OUR POSITION

THE ASSOCIATION OF MEDICAL LABORATORY SCIENTISTS OF NIGERIA (AMLSN) has noted with shock and dismay recent reports in the media in which the Nigerian Medical Association reportedly threatened to confront the nation's apex bank- the Central Bank of Nigeria (CBN) over the latter's recent circular dated April 24 directing that all importers of In-vitro Diagnostics (IVDs) must obtain a certificate of registration from the Medical Laboratory Science Council of Nigeria (MLSCN). In the interest of the health sector and more especially the citizens of this country who have continued to clamour forquality medical laboratory diagnosis, we would like to submit as follows: 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 in-vitro diagnostics and Make rules for the maintenance of good standard of medical laboratory practice and services with respect to regulation and control of practice including statutory inspection, approval and monitoring of all medical laboratories including those adjoined to clinics, private and public health institutions", There is no gainsaying the fact that the accuracy of medical laboratory diagnostic test results is clearly and largely a function of the integrity and quality of the in-vitro diagnostic products used in performing the tests (namely reagents, chemicals and equipment) used by professionals in the performance of the laboratory investigations. 

• 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 intrinsic, 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. 

• 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, Mr. President,His Excellency, DrGoocluck Ebele Jonathan, pursuant to his Transformation Agenda in the health sector, commissioned the MLSCN Public Health in-Vitro Diagnostics Control Laboratory in Lagos on September 5,2013. The quality assurance facility, the first of its kind in the entire West African sub-region, was described by Mr. 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." 

• By threatening the CBN for performing its lawful duty, the NMA as a group is once again over reaching itself. Typically, it 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.

• 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 Honourable Minister of Health and even Mr. President who commissioned the In-vitro Diagnostics Control laboratory for quality assurance in Lagos, and publicly acknowledged its benefit towards realizing his Transformation Agenda. 

• Indeed Mr. President 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 Mr. President's speech during the commissioning of the facility was his declaration of zero tolerance for substandard IVDs in the country. 

"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," he said. And genuine lovers of Nigeria's teeming patients couldn't agree more! 

• While noting, that "this facility being commissioned today, will obviously strengthen the regulatory function of the Medical Laboratory Science Council of Nigeria with respect to the verification, validation, listing and registration of in-vitro laboratory diagnostic inputs. President Jonathan also enjoined "manufacturers, producers and importers alike, of diagnostic laboratory reagents, chemicals and equipment to submit their products to this laboratory for necessary testing, analysis and certification. Doing so is not only an ethical requirement but indeed compliance with extant laws." Is the NMA suggesting that the CBN should have ignored the President's public declaration so as not to incur the wrath of a profoundly insufferable and judgmental group? 

• If following his recent election, the new NMA president, Dr Kayode Obembe needed a huge platform to talk tough even at the risk of over reaching himself, in the hope of impressing his followers. is it dnly by threatening the CBN over a matter that was not within its purview that it could achieve that? 

• According to the NMA president, the CBN "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." Yet the NMA president failed to explain what made the CBN circular very dangerous or what makes one seeking certification from the MLSCN completely wrong. www.medicalworldnigeria.com

• We submit that the intellectual and professional starting point for an NMA president wishing to talk tough and make unguarded threats ought to be the law. In words, he should have availed himself of the provision of the Law, especially Cap M25, LFN 2014, the law establishing the MLSCN,which also charged it will the regulation of IVDs among other functions.  

• By their training, doetors aqe expected to be dispassionate and to be able to make informed decisions after carefully analyzinglthe findings (Evidence-based Diagnosis). Regrettably, our medical doctors now seem to be focusi,ng on unnecessary sentiments and in most cases dropping the names of other organizations or professionals to drum up support for their cause whether right or wrong. This time, it is the National Agency for Food and Drug Administration and Control (NAFDAC) and the Standards Organization of Nigeria (SON) that the NMA is pretending to be fighting for as if these agencies were not also created by law and as if they cannot fight for themselves if necessary. It is preposterous for the NMA to assert that"already, importation of medical products is being regulated by the National Agency for Food and Drug Administration and Control (NAFDAC) and the Standards Organization of Nigeria (SON) ... 

if we go on to proliferate, it is very destructive, and very devastating." 

