Official Report 630KB pdf
“Organs, Tissues and Cells (apart from embryos and gametes) Provisional Common Framework”
“Blood Safety and Quality Provisional Common Framework”
Welcome back. Our third agenda item is an evidence session on two common frameworks. The Minister for Public Health, Women’s Health and Sport, Maree Todd, is still with us. I thank her for staying on. Joining the minister online are Sam Baker, donation and abortion policy team leader, and Sharon Grant, donation and abortion policy team member.
Minister, whenever it comes to frameworks, I ask this general question: what does the framework mean for Scotland?
I have some introductory remarks that I can use to set the context, convener.
You are most welcome to deliver them.
Thank you. First, thank you for inviting me along to the committee to discuss the two provisional common frameworks. Officials in my team have been working with our counterparts in the UK Government, the Welsh Government and the Northern Ireland Executive to develop a four-nations approach to the delivery of the European Union repatriated functions on common areas of interest in the frameworks. The ministers of the four nations have agreed the content of the provisional frameworks, which were published on 2 December 2021.
Policy on organs, tissues, cells and blood safety and quality were and continue to be highly regulated at EU level. The purpose of the frameworks—and what they give Scotland, to respond to your question—is to ensure that, post EU exit, there is a joined-up approach across the UK to the continued maintenance of high standards of safety through the delivery of regulatory functions in these areas. That includes agreement as to how divergence will be managed within the UK, as well as governance and decision-making processes.
Throughout the process, we have committed to continuing to work collaboratively to develop common frameworks on the basis of consensus and in line with the agreed principles of the joint ministerial committee on EU negotiations as of October 2017. The provisional frameworks have been operational on an interim basis since the end of the transition period and they will remain provisional until the parliamentary scrutiny by all legislatures has been completed. I am happy to take questions.
Thank you. That answers my very broad question. Emma Harper has a follow-up question.
I am a former liver transplant nurse in Los Angeles and I was always interested in looking at the tracking, the tracing, the safety and where the organs came from. To what extent is the cross-border sharing of tissues, organs and blood an issue for us in Scotland?
It is an area on which we have always worked and collaborated well on a four-nations basis, and it is vital that we do that. We are quite a small country and we sometimes require organs for individual citizens that are not available in Scotland. Conversely, we sometimes have organs that we cannot use in Scotland and it is really important that we have ways of sharing them. It is not unusual for such a system to be operated across units like the UK, and such collaborations sometimes occur even more widely. In a couple of instances, we have shared organs into the Republic of Ireland, and I think that there are arrangements in place for that to happen with France as well.
It is really important that there are high standards and that each nation is aware of the standards that operate in each country in order to make sure that the system is safe and transparent.
Just out of curiosity and interest, given that anyone who is a donor will want to make sure that every organ that they donate on their death can be used, is there anything in the provisional common framework that will inhibit that?
No. It is an incredible gift that people give when they donate their organs and I reassure them that we are grateful for that and will use organs all over the UK to help people who need them.
What discussions took place during the development of the framework? What were the key areas of debate? Were there any notable areas of disagreement?
I reassure you that a great deal of collaboration goes on in this policy area and there are good, strong reasons for us not to have disputes and to work well together. I do not anticipate areas of divergence but, as with all these frameworks, it is really important to build in a possibility for that to happen. We have different legislation and a different NHS, and it might be necessary to do things slightly differently in each of the four UK nations.
A possibility of divergence is built into the framework. That does not mean that it will inevitably happen, but the possibility is there. It is really important that that is maintained and that there are mechanisms for resolving any areas of conflict and for enabling divergence, should that be needed.
Did stakeholders raise any concerns about the frameworks? The committee did not receive any responses to its calls for views, but it would be good to understand whether any concerns were raised with the Government.
I am not aware of any concerns being raised, certainly on the specific frameworks that we are discussing. There is a general concern about the way that the frameworks operate and the powers that were repatriated from the EU, and the United Kingdom Internal Market Act 2020 certainly causes all the devolved Governments real concern. It was not given consent in Scotland or in Wales. There are some general discussions, but I am not aware of any concerns being raised in the specific policy areas that we are discussing. In fact, it is in our interests and everyone’s interests for us to work together closely in order to meet the needs of our citizens on this front.
Emma Harper has some questions about the Northern Ireland protocol.
It is obvious that everybody needs to collaborate and work together, and the utmost safety of any policy is crucial. I am curious to know whether the Northern Ireland protocol will have an impact. Under the EU-UK withdrawal agreement, Northern Ireland is in the UK customs territory, but it remains aligned with EU regulations. The rules in Northern Ireland could change in order to remain aligned with the EU, and the framework sets out the structures and processes for managing the impact of such changes. Could changes that result in divergence between Northern Ireland and the rest of the UK obstruct any sharing of blood, tissues or organs?
