‘The old concept of the patient belonging
to the doctor is now outdated’

Dr. Godswill C. Okara (PhD) is the National President,
Association of Medical Laboratory
Scientists of Nigeria (AMLSN) and
Chairman, Assembly of Healthcare
Professional Associations (AHPA). Okara recently addressed
journalists concerning Invitro diagnostics regulation in Nigeria,
recent Central Bank of Nigeria (CBN) circular on the import of
medical laboratory equipment and Nigeria Medical Association
(NMA) reaction to CBN directive. CHIOMA UMEHA (HEALTH
EDITOR) provides the details:


Recently, the Central Bank of Nigeria (CBN) issued a circular
which directs all importers of medical laboratory equipment to
obtain a certificate of registration from the Medical
Laboratory Science Council of Nigeria (MLSCN). But, the
Nigerian Medical Association (NMA) has condemned this
move, saying it is a dangerous development. Kindly throw
more light on the issue?
The Association of Medical Laboratory Scientists of Nigeria
(AMLSN) has watched with keen interest and grave concern
the continuous grandstanding and posturing of the Nigerian
Medical Association (NMA) to browbeat and arm-twist
Government to renege in her commitment to sanitize and
strengthen medical laboratory services and practice in Nigeria.
In ‘This Day’ newspaper of Saturday, May 17, 2014 it was
reported that: “The Nigerian Medical Association (NMA)
yesterday took a swipe at the Central Bank of Nigeria (CBN)
over a circular it issued directing that all importers of medical
laboratory equipment must obtain a certificate of registration
from the Medical Laboratory Science Council of Nigeria
(MLSCN). But the new President of NMA, Dr Kayode Obembe,
warned that the circular would set a dangerous trend in the
nation’s health sector.
Obembe in the publication said: ‘The circular is very
dangerous (); it is completely wrong that one would have to go
the MLSCN to get an approval in order to import medical
laboratory equipment.’ The NMA president also explained that
‘already, importation of medical products is being regulated by
the National Agency for Food and Drug Administration Control
(NAFDAC) and the Standards Organisation of Nigeria (SON).’
NMA further included this in its demand in the on-going strike.
In an open letter to the President, Dr. Goodluck E. Jonathan,
the NMA was quoted as follows: ‘NMA calls for immediate
withdrawal of CBN circular authorizing the Medical Laboratory
Science Council of Nigerian (MLSCN) to approve licenses for
the importation of in vitro diagnostics (IVDS).’
What is the World Health Organization (WHO) position on
medical laboratory equipment and services?
The World Health Organization (WHO) recognizes quality
medical laboratory services as key to improving global health
and attaining the Millennium Development Goals.
Strengthening the breadth of medical laboratory services
accessible to clients/patients, and ensuring that laboratory
results are accurate, reliable, reproducible, and rapid enough
to be useful is crucial to improved outcomes. Medical
treatment without accurate and reliable diagnosis is a waste of
resources, both for the attending physicians and the patients. It
is an exercise in guess work and at best the practice of
‘polypharmacy.’
No matter how skilled a laboratory professional is, without
standard reagents and equipment he can never produce
accurate and reliable diagnostic tests results. It is on record
that close to 50 per cent of public health in-vitro diagnostics
(reagent test kits, chemicals and equipment) in the Nigerian
open market today are sub-standard, fake, expired or poorly
stored and distributed. It was in order to stem this ugly trend
that the Medical Laboratory Science Council of Nigeria in
keeping with her statutory mandate and the Transformation
Agenda of the President decided to set up the ultra modern
Public Health In-Vitro Diagnostic Control Laboratory in
Nigeria, the first of such a specialized laboratory in West
Africa.
Give background of In vitro diagnostics (IVDs)
In vitro diagnostics (IVDs) are those inputs intended for use to
perform tests for diagnoses in a controlled environment
outside a living organism.
‘In vitro diagnostic device’ means any medical device which is
a reagent, reagent product, chemical calibrator, control
material, kit, instrument, apparatus, equipment, or system,
whether used alone or in combination, intended by the
manufacturer to be used in vitro for the examination of
specimens, including blood and tissue donations, derived from
the human body, solely or principally for the purpose of
providing information for diagnoses and treatment.”
Medical laboratory scientists by their professional training and
practice possess the technical and scientific skill and dexterity
to prepare, standardize and calibrate diagnostic laboratory
reagents, manufacture vaccines and other biological products;
we possess the knowledge and skill to fabricate and calibrate
diagnostic laboratory equipment and instruments for the
performance of the laboratory investigations.

