Pharmacy and Poisons Board v Wanjala & 7 others (Civil Appeal 211 of 2017) [2021] KECA 348 (KLR)
The bottom line
#Kenya's Court of Appeal confirmed the National Quality Control Laboratory answers to the Pharmacy and Poisons Board, which now handles drug manufacturing inspections.
What this practically means
#Executive summary
#Key legal issues
#Who, between the Pharmacy and Poisons Board and the National Quality Control Laboratory, has the legislative mandate to carry out GMP inspections and issue certificates of compliance
The appeal on this issue was rendered moot because section 34 of Act No. 20 of 2017 amended the Pharmacy and Poisons Act to vest the inspection and GMP compliance functions in the Board. The Court also held, on the merits of the role of the Laboratory, that the legislature intended to create a subordinate facility, not an independent body.
Parliament, by section 34 of Act No 20 of 2017 dated June 23, 2017, deleted the words vesting inspection powers in the Director of the National Drug Quality Control Laboratory and substituted 'The Board or any person authorized in writing by the Board', and deleted section 35I(b). This achieved the effect the impugned circular sought, resolving the dispute legislatively before the appeal was heard and rendering it largely academic. The appeal had merit given the Court's findings on the Laboratory's role.
The status of the National Quality Control Laboratory vis-à-vis the Board
The use of the term 'facility' in section 35D(1) shows the legislature intended an organ subordinate to or within the control of the Board, not a complementary or independent second regulatory body.
The Court examined Part IIIB of the Act establishing the Laboratory, noting it is described as a 'facility' used for examination and testing of drugs, governed by a Board of Management appointed by the appellant, with a Director appointed by that Board of Management. This structure indicated subordination to the appellant rather than complementarity, contrary to the trial court's conclusion and the 1st respondent's submissions.
Whether the appeal on rule 10 of the Pharmacy and Poisons (Registration of Drugs) Rules remained live
The rule 10 issue was also rendered moot by the legislative amendments, since all functions under the Act would now be performed by the appellant.
Once the legislature amended the law to vest the functions in the appellant, the question of who is the 'relevant agency' under rule 10 ceased to matter. The Laboratory operates as a facility within the control of the appellant with technical testing functions under section 35D(1)(c).
Whether the trial court's order of prohibition exceeded its jurisdiction in judicial review proceedings
This issue was rendered moot by the legislative amendments; the Court did not resolve it on the merits.
The appellant argued the trial court wrongly concluded the Laboratory's mandate amounted to GMP inspection and wrongly issued prohibitory orders. The Court took the view that the amendments to the Act by Act No 20 of 2017 rendered this issue moot as well, leaving only the question whether the trial court's orders could stand.
Legal principles established
#- The National Quality Control Laboratory was established under section 35D(1) of the Pharmacy and Poisons Act as a 'facility' subordinate to and within the control of the Pharmacy and Poisons Board, not as an independent or complementary second regulatory body
- Where legislation is amended so as to resolve the dispute, an appeal on those issues becomes moot and orders granted by the trial court based on the repealed provisions can no longer stand
Court orders
#- 1.Set aside orders (1), (2), (3) and (4) of the judgment by the trial Court dated March 16, 2017, delivered in Nairobi HC Miscellaneous Application No 159 of 2016
- 2.Each party shall bear its own costs of the trial in the High Court and of this appeal
- On appeal from
- High Court of Kenya at Nairobi
- Nairobi HC Miscellaneous Application No. 159 of 2016
- Jurisdiction invoked
- First appeal to the Court of Appeal against the High Court's decision in judicial review proceedings (as framed by the Court, invoking its mandate on a first appeal per Peters v Sunday Post Limited)
Key timeline
#Practical implications
#Frequently asked questions
#Cite this brief
#Cite this brief
Caselaw, "Pharmacy and Poisons Board v Wanjala & 7 others (Civil Appeal 211 of 2017) [2021] KECA 348 (KLR)", Case Analysis (2021). Memorandum of Appeal dated July 3, 2017 (from Nairobi HC Miscellaneous Application No. 159 of 2016). Source: https://new.kenyalaw.org/akn/ke/judgment/keca/2021/348/eng@2021-12-17
Suggested citation format for research notes or client memos. Always verify the original judgment before relying on any point.