before they can be sold or used in South Africa. In practice, a manufacturer will therefore need to apply for registration of the medical device before starting to manufacture the device.

Advertising

The advertising of medical devices in South Africa is not currently regulated. The only exception concerns the advertising of group III medical devices. The definition of "sell" under the Hazardous Substances Act includes "advertise", so that only persons licensed under this Act can advertise group III medical devices.

When they come into force, the draft Medical Device Regulations will regulate the advertising of medical devices far more comprehensively. The draft Regulations currently provide that only class A and B medical devices (that is, low risk and low to moderate risk devices) can be advertised to the public or lay persons (that is, consumers). However, the draft Regulations are ambiguous regarding the restrictions applicable to the advertising of class C and D medical devices (that is, moderate to high risk and high risk devices). Currently the draft Regulations provide that (draft regulation 22(5)):

  • When a class C or class D medical device or in vitro diagnostic device is advertised for the first time to any prospective user, written information must be simultaneously given to the person(s) to whom the oral, electronic or printed advertisement is directed.

  • When the medical device is advertised on subsequent occasions, such information must be available on request.

It is evident from this regulation that the drafters have not explicitly prohibited the advertising of class C and D medical devices to consumers (which one would have expected), but have rather provided that certain information must accompany the advertising of class C and D medical devices to consumers. The draft Medical Device Regulations also provide that an advertisement for a medical device cannot contain a statement that deviates from, or conflicts with, evidence accepted by the MCC in the application for registration of the device (and which is incorporated in the approved instructions for use).

Sale

A person must be licensed by the Director-General (DG) of Health to sell, let, use, operate, apply or install a group III medical device. Before a licence is issued, the DG can investigate the person applying for such licence. To issue a licence, the DG must be satisfied that:

  • The applicant is a suitable person to carry on the activities to be licensed.

  • If another person has an interest in the applicant, then such interest must be reconcilable with the provisions of the Hazardous Substances Act.

  • The applicant will be able to exercise sufficient control over the activities authorised by the licence.

  • The licence applied for has been issued to insufficient numbers of other licensees.

  • The issuing of the licence is in the public interest.

 
10. What authority is responsible for regulating the manufacture, advertising and sale of medical devices?

Currently, the Director-General (DG) of Health is the responsible authority. The DG acts through the Directorate of Radiation Control within the Department of Health (DoH). The Medicines Control Council (MCC) will be the responsible authority once the draft Medical Device Regulations comes into force.

For more information on the DoH and the MCC see box: The regulatory authorities.

 
11. Are there fewer or different requirements for medical devices that have already been licensed/approved in another jurisdiction?

There are no fewer or different requirements for medical devices that have already been licensed/approved in another jurisdiction.

 
12. Is it possible to sell devices to or buy devices from other jurisdictions?

It is possible to sell medical devices to or buy devices from other jurisdictions.

 
13. Is it permitted to advertise medical devices to consumers? Are there restrictions on advertising?

The advertising of medical devices is not currently regulated. The only exception concerns group III medical devices (see Question 9, Advertising). A person licensed to sell a group III medical device can advertise such device directly to consumers. The draft Medical Device Regulations provide for more stringent advertising restrictions (see Question 9, Advertising).

 

Biological products

14. What are the general requirements for a biological product to be manufactured, advertised and sold?

Manufacturing

To the extent that a biological product falls within the definition of medicine, the requirements are the same as for medicines (see Question 3, Manufacturing).

Advertising

To the extent that a biological product falls within the definition of medicine, the requirements are the same as for medicines (see Question 3, Advertising).

Sale

To the extent that a biological product falls within the definition of medicine, the requirements are the same as for medicines (see Question 3, Sale).

 
15. What authority is responsible for regulating the manufacture, advertising and sale of biological products?

The regulatory authorities are the same as for medicines (see Question 5).

 
16. Are there fewer or different requirements for biological products that have already been licensed/approved in another jurisdiction?