I would like to think not. Such concerns are precisely what the framework is intended to address. It is a four-nations agreement that is intended to drive a consistent approach across the four nations, but it acknowledges that there is a possibility of divergence. It is clear that, if there is a change in EU law, that will apply in Northern Ireland. That will need to be considered through the framework processes. The Scottish Government set out its view that, although we are not in the same situation as Northern Ireland, we are pretty keen to remain aligned with EU law where such alignment is appropriate and in Scotland’s best interests.
That is the reason for the potential in the framework to enable policy divergence between the four nations. It may well be necessary for Northern Ireland and we may well want it for Scotland. Through the framework process, we are able to seek and access expert advice to ensure that any on-going decisions or any divergence are taken into account and to make sure that it works well. However, the framework simply provides a means of discussion between the four nations.
If any change or policy divergence is proposed, it will be important for there to be clear and timely communication so that the Scottish Government is aware of that.
Absolutely. The framework should enable respectful communication between the four nations. It enables those discussions and that divergence to occur with respect being paid to the devolution settlement. It is not likely that there will be policy divergence, or huge policy divergence, in these areas, but the framework enables it to happen in such a way that there is good communication and understanding and it is worked out in a respectful way between the four nations.
One thing that is happening at the moment, though, is the continued pursuit of the United Kingdom Internal Market Act 2020, which we are seeing time and again. On Saturday morning, my colleague the Cabinet Secretary for the Constitution, External Affairs and Culture, Angus Robertson, was summoned to a meeting with the UK Government where policy was announced that we knew nothing about. The dialogue is often strained. The framework is intended to improve the dialogue, to ensure that each of the four nations is content with the divergence, and to enable divergence should that be in the interests of any of the countries that are signed up to it.
Ultimately, this is about organ accessibility and saving lives.
Absolutely. As I said, it is in everyone’s interests that we make this work well, and thus far it has worked well. We have a separate NHS, separate legislation and different systems in Scotland to the rest of the UK, but we work together really closely and well in this area because it is in our shared interests to do so.
I think that we all agree that collaboration across the UK on blood, tissues and organs is vital. Divergence is an option in the framework. Can you give us an example of circumstances where Scotland may diverge?
I cannot think of a specific example at the moment. It is important that the option is there, because I do not have a crystal ball and I cannot see into the future. One example might be a situation where EU law changes, given that Scotland generally wants to align itself with the EU. We have an intention of returning to the EU when we are an independent country, so we want to remain aligned with EU legislation. That might well be an area where policy divergence occurs, but I cannot foresee it at the moment.
As Sue Webber said, organ donation is the greatest gift that somebody can give, and we do not want to waste organs. Is there a risk of that if we have divergence? What impact might divergence between Scotland and the rest of the United Kingdom have?
That is not a risk. I absolutely reassure people who want to give this immense gift to help their fellow citizens that there is no risk whatsoever that the framework will prevent them from doing that. The framework will enable good co-operation, and continued co-operation. We already work really well and closely together. The framework will enable further co-operation and collaboration even in the event of policy divergence. It will prevent the concerns that you raise, rather than contributing to them.
Carol Mochan has a question about dispute resolution mechanisms in the framework.
Everything seems to have been put in place—quite rightly—to make things work as smoothly as they can. However, if there was a suggestion that any of the Governments wished to dispute anything or withdraw from the agreement, how would that work? How would the Scottish Government bring that to us, as parliamentarians?
I will ask one of my officials to comment on that, but I reiterate that the whole purpose of the framework is to prevent disputes from arising. The point is to enable close collaboration between the four UK nations and to enable policy divergence, should that be a choice. It respects the devolution settlement, so the circumstance that you describe, with the need for dispute resolution, should not arise. The point of the framework is to prevent that from occurring.
The dispute avoidance and resolution arrangements that exist are robust, as you would expect. Formal processes are in place through the appropriate intergovernmental structures to resolve disputes at the lowest possible level. If that is not possible, the matter can be escalated right up to ministers. However, I ask one of my officials to comment.
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As the minister said, the frameworks set out the process for resolving disputes and they contain mechanisms for that, starting with officials and escalating to more senior officials, to ministerial level and, if necessary, up to cabinet secretary level. The aim is to make sure that any dispute about the framework can be resolved. As the minister said, if we could not reach an agreement, we would agree to disagree and, if necessary, diverge in regulations. However, the aim is certainly to try to resolve any dispute, to work together where possible and to ensure that there is as much alignment as possible.
I do not see any member indicating that they want to ask a further question, so I bring this session to a close. I thank the minister for her time and her evidence on the frameworks and the other issues that we have discussed.
At our next meeting, on 8 February, the committee will take further evidence from the Scottish Government as part of our inquiry into the health and wellbeing of children and young people. We will also take evidence on two supplementary legislative consent memoranda related to the UK Health and Care Bill.
That concludes the public part of our meeting.
11:31 Meeting continued in private until 12:59.