Medicine Information Systems
The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of DHSC. It acts on behalf of the UK’s licensing authority 3 , and is responsible for overseeing the regulatory regime for human medicines in the UK as set out in the Human Medicines Regulations 2012. The regime provides a comprehensive scheme for regulating human medicines that covers licensing, manufacture, importing, brokering, labelling, distribution, advertising, and pharmacovigilance.
	The MHRA’s pharmacovigilance activities are a key way that the safety of medicines on the market is monitored. This includes assessing the risk and benefits of medicines so that necessary steps may be taken to improve their safe use, monitoring the everyday use of medicines to identify new, or changes in existing, patterns of adverse events and providing information to healthcare practitioners and patients to promote safe and effective use of medicines.
	Comprehensive UK-wide registries have the potential to be an important tool in improving post marketing surveillance of the use of medicines, and in turn improving patient safety, as they are a valuable source of evidence on the use, safety, and effectiveness of medicines. Registries consolidating prescribing data for specific medicines and linking it with data from clinical care and other social administrative databases with additional bespoke patient-focused data capture, enable the exploration of trends in prescribing and associated patient experiences and the identification of issues that may impact on patient safety. The establishment of registries was recommended in the Independent Medicines and Medical Devices Safety (IMMDS) Review published on 8 July 2020.
	The evidence generated through medicines registries can be used to inform regulatory decision making, support local clinical practice and provide patients and prescribers with the evidence they need to make better informed decisions.
	UK-wide obligations to capture data, potentially through a registry, can already be placed on companies or other legal entities that have the authorisation to market a medicine (also known as Marketing Authorisation Holders) in the UK by the MHRA, through post-authorisation commitments detailed in a medicine’s approved Risk Management Plan. However, Marketing Authorisation Holders cannot oblige healthcare providers to share information with them, which in many circumstances leads to the incomplete capture of evidence. These types of registries have not consistently delivered the required evidence in reasonable timeframes, partly due to a lack of trust from clinicians and patients but also partly due to the way in which they are set up, placing burdens on healthcare providers for additional data entry, meaning that they have often failed to recruit sufficient patients to meet the required objectives.
	To improve the existing monitoring of the use, benefits and risks of medicines and to improve patient safety, the Act creates powers through which one or more medicines information systems can be established and operated to allow for the creation of centrally held UK-wide medicine registries. The core of these registries would be made up of existing routinely collected data which would be supplemented with bespoke data extracts from other systems to minimise the burden on healthcare professionals to input additional information.
	The central vehicle through which the health service in England collects and disseminates health service information and data is the Health and Social Care Information Centre, known as NHS Digital. NHS Digital is a statutory corporation established under section 252 of the 2012 Act. The 2012 Act sets out the general functions of NHS Digital, such as collecting, analysing and presenting national health and social care data, setting up and managing national IT systems as well as publishing rules around the handling and management of personal confidential information of patients.
	The Act provides a power to make regulations which will enable NHS Digital to collect a range of information about the use of medicines and their effects in the UK and to hold this data in one or more information systems. The MHRA would be able to then use the information held in an information system to establish and maintain comprehensive UK-wide medicines registries. This would improve post-market surveillance on the use of medicines. For example, where a safety issue has led to the introduction of measures to minimise risk to patients, registries would facilitate the early identification and investigation of potential non-compliance so that additional action can be taken by regulators in conjunction with health service providers at a national, local, or individual patient level.
	It is not the intention to create a registry for every medicine used in the UK. A registry will only be established where there is a clear public health need and after the Commission on Human Medicines (CHM), the independent expert advisory body to the MHRA, has made a formal registry-specific recommendation. A similar power to establish and operate one or more information systems for medical devices is found in the Medicines and Medical Devices Act 2021 (c.3) (section 19). This Act amends that Act; this will ensure both powers are set out in the same piece of legislation.