Departmental Correspondence related to Medicines and Medical Devices Bill: Further Legislative Consent Motion

DoH responses to Health Committee Questions Chair, Colm Gildernew

1. The Minister has sought assurances that the regulations to be developed to implement the Medical Devices Information System take account of the governance arrangements around medical devices and patient safety in NI. What particular governance arrangements is the Minister referring to, and is the Department content with the assurances received, that the devolved regions will be consulted on these regulations?

Northern Ireland has in place strong information governance and privacy systems on the sharing of patient identifiable information both for direct care and secondary use to ensure informed patient consent and privacy of patient data.

It is these governance arrangements that the Minister is referring to and to which draft regulations would need to conform.

An amendment to the Bill has been proposed whereby the Secretary of State will have a statutory duty to consult Scottish Ministers, Welsh Ministers and the Department of Health in Northern Ireland. This will be written into the Bill.

In addition to this amendment there is also a separate non-legislative commitment from the Department of Health and Social Care to ongoing discussions on the medical devices information system governance arrangements and other operational details that will ensure that the Department of Health in NI is engaged in relevant policy and operational discussions and the development of draft regulations.

The Department is content the assurances received with this legislative and non- legislative approach.

 

Deputy Chair, Pam Cameron

2. Is it the case that laws covered by this Bill are covered by Annex 2 to the Protocol?

The Bill’s powers will be exercised in compliance with the NI Protocol.

Medical devices appear in the list of subject areas in Annex 2 to the NI Protocol, and consideration has been given to whether the amendment to provide for a Medical Devices Information System may be subject to a different “regime” in Northern Ireland, but this will not be the case.

The UK-wide Medical Device Information system (MDIS) does not deal with the placement of medical devices on the market. The MDIS is to record to the post- market use of the medical device by healthcare providers, enabling track and trace of patients who have medical devices with an identified issue implanted, and monitoring of the efficacy of the device in use. Therefore this system is to improve patient safety.

 

3. How would Northern Ireland’s role in the medical device information system be complicated by future divergence in standards between GB and EU in future years?

NI’s involvement in the MDIS will not be affected by any divergence in standards between EU and GB. The MDIS relates to the post-market safety of devices and is completely separate from Medical Device Regulations. The MHRA, as regulator for the whole of the UK, will continue to regulate devices on the marketplace and this should mitigate any potential divergence in standards between GB and NI, particularly as NI will remain part of the EU acquis for medicines.

There have been a number of actions taken that will mitigate against any risk of divergence in regulations for patient data. In response to concerns raised by the Devolved Administrations that regulations to be developed to implement the Medical Device Information System take account of the governance arrangements in their respective administrations, the UK Government is taking forward an amendment whereby the Secretary of State will have a statutory duty to consult Scottish Ministers, Welsh Ministers and the Department of Health in Northern Ireland.

In addition to this amendment there is also a separate non-legislative commitment from the Department of Health and Social Care to ongoing discussions on the MDIS governance arrangements and other operational details that will ensure that the Department of Health in NI is engaged in relevant policy and operational discussions and the development of draft regulations.

 

4. How would patients be protected under this new system?

The purposes for which data can be shared and the types of organisations that can receive this information will be specified in the regulations made under the powers contained in the Bill.

DoH will be fully consulted in the making of these regulations which will determine the scope and limitations on data-sharing. Patient’s data shall be held securely, controlled and processed in compliance with data protection laws and General Data Protection Regulation (GDPR) that will ensure patient information will be protected.

The aim of a Medical Device Information System is to improve the safety and standards of medical devices, by ensuring better information can be captured and shared on implanted devices, in order to identify risks posed by specific devices much earlier.

The Medical Device Information System will provide some critical benefits to patients who have been, or will be in the future, implanted with medical devices. These include:

• the collection and storing of information linking unique device identifiers to patients, clinicians, and the specific surgical procedure that implanted the device; and
• establishing systems that will enable health providers to trace patients who have been treated by, or implanted with, a medical device so that the patient can be provided with appropriate medical treatment, if a safety issue subsequently occurs with the device.

