Brief background;
1. On 21st December 2020, the Respondent issued a memo directing all its clients that the renewal of licenses for all laboratories for the year 2021 should be lodged not later than the 31st March 2021 and that the said registration would be subject to evidence that the test kits/reagents and equipment being used for clinical lab tests are validated by the Respondent. The memo was purportedly issued pursuant to Section 25 of The Medical Laboratory Technicians and Technology Act Cap 253 A as read with Legal Notice no.113 of 2011. The Respondent directed further that all suppliers, vendors and distributors must also be registered by the Respondent.
2. On 12th March 2021 the Respondent issued another memo referring to the previous one dated 21stDecember 2020 in which they referred to the renewal of facility licenses contingent on evidence that test kits/reagents and equipment being used in clinical testing are validated by the Respondent. The Respondent maintained that issuance of pre-validation registration certificates was an ongoing activity further stating that they were being reminded to renew their licenses for the year 2021. The memo further directed that the intended recipients provide details of all reagents, kits, equipment/analyzers, chemicals and consumables used in their facilities.
3. The Respondent issued another memo dated 15thFebruary 2021, to members of the Exparte Applicant asserting that the Respondent is mandated by law to validate invitro diagnostics (IVDs).
4. In Addition to the foregoing, a number of the Exparte Applicant’s members received SMSs from the Respondent to provide evidence of certification for test kits/reagents and equipment from external bodies such as United States Food and Drug Administration (FDA).
5. This has precipitated the filing of the application before this court for determination dated 5th April 2021 wherein the Applicant seek the following orders:
1) Orders of Certiorari quashing the memos dated 21stDecember 2020 and 12th March 2021 issued by the Respondent requiring kits/Reagents and equipment used for clinical lab tests be validated by the Respondent and all suppliers, vendors and distributors to be registered with the Respondent.
2) Orders of Prohibition prohibiting and restraining the Respondent either by itself, agents, employees or whatsoever means from taking steps, actions and measures to enforce its memo dated 21st December 2020 and 12 March 2021.
The Applicants case;
6. The application is supported by that verifying Affidavit and a supplementary affidavit of Feroz Nawab, the Secretary of the Applicant.
7. It is the Applicants’ case that the Interested Party has over the years exercised the role contemplated in the said Memo pursuant to Legal Notice 192 of 2010 and Gazette Notice No. 1879 dated 21 March 2014 and clarified by the Ministry of Health and the Interested Party.
8. The Applicants argue that the Respondent herein had filed Judicial Review Application at High Court of Kenya. Nairobi being JR. Miscellaneous Application No. 229 of 2014 against among others, the Interested Party challenging Legal Notice No.192 of 2010 and Gazette Notice No. 1879 dated 21st March 2014 with regard to the mandate of the Pharmacy and Poisons Board regulating laboratory equipment and reagents. The Respondent withdrew from the proceedings on August 2014.
9. The Health Act 2017, the Ministry of Health has not given guidance on the sole regulatory body responsible for medical laboratory equipment and reagents.
10. It is argued that the Legal Notice 113 is not in tandem with the global equipment and reagent verification standards as stipulated on ISO/IEC 15189:2012 clause 5.5 to make it implementable.
11. Legal Notice No.113 of 2011 is ultra vires and a violation of the Kenya Medical Laboratory and Technicians and Technologists Board Act Cap 253A.
12. According to the applicant, there has not been any public participation in enactment of Legal Notice Number 113 of 2011 and neither has it been implemented until the issuance of the Memo dated 21st December 2020.
13. The Applicant argues that The Interested Party has already invested in a wide infrastructure on product registration and evaluation and which achieves product validation.
14. The Applicant argues that there have been constant conflicts between the Respondent and Interested Party on regulation of invitro diagnostics leading to confusion among members of the Applicant. It argues that the Memo dated 21st December 2021 lacks clarity on the process of validation of medical devices by the Respondent. The process and the outcome are vague.
15. It is their case that the accuracy, precision, linearity, robustness and ruggedness of the medical laboratory equipment are affected by movement and environmental factors; therefore, it may not be prudent moving all equipment to the Respondent as intimated in Legal Notice 113 of 2011 and Memo dated 21st December 2020.
16. The Applicant is concerned that the Memo dated 21st December 2020 by the Respondent introduces parallel regulating regime to that already in place by the Interested Party and will subject members of the Applicant to confusion and unnecessary huge costs in complying with the same.
17. It argues that the business of the Respondent as contemplated under Section 5 of the Medical Laboratory Technicians and Technologies Ac (Cap 253A) does not include manufacture of IVDs, buying, selling, installation, care and maintenance of IVDs or validation of reagents, equipment and test kits.
18. It the Applicant's case that the World Congress of Biomedical Laboratory Science had nothing to do with enactment of Legal Notice No. 113 of 2011 or regulatory framework for Invitro Diagnostics and neither does Annexure “AA2a” and “AA2b” give such indication. Further the meeting was organized by Association of Kenya Medical Laboratory Scientific Officers (AKLMSO) and not the Respondent.
19. The members of the Applicant were invited and attended the conference as sponsors to exhibit their products and the stakeholder engagements were undertaken after the Legal Notice had already been enacted but no evidence has been tendered on the final report from the stakeholder engagements and none was given.
20. It argues that all imports by the members of the Applicants are subjected to Pre-Export Verification of Conformity (PVOC) to ensures the safety and quality of the imported goods are pursuant to Legal Notice 78 of 15/ 07/2005.
21. It further argues that the importers of among others medical devices must obtain Certificates of Conformity (COC) for their cargo before applying for Import Permits from the Interested Party through the Kenya National Single Window Electronic (Kentrade) System.
22. The Applicant argues further that all suppliers and importers are required to submit manufacture registration and certification from the country of origin. Thereafter the applicant argues that they are required to provide products to be listed for sale in Kenya and have all certificate of analysis and other recognized international certification such as Federal Drug Administration of the United States of America.
