Patents (Amendment) (EU Exit) Regulations 2018

Baroness Vere of Norbiton Excerpts

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.