The requirements are the same as for medicines (see Question 6).

 
17. Is it possible to sell biological products to or buy biological devices from other jurisdictions?

The possibilities are the same as for medicines (see Question 7).

 
18. Is it permitted to advertise biological products to consumers? Are there restrictions on advertising?

The restrictions on advertising are the same as for medicines (see Question 8).

 

Natural health products

19. Is there a category for natural health products (including, for example, traditional medicines, homeopathic medicines, supplements, vitamins and minerals)?

Natural health products are referred to as complementary medicines.

 
20. What are the general requirements for natural health products to be manufactured, advertised and sold?

Complementary medicines (or natural health products) may fall within the definition of medicine in the Medicines Act, and would accordingly be subject to the same manufacturing, advertising and selling requirements as medicines (see Question 3).

There is some confusion in South Africa regarding the requirement to register complementary medicines (which has not been resolved yet). Before 2002, there were a number of call-up notices for complementary medicines. However, in 2002, the Medicines Control Council (MCC) published a Call-up Notice for Medicines Frequently Referred to as Complementary Medicines (Government Notice R2014 of Government Gazette 23128 of 22 February 2002) (2002 Notice), which categorised the following as complementary medicines:

  • Anthroposophic medicines.

  • Aromatherapeutic medicines.

  • Ayurvedic medicines.

  • Chinese traditional medicines.

  • Energy substances.

  • Homeopathic medicines.

  • Nutritional substances that purport to have therapeutic or medicinal effects.

  • Western herbal medicines.

  • Unani-Tibb medicines.

  • Combination homeopathic/flower essence.

  • Combination complementary medicines.

The 2002 Notice indicated that the submission of an application in response to the 2002 Notice would not constitute product registration, but would rather be considered as a primary step in the registration process. The 2002 Notice also stated that it "supersedes all previous call-up notices for preparations of this nature". The High Court considered the impact of the 2002 Notice in Treatment Action Campaign and Another v Rath and Others [2008] 4 All SA 360 (C) and decided that it was not a call-up notice and did not subject the products identified in it to registration (paragraphs 64 and 65).

Subsequently, the Minister of Health amended the General Medicines Regulations so that complementary medicines are currently categorised. It appears that the purpose of such categorisation is to start calling up complementary medicines so that they are subject to registration. The MCC has published a Guideline entitled "Roadmap for Registration of Complementary Medicines", dated 15 November 2013 (Complementary Medicine Guideline), which confirms that (pages 5 and 6):

  • Manufacturers, wholesalers and distributors of complementary medicines must be licensed to supply complementary medicines.

  • Complementary medicines must comply with the labelling requirements set out in the Medicines Act and General Medicines Regulations.

Manufacturers of complementary medicines and persons wishing to sell complementary medicines in South Africa are advised to consider whether their products fall within the categories of medicines that have already been called up (to determine if the medicine should be registered). In addition, they should expect that all complementary medicines will be called up by November 2019 (page 8, Complementary Medicine Guideline).

 
21. What authority is responsible for regulating the manufacture, advertising and sale of natural health products?

The Medicines Control Council (MCC) and the Department of Health (DoH) are responsible for regulating the manufacture, advertising and sale of natural health products.

For more information on the MCC and the DoH see box: The regulatory authorities.

 
22. Are there fewer or different requirements for natural health products that have already been licensed/approved in another jurisdiction?

There are no fewer or different requirements for complementary medicines that have already been licensed/approved in another jurisdiction.

 
23. Is it possible to sell natural health products to or buy natural health products from other jurisdictions and/or electronically?

If the complementary medicine is a medicine subject to registration, then it will need to comply with the requirements of the Medicines Act and its regulations (see Question 3). If not, then it is possible to sell/buy complementary medicines to/from other jurisdictions, including electronically.