23. It argues that there is public a notice by the Kenya Bureau of Standards and the Interested Party as well as Medical Device Registration Certificates for test kits issued by the 1st Interested Party and PVOC Certificate from KEBS.
24. The apparent supremacy wars between the 1st Interested Party and the Respondent has led to some members having no choice but to subject themselves to parallel regulatory requirements of the said regulatory bodies.
25. Validation of the medical devices and IVDS are carried out by third party accredited laboratories in line with WHO guidelines and Kenya Service Accreditation Service Act No. 17 of 2019.It is the Applicants case that nothing in the Legal Notice No. 113 of 2011 provide for accreditation of laboratories and neither are those accredited laboratories reserved for the Respondent.
26. They argue that the case of Republic versus Kenya Medical Laboratory Technicians and Technologists Board & Anor Ex Parte Anil Tailor & 4 Others (2013) EKLR is not relevant. They argue that they are not aware of any attempt by the 1stInterested Party to regulate private medical laboratories.
27. The Interested Party has been recognized as the National Regulatory Authority with respect to medical devices as set out in the excerpt of the World Bank publication on medical devices regulation at Country Level.
Applicant’s Submission
28. It is submitted that Section 4 of the Health Act Cap 241 of the laws of Kenya provides as follows:
“It is a fundamental duty of the State to observe, respect, protect, promote and fulfill the right to the highest attainable standard of health including reproductive health care and emergency medical treatment by inter alia” –
developing policies, laws and other measures necessary to protect, promote, improve and maintain the health and well-being of every person;
ensuring the prioritization and adequate investment in research for health to promote technology and innovation in health care delivery;
ensuring the provision of a health service package at all levels of the health care system, which shall include services addressing promotion, prevention, curative, palliative and rehabilitation, as well as physical and financial access to health care;
29. Section 62 of the Health Act further provides as follows:
“There shall be established by an Act of Parliament a single regulatory body for regulation of health products establishment of a single regulatory body for health and health technologies,”
30. Reliance is placed in the case of ELRC Judicial Review No. E049 of 2023 R v Pharmacy and Poisons Board and Kenya Medical Laboratory Technicians and Technologist Board (Interested Party) in which Lady Justice Ngibuini held with respect of the role of PPB the Respondent: -
“64. The Respondent has proved that it indeed is the regulatory body established under Section 62 of the Health Act to regulate health products and health technologies and therefore it was within its mandate to invite applications for the positions of In-Vitro Diagnostics Experts and for the positions of Blood and blood products experts” further that
“65. The Act is clear the roles of the Interested Party (KMLTTB) is distinct from the role of the Respondent the Pharmacy and Poisons Board as per the various legislation regulating the two respective bodies”
31. In the matter of Council of County Governors v Attorney General & another [2017] eKLR the guiding principles of interpreting laws to determine their effect and constitutionality were very well set by the bench as it was then constituted in the High Court at Nairobi. That at any point where a dispute involves the effect of enacted laws, the Courts should first start from a point of view that the statute in question is lawful and must then proceed to determine the object and purpose of the statute for it is important to discern the intention expressed in the Act itself.
32. It is submitted that Members of the Applicant supply equipment used for tests and kits/reagents used for clinical lab tests which has always been regulated by the 1st Interested Party. The memos by the Respondent has exposed members of Applicant to double regulation. It is sun submitted that the memos by the Respondent are ultra vires and have no basis in law.
33. The Respondent is a body established under the Medical Laboratory Technicians and Technologists Act Cap 253A Laws of Kenya (“the MLTT Act”) and which prescribes its powers.
34. The preamble to the Act sets its object as follows: -
“An Act of Parliament to provide for the training, registration, and licensing of medical laboratory technicians and technologists, to provide for the establishment, powers, and functions of the Kenya Medical Laboratory Technicians and Technologists Board and for connected purposes”
35. Section 5 of the MLTT Act. Under Section 5 (2), of the said Act, the specific functions of the Respondent are:
a) prescribe, in consultation with the College and such approved training institutions as the Board may deem appropriate, the courses of instruction for laboratory technicians and technologists;
b) consider and approve the qualifications of laboratory technicians and technologists for the purposes of registration under this Act;
c) approve institutions for the training of laboratory technicians and technologists;
d) licence and regulate the business and practice of registered laboratory technicians and technologists; and
e) regulate the professional conduct of registered laboratory technicians and technologists and take such disciplinary measures as may be appropriate to maintain proper professional standards”. (Emphasis added)
36. In Republic v. Kenya Vision 2030 Delivery Board & Another Ex-Parte Eng. Judah Abekah [2014] eKLR, the court emphasized that when interpreting statutes, the literal meaning of the words must be taken into account, and the statute must be read as a whole to avoid inconsistencies. Additionally, the court discussed the ejusdem generis rule, explaining that when general words follow specific words in a statute, the general words should be interpreted as applying only to items of the same kind or class as the specific words listed.
37. It is submitted that a reading of section 5 of the MLLT Act reveals that the Respondent is mandated with the oversight of the education of laboratory technicians and technologists and how they behave (ethics) in the conduct of their profession and not the role that they intend to usurp through the memos.
38. It is submitted that there is no provision under the MLTT Act requiring the registration of member Applicants as intimated in the memo dated 12th December 2020. In fact, the Respondent is categorical that its “memos were not directed to the Applicant” and instead were “reminders to the medical laboratories regulated by the Respondent” as evident at Page 50 of the Respondent’s Replying Affidavit dated 20th April 2021 and page 22 and 23 of the Supplementary Affidavit dated 15th June 2021.
39. According to the Respondent it has the mandate to regulate test kits/reagents, IVDs and equipment being used for clinical lab tests pursuant to Section 25 subsection 2 of the MLTT Act read together with Legal Notice 113 of 2011(Equipment and Reagents Validation Regulations, 2011).
40. Section 25 Subsection (1) and (2) of the MLTT Act falls under Part IV of the Act which sets out provisions relating to private practice. The said Section 25 provides that: -
“(1) The Board shall, in regulations, prescribe the terms and conditions of the business and practice of laboratory technicians and technologists engaged in private practice.
