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

3

Office of the Health Standard

and Compliance

OHSC Board

CEO

Ombud

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.

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.

6

CERTIFICATE OF NEEDSECTIONS 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…”

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)).

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)”.

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

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.”

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”

12

THE MEDICINES AND RELATED SUBSTANCES AMENDMENT BILL B6-2014

> Published on 26 February 2014

> Amendment Bill includes definition of “complementary medicines”

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.

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”;

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.

THANK YOUDate 23 July 2014

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