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

Lord Lansley Excerpts

Monday 2nd November 2020 Grand Committee

[Lord Lansley (Con)]

My Lords, I am likewise very grateful to my noble friend the Minister for his very clear explanation of the purpose of these regulations. I wish to speak only to the first set, relating to blood safety and quality.

As the Minister quite rightly explained, the purpose of the regulations is to enable the protocol to be applied and therefore for the regulations in Northern Ireland to continue to be those prescribed by EU law, rather than those under UK law. So the issues, as noble Lords have already said, including the noble Lord, Lord Hunt of Kings Heath, are very much around what will happen if there is some degree of divergence in the future.

My point is that I do not regard this as an unlikely prospect: I fear that it is a quite likely—and perhaps even an imminent—prospect. I say this because it is just over a year since the European Commission published its working document, Evaluation of the Union Legislation on Blood, Tissues and Cells. My expectation is that, probably this month, an inception impact assessment will be published by the European Commission, and its working plan says that it expects to publish a legislative proposal in the third quarter of next year—so this is not a speculative prospect.

It may not occur because the United Kingdom chooses to have different regulations. Notwithstanding my noble friend’s optimistic scenario, it is not simply a question of whether the United Kingdom chooses to have higher standards of regulation. Divergence does not necessarily mean that one jurisdiction has high standards and one has low standards; they have different standards.

Let me give some examples of where this might arise. The first relates to advanced therapy medicinal products; here, I am talking about gene therapies and somatic cell therapies. It is clear from the European Commission’s work on what it terms “strategic value chains” that one of the nine areas it has identified is personalised medicines. We know from discussions in the European Parliament in relation to these matters, and from the way in which the Commission has responded to them, that it does not simply regard this as strategic but also regards Europe’s own legislation on the governance of gene therapies as potentially differing from where it is now—and it may well be different from the way in which we choose to govern gene therapies in this country. So we may diverge in that respect.

Secondly, the noble Lord, Lord Scriven, referred to plasma and plasma products. The European Union is dealing with substantial excess, and rising, demand for plasma and plasma products. There is a serious deficiency in supply in the European Union, much of which is presently met from the United States. It may well be that the European Union adopts measures the purpose of which is to increase supply within it. That may have implications for the supply of plasma products heading out of the EU to non-EU member states. Of course, for these purposes, the United Kingdom will become a non-EU member state, so we may have divergence in that respect.

This is not confined to the European Union. On 30 October, the US Food and Drug Administration published a list of 230 sensitive products in this area, five of which relate to plasma and plasma products. There are rising demands for products in this area and international constraints on supply. I will not repeat him but the noble Lord, Lord Hunt, asked a perfectly reasonable question about the ability of the HTA to be a competent authority for two different jurisdictions, and whether my noble friend the Minister is happy that the HTA can exercise both roles.

Finally, if I may be forgiven for this question, how are we at this moment discussing these regulations in this Committee to give effect to the protocol, while discussing a Bill this afternoon in the Chamber Clauses 43 and 44 of which seem on the face of it to give the Government the power—indeed, give Ministers the responsibility—potentially to disapply the protocol in relation to regulations in this area? This is an absurd proposition. Perhaps my noble friend would be kind enough to explain how we arrived at this place.