Region: Africa
Year: 2010
Court: High Court - North Gauteng Division, Pretoria
Health Topics: Health information, Health systems and financing, Medicines
Human Rights: Freedom of association, Right to participation
Tags: Access to medicines, Awareness, Health regulation, Notification
Two cases (numbers 37505/09 and 21352/09) were consolidated by an order of the court along with this case of the Hospital Association of South Africa Ltd (number 37377/09), as they all dealt with the same issues.
The Applicants sought relief in respect of the promulgation by the Minister of Health (Minister) of Regulations Relating to the Obtainment of Information and the Process of Determination and Publication of the Reference Price List (the Regulations) in terms of section 90 of the National Health Act 61 of 2003 (NHA) and the determination and publication by the Director-General of the Department of Health (Director-General) of a national health reference price list (NHRPL).
The court considered whether the Regulations were properly promulgated by the Minister. The Applicants contended that the Minster did not first consult with the National Health Council before promulgating the Regulations, as required by section 90(1) of the NHA. The Applicants succeeded on this ground.
The Applicants also argued that section 90(1)(v) of the NHA did not permit the Minister to make regulations that delegated to the Director-General of Health the power to develop a methodology for determining the NHRPL. Instead, Applicants maintained that the subsection empowered the Minister to prescribe the processes and procedures in terms of which the Director-General may determine the NHRPL, but not the manner in which an NHRPL may be determined. Furthermore, they contended that the information required in regulation 2 of the Regulations was requested in terms of an incorrect sub-regulation and was therefore invalid. The Applicants also succeeded in this challenge.
The court further held that the Minister’s promulgation of the Regulations was for an ulterior purpose and thus invalid. It held that the Regulations were not salvageable and therefore set them aside. The court ordered the whole process to commence afresh in a “proper, open and transparent manner and in terms of reconsidered regulations.”
“Under the circumstances this court is compelled to find that there is no acceptable evidence before the court upon which the court can find, as a fact, that the Minister consulted with the National Health Council prior to and in respect of the promulgation of the Regulations and rejects the bald statements [made] in this regard and the attack on the validity of the Regulations regarding the lack of prior consultations must therefore succeed.” Para. 28.
“It is abundantly clear that both in respect of the use of the powers afforded her under subsection 90(1)(u) for purposes of promulgating regulations for the determination of an NHRPL as also for her motives in attempting to regulate health care in South Africa through an NHRPL, the Minister's promulgation of the Regulations was in any case for an ulterior purpose and invalid and it must be set aside on those grounds too.” Para. 164.
“It is clear that the Regulations must be set aside, firstly, due to the lack of the required consultations between the Minister of Health and the National Health Council, and, secondly, on the other grounds referred to in this judgment. As nothing that was done in terms of the ill-fated Regulations is salvageable it is clear that all that was done qua the Regulations must also be set aside and that the whole process commence de novo and in a proper, open and transparent manner and in terms of reconsidered regulations.” Para. 165.