making false claims about medicines - selling, advertising enforcing the law fatima hassan senior...
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Making false claims about medicines - selling, advertisingEnforcing the law
Fatima Hassan
Senior Attorney
26 September 2006
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The legal framework
Three tiers: – The manufacture, importation, advertising,
distribution and sale of medicines and related substances is controlled by the Medicines and Related Substances Control Act (101 of 1965), as amended
– Regulations issued under the Act – Foodstuffs Act
If x is a medicine then this is not applicable
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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;
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Defining a medicine
Definition of medicine is broad – Any therapeutic claim or claim about improving health is regarded
as a medicine – Irrespective of ‘selling’ in profit sense – Includes claims on vitamin supplement, diet supplements,
traditional medicines – Test is whether it falls under definition of medicine -not whether it
is registered or not Example, TAC et al v MCC, Rath et al
– If a medicine, then prohibited from making false claims, cannot claim efficacy other than that approved by MCC, cannot claim purpose other than that approved by MCC (s20)
– If a medicine, and subject to resolution calling for registration, prohibited from selling (broad sense) until registered (s14)
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What is an advert?
‘Advertisement', in relation to any medicine or scheduled substance, means any written, pictorial, visual or other descriptive matter or verbal statement or reference-
– appearing in any newspaper, magazine, pamphlet or other publication; or
– distributed to members of the public; or– brought to the notice of members of the public in any
manner whatsoever, which is intended to promote the sale of that medicine or Scheduled substance; and 'advertise' has a corresponding meaning;
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Violations of Act
Section 29: Offences– Violation of s14
Making false or misleading statement in connection with any medicine or Scheduled substance in registration application or in sale
Container has false or misleading statement Selling is defined broadly Distributing and promoting are included
– Violation of s20 False or misleading advert or making additional unauthorised claims
re. efficacy or purpose Section 30: Penalties
– Fine; or – Imprisonment for a period not exceeding 10 years
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Who enforces?
Law Enforcement Unit Under Medicines Regulatory Authority DoH
Forefront of enforcement Needs more resources
Civil Society and ASA Watchdog?Litigant?Voluntary subscription Gaps in ASA Code
MCCRegulatory authority DoHIndependent? By law register medicines + approve trials
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Enforcement
Law Enforcement Unit – s26 appoints health inspectors with powers to
enter, search, seize– It is obliged to enforce the Act – It is not the job of the SAPS to enforce
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Conclusion
A medicine is what the Act defines it to be in s1 False claims when selling, promoting, advertising and distributing
(regarded broadly) is prohibited – Also, prohibit selling if called up for registration by resolution until it is
registered The LEU has a statutory duty to investigate and prohibit false claims
and illegal sales, advertising, distribution and promotion – The MCC must register and approve medicines and trials
A violation is punishable The real issue is what we do about the known lack of capacity and
unwillingness to enforce - Lack of sufficient resources Lack of political will to investigate certain claims and obvious violations
(denialism)