Stakeholders in medical laboratory science practice in the country easily acknowledge that Professor Anthony Emeribe brought about sterling change in the regulation of the profession, when he presided over the Medical Laboratory Science Council of Nigeria (MLSCN)
as Registrar and Chief Executive.
Recently he was appointed by the World Health Organisation as Lead Consultant in the ongoing effort to create the Nigeria Essential Diagnostics List aimed at helping the country achieve key goals of the universal health coverage initiative. He spoke with Sunday Sun.
For quite awhile you have been off the media radar. Please tell us what you have been doing since you left office as the Registrar/CEO of the Medical Laboratory Science Council of Nigeria.
I returned to my primary duties as Professor at the University of Calabar and Honorary Consultant at the UNICAL Teaching Hospital from where I left for national assignment to the Medical Laboratory Science Council of Nigeria.
Looking back at your tenure at the Council, what changes did you bring about, and which are subsisting as legacies of your tenure?
Several changes happened under my watch. During that period, MLSCN successfully instituted subsidiary legislations on practice standards, processes and guidelines for continual quality improvement and accreditation of public and private medical laboratories in Nigeria; established the first Public Health In-Vitro Diagnostics Control Laboratory in Lagos that was commissioned by Mr. President in 2013; mooted, conceptualized and built the biggest health professional regulatory ultra-modern headquarters and laboratories complex on a 10,000 sq. meters of choice land in Durumi, Abuja within three years. The complex was commissioned by Mr. President with commendation in May 2015; restructuring of Council with Governing Board’s approval into six functional departments with directors; instituted crosscutting National Taskforce for Laboratories and IVDs Inspection to comprehensively check quackery and malpractice; inaugurated the Independent Laboratory Advisory Committee for approval of Accreditation and Inspection Reports in line with global best practice with Prof Oyewale Tomori (former President of the Nigeria Academy of Science and a distinguished world-class virologist) as the foundation chairman.
As principal investigator we secured the US Centres for Disease Control (CDC) -MLSCN Cooperative Agreement (2011-2015) that was successfully executed with realization of set objectives including the reinvigorated National External Quality Assurance Programme with laboratories established in Saye Zaria and Abuja; training and re-training of medical laboratory personnel from several tertiary health institutions across all the geopolitical zones on Quality Management System and Accreditation preparedness etc. Furthermore, under my leadership, MLSCN was admitted into the prestigious membership of the International Laboratory Accreditation Cooperation (ILAC) and African Regional Accreditation Cooperation (AFRAC), the first agency in West and Central Africa to be so admitted as at 2014. Council also got the Federal Ministry of Education confirmation that AIMLT Certificate of Council is equivalent to an honours university degree; issuance of the 2014 Central Bank of Nigeria (CBN) Circular on IVDs Regulation by MLSCN as well as Nigeria Customs Service (NCS) radio linkage with MLSCN Headquarters for monitoring of IVDs importation with staff training; mobilization of only post-internship Medical Laboratory Science graduates for the NYSC, commenced pre-registration examination for foreign graduates of MLS; structured lab posting manual for MLS undergraduate students; objective accreditation checklists for training institutions etc. These were geared towards improved health laboratory services and cutting down of capital flight due to medical tourism associated with poor medical diagnosis and management.
Before my tenure as Registrar/CEO in July 2010, MLSCN Headquarters was in a pre-fab bungalow/metal container previously used to import goods in Yaba, Lagos for about 40 years from which about 40 per cent of the Council functions could not be effectively performed.
Of the things you have enumerated, which one of them are you most happy about, something you remember privately and you feel warm inside?
Relocation of MLSCN Headquarters from a prefabricated structure in Lagos to a befitting permanent structure in Abuja with expansion of Council activities in line with its set mandate within a rather short time frame considering the very limited available resources. The second was the establishment of the first ever Public Health In-vitro Diagnostics Control Laboratory in West Africa located in Lagos for the certification and regulation of quality of medical laboratory test kits for use in Nigeria to ensure patients’ safety.
What would you say other West African regulatory agencies on medical laboratory science have learnt from Nigeria as a fall out of your erstwhile headship of the Council?
I would say they have imbibed the need for a holistic regulation of medical laboratory services, including laboratories certification and accreditation, workforce training and licensure; IVDs testing and certification; external quality assessment/PT and post-market validation etc.
The WHO recently appointed you as a Lead Consultant on an initiative for the Nigeria health sector. Please talk about this in some detail and explain the major benefits that would accrue to the country from the initiative.
The appointment as the Lead Consultant by the World Health Organization is to facilitate the development of the Nigeria Essential Diagnostics List (NEDL), including determination of barriers to accessing diagnostic test services across Nigeria with and for the Federal Ministry of Health, Abuja.
The WHO EDL (essential diagnostic list) is a core guidance document to help countries prioritize critical health in-vitro diagnostic products based on: wide availability and affordability throughout the national health system. The EDL lists a set of priority IVD categories for use at various levels of the healthcare system. The EDL is expected to: provide evidence-based guidance to member states for the development of local and national essential in-vitro diagnostics lists; inform United Nations (UN) agencies and NGOs who support selection, procurement, supply, donations or provision of IVDs and provide guidance to the medical technology industry and private sector on diagnostics priorities needed to address global health issues.
The first WHO EDL edition was launched at the World Health Assembly in May 2018. It included high priority infectious diseases (TB, malaria, HIV, HBV & C, HPV, syphilis) and general lab tests; no brand names or specific products (62 tests) were included. The plan is for an annual review to add tests for both infectious diseases and non-communicable diseases (NCDs) using a process generally similar to that for Essential Medicines List (EML) but adapted for IVDs. The WHO Strategic Advisory Group of Experts on IVDs oversees the scope, prioritization, inclusion criteria, process etc.
