Issued by Department of Health
11 March 2005
The Department of Health welcomes the ruling of the Constitutional Court on the application made by the Affordable Medicines Trust and the National Convention on Dispensing against the provisions of the Medicine Control Act dealing with dispensing of medicines.
The Constitutional Court upheld the constitutionality of the provision of the Act which stipulates that health providers such as medical practitioners, dentists and nurses, may not dispense medicine unless they have been issued with a licence to dispense medicine by the Director-General.
In a unanimous judgement, the Court found that discretionary powers of the Director General to determine conditions upon which a licence may be issued are not vague as contended by the applicant but are appropriately guided by the statute. The court held that the conditions that may be imposed are only those that further the objective to increase access to medicines that are safe for consumption by the public.
This means that the Department can continue to regulate the dispensing of medicine including the issuing of licences to professionals with necessary competencies to dispense medicines.
Contrary to the argument by the applicants, the Court also found that the Minister of Health did not exceed her powers by making regulations that link these licences to particular premises where medicines are compounded and dispensed. The court found that the Medicines Act confers wide powers on the Minister to make regulations with regard to any matter to ensure the safety, quality and efficacy of the medicines. The court found if the public is to have access to medicines that are safe, then dispensing could not be de-linked from the premises from which such dispensing occurs and linking licences to premises does not violate any constitutional right.
This is a major victory in the Department's efforts to ensure that medicines are kept and dispensed from an environment that is conducive to safety, quality and efficacy of the medicines.
The Constitutional Court found that the provisions of the regulations that allow the Director General in considering a licence application, to protect pharmacies against competition from medical practitioners and nurses were outside of the scope of the Medicines Act and therefore unconstitutional.
The Department of Health has always been of the view that the consideration of the proximity to a pharmacy could not, on its own, constitute ground for denying a dispensing licence.
The Department of Health therefore views the ruling of the Constitutional Court as a major victory in its efforts to ensure that dispensing health professionals have the necessary competencies to compound and dispense medicine and that medicine are kept and dispensed in an environment that promotes safety, quality and efficacy of medicines.
The Constitutional Court endorsed the right of government to regulate where people practice in order to protect the public interest. The Constitutional Court has unequivocally ruled and upheld government's intention to protect the public, ensure patient safety and improve access to safe, quality medicines.
Contact: Sibani Mngadi @ 0827720161