Patents (Amendment) (EU Exit) Regulations 2018

Debate between Lord Warner and Baroness Vere of Norbiton

Monday 14th January 2019 Grand Committee

[Lord Warner]

According to the BIA, which is a cautious body that keeps its finger on the pulse of the sector very well and in my experience always represents that sector extremely accurately, it is concerned about the impact of this approach on patients’ access to new medicines and the effect on jobs of a decline in using the UK for the growth of innovative products in the bioindustry sector. It says:

“Eroding intellectual property protection whilst also seeking global free trade deals sends a signal to industry that the UK Government may further erode protection as it seeks to quickly conclude deals. This would further impact the industry in the UK and future inward foreign investment”.


That is what the industry is saying, it is not what I am saying. I am repeating to the Grand Committee what the sector and the industry are saying, having been involved in this set of regulations. The BIA and the industry are also concerned that the proposal has simply not been properly consulted on:

“The suggestion that the government might take this approach first appeared in a Technical Notice at the end of August”,


2018. The BIA,

“raised concerns with Ministers and the MHRA. The MHRA stated that concerns should be included in responses to their ‘no deal’ consultation which concluded on 1 November (the consultation did not ask specifically about exclusivity)”.

So the Government did not actually consult on the point of exclusivity. That is the view of the trade body which is responsible in this area. This is why I urged a bit of caution on the reassurances that the Minister might want to give until after I had spoken. This is what the industry is saying. The statutory instrument,

“was tabled on 1 December, when follow-up discussions from the consultation were still ongoing. There has been no formal consultation”,

on this issue, which undermines the validity of the regulations.

The sector is saying that it was not consulted on the specific items in the regulations and that is as a result of its contact with the MHRA, the regulator.

In its response to the MHRA no-deal consultations, the BIA, together with the ABPI, stated:

“We are also concerned that the proposal for data and market exclusivity for marketing authorisations is not being consulted on”.


It has made that clear beyond peradventure. I do not know who the IPO spoke to. It may have been one individual company—that is what my intelligence from the BIA suggests. By any stretch of the imagination, it was simply not a proper consultation with the sector that is most affected and which is genuinely concerned that the regulations will have a massive adverse effect on the life sciences industry in this country.

In its response to the consultation, the MHRA stated on 3 January that there would be a review within two years. However, by that time some UK patients will not be able to receive the medicines that they would have if the UK was a member of the EU and there will have been a significant impact on the UK industry as well as on the global industry’s perception of the UK. This is what a responsible trade body is saying has been the effect—

[Baroness Vere of Norbiton (Con)]

This is too long.

[Lord Warner]

I am sorry if I am taking up a bit of time. I have heard longer speeches and I have been interrupted a few times.

Nuclear Safeguards Bill

Debate between Lord Warner and Baroness Vere of Norbiton

Committee: 1st sitting (Hansard - continued): House of Lords
Thursday 22nd February 2018 Lords Chamber

[Baroness Vere of Norbiton (Con)]

My Lords, I thank noble Lords for the opportunity to address this important set of issues around the UK’s future relationship with Euratom. As my noble friend Lord Henley said, the EU and Euratom are uniquely legally joined. Noble Lords will be aware that when we formally notified our intention to leave the EU, we also commenced the process of leaving Euratom. I repeat my noble friend’s assurances, however, that the Government want to maintain the continuity of our mutually successful civil nuclear co-operation with Euratom and other international parties when we leave the EU.

The first half of the proposition of Amendment 4 —that,

“it is no longer possible to retain membership of Euratom”—

has already passed. On 29 March 2017 the Prime Minister notified President Tusk of the United Kingdom’s intention to withdraw from Euratom. We are withdrawing from Euratom but we want a close relationship with it in the future. I believe that it would be deeply irresponsible of Parliament to pass an amendment which, quite explicitly, prevents us from using the powers in this Bill until we have attempted to do exactly the opposite of what the Article 50 letter says we are doing. That leaves the second half of the proposition: that we achieve, “an association with Euratom” that means that it is Euratom rather than our own regulator, the ONR, that carries out safeguarding in the UK after we leave the EU. To reiterate the point made by my noble friend, while the Euratom treaty allows for the conclusion of association agreements that allow third parties to participate in some Euratom activities, these agreements have so far been limited primarily to research and training activities.

This amendment would require us to have explored every avenue and concluded that,

“it is no longer possible”,

before we make regulations to enable the UK’s own domestic regime. That presents enormous timing difficulties and will introduce a risk of the one thing I believe everyone agrees we must avoid—being left with nothing in place from day one of Brexit. I do not believe that the industry would support such a position. We simply cannot await the outcome of the future relationship discussions before we use the regulation-making powers in the Bill. Of course, it may all happen very quickly but, then again, it may not. It would be deeply irresponsible to put ourselves in a position where we cannot exercise the powers in the Bill.

[Lord Warner]

I am sorry to interrupt the Minister’s debut on the Bill. I am trying to make clear that I am not asking the Government to stop proceeding with the Bill; all I am asking them to do is to set out on a piece of paper the nature of their future association and relationship. The Front Bench keeps avoiding that issue. I do not use the words “associate membership”, I use the word “association”. I am willing to change it to “relationship”. What I am trying to get the Government to do is set out how they see their relationship with Euratom—because they have acknowledged that they will have a relationship with it in some way—and what that relationship will cover. If we could get some clarity from Ministers on that, we would not be having these endless discussions about the issue.

[Baroness Vere of Norbiton]

I thank the noble Lord for his intervention. I am on paragraph 11. I have many more paragraphs to go and I hope that in those paragraphs I will be able to keep him very happy indeed.

I understand and share the sentiment of wanting to maintain a close relationship with Euratom. The noble Lord, Lord Warner, mentioned this relationship and it could indeed include any of the things that he mentioned, but they are subject to the negotiations. However, we have already stated very clearly that the Government will seek a close and effective association as part of phase 2 of the exit negotiations with the European Commission. What we cannot accept is that the regulations must await a definitive outcome of talks which are by their nature uncertain in both timing and result. It is therefore vital that we continue to work to enable the set-up of a domestic safeguards regime, and to have ready the bilateral safeguards and nuclear co-operation agreements that we will need to function as a responsible nuclear state from day one of exit.

This approach will reassure the international community that the UK remains committed to nuclear non-proliferation, and will provide clarity to industry that it will continue to be able to move vital materials, parts and expertise once we leave Euratom. There can be no question of waiting until we know the outcome of the negotiations on our future relationship before we can put in place our own arrangements. The implications of not having the right systems operating from when Euratom safeguards arrangements no longer apply are too serious for industry and for our position within the international civil nuclear community.

[Lord Teverson]

Can we actually make this clear? I have not heard anyone in this Committee saying, “Please, Her Majesty’s Government, do not do anything until this thing is finished”. We are not asking for anything to be delayed, we are saying, “Please get on with it”, but we need some information on the way; we have to have some idea of the destination, and Brussels wants some idea of the destination by 22 March and then in October. If it does not happen, what are the contingency plans? We are not asking for anything to not happen now. I do not think the Minister understands that. Did I hear anybody say that?

--- Later in debate ---

[Baroness Vere of Norbiton]

I thank the noble Lord, Lord Teverson, for that interesting question. If it is okay, I shall write to him, because I should like to find out more information about what we are allowed to say at this time.

[Lord Warner]

I beg leave to withdraw the amendment.