The current status of the South African healthcare law programme

1. ROSES ARE RED VIOLETS ARE
BLUE…
Anele Khumalo

2. NATIONAL HEALTH ACT NO. 61 OF
2003
National Health Amendment Act No. 12 of 2013, effective from
1 September 2014 -
> Establishes the Office of Health Standards Compliance
> Minister to determine “Norms and Standards”
> Certificate of Need
> Investigatory powers of health officers and inspectors
2

3. Office of
the Health
Standard
and
Compliance
OHSC
Board
CEO
Ombud
3
THE OFFICE OF HEALTH STANDARDS
COMPLIANCE (“OFFICE”)

4. THE OFFICE OF HEALTH STANDARDS
COMPLIANCE (“OFFICE”)
THE OFFICE
> Advises the Minister on matters relating to the determination of the norms and standards and
assists the Minister with the review of the norms and standards.
> Issues compliance certificates.
> Inspects and certifies health establishments as compliant or non-compliant with the norms
and standards.
THE BOARD
> The Office functions under the control of the Board.
> The Board is the accounting authority of the Office and determines the policy of the Office.
4

5. THE OFFICE OF HEALTH STANDARDS
COMPLIANCE (“OFFICE”)
The CEO
> Is the head of the Office in terms of section 79(1)(a).
> Is appointed by the Board in consultation with the Minister of
Health.
Ombud
> Considers and investigates complaints.
> Can initiate investigations.
> Has inquisitorial powers.
5

6. CERTIFICATE OF NEED
SECTIONS 36 TO 40
“certificate of need” means a certificate contemplated in section
36. A certificate of need is required to -
“ (a) establish, construct, modify or acquire a health establishment
or health agency;
(b) increase the number of beds in, or acquire prescribed health
technology at, a health establishment of health agency;
(c) provide prescribed health services; or
(d) continue to operate a health establishment or health agency
after the expiration of 24 months from the date this Act took
effect…”
6

7. MEDICINES AND RELATED
SUBSTANCES ACT 101 OF 1965
Regulations made in terms of the Medicines Act published in
Government Gazette 37032 dated 15 November 2013:
> introduced the definition of “complementary medicine”;
> required compliance within 3 months of the publication of the
Regulations;
> all complementary medicines falling in Category D are now
subject to registration; and
> pharmacological classification of the complementary
medicine will determine whether the complementary
medicine must be registered within 6 months or 30 months
of the regulations being published (regulation 48C(2)).
7

8. MEDICINES AND RELATED
SUBSTANCES ACT 101 OF 1965
“complementary medicine means any substance or mixture of
substances that –
(a) originates from plants, minerals or animals;
(b) is used or intended to be used for, or manufactured or
sold for use in assisting the innate healing power of a
human being or animal to mitigate, modify, alleviate or
prevent illness or the symptoms thereof or abnormal
physical or mental state; and
(c) is used in accordance with the practice of the
professions regulated under the Allied Health Professions
Act, 1982 (Act No. 63 of 1982)”.
8

9. WHAT ARE COMPLEMENTARY
MEDICINES?
> African Traditional Medicine
> Anthroposophical Medicine
> Aromatherapy
> Ayurvedic Medicine
> Biochemical Tissue Salts
> Chinese Medicine
> Energy Substances
> Gemmotherapy
> Herbal Medicine
> Homeopathic Medicine
> Sowa Rigpa Medicine
> Unani-Tibb Medicine
> Orthomolecular Medicine
> Nutritional Food Substances
9

10. MEDICINES AND RELATED
SUBSTANCES ACT 101 OF 1965
Important changes introduced by the Regulations
> Labels, package inserts, patient information leaflet of
complementary medicines must contain a statement
identifying the discipline of the medicine.
> If the complementary medicine has not been registered with
the Medicines Control Council the complementary medicine
must have the prescribed disclaimer: "This medicine has not
been evaluated by the Medicines Control Council. This
medicine is not intended to diagnose, treat, cure or prevent
any disease.”
10

11. MEDICINES AND RELATED
SUBSTANCES ACT 101 OF 1965
Guideline documents published by the MCC
> Complementary Medicines – Use of the ZA-CTD Format in
the Preparation of a Registration Application”
> “Guidelines on Complementary Medicines – Quality, Safety
and Efficacy”
> “Roadmap for Registration of Complementary Medicines”
11

12. THE MEDICINES AND RELATED
SUBSTANCES AMENDMENT BILL B6-
2014
> Published on 26 February 2014
> Amendment Bill includes definition of “complementary
medicines”
12

13. MEDICAL INNOVATION BILL
> Legalisation of cannabis in South Africa for medical,
economic and industrial purposes.
> To establish one or more research hospitals where medical
innovation can take place, especially with regards to the
treatment and cure of cancer.
13

14. LABELLING & ADVERTISING OF
FOODSTUFFS
Draft Regulations Relating to the Labelling and Advertising of
Foods, published in Government Gazette 37695, dated 29 May
2014:
> will replace Labelling and Advertising regulations published in
2010;
> introduces 41 new definitions such as “complementary
medicine”; “Glycaemic Index (GI)” and “health claim”;
14

15. LABELLING & ADVERTISING OF
FOODSTUFFS
> the use of complementary medicines as an ingredient in a
foodstuff if the presence of the complementary medicine is
indicated by its brand name in the list of ingredients is
prohibited;
> stricter regulation of energy, nutrition, ingredient content
and health claims; and
> places restrictions on the marketing of foods to children.
15

16. THANK
YOU
Date 23 July 2014
Legal notice: Nothing in this presentation should be construed as
formal legal advice from any lawyer or this firm. Readers are
advised to consult professional legal advisors for guidance on
legislation which may affect their businesses.
© 2014 Werksmans Incorporated trading as Werksmans Attorneys.
All rights reserved.