CS Duale defends new pharmacy standards amid protests by diploma holders

In a press statement issued on Wednesday, September 3, Health Cabinet Secretary Aden Duale said the standards distinguish between working as a pharmacy professional and serving as a superintendent responsible for the overall professional and regulatory management of a health facility.

Duale maintained that diploma and degree holders would continue working across different levels of the health system, provided they are duly registered, enrolled and licensed to practise within their respective legal scope.

“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,” the Ministry stated.

However, the Cabinet Secretary explained that the minimum qualifications required for a superintendent would depend on the nature, complexity and level of risk associated with the pharmaceutical services offered at a facility.

According to the Ministry, the requirement is based on professional competency and patient safety, with more specialised services requiring higher levels of qualifications and competency from the person bearing overall responsibility.

“The principal purpose of the Good Pharmacy Practice Standards is to protect the patient and assure the quality of pharmaceutical care,” Duale stated.

The Ministry further argued that the standards would help tackle illegal and unethical practices within the pharmaceutical sector.

These include the alleged renting or leasing of professional licences, operating pharmaceutical premises without proper professional oversight, inappropriate dispensing of medicines, misuse of antimicrobials and the diversion or misuse of narcotic and psychotropic substances.

Duale also defended the legal basis of the new standards, citing Articles 43 and 46 of the Constitution, which guarantee the right to the highest attainable standard of health and protect consumers' rights to quality services, adequate information and protection of their health and safety.

The Ministry also cited Section 3B(3)(a) of the Pharmacy and Poisons Act, which mandates the Pharmacy and Poisons Board to promote pharmacy practice that complies with universally accepted norms and values.

Addressing concerns that the standards were introduced without sufficient consultation, the Ministry said their development took more than five years and involved 11 iterations, stakeholder engagements and technical reviews.

According to the statement, the process involved the Ministry of Health, county governments, professional associations representing diploma and degree holders, academic institutions, public and private healthcare facilities, the pharmaceutical industry, development partners and other stakeholders.

“The inputs received were considered and incorporated, where appropriate, in accordance with the law, professional competencies, patient safety and the wider public health interest,” the Ministry stated.

Duale said the Ministry remained open to engaging pharmacy professionals as concerns over the implementation of the standards continue.

The Pharmacy and Poisons Board will also provide clarification and implementation support ahead of the commencement of the 2026 Good Pharmacy Practice Standards on January 1, 2027.