Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 - Motion to Approve

Part of the debate – in the House of Lords at 2:30 pm on 7th March 2019.

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Photo of Baroness Manzoor Baroness Manzoor Baroness in Waiting (HM Household) (Whip) 2:30 pm, 7th March 2019

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.

Motion agreed.