(2) Regulations under subsection (1) shall in particular provide for—
(a) the equipment and reagents to be provided in private medical laboratories;
(b) the services to be rendered by laboratory technicians and technologists in private practice; and
(c)the employment of laboratory technicians and technologists in private medical laboratories.” (emphasis added).
41. The contemplated regulations under Section 25 are intended to deal with the “business and practice of laboratory technicians and technologists engaged in private practice”.
42. Section 25 Subsection (2) sets out three matters that the contemplated Regulations will address and for the present Paragraph (a) is the relevant. The question then is what is the scope of the contemplated regulation providing for “the equipment and reagents to be provided in private medical laboratories.”
43. The regulations under the said Section 25 of the MLTT Act are intended to deal with the “business and practice of laboratory technicians and technologists engaged in private practice” and not the regulation of test kits/ reagents, equipment used for clinical lab tests and IVDs.
44. Pursuant to Section 25(2)(a) the contemplated Regulations under the said section ought to deal with the manner in which private laboratories are to be stocked and equipped and not validation of the reagents and equipment used in medical laboratories.
45. Reliance is placed on the case of Scion Healthcare Limited & another v Kenya Medical Laboratory Technicians and Technologists Board & another [2020] Justice Mrima relying on Machakos High Court Judicial Review No. 408 of 2017 which made extensive reference to Kisii High Court Judicial Review No. 82 of 2011 quoted the court’s interpretation of Section 25(2)(a) of the MLTT Act and said: -
“It is therefore clear that Section 25(2)(a) is a departure from what appears in the long title and the object and purpose of the Board. By empowering the Board to make regulations providing, not only for terms and conditions of the business and practice of laboratory technicians and technologists but also providing for the equipment and reagents to be provided in private laboratories, the Act empowers the Board to actually regulate the manner in which private laboratories are to be stocked and equipped.That in my view is an extension of the power of the Board to not only regulate technicians and technologists but to an extent, private laboratories.” (Emphasis added)
46. The validation and stocking of medical laboratories are distinct roles noting that Section 25(2) was drafted in the manner contemplating existence of distinct regime for validation of reagents and equipment used in medical laboratories. This is buttressed by the fact that MLTT Act was enacted in 2000 when there was already a regime enacted in 1957that is the Pharmacy and Poisons Act Cap 244 of the laws of Kenya (“PPB Act”) regulating ‘medicinal substances’ and ‘drugs.’
47. In the memos the Respondents cited Legal Notice No. 113 of 2011 the Medical Laboratory (Equipment and Reagents Validation) Regulations, 2011 as legal basis for the memos.
48. The said notice purported to extend the Respondent’s mandate to include validation of equipment or reagents for use within medical laboratories. The term “validation” is neither used nor defined in the parent MLTT Act.
49. Instead it is defined in said Regulations, 2011 as:
“the process of authentication undertaken by Board or its appointed agents for the purposes of confirming the quality of medical laboratory reagents and equipment by performing tests to confirm the information provided by the manufacturers relating to their precision, linearity, specificity, sensitivity and accuracy in the description of the equipment, reagents and chemicals for use within medical laboratories in Kenya.”
50. The net effect is that the Regulations purported to expand the mandate of the Respondent beyond that which is provided under the parent Act. Had the legislature intended to include the expanded role, the proper way would have been to amend the MLTT Act. The Legal notice No.113 of 2011 is thus ultra vires and therefore void for being inconsistent with the parent Act.
51. In the case of Kenya Hospital Association t/a Nairobi Hospital v Medical Practitioners and Dentists Board & 4 others [2018] eKLR the court reiterated that a regulation cannot amend a Parent Act. The court cited section 31(1)(b) of the Interpretation and General Provisions Act, Cap 2 of the Laws of Kenya stipulating that subsidiary legislation cannot be inconsistent with the provision of the Act.
52. The PPB Act makes provisions on the regulation of products that the Respondent is purporting to regulate through its memos. Section 3A, 3B of the PPB Act which were introduced vide Health Laws Amendment Act of 2019 sets out the powers and functions of the Interested Party.
53. Under Section 3A of the PPB Act the powers of the 1stInterested Party include the following with respect to medical products: -
“(a) formulate guidelines for regulating the manufacture, import and export, distribution, sale and use of medical products
(b) …
(c) grant or withdraw marketing authorization for medical products subject to appropriate conditions and revise such conditions for marketing authorization as necessary;
(d) …,(f)…,(g) …
(h) prescribe the standards appropriate for new medical products; new uses, dosages, and formulations of existing medical products; and such other categories as may be appropriate;
54. Further Section 3B of the PPB Act Subsection (1) gives the Interested Party the responsibility for regulating inter alia health products. Subsection 2 sets out the functions of the Interested Party in relation to regulation of health products, technologies to include: -
“(b) ensure that all medicinal products manufactured in, imported into or exported from the country conform to prescribed standards of quality safety and efficacy;
(c)…
(d) enforce the prescribed standards of quality, safety and efficacy of all medicinal substances manufactured, imported into or exported out of the country;
(e) grant or revoke licenses for the manufacture, importation, exportation, distribution and sale of medicinal substances;
(f) maintain a register of all authorized medicinal substances;
(g) publish, at least once in every three months, lists of authorized or registered medicinal substances and of products with marketing authorizations;”
55. Section 2 of the PPB Act, defines health product to include; medical products as well as medicinal substances, diagnostics, and medical devices. Even though the Act does not define ‘medical products’, it is safe to conclude that medical product is a type of health product just as the defined by the World Health Organization (WHO). According to the WHO:
"Medical products are medicines, devices, and other items used to diagnose, treat, or prevent diseases or other abnormal conditions. They include pharmaceuticals, biologics, vaccines, and diagnostic tools." (Emphasis Added)
56. Section 2 of the PPB Act further defines medicinal substances to include a product, article or substance which is claimed to be useful for, inter alia, “diagnosing disease or ascertaining the existence, degree or extent of a physiological condition”. This definition has largely remained unchanged since the enactment of the Act.
