The Kenya Drugs Authority Bill, 2022

Background

The Kenya Drugs Authority Bill, 2022 (National Assembly Bill No. 54 of 2022) was published on 6th October 2022 and undergone its First Reading on 9th November 2022. The primary objective of the Bill is to consolidate the regulation of health products and technologies (HPTs) under a single, centralized regulatory framework that meets international best practices and World Health Organization (WHO) maturity standards.

By establishing a dedicated regulator, the Bill aims to guarantee the safety, quality, and efficacy of medical products in Kenya while resolving regulatory overlaps between different government agencies, particularly concerning food, veterinary products, and agricultural pesticides.

Key Amendments

• Renaming the Authority and Scope: The Bill changes the name of the proposed regulatory body from "Kenya Drugs Authority" to the Kenya Health Products and Technologies Regulatory Authority to accurately reflect its broader regulatory jurisdiction, which covers medical devices, diagnostic reagents, and nutritional supplements rather than just pharmaceutical drugs.
• Exclusion of Veterinary Medicines: All references to animal health, veterinary surgeons, and veterinary medicines are deleted. These remain under the regulatory scope of the Veterinary Surgeons and Veterinary Para-Professionals Act (Cap. 366) and the Veterinary Medicines Directorate (VMD) to avoid dual-regulation.
• Exclusion of Food and Pest Control Products: Clauses relating to food safety and pesticide chemicals have been removed to prevent regulatory overlap with the Pest Control Products Board (PCPB) and existing food safety laws (Cap. 254).
• Autonomy of the National Quality Control Laboratory (NQCL): The NQCL is formally structured as an independent regulatory facility with its own Board of Management, rather than operating merely as a department of the main Authority.

New Obligations

• Mandatory Licensing & Registration: All manufacturers, wholesalers, distributors, importers, exporters, and retailers of health products and technologies must be licensed by the Authority. No medical product may be sold or distributed in Kenya unless it has been formally registered.
• Clinical Trial Approvals: Any clinical trials involving human subjects require joint approval from both the Authority and a recognized ethics review body. Sponsors must present detailed protocols, including post-trial access programs for investigational medical substances.
• E-Pharmacy and Telemedicine Compliance: Providers offering digital pharmacy services or telemedicine platforms must secure specialized licenses. They are obligated to implement verification protocols for both the prescriber's and patient's identities and maintain end-to-end traceability of dispensed scheduled substances.
• Good Manufacturing Practices (GMP): All domestic and international manufacturing sites supplying health products to Kenya must comply with WHO-aligned GMP guidelines. The Authority has the power to inspect premises and issue compliance certificates.

Penalties

• Substandard & Falsified Products: Releasing falsified, counterfeit, or substandard medications into the market is classified as a severe offense, punishable by a fine of up to KSh 100 million, a prison term of up to 10 years, or both.
• Unlicensed Manufacturing & Clinical Trials: Operating a manufacturing facility or executing unauthorized clinical trials without valid permits carries a fine not exceeding KSh 10 million or up to 10 years in prison.
• Violation of E-Pharmacy Regulations: Conducting unauthorized electronic distribution of prescription-only drugs carries a maximum fine of KSh 1 million, up to one year of imprisonment, or both.
• Unregistered Importation / Smuggling: Illegal importation, cross-border smuggling, or misdeclaration of health products at ports of entry attracts a fine of up to KSh 1 million or imprisonment of up to two years.

Transitional Provisions

• Transition of Assets and Staff: The assets, liabilities, and ongoing obligations of the former Pharmacy and Poisons Board (PPB) and the previous National Quality Control Laboratory are transferred directly to the newly established Authority and autonomous NQCL.
• Continuity of Service: To prevent regulatory gaps during the transition phase, members of the former boards and their executive staff will continue serving for the remainder of their unexpired terms.