CEO Update: Monday 6 August

UK Government has today published four guidance documents about how life sciences companies will be able to operate during an implementation/transition period.  They provide clarity from the MHRA about how they anticipate regulation will work during an implementation period. There will be an implementation period if the Withdrawal Agreement is finalised and approved, and an "exit deal” is agreed. They state that it “does not constitute legal advice and companies should seek independent legal advice dependent on their specific circumstances”.  The documents are:

• What the implementation period means for the life sciences sector
• Technical information on what the implementation period means for the life science sector
• Clinical trials regulation
• Medical Devices: UK notified bodies

Brexit continues to evolve.  We have long advocated for the UK’s continued engagement in Horizon 2020 and Horizon Europe 2021 post Brexit. The EuroScience Open Forum in July reinforced the desire of the European scientific research community for the UK to remain part of the initiative. The proposed rules for Horizon Europe 2021 include an intention to be more open to associate memberships, therefore signs are looking positive.  This would be a change from the membership the UK has enjoyed as part of Horizon 2020, but the ability to remain a part of collaborative research is news to be welcomed. Sam Gyimah, UK Science Minister, has been clear that the UK wishes to remain a part of the research community post-Brexit. The UK has also guaranteed to underwrite all payments to Horizon 2020 grant recipients until the programme finishes, regardless of the outcome of Brexit.

The European Commission launched a public consultation in May to gather stakeholders’ views on the EMA fee system. This included fees paid by industry for EMA activities relating to the approval and monitoring of medicines, as well as the remuneration to national competent authorities (NCAs) for the assessment of centralised marketing authorisation applications and performing regulatory services including pharmacovigilance at EU level. Findings will feed into a study, conducted by RAND Europe on behalf of the European Commission’s DG SANTE, to assess the extent to which the current EMA fee and remuneration system is cost-based, fair, proportionate and not unduly complex. BIA has worked in collaboration with EuropaBio to develop a consolidated response based on members’ input. You can read the response here.

In funding news, according to government budget allocations published on 2 August, Innovate UK’s annual budget will rise from £714 million in 2017-18 to £829m in 2018-19 and £906m in 2019-20. This means in two years’ time it will claim nearly 13% of UKRI funding, compared with just over 11% now. The Industrial Strategy Challenge Fund Wave 2 accounts for this increase. The BIA will be feeding into next year’s spending review, which will determine post-2020 budgets, making the case for increased investment in research and innovation, especially at this time of uncertainty due to Brexit.

The next round of BMC competitions goes live for applications today 6 August and will consist of a primer and late stage award, see here for more details. SMEs can apply for a share of up to £5M in the primer award competition, and a share of up to £10M in the late stage competition. The applications for both primer and late stage awards close on 3 October 2018. BIA members have had great success with the BMC in the past, and the BIA has long campaigned for the BMC, so it’s great to see it having an impact.

It’s also great to see that £2m in funding has now been made available by the UK Government, in conjunction with two corporate sponsors (and BIA members) Sanofi and GSK, to reduce the number of animals used in research. The Home Office published 2017’s statistics on animal research recently and trends show that the number of animals used is reducing year on year. Applications for the funding are due in November, and you can find out more about the project here.

In further positive news, I’d like to extend a warm welcome to new ABPI president Erik Nordkamp. Erik is a former Managing Director at Pfizer UK and will succeed Lisa Anson. Erik is passionate about transforming patient care and has spoken about his focus on improving access to medicines. He will be a great addition to the team at ABPI.