Making false claims about medicines - selling, advertising Enforcing the law Fatima Hassan Senior Attorney 26 September 2006

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

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;

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)

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;

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

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 MCC Regulatory authority DoH Independent? By law register medicines + approve trials

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

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)