The evolution of regulations in healthcare has been a complex and iterative process, influenced by several factors including advances in medicine and technology, shifting social and economic conditions, and evolving political and public attitudes.
Healthcare regulations have developed to address critical issues such as patient safety, quality of care, and access to comprehensive and affordable services.
The proper regulation of healthcare institutions involves several aspects including Licensing and Registration, Quality Standards, Drug and Product Regulation, and Professional Regulation. Until the beginning of the 20th century, however, healthcare regulations were relatively minimal, with little oversight of medical practices, pharmaceuticals, or healthcare facilities.
This lack of superintendence led to widespread problems, including unsafe medications, unqualified practitioners, and substandard facilities.
In response to these challenges, the first regulations were designed to ensure the safety and efficacy of medical products and the competence of healthcare providers. The Pure Food and Drug Act of 1906, for example, was a significant milestone in the history of healthcare regulation, as it established the first federal standards for the safety and labelling of food and drugs in the USA.
The Food and Drugs Act of 1955 took into consideration the modern means of processing food and drugs, and the Food Safety Act of 1990 comprehensively restructured British food legislation.
The expansion of healthcare services and the increasing specialization of medical practices in the mid-20th century prompted further regulatory changes. For example, the Hill-Burton Act of 1946 provided federal grants and loans to support the construction and modernization of hospitals in the USA.
The latter half of the 20th century also saw significant advancements in patient rights and protections. The introduction of informed consent requirements and privacy regulations aimed to empower patients and protect their privacy.
The emergence of managed care, the rise of patient advocacy, and the increasing influence of technology in healthcare have also triggered fundamental and ongoing changes in healthcare regulations with significant consequences for healthcare providers.
For instance, the World Anti-Doping Agency (WADA) recently suspended Africa’s only accredited drug-testing laboratory for numerous deviations from international standards.
In a related development in the United States of America, the Alabama State Supreme Court recently ruled that frozen embryos are human beings and that those who destroy them can be held liable for wrongful death. This has thrown the future of fertility care into jeopardy, raising costs and restricting access to those affected by this ruling.
Alabama Governor Kay Ivey, seeking to protect patients and fertility care providers from legal liability, signed a fast-tracked Bill into law, providing civil and criminal immunity to patients and IVF providers.
Some experts have expressed scepticism over this legislation noting that while the bill protects IVF providers from liability, it could also insulate them from medical malpractice claims.
The American Society for Reproductive Medicine, on the other hand, has warned that IVF providers will continue to be vulnerable to civil and criminal prosecution until the issue of whether a fertilised egg is legally considered a person is determined.
These examples underscore the importance of setting and adhering to well-thought-out healthcare regulations that protect both patients and healthcare providers.
Healthcare institutions in Nigeria are regulated by several government bodies to ensure that they meet specific standards and provide quality care to patients.
The primary regulatory body for healthcare in Nigeria is the Federal Ministry of Health, which sets policies, guidelines, and standards for healthcare delivery in the country. Additionally, the National Agency for Food and Drug Administration and Control (NAFDAC) regulates the quality, safety, and efficacy of pharmaceuticals, medical devices, and other healthcare products, while the Standards Organisation of Nigeria (SON) prepares standards relating to product, measurements, materials, processes and services.
The Medical and Dental Council of Nigeria (MDCN), established in 1963, is tasked with ensuring the competence, licensing and registration of medical professionals in Nigeria. Several other bodies are involved in the regulation of healthcare in Nigeria. Different agencies regulate various categories of healthcare providers including nurses and midwives, pharmacists, laboratory scientists and other healthcare workers.
In Lagos State, the Healthcare Facilities Monitoring and Accreditation Agency (HEFAMA), accredits and monitors healthcare facilities. Similar agencies exist in other states across the country.
There are, however, several challenges currently facing the regulatory framework about healthcare in Nigeria.
The existing framework is highly fragmented which has led to a lack of coordination and inconsistent standards between different regulatory authorities with no specific focus on overall output as it affects the patient.
Virtually all healthcare regulatory agencies have been set up to react to issues rather than proactively ensure the establishment and maintenance of healthcare facilities to laid down standards.
Although the MCDN, for example, has a code on medical negligence and responds effectively when claims are made, the problem is that a claim must be made before the Council can respond. The damage has already been done and this is not good enough when lives are at stake.
Weak regulatory enforcement is another major challenge affecting safe and effective healthcare delivery. The various medical specialties and sub-specialties have well-established guidelines for the minimum standard of practice. However, these guidelines serve only as a reference point for practitioners and have no legal structure to uphold and enforce them.
Recently, a medical practitioner, who had contravened the guidelines laid down by the governing body of his specialty and was subsequently sanctioned, was able to successfully sue both the society to which he belonged as well as HEFAMAA for lack of jurisdiction.
Despite this discouraging experience, some healthcare providers have realised that operating according to international standards is the only route to credibility. In 2004, Bridge Clinic became Nigeria’s first IVF centre to be ISO certified, a status it has maintained for over two decades.
The Nigerian Heart Foundation (NHF) champions best practices in cardiovascular care and has been pivotal in facilitating advancements in standardizing heart disease treatment, attesting to the overarching movement towards excellence in diverse medical fields.
Furthermore, the underfunding and mismanagement of many regulatory agencies significantly hinder their effectiveness.
Despite these setbacks, efforts continue towards fortifying the regulatory framework, ensuring better oversight, thus fostering safe and effective healthcare delivery.