• Need we remind the NMA that rhetoric and exaggerations cannot change the fortunes of the health sector. Disdain for the fact, which is that the law mandating the MLSCN to regulate IVOs is over a decade old; therefore, no new agency has just been established and no proliferation is going on also cannot do so. Therefore, the warnings of an apocalypse over a well-intended circular from CBN are merely intended to cause panic and disaffection between responsible, law-abiding organizations that should be working together harmoniously to advance the cause of quality healthcare delivery to Nigerian citizens. The attempt to bully CBN into withdrawing its circular is a self-serving effort. If it succeeds, it will bring the apex bank to ridicule as an organization that does not know what it is dOing. It is neither in the interest of the health sector nor in the interest of the public. It can only achieve one thing: assuage the ego of the NMA leadership. . 

• The threat to the CBN over the performance of its lawful duty is unnecessary, ludicrous and self- serving, especially because NMA failed to explain how the circular would adversely affect it as a body or affect the functions of its members unless we are to believe that the insatiable, Omni-present desire of doctors to dominate everyone and everything in the health sector has now extended to the importation of reagents, kits, chemicals, consumables and equipment used in the laboratory. 

• We unequivocety suPPqrt the views expressed by Prof Anthony Emeribe, Registrar/CEO, MLSCN that it is only anti-qualityunions and status quo-driven groups that would antagonize the CBN Circular, which should rather be seEfn as bn instrument that will "enhance medical services by ensuring that medical laboratory equipment are of good'quality." 

• If indeed the NMA is. concerned about saving lives, as it claimed in its rhetoric, shouldn't it be alarmed by the fact that at least 50% of IVDs being brought into this country are in the open market and are sub-standard, fake, expired\or poorly stored and distributed as compared to less than 17% for fake or sub-standard drugs and food products. 

• Could the NMA honestly claim ignorance of the preponderance of non-professionals and even the uneducated in the IVD sector? 

The fact, however, remains that the business of importing and marketing of IVDs is currently an all-comers affair, which is why open markets such as Idumota market in Lagos, Head Bridge in Onitsha and Sabon Gari in Kano are flourishing, with reagents, kits, chemicals etc being handled in the same manner as vehicle spare parts and second-hand clothing. In fact, more often than not, these delicate, life-saving apparatus are stored in poor conditions with little or no regard to quality assurance. 

• No matter how skilled, educated and experienced a medical laboratory practitioner is, he is unlikely to produce an accurate and reliable test result and report if the investigation is based on fake or sub- standard reagents, kits, equipment, chemicals etc. Our hope of cleaning the Augean stable that the medical laboratory sector has become lies in addressing the challenges holistically. And laboratory kits, reagents, equipment, chemicals and consumables are so delicately interwoven with the outcome of laboratory-based investigations to be left partially or completely unregulated. 

• We suspect that NMA is not saying that these items should not be regulated; it would not even matter to the group if these items were regulated by Council of Registered Engineers or Nigerian Press Council. Provided the regulator is not the MLSCN or 

PCN or any other regulatory agency in the health sector, which doctors perceive to be their slaves, all is well. But such a beggar-my-neighbour attitude is part of the reason that the health care sector is in shambles. There might be some sense in the definition of madness as doing the same thing over and over again while expecting a different result. 

• The incessant threats by doctors, readily and sometimes carelessly, directed at just about any organization, group or individuals whose position or action is not in consonance with the holier-than-thou posturing of the NMA are beginning to expose an otherwise respectable group to public ridicule as the question continues to be asked what does the NMA really want? 

CONCLUSION

The AMLSN hereby salutes the foresight and the enthusiasm of Mr. President towards bequeathing a quality-driven and inclusive health sector to the country through his Transformation Agenda. We believe that posterity will celebrate him for commissioning the MLSCN Public' Health In-Vitro Control Laboratory in Lagos even to the chagrin of naysayers. www.medicalworldnigeria.com

We also commend the Hon. Minister of Health, Prof Onyebuchi Chukwu for his contributions towards the establishment of the quality assurance facility as well as the actualizafion of the lawful mandate of the MLSCN in regulating the IVD sector. 

We submit that an unregulated IVDs market has the potential to cause further danger and devastation in the health sector, which this country can ill afford. It is only an anti-quality, anti-standards, status quo-loving group that would oppose the patriotic circular issued by CBN. Nigerian patients deserve better than any medical laboratory diagnosis based on fake, sub-standard and. poorly stored medical laboratory reagents, kits, chemicals, equipment and consumables as currently sold even in the open market. 

Finally, we commend the Central Bank of Nigeria for issuing such an important circular. It shows that its leadership is in tune with the yearning of our citizen . We therefore, urge the bank to remain resolute and never ever allow any self-serving group riducule and bully it into withdrawing the circula

 

SIGNED

DR GODSWILL OKARE

NATIONAL PRESIDENT