The Joint Health Sector Union (JOHESU) has petitioned President Bola Tinubu to urgently address alleged irregularities in NAFDAC’s policies which are causing difficulties for Nigerians in accessing affordable and effective drugs, demanding systems audit of the Agency’s affairs....CONTINUE READING
JOHESU in the letter also accused Prof. Christianah Adeyeye, Director General, National Agency for Food and Drug Administration and Control (NAFDAC) of not consulting with other stakeholders with regard to the policy thrust of the Agency.
Signed by Comrade Matthew Ajurotu, JOHESU’s National Secretary, and titled, ‘The Escalating Cost of Drugs/Other Regulated Products and the Catalytic Activities of the DG, NAFDAC,’ the petition further alleged that NAFDAC activities negate the National Drug Policy.
Specifically, JOHESU accused NAFDAC’s policies of causing hardship and misfortune for Nigerians as they struggle to obtain affordable and effective drugs, contradicting the objectives and targets outlined in the National Drug Policy.
JOHESU in its petition jointly signed by the Assembly of Healthcare Professionals Association (AHPA) provided updates on a series of policies implemented by NAFDAC which are causing a distressing situation in access to affordable and effective drugs in the country.
This includes the recent policy paper issued by NAFDAC on the quality of Active Pharmaceutical Ingredients (APIs) used in the manufacture of Finished Pharmaceutical Products (FPPs) for the Nigerian market.
Others are payment of Good Manufacturing Practice (GMP) tariffs by importers; selective and discriminatory sanctions through payment of arbitrary sums of monies for violations in the pharmaceutical value chain and declaration of 50 percent fake products in circulation in Nigeria.
The statement partly reads, “The JOHESU/AHPA which is a major body of key stakeholders in the Healthcare Sector finds it necessary to identify with consumers of health who are subjected to living with the high cost of drugs, foods and other regulated products because of the highhandedness, inexperience and unrepentant arrogance of the incumbent DG, NAFDAC who has continued to march on the pharma eco-space of our sector like a tyrant as she is not used to consulting with other stakeholders with regards to the policy thrust of the Agency.
“Your Excellency, the JOHESU/ AHPA will provide insight into gory details of how various policies at NAFDAC have combined to inflict hardship and bad fortune on Nigerians who find it increasingly difficult to have access to affordable and efficacious drugs in line with the objectives and targets of the National Drug Policy.”
NAFDAC’s Recent Policy Paper On APIs Quality
The petition also reads, “Recently, the DG, NAFDAC issued a Fatwa directing all stakeholders intending to submit dossiers for product registration starting from January 2024, that only applications supported by APIs or FPPs sourced from the underlisted approved sources will be accepted for review.
These are: WHO Prequalified APIs; APIs with Certificates of Suitability to the monograph of the European Pharmacopoeia (CEP); APIs and FPPs sourced from facilities certified by PIC/s participating authorities.
Others are, APIs sourced from facilities certified by Stringent Regulatory Authorities (SRA) or WHO Listed Authorities (WLA) and APIs certified by accredited quality control laboratories.”
JOHESU condemned the recent policy paper on APIs quality, saying it is destroying the Pharmaceutical Sector. The petition said, “The memo from NAFDAC and the attendant wish list and expectations is both an open and direct invitation to more fatalities in the Pharmaceutical Sector because of the limitations it imposes on the number of players who can meet the listed condition precedent.
“The direct fallout is more prohibitive cost of drugs at a time Your Excellency and the Coordinating Minister of Health keep assuring the citizens of Nigeria that you are doing everything possible to bring down the rising cost of drugs in Nigeria.
“India, which is the biggest source of our APIs and FPPs in Nigeria, has facilitated the growth of its local pharmaceutical industry through friendly and result-oriented goals and objectives such that the local pharma industry in India contributes close to three percent of the GDP of India today.
“India runs policies that are suited for its citizens to compel access to affordable medicines and do not allow itself to be subsumed to the unrealistic gargantuan propensities of global imperialists who continue to manipulate trade and economic balance to permanently tilt in favour of their whims and caprices. Nigeria, with poor foundational advances in the pharma industry, is currently enjoying level three ratings, while productive and fruitful India is on level one.”
JOHESU accused Prof. Adeyeye of stifling growth in the Nigeria Pharma Industry which would move “Nigeria to level 4 rating in an act grounded only in self-glorification.”
The Union accused the NAFDAC DG of sabotaging national interest, pointing out that the primary responsibility of public officers is to serve and work towards the national interest and certainly not foreign expectations.
The petition further reads, “If Prof. Adeyeye seeks a WHO appointment, the Federal Government must encourage her now to quit as Director General, NAFDAC for her preferred international job rather than allow her to continue to mess-up genuine attempts to boost the growth of our local industry which is all we have seen in the over 6 years of her stewardship at NAFDAC.
