Minister of Health and Social Services v. Medical Association of Namibia

The Minister of Health and Social Services issued regulations for the Medicines Act that created a licensing scheme for medical practitioners to be able to continue to dispense certain medicine. It also established a three-month transitional grace period, where medical practitioners already dispensing medicine could apply for the license and continue dispensing medicine while their application was processed. Some practitioners failed to file for a license during the three-month transitional period and were denied an extension.

The respondents filed suit to declare the regulations as invalid on procedural grounds. The lower court agreed and set aside the regulations in its entirety for a number of procedural errors. The lower court found that the Medicines Control Council, required by the Medicines Act, hadn’t been properly established nor consulted and there could not have been meaningful consultation between the Minister and the Council because there was insufficient time between the publishing of the Medicines Act and the regulations.  It suspended the regulations and continued the transitional period until new regulations were issued. The Minister and others appealed.

The Court held that the lower court erred in declaring all the regulations made by the Minister to be invalid, after noting that the appeal was properly brought.

The Court found that Council had been properly established in 1965 and that the draft regulations had to be published prior to the operation of the Medicines Act to implement the Act, making the regulations as a whole valid. The Court also found that consultation between the Minister and the council did occur because evidence of the Council’s discussion regarding the draft regulations was provided through Council minutes and the Registrar acted as the liaison between the Council and the Minister. The Court did not allow respondents to take issue with the adequacy of the consultation because they did not bring it as an issue in their founding affidavit.

The Court held that regulations that limited medical practitioners from dispensing medicine, regulations 34(3)(a), (c), (d), and (e), were beyond the powers granted to the Minster in the Medicines Act. These criteria represented a drastic change in policy from the provisions of the Act. The Court noted that the general power of the Council to issue a license is to be done “in the public need and interest.” The Court viewed this phrasing as to be interpreted broadly and cannot be grounds to restrict medical practitioners from dispensing medicine. Finally, the Court noted the substantively similar South African case of Affordable Medicines Trust and Ors. v. Minister of Health and Anr. found invalid regulations identical to the regulations in this case.

The Court held that the lower court did not have power to suspend the operation of the moratorium that was provided for in Section 46(3), during which medical practitioners could apply for licenses to dispense medicine. The order had created an indeterminate period during which medical practitioners could apply for licenses and continue to dispense medicines while the applications were processed after the lapse of the three month period that had been provided by the Act. This amounted to a rewriting of the law, something that only Parliament could do.

“Similarly it was necessary to publish the draft regulations prior to the Medicines Act coming into operation. The reason for this was that various institutions and persons were to comment on the regulations and provide amendments or additions thereto before publication of the regulations proper. In this instance it was necessary that the Act and the regulations become operative at the same time to avoid a situation where the Act was operative but could not be implemented without its regulations. Furthermore bodies created by the Act had to become immediately operative on its promulgation in order to be able to deal with issues such as the registration of medicine and drugs, medical practitioners etc. This had to be achieved through the regulations.” (Para. 69)

“It seems to me that it is immediately clear that the public need and interest to receive medicine is very much different from the public interest to have access to intoxicating liquor. Where in the first instance a restrictive interpretation was placed on the words “public interest” the dispensing of medicine does not require such restrictive interpretation. The purpose for the dispensing of medicine is to heal or to bring relief to people who are ill or in pain and in need of treatment for their illnesses. There exists no need to limit access to medicine to pharmacists to the exclusion of medical practitioners, and there is in my opinion also no reason why people should not have a free choice whether to obtain their medicine from a medical practitioner or a pharmacy.” (Para. 92)