To what extent has the country gone in local manufacturing of
laboratory equipment?
It is a known fact that a number of Nigerian medical laboratory
scientists have designed and manufactured Electrophoresis
equipment, incubators, hot air ovens, centrifuges and a host
other laboratory equipment. It is on record that a member of
the Association of Medical Laboratory Scientists of Nigeria is
presently manufacturing HIV diagnostic reagent kits which
have been evaluated and included in the Nigerian national HIV
testing algorithm.

Is the CBN new circular on the import of medical laboratory
equipment legal?
To set the records straight it is important to state categorically
that the laws of Nigeria specifically mandate and empower the
Medical Laboratory Science Council of Nigeria to perform this
onerous duty of ensuring that fake and substandard in-vitro
diagnostics are eliminated from the Nigerian healthcare sector.
Sections 4e and 19d of the Medical laboratory Science Council
law Act 11, 2003 (Cap M25, LFN 2014) specifically mandates
the Council to “Regulate the production, importation, sales and
stocking of diagnostic reagents and chemicals and Make rules
for the maintenance of good standard of medical laboratory
practice and services with respect to regulation and control of
private practice including statutory inspection, approval and
monitoring of all medical laboratories including those adjoined
to clinics, private and public health institutions.”
It is indeed petty that NMA included this issues in their current
demand for going on strike because the Federal Government
(which means well for Nigerians), has taken the bull by the
horn by making sure that fake/ substandard invitro-
diagnostics are removed from the system, by effectively
empowering MLSCN- the Agency that has the legal and
statutory function to do this job.
One really wonders what the Nigerian Medical Association is
out to achieve in her baseless outburst and attack on the
Central Bank of Nigeria for doing her official duties. Rather
than castigating the apex bank, NMA should actually be
commending the CBN for its foresight and public-spiritedness
in aligning itself with the legitimate efforts of the MLSCN to
bequeath to our citizens a medical laboratory service sector
that is driven by quality in-vitro diagnostics. Nigerians deserve
no less.
CBN is a responsible and pivotal national institution that will
not just wake up and issue circulars without recourse to the
law or proper understanding of the framework, implementation
and other parameters and ramifications of a project before
issuing a supportive circular.
The CBN circular, unlike the chauvinistic undertones of
everything done by the NMA, is not about the MLSCN or any
other professional group, but about the citizens of this country
who spend a whopping sum of $1.7 billion annually seeking
quality diagnosis and treatment abroad and who have
continued to clamour for reliable medical diagnosis.

Is the NMA not aware that the President commissioned the
MLSCN Public Health In-Vitro Diagnostics Control Laboratory
in Lagos, September last year?

If the NMA leadership had bothered to first seek knowledge
before needlessly upbraiding a more patriotic organization
such as the CBN, it would have been better educated about the
background to the CBN circular. For the records, the President
Jonathan, pursuant to his ‘Transformation Agenda’ in the
health sector, commissioned the MLSCN Public Health In-Vitro
Diagnostics Control Laboratory in Lagos on September 5, last
year. The quality assurance facility, the first of its kind in the
entire West African sub-region, was described by the President
as: ‘A feat which marks the beginning of a new era in the
production, importation, storage and sale of diagnostic
laboratory reagents and chemicals in Nigeria was necessitated
by the general principle underlying the Transformation Agenda
of the Federal Government and is aimed at achieving the
Millennium Development Goals on Health, which is largely
dependent on a strengthened health system, the laboratory
being a critical component of the health system.’