57. Section 2 of the PPB Act gives elaborate definition of medical device to mean “any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article— (a) intended by the manufacturer to be used, alone or in combination, for humans or animals for;
i. diagnosis, prevention, monitoring, treatment or alleviation of disease;
ii. diagnosis, monitoring, treatment, alleviation of or compensation for an injury;
iii. investigation, replacement, modification or support of the anatomy or of a physiological process; (iv) supporting or sustaining life;
iv. control of conception;
v. disinfection of medical devices; or
vi. providing information for medical or diagnostic purposes by means of in vitro examination of specimens derived from the human body; and (b) which does not achieve its primary intended action in or on the human or animal body by pharmacological, immunological or metabolic means, but which may be assisted in its intended function by such means” (Emphasis Added).
58. It is submitted that the cumulative effect of Sections 3A and 3B is that PPB, the Interested Party, is the proper single regulatory body mandated to regulate and/or validate test kits/reagents, IVDs and other equipment used for medical tests fall under the definitions of health products and medicinal substances.
59. Section 4 of the Health Act, 2017, dictates that it is the fundamental duty of the state to observe, respect, protect, promote and fulfill the right to the highest attainable standard of health by performing among other things, the duty of developing policies, laws and other measures necessary to fulfill the said mandate. The Ministry of Medical Services developed the Guidelines on Submission of Documentation for Registration of Medical Devices available in the PPB website. It provides under Article 3(1) that the guidelines shall apply to:
“…medical devices and their accessories. For the purposes of these guidelines, accessories shall be treated as medical devices in their own right.”
60. Further, Article 5(3) of the Guidelines defines In-Vitro Diagnostic Devices (IVDs) to mean: medical devices, whether used alone or in combination, intended by the manufacturer for the in-vitro examination of specimens derived from the human body solely or principally to provide information for diagnostic, monitoring or compatibility purposes. IVD medical devices include reagents, calibrators, control materials, specimen receptacles, software, and related instruments or apparatus or other articles. It is further observed that the Exparte Applicant is mandated with the observation of these guidelines.
61. It is submitted that the above provisions make it clear that the 1st Interested Party is mandated to regulate and validate medical devices, including test kits/reagents, IVDs, and other equipment used for medical tests.
62. It is further submitted that the Respondent has, before the institution of this Application, initiated another application through The Nursing Council of Kenya; Judicial Review Misc Application No.229 of 2014 R vs The Pharmacy and Poisons Board, concerning functions which they seek to usurp through their disputed Memos. The Respondents withdrew from the said application and proceeded to conduct ‘Internal Discussions’, the outcome of which was a press Statement from the Office of the 2ndInterested Party affirming that the 1st Interested Party is the body mandated to carry out the duty of validating medicines, medical devices, medical equipment and reagents and In-Vitro Diagnostic Devices (IVDs).
63. The 2nd Interested Party in its press statement further affirmed that this role of the 1st Interested Party is supported by Legal Notice 192 of 2010 and Gazette notice no. 1879 of 21st March 2014. Therefore, these attempts through the memos by the Respondent are ultravires and intent on usurping powers for their unknown gain.
64. These functions the Respondent now seeks to assume,it is submitted are outside its scope of mandate as illustrated, and those functions only fall within the legal mandate of the 1stInterested Party. Members of the Exparte applicant have been taking measures to ensure that they comply with legal provisions as they are. The Respondent seeking to act outside its scope puts members of the Exparte applicant at risk of unwarranted financial losses and unpredictable business environment.
65. The assumption of these roles by the Respondent, which is the mandate of the 1st Interested Party, would subject members of the Exparte Applicant to unfair administrative action. In light of Article 47 of the Constitution, which guarantees the right to fair administrative action, the ex-parte Applicant invokes its right as it is likely to suffer and in line with the position of the court in the matter Nancy Makokha Baraza v Judicial Service Commission & 9 Others [2012]eKLR this court has wide discretion, which is inclusive rather than exclusive and therefore allows this Court to make appropriate orders and grant remedies as the situation demands and as the need arises.
66. They further submit that it is of no use to subject suppliers to double registration and have them register with the Respondent while at the same time registered with another statutorily created body; the 1st Interested party. It is submitted that members of the Applicant are already regulated by the Interested Party.
67. The requirement imposed by the Respondent to provide evidence of certification for test kits/reagents and equipment from United States Food and Drug Administration (FDA) has no basis in law it is submitted.
68. Matters of certification is under the purview of the Kenya Bureau of Standards (KEBS) established under the Kenya Standards Act Cap 496. Section (4)(1) specifies these functions as follows: -
‘(a) to promote standardization in industry and commerce;
(b) to make arrangements or provide facilities for the testing and calibration of precision instruments, gauges and scientific apparatus, for the determination of their degree of accuracy by comparison with standards approved by the Cabinet Secretary on the recommendation of the Council, and for the issue of certificates in regard thereto;
(c) to make arrangements or provide facilities for the examination and testing of commodities and any material or substance from or with which and the manner in which they may be manufactured, produced, processed or treated;
(d)…(e)…(f)..;
(g) to assist the Government or any local authority or other public body or any other person in the preparation and framing of any specifications or codes of practice;
(h) to provide for co-operation with the Government or the representatives of any industry or with any local authority or other public body or any other person, with a view to securing the adoption and practical application of standards;
to provide for the testing at the request of the Cabinet Secretary, and on behalf of the Government, of locally manufactured and imported commodities with a view to determining whether such commodities comply with the provisions of this Act or any other law dealing with standards of quality or description.” (Emphasis added).
69. The Interested Party is among entities specified as regulatory authority for products under its purview and thus exempt from PVoC program. The Respondent is not listed as such and neither is FDA referred to as the certification body in Kenya.
