Pharmacists Kick Against Proposed National Health Facility Regulatory Agency

… Say Initiative Conflicts With Existing Regulatory Frameworks In Sector

Pharmacists under the auspices of the Pharma­ceutical Society of Nige­ria (PSN) have expressed strong objections over the pro­posed establishment of a National Health Facility Regulatory Agen­cy (NHFRA), an initiative champi­oned by the Minister of State for Health, Dr. Tunji Alausa.

Specifically, the PSN artic­ulated its objections about the NHFRA, saying the initiative might potentially conflict with existing regulatory frameworks, particularly in the pharmaceuti­cal sector.

In a detailed letter signed by Prof. Cyril Usifoh, President of the PSN, and addressed to the Minister of Justice and Attor­ney General of the Federation, Mr. Lateef Fagbemi, the society voiced strong criticisms about the NHFRA.

The PSN called for further di­alogue and consideration of its implications for the healthcare sector. The society’s concerns highlight the need for a compre­hensive evaluation of the agency’s potential impact on pharmaceuti­cal practices and health service delivery in the country.

It emphasised that in both the UK and the U.S., the regulation of pharmacy services operates independently from broader healthcare facility regulators, underscoring the critical role of the Pharmacy Council of Nigeria (PCN).

The PSN outlined the historical context of pharmacy regulation in Nigeria, noting that the PCN has been pivotal in overseeing pharmacy education, training, and practice standards. Estab­lished by the Pharmacy Council of Nigeria (Establishment) Act 2022, the PCN is empowered to regulate all aspects of pharma­cy practice, including pharmacy technicians and patent and pro­prietary medicine vendors (PPM­Vs). This regulatory framework is crucial for maintaining the integrity and quality of pharma­ceutical care in Nigeria.

Usifoh raised concerns that merging the PCN with the pro­posed NHFRA could dilute its regulatory authority.

The PSN consequently high­lighted that the PCN has devel­oped a robust structure, with state offices across Nigeria and a trained workforce capable of effectively regulating pharmacy practices.

It, however, warned that such a merger could undermine the quality of pharmaceutical ser­vices by losing the specialised oversight required for this field.

Furthermore, the letter point­ed out that the NHFRA would not adequately address existing regulatory gaps, particularly concerning tertiary health insti­tutions. Currently, these facilities, including Teaching Hospitals and Federal Medical Centres, lack suf­ficient oversight.

The PSN believes this gap could be filled by activating provisions in the National Health Act of 2014 that call for establishing a Tertia­ry Health Facility Commission.

The society argued that instead of creating a new regulatory agency, the government should focus on strengthening existing frameworks for effective over­sight.

The PSN also highlighted the pressing need for increased fund­ing for the PCN and the National Agency for Food and Drug Admin­istration and Control (NAFDAC). Adequate funding is essential for these organisations to enhance their operational capabilities and improve health outcomes nation­wide.

Usifoh also expressed concerns that diverting resources to estab­lish the NHFRA would be a misal­location of funds, especially given the challenges already faced by the healthcare sector in Nigeria.

In addition, the PSN raised historical antecedents that have shaped the current regulatory landscape. The organisation noted that prior to the National Health Act’s enactment in 2014, various healthcare professions had their own regulatory agen­cies. Drug matters are listed on the Exclusive List of the Nigerian Constitution, meaning that only the National Assembly has the au­thority to legislate on pharmacy and drug laws. This structure has long placed pharmacy regulation within the purview of the PCN, separate from broader healthcare regulations.

The PSN underscored that establishing the NHFRA could lead to confusion and inefficien­cy within the regulatory frame­work. The president of PSN argued that while the NHFRA may aim to improve healthcare standards, its overlap with exist­ing agencies like the PCN could create bureaucratic hurdles that hinder effective regulation. The PSN therefore called for clearer delineation of responsibilities among regulatory bodies to avoid duplication of efforts.

The statement partly reads,“ 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, potentially affecting the quality of pharmacy education and practice, and Nigeria’s rec­ognition in international phar­maceutical collaborations.

“In this respect, we are talking about the all-encompassing nature of the statutory mandate of the Council as the regulator of all prem­ises where medicines or drugs are manufactured, stocked, imported, exported, dispensed or sold.

“The mandate includes all personnel involved in all forms of pharmaceutical activity which persons include pharmacists, pharmacy technicians, pharma­ceutical and sales representa­tives, and Patent and proprietary medicines vendors. The mandate also extends to the scope of prac­tice of these personnel involved in pharmaceutical activities. Looking at these, it is obvious that the mandate of the council is wide and all-encompassing with respect to all conceivable pharma­ceutical activities.

“The importance of this man­date cannot be overemphasized taking into account the all-im­portant role of pharmaceutical care in the health system of any country.

“We therefore strongly believe that the status of the Council as a standalone pharmaceutical pro­fession, practice, and business ought to be maintained in the in­terest of the nation and not to be overburdened by merging it with any other regulatory body.

“The PCN is specifically tasked with regulating the pharmacy pro­fession; ensuring pharmacists and other cadres of the pharmacy pro­fession meet rigorous standards in education, ethics, and practice. Pharmacy is a unique field that requires specialised oversight, particularly in areas like drug dispensing, management, and patient care. Merging with other health regulatory bodies could di­lute this expertise, leading to less effective oversight and a decline in professional standards.”

As discussions regarding the NHFRA continue, the PSN has pledged commitment to advocate for the preservation of special­ised regulatory frameworks that uphold the integrity and effective­ness of pharmacy practice.

Usifoh stated that the PSN is prepared to engage in dialogue with government officials and stakeholders to ensure that the unique needs of the pharmacy profession are adequately ad­dressed.

In conclusion, the PSN’s call for careful consideration of the NHFRA proposal reflects a broad­er concern within the healthcare sector about the need for effec­tive governance and regulation. As Nigeria strives to enhance its healthcare system, new ini­tiatives must align with existing frameworks and support the over­arching goal of improving health outcomes for all Nigerians.

The PSN believes that main­taining a separate and empowered regulatory body for pharmacy is essential to achieving these objec­tives and ensuring high standards of pharmaceutical care across the nation.

The statement reads, “The Federal Government is invited to activate the necessary tem­plates to establish the Regulato­ry Commission that will regulate Tertiary Hospitals at the Federal level which is the major area of deficiency in the regulatory land­scape in our sector.

“If the Federal Government also wants the equivalent of CQC in the UK or the Joint Commis­sion in the USA. Section 1 of the National Health Act which pro­vides for the establishment of a National Health System which regulates health services is more than enough to meet that objec­tive if nothing sinister or ulterior is not the ultimate target.

“The Federal Ministry of Health should 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. Any agenda bordering on a centralised Health Regulatory Facility Agency will be ground­ed in immediate suspicion which will jeopardise our fragile peace and this will be resisted by stake­holders.

“The general perception of health workers on the NHFRA initiative is that Dr. Alausa is working on an agelong 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 percent which in itself spells doom for the Health Sector because inputs accrue from only one profession in a multidisci­plinary sector.

“The PSN remains commit­ted to the ideals of growing the Health Sector. We however insist that the methodology to achieve this must be grounded in justice and fairness to all concerned.”