Strengthening healthcare regulation in Nigeria

There is tremendous progress being made with healthcare development in Nigeria. The steady trickle of trained Nigerian doctors returning home to practice are bringing back skills that were hitherto not present in the country. Procedures that people used to travel abroad for, are increasingly being done in Nigeria.

Unfortunately, at the same time, the media is replete with doom and gloom stories of medical mishaps which erode trust in the system and further drives medical tourism. The public response to these mishaps is a demand for more effective regulation and protection from the government.

Healthcare more than any industry requires effective regulation. Our regulatory framework is fragmented with different agencies having oversight over different aspects of the healthcare Eco system without an integrated approach with a focus on patient safety and effectiveness of therapy.

Furthermore, the approach is to respond when things go wrong (Quality control) rather than develop a system that minimises the risks of things going wrong. I will approach this article by explaining the challenges with the current system in Nigeria, using the United Kingdom as a case study to understand how an effective system can be developed before making recommendations for strengthening our system in Nigeria.

The Medical and Dental Council of Nigeria (MDCN) is responsible for assuring the competence, licensing, and regulation of medical professionals in Nigeria. It has an effective code on medical negligence and responds effectively when claims are made against medical professionals.

The issue is that a claim needs to be made before the council can respond. Furthermore, medical negligence occurs when a healthcare professional fails or neglects to provide appropriate action or gives substandard treatment that causes harm, injury, or loss of life to the patients. Medical negligence therefore is a concept that can only be proven after the fact — the damage has already been done. This is not good enough where human lives are involved.

Similarly, the Nigerian Health Act of 2014 makes provision for the regulation and licensing of medical premises. There is a federal regulatory body responsible for the regulation of federal teaching hospitals and Federal medical centres and the state ministry of health is responsible for the regulation of medical practices and hospitals within the state. Some states such as Lagos State have been exemplary in this regard.

The Health Facility Monitoring and Accreditation Agency (HEFAMMA) was established in March 2006 and is charged with the responsibility of monitoring both private and public health facilities to ensure registration and in the near future accreditation of all health facilities. The functions of the agency are clearly stated on its website and are a step in the right direction but there are capacity challenges in meeting this ideal.

All medical subspecialties in Nigeria have societies for members of the subspecialty and, one of the purposes of these societies is to set guidelines for minimum standard of practice within the medical subspecialty. The Society of Gynaecologists and Obstetricians of Nigeria (SOGON) , the association of Nigerian private medical practitioners (ANPMP) and the Association of Reproductive Health (AFRH) are examples of such societies.

Unfortunately, these guidelines can only serve as a reference point for practitioners who choose to observe them, and they have no legal structure to uphold them and are therefore not enforceable.

A further driver of the call for better regulation in healthcare in Nigeria is information asymmetry between the buyers of healthcare and the providers of healthcare. The buyers must depend on the expertise, experience, and good will of the providers of healthcare to guide their healthcare purchases.

This could lead to over servicing with the patient receiving services that they do not need for the commercial advantage of the provider. The MDCN registers additional qualifications for specialists in a sub speciality but there are many doctors without specialist qualifications parading themselves as specialists. Not all specialists are cut from the same cloth and there is a need to keep an eye on outcomes of treatment to make sure the services meet the needs of the people. This is also not currently available, and patients have no reference point to guide them when paying for medical services.

A facility may be well equipped and set up to meet the needs of the patients but may be considered expensive by the patients who in the search for cheaper alternatives may end up in the hands of quacks. Lastly, commercial considerations may trump ethical considerations in the provision of service which could further challenge the reputation of the industry.

There are other regulatory bodies involved with healthcare in Nigeria. I have mentioned the MDCN for medical doctors as well as the regulation of medical premises above. In addition, there are different agencies for all cadres of healthcare providers, nurses and midwifes, pharmacists, laboratory scientists, and other health workers as well as the National agency for Food and Drug Administration (NAFDAC) for the safety, efficacy and quality of pharmaceuticals, medical devices, and other healthcare products.