70. The Section 27 of the Civil Procedure Act provides that: -
“(1) Subject to such conditions and limitations as may be prescribed, and to the provisions of any law for the time being in force, the costs of and incidental to all suits shall be in the discretion of the court or judge,
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1. On 21st December 2020, the Respondent issued a memo directing all its clients that the renewal of licenses for all laboratories for the year 2021 should be lodged not later than the 31st March 2021 and that the said registration would be subject to evidence that the test kits/reagents and equipment being used for clinical lab tests are validated by the Respondent. The memo was purportedly issued pursuant to Section 25 of The Medical Laboratory Technicians and Technology Act Cap 253 A as read with Legal Notice no.113 of 2011. The Respondent directed further that all suppliers, vendors and distributors must also be registered by the Respondent.
2. On 12th March 2021 the Respondent issued another memo referring to the previous one dated 21stDecember 2020 in which they referred to the renewal of facility licenses contingent on evidence that test kits/reagents and equipment being used in clinical testing are validated by the Respondent. The Respondent maintained that issuance of pre-validation registration certificates was an ongoing activity further stating that they were being reminded to renew their licenses for the year 2021. The memo further directed that the intended recipients provide details of all reagents, kits, equipment/analyzers, chemicals and consumables used in their facilities.
3. The Respondent issued another memo dated 15thFebruary 2021, to members of the Exparte Applicant asserting that the Respondent is mandated by law to validate invitro diagnostics (IVDs).
4. In Addition to the foregoing, a number of the Exparte Applicant’s members received SMSs from the Respondent to provide evidence of certification for test kits/reagents and equipment from external bodies such as United States Food and Drug Administration (FDA).
5. This has precipitated the filing of the application before this court for determination dated 5th April 2021 wherein the Applicant seek the following orders:
1) Orders of Certiorari quashing the memos dated 21stDecember 2020 and 12th March 2021 issued by the Respondent requiring kits/Reagents and equipment used for clinical lab tests be validated by the Respondent and all suppliers, vendors and distributors to be registered with the Respondent.
2) Orders of Prohibition prohibiting and restraining the Respondent either by itself, agents, employees or whatsoever means from taking steps, actions and measures to enforce its memo dated 21st December 2020 and 12 March 2021.
The Applicants case;
6. The application is supported by that verifying Affidavit and a supplementary affidavit of Feroz Nawab, the Secretary of the Applicant.
7. It is the Applicants’ case that the Interested Party has over the years exercised the role contemplated in the said Memo pursuant to Legal Notice 192 of 2010 and Gazette Notice No. 1879 dated 21 March 2014 and clarified by the Ministry of Health and the Interested Party.
8. The Applicants argue that the Respondent herein had filed Judicial Review Application at High Court of Kenya. Nairobi being JR. Miscellaneous Application No. 229 of 2014 against among others, the Interested Party challenging Legal Notice No.192 of 2010 and Gazette Notice No. 1879 dated 21st March 2014 with regard to the mandate of the Pharmacy and Poisons Board regulating laboratory equipment and reagents. The Respondent withdrew from the proceedings on August 2014.
9. The Health Act 2017, the Ministry of Health has not given guidance on the sole regulatory body responsible for medical laboratory equipment and reagents.
10. It is argued that the Legal Notice 113 is not in tandem with the global equipment and reagent verification standards as stipulated on ISO/IEC 15189:2012 clause 5.5 to make it implementable.
11. Legal Notice No.113 of 2011 is ultra vires and a violation of the Kenya Medical Laboratory and Technicians and Technologists Board Act Cap 253A.
12. According to the applicant, there has not been any public participation in enactment of Legal Notice Number 113 of 2011 and neither has it been implemented until the issuance of the Memo dated 21st December 2020.
13. The Applicant argues that The Interested Party has already invested in a wide infrastructure on product registration and evaluation and which achieves product validation.
14. The Applicant argues that there have been constant conflicts between the Respondent and Interested Party on regulation of invitro diagnostics leading to confusion among members of the Applicant. It argues that the Memo dated 21st December 2021 lacks clarity on the process of validation of medical devices by the Respondent. The process and the outcome are vague.
15. It is their case that the accuracy, precision, linearity, robustness and ruggedness of the medical laboratory equipment are affected by movement and environmental factors; therefore, it may not be prudent moving all equipment to the Respondent as intimated in Legal Notice 113 of 2011 and Memo dated 21st December 2020.
16. The Applicant is concerned that the Memo dated 21st December 2020 by the Respondent introduces parallel regulating regime to that already in place by the Interested Party and will subject members of the Applicant to confusion and unnecessary huge costs in complying with the same.
17. It argues that the business of the Respondent as contemplated under Section 5 of the Medical Laboratory Technicians and Technologies Ac (Cap 253A) does not include manufacture of IVDs, buying, selling, installation, care and maintenance of IVDs or validation of reagents, equipment and test kits.
18. It the Applicant's case that the World Congress of Biomedical Laboratory Science had nothing to do with enactment of Legal Notice No. 113 of 2011 or regulatory framework for Invitro Diagnostics and neither does Annexure “AA2a” and “AA2b” give such indication. Further the meeting was organized by Association of Kenya Medical Laboratory Scientific Officers (AKLMSO) and not the Respondent.
19. The members of the Applicant were invited and attended the conference as sponsors to exhibit their products and the stakeholder engagements were undertaken after the Legal Notice had already been enacted but no evidence has been tendered on the final report from the stakeholder engagements and none was given.
20. It argues that all imports by the members of the Applicants are subjected to Pre-Export Verification of Conformity (PVOC) to ensures the safety and quality of the imported goods are pursuant to Legal Notice 78 of 15/ 07/2005.
21. It further argues that the importers of among others medical devices must obtain Certificates of Conformity (COC) for their cargo before applying for Import Permits from the Interested Party through the Kenya National Single Window Electronic (Kentrade) System.
22. The Applicant argues further that all suppliers and importers are required to submit manufacture registration and certification from the country of origin. Thereafter the applicant argues that they are required to provide products to be listed for sale in Kenya and have all certificate of analysis and other recognized international certification such as Federal Drug Administration of the United States of America.
