Act 101 – Draft
Amendment Bill
Norman Fels
Janet Welham
Howard Snoyman
5 Nov. 2014
The Parliamentary
Portfolio Committee on
Health
Presented by
The Health Products Association (HPA) of South
Africa
Honourable Members –
Thank you for this opportunity.
Our Presentation
• Confined to: Who we are & a Brief History
• Our market place and diversity of players.
• The current situation. Why we have problems and
projected consequences
• Act 101 – Medicines = Transport & “clubs”
• One size fits all?
• Key Issues
• The route to success
WHO IS THE HPA
• Established 1976
• Represent 114 member companies from the Health
Products Industry
• A R7 Billion turnover Industry
• Founding Member of IADSA (International Alliance of
Dietary Supplements Association) which works
closely with CODEX
HPA POSITION
The HPA hopes to continue with the constructive and proactive
approach adopted over the past 30 years.
The HPA supports:
– The control of Complementary and Traditional Medicines
through Separate, Appropriate and Equitable Regulations
that control appropriate Quality, Safety and Efficacy
The HPA does not support:
– Misleading and irresponsible advertising
– Manufacturers and marketers of products that do not take
safety, efficacy and quality seriously
The Current Situation
• Misguided perception that the HPA does not want to be
regulated
• The Legislative and Regulatory framework for CAMS is unclear,
confusing and problematic. Carts before horses!
• The November 2013 Regulations precipitated litigation which
is unfortunate.
• This process legal will not solve anything – only constructive
engagement and rational debate among all stakeholders can
produce a successful outcome.
What happened?
• Act 101 of 1965 was written for allopathic medicine and the
definition of a medicine has stood the test of time.
• In the 1980s it was acknowledged that CAMS were different
and had to be regulated against some different criteria (e.g.
Paradigms, belief & energy systems/traditional practice)
• Not so easy with one “rule book” . Good progress made but
never promulgated (2004,2008,2011)
• Total change in direction in 2013 Regulations. No comment
period.
• No impact assessment.
Potential Consequences
• Estimated 60% of products may be removed from shelves. (i.e. R4 Billion).
Impact on S.A. economy about R20 billion. Tax revenue lost.
• Registration could take 5 years or longer. (CTD system)
• Few CAMS companies could survive the loss of revenue.
• Consumers could be deprived of their freedom of choice of products and
health modality.
• Practitioners may not have access to product.
• Retailers (particularly small pharmacies) will suffer badly.
• The distribution chain, advertising, manufacturing and packaging
industries will lose revenue.
• Job losses are difficult to quantify but will be significant.
• Import and export trade jeopardised.
What is a Medicine?
• Act 101 says EVERYTHING THAT ENTERS OUR BODIES – Brilliant!
• Can all medicines be regulated in the same way? Natural does not
mean safe. Regulation does not guarantee safety.
• The Transport Analogy. Diversity= complexity.
• Trains and Boats Planes
• What is Appropriate? A = f{Risk} Clubs & money. SABS
• Easy, inexpensive and fast registration will promote conformance.
Under-regulation and bad or inappropriate
regulations breed “cowboys”
Key Issues.
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Definitions
Licenses
Responsible pharmacist/person
CTD Registration & capacity concerns
Schedules
Concern: The link between Act 101 and the
Pharmacy Act
The Roadmap to Success
• Amend the Bill to create a sustainable structure and management team
for SAHPRA.
• Broadly define the various “Pillars” of Control (i.e. Allopathic, Devices, Vet,
Cosmetics, CAMS) in the ACT. CAMS definition to excluded Allopathic
medicines.
• Empower the Minister to create and define, in the Regulations, subcategories/classes to accommodate the various modalities/classifications
• Apply appropriate criteria for each. E.g. Listing system.
• Uncouple Act 101 from the Pharmacy Act (vis-a-vis licences and
Responsible Person/Pharmacists where appropriate).
The ACT
SAHPRA BOARD
Cat A
Cat D
Allopathic
CAMS
COS
VET
DEV
ETC
Regulations
AHP
CAMS and
Traditional
Medicines
Indian TM
Chinese TM
African TM
Non invasive
Supplements
Accommodate and regulate
all classes/modalities of
CAMS and Traditional
Medicines in an appropriate
and risk related way.
THE WAY FORWARD
• Clearly, there is a great sense of urgency in finding
solutions. The Act can make this possible.
• Litigation should be avoided – it can’t solve the
problems
• The process of constructive engagement must
continue.
• Legislate and regulate in “bite-sizes pieces” – it’s
much easier.
THANK YOU