Factsheet: international data sharing
Updated 25 January 2021
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Top lines
In the UK, medicines and medical devices are regulated by the Medicines and Healthcare products Regulatory Agency (MHRA). Veterinary medicines are regulated by the Veterinary Medicines Directorate (VMD).
It is of vital importance to the work of both regulators that they are able to share information and collaborate internationally, for example with other regulators. This ensures that the MHRA and VMD are informed of safety information and can protect UK patients.
We are committed to sharing information in a way that protects patient data and complies with data protection legislation.
Why these powers are needed
Prior to the end of the transition period, the MHRA was sharing and receiving intelligence from its counterparts in EU member states through membership of the European Union.
The VMD also previously shared information, through EU membership, with regulatory authorities in EU member states such as the HPRA (Health Products Regulatory Authority, the Irish regulatory authority).
At the end of the transition period, the arrangements that facilitated this information sharing came to an end.
What information is shared now and what might be shared in the future
The MHRA shares data relating to product and patient safety including in relation to adverse events.
The VMD shares pharmacovigilance information from adverse event reports with other regulators outside of the UK.
In the future the VMD may wish to share pharmacovigilance system inspection reports.
Future reciprocal information sharing agreements with international regulators will help the MHRA to take swift regulatory action on medicines and medical devices that pose a risk to UK patients.
What the bill changes
The bill will give the government the power to share information it holds in connection with human medicines, veterinary medicines and medical devices, where this is required to give effect to future international agreements or arrangements.
This power would allow the MHRA and the VMD to share information as part of an international agreement or arrangement. This will facilitate effective sourcing and sharing of information for use within their regulatory roles.
The effective exchange of information, as facilitated by this bill, is of vital interest to ensuring patient safety in the UK and supporting the government’s commitment to improving safety standards.
The bill cannot be used to authorise a disclosure of information which would contravene data protection legislation and any international sharing of patient identifiable data can only take place with consent.
Supporting information
The MHRA regulates human medicines and medical devices on a UK wide basis and its aim is to protect and improve public health and improve patient safety.
The VMD promotes animal health and welfare by assuring the safety, quality and efficacy of veterinary medicines.