Payment Of GMP Tariffs By Importers
The statement reads, “The abuse of the mature status of key pharm importers was explored infinitely about 31/2 years ago when Prof. Adeyeye, in defiance to consultations within and outside of her profession and primary constituency, stuck to this most retrogressive policy.
Some stakeholders warned in 2021 that this inglorious policy would raise drug prices in huge quantum. An audit of the drug pricing regimen in 2021 compared to January 2024 prices will confirm that drug prices have risen by over 500 percent.
“A public statement by an arm of PSN declared that critical appraisals confirmed the resort to new GMP tariffs was a fundraising measure to boost the IGR of NAFDAC.”
The petition further alleged that NAFDAC ties registration of some categories of payments, including GMP tariffs, to the use of US$, which is now contrary to fresh CBN guidelines.
What this NAFDAC policy does is to alter, albeit upwardly, the cost of registration charges daily as CBN adjusts exchange rates, it explained.
“The original concept of GMP tariffs by the predecessors of Adeyeye at NAFDAC was to charge the foreign manufacturer a sum of $10,800 as GMP inspection fees.
“Adeyeye has now changed that to impose another $5,400 on all Nigerian importers with regards to the same $10,800 GMP inspection fee already paid by the foreign manufacturer for the same purpose.
“Some of these foreign manufacturers handle the products of over 100 Nigerian importers who collectively pay $540,800 in such circumstances when GMP Inspection Fees were designed to be $10,400 per manufacturer.
“Many of the struggling and budding companies are SMEs who could not afford this exorbitant fee per manufacturer of their products and have been sent out of business. At today’s exchange rate of about $ to N1,500, it costs over N8M to pay GMP Inspection Fee for one manufacturer of drugs at NAFDAC, which is one of the reasons some life-saving drugs that the local industry cannot produce are no longer available in our country,” it lamented.
Discriminatory Sanctions, Arbitrary Payment For Violations
The petition frowned at selective and discriminatory sanctions through payment of arbitrary sums of money for violations in the pharmaceutical value chain.
It said, “We put it on record that in the over six years of the Adeyeye leadership, regulatory functions to checkmate illegalities in the pharmaceutical and food value chain has been at the lowest ebb.
“The statutes domicile the Task Force on Counterfeit Drugs and Unwholesome Food at NAFDAC, but that template of NAFDAC has been outrightly cold or, as a matter of fact, dead.
“The Federal Task Force on Fake Drugs has not embarked on any meaningful activity in over five years despite the unending abuse potential and reality in the drug distribution channels.
The FMOH adopted the National Drug Distribution Guidelines (NDDG) to force a departure from the status quo in drug distribution, but the DG, NAFDAC has refused to activate salient portions of that policy thrust which should be driven by NAFDAC.
“Rather than drive holistic processes which will impact the landscape, what NAFDAC specializes in is to over-regulate pharma players who are compliant in the context that they are registered to practice by the appropriate regulatory agency.
“In some instances, NAFDAC has imposed fines ranging from N2.5 million to N5 million on alleged violations by Registered pharmaceutical companies in Nigeria, when rather embarrassingly, it has not dealt decisive blows on unregistered pharmaceutical premises or any hospital facility in both the public and private sectors. It is worrisome if not shameful that no hospital facility especially at the private sector level has ever been held accountable by the Adeyeye-led NAFDAC in the last six years, yet these facilities carry drug stock of all shades irrespective of whether they are registered or not by NAFDAC.”
50 Percent Fake Products In Nigeria
JOHESU berated NAFDAC’s declaration of 50 percent fake products in circulation in Nigeria, saying it is a sign of failure in the agency’s assignment. The petition stated, “In what should be perceived as the apogee of the many misnomers of Prof. Adeyeye, she declared at a recent stakeholder’s engagement in Abuja that “50 percent of imported pharmaceutical products in Nigeria are fake.” This is a grand exposition of failure at both personal and organizational levels.
“Normative civility ought to dictate that a public officer who admitted 50 percent failure of the international desk management of imported products and their distribution after destroying the same sector through unprecedented impunity in the guise of regulation should throw in the towel for the sake of integrity rather than allow interventions from other quarters.”
JOHESU therefore urged the Presidency to do an “urgent redress of the aberrations at NAFDAC by ordering an immediate systems audit of the NAFDAC affairs with a view to halting the unquenchable excesses of Prof. Adeyeye in the public interest.
“The JOHESU/AHPA will work with the FG in fast-tracking sustainable reforms that will compel reduction in drug prices through acceptable norms and modalities,” it assured.
