Complementary Medicines (CMs) in the new dispensation The terms "complementary medicine" or "alternative

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  • Complementary Medicines (CMs)

    in the new dispensation respice adspice prospice

    Dr Neil Gower MTech Hom (UJ) CML (UNISA)

    Member: Medicines Control Council

    Chairperson: Complementary Medicines Committee

    Member: Legal Committee, Good Practices Compliance Committee

    Senior Lecturer: Faculty of Health Sciences, University of Johannesburg

  • Introduction

    ▪ Complementary Medicine in South Africa

    ▪ Principles

    ▪ CM Regulation in South Africa

    ▪ Towards SAHPRA

    ▪ Application Process

    SAAPI 2017; Industry in Transition; Midrand, South Africa; 05 October 2017 2

    Old System

    New System

  • Complementary Medicine in South Africa

    SAAPI 2017; Industry in Transition; Midrand, South Africa; 05 October 2017 3

    ALLIED HEALTH PROFESSIONS COUNCIL OF

    SOUTH AFRICA

    MEDICINES CONTROL COUNCIL

    MEDICINES

    NON- PROPRIETARY

    Compounded or Extemporaneous

    PROFESSIONAL PRACTICE

    PROPRIETARY

    Commercialised / manufactured

  • Complementary Medicine in South Africa

    SAAPI 2017; Industry in Transition; Midrand, South Africa; 05 October 2017 4

    ALLIED HEALTH PROFESSIONS COUNCIL OF

    SOUTH AFRICA

    MEDICINES CONTROL COUNCIL

    MEDICINES

    NON- PROPRIETARY

    Compounded or Extemporaneous

    PROFESSIONAL PRACTICE

    PROPRIETARY

    Commercialised / manufactured

    • Section 22C(1)(a) of the Act (Licensing)

    • Regulation 3 (Conditions)

    • Regulation 10(5) and (6) (Label)

    • Regulation 12(7) (PIL)

    • Regulation 35 (Prescription book)

    • Regulation 40 (Vigilance)

    • Regulation 44 (Destruction)

  • SAAPI 2017; Industry in Transition; Midrand, South Africa; 05 October 2017 5

    Alignment with WHO Definitions Traditional vs Complementary Medicine

    Traditional medicine

    Traditional medicine is the sum total of the knowledge, skills, and practices based on the theories, beliefs, and experiences indigenous to different cultures, whether explicable or not, used in the maintenance of health as well as in the prevention, diagnosis, improvement or treatment of physical and mental illness.

    Complementary/alternative medicine (CAM)

    The terms "complementary medicine" or "alternative medicine" are used inter-changeably with traditional medicine in some countries. They refer to a broad set of health care practices that are not part of that country's own tradition and are not integrated into the dominant health care system.

    WHO. (2017). Traditional Medicine: Definitions. http://who.int/medicines/areas/traditional/definitions/en/

    AFRICAN TRADITIONAL MEDICINE

    NON-INDIGENOUS DISCIPLINES

    http://who.int/medicines/areas/traditional/definitions/en/

  • SAAPI 2017; Industry in Transition; Midrand, South Africa; 05 October 2017 6

    Alignment with WHO Definitions Traditional vs Complementary Medicine

    Traditional medicine

    Traditional medicine is the sum total of the knowledge, skills, and practices based on the theories, beliefs, and experiences indigenous to different cultures, whether explicable or not, used in the maintenance of health as well as in the prevention, diagnosis, improvement or treatment of physical and mental illness.

    Complementary/alternative medicine (CAM)

    The terms "complementary medicine" or "alternative medicine" are used inter-changeably with traditional medicine in some countries. They refer to a broad set of health care practices that are not part of that country's own tradition and are not integrated into the dominant health care system.

    WHO. (2017). Traditional Medicine: Definitions. http://who.int/medicines/areas/traditional/definitions/en/

    AFRICAN TRADITIONAL MEDICINE

    NON-INDIGENOUS DISCIPLINES

    http://who.int/medicines/areas/traditional/definitions/en/

  • SAAPI 2017; Industry in Transition; Midrand, South Africa; 05 October 2017 7

    Alignment with WHO Definitions Traditional vs Complementary Medicine

    Traditional medicine

    Traditional medicine is the sum total of the knowledge, skills, and practices based on the theories, beliefs, and experiences indigenous to different cultures, whether explicable or not, used in the maintenance of health as well as in the prevention, diagnosis, improvement or treatment of physical and mental illness.

