The Pharmaceutical Society of Nigeria (PSN) has expressed strong opposition to plans for establishing a National Health Facility Regulation Agency (NHFRA), arguing that it undermines the integrity and authority of the pharmacy profession and disrupts the existing regulatory framework, which they deem sufficient. Professor Cyril Usifoh, President of PSN, stated that NHFRA would be counterproductive to ongoing efforts to enhance healthcare delivery in the country, as the established regulatory structure under the Pharmacy Council of Nigeria (Establishment) Act 2022 is already adequate.
In a recent letter addressed to the Minister of Justice and Attorney General of the Federation, Mr. Lateef Fagbemi, SAN, Prof. Usifoh criticized the Minister of State for Health, Dr. Tunji Alausa, for citing the United Kingdom’s Care Quality Commission (CQC) and the United States’ Joint Commission as inspirations for the NHFRA. He contended that, unlike in the UK and the US, pharmaceutical services in those countries are regulated independently. “Pharmacy education, training, licensure, practice standards, and professional ethics are overseen by pharmacy regulatory bodies, while the State Board of Pharmacy is responsible for inspecting and registering pharmacy facilities in the US. In the UK, the General Pharmaceutical Council regulates pharmacists and pharmacy technicians, sets practice standards, and addresses investigative complaints, while the Medicines and Health Regulatory Authority (MHRA) focuses on the regulation of medicines and medical devices,” he explained.
Usifoh elaborated, “While the CQC and the Joint Commission primarily oversee broader regulations of healthcare facilities and services, the Pharmacy Council of Nigeria’s mandate is specific to pharmaceutical services, encompassing regulatory duties similar to those of its counterparts in the UK and the US. The Pharmacy Council of Nigeria (PCN)—established by the PCN (Establishment) Act 2022—functions as a federal agency responsible for regulating and controlling all aspects of pharmacy education, training, and practice, including Pharmacy Technicians and Patent and Proprietary Medicine Vendors (PPMVs).”
He added that drawing parallels between the NHFRA and international regulatory bodies fails to acknowledge the unique scope and specialization needed for regulating pharmaceutical services in Nigeria. Expressing his surprise at the decision to establish NHFRA, Usifoh remarked, “The PSN wonders what drives this agenda for a new NHFRA, which would introduce new legal and structural imperatives when existing agencies already regulate these professions and health facilities.”
In their communication, PSN referenced the historical context and legal foundation of pharmacy regulation in Nigeria, arguing that the NHFRA is unnecessary. “We examined the legal background, beginning with the Lagos Pilotage and Harbour Ordinance of 1878, the Hospital Ordinance of 1881, and the Ereko Dispensary Rules of 1889, all of which acknowledged the need for regulating dispensers, druggists, and chemists. The regulation of the profession has been overseen by the Pharmacists Board as delineated in the Pharmacy Ordinance of 1927, the Poisons and Pharmacy Act of 1958, and the Pharmacists Act of 1964,” he asserted.
Despite changes in legislation, the core principles have remained consistent, and the establishment of the Pharmacists Council of Nigeria through Decree No. 91 of 1992, later enhanced by the PCN Act Cap P17 LFN 2004, signifies a commitment to modernizing the regulation of pharmacy practice and aligning it with international standards through the Pharmacy Council of Nigeria (Establishment) Act 2022.
In their letter to the minister, PSN emphasized the importance of stable regulation in pharmacy practice, noting that prior to the National Health Act of 2014, all major professions had professional regulatory agencies. “Drug matters are explicitly listed in the Exclusive List of the 1999 Constitution, allowing only the National Assembly to legislate on Pharmacy and Drug laws,” the organization stated. “The Federal Ministry of Health, through agencies like the PCN and NAFDAC, enforces these laws, while only the Federal High Courts have the jurisdiction to adjudicate on drug matters and pharmacy practices in Nigeria.”
Professor Usifoh pointed out that government and lawmakers have often relied on conventions and norms to allow health matters to remain in the purview of state and federal governments. He added that most state governments have established their regulatory agencies for healthcare facilities, in addition to pharmacies. “Typically, state apparatus oversees the regulation of healthcare practices, while professional regulatory agencies manage the professionals,” Usifoh explained.
He underscored the historical significance of pharmacy regulation in Nigeria, noting that the first legal framework for regulating pharmacy, the Pharmacy Ordinance of the 1800s, has evolved into what is now the Poisons and Pharmacy Act Cap 535 LFN 1990. Notably, by 1958, the Pharmacists Board of Nigeria had become an autonomous body regulating pharmacy facilities throughout the country.
Furthermore, PSN accused the government of perpetuating unhealthy discrimination and a dominant attitude of medical professionals over other healthcare workers. “We must remind the government that there is a persistent mutual suspicion regarding the motives of successive leaders at the Federal Ministry of Health, who are often perceived to favor the medical profession and its aspirations. This has led to ongoing discord among various health workers in Nigeria,” they said.
The letter highlighted that it took over a decade to establish a National Health Act because early drafts sought to place all health professions under the control of the medical profession. “Both PSN and the Joint Health Sector Union (JOHESU) resisted this clause, seeing it as a move to undermine other health professions,” Usifoh noted, adding that the original draft of the health statutes concentrated privileges solely on medical practitioners.
