Robin Swann
North Antrim · Ulster Unionist Party · Northern Ireland
“I thank the Minister for his detailed statement. I know how passionate he is about the subject and how many times he has brought it to the Executive.”
“It has been reported that today will potentially be the warmest day of the year. As we move into the summer and our summer holidays, I want to raise public awareness of wildfires across Northern Ireland, which have been detrimental to farmland and our environment over the past number of years.”
“Wildfires are still having a detrimental impact on our environment and, occasionally, on livestock, but that reduction shows the impact of the Northern Ireland Fire and Rescue Service's proactive approach to educating the general public and engaging with rural communities and schools on its fire safety message, which is to stay alert, not…”
“There has been a lot of talk of sport in this place over the past few days, with everybody concentrating on UEFA. One sport that is going on across Northern Ireland at the minute is cross-community and goes across all age groups without fear, favour or distinction: pigeon racing.”
“I want to put on record that, since this place passed the amendment that recognised pigeon racing as a sport under the 2016 Act, over the past five years, pigeon racing clubs across Northern Ireland have been able to obtain £113,000 of rates rebates through the sports and recreation rate relief, allowing many of those clubs to continue ra…”
“There was much coverage on social media over the weekend of an incident in Staines in England, in which a police car rammed a young calf to bring it under control. It has restarted the conversation about animal cruelty. <BR /> <BR />I am dealing with a specific case in my constituency.”
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“The 2017 consultation also included questions related to possible issues for future legislation. The UK Government's response, which was published in 2019, confirmed that the proposals for reform were widely welcomed by stakeholders, including professional organisations, regulatory bodies and employers. That view was also confirmed by stakeholders in Northern Ireland. The consultation response also highlighted the case for broader changes to the regulatory landscape, which included the potential for reducing the number of regulatory bodies that operate on a UK-wide basis. The Secretary of State for Health and Social Care subsequently committed to reviewing the number of such UK-wide health and care professional regulatory bodies in the 'Busting Bureaucracy' policy paper that was published in November 2020.”
“<BR /> <BR />To be clear, the UK Government, with the support of the devolved Administrations, are committed to reforming the regulatory framework for health and care professions across the UK. To be clear, however, there is no intention to change the regulatory framework of the Pharmaceutical Society of Northern Ireland, which is specifically excluded from policy work on the UK's regulatory landscape. No change will be made to the society's legislation without the full agreement of the Northern Ireland Health Minister, whoever that may be.”
“In 2017, the UK Government and the devolved Administrations launched a consultation on promoting professionalism and reforming regulation. That focused on high-level principles for reforming the regulatory framework of healthcare professionals. The consultation set out five objectives for the reform process. Those are to improve the protection of the public from the risk of harm from poor professional practice; to support the development of a flexible workforce that is better able to meet the challenges of delivering healthcare in the future; to deal with concerns about the performance of professionals in a more proportionate and responsive fashion; to provide greater support to regulated professions in delivering high-quality care; and to increase the efficacy of the regulatory systems.”
“<BR /> <BR />I will now expand on the reasoning behind the proposed expansion of the scope of section 60 and illustrate for Members how those widened provisions will be used. The case for reforming the regulation of healthcare professionals has long been acknowledged. There is consensus across stakeholders that the UK model of regulation of healthcare professionals is rigid and overly complex. It needs to change in order to better protect patients, support our health and care services and help the workforce to meet future challenges. In doing so, it needs to be faster, fairer, more flexible and more cost-effective. <BR /> <BR />The four Administrations across the UK work collectively on the regulation of healthcare professionals under the UK-wide reach of the main regulators. Those are the focus of the measure.”
“I point out to Members that what is being sought for here is limited to the widening of the permissive power to legislate, under section 60 of the Health Act 1999, by means of secondary legislation at Westminster. In the field of the regulation of healthcare professionals, it does not implement specific policy proposals on, for example, the number and the composition of the UK regulators. Legislative proposals on such matters will be subject to the separate, subsequent process for the making of requisite Orders in Council at Westminster made under section 60 of the 1999 Act. Those will be subject to the affirmative parliamentary process and will therefore be debated and approved by both Houses of Parliament.”
