•Says FG Should Retain Drug Matters On Exclusive
List To Avoid Abuse
Chioma Umeha
Pharm. Bolanle Adeniran, Chairman, Lagos State
Branch of the Pharmaceutical Society of Nigeria (PSN) has criticised the
National Agency for Food, Drug Administration and Control (NAFDAC) for
increasing drug and product registration tariff by a whopping 350 percent,
warning that it would bring about grave consequences of morbidity and mortality
to consumers of healthcare products in the country.
Adeniran who was quest speaker on the “Ease of
Doing Healthcare Business with the National Agency For Food, Drug
Administration And Control (NAFDAC), the Standard Organisation of Nigeria (SON)
and the Nigeria Customs Service” on Thursday, June 20, 2019 at the Lagos
Chamber of Commerce and Industry (LCCI), explained that it would now cost N1.05
million to register a prescription only medicine up from N350,000.00, while
Over The Counter (OTC) drugs have moved from a hitherto expensive N1 million to
N4 million.
She said the Lagos PSN has analysed the increase
and declares that there is absolutely no basis for it in terms of improvement
in the economic fortunes in the industry or propensity for drastic improvement
in service, or in provision of vital index in the ease of doing healthcare
business in Nigeria.
“If this draconian policy is not reversed or
immediately remedied, the PSN, Lagos State Branch, wishes to warn through this
forum that Nigeria will experience at least a 100 per cent increase in drug
prices in about six months with grave consequences of morbidity and mortality
to consumers of healthcare in our nation.
“In the light of the extremely depressed economy,
we contend with pricing which remains a critical element in analysing trends
and development in the pharmaceutical sector because it comes down to saving
lives,” the Lagos PSN boss said.
She said that NAFDAC must have invoked the spirit
of Section 5(f) of the enabling Act which empowers it to “undertake the registration
of foods, drugs, cosmetics, medical devices, bottled water and chemicals,”
adding that even in the light of that, the Lagos PSN submits that despite the
proviso of the law, matters relating to tariff reviews or increase should be
treated as policy.
“We belong to the school of thought that defines
policy as a deliberate system of principles to guide decisions and achieve
rational outcomes. A policy is a statement of intent, and is implemented as a
procedure or protocol. Policies are generally adopted by the management within
organisations where protocols are developed and adopted by the Executive or
operating officers.
“The truth about policies is they can assist in
both subjective and objective decision making. Policy differs from laws. While
laws can compel like in Section 5(f) of the NAFDAC Act, policy merely guides
action towards those that are most likely to achieve a desired outcome,” she
explained.
Adeniran contended that while her invitation
focused on the ease of doing healthcare business with NAFDAC, SON and the
Nigeria Customs, a very strategic agency involved with the cost of healthcare
business with regards to the pharmaceutical industry remains the Pharmacists
Council of Nigeria (PCN).
“In our statute books today, the Pharmacists Council
of Nigeria (PCN) remains the only body in law that has a specific approbation
to regulate and control Pharmacy practice in all its aspects and ramifications
in Nigeria.
“This paper will be limited to the Terms of
Reference which specifies NAFDAC, SON and Customs roles. In reality, SON has
very insignificant roles to play in salient regulatory controls in the
pharmaceutical sector. This is because most issues bordering on quality
control, analysis and Standard Operating Procedures (SOPs) in the sector are
statutorily driven by NAFDAC and the PCN. The Nigeria Customs as the relevant
template of the Federal Government in the collection of taxes, duties, tariffs
and others is also a strategic regulator in the pharma industry,” she said.
Pharm. Adeniran said the functions and powers of
the Governing Council of NAFDAC are laid down in Sections 6 & 7 of the
NAFDAC Act. Perhaps one of the most potent powers of NAFDAC which gives it
specific and exclusive regulatory authority in the pharma industry remains
Section 5(a) which states inter-alia ‘The Agency shall have powers to regulate
and control the importation, exportation, manufacture, advertisement,
distribution, sale and use of food, drugs, cosmetics, medical devices, bottled
water and chemicals in Nigeria. It is reasonable to infer the famous cliché
which asserts the responsibility of NAFDAC to ensure a safety margin in the
management of endeavours pertaining to drugs, food, cosmetics etc.’
She noted that most responsible and responsive
countries place drug matters under Federal or Central control because of the
need to place premium on safety and well-being of consumers of health, warning
that government must never attempt to remove drug matters on the Exclusive List
because of our notoriety for poor regulatory control. She said that ineffective
regulatory control of pharmaceuticals continued to breed and generate fake drug
syndrome and challenges of drug abuse/misuse with damning consequences of high
morbidity and mortality.
Adeniran, however, noted that the leadership of
pharmacists has impacted well on NAFDAC especially with the first two
Director-Generals who were Pharmacists of distinction, Prof. Gabriel Osuide,
FPSN and late Prof. Dora Akunyuli (FPSN). Dr. Paul Orhii held sway for four
years before another eminent Pharmacist, Prof. Moji Adeyeye (FPSN), emerged as
the 4th substantive Director-General of NAFDAC in late 2017. “NAFDAC continues
to be one of the few strong institutions the public bureaucracy ever built with
Osuide and Akunyuli excelling on the beat as Directors-General,” she said.
She said the Adeyeye-led team has also come up
with a modest, but impactful output in recent months by improving the
Internally Generated Revenue (IGR) of NAFDAC and reducing the political
exposure which comes with vulnerability in the Nigerian space.
She said the height of the various reforms under
Prof. Adeyeye is the ISO Certification of laboratory facilities at NAFDAC which
repositioned the pharma industry especially local manufacturers to enjoy
greater exports of their products in the months ahead and the positive measure
of subjecting NAFDAC to the World Health Organisation (WHO) global benchmarking
is also a landmark achievement in the regulatory process in healthcare
business.
She said NCS apart from collecting revenue which
includes excise duties and tariffs, taxes and other tariffs on behalf of the
Federal Government, the agency subjects importers of drugs and pharmaceuticals recipients
to processing “Form M” before they proceed to import. She explained that when
the consignment arrives, the NCS sets a condition precedent of prospective
importers processing PAAR (Pre-Arrival Assessment Report) before batches of
goods can be cleared.
Adeniran lamented that the pharmaceutical
importers are at the mercy of the NCS portal which sometimes malfunction and
therefore delays the clearing process with sometimes excruciating financial
consequences to the importers, adding that the other fundamental issue was that
the NCS takes a position it does not charge duties on drug imports.
Pharm. Anthony Bola Oyawole, former Chairman,
Lagos PSN, enjoined the LCCI to collaborate with NAFDAC to shorten the unduly
long registration procedures and put in place rules of engagement to resolve
challenges of the output of its hi-tech regulatory tools.
Oyawole also urged stakeholders to prevail on
NAFDAC to reverse the 350 percent hike in registration fee as it would
encourage fake drug dealers to bring in deadly merchandise at cheaper rates
relative to expensive registered products.
He called on the Federal Government to sensitise
Customs that drugs are lifesaving entities which need some level of
prioritisation and that processing of “Form M” and “PAAR” must therefore be
accelerated by the industry.
Oyawole urged the Federal Ministry of Finance and
NCS to tidy up the tariff regime of drug recipients, imports and other gadgetry
in tandem with the operating environment.
