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Medicines

If people let the Government decide what
foods they eat and what medicines they take,
their bodies will soon be in as sorry a state
as the souls who live under tyranny.1

Thomas Jefferson

If Thomas Jefferson, the principal author of the 1776 American Declaration of Independence, and third President of the United States, had lived today his undoubted wisdom may have penned something different. The common painkiller, paracetamol, was first used on a patient only in 1887, for example, more than a century later. Penicillin was only discovered in 1928.

Modern medicines can be powerful and immeasurably beneficial, but also very dangerous – in short, we need to be protected against ourselves.

The Medicines and Related Substances Act 1965 provides for the controlled registration, advertising, sale, and use of medicines and medical devices for human (and non-human) ailments.

  • A ‘medicine’ is any substance which is used, or which purports to be suitable for use, or is manufactured or sold for use in relation to just about anything to do with treating humans, human functions – and also treating animals, birds, fishes, reptiles and amphibians (i.e. veterinary medicines);

  • A ‘medical device’ means just about any kind of thing (including software) for diagnosis, prevention, monitoring, treatment, investigation, and so forth.

  • An ‘IV Device’ is a medical device intended to be used in vitro – in other words, inside the body.

A. Sale of medicines and medical devices

The Medicines Control Council used to be responsible for determining whether a medicine must be registered in terms of the Act, as well as – in particular – the conditions2 upon which it may be sold and used. (The determination is published in the Government Gazette.) Since an amendment effected in 2017, the Authority has been replaced by the South African Health Products Regulatory Authority.

  1. Section 22A of the Act sets out the circumstances and controls under which the various scheduled medicines (schedule 0 to schedule 8) may be sold, manufactured and possessed. It is a crime to sell or manufacture any medicine or medical device, or have it in your possession, except as is permitted in terms of those prescribed regulations.3

  2. It is a criminal offence to sell any medicine or medical device required to be registered, if it has not been registered with the Authority.4

  3. It is a crime to make any false or misleading statement in connection with any medicine or medical device in an application to the Authority for registration, or in the course of selling the medicine or medical device.

  4. If any person fails to comply with any condition imposed by the Authority on its use or sale he commits a criminal offence.5

  5. It is an offence to sell any medicine unless the (immediate) container or package in which it is sold bears a label stating all the details required by Regulation.6

  6. It is a criminal offence to supply any medicine, free of charge, to any pharmacist, doctor, dentist, vet or other health practitioner.7 8

  7. All medicines must comply with certain requirements prescribed by the Minister of Health. It is an offence to sell any medicine which does not so comply.9

  8. The Authority may direct any manufacturer, wholesaler, retailer or any person who administers or prescribes any medicine to furnish the Council with information regarding such medicine. It is an offence not to comply with such a direction.10

  9. Not anyone may dispense or compound (that is, make up) a medicine. It is a criminal offence to do so unless such person is a veterinarian, a holder of a licence, or is authorised to do so in terms of the Pharmacy Act 1974.11

  10. Not anyone may manufacture, import, export, wholesale, or distribute medicines and it is an offence to do so unless licensed by the Authority.12

  11. The Minister of Health is empowered to prohibit the manufacture, sale or use of certain veterinary medicines. It is an offence to fail to comply with any such prohibition, or any condition that may be imposed by the Minister on its manufacture, sale or use.13

B. Advertising of medicines

  1. No person may advertise any medicine for sale unless the advertisement complies with prescribed requirements14 and it is an offence to do otherwise.15

  2. It is an offence to publish, distribute or in any way bring to the notice of the public an advertisement, concerning any medicine, which is false or misleading.16

  3. As soon as practicable after it has been registered, the Authority informs medical practitioners, dentists and pharmacists (and the applicant for registration) of the therapeutic efficacy and effect of the medicine in question.17 It is a crime to make any claim, directly or indirectly, that the efficacy or effect is otherwise than so stated by the Authority.18

  4. The Authority also notifies (them) of the purpose for which, the circumstances under which, and the manner in which such medicine should be used. It is a crime to suggest or state, in any advertisement, another purpose, circumstance or manner of use.19

C. Generic substitution

Certain medicines are only available on prescription from a medical practitioner. (This is part of the controls imposed via the various different schedules.) Previously, if the doctor prescribed a certain proprietary brand medicine, that medicine – and that medicine only – had to be supplied by the pharmacist.