23. It argues that there is public a notice by the Kenya Bureau of Standards and the Interested Party as well as Medical Device Registration Certificates for test kits issued by the 1st Interested Party and PVOC Certificate from KEBS.
24. The apparent supremacy wars between the 1st Interested Party and the Respondent has led to some members having no choice but to subject themselves to parallel regulatory requirements of the said regulatory bodies.
25. Validation of the medical devices and IVDS are carried out by third party accredited laboratories in line with WHO guidelines and Kenya Service Accreditation Service Act No. 17 of 2019.It is the Applicants case that nothing in the Legal Notice No. 113 of 2011 provide for accreditation of laboratories and neither are those accredited laboratories reserved for the Respondent.
26. They argue that the case of Republic versus Kenya Medical Laboratory Technicians and Technologists Board & Anor Ex Parte Anil Tailor & 4 Others (2013) EKLR is not relevant. They argue that they are not aware of any attempt by the 1stInterested Party to regulate private medical laboratories.
27. The Interested Party has been recognized as the National Regulatory Authority with respect to medical devices as set out in the excerpt of the World Bank publication on medical devices regulation at Country Level.
Applicant’s Submission
28. It is submitted that Section 4 of the Health Act Cap 241 of the laws of Kenya provides as follows:
“It is a fundamental duty of the State to observe, respect, protect, promote and fulfill the right to the highest attainable standard of health including reproductive health care and emergency medical treatment by inter alia” –
developing policies, laws and other measures necessary to protect, promote, improve and maintain the health and well-being of every person;
ensuring the prioritization and adequate investment in research for health to promote technology and innovation in health care delivery;
ensuring the provision of a health service package at all levels of the health care system, which shall include services addressing promotion, prevention, curative, palliative and rehabilitation, as well as physical and financial access to health care;
29. Section 62 of the Health Act further provides as follows:
“There shall be established by an Act of Parliament a single regulatory body for regulation of health products establishment of a single regulatory body for health and health technologies,”
30. Reliance is placed in the case of ELRC Judicial Review No. E049 of 2023 R v Pharmacy and Poisons Board and Kenya Medical Laboratory Technicians and Technologist Board (Interested Party) in which Lady Justice Ngibuini held with respect of the role of PPB the Respondent: -
“64. The Respondent has proved that it indeed is the regulatory body established under Section 62 of the Health Act to regulate health products and health technologies and therefore it was within its mandate to invite applications for the positions of In-Vitro Diagnostics Experts and for the positions of Blood and blood products experts” further that
“65. The Act is clear the roles of the Interested Party (KMLTTB) is distinct from the role of the Respondent the Pharmacy and Poisons Board as per the various legislation regulating the two respective bodies”
31. In the matter of Council of County Governors v Attorney General & another [2017] eKLR the guiding principles of interpreting laws to determine their effect and constitutionality were very well set by the bench as it was then constituted in the High Court at Nairobi. That at any point where a dispute involves the effect of enacted laws, the Courts should first start from a point of view that the statute in question is lawful and must then proceed to determine the object and purpose of the statute for it is important to discern the intention expressed in the Act itself.
32. It is submitted that Members of the Applicant supply equipment used for tests and kits/reagents used for clinical lab tests which has always been regulated by the 1st Interested Party. The memos by the Respondent has exposed members of Applicant to double regulation. It is sun submitted that the memos by the Respondent are ultra vires and have no basis in law.
33. The Respondent is a body established under the Medical Laboratory Technicians and Technologists Act Cap 253A Laws of Kenya (“the MLTT Act”) and which prescribes its powers.
34. The preamble to the Act sets its object as follows: -
“An Act of Parliament to provide for the training, registration, and licensing of medical laboratory technicians and technologists, to provide for the establishment, powers, and functions of the Kenya Medical Laboratory Technicians and Technologists Board and for connected purposes”
35. Section 5 of the MLTT Act. Under Section 5 (2), of the said Act, the specific functions of the Respondent are:
a) prescribe, in consultation with the College and such approved training institutions as the Board may deem appropriate, the courses of instruction for laboratory technicians and technologists;
b) consider and approve the qualifications of laboratory technicians and technologists for the purposes of registration under this Act;
c) approve institutions for the training of laboratory technicians and technologists;
d) licence and regulate the business and practice of registered laboratory technicians and technologists; and
e) regulate the professional conduct of registered laboratory technicians and technologists and take such disciplinary measures as may be appropriate to maintain proper professional standards”. (Emphasis added)
36. In Republic v. Kenya Vision 2030 Delivery Board & Another Ex-Parte Eng. Judah Abekah [2014] eKLR, the court emphasized that when interpreting statutes, the literal meaning of the words must be taken into account, and the statute must be read as a whole to avoid inconsistencies. Additionally, the court discussed the ejusdem generis rule, explaining that when general words follow specific words in a statute, the general words should be interpreted as applying only to items of the same kind or class as the specific words listed.
37. It is submitted that a reading of section 5 of the MLLT Act reveals that the Respondent is mandated with the oversight of the education of laboratory technicians and technologists and how they behave (ethics) in the conduct of their profession and not the role that they intend to usurp through the memos.
38. It is submitted that there is no provision under the MLTT Act requiring the registration of member Applicants as intimated in the memo dated 12th December 2020. In fact, the Respondent is categorical that its “memos were not directed to the Applicant” and instead were “reminders to the medical laboratories regulated by the Respondent” as evident at Page 50 of the Respondent’s Replying Affidavit dated 20th April 2021 and page 22 and 23 of the Supplementary Affidavit dated 15th June 2021.
39. According to the Respondent it has the mandate to regulate test kits/reagents, IVDs and equipment being used for clinical lab tests pursuant to Section 25 subsection 2 of the MLTT Act read together with Legal Notice 113 of 2011(Equipment and Reagents Validation Regulations, 2011).
40. Section 25 Subsection (1) and (2) of the MLTT Act falls under Part IV of the Act which sets out provisions relating to private practice. The said Section 25 provides that: -
“(1) The Board shall, in regulations, prescribe the terms and conditions of the business and practice of laboratory technicians and technologists engaged in private practice.
