MLSCN Has Mandate To Regulate Laboratory Equipment Importation – Okara

On 17/Jul/2014 / In Medical News

‘The old concept of the patient belonging to the doctor is now outdated’
Dr. Godswill C. Okara is 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.
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