    Complementary/alternative medicine (CAM)

    The terms "complementary medicine" or "alternative medicine" are used inter-changeably with traditional medicine in some countries. They refer to a broad set of health care practices that are not part of that country's own tradition and are not integrated into the dominant health care system.

    WHO. (2017). Traditional Medicine: Definitions. http://who.int/medicines/areas/traditional/definitions/en/

    AFRICAN TRADITIONAL MEDICINE

    NON-INDIGENOUS DISCIPLINES

    INTERATIVE MEDICINE?

    http://who.int/medicines/areas/traditional/definitions/en/

  • SAAPI 2017; Industry in Transition; Midrand, South Africa; 05 October 2017 8

    Recent History of CM Regulation

    Date Regulation Status

    22 July 2011 Publication of proposed amendment to the General Regulations

    Definition of Complementary Medicines

    For Comment

    3 Months

    15 November 2013 Implementation of General Regulations

    Definition of Complementary Medicines

    Category D

    Associated registration deadlines

    Inclusion in labelling requirements

    Implemented

    15 September 2014 Publication of proposed amendments to the General

    Regulations for comment

    Definition of Complementary Medicines to include Health

    Supplements

    Associated considerations for such inclusion.

    For Comment

    3 Months

  • SAAPI 2017; Industry in Transition; Midrand, South Africa; 05 October 2017 9

    Recent History of CM Regulation

    Date Regulation Status

    25 July 2016 Publication of proposed amendments to the General

    Regulations for comment

    including the intentions of the prior publication and

    incorporation of the definition of Health Supplement

    For Comment

    3 Months

    16 January 2017 Publication of proposed amendments to the General

    Regulations

    Provision for function of SAHPRA (see amended Act)

    Proposed global changes

    CMs: CM Definition, HS Definition, matters connected

    herewith

    For Comment

    3 Months

    25 August 2017 Implementation of General Regulations Implemented

  • SAAPI 2017; Industry in Transition; Midrand, South Africa; 05 October 2017 10

    CM Market Size

    ▪ 1996: the market share was R 900 million

    ▪ 2003: was estimated at R 1.35 billion

    ▪ 2010: SA Market size approx. R 7.8 billion - representing

    approx. 0.7 % of world market

    ▪ 2017: ???

    HPA. (2010). CAMs in South Africa, Alan Tomlinson; https://goo.gl/eAQB6O

    https://goo.gl/eAQB6O

  • Definitions

    Section 1(3)

    (3) In determining whether or not the registration or

    availability of a medicine is in the public interest,

    regard shall be had only to the safety, quality and

    therapeutic efficacy thereof in relation to its effect on

    the health of man or any animal, as the case may be. [Sub-s. (3) substituted by s. 1 of Act 17/79]

    SAAPI 2017; Industry in Transition; Midrand, South Africa; 05 October 2017

    Medicines and Relates Substances Act, 1965 (Act 101 of 1965) [as amended]

    11

  • Definitions

    “medicine” means any substance or mixture of substances used or purporting to be suitable for use or manufactured or sold for use in-

    (a) the diagnosis, treatment, mitigation, modification or prevention of disease, abnormal physical or mental state or the symptoms thereof in man; or

    (b) restoring, correcting or modifying any somatic or psychic or organic function in man,

    and includes any veterinary medicine; [Definition of “medicine” substituted by s. 1 of Act 17/79]

    SAAPI 2017; Industry in Transition; Midrand, South Africa; 05 October 2017 12

    Medicines and Relates Substances Act, 1965 (Act 101 of 1965) [as amended]

  • Definitions

    “complementary medicine” means any substance or mixture of substances that-

    (a) originates from plants, fungi, algae, seaweeds, lichens, minerals, animals or other substance as determined by the Authority;

    (b) is used or purporting to be suitable for use or manufactured or sold for use-

    (i) in maintaining, complementing or assisting the physical or mental state; or

    (ii) to diagnose, treat, mitigate, modify, alleviate or prevent disease or illness or the symptoms or signs thereof or abnormal physical or mental state of a human being or animal; and

    (c) is used-

    (i) as a health supplement; or

    (ii) in accordance with those disciplines as determined by the Authority;

    SAAPI 2017; Industry in Transition; Midrand, South Africa; 05 October 2017 13

    General Regulations made in terms of the Medicines and Related Substances Act, 1965 (Act 101 of 1965) [Gov.Not. 859 in GG 41064 of 25 Aug 2017]

  • Definitions

    “health supplement” means any substance, extract or

    mixture of substances a