“It also requires the delegation of previously restricted functions to other regulatory bodies through legislation, and it includes the regulation of groups of workers concerned with health and care, regardless of whether they are generally regarded as a profession.”
“The powers sought through the Bill form part of a wider programme aiming to create a more flexible and proportionate framework across the UK for the regulation of healthcare professionals, which is a framework that is better able to protect patients and the public. The provisions set out in clause 127 of the Health and Care Bill would widen the scope of section 60 of the Health Act 1999 on the regulation of healthcare professionals. The proposed additional powers will enable the abolition of an individual health and care professional regulatory body where the professions concerned have been deregulated or are being regulated by another body. They also provide for the removal of a profession from regulation where it is no longer required for the protection of the public.”
“We already have on the record that the Health and Care Bill was introduced in the House of Commons on 6 July, and, on 15 October, the Northern Ireland Executive gave their consent in principle for the need for legislative consent motions (LCM) for the transferred matters in the Bill. <BR /> <BR />Specifically, clause 127 in part 5, which is headed "Miscellaneous", addresses the:”
“I thank the Health Committee for taking the time to examine the legislative consent memorandum and for its helpful and positive engagement with my officials on the matter. I appreciate that the Committee again had to work within a challenging timescale, and I thank the members for their patience, understanding and cooperation. I also thank my Executive colleagues for their support in agreeing to the need for the legislative consent motion. I commend the motion to the House.”
“Thank you very much, Mr Principal Deputy Speaker. Again, I thank the Members who contributed to the debate. <BR /> <BR />The Chair of the Health Committee mentioned a number of concerns about North/South healthcare cooperation that had been raised in Committee. I assure him that the clause will have no impact on North/South healthcare cooperation, which is separately delivered under the Department, the Executive and the Belfast Agreement. That was clarified by the contribution of the Deputy Chair, Mrs Pam Cameron. <BR /> <BR />I thank other Members for their support for the LCM, and I put on record again my thanks to Ms Bradshaw for acknowledging the work of departmental officials who, with everything else that they have been dealing with, have been dealing with these issues as we bring them through a competent legislative process.”
“In addition to that statutory obligation to consult my Department, a separate commitment has been given by the Department of Health and Social Care to revise the memorandum of understanding that underpins the Healthcare (European Economic Area and Switzerland Arrangements) Act 2019 to enhance the mechanisms by which the UK nations will work together to deliver international healthcare arrangements from negotiation to implementation. <BR /> <BR />I hope that Members will support the additional provisions in the Health and Care Bill. Ultimately, the amendments would improve access to healthcare locally and abroad and to support international relations. I ask Members to support the motion.”
“I know that some Members hold the view that, as a matter of principle, any legislation that falls within the devolved competence of the Northern Ireland Assembly should be made here, and health is one such competence. As I said, I agree with that view, but I consider that the UK-wide legislation for international healthcare arrangements will ensure a consistent framework for the implementation of the agreements, which are also a reserved matter under international relations. <BR /> <BR />Any future regulations that cut across devolved competence are subject to a statutory duty to consult.”
“That helps to support student travel, holidays and business travel, and the same applies to visitors to the UK and Northern Ireland from Europe. This clause would expand the territorial scope of the powers, meaning that the Secretary of State would be able to negotiate and implement comprehensive reciprocal healthcare arrangements with the rest of the world. That includes, for example, British overseas territories and Crown dependencies, as the current international healthcare arrangements outside Europe are very limited in scope to, basically, a waiver of charges in limited circumstances.”
