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 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.
He said, “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.
“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 specialized 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.’’
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 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 ten 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.
Stressing further on why the Pharmacy Council of Nigeria (PCN) should not be merged with any other health regulatory body or bodies in the country, Prof. Usifoh, noted that the ‘’Pharmacy Council of Nigeria has undergone phenomenal development and growth in the performance of its duty as regulator of pharmacy practice, premises and personnel. It currently has developed its regulatory personnel and structure to such an extent that it is well entrenched with state offices in each state of the Federation, 6 zonal offices in each of the geopolitical zones, Lagos as a special zonal office and its head office in Abuja. These physical structures manned by staff who have acquired capacity in regulatory activities over the years, have adequately reached a stage whereby the Council is now effectively regulating the drugs distribution system in the country.
‘’The effectiveness of the PCN particularly as currently backed by the PCN Act, 2022 and robust regulations made hereunder can be seen from recent strides achieved in enforcing compliance with the law and closure of opened drug markets in three locations in Kano, Zaria and Gombe and the fact that the operators are compelled and relocated to the CWC which the coordinating Minister of Health and Social Welfare had commissioned. Other opened drug markets which have been blighted on the issue of public health are also penciled for closure upon completion of such CWCs in various states. Now that a solution is being found, it will be ill-advised to truncate the process,’’ he stated.
PSN further posited that ‘’due to the effectiveness of the Pharmacy under the new dispensation, the World Health Organisation benched marked Nigeria as stage three along with NAFDAC in which the two agencies are jointly recognized as National Regulatory Agency for Nigeria. With this rating, Nigeria is now rated one of the very few in Africa with that capacity; and that it can now produce vaccines, among others. By the end of the year, the country will be due for further appraisal and rating. This momentum should be upheld and built upon rather than having it disrupted.
‘’It is the general practice globally that Pharmacy profession, practice and business is regulated exclusively by the practitioners of the profession as an entity. Countries with similar backgrounds as Nigeria including Great Britain, United States of America, Canada, Republic of South Africa, Ghana and Kenya have a pharmacy regulatory body as the sole sector regulator. None is subjected to or merged with any other health sector regulatory body and each is headed by a seasoned senior pharmacist as head of the pharmacy regulatory body.
Continuing, it said,‘’Globally, pharmacy councils or similar regulatory bodies operate independently to ensure that pharmacists and other cadres of the pharmacy profession adhere to international standards. A merger could make it harder for Nigeria to align with these standards, will potentially affect the quality of pharmacy education and practice, and Nigeria’s recognition in international pharmaceutical collaborations’’.
While proposing an alternative solution instead of the NHFRA, PSN advised the government to focus on establishing a regulatory commission for tertiary health institutions at the federal level, as mandated by the National Health Act of 2014.
The body argued that maintaining the independence of the Pharmacy Council of Nigeria is essential for upholding the specialized expertise, professional standards, and public health protections that are critical to the pharmacy profession, practice and business. A merger with other health regulatory bodies risks diluting these key functions, and compromising both the profession and public safety. These reasons demonstrate the importance of maintaining the independence of the Pharmacy Council of Nigeria to ensure the highest level of professional standards, public health protection, and regulatory efficiency.
It noted that the only groups of health facilities that are not regulated in Nigeria today are the Tertiary Health Institutions at the Federal level consisting of Teaching Hospitals, Federal Medical Centres (FHIs) and a host of other hospitals and clinics maintained by MDAs at the Federal level.
‘’As it stands today, it appears it is the negligence of the Federal Ministry of Health since 2014 that has encouraged this loophole as the NH 2014 Act provides for a regulatory instrument in Section 9 to establish a Tertiary Health Facility Commission which should undertake this statutory responsibility. It is therefore logical to encourage the Federal Government to activate the areas of negligence in the NH 2014 Act which are obviously not limited to the establishment of the Tertiary Health Facility Commission. This, it said, is the major area that needs a redress within the purview of existing laws.
PSN commended the efforts of the coordinating Minister of Health in securing the best budget for Health in many years, adding that but the full activation of the Basic National Health Fund remains the major focus that will compel a change agenda in funding.
‘’It is our conviction that we must encourage the Federal Government to improve funding of the PCN and NAFDAC to elevate their statutory outputs and ultimately health outcomes in public interest. The enabling Acts of Parliament that establish the PCN and NAFDAC are specific laws which cannot be superseded by general laws of any type or nature.
‘’We also strongly urge the Federal Ministry of Health not to commit its limited funds in driving a needless NHFRA agenda because it is the least of our priorities in the Health Sector now.
PSN advised the Federal Ministry of Health ‘’to leverage on the existing status-quo that has ensured some relative peace in the Health Sector by jettisoning any move that will stir the hornets’ nest, as any agenda bordering on a centralized Health Regulatory Facility Agency will be grounded in immediate suspicion which will jeopardize our fragile peace and this will definitely be resisted by stakeholders. The general perception of health workers on the NHFRA initiative is that Dr. Alausa is working on an age-long script to put all health professions under the supervision of his medical constituency.
‘’Nothing buttresses the viewpoint that this is an agenda of suppression than the fact that membership of the Committee to superintend the proposed NHFRA is made up of physicians to the extent of 99% which in itself spells doom for the Health Sector because inputs accrue from only one profession in a multidisciplinary sector,’’ it stated.
