Kenya plans to implement the 2026 Good Pharmacy Practice (GPP) Standards on January 1, 2027, following years of drafting and revisions by the Pharmacy and Poisons Board (PPB).
However, the latest version has sparked a dispute with pharmaceutical technologists, who argue that some provisions would reduce their responsibilities in healthcare facilities.
The Kenya Pharmaceutical Association (KPA) has rejected Draft 11, saying it limits the role of diploma-trained pharmaceutical technologists.
The PPB and the Ministry of Health maintain that the standards do not bar diploma holders from practising. Instead, they say the rules assign different responsibilities to pharmacy professionals based on their qualifications and roles within a facility.
What are the Good Pharmacy Practice Standards (GPP)?
The GPP Standards set out how pharmacy services should be delivered, including professional responsibilities, supervision, patient safety, and the management of pharmaceutical facilities.
The PPB says the standards are designed to strengthen professional oversight, curb unsafe dispensing and antimicrobial misuse, and promote safe, accountable pharmaceutical care.
They are part of broader pharmacy reforms that include digital licencing for professionals and facilities. The PPB says it has already assessed more than 600 facilities across 43 counties.
Why has the government introduced them?
The Ministry of Health says the standards are intended to protect patients and improve the quality of pharmaceutical care.
The government argues that pharmacy services have become more specialised and that professionals overseeing them should have the qualifications and competencies required for increasingly complex care.
"This is a competency-based, patient-safety measure. As services become more specialised and risks to patients increase, the superintendent's qualifications and competencies must increase accordingly," said Health Cabinet Secretary Aden Duale.
What has changed under latest standards?
Draft 11 is the focus of the dispute.
The KPA says it narrows the responsibilities of pharmaceutical technologists, including who can serve as superintendent at Level 3 facilities and handle certain medicines. The association also disputes its involvement in the later stages of drafting.
The PPB and the Ministry of Health say the standards do not prevent licensed pharmaceutical technologists from working at any level of the health system. Instead, they distinguish between practising as a pharmaceutical professional and serving as the superintendent, who has overall responsibility for pharmaceutical services at a facility.
"The standards do not bar any category of pharmacy professional, whether diploma or degree holder, from practising or working at any level of the health system," Duale said.
He added that professionals can continue to practise if they are duly enrolled, registered, licensed, and working within their legal scope of practice.
Why are pharmaceutical technologists opposing Draft 11?
Pharmaceutical technologists say the proposed standards could reduce their responsibilities, particularly in public health facilities.
The KPA argues this could create staffing gaps by reserving more supervisory roles for pharmacists.
"How can 2,559 Level 3 facilities realistically be supervised by 2,931 pharmacists while excluding the 10,533 pharmaceutical technologists who form the backbone of pharmaceutical care?" asked KPA president Chitechi Amboka.
The association says it supports regulation but opposes provisions it believes could restrict the profession and reduce access to medicines.
What is the dispute over Levels 3 to 6?
The disagreement centres on who can take overall responsibility for pharmaceutical services at Levels 3 to 6 health facilities.
Pharmaceutical technologists argue the standards could limit diploma-trained professionals from serving in supervisory roles at these facilities while giving greater responsibility to degree-trained pharmacists.
The PPB says technologists are not being barred from working at these facilities. It says the standards simply set different qualification requirements for the superintendent.
Why is the superintendent role so important?
The superintendent is the professional legally responsible for pharmaceutical services at a facility.
Their duties include ensuring medicines are handled safely, professional standards are followed, and the facility complies with the law.
The government says this role requires qualifications and competencies that match the complexity of pharmaceutical services.
Pharmaceutical technologists argue the proposed requirements unnecessarily restrict their career progression.
What other practices are the standards trying to address?
The standards seek to curb practices such as renting professional licences, where a professional's credentials are allegedly used to legitimise a facility without proper oversight.
The PPB also says the standards target inappropriate dispensing, antimicrobial misuse, unqualified individuals handling medicines, and facilities operating without proper supervision.
The KPA has raised concerns that restricting narcotic and psychotropic medicines to pharmacists could make pain management, palliative care, and some mental health services less accessible, especially in rural and underserved areas.
What happens if a pharmacy or professional does not comply?
The GPP Standards do not prescribe a single penalty for every breach.
Compliance will be enforced through the PPB's licensing, inspection, and enforcement framework. The Board says recent operations have resulted in arrests and the closure of non-compliant premises.
Depending on the offence, penalties may include disciplinary action, licence suspension or revocation, prosecution, or other regulatory measures.
