Allergan Pharmaceuticals (Pty) Ltd v Medicines Control Council and Others (992/2015) [2015] ZAGPPHC 319; [2015] 3 All SA 173 (GP) (5 May 2015)

Allergan Pharmaceuticals (Pty) Ltd v Medicines Control Council and Others (992/2015) [2015] ZAGPPHC 319; [2015] 3 All SA 173 (GP) (5 May 2015)

The court found that the Optive range of products are medical devices as defined in the Medicines and Related Substances Act, not medicines. The products achieve their intended effect through physical and mechanical means, not pharmacological, immunological, or metabolic action. The court relied on expert evidence from Dr Baudouin and international regulatory classifications, noting that benchmark countries universally recognize the products as medical devices. The respondents' expert evidence was found speculative, lacking probative value, and did not establish a genuine dispute of fact. The Call-up Notice applies only to medicines, and since the Optive products are medical devices, they...

Citation
[2015] ZAGPPHC 319
Parties
Applicant: Allergan Pharmaceuticals (Pty) Ltd; Respondent: Medicines Control Council; Respondent: Director-General of the National Department of Health; Respondent: Minister of Health
Court
North Gauteng High Court, Pretoria
Jurisdiction
South Africa
Judgment Date
5 May 2015
Case Number
992/2015
Procedural Posture
Urgent Application / Final Determination on Declaratory Relief
Outcome
Application granted. Declaratory relief issued in favour of the applicant. Costs awarded against the respondents.
Judges
Jansen
Legal Topics
Medicines and Related Substances Act, Medical Device Regulation, Declaratory Relief, Call Up Notice Interpretation
Administrative Law Commercial and Corporate Medicines and Related Substances Act Medical Device Regulation Declaratory Relief Call Up Notice Interpretation

Case Brief

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Parties

Allergan Pharmaceuticals (Pty) Ltd

Applicant

Medicines Control Council

Respondent

Director-General of the National Department of Health

Respondent

Minister of Health

Respondent

Procedural Posture

Urgent Application / Final Determination on Declaratory Relief

Legal Issues

  1. 1 Whether the Optive range of products are medical devices or medicines under the Medicines and Related Substances Act.
  2. 2 Whether the Call-up Notice in Government Gazette No R2179 of 28 October 1977 applies to the Optive range of products.
  3. 3 Whether the respondents are empowered to regulate, detain, or require registration of the Optive range of products absent promulgated regulations.

Ratio Decidendi

The court found that the Optive range of products are medical devices as defined in the Medicines and Related Substances Act, not medicines. The products achieve their intended effect through physical and mechanical means, not pharmacological, immunological, or metabolic action. The court relied on expert evidence from Dr Baudouin and international regulatory classifications, noting that benchmark countries universally recognize the products as medical devices. The respondents' expert evidence was found speculative, lacking probative value, and did not establish a genuine dispute of fact. The Call-up Notice applies only to medicines, and since the Optive products are medical devices, they...

Court Disposition

Application granted. Declaratory relief issued in favour of the applicant. Costs awarded against the respondents.

Orders

  • The products identified in annexure 'FA1' to the founding affidavit (the Optive range of products) are medical devices as defined in section 1 of the Medicines and Related Substances Control Act 101 of 1965.
  • In the absence of promulgated regulations under section 35(1)(xxvii) and/or (xxviii) of the Act, the first and second respondents are not empowered to regulate, control, restrict, or prohibit the registration, manufacture, importation, exportation, sale, or use of the Optive range of products.