“Those powers will enable the Secretary of State for Health to implement comprehensive bilateral healthcare arrangements across the world, to pay for those treatments outside the UK and to facilitate the necessary data processing. <BR /> <BR />I will put clause 122 in some context: reciprocal healthcare is a small and important element of general healthcare policy in the UK. It supports people from the UK to obtain healthcare when they live in, work in or visit other countries, and vice versa for people from other countries who are in the UK. Within Europe, UK citizens have benefited from being able to get access to needs-arising healthcare when visiting other countries and have it paid for by the UK.”
“As has been said prior to this debate, the Health and Care Bill was introduced in the House of Commons on 6 July. On 15 October, the Northern Ireland Executive gave their agreement in principle to the need for legislative consent motions (LCMs) for the transferred matters within the Bill. Specifically, that is clause 122 in Part 5, "Miscellaneous", which concerns international healthcare arrangements. Clause 122 seeks to amend the Healthcare (European Economic Area and Switzerland Arrangements) Act 2019 to expand the territorial scope of this Act to countries, territories and international organisations outside the EU, EEA and Switzerland.”
“It will ensure a consistent legal framework for the information system and support the MHRA's regulatory functions as a UK-wide registry. It is actually more robust for the pharmacovigilance that is particularly important for high-risk medicines, as there is the potential that making these registries mandatory will improve the ability to reduce harm. For that reason, on this occasion, it is appropriate and makes good sense for Westminster to legislate on matters that are devolved to the Northern Ireland Assembly. <BR /> <BR />I consider that the provisions of the Bill provide for a UK-wide medicines information system, which is an important measure to improve patient safety through generating high-quality evidence on the benefits and risks of certain high-risk medicines. <BR /> <BR />I commend the motion to the House.”
“I appreciate that the Committee had to work within a challenging timescale and would like to thank the members for their patience, understanding and cooperation with my Department. I also thank Executive colleagues for their support in this matter and for agreeing to the need for a legislative consent motion in relation to the Bill. <BR /> <BR />Some Members hold the view that, as a matter of principle, any legislation that falls within the devolved competency of the Northern Ireland Assembly should, when possible, be made by the Assembly. I fully agree with that view, but it is important to understand that having UK-wide legislation for a medicine information system will be in the best interests of UK patients.”
“I thank Members who contributed to the debate. I note not only their support for these clauses but their concerns. Regarding the Chair's specific query about clauses 86 to 92, the arm's-length transfer of functions, which was the fourth LCM, a further assessment by the Department and the Executive was that it did not add any further benefit to health and social care in Northern Ireland and was not required at this time. That is why the fourth LCM was not moved. <BR /> <BR />I take this opportunity to thank the Health Committee for taking the time to examine the legislative consent memorandum and for their helpful and positive engagement with departmental officials on the matter.”
“That means that the devolved Administrations can legally challenge the Secretary of State if there is a failure to consult properly. Furthermore, any regulations to be taken forward will be made within the boundaries of data protection legislation, including GDPR and the Data Protection Act 2018. <BR /> <BR />I trust that Members will understand how important it is for Northern Ireland to be included in the provisions of the Health and Care Bill as, ultimately, they seek to improve patient safety through generating high-quality evidence on the use, benefits and risks of certain high-risk medicines. I ask Members to support the motion.”
“To be frank with the Member, nothing has been brought to my attention. That is why I have brought these LCMs forward as they are. They are supported by the Executive as they are drafted. However, as always, I will seek clarity for the Member on the detail. <BR /> <BR />The situation is different for the medical devices information system, for which the Secretary of State has sole authority as the subject matter of medical devices is a reserved matter. Members will recall that, last year, the devolved Administrations negotiated the inclusion of a statutory consultation clause in the Medicines and Medical Devices Bill, and that no regulations can be made without the proper consultation with the devolved Administrations.”
“When the regulations are to be made under the new section of the Medicines and Medical Devices Act 2021 for the medicines information system, the Department of Health will be the appropriate authority, either alone or jointly with the Secretary of State for Health in England. Therefore, the Department's consent is necessary. That is in recognition of medicines being a devolved matter. <BR /> <BR />All regulations under the power of the Medicines and Medical Devices Act 2021 on the medicines information system will also be subject to the draft affirmative process and, therefore, subject to the scrutiny of the Health Committee and debated in the Assembly for agreement by resolution before they are made.”