(2) Regulations under subsection (1) shall in particular provide for—
(a) the equipment and reagents to be provided in private medical laboratories;
(b) the services to be rendered by laboratory technicians and technologists in private practice; and
(c)the employment of laboratory technicians and technologists in private medical laboratories.” (emphasis added).
41. The contemplated regulations under Section 25 are intended to deal with the “business and practice of laboratory technicians and technologists engaged in private practice”.
42. Section 25 Subsection (2) sets out three matters that the contemplated Regulations will address and for the present Paragraph (a) is the relevant. The question then is what is the scope of the contemplated regulation providing for “the equipment and reagents to be provided in private medical laboratories.”
43. The regulations under the said Section 25 of the MLTT Act are intended to deal with the “business and practice of laboratory technicians and technologists engaged in private practice” and not the regulation of test kits/ reagents, equipment used for clinical lab tests and IVDs.
44. Pursuant to Section 25(2)(a) the contemplated Regulations under the said section ought to deal with the manner in which private laboratories are to be stocked and equipped and not validation of the reagents and equipment used in medical laboratories.
45. Reliance is placed on the case of Scion Healthcare Limited & another v Kenya Medical Laboratory Technicians and Technologists Board & another [2020] Justice Mrima relying on Machakos High Court Judicial Review No. 408 of 2017 which made extensive reference to Kisii High Court Judicial Review No. 82 of 2011 quoted the court’s interpretation of Section 25(2)(a) of the MLTT Act and said: -
“It is therefore clear that Section 25(2)(a) is a departure from what appears in the long title and the object and purpose of the Board. By empowering the Board to make regulations providing, not only for terms and conditions of the business and practice of laboratory technicians and technologists but also providing for the equipment and reagents to be provided in private laboratories, the Act empowers the Board to actually regulate the manner in which private laboratories are to be stocked and equipped.That in my view is an extension of the power of the Board to not only regulate technicians and technologists but to an extent, private laboratories.” (Emphasis added)
46. The validation and stocking of medical laboratories are distinct roles noting that Section 25(2) was drafted in the manner contemplating existence of distinct regime for validation of reagents and equipment used in medical laboratories. This is buttressed by the fact that MLTT Act was enacted in 2000 when there was already a regime enacted in 1957that is the Pharmacy and Poisons Act Cap 244 of the laws of Kenya (“PPB Act”) regulating ‘medicinal substances’ and ‘drugs.’
47. In the memos the Respondents cited Legal Notice No. 113 of 2011 the Medical Laboratory (Equipment and Reagents Validation) Regulations, 2011 as legal basis for the memos.
48. The said notice purported to extend the Respondent’s mandate to include validation of equipment or reagents for use within medical laboratories. The term “validation” is neither used nor defined in the parent MLTT Act.
49. Instead it is defined in said Regulations, 2011 as:
“the process of authentication undertaken by Board or its appointed agents for the purposes of confirming the quality of medical laboratory reagents and equipment by performing tests to confirm the information provided by the manufacturers relating to their precision, linearity, specificity, sensitivity and accuracy in the description of the equipment, reagents and chemicals for use within medical laboratories in Kenya.”
50. The net effect is that the Regulations purported to expand the mandate of the Respondent beyond that which is provided under the parent Act. Had the legislature intended to include the expanded role, the proper way would have been to amend the MLTT Act. The Legal notice No.113 of 2011 is thus ultra vires and therefore void for being inconsistent with the parent Act.
51. In the case of Kenya Hospital Association t/a Nairobi Hospital v Medical Practitioners and Dentists Board & 4 others [2018] eKLR the court reiterated that a regulation cannot amend a Parent Act. The court cited section 31(1)(b) of the Interpretation and General Provisions Act, Cap 2 of the Laws of Kenya stipulating that subsidiary legislation cannot be inconsistent with the provision of the Act.
52. The PPB Act makes provisions on the regulation of products that the Respondent is purporting to regulate through its memos. Section 3A, 3B of the PPB Act which were introduced vide Health Laws Amendment Act of 2019 sets out the powers and functions of the Interested Party.
53. Under Section 3A of the PPB Act the powers of the 1stInterested Party include the following with respect to medical products: -
“(a) formulate guidelines for regulating the manufacture, import and export, distribution, sale and use of medical products
(b) …
(c) grant or withdraw marketing authorization for medical products subject to appropriate conditions and revise such conditions for marketing authorization as necessary;
(d) …,(f)…,(g) …
(h) prescribe the standards appropriate for new medical products; new uses, dosages, and formulations of existing medical products; and such other categories as may be appropriate;
54. Further Section 3B of the PPB Act Subsection (1) gives the Interested Party the responsibility for regulating inter alia health products. Subsection 2 sets out the functions of the Interested Party in relation to regulation of health products, technologies to include: -
“(b) ensure that all medicinal products manufactured in, imported into or exported from the country conform to prescribed standards of quality safety and efficacy;
(c)…
(d) enforce the prescribed standards of quality, safety and efficacy of all medicinal substances manufactured, imported into or exported out of the country;
(e) grant or revoke licenses for the manufacture, importation, exportation, distribution and sale of medicinal substances;
(f) maintain a register of all authorized medicinal substances;
(g) publish, at least once in every three months, lists of authorized or registered medicinal substances and of products with marketing authorizations;”
55. Section 2 of the PPB Act, defines health product to include; medical products as well as medicinal substances, diagnostics, and medical devices. Even though the Act does not define ‘medical products’, it is safe to conclude that medical product is a type of health product just as the defined by the World Health Organization (WHO). According to the WHO:
"Medical products are medicines, devices, and other items used to diagnose, treat, or prevent diseases or other abnormal conditions. They include pharmaceuticals, biologics, vaccines, and diagnostic tools." (Emphasis Added)
56. Section 2 of the PPB Act further defines medicinal substances to include a product, article or substance which is claimed to be useful for, inter alia, “diagnosing disease or ascertaining the existence, degree or extent of a physiological condition”. This definition has largely remained unchanged since the enactment of the Act.
