Policy paper

Health and Care Bill: medicine information systems

Updated 10 March 2022

This was published under the 2019 to 2022 Johnson Conservative government

The report of the Independent Medicines and Medical Devices Safety Review said:

We want to see a registry for all women on anti-epileptic drugs who become pregnant, to include mandatory reporting and data relating to them and their child(ren) collated over lifetimes. This should not be limited to sodium valproate but should also include all AEDs [anti-epileptic drugs]. We have heard from patients and experts who are concerned that the long-term outcomes of the newer generation of AEDs are not yet known … This registry could potentially be expanded to collect data on paternal and transgenerational effects.

This fact sheet explains how the government plans to improve patient safety in the UK through powers to establish and operate medicines information systems to enable the creation of UK-wide medicines registries.

Background

After a medicine is placed on the UK market continued monitoring of the medicine is important to ensure its safe use. Registries are organised systems that continuously collect relevant data, evaluate meaningful outcomes and comprehensively cover a defined population, in order to improve the quality of patient care. Medicines registries can drive improvements to patient safety by generating evidence on the use, safety, and effectiveness of medicines.

There is greater need for information to be captured on the use of certain medicines where there are known, or potential for, concerns to patient safety, to enable earlier identification of risks and to ensure patients and prescribers have the information they need to make better informed decisions. The evidence built from a medicines registry can be used to support local clinical practice, monitor compliance with measures intended to reduce risk to patients, enable the exploration of trends in prescribing and changes in practice, and help with our understanding of patient experiences.

UK-wide obligations to capture information, potentially through a registry, can already be placed on companies or other legal entities that have the authorisation to market a medicine in the UK (also known as Marketing Authorisation Holders) by the UK’s medicines regulator (the Medicines and Healthcare products Regulatory Agency, MHRA). However, there remains a need for the development of comprehensive publicly held registries that can benefit all patients, healthcare professionals, and regulators.

To improve the existing monitoring of the use, benefits, and risks of medicines and to improve patient safety, the Bill provides powers through which one or more medicines information systems can be established and operated by NHS Digital which will capture, process, and store data to allow for the creation of centrally held UK-wide medicine registries.

What the Bill will do

The Bill will introduce a new power to make regulations setting out how medicines information systems will be established and operated. We will be able to ensure NHS Digital can collect or collate a range of information about the use of medicines and their effects in the UK and hold this data in one or more information systems. NHS Digital will then be able to share the information with the MHRA. The MHRA will use the information held in an information system to establish and maintain comprehensive UK-wide medicines registries. This will ensure that the UK makes step change improvements in how medicines are monitored after they are introduced on the UK market.

The Bill ensures we have the powers to promptly amend what information is collected by NHS Digital, as public health needs change or develop, and the need for new or different information emerges. This provides us with the ability to respond more quickly to emerging risks to patient safety as and when they develop.

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 cases where those measures are not being followed, so that additional action can be taken by regulators in conjunction with health service providers at a national, local, or individual patient level.

Data security will be of utmost importance in the establishment of any medicines information system. The provisions in the Bill will safeguard personal information of patients by ensuring that the operation of a medicines information system is consistent with data protection legislation and that there is an appropriate deterrent is in place against, and appropriate consequence for, any unauthorised onward disclosure of information from the information system.

There are similar provisions in section 19 of the Medicines and Medical Devices Act 2021 for medical devices information systems.

How these provisions help promote patient safety

These provisions are part of the government’s wider plans to improve quality and safety through the Bill. They will ensure that we have a more systematic, proactive approach to monitoring certain medicines where a risk, or potential risk, of serious harm has been identified and will ensure patients and prescribers have the information they need. They will also support regulatory activity by informing decisions about necessary regulatory action to be taken to ensure the safety of medicines on the market.

Further information

Working together to improve health and social care for all

The need for the establishment of registries was recommended in The Independent Medicines and Medical Devices Safety Review published on 8 July 2020.