THE SELF MEDICATION MANUFACTURERS ASSOCIATION OF SOUTH AFRICA (SMASA) MEDICINES AND RELATED SUBSTANCES AMENDMENT BILL, 2008 Nicola Brink Chairperson Health Portfolio Committee Cape Town August 2008

SMASA Members Adcock Ingram Bayer Consumer Care Boehringer-Ingelheim DJ Pharmaceuticals GlaxoSmithKline Johnson & Johnson Medreg Consultants Merck (Pty) Ltd Norgine Novartis Consumer Health Nycomed Madaus Pharmafrica Proctor & Gamble Reckitt Benckiser Smith & Nephew Wyeth Consumer Healthcare

Main Areas of Concern for SMASA Two tier system of registration and certification The definition of product – to include cosmetics and foodstuffs with medicinal claims Complementary medicines - lack of registration S0 medicines – current exemption from 18A & 22G of the Act Complementary medicines - 18A & 22G 22H(1) – current status

Two Tier System of Registration and Certification Medicine registration should remain purely a scientific and technical process implemented by a specialist body (the Authority) based purely on objective considerations of safety, quality and efficacy

OTC & Complementary Medicines Similar to other FMCG 97% not patent protected A prescription is not required Generally marketed directly to the consumer Consumers are the primary demand drivers Medical schemes do not generally offer reimbursement

Unnecessary addition to the Medicines Act Definition of Product - Foodstuffs and Cosmetics in Respect of which a Medicinal Claim is Made Unnecessary addition to the Medicines Act Uncertainty as to the type of product to fall within the ambit of the Act toothpaste, yoghurt, cereal ?? Unnecessary and confusing for the definition of “product” to include a cosmetic or foodstuff “in respect of which a medicinal claim is made Food labeling regulations when published will cover this

Definition of Product - Foodstuffs and Cosmetics in Respect of which a Medicinal Claim is Made SMASA Proposes: Definitions of “cosmetic” and “foodstuff” should be deleted from the Bill The phrase “or any cosmetic or foodstuff in respect of which a medicinal claim is made” should be deleted from the definition of “product”

Complementary Medicines 1000’s of complementary medicines sold in SA are not currently registered therefore not subject to the quality, safety and efficacy controls Must be properly called up for registration ASAP Must be assessed in terms of safety, quality and efficacy

Exemptions – 18A & 22G S0 medicines currently exempt from:  18A of the Medicines Act 22G (in so far as pricing is concerned) of the Medicines Act Effective from 30 May 2008 Previous exemption granted in 2004 (3 yrs) 18A – prohibits bonusing, discounts & rebates 22G – Single Exit Pricing The Bill does not provide for this exemption

Exemptions – 18A & 22G SMASA Proposes: Bill must be amended so clear that sections 18A and 22G of the Medicines Act do not apply to S0 medicines

Complementary Medicines – 18A & 22G For the same reasons that S0 medicines should be excluded from the requirements of sections 18A & 22G of the Medicines Act, Complementary medicines that have not been called up should also be excluded from the operation of sections 18A & 22G

22H (1) -Prohibits the Sale of Medicines Between Wholesalers In the FMCG environment - one wholesaler selling to another wholesaler is common Ensures maximum distribution of products to end users

22H (1) -Prohibits the Sale of Medicines Between Wholesalers SMASA Proposal: S0 & complementary medicines must be excluded from 22H (1)

Questions

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