57. Section 2 of the PPB Act gives elaborate definition of medical device to mean “any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article— (a) intended by the manufacturer to be used, alone or in combination, for humans or animals for;
i. diagnosis, prevention, monitoring, treatment or alleviation of disease;
ii. diagnosis, monitoring, treatment, alleviation of or compensation for an injury;
iii. investigation, replacement, modification or support of the anatomy or of a physiological process; (iv) supporting or sustaining life;
iv. control of conception;
v. disinfection of medical devices; or
vi. providing information for medical or diagnostic purposes by means of in vitro examination of specimens derived from the human body; and (b) which does not achieve its primary intended action in or on the human or animal body by pharmacological, immunological or metabolic means, but which may be assisted in its intended function by such means” (Emphasis Added).
58. It is submitted that the cumulative effect of Sections 3A and 3B is that PPB, the Interested Party, is the proper single regulatory body mandated to regulate and/or validate test kits/reagents, IVDs and other equipment used for medical tests fall under the definitions of health products and medicinal substances.
59. Section 4 of the Health Act, 2017, dictates that it is the fundamental duty of the state to observe, respect, protect, promote and fulfill the right to the highest attainable standard of health by performing among other things, the duty of developing policies, laws and other measures necessary to fulfill the said mandate. The Ministry of Medical Services developed the Guidelines on Submission of Documentation for Registration of Medical Devices available in the PPB website. It provides under Article 3(1) that the guidelines shall apply to:
“…medical devices and their accessories. For the purposes of these guidelines, accessories shall be treated as medical devices in their own right.”
60. Further, Article 5(3) of the Guidelines defines In-Vitro Diagnostic Devices (IVDs) to mean: medical devices, whether used alone or in combination, intended by the manufacturer for the in-vitro examination of specimens derived from the human body solely or principally to provide information for diagnostic, monitoring or compatibility purposes. IVD medical devices include reagents, calibrators, control materials, specimen receptacles, software, and related instruments or apparatus or other articles. It is further observed that the Exparte Applicant is mandated with the observation of these guidelines.
61. It is submitted that the above provisions make it clear that the 1st Interested Party is mandated to regulate and validate medical devices, including test kits/reagents, IVDs, and other equipment used for medical tests.
62. It is further submitted that the Respondent has, before the institution of this Application, initiated another application through The Nursing Council of Kenya; Judicial Review Misc Application No.229 of 2014 R vs The Pharmacy and Poisons Board, concerning functions which they seek to usurp through their disputed Memos. The Respondents withdrew from the said application and proceeded to conduct ‘Internal Discussions’, the outcome of which was a press Statement from the Office of the 2ndInterested Party affirming that the 1st Interested Party is the body mandated to carry out the duty of validating medicines, medical devices, medical equipment and reagents and In-Vitro Diagnostic Devices (IVDs).
63. The 2nd Interested Party in its press statement further affirmed that this role of the 1st Interested Party is supported by Legal Notice 192 of 2010 and Gazette notice no. 1879 of 21st March 2014. Therefore, these attempts through the memos by the Respondent are ultravires and intent on usurping powers for their unknown gain.
64. These functions the Respondent now seeks to assume,it is submitted are outside its scope of mandate as illustrated, and those functions only fall within the legal mandate of the 1stInterested Party. Members of the Exparte applicant have been taking measures to ensure that they comply with legal provisions as they are. The Respondent seeking to act outside its scope puts members of the Exparte applicant at risk of unwarranted financial losses and unpredictable business environment.
65. The assumption of these roles by the Respondent, which is the mandate of the 1st Interested Party, would subject members of the Exparte Applicant to unfair administrative action. In light of Article 47 of the Constitution, which guarantees the right to fair administrative action, the ex-parte Applicant invokes its right as it is likely to suffer and in line with the position of the court in the matter Nancy Makokha Baraza v Judicial Service Commission & 9 Others [2012]eKLR this court has wide discretion, which is inclusive rather than exclusive and therefore allows this Court to make appropriate orders and grant remedies as the situation demands and as the need arises.
66. They further submit that it is of no use to subject suppliers to double registration and have them register with the Respondent while at the same time registered with another statutorily created body; the 1st Interested party. It is submitted that members of the Applicant are already regulated by the Interested Party.
67. The requirement imposed by the Respondent to provide evidence of certification for test kits/reagents and equipment from United States Food and Drug Administration (FDA) has no basis in law it is submitted.
68. Matters of certification is under the purview of the Kenya Bureau of Standards (KEBS) established under the Kenya Standards Act Cap 496. Section (4)(1) specifies these functions as follows: -
‘(a) to promote standardization in industry and commerce;
(b) to make arrangements or provide facilities for the testing and calibration of precision instruments, gauges and scientific apparatus, for the determination of their degree of accuracy by comparison with standards approved by the Cabinet Secretary on the recommendation of the Council, and for the issue of certificates in regard thereto;
(c) to make arrangements or provide facilities for the examination and testing of commodities and any material or substance from or with which and the manner in which they may be manufactured, produced, processed or treated;
(d)…(e)…(f)..;
(g) to assist the Government or any local authority or other public body or any other person in the preparation and framing of any specifications or codes of practice;
(h) to provide for co-operation with the Government or the representatives of any industry or with any local authority or other public body or any other person, with a view to securing the adoption and practical application of standards;
to provide for the testing at the request of the Cabinet Secretary, and on behalf of the Government, of locally manufactured and imported commodities with a view to determining whether such commodities comply with the provisions of this Act or any other law dealing with standards of quality or description.” (Emphasis added).
69. The Interested Party is among entities specified as regulatory authority for products under its purview and thus exempt from PVoC program. The Respondent is not listed as such and neither is FDA referred to as the certification body in Kenya.
70. The Section 27 of the Civil Procedure Act provides that: -
“(1) Subject to such conditions and limitations as may be prescribed, and to the provisions of any law for the time being in force, the costs of and incidental to all suits shall be in the discretion of the court or judge,
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