“I recognise that, with the enabling provisions that deal with medicines and medical devices information systems, proper safeguards need to be in place to ensure that regulations that are to be developed take account of Northern Ireland's legislation on the disclosure of information, alongside information governance and the code of practice on the sharing of a patient's identifying information for direct care and secondary care. <BR /> <BR />With particular respect to Northern Ireland, no regulations can be taken forward on the medicines information system without the consent of the Department of Health.”
“<BR /> <BR />Clause 85 also makes amendments to section 43 of the Medicines and Medical Devices Act to allow for technical elements of the Health and Social Care Act 2012 that established and constituted NHS Digital to be amended. Those amendments will ensure that the secondary legislation that is taken forward for both medicines information systems and medical devices information systems is coherent and consistent. That power will be exercised only when making regulations under the new provision of the medicines information system or under existing provisions for the medical devices information system.”
“The amendments are intended to align with the new provisions of the medicines information system and to enable NHS Digital to share information that it receives that comes from data linkage and to contain commercially sensitive technical information about devices. <BR /> <BR />Furthermore, in order to align provision for an offence of disclosing information that is already included in the Medicines and Medical Devices Act for the medical devices information system, similar provision is also now made for the medicines information system. That new provision was shared with the Department of Justice, and advice was received from officials that the new offence of disclosure of information is consistent, proportionate and will not have a detrimental effect on the justice system in Northern Ireland.”
“<BR /> <BR />It is expected that the powers will initially be used to capture the data needed to establish the registry on the use of sodium valproate and other anti-epileptics, as recommended in the report of the independent medicines and medical devices safety review, led by Baroness Cumberlege. However, the intention is that the powers will be used to develop registries for other medicines in the future in order to enhance regulatory oversight and the monitoring of specific medicines with which a potential risk of severe harm has been identified. <BR /> <BR />Clause 85 of the Health and Care Bill also makes some technical amendments to section 19 of the Medicines and Medical Devices Act, which deals with the medical devices information system.”
“First, requirements about the information relating to medicines will be provided to NHS Digital, which will combine the data from various sources and hold it in an information system. Secondly, MHRA will use the data compiled by NHS Digital to establish specific medicine registries. The proposal for the establishment of a new registry will be presented to the Commission on Human Medicines, which is an independent advisory group to the MHRA. It would issue a formal registry-specific recommendation if it were considered essential to support patient safety.”
“<BR /> <BR />A UK-wide registry is more robust for pharmacovigilance reasons, and that is particularly important with regard to high-risk medicines, as there is the potential that having mandatory registers will improve the ability to reduce harm. It is important for Members to note that the intention is not to create a registry for all medicines used in the UK, and the need for establishing a particular medicines registry will be justified on public health grounds and when alternative approaches to capturing sufficient data are not feasible. <BR /> <BR />It is envisaged that a two-stage approach will be adopted for the collection of information about medicines.”
“The Health and Care Bill is being used as the legislative vehicle to amend the Medicines and Medical Devices Act 2021 to extend to Northern Ireland provisions dealing with the medicines information systems. This is similar to the provisions agreed by the Assembly last autumn with what was then the Medicines and Medical Devices Bill for medical devices information systems. A comprehensive UK-wide medicines registry can be a potentially important tool in improving patient safety through better post-market surveillance of the use of medicines and will support the Medicines and Healthcare products Regulatory Agency's (MHRA) regulatory functions.”
“The Member is correct. As I said in an earlier answer, the vaccine management system now verifies the vaccine history of anyone who comes forward for their booster, third dose or even their second dose so that whoever administers it can check that medical history as well. That is why phase 2, which, as I said to Mr Allister, was rolled out in September, includes that additional data. It allows the cross-checking of vaccine history with any provider location in order to include the expansion of the vaccine programme and the next steps.”
