Formal regulation of medicines and medical devices in the United Kingdom started in the 1960s after the thalidomide incidence. Thalidomide was a prescription drug for relieving morning sickness in pregnant women used widely in the late 1950s and early 1960s before the discovery of unpredicted disastrous birth defects. Since then, serious legislation has been drafted to establish bodies to regulate medicines and medical devices such as the Medicines Act of 1968 which established the Committee on Safety of Medicines (CSM). CSM gave the legal framework for the control of medicines in the country (Griffin, 1998).
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Health Care Regulatory Agencies are national, state or local organizations mandated to check health care practitioners and amenities, promote the provision of quality services, provide accessibility to the industry information, and uphold safety while ensuring legal compliance. Some require voluntary membership while others are mandatory to join for health care providers and others oversee various segments of the industry as a whole. One such Agency is the Medicines and Healthcare Regulatory Agency (MHRA). This is a United Kingdom government agency formed as a result of a merger between the Medicines Control Agency and the Medical devices Agency in 2003 (Griffin, 1998).
The Agency regulates materials obtained from tissue engineering such as drugs, medical devices, blood, therapeutic products, and services. The agency carries out its mandate by licensing for marketing of medicines directly, issuing licenses to manufacturers and distributors of medicines. In the case of medical devices, they are approved by private sector organizations known as ‘Notified bodies’ which are audited by MHRA (MHRA, 2008).
History of MHRA
Regulation of medical devices started in the 1990s in the United Kingdom, which was a result of a European-wide campaign. Before this, the Scientific and Technical Branch (STB), founded in the 1960s in collaboration with the Department of Health, was in charge of the quality and safety of medical equipment. In the 1980s STB became part of the NHS Procurement Directorate which later split to form the Medical Devices Agency (MDA) in 1994. MDA merged in 2003 with the Medicines Control Agency to form MHRA (Griffin, 1998).
MHRA is a government agency established in 2003 after the merger between Medicines Control Agency and the Medical Devices Agency. It is mandated to regulate all medicines and medical devices in the country by ascertaining that they are acceptably safe for human consumption. The MHRA does not regulate cosmetic products, food items, controlled drugs, or veterinary medicines. The agency has the legal authority to investigate and prosecute individuals or companies that break the law concerning its mandate. The maximum penalty is two years imprisonment and an unlimited fine which is at the judge’s discretion (MHRA, 2008).
The structure of MHRA
The activities of this agency are supported by ten divisions that carry out duties regarding information management; providing executive support services; human resources; and finance for the smooth running of the agency.
The corporate governance
Topmost is the Agency Board responsible for advice in strategic development and making certain that the business plan targets are met. It implements the minister’s goals regarding the direction the agency takes and advice on the same to the minister and the stakeholders. It is comprised of 12 non-executive members representing no particular interest, appointed by the state secretary after open competition. The board is not in charge of any line management and has no constitutional role in executive functions or decisions. It does not have any say concerning regulatory policy or decisions involving medicines and medical devices. It meets on regular basis, attends sub-committee’s meetings, agency events, and reflects on strategy papers from other arms of the agency.
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The Executive Board manages the day-to-day running of the agency, formulates strategy papers, agrees on how to deliver the strategic direction set by the Board, and reports to the Board on the business of the agency. It has the responsibility to promote and protect public health, offer authoritative information, sway international views on healthcare, and support innovation in the same. Communication of its deliberations is through minutes of its meetings to the Agency Board, minutes from its subcommittees are provided to the Executive Board, and ‘Notes to staff’ informs the employees of the board’s decisions through the various divisions.
This is composed of executive directors in charge of divisions in medicines, devices, support, and policy. It is chaired by a chief executive. Under the executive Board are the ten divisions with each board member being in charge of a division that carries out day-to-day activities of the agency.
The independent advisory committees
These have the purpose of advising the minister on the various aspects of the regulation of medicines and medical devices. These committees are non-statutory and independent and draw their membership from senior and well-regarded professionals in their respective disciplines. These are then divided into working groups to address specific problems. The members are not paid but, receive expenses allowance. Examples of such committees are the Herbal Medicines Advisory Committee and Chemistry, Pharmacy and Standards Expert Advisory Group (MHRA, 2008).
The day-to-day running of MHRA
MHRA is organized into ten divisions, with each carrying out its responsibilities to ensure smooth day-to-day running. These divisions have specific responsibilities to carry in the agency. A brief discussion on some of the divisions follows.
