A Windhoek pharmacy has won a court battle against the Namibia Medicines Regulatory Council and the minister of health and social services over attempts by the council to restrict the pharmacy’s preparation of tailor-made medicines that are not otherwise available in Namibia.
The pharmacy scored the win in a judgement in which Windhoek High Court judge Shafimana Ueitele declared a regulation published in July 2008 under the Medicines and Related Substances Control Act as invalid, after finding that the minister acted beyond the scope of the powers given to him in the act when he made the regulation.
Novecy Pharmacy in Windhoek is primarily a compounding pharmacy, selling medicines prepared by it for individual patients on request from medical doctors and also other pharmacies, the court was informed in an application that the close corporation Novecy Pharmacy CC filed against the Namibia Medicines Regulatory Council, the health minister and the registrar of medicines in January 2022.
A member of the close corporation, pharmacist Riana Potgieter, also informed the court that inspectors of the council in September 2020 and also in July 2021 confiscated medicines prepared by Novecy Pharmacy, while claiming that the pharmacy was carrying out the manufacturing of medicines under the guise of compounding medicines.
As a result of the council’s stance, the medical aid claims administrator Methealth Namibia Administrators decided to reject medical aid claims for medicines prepared by Novecy Pharmacy, Potgieter said in an affidavit filed at the court.
Potgieter said Novecy Pharmacy prepares medicines that are not otherwise available in Namibia and are often needed by people with life-threatening illnesses.
The medicines prepared by the pharmacy and not otherwise available in Namibia include medication used for the treatment of various types of cancer and to extend the lives of patients with incurable cancer and nevirapine syrup that is given to babies to prevent them from contracting HIV from their mothers.
The pharmacy also prepares chemotherapy medication that is not available in Namibia and anti-nausea medicine that is given to patients undergoing intravenous chemotherapy, Potgieter related in her statement.
Potgieter also said in her affidavit that the medicines prepared by Novecy Pharmacy in many instances cost less than what manufactured versions of the same medicines used to cost when it was available in Namibia previously.
Ueitele found that the Medicines and Related Substances Control Act, by giving pharmacists the right to compound medicine for sale in small quantities to ultimate consumers, implies that a pharmacist may prepare medicines by mixing their ingredients proactively, to meet patients’ foreseen needs.
In the regulation that was declared invalid, it was stated that a pharmacist may only compound or prepare medicine “extemporaneously”.
During the hearing of Novecy Pharmacy CC’s case against the Namibia Medicines Regulatory Council, the health minister and the registrar of medicines, it was argued on behalf of the respondents that the term “extemporaneously” meant a pharmacist was allowed to only prepare medicine for a particular patient and that the pharmacist was not permitted to prepare medicines in advance for use by patients.
Ueitele noted in his judgement that the act allows the health minister to make regulations prescribing the quantities of unregistered medicine which may be compounded and sold in the pharmaceutical trade and the conditions under which the compounded medicine may be sold.
The regulations made by the minister may not take away the right to prepare medicine in small quantities that the act granted to pharmacists, Ueitele said.
He added that in so far as the regulations attempted to take away Novecy Pharmacy’ right to prepare medicines in advance, the regulation was against the act and had to be declared invalid.
Novecy Pharmacy CC was represented by senior counsel Raymond Heathcote, assisted by Japie Jacobs and instructed by Stephen Vlieghe of the law firm Koep & Partners.
Senior counsel Geoff Budlender, assisted by Marius Boonzaier, represented the council, minister and registrar of medicines.
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