Human Medicines (Amendment etc.) (EU Exit) Regulations 2019

Lord Warner Excerpts

Thursday 7th March 2019 Lords Chamber

Finally, in last week’s debate we heard from the noble Baroness, Lady Cumberlege, the chair of the Government’s Independent Medicines and Medical Devices Safety Review, about the review and its work so far, talking to patient groups about their concerns and experiences. The review was welcomed by noble Lords and is due to report this year. How will these new arrangements be considered by the review?

[Lord Warner (CB)]

My Lords, I want to start by providing the House with a few vital statistics on these three life sciences statutory instruments. On my bathroom scales this morning, they weighed in at a little over 2 kilograms. There are 416 pages of statutory instrument and 132 pages of explanatory memorandum, including impact assessments. There are now just 22 days for those working in the life sciences industry to understand how they might be affected by these SIs if our beloved Prime Minister inadvertently drives the Brexit car over the cliff on 29 March. The one thing that I can congratulate the Government on is that the MHRA has done its best to consult the industry on these SIs and has done a reasonably professional job on risk assessments. I want to concentrate on the first two SIs, although I share many of the concerns about all the SIs voiced by the noble Baroness, Lady Wheeler.

No doubt the Minister, like other Members of your Lordships’ House, has read every page of these documents. I make no such claim, but I have tried to understand the impact assessments and have had the benefit of some very helpful briefing from the industry, especially the BIA.

It is very clear that, despite the expertise and professionalism of the MHRA and the industry, they have been left with ludicrously little time to master a massive amount of new detail and system change, particularly as many of the companies in this sector are SMEs. These SIs create a great deal of additional red tape and running costs. They have already taken funding and resources away from research and development, and, as the impact assessments show, this will continue into the future.

I start with the clinical trials statutory instrument and the assurances given by the noble Lord, Lord O’Shaughnessy—an ex-Minister for whom I have great respect and who has wisely removed himself from the scene. In a speech that he gave in July 2017, he said:

“In the event that it is not possible to reach a deal that secures ongoing, close collaboration between the UK and Europe, we will set up a regulatory system in the UK that protects the best interests of patients, and supports industry to grow and flourish. We will ensure that our system is robust, efficacious and does not impose any additional bureaucratic burdens”.


Fine words, but what we have before us today fails to meet those three guarantees that the noble Lord, Lord O’Shaughnessy, gave on behalf of the Government back in the heady days of July 2017.

Regulation 18 of the clinical trials SI will add another layer of red tape and runs totally counter to what I will call the “O’Shaughnessy assurances”. Specifically—here I quote the BIA briefing:

“Industry does not understand the need for the requirement for an additional UK-based quality assurance system to verify QP certification of investigational medicinal products (IMPs) imported from EU/EEA countries on the approved country list given that the clinical trial sponsor is responsible for ensuring the integrity of the IMP supply chain”.


Therefore, it is saying to the Government, “You’ve introduced something which is not necessary”.

It gets worse. I am told that the August 2018 government technical notice on the batch release of medicines and IMPs stated that the UK would unilaterally recognise EU batch release for IMPs. Therefore, despite the assurances given to the industry in 2017 and 2018, the Government have now added a new layer of red tape that will reduce the benefit for the sector of that batch release recognition. This, in turn, will impact adversely on the attractiveness of the UK as a location for clinical trials. Perhaps the Minister can explain to us and to the industry why there has been this last-minute change of policy.

I now turn to the human medicines SI and will address, first, the issue that I raised during debate on earlier SIs in Grand Committee—the start date for market exclusivity. It is proposed that market exclusivity will start on the date of authorisation of the drug in the EU or in the UK, whichever is earlier. The Government claim that this will encourage companies to submit applications for innovative products to the UK as soon as possible. The BIA says something different. It says that many of its members take a totally different view from that of the Government and that that will delay market authorisation in the UK, thereby reducing company revenue because of a shorter period of exclusivity. This would also reduce the access of UK patients to innovative medicines. Perhaps the Minister can say why the industry’s view has been rejected by the Government.

The impact assessment on this SI very honestly sets out a raft of reasons why a separate UK regulatory system will increase the costs of securing UK market authorisation for new drugs. These are not my words; they are in the impact assessment. The cumulative effect of these duplicated costs on pharmaceutical companies is likely to be considerable, as the MHRA makes abundantly clear. The assessment goes on to say:

“It is likely manufacturers would seek to recoup these additional regulatory costs through price increases, which would affect NHS budgeting and spending choices”.


The assessment also cites independent analysis suggesting that there could be delays in new, innovative medicines coming to the UK market once the UK has legislated to become a stand-alone regulator.

--- Later in debate ---

[Lord Warner]

The Minister does not need to convince me; she needs to convince the industry. It is simply not convinced by the changes that have been introduced. These are the companies earning their living in this sector day to day. The Government have a lot of work to do to try to convince the industry that they have not damaged the exclusivity period for many of these biotech companies. They are the people who have done the briefing on this and the Government—not the Minister personally—have failed to convince them, just as they have failed to convince them by going back on the kind of assurances about no more bureaucracy that the noble Lord, Lord O’Shaughnessy, gave to the industry in July 2017.

[Baroness Manzoor]

My Lords, I would like to think that I am trying to convince the noble Lord as well as the industry. I reassure him that we work closely with industry and take its views seriously. As I was saying, maintaining the start of data exclusivity as the date of first authorisation in the UK or EU should incentivise parallel applications to the EU and UK and thus help to mitigate any risk of delays in innovative products being brought to the UK for licensing. This is an appropriate way to address, through the powers in the EU withdrawal Act, something that would otherwise present a risk to public health in the UK. However, we have committed to reviewing this position and of course we will continue to work with industry on this issue.

There were a number of other questions; I will go through those very quickly to ensure that I have not missed anything. The noble Lord, Lord Warner, and the noble Baroness, Lady Wheeler, asked what assessment of impact on EU researchers and clinical trials there will be. The Government recognise the need for accessing highly skilled researchers and the clinical trials research delivery workforce. The Government have published our immigration White Paper and are working with stakeholders to ensure that, after exit, the system will support researchers and clinical trials. Of course we recognise that the clinical trials research delivery workforce is important.

I have a brief note on the comments from the noble Lord regarding industry. As I said in my opening comments, it is a priority for the Government to ensure that the UK continues to be a competitive destination for life sciences companies from around the world, in any Brexit scenario. The Government are committed to maintaining our world-renowned strength in science and research and plan to increase R&D expenditure to 2.4% of GDP by 2024. Since the referendum, we have seen many signs of industry’s continued confidence in the UK. In 2017, we received the highest level of life sciences investment in Europe, and worldwide were second only to the US. In the same year, UK biotech initial public offerings raised twice as much money as in 2016. That is a strong vote of confidence.

I end by stating very clearly that the effect of these three sets of regulations is to ensure continuity in the area of medicines, medical devices and clinical trials in a no-deal EU exit. The department has sought to minimise any disruption to patients and industry; to make sure that UK regulators can still protect public health; and to ensure that the UK’s life sciences sector contributes, and continues to be a world leader in clinical research and the pharmaceutical sector. This legislation does not prevent future changes we may wish to make to ensure that the UK maintains a competitive regulatory environment and remains one of the best places in the world for science and innovation. With the assurances I have given, I hope that the House will approve these important SIs. I commend them to the House.