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

Lord Hunt of Kings Heath Excerpts

Monday 2nd November 2020 Grand Committee

[Lord Hunt of Kings Heath (Lab)]

My Lords, I thank the Minister for introducing and explaining so carefully the statutory instruments. Clearly, as he said, they are very important. The key statement he made, which is repeated in paragraph 7.7 of the Explanatory Memorandum, is:

“Neither the 2019 SIs, nor the 2020 SIs make changes to the safety and quality standards, which will remain the same across the UK from 1 January 2021.”


However, for Northern Ireland, these standards are expressed by reference to EU legislation, whereas for Great Britain they are not; although, at the moment, the substance is the same in both cases. So I ask the Minister: what are the implications of any future change made in EU directives or in UK law? Since we may not stay aligned with the EU, there must be some inevitability, at that stage, of that arising. Will that not then lead to a confusing situation in future where UK regulators are responsible for overseeing different laws in separate parts of the UK? If that is the case, and given that this is a hugely sensitive area, will this inhibit the movement of tissues and organs between Ireland and Great Britain? The Minister mentioned such movement, but will he clarify how much movement there is at the moment?

I would also like to ask the Minister about the six-month transition period from exit day to allow establishments time to put the necessary arrangements into place for importing and exporting tissues and cells with the EU? Is he confident that that is sufficient time for those establishments?

I refer to our recent debate on the Human Tissue Act during the passage of the Medicines and Medical Devices Bill. As the Minister knows from our debate, it is our view at least that the Human Tissue Act does not require appropriate consent for imported human tissue, and, in addition, imported human tissue for use in medical research does not require traceability. Of course, this is very relevant in the case of China and the shocking use of organs of prisoners and minority groups for commercial exportation. I readily acknowledge that we are currently in discussion with the Minister’s department about a suitable amendment to deal with this, but will any such amendment agreed in the Medicines and Medical Devices Bill apply also to Northern Ireland?

I am sure the noble Lord, Lord Alton, will speak in some detail on this, but, as I have the opportunity, I would like also to talk about human tissue. As the Minister will know, we have been concerned about the view of the WHO on the practices in China, as it is based upon a self-assessment by China itself. This has been the subject of correspondence between the Government and the World Health Organization. The Minister, the noble Lord, Lord Ahmad, has now turned down a freedom of information request from the noble Lord, Lord Alton, and I want to express my disappointment. This is so important that the Government really ought to publish the correspondence. Having said that, I am very grateful for the opportunity to debate these regulations.