Does it mean that NMA is not following trends in the health
industry?
Typically, NMA has chosen to first rush onto the podium and
play to the gallery before doing its homework, thereby ending
up embarrassing itself and its followers. By threatening the
CBN for performing its lawful duty, the NMA as a group is
once again over reaching itself.
Despite its all-knowing posturing and grand-standing, the
NMA cannot claim to love Nigerians more or better understand
what is in the best interest of the country than the leadership of
the CBN, the Minister of Health and even the President who
commissioned the In-vitro Diagnostics Control Laboratory for
quality assurance in Lagos on the September 5, last year, and
publicly acknowledged its benefit towards realizing his
Transformation Agenda.
Indeed, the President during the occasion acknowledged the
pivotal role that health laboratories play in diagnosis and
monitoring of diseases, patient treatment and management,
noting also that they rely on the availability of the highest
possible quality of personnel, equipment, reagents and
chemicals to produce consistently reliable results for the
correct diagnosis and proper monitoring of many a disease
condition.
The high point of the President’s speech during the
commissioning of the facility was his declaration of zero
tolerance for substandard IVDs in the country.
According to him, there cannot be anything other than a zero
tolerance for sub-standard practices or equipment or
diagnostic reagents and chemicals. Doing otherwise would
have a hugely negative impact on the health of our citizens.
And genuine lovers of Nigeria’s teeming patients have highly
commended the development.

What is your advice to NMA?
The NMA should be advised to subject herself to the rule of
law, put ego-tripping aside and embrace laudable objectives
that will improve the health sector of our country. The dog-in-
the-manger attitude will not help the health sector; neither will
the first-born mentality often being displayed by the NMA and
her members. Modern healthcare practice is multidisciplinary
and multi-professional in
dimension and scope. The WHO concept of health service
provision puts the patient in the centre of a circle formed by
healthcare professionals. The old concept of the patient
belonging to the doctor is now outdated and relates only to the
medieval era. The quest to demand for what it wants and also
turn around to dictate what others should be given is to say
the least reprehensible and nihilistic. NMA does not have the
exclusive preserve to strike action, it should be told.
AMLSN commends the Central Bank of Nigeria, the Minister of
Health and above all, President Jonathan for their foresight
and patriotic resolve to support the Medical laboratory Science
Council of Nigeria to perform this bounding duty of sanitizing
the Nigerian health laboratory sector to stem the tide of wrong
diagnosis.
By: CHIOMA UMEHA
My DailyNews Watch

nd to evn tink dt mst of doz importing d ivds ar nt evn medical practioners yet nma is fytin on who shuld import or regulate its importation

Where would these doctors' arrogance and spitefulness stop?
Shameless ppl, who is more competent to regulate laboratory reagents and equipment if not those who use them daily in their profession (i.e the lab scientists) - how petty and silly can these doctors get?

It is evident they are still smarting over the loss of control of the labs to the scientists (after the recent historic court judgement against them) so they are looking for other ways to frustrate them - as it seems lab scientist are now their no.1 enemies in the health sector.

pembisco:
nd to evn tink dt mst of doz importing d ivds ar nt evn medical practioners yet nma is fytin on who shuld import or regulate its importation

Must Nigerins think we are bound to be importing every thing on a permanent basis?
Which Agency/Body is saddled with the local manufacturing of Medical equipments including Invitro diagnostic equipments?
What if these IVDs are to be produced in Ibadan,Aba or Potiskum,who is to regulate them?
Instead of fighting one another,I want the healthcare professionals come together in a PRIVATE partnership with core investors and start LOCAL manufacturing of Incumbators, centrifudge, syringes, pipetted, Miscroscopes, reagents,Latex glooves, busen burner, test trips etc on a massive scale that can meet Nigeria's demand and of good quality that can compete with foreign ones.

oyatz:


Must Nigerins think we are bound to be importing every thing on a permanent basis?
Which Agency/Body is saddled with the local manufacturing of Medical equipments including Invitro diagnostic equipments?
What if these IVDs are to be produced in Ibadan,Aba or Potiskum,who is to regulate them?
Instead of fighting one another,I want the healthcare professionals come together in a PRIVATE partnership with core investors and start LOCAL manufacturing of Incumbators, centrifudge, syringes, pipetted, Miscroscopes, reagents,Latex glooves, busen burner, test trips etc on a massive scale that can meet Nigeria's demand and of good quality that can compete with foreign ones.

For once I agree with you on this
But the question is can our government key into this laudable things. Are our engineers capable of producing most of these equipment (centrifuge at least).