Supplementary Protection Certificates (Amendment) (EU Exit) Regulations 2020

Lord Stevenson of Balmacara Excerpts

Friday 27th November 2020 Lords Chamber

[Lord Stevenson of Balmacara (Lab) [V]]

My Lords, I am grateful to the Minister for his clear introduction of what is turning out to be a rather complicated issue. I certainly felt that his remarks were a lot clearer than the Explanatory Memorandum, which I have been struggling through and which brought me to a stop around paragraph 7.7 or 7.8; I will ask a couple of questions about that, so the Minister has advance notice. Most of the points that I was going to make were made in the expertise displayed by earlier speakers —particularly the noble Lord, Lord Lansley, and the noble Baroness, Lady Wheatcroft—and in the supplementary questions asked by the noble Baroness, Lady Bowles.

The Explanatory Memorandum struggles to answer questions because it is trying to do the impossible: to make a rationale behind what is obviously a bit of a fudge in relation to requirements that could have been dealt with better in the Northern Ireland protocol—but that is easy to say with the benefit of hindsight. The issue that I get stuck on occurs when I get to paragraphs 7.7 and 7.8 of the Explanatory Memorandum. It concerns the same question that the noble Baroness, Lady Bowles, asked about. What do companies have to do to be sure that they do not run the risk of losing control of their intellectual property in relation to the need to have a set of regulatory approvals that faces the UK market but does not put them outside the ability to market the same product through Northern Ireland into the EU?

Paragraph 7.8 suggests:

“Products which are subject to regulatory approval before they can be placed on the market in Northern Ireland must … be assessed in accordance with EU law”,


but it is not at all clear to me what that actually means in practice. It goes on to say:

“Approval may be given by the UK regulator acting on behalf of Northern Ireland”.


What does that mean? It also says that such approval may instead be given

“by the European Medicines Agency.”

Obviously, we all understand and know about that process.

Paragraph 7.9 helpfully states:

“This means that products … may have a marketing authorisation granted under EU law.”


However, paragraph 7.10, which I was hoping would explain that, simply repeats this fact:

“A specific product may have two authorisations … in most cases, a GB authorisation and an NI authorisation.”


Is that the same as an EU authorisation? Are we hearing that this is a mutual recognition issue, as suggested by the noble Lord, Lord Lansley? I look forward to the Minister’s response on that.

My only other point relates to later on in the Explanatory Memorandum, under paragraph 9. I was grateful to see that the IPO will prepare some Keeling schedules, of which I am a great fan. Although the timing of this is complicated because the date of publication is a lot earlier than today, paragraph 9.2 states:

“The IPO has prepared, and will be making publicly available, informal consolidated texts of Regulations … which take into account all legislative changes for the end of the transition period.”


That is obviously very imminent. It goes on:

“A draft of this material has been laid in the Libraries of both Houses”.


In fact, when I checked in the Library, I could not find it. Can the Minister confirm whether we have gone past the draft stages and now have a final version? If so, would it be possible to circulate that to noble Lords who participated in this debate, as I would like to have confirmation that this has all been done properly?