The 2nd WHO EDL was released on July 9, 2019, with scope expanded to include additional NCDs and communicable diseases. The final list contains 122 test categories with a section on Neglected Tropical Diseases (Schistosomiasis, Dengue, Visceral Leishmaniasis). Cancer section was added for more common cancers. Other new sections included haemoglobinopathies – sickle cell anaemia; anatomical pathology; screening of blood donations for transmissible diseases as well as expansion of the general IVDs including iron studies, D-dimers etc.
The WHO EDL is only a list until it is adopted by countries to support access to in-vitro diagnostics testing.
The purpose of the NEDL is to aid health planning, budgeting, procurement, utilization and ease of access to quality diagnostic testing across the nation geared towards achieving the Universal Health Coverage (UHC) goals. Access to National EDL would require good procurement practices; effective supply chain; quality management protocol; qualified lab workforce; robust technical specifications; availability of carefully designed laboratory network; adequate supporting infrastructure and appropriate education of users and patients on safety.
The scope of the NEDL for various priority diseases will include in-vitro test purpose, test format/platform, specimens required with link to the National Medical Laboratory Services Policy, National Medical Laboratory Services Strategic Plan and National Essential Medicines List. The realization of the NEDL will be in consultation with stakeholders across public and private institutions including all tiers of health facilities, industry and various key professional societies. Before this appointment, I had served as a foundation member of the WHO Strategic Group of Experts on IVDs (SAGE-IVD) for two years.
The benefits of a National EDL include: EML and EDL link medicines and diagnostic tests to advance UHC; replacement of syndromic/empirical therapies with precision therapies based on tests; reduction in polypharmacy with its attendant hazards and strengthening of the weak diagnostic link in the health system with its consequences.
The urgent need to tie diagnostics with medicines became obvious for the goals of the Universal Health Coverage (delivery of quality health care) to be realized globally. Secondly there is a need for a paradigm shift from syndromic management of patients’ ailments (poly-pharmacy) to precision therapies based on scientific investigations with the growing awareness that laboratory test results provide about 70 per cent of evidence for clinical decision making in patients’ disease management – hospital admission, disease diagnosis, prognosis, choice and scope of therapy, discharge, monitoring, disease forecasting, surveillance etc. This shockingly contrasts with the less than 5 per cent of meagre hospitals’ budget usually assigned for the provision of laboratory services in our health institutions.
What changes need to be made for Nigeria to benefit maximally from the WHO project?
Limited access to in-vitro diagnostic tests can have a direct impact on misdiagnosis and inadequate access to treatment and can also frustrate health providers as well as reduce patients’ trust in the health system. This necessitates the need for a conscious control of the various barriers to quality medical laboratory services delivery under four major categories viz: (1). Lack of tools to address challenging types of diagnostic problems. (2) Health system-related barriers to diagnostic process. (3) Patients’ barriers to diagnostic referrals and (4). ideas for technological innovations to enhance diagnostic process, for instance, multiplex test designed for different diagnoses of common diseases such as malaria, typhoid, pneumonia etc. with similar clinical features.
How do you feel about the budgetary provision for Health sector vis-à-vis other sectors like Works, Housing and Transportation?
Sad. There is urgent need to reverse the dwindling budgetary allocation to health towards the UN target of 15 per cent for developing countries from the current low of about 5 per cent. A healthy nation provides a healthy workforce to grow the economy even much more than oil wealth if properly harnessed as seen in Dubai, Singapore and many other countries with no oil wells but being run efficiently and effectively applying verifiable principles of honesty, meritocracy and pragmatism. Education and health budgets therefore ought to be coming up tops on our national budget for obvious reasons contrary to the current reality.
Why has it proven difficult to effectively combat the menacing existence of sub-standard, quasi-medical laboratories in the country?
The major problem is stiff resistance to proper regulation by quacks, some practitioners and even government agencies. About 70 per cent of medical laboratories in Nigeria (public and private) are not enlisted in the national database and hence not certified by the MLSCN which is in brazen breach of the extant law; poor or no funding whatsoever for regulation of laboratory services quality in Nigeria; inter-professional rivalry; impunity by some agencies of government intentionally recruiting quacks to be rendering medical laboratory tests thus encouraging quackery in the field. Under my watch as Registrar/CEO of MLSCN, we had designed the system with input of various security agencies to tackle and overcome this hydra-headed monster for the good health of Nigerians after a number of pilot runs. This was unfortunately scuttled in February 2016 for no just cause whatsoever. The Council taskforce was then in the field in Lagos State and was instantly recalled on the directive of the then Minister of Health. Since then there had been proliferation of more sub-standard laboratories, training institutions and increasing abuse of admission quota for the various lab workforce training programmes in the country. The cumulative effect of these are poorer quality of test results across the country with patients’ dissatisfaction, associated morbidity/mortality and encouragement of medical tourism; glut in unemployment of qualified lab workforce with some university graduates of MLS spending three to five years to get internship slots before they can proceed on NYSC since the space had been filled by charlatans in both public and private hospitals’ laboratories. Science laboratory technologists and others with no business in performance of medical lab tests have illegally and inappropriately taken over medical lab testing in several secondary and primary health institutions in many states of the federation. The then Zamfara State Governor hearkened to the call of the MLSCN in 2013/2014 by replacing over 400 quacks on its pay roll with qualified medical laboratory scientists and medical laboratory technicians. Other state governors are urged to emulate this example to support quality medical laboratory services to their citizens.