Health Cabinet Secretary Aden Duale has sought to settle the growing dispute over new pharmacy rules, saying diploma holders will not be pushed out of the health sector when the 2026 Good Pharmacy Practice Standards come into force next year.
Duale said the standards, which are scheduled to take effect on January 1, 2027, allow both diploma and degree pharmacy professionals to continue working at different levels of the health system as long as they are properly enrolled or registered, licensed and remain within the limits of their professional practice.
"It is 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," he stated.
The CS said the rules should not be interpreted as preventing diploma holders from practising, explaining that they instead make a distinction between pharmacy professionals working in healthcare facilities and those appointed to take overall responsibility for a pharmacy facility.
At the centre of the distinction is the position of the superintendent, who Duale said is responsible for the professional and regulatory running of a facility.
He said the qualification needed for such a position would therefore depend on the kind of pharmaceutical services offered, their level of complexity and the risks involved.
Duale maintained that professionals from different cadres would continue working alongside one another throughout the health system. He described the requirements for superintendents as a measure aimed at ensuring that those with overall responsibility have the right level of skills to protect patients.
“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,” Duale said.
The CS said the position taken in the standards is also in line with the Ministry of Health’s Human Resources for Health Norms and Standards Guidelines.
Those guidelines, he said, provide for staffing and professional responsibility to be matched with the services being offered at each level of healthcare.
Duale said the wider goal of the Good Pharmacy Practice Standards is to improve patient safety and ensure that people receive quality pharmaceutical care.
He said the new framework would also give the sector a stronger way of dealing with illegal and unethical activities that have continued to expose patients to danger.
"These include the ‘renting’ or ‘leasing’ of professional licences, operation of premises without proper professional oversight, inappropriate dispensing, misuse of antimicrobials and diversion or misuse of narcotic and psychotropic substances," he said.
The CS said the standards are supported by existing laws and constitutional provisions that safeguard the right to health as well as the rights of consumers.
He cited Articles 43 and 46 of the Constitution, which guarantee the right to the highest attainable standard of health and protect consumers’ entitlement to quality services, adequate information and safeguards for their health and safety.
Duale also defended the process through which the standards were developed, saying they were not drawn up suddenly or without input from those in the sector.
He said the process had lasted more than five years and involved 11 different iterations, together with several rounds of consultation and technical review.
The exercise brought together the Ministry of Health, county governments, professional associations representing diploma and degree holders, universities and other academic institutions, public and private health facilities, the pharmaceutical industry and development partners.
According to Duale, contributions received during the consultations were reviewed and included where considered appropriate, with decisions guided by the law, professional competence, patient safety and the broader public health interest.
The Ministry said it would continue discussions with pharmacy professionals ahead of the January 2027 start date.
"The Ministry remains committed to constructive engagement with all pharmacy professionals and the Pharmacy and Poisons Board will continue providing clarification and implementation support ahead of the commencement of the Standards on 1st January 2027," the statement concluded.
However, the clarification has not ended the concerns among a section of pharmaceutical technologists, who have challenged the new guidelines over what they say was inadequate involvement in their preparation.
The professional associations have accused the regulator of failing to respond to several requests for dialogue, while also saying that issues raised by their members were not captured in the latest version of the standards.
The disagreement has left the professionals calling for additional talks with the regulator before the new requirements are put into effect.