1. 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

2. 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

3. 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

4. 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

5. 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

6. 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

7. 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”

8. 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

9. 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

10. 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

11. 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

12. 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

13. 22H (1) -Prohibits the Sale of Medicines Between Wholesalers
SMASA Proposal:
S0 & complementary medicines must be excluded from 22H (1)

14. Questions

15. Thank you