“Data is also recorded for audit purposes. Employers have the responsibility to ensure that only legitimate access is sought in order to support legitimate clinical processes. I do not have with me the number of people who have access to the system, but I will get it to the Member in writing.”
“I thank the Member for seeking that clarity. Since the VMS was first launched, it has been the case that, once users log on to the system, their actions are logged in an audit trail, whether they create a record, view a record or update patient details. The original version, which the Member refers to, was the system provided by GP surgeries, and that had access only to their patients' details. Phase 2 of the VMS, which was rolled out in September, was designed to support the delivery of boosters. Vaccine history needed to be cross-checked with any provider location, and that required the inclusion of expanded search criteria. <BR /> <BR />Access to citizens' data is monitored by security and authentification mechanisms. Data is accessed only by clinical users, VMS administrators and development staff.”
“All those users are used to working with clinical systems and having access to patient data as part of their duties in providing patient care. Those users are fully aware of the information governance that is associated with such activity, and all activity on the VMS is logged and auditable.”
“I thank the Member. The point that he makes is that accessing the vaccine management system is no different from accessing any other healthcare record. The only people who can log on and access the vaccine management system are licensed registered users, who are healthcare professionals directly involved in the delivery of the COVID-19 vaccination programme, following requests from the organisations that employed or engaged them, should that be trusts, GP practices or community pharmacies. User accounts are only granted to those for whom access is necessary to ensure the safe and efficient delivery of the COVID-19 vaccination programme. <BR /> <BR />The VMS is a clinical system. That is clearly stated to all users when they log on to the platform.”
“<BR /> <BR />The last data that was published by the information and analysis directorate in my Department showed that 75% of COVID inpatients under 50 years old were unvaccinated. A COVID inpatient under 50 was 15 times more likely to be unvaccinated, and those over 50 were five times more likely to be unvaccinated. That shows the benefits that vaccination has, and I would be concerned if anyone was put off being vaccinated by what they may have read. I want to address the concerns about the benefits of vaccination and the security of their data in the vaccine management system.”
“I thank the Member for that. What concerned me about where this story went over the weekend was that it could have deterred people from coming forward to receive their vaccine because of a misconception that their details would be widely publicised. That is not the case, they will not and I hope that the assurances that I have given in my answers to the question show that. In this last charge, we are engaging with those people who need to be convinced and to be given additional support to come forward to get their vaccines. I agree with the Member about the need to encourage everyone who can still come forward. That is not just for those who will receive their booster or third dose but for those who are hesitant about receiving their first dose. They should also come forward to take up their flu vaccines.”
“As I said earlier with regard to the health and social care systems that we use, the vaccine management system was based on that crux and the same requirements as GDPR, because the VMS developers implemented and maintained the appropriate technical and organisational security measures. As I said, that includes the measures that meet the requirements of ISO 270001 and ISO 270018.”
“The published privacy notice regarding the data can also be found.”
“I thank the Member, and I will refer her back to what I said. The full data protection impact assessment of the VMS has been carried out and can be found online. I will share the website link with members of the Health Committee so that they have access to it.”
“I thank the Member for her question, but the system does not, as far as I am aware, include the employment status of an individual, and to use it in that sphere would be to go outside what we have agreed with the Information Commissioner. It is purely a technical and medical vaccine management system, not one that can be used retrospectively to query who has and who has not been vaccinated. That seems to be from where some of the misconceptions in the article over the weekend have come.”
“I thank the Member for his question. I will take his last point first. I can confirm that no data breach has occurred. Even the report in the papers talked about hypotheticals. A full data protection impact assessment of the vaccine management system has been carried out and can be found online, at covid-19.hscni.net/dpia-ni-vaccine-management-system. There is also a published privacy notice regarding data, and that can also be found on the Department's website, at covid-19.hscni.net/vaccine-service-privacy-notice. In the build of the vaccine management system, security and privacy have always been key considerations throughout, as is the case with all our systems. The system has been through end-to-end security assessment and penetration testing.”