The Standards Organisation of Nigeria (SON) has a mandate which includes the preparation of standards relating to products, measurements, materials, processes, and services. As well as certification of products, assistance in the production of quality goods and services; improvement of measurement accuracies and circulation of information relating to standards.

The many different licensing bodies for the different cadres of healthcare workers has created different safety concerns within healthcare with different cadres fighting for independence and prominence without a focus on what best serves the patient.

The Association of Medical laboratory Scientists of Nigeria (AMLSN) believe all medical diagnostic laboratories should fall under their purview despite the fact that the laboratories are headed by pathologists who are licensed by the MDCN.

Pathologists are trained to have the full view of the patient and can interpret test results with reference to whatever else might be going on with the patients in a way that a laboratory scientist never can. An effective integrated regulatory body with a focus on patient safety and effectiveness of interventions would provide the right legal structure for regulation.

Healthcare delivery is about people’s lives. It’s about safety and efficacy of care and we must put more systems in place to minimise the risks to patients. There is no point waiting for people to die before we close a facility. The systems employed around the medical practitioners must make sure patients are not at risk from medical intervention. That is what effective healthcare regulation is all about.

Lessons from other countries — England as a case study

Medical professionals are highly trained professionals, and, in most cases, their professionalism can be relied upon for the protection of the patients. The Bristol Heart Scandal of the late 1980s shed new light on this. The Bristol Royal Infirmary enquiry was set up in 1998 to investigate the deaths of 29 babies undergoing heart surgery at the hospital.

The report was released in 2001 and its recommendations led to significant changes in the practice of medicine in England. Recommendations included making doctors more accountable, the creation of national standards both in clinical care and for hospitals and more openness in clinical performance to name a few. Excerpts of the report are available here.

The response of the Government was robust and included the formation of the Commission for Health Improvement (CHI) in 2003 to inspect and regulate healthcare providers to ensure they meet minimum standards of quality and safety of care as well as the National Institute of Clinical Excellence to evaluate efficacy and cost effectiveness of various treatments.

Despite these changes, there were more scandals such as the Mid Staffordshire Hospital Scandal as well as the Shipman enquiry to name a few. These further highlighted inadequacies in regulatory oversight and the need for a more effective and robust system.

Healthcare regulation was fragmented across multiple agencies and bodies. Each sector or organisation had its own regulatory body leading to inconsistencies in standards and lack of unifying oversight. Furthermore, the regulatory focus was to respond to things going wrong rather than prevention. This need to streamline and consolidate the regulatory framework led to the formation of the Care Quality Commission(CQC).

The Care Quality Commission (CQC) plays a crucial role in driving quality assurance in healthcare in England. Here are some ways through which the CQC ensures and enhances the quality of healthcare services:

1. Regulation and Inspection: The CQC is responsible for regulating and inspecting all healthcare services in England, and through a robust inspection process, the CQC assesses whether these services meet essential quality and safety standards.

2. Standards and Guidelines: The CQC sets out clear standards on patients’ safety, effectiveness of treatment, patients experience and governance as well as staff qualifications. Providers are expected to continuously meet these standards to maintain their registration with the CQC.

3. Monitoring and Enforcement: The CQC continuously monitors healthcare providers to ensure they maintain the required standards. This includes reviewing data, including treatment outcomes, patient feedback, and complaints. In case of non-compliance, the CQC has enforcement powers to act, such as issuing warning notices, imposing fines, or even cancelling a provider’s registration.

4. Rating System: The CQC employs a rating system to inform the public about the quality of healthcare providers. After inspections, providers are given one of the following ratings: Outstanding, Good, Requires Improvement, or Inadequate. These ratings help patients make informed choices about their care and put pressure on providers to improve their quality.