In 1997, generic substitution was permitted. As a result, a pharmacist can dispense a medicine which does the same thing as the proprietary brand medicine prescribed by the doctor. The idea is that the generic equivalent20 will be cheaper, thus helping to reduce the cost of health-care.

  1. The pharmacist commits a criminal offence if he does not advise the public, when they present a prescription for a branded medicine, of the benefits of generic substitution.21

  2. He also commits a criminal offence if he does not dispense a generic substitute, instead of the branded medicine prescribed by the medical practitioner, unless:
    • the doctor (etc.) has specified on the prescription ‘no substitution’;22
    • the patient forbids the substitution;23 or
    • the retail price of the substitute is higher than that of the prescribed medicine.24

  3. If the patient forbids the substitution, the pharmacist commits an offence if he does not note this on the prescription.25

  4. If the pharmacist dispenses a generic substitute, he commits an offence if:
    • he fails to note, in the prescription book, its brand name or the name of its manufacturer;26
    • he does not take reasonable steps to inform the prescribing doctor (etc.) of the substitution.27

D. Inspectors

The Director-General: Health appoints inspectors for the enforcement of the Act. They have wide powers of entry, search, inspection, seizure, taking samples, etc.

  1. Any person who obstructs or hinders an inspector in the exercise of his powers, or performance of his duties commits an offence.28

  2. Any person who tampers with a sample commits an offence.29

  3. It is also an offence to use any report or certificate issued by an inspector (or an analyst, pharmacologist or pathologist) for purposes of business or trade.30

  4. Except for purposes of exercising powers or duties, or if required in legal proceedings, it is an offence for an inspector to disclose any information relating to the business or affairs of any person which he acquired in the exercise of his powers or duties; or to use such information for self-gain, or that of his employer.31

  1. Quote taken from www.goodreads.com/quotes/tag/medicine. ↩

  2. In particular, the so-called ‘Schedule’ under which it falls. In degrees of strictness, controls increase from a schedule 0 medicine (it may be sold in an open shop) to a schedule 8 drug (only the Director-General in the Department of Health can acquire it). ↩

  3. Section 22A(1) read with section 29(k). ↩

  4. Section 14(1) read with section 29(b). ↩

  5. Section 15(7) read with section 29(e). ↩

  6. Section 18 read with section 29(b). ↩

  7. This ‘sampling’ does not apply in the case of clinical trials, donations to the State, or quality control by inspectors. ↩

  8. Section 18B read with section 29(b). ↩

  9. Section 19(1) read with section 29(c). ↩

  10. Section 19(2) read with section 29(c). ↩

  11. Section 22C(5) read with section 29(k). ↩

  12. Section 22C(6) read with section 29(k). ↩

  13. Section 36A read with section 29(m). ↩

  14. Listed in Regulation 45 – at least, the proprietary name of the medicine, the name and quality of each active ingredient and registration number must appear. ↩

  15. Section 18(2) read with section 29(b). ↩

  16. Section 20(1) read with section 29(d). ↩

  17. Section 22(1). ↩

  18. Section 20(1)(b). ↩

  19. Section 20(1)(b). ↩

  20. Referred to in the Act as an ‘interchangeable multi-source medicine’. ↩

  21. Section 22F read with section 29(k). ↩

  22. Section 22F(4)(a). ↩

  23. Section 22F(1)(b). ↩

  24. Section 22F(4)(b). ↩

  25. Section 22F(2) read with section 29(k). ↩

  26. Section 22F(3) read with section 29(k). ↩

  27. Section 22F(1)(a) read with section 29(k). ↩

  28. Section 29(a). ↩

  29. Section 29(g). ↩

  30. Section 29(j). ↩

  31. Section 34 read with section 29(l). ↩

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