“Once logged into the VMS, a user's actions are logged in an audit trail that includes options to create, view or update events on a patient's details. That is similar to all the equivalent health and social care systems. The difference is that this one covers the entirety of Northern Ireland and can be expanded. As we have seen, people seeking their first, second and third doses, and even their booster vaccine, are going to different locations where those are accessible, so whoever is administering them has to have the information on what people have received and when they received it in order to make sure that they are compliant, safety-wise and technically.”
“I thank the Member for his question. Having been made aware of the reports in the media over the weekend, I am disappointed, having checked, that some of the answers and additional information that we as a Department provided were not utilised in that article. If that had been done, it would have addressed some of the concerns that have been raised today. <BR /> <BR />As I have said, as required by GDPR, the VMS developers implemented and maintained the appropriate technical and organisational security measures, and that includes measures that meet the requirements, as I said, of ISO 27001 and ISO 27018 to protect personal data, its processes and a data processor or sub-processor on its customers' behalf.”
“They need access, however, to information on where people received their first and second doses in order to enable them to do that safely, both clinically and technically.”
“<BR /> <BR />The next step was that we engaged with Community Pharmacy. It started its operation to supply booster vaccines last month. A total of 240 community pharmacies across Northern Ireland can now supply booster and third dose vaccinations.”
“I thank the Member for his questions. He will be aware that I spoke last week about the Public Health Agency (PHA) supplying not only vaccinators but administrative support for the system. I think that the Member is actually asking about the crux of the vaccine management system, which is this: if you received your first or second dose at a GP practice and then go to a community pharmacy for your third dose or a booster vaccine, that pharmacy must have access to that information as well. That is why we control the healthcare providers and administrators who use the system, and they are subject to security checks as part of the normal employment processes. That administration is managed by the health and social care trust, the GP practice or the community pharmacy under their data protection protocols.”
“<BR /> <BR />Since the launch, once logged into a VMS, user actions are logged in an audit trail that creates "create view" update events on patients' details. If clinicians are indicating that people who should not be accessing the system are accessing it, it is up to them to come forward and say how they have been given access to the system when it is clear that it should be accessible only to those who have been expressly identified by their employer, be that an HSC trust, GP or community pharmacy.”
“I thank the Member for her question, but the people who access this system are, as I said, managed and put forward for access to the system by their employer, be that an HSC trust, GP or community pharmacy. It is necessary to ensure that information on anyone coming forward to receive a booster dose or third dose is accessible across all manufacturers. <BR /> <BR />There has been extensive engagement by the Information Commissioner's Office and National Cyber Security Centre teams on securing the information. As required by GDPR, the vaccine management system developers implement and maintain appropriate technical and organisational security measures. Those include measures that meet the requirements of ISO 27001 and ISO 27018 to protect personal data, data processes, a data processor or sub-processor on its customers' behalf.”
“That is standard practice for all HSC systems.”
“To help to maximise uptake, vaccination is being provided by different healthcare providers, each of whom must be able to cross-check key details before dispensing vaccines. Controlled access to patient information is not unique to the vaccination system. Each of the healthcare providers and administrators who use the system are subject to security checks as part of normal employment processes. The access controls for our VMS are managed by each health and social care trust, GP practice or pharmacy. That includes the selection and training of all staff members, and it specifically requests that they are provided with access to the VMS. All those employers have professional and legal data protection responsibilities. All actions undertaken by those using the system are logged and subject to audit.”
“I was made aware of reports in local weekend papers of concerns over the amount of access that health and social care (HSC) staff have to patient information that is held in the vaccine management system (VMS). I can assure Members that strict controls are in place over access to information that is held in the VMS and other HSC systems. The VMS is used by a wide range of healthcare providers in order to maximise vaccine uptake, so it is important that those staff ensure that safety checks are undertaken before each vaccine is dispensed and that those checks are recorded accurately. <BR /> <BR />Controlled access to patient information is essential in ensuring that we have clinically safe and quality data.”