5 Jun 1997

5 June 1997



Two important Bills have been introduced by the Minister of Health,
Dr Zuma, to extend the public`s access to cheap and effective medicines.
The Pharmacy Amendment Bill aims to increase the range of outlets at which
medicines can be dispensed, while the Medicines and Related Substances
Control Amendment Bill aims to reduce the cost of medicines by introducing
new purchasing and dispensing regulations.

Pharmacy Amendment Bill

Under present legislation, only registered pharmacists are permitted
to own pharmacies. This gives pharmacists a monopoly on the ownership of
pharmacies, which is where the majority of medicines in South Africa are
dispensed. The new Bill proposes to allow any person, corporation and body
corporate to own and carry on a pharmacy business, subject to the requirement
that the pharmacy businesses are under the continuous personal supervision
of registered pharmacists.

In effect, this not only means that anyone can own a pharmacy and employ
a pharmacist to run it, but that other outlets can open pharmacy businesses
on their premises. Supermarkets like Pick`n`Pay, Shoprite Checkers and
OK Bazaar, or shops like Clicks, would be allowed, under the Bill, to open
pharmacy counters or sections within their stores, as long as these pharmacy
sections are supervised by a registered pharmacist.

The benefits of this proposal include:

  • an increase in the number of outlets able to dispense medicines - which
    should improve public access to medicines
  • increased competition - which should reduce prices
  • increased job opportunities among pharmacists, who are unable to establish
    pharmacies on their own.

How will Pharmacies be Controlled?

Pharmacies would be strictly regulated and supervised by a new South
African Pharmacy Council, a new body proposed in the Bill. The controls,
which will ensure safety and quality, include that:

  • anyone wishing to carry out a business as a pharmacy must apply for
    a licence to the Director General of the Department of Health
  • the license can be suspended or cancelled by the Director General
  • the business of the pharmacy must be conducted under the personal supervision
    of a pharmacist registered with the Council
  • the registered pharmacist will be responsible to the Council for any
    act performed by the pharmacy (unless responsibility rests with another
    registered pharmacist employed in the same capacity)
  • the Council will have the right to inspect the premises in which the
    pharmacy business is being carried out.

The proposals in this Bill will allow South Africans the same access
to pharmacy services as is already enjoyed by people in Britain, America
and many other countries throughout the world.

Medicines and Related Substances Control Amendment Bill

Under present legislation, only medicines registered in South Africa
can be imported and supplied. It is not currently possible for pharmacies
to obtain or dispense `generically equivalent` medicines - medicines which
contain the same active ingredients and are identical in dose or concentration
and dosage form to the registered, branded medicines, but which are usually
considerably cheaper. This Bill proposes to change this situation and thereby
considerably increase South Africa`s access to cheap, reliable medicines.

Parallel Importation

A key proposal is to allow the `parallel importation` of medicines,
which means buying an identical product made by the same company, but from
a different location than the South African company purchases it - and
at a lower price. It will also be permissible to import medicines not currently
registered in South Africa if they are generically equivalent to
medicines registered in South Africa.

Prescribing Generically Equivalent Medicines

Doctors and others issuing prescriptions will be permitted to prescribe
generically equivalent medicines, instead of branded medicines. Moreover,
whenever a person takes a prescription to a pharmacist, the pharmacist
will have the following obligations:

  • to inform the person of the benefits of substituting the prescribed
    medicine with a generically equivalent medicine
  • to dispense a generically equivalent medicine, instead of the medicine
    prescribed, unless expressly forbidden to do so by the patient.

A pharmacist will not be permitted to dispense a generically
equivalent medicine if:

  • the person prescribing the medicine has written `no substitution` in
    his/her own handwriting on the prescription
  • the retail price of the generically equivalent medicine is higher than
    that of the prescribed medicine
  • the product has been declared unsuitable by the Interim Pharmacy Council
    of South Africa, or its successor.

Other Proposals in the Bill

Pricing Committee to be established to advise the Minister on
a transparent pricing system for all medicines, to monitor the pricing
of medicines and advise on an appropriate dispensing fee.

Bonusing to be banned. No person will be allowed to supply any
medicine according to a bonus system, a rebate system or any other incentive

Sampling to be banned. No person will be allowed to sample any
medicine, which means that no manufacturer, wholesaler or agent will be
allowed to supply free medicines to any pharmacist or any other licensed

Code of ethics a code of ethics will be prescribed by the Minister
relating to the marketing policies of pharmaceutical companies.

These two Bills are a major step forward in the drive to improve South
Africa`s access to cheap, safe, quality medicines. The reduction in costs
will allow the Health Department to use money currently being spent on
medicines to improve other areas of health, will reduce costs to patients,
reduce costs to medical aid providers and bring South Africa`s medicines
supply and dispensing policies in line with those in other countries.