Blood Safety and Quality (Amendment) (EU Exit) Regulations 2020

Baroness Walmsley Excerpts

Monday 2nd November 2020 Grand Committee

[Baroness Walmsley (LD) [V]]

My Lords, I intend to focus my remarks on the human tissue and organ transplant regulations and, in particular, on the issues of timeliness and trust.

I have a particular interest in both of these issues. Back in 1995, I gave my consent in Brussels for organs from my deceased husband to be removed for transplantation. I was happy to do so and received considerable comfort from the fact that, even after his death, he could do some good for other human beings somewhere in Europe. I mention this because, at the time, we and Belgium were both members of the European Union, and the administration and procedure were expedited smoothly and professionally. Since the 2016 referendum, I have been anxious that no barriers should be put in the way of the continued smooth running of this process.

As we have heard, in 2019 a set of regulations was approved to ensure that EU standards would continue during the implementation period, and today we have regulations that take account of the unusual position of Northern Ireland following our exit from the EU. The regulations ensure that, as long as Northern Ireland takes certain steps which have little or no cost, the same standards will apply and no barriers will be put in the way. I am reassured about that—in theory.

However, there are many practical considerations when you are dealing with human tissues that must be delivered in a timely way. The numbers we are dealing with are significant. Between April 2019 and March 2020, 32 organs from deceased donors moved from GB to Northern Ireland, and 126 organs moved in the other direction. As the Minister said, there are two tissue establishments in Northern Ireland, and they will continue to be able to receive tissues and cells from GB, but they will treat GB as a non-EU member state for this purpose.

I understand that Northern Ireland must continue to meet the requirements of EU directives for as long as the protocol is in force. But, as other noble Lords have said, changes to these instruments may be needed if there are changes to the directives. Can the Minister confirm that the Northern Ireland Administration intend to make these changes if they happen, and, if that is the case, what is the British Government’s intention?

My interest in the human tissue regulation is both personal and general. I have a family member who is currently awaiting a bone marrow transplant and, fortunately, matches have been found in other countries, possibly Northern Ireland. Time is of the essence, so my concern is whether organs and tissues from abroad will reach UK patients in a timely way after the end of the transition phase. If the ports are blocked, the Government have suggested that tissue and medicines—and indeed pharmaceuticals—will be flown in. But look what has happened to the aerospace industry during the pandemic. Will there be enough resource? Will the military be used if there are blockages?

I am also concerned about UK bioscience research. There are about 5,000 imports of tissues and cells from the EU alone in a typical year, so it is essential for UK life sciences that there are no barriers to this work. Can the Minister reassure me?

These SIs are to bring EU regulation into UK law, whether or not we get a deal. It is looking as if we will not. When the 2019 SIs were debated in Grand Committee on 9 January 2019, in Hansard col. 201 the Minister said that such materials would be “prioritised”. However, the problem is that everything will need to be prioritised.

In that debate my noble friend Lady Barker raised the issue of inspection of premises, pointing out that the UK and the EU will each inspect their own premises. But what happens if there is a serious incident on one side or the other? Will this not destroy the trust that is needed for this system to work? It is also essential that the public trust the regulations since, in many cases, such as transplantation, their permission is needed. How will the Minister reassure any member of the public listening to this debate that they can have the confidence to give that consent once we are independently responsible for our own standards? As the noble Lord, Lord Alton, said, confusion and inconsistency can destroy trust.