Health Cabinet Secretary Aden Duale has responded to demonstrations by holders of Diploma in Pharmacy over the implementation of the 2026 Good Pharmacy Practice Standards.
Duale said the Ministry of Health had taken note of the concerns raised by the pharmacy professionals and respected their right to demonstrate and engage the government on issues affecting their practice.
He, however, clarified that the new standards do not prevent diploma or degree holders from practising or working at any level of the health system.
“It is, however, necessary to clarify that the Standards do not bar any category of pharmacy professionals (whether diploma or degree holders) from practising or working at any level of the health system, provided they are duly enrolled or registered, licensed and operate within their lawful scope of practice,” Duale said.
The CS said the standards distinguish between working as a pharmacy professional at a particular level of care and serving as the superintendent of a pharmacy facility.
According to Duale, the superintendent carries overall professional and regulatory responsibility for the facility.
“Pharmacy professionals of different cadres will continue to work together across the health system. However, the minimum qualification of the superintendent must correspond to the nature, complexity and level of risk of the pharmaceutical services offered,” he said.
Duale said the requirement was based on competency and patient safety rather than discrimination against a particular category of pharmacy professionals.
“This is a competency-based patient-safety measure. As services become more specialised and the risks to patients increase, the qualifications and competencies of the person bearing overall responsibility (the superintendent) must increase accordingly,” he added.
Why the Ministry Introduced New Pharmacy Standards
Duale said the approach is consistent with the Ministry of Health’s Human Resources for Health Norms and Standards Guidelines for the Health Sector.
The guidelines align staffing levels and professional responsibilities with the type and complexity of services offered at different levels of healthcare.
He said the primary objective of the Good Pharmacy Practice Standards is to protect patients and improve the quality of pharmaceutical care.
The standards are also expected to help the government address illegal and unethical practices within the pharmacy sector.
Duale cited practices such as renting or leasing professional licences, operating pharmaceutical premises without proper professional oversight, inappropriate dispensing of medicines, misuse of antimicrobials and diversion or misuse of narcotic and psychotropic substances.
“These practices continue to endanger patients,” the CS said.
Duale said the Good Pharmacy Practice Standards are anchored in Kenyan law and constitutional provisions on healthcare and consumer protection.
He cited Article 43 of the Constitution, which guarantees the right to the highest attainable standard of health, and Article 46, which protects consumer rights to quality services, adequate information and the protection of health and safety.
He also cited Section 3B(3)(a) of the Pharmacy and Poisons Act, Cap 244, which mandates the Pharmacy and Poisons Board to promote pharmacy practice that complies with universally accepted norms and values.
The CS said the standards were therefore developed to strengthen professional practice and protect patients.
Duale rejected claims that the standards were introduced abruptly or without consultation.
“It is also important to clarify that the Standards were not developed abruptly or without consultation. Their development took more than five years and involved eleven iterations and multiple rounds of stakeholder engagement and technical review,” he said.
The process involved the Ministry of Health, county governments, professional associations representing both diploma and degree holders, academia, public and private healthcare institutions, the pharmaceutical industry and development partners.
Other relevant stakeholders were also involved in the consultations and technical reviews.
Duale said the views submitted during the process were considered and incorporated where appropriate.
He said the final standards were developed with consideration for existing laws, professional competencies, patient safety and the wider public health interest.
“The final Standards are therefore the outcome of an extensive, inclusive and consultative process,” he said.
The Health Ministry said it remains committed to engaging pharmacy professionals over the new standards.
Duale said the Pharmacy and Poisons Board would continue providing clarification and implementation support to stakeholders before the standards take effect.
The Good Pharmacy Practice Standards are scheduled to commence on January 1, 2027.
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