This ensures that accurate, clear, and timely information reaches all stockholders so they can make the right decisions on the products. This is done through operating an inquiry telephone line and email address to provide information to those in need; providing a publicly available website; operating a 24-hour press center; organizing conferences and events to inform the public and professionals on developments in its mandated areas; maintaining contact with partners; carries out market research, and manages internal communication within the agency.
Devices clinical division
This oversees effective and express two-way contact with the professionals in medicine and nursing in need of guidance and information on safe and efficient medical devices. The team takes part in investigations and evaluation of devices, assessment of proposals by manufacturers, and enforcement of directives, and takes part in relevant committees.
Device technology and safety division
This has the responsibility of investigating reports of unfavorable incidents of medical devices coming from the public directly, hospitals care homes, and manufacturers. The manufacturers are then notified of such incidents involving their products and the healthcare professionals are given the relevant advice on the safe use of devices.
Inspection, Enforcement, and Standards division
This division ensures that manufacturers and suppliers of the medicines in the UK market comply with the laid down regulations. This is done through issuing licenses and inspecting all players in the medicines category. This division collects intelligence information and investigates suspected illegal sales.
The MHRA is funded mainly from the government coffers and by fees from the pharmaceutical industry to regulate medicines.
The decisions of the MHRA are reached impartially by considering each product separately regarding its characteristics, drawbacks, and advantages. Also about this, the employees are not allowed to have any financial interests in pharmaceutical companies or medical device manufacturing industries.
The MHRA works closely with international regulators such as European Medicines Agency (EMEA), US Food and Drug Administration (FDA), and local agencies. This is to share expertise and information on medicines, medical devices, and regulation policies (MHRA, 2008).
MHRA is mandated to safeguard public health. This is by ensuring that the products reaching the UK market are regulated and meet the laid down standards and that they work and are acceptably safe for human consumption.
It also provides accurate, timely, and clear information on medicines and medical devices to healthcare professionals, patients, and the public. An example of this role is given on 27 October 2009, where an alert on the Aluminum double adjustable elbow crutches model is given. This follows some reports received about this model being loose on the rivets that retain the crutch handle.
It is also mandated to support innovative research which applies better regulation. MHRA does not do this on its own; rather it has an expert advisory body to advise on research-related requests on data from the Yellow card scheme and general practice research file.
It also shapes potential regulatory framework by influencing international players involved in Medicines and medical devices. This is done through maintaining effective relationships with the players.
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MHRA also improves public health by supporting and making it possible for the development of products that will be of help to people. One such case concerns the introduction of traditional herbal medicine registration and certification on October 20, 2009.
It ensures that medical devices are fit for purpose and are used safely (Treweek, Heller & MacQueen, 2006).
Impacts of MHRA on the healthcare industry
The agency has made significant impacts in the health industry by the creation of public awareness on medicines and devices by making available information on these issues. This is demonstrated by the reports they receive through their communication channels and the seminars it holds for all stakeholders. The agency has also contributed to the promotion of public health by upholding the safety of medicines and medical devices. Moreover, the industry has seen more adherence to the standards and regulations by manufacturers and pharmaceutical industries due to MHRA regulation (Treweek al, 2006).
Formal regulation of the healthcare industry has tightened in recent times to safeguard the health of the public. This has been made possible by agencies with specific mandates and responsibilities in the regulation of medical products and services supervision of health care practitioners and amenities, providing accessibility to the industry information, and upholding safety while ensuring legal compliance. MHRA’s principal aim is to safeguard public health by ensuring that medicines and medical devices are acceptably safe for human use. The agency has the legal authority to investigate and prosecute individuals or companies that break the law regarding its mandate.
Its structure consists of an Agency Board responsible for advice and strategic development; executive board in charge of its ten operating divisions which run it on a day-to-day basis; and advisory Committees of professionals for advice. The agency has also made a great contribution to the healthcare industry through the creation of awareness, promotion of public health, and maintaining compliance to the laid down standards and regulations.
Griffin, J. P. (1998). The Evolution of Human Medicines Control from a National to an International Perspective. Oxford University Press.
MHRA. (2008). Medicines and Medical Devices Regulation: What You Need to Know. MHRA.
Treweek, G. L, Heller, T & MacQueen, H. (2006). Complimentary and Alternative Medicine: Structures and Safeguards Book 2 of Perspectives on complementary and alternative medicine. Routledge.