These improvements to the information that is gathered about the use of these devices will increase patient safety by identifying issues with individual devices or types of procedures, which can then be addressed at the earliest possible time.

 

5. Will NI end up governed by two information sharing systems within the EU and UK?

No, NI will be part of the UK information sharing system, provided through the Medical Devices Information System. The MDIS relates to the sharing of patient data on implanted devices within a central UK system only. It relates to the provision of direct care to a patient and subsequent care if needed in the future.

The EU does not require the storage of patient data at a central level and its forthcoming regulations only require that service providers record (preferably by electronic means) where, and on whom, implantable devices have been used. The MDIS will assist our service providers in meeting this requirement.

Individual EU member states are responsible for their own healthcare systems, including the use of any devices on the EU market. Each member state’s regulator for devices monitors compliance with the EU regulations. The MHRA will remain the regulator for NI (and GB) after the end of the Transition Period.

 

6. How can the attractiveness of NI in terms of supply of medicines and medical devices be promoted if there are barriers to trade between GB and NI in the first place?

The UK is currently aligned with the EU acquis for medicines and medical devices. This will change after transition when NI will remain aligned with the EU and Great Britain (GB) will not. There are long term implications for both the supply and regulation of medicines in NI, where the large majority of medicines supplies are drawn from the UK market via GB.

Northern Ireland is part of a UK-wide medical supplies contingency programme for EU Exit which is led by the Department of Health and Social Care, with the involvement of the Devolved Administrations.

At the fourth meeting of the Ireland/Northern Ireland Specialised Committee on 5 November 2020, the UK Government and the EU Commission reached an agreement to allow the pharmaceutical industry twelve months from 1 January 2021 to comply with new regulatory requirements which apply only to NI and are a consequence of the NIP. This will allow industry time to adapt to the new arrangements and to mitigate risks to barriers to trade.

The MHRA will continue to regulate medicines for Northern Ireland and as the UK regulator will represent all parts of the UK in ensuring their attractiveness as a place to trade.

To respond specifically to concerns about the absence of a definition of ‘attractiveness’ of the UK in the Medicines and Medical Devices Bill, the UK Government intends to clarify that this is a consideration of the likelihood of the relevant part of the United Kingdom being seen as an attractive or favourable place in which to supply and conduct clinical trials for human medicines and develop and supply veterinary medicines.

The Department of Health will continue to work with both the Department of Health and Social Care (DHSC) and the Medicines and Healthcare products Regulatory Agency (MHRA) in relation to compliance with the Northern Ireland Protocol and future relations with the EU. This will include consideration of the optimal supply and logistics models for medical supplies for Northern Ireland, the attractiveness of Northern Ireland for clinical trials and opportunities that may arise for the life science industry.

 

Committee Member’s questions:

7. What reporting mechanisms does the MDIS have arranged with the assembly? Does it only report to Westminster and are we here in the north reliant on reporting from NHS England or Public Health England?

Full consultation with all stakeholders will be required before regulations on MDIS can be drafted. The Department will be involved in the development of these regulations and, as part of this process, will input into decision making regarding what we consider to be the most appropriate reporting mechanism for the system.

 

8. How does the MDIS interrelate with the EU medical devices alert system.

Medical device alert systems are operated by national regulators, and in the case of the UK, this is the MHRA. The MHRA generate medical device alerts on the basis of post market surveillance involving legal requirements on manufacturers to report any faults in their device. Once MDIS is operational, the MHRA will be able to gather intelligence on the efficacy of devices from the new information system that will help improve patient safety.

 

9. Is there any interplay between the MDIS and the Irish Protocol? Surely medical devices count as “goods” and so would come under its remit. If so, would it not be better for the North to have its own system, in order to facilitate continuing standards alignment with the EU.