 
24. Is it permitted to advertise natural health products to consumers? Are there restrictions on advertising?

If the complementary medicine is a medicine subject to registration, then it will need to comply with the requirements of the Medicines Act and its regulations (see Question 3). If not, then there are no restrictions on advertising complementary medicines to consumers.

 

Reform

25. Are there any plans to reform the rules on the development, manufacture, advertising and sale of medical products?

The Minister of Health has published the draft Regulations on Medical Devices, which are set to comprehensively regulate medical devices in South Africa. The Regulations will require the registration of medical devices with the Medicines Control Council (MCC) and the licensing of entities that supply medical devices. They will also restrict the advertising of medical devices.

The Department of Health (DoH) is committed to decreasing the price of medicines in South Africa. Like in most jurisdictions, medicine prices are regulated. However, it is likely that international benchmarking of medicine prices will be introduced. This means that medicine manufacturers will have to benchmark the price of a medicine sold in South Africa against the lowest price of such medicine in a basket of comparator countries.

The DoH is in the process of introducing the National Health Insurance (NHI). The NHI Policy Paper suggests that it will involve the provision of a state-funded comprehensive package of care to all South Africans. Members of the public will still be entitled to purchase private healthcare insurance but they will not receive any tax subsidies (paragraph 137, NHI Policy Paper). The package of care is intended to include a wider range of primary healthcare services than are currently provided in state hospitals. Healthcare services will be provided by existing public and private healthcare providers, and the cost of such services will be financed through the NHI Fund. Very little has been said about medicines in the NHI Policy Paper. However, it appears that only generic medicines will be included in the care package, and not originator medicines (paragraph 116(b), NHI Policy Paper). However, the package of care will not include medicines that are not on the Essential Drug List (EDL), except where approved by the Minister of Health (see the media statement issued by the Minister on NHI on 11 August 2011).

 

The regulatory authorities

Medicines Control Council (MCC)

W www.mccza.com

Principal responsibilities. The MCC is primarily responsible for the registration of medicines (and therefore for their safety and efficacy) and the licensing of suppliers.

Department of Health (DoH)

W www.doh.gov.za

Principal responsibilities. The DoH is responsible for the enforcement of the Medicines Act and its regulations. It also plays a role in the regulation of medicine prices and charges rendered by suppliers.



Online resources

Medicines Control Council (MCC)

W www.mccza.com

Description. Official website of the MCC. This website is not updated regularly.

Department of Health (DoH)

W www.doh.gov.za

Description. Official website of the DoH.



Contributor profile

Kerry Williams, Partner

Webber Wentzel

T +27 11 530 5805
F +27 11 530 6806
E kerry.williams@webberwentzel.com
W www.webberwentzel.com

Professional qualifications. High Court of South Africa, Attorney

Areas of practice. Healthcare law; procurement law; administrative law and constitutional law.

Non-professional qualifications.

  • BA(Hons), University of Cape Town.
  • LLB, University of Cape Town.
  • LLM, University of London.
  • Mid-career MPA, Harvard University, John F. Kennedy School of Government.

Recent transactions

  • Advising the representative body of pharmacists in South Africa in relation to the regulation of pharmacists' dispensing fees, which included a judicial review challenging the dispensing fee heard in the High Court, the Supreme Court of Appeal and the Constitutional Court.
  • Advising the representative body of specialist medical practitioners in relation to a reference price list for their professional services, and to medical schemes' obligation to reimburse for prescribed minimum benefits (this advice has included representing clients before the Council for Medical Schemes' Appeal Board and in the High Court).
  • Regularly advising all participants in the medicine supply chain in relation to supply agreements and other regulatory requirements, including specialised advice on the conduct of clinical trials, emerging technologies and new inventions.

Languages. English

Professional associations/memberships.

  • Law Society of South Africa.
  • African Leadership Network.

Publications. "Pharmaceutical Price Regulation", South African Journal of Human Rights, 1 (23), 2007, p 1- 33.


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