5. Patient and Public Involvement: The CQC actively involves patients, service users, and the public in influencing and shaping its inspection processes. It seeks their feedback and encourages them to share their experiences of care. This involvement helps identify areas of improvement and ensures services are patient centred.

6. Learning and Guidance: The CQC disseminates learning from inspections and investigations across the healthcare system. It publishes reports, case studies, and guidance to share best practices and lessons learned. This knowledge-sharing helps providers identify areas for improvement and encourages the adoption of effective strategies.

Overall, the CQC’s efforts drive quality assurance in healthcare by setting standards, inspecting services, monitoring compliance, empowering patients, and enforcing regulations. Its aim is to ensure that the healthcare services in the UK are safe, effective, compassionate, and of high quality. The CQC was designed to be an independent body with the authority to monitor, inspect and regulate all healthcare providers ensuring that they meet certain standards of quality and safety.

Integrated Healthcare regulation in other countries.

In Germany, the “Gemeinsamer Bundesausschuss” (G-BA) or the Joint Federal Committee is an independent body responsible for determining the medical and dental care provided by statutory health insurance in Germany.

In France, “Haute Autorité de Santé” (HAS) or the High Authority of Health is an independent public body that aims to improve the quality, safety, and efficiency of healthcare services and provides guidance to healthcare professionals and institutions.

Similarly, South Africa, has the South African Health Products Regulatory Authority (SAHPRA). SAHPRA is responsible for the regulation, registration, surveillance, and inspection of healthcare facilities and the quality of healthcare products in South Africa.

Recommendations for Strengthening Healthcare regulation in Nigeria.

Quality control is about responding to defects to improve the quality of output and is not good enough for healthcare. Healthcare regulation needs to focus on setting up systems that minimise risk to the patient. We need to develop a structure that is focused on assuring the quality of care that our patients receive. The key elements of quality assurance for healthcare regulation in a country typically include the following:

1. Regulatory Agencies: Establishing regulatory bodies responsible for overseeing healthcare standards, licensing, and enforcing regulations is essential. These agencies monitor healthcare providers and facilities, investigate complaints, and take appropriate action when violations occur.

The current situation is that there is a federal agency for federal teaching hospitals and federal medical centres and each state has a different approach to monitoring medical facilities. All these need to be aligned into one agency. HEFAMMA in Lagos State has made tremendous progress in this regard and could provide the foundation for this alignment into a national body.

2. Accreditation of healthcare facilities: Accreditation ensures that healthcare facilities, such as hospitals and clinics, meet specific standards of quality and safety.

There are many medical facilities in Nigeria that are not fit for purpose. Many private hospitals are converted residential houses without the required safety modifications for a hospital. The doors may be too narrow for hospital beds, and they are unable to move patients safely in an emergency.

Similarly, the corridors may not be wide enough to move the beds through and the operating theatre may be makeshift without the appropriate safety modifications to keep patients safe during operations. The operating theatre may be on a different floor from the admitting wards and there may be no lifts to move the patient between floors and where there is a lift, the appropriate safety standards for medical lifts may not be deployed.

These are not acceptable in modern healthcare. It may be necessary to define minimum share capital requirements for private hospitals to ensure that hospitals meet a minimum standard of safety.

The trap we set for ourselves in Nigeria is to look at the deployment of healthcare infrastructure from the point of view of our lack of resources rather than what is required and indeed, many government hospitals are also not fit for purpose. Whilst this approach could be understood, diseases such as cancer or heart disease will rage on without recourse to the resources you have to deploy.

We must deploy resources that will meet the minimum safety and effectiveness requirements for the patient. This resource challenge by the government increasingly makes the case for more private sector participation in the national strategy for health care provision and we need to look beyond Private Public Participation and more towards Private Public integration with a phased concessioning of most government hospitals to the private sector with the government focusing more on regulation of healthcare rather that service provision.

A further value of accreditation will be in defining the geographical spread of medical facilities using instruments such as the certificate of need (CON). A certificate of need (CON) is a legal document that is required to construct a new healthcare facility.

