CEO Update Monday 5 November

This week I am heading to Hong Kong and then Shanghai in China. Hong Kong stock market rules have recently changed making it easier for pre revenue companies to list on its stock market. I am exploring there how we can jointly build the life science analytical capability needed for global liquidity - and make dual listing - or similar - a practical reality for UK companies seeking investment.  This trip is the centrepiece of the BIA’s ramp up of engagement East in 2018. Building on our China Special Interest Group we are seeking to increase the number of UK biotech companies collaborating with, generating revenue from, and receiving investment from the Chinese market. Next week I’ll be leading a group of members on a delegation to the Biocentury Shanghai summit to promote UK science to Chinese companies and investors to encourage further collaboration between the UK and China.

Also this week we have members of the BIA team at BioEurope in Copenhagen – do go and visit them at the UK stand if you are there.

On Brexit the BIA and ABPI submitted a joint submission in response to the MHRA and DHSC consultation on no deal contingency legislation for medicines and devices regulation for the UK. The MHRA and DHSC consultation seeks views on how the MHRA’s legislation and regulatory processes would have to be modified in the event of the UK not securing a deal with the EU after the UK’s exit, with no Implementation Period. It covers no-deal proposals on medicines, clinical trials and medical devices and the BIA and ABPI believe this is a pragmatic response to a no deal scenario. However, I want to emphasise that a no deal Brexit would lead to double red tape for life sciences companies wanting to operate in the UK and EU. Although the measures outlined in this consultation would help to deal with the practicalities of a no deal Brexit, industry is concerned that there are only 150 days for the statutory instruments to go through both houses of the UK parliament. Time is tight and any delay could leave companies in legal limbo. There are no measures in the consultation to replace existing incentives for innovative biotech companies currently in EU legislation – this would make the UK less attractive than the EU for companies wanting to launch orphan drugs. The BIA and the ABPI continue to have a constructive dialogue with the MHRA and government on those issues. We will progress the issues of concern highlighted in this consultation document alongside our broader advocacy and engagement work on impacts on the sector from the UK’s exit from the EU.  You can read more on the BIA website.

For UK life sciences, the Autumn Budget was short on big announcements but packed full of nuanced measures that could have a significant impact on BIA members. You can read more on all the key announcements on the BIA blog. With the Brexit negotiations it is hard to predict what’s next, but the Chancellor and many others hope this was the last Budget before we leave the EU. However, in his Statement, the Chancellor did reserve the right to upgrade the Spring Statement to a full Fiscal event if necessary. A number of measures in this Budget also require further engagement with government on and responses to consultations, which will be led by the BIA’s Finance and Tax Advisory Committee. If you have any questions or comments about anything above, please do not hesitate to contact us – [email protected].

Last week the Cell and Gene Therapy Catapult published the outputs of the workshop we co-hosted with them and ABPI in September. The aim of the workshop was to explore how the recently established Advanced Therapy Treatment Centres will work as a national network to overcome barriers to the adoption of cell and gene therapies in the NHS. Topics covered include procurement, manufacturing scale-up, supply chain issues, frontline delivery to patients, health economics and reimbursement. Check out the event summary for a full list of actions stemming from the discussion or the Cell and Gene Therapy Catapult’s highlights video for an overview of the event. You can also find out more about the network of Advanced Therapy Treatments Centres on their website, also launched this week.

Finally, the BIA has been granted permission to intervene in a Supreme Court case that we have concerns could have a wide impact on our sector. In our submission we’re arguing that medical innovations should be patentable irrespective of how the invention is made. Thank you to Fieldfisher and the other members of the BIA IP Advisory Committee for helping with the submission. See our press release for more information.