Pharmacists Kick Against National Health Facility Regulation Plans

The Pharmaceutical Society of Nigeria (PSN) has kicked against plans to establish a National Health Facility Regulation (NHFRA) as it undermines the integrity and authority of the pharmacy profession and would destabilise existing regulatory framework, describing it as redundant.
Prof. Cyril Usifoh, President of PSN, said that NHFRA would be counterproductive to efforts to entrench effective healthcare delivery in the country as an already established regulatory structure under the Pharmacy Council of Nigeria (Establishment) Act 2022 is enough.

In a letter to the Minister of Justice and Attorney General of the Federation, Mr Lateef Fagbemi, SAN; Prof. Usifoh, described as misleading, the Minister of State for Health, Dr. Tunji Alausa’s adoption of the United Kingdom’s Care Quality Commission (CQC) and the United States’ Joint Commission as examples that inspired the creation of National Health Facility Regulatory Agency (NHFRA).

He argued that contrary to what obtains in Britain and USA, pharmaceutical services in both countries are regulated independently.
According to him, “Pharmacy education, training, licensure, practice standards, and professional ethics is overseen by the pharmacy regulatory bodies, while the State Board of Pharmacy inspects and registers the pharmacy facilities in the USA. In the UK, the General Pharmaceutical Council regulates Pharmacists and Pharm. Technicians while also setting practice standards and handling investigative complaints. Similarly, the Medicine and Health Regulatory Authority (MHRA) regulates medicines and medical devices.”

Usifoh further explained that “While the CQC and the Joint Commission focus primarily on the broader regulations of healthcare facilities and services, the PCN’s mandate is specific to pharmaceutical services, encompassing regulatory duties similar to its counterparts in the UK and in the US.

“For emphasis, the Pharmacy Council of Nigeria (PCN) occupies a similar regulatory position as these specialised pharmacy bodies in the United Kingdom and the United States. Established by PCN (Establishment) Act 2022, the PCN is a federal government parastatal charged with the responsibility of regulating and controlling pharmacy education, training and practice in all aspects and ramifications, including regulating Pharmacy Technicians and Patent and Proprietary Medicine Vendor (PPMVs).

“Therefore, drawing parallel between the NHFRA and these international bodies does not adequately account for the distinct scope and specialisation required for regulating pharmaceutical service in Nigeria,” he said.

Expressing surprise at the decision to establish NHFRA, Usifoh said, “The PSN is left to wonder what then drives this agenda of a new NHFRA which will come with legal and structural imperatives when all the professions and health facilities already have agencies that should regulate them.”

Citing historical antecedents and legal background of pharmacy regulation in the country, PCN argued that the idea of NHFRA was unnecessary.

 “We have looked at the legal background and development of Pharmacy regulatory laws in the country beginning from the Lagos Pilotage and Harbour Ordinance 1878, the Hospital Ordinance of 1881 and the Ereko Dispensary Rules of 1889, these early legislations recognised the purpose of regulating dispensers, druggists and chemists.

“The regulation of the practice of the profession in that regard was overseen by the Pharmacists Board as contained in the Pharmacy Ordinance of 1927, The Poisons and Pharmacy Act 152 of 1958 and the Pharmacists Act No. 26 of 1964. Despite changes in the contents of the legislation, the substances were the same.

“The Decree No. 91 of 1992 created the Pharmacists Council of Nigeria which was further improved upon by the Pharmacists Council of Nigeria Act Cap P17 LFN 2004. The current extant legislation the Pharmacy Council of Nigeria (Establishment) Act 2022 not only emboldened the previous legislations but substantially expanded the scope of practice and personnel involved in the practice and brought the law to be at par with the best international practice.”

In the letter, PSN drew the attention of the minister to the effects of the inputs of the antecedents to stable regulation of the pharmacy practice stressing that “the status quo before 2014 when we had a National Health Act was that all the major professions had Professional Regulatory Agencies/Councils, which regulated and controlled their professions. Drug matters are listed on the Exclusive List as item 21 in Part 1 of the 2nd schedule in the 1999 Constitution.

“This latitude compelled only the National Assembly to make Pharmacy and Drug laws, while the Federal Ministry of Health through agencies like the Pharmacy Council of Nigeria (PCN) and NAFDAC enforced laws by the National Assembly. Only the Federal High Courts are by virtue of its being listed on the Exclusive List can adjudicate on Drug Matters and Pharmacy Practices in Nigeria.

“The other notable professions in healthcare were listed on the Concurrent list in the 1979 Constitution. This gave the federal and state governments a jurisdiction to regulate and control Medical Laboratories, Hospitals, Diagnostic Centres, Nursing Homes, and others. Presently, Health matters are not listed on the concurrent list in the 1999 Constitution,’’ PSN said.

Prof Usifoh noted that, “Government and lawmakers have only invoked conventions as well as norms to continue to allow health matters to remain in the domain of the states government and the federal government, adding that, “This is why almost all the state governments already have state regulatory agencies which regulates and controls hospitals, diagnostics facilities and other health facilities apart from pharmacies at this level of governance.

“Oftentimes the state apparatus has regulated healthcare practices and facilities in the states, the professional regulatory agencies/councils have always regulated the professionals. This is why the Medical and Dental Council of Nigeria (MDCN) regulates Physicians and Dentists, Nursing and Midwifery Council of Nigeria (NMCN) regulates Nurses and Midwives, while Medical Laboratory Scientists Council of Nigeria (MLSN) regulates Medical Laboratory Scientists. This has been the status-quo for several decades now with the various health professions.”

He further posited that “Pharmacy practice in particular is laced with substantial antiquity because the first legislation to regulate pharmacy was historically documented as the Pharmacy Ordinance of 1800’s which has metamorphosed to what is now the Poison and Pharmacy Act Cap 535 LFN1990. Noteworthy however, is the reality that as far back as 1958, the erstwhile Pharmacists Board of Nigeria (PBN) which was further reinforced to become the PBN Cap 154 of 1964 had become an autonomous board of only registered pharmacists which regulates and controls pharmacy facilities in Nigeria.”

PSN accused the government of allegedly encouraging and promoting unhealthy discrimination and domineering attitude of Medical professionals over other health workers in the subsector.

“It is important to remind the government that the perpetual mutual suspicion of the motives of successive leadership of the Federal Ministry of Health, often perceived to work in favour of the aims as well as the aspiration of the medical profession through its umbrella body, has always been a major issue in the unending entropy that is generated amongst health workers in Nigeria.

In the letter, PSN said, “For over 10 years, it was impossible to have a National Health Act because the first proviso in the draft bill in Section 1 (I) had posited that there shall be a “National Health System which shall regulate and control all the health professions.”

The PSN and the Joint Health Sector Union (JOHESU), Usifoh said strongly resisted this clause which was a clever ploy to undermine all the health professions by placing them under the stewardship control of their counterparts in medicine.

‘’This school of thought was confirmed because typical of health statutes in Nigeria, all the privileges and rights were ceded to only practitioners of medicine in the originating draft.