To obtain a CON, investors in a new healthcare facility must apply to the local governmental authorities by making the case for why the community in question would benefit from that new hospital. This is important to ensure the financial sustainability of hospitals that meet the required standards and will increase private sector investments in healthcare.

Some may argue that the CON framework protects the interests of established facilities who may have more political influence. I believe we need to attract more private capital to healthcare development in Nigeria and the CON is one of the instruments that will support that initiative.

3. Licensing ensures that healthcare professionals, such as doctors and nurses, meet the required qualifications and adhere to professional standards. The MDCN allows a medical practitioner to register an additional qualification as a specialist in a field of medicine.

It is important to define clearly what procedures specialists can carry out and the ones that general medical practitioners can carry out and this must have legislative backing. The current situation where non specialists are carrying out complicated procedures without the required certification or the required supervision is not acceptable.

3. Standards and Guidelines: Developing and implementing national standards and guidelines for healthcare is crucial. These standards define the expected quality of care, safety protocols, ethical practices, infection control measures, and more.

They provide clear benchmarks for healthcare professionals and facilities to follow. The many speciality societies that we have in medicine in Nigeria will be a great resource for the set-up of a National Guidelines Compendium, but they will need to have legislative backing to hold practitioners accountable to the standards. As I have mentioned above, the standards must have international benchmarks with the objective of patient safety and effectiveness of therapies.

4. Inspection and Auditing: Regular inspections and audits of healthcare facilities and providers should be conducted to assess compliance with regulations and standards. This process ensures that healthcare organisations maintain their quality of care and safety measures consistently.

These inspections must be with a reference to the accreditation, standards, licensing, and proficiency of the medical professions as well as adherence to minimum standards of practice. There is a need to focus on outcomes as well, and in some countries such as the England, there are league tables where results are published for public scrutiny to guide the patients on healthcare procurement decisions.

5. Continuous Quality Improvement: Encouraging a culture of continuous quality improvement is vital. This involves regular assessment, monitoring, and evaluation of healthcare services. Identifying areas for improvement and implementing evidence-based practices helps enhance patient outcomes and overall quality of care.

The inspections should have a consultative rather than a punitive approach. This ensures transparency and buy in by the providers and where facilities are not meeting the required standards, the emphasis must be on getting them to improve rather than closing them down.

6. Reporting and Transparency: Establishing mechanisms for incident reporting, adverse event reporting, and transparency in sharing information with the public are crucial for accountability and trust. Open communication channels enable patients and healthcare professionals to report concerns, track improvements, and ensure transparency in healthcare regulatory processes.

7. Patient-Centred Care: Ensuring that healthcare regulations prioritise patient safety, rights, and satisfaction is essential. Promoting patient-centred care involves involving patients in decision-making, respecting their autonomy, and protecting their confidentiality.

We already have a Patients Bill of Rights (PBOR) which should form the framework for patient centred care. An important extension of this is patient reported outcome measures (PROM)as a key performance indicator for medical interventions.

Read also: How to bring back doctors, health professionals who left Nigeria – Pate

8. Data Collection and Analysis: Effective healthcare regulation requires collecting and analysing data to monitor trends, identify areas of concern, and track the impact of regulatory interventions. This information helps shape future policies and allocate resources effectively.

It will be essential to deploy an effective nation-wide electronic system to ensure effective data collection and analysis. Most hospitals will want to deploy systems that will meet their own needs, but it will be important that they all report to a central system that will allow the collection and analysis of data.

My objective with this article was to explore a framework for more effective regulation of healthcare in Nigeria. This is necessary to drive healthcare development and consequently national development. I believe regulation rather than service provision should be main role of government.

The provision of service should be increasingly transferred to the private sector through a concessioning process to free up government resources which could be directed towards building an effective regulatory system to drive healthcare development in Nigeria.