CEO Update | 21 March 2022

IP Trips Waiver compromise proposed at the WTO

Many of you will be aware that there have been reports this week from the World Trade Organisation in Geneva that the EU, South Africa, India and the US are agreeing a compromise on the waiver of intellectual property rights on COVID-19 vaccines.  The key part of the compromise would be that developing countries that have exported less than 10% of the world’s vaccines in 2021, (so India but not China) would be able to authorise the use of a patented coronavirus vaccine without the patent owner’s consent. I have been liaising with international colleagues through the International Council of Biotech Associations (ICBA) to understand the detail of the compromise and where best to influence.

My view on the proposal is that, if agreed, will have a chilling impact on investment into the small companies that have been at the heart of the solutions to COVID-19. It would do nothing to solve the challenges we face in 2022 and make it far harder for small companies pioneering in this space in future.

Small biotech’s, including, for example, companies such as Canada-based Acuitas Therapeutics, BioNTech from Germany and the UK’s Vaccitech, all depend on their intellectual property to deliver key innovations that underpin the current generation of COVID -19 vaccines. Alongside these successes there are many, many companies in our community that invested heavily and failed to make breakthroughs. This proposal directly threatens this innovative ecosystem’s ability to attract the capital needed to develop next generation of vaccines whilst doing nothing to solve the access challenges we have in 2022.  

 The reported proposal misguidedly casts IP as a barrier to COVID-19 vaccine access and distribution despite there being abundant supply of COVID-19 vaccines given the collective manufacturing globally of over 11 billion doses in 2021. Weakening IP rights does nothing to facilitate the distribution of these manufactured vaccines to people around the world who most need them – rather prioritizing addressing healthcare infrastructure and vaccine hesitancy in the developing world would lead to more shots in arms. It’s vital the UK maintains its principled position as a full member of the WTO on this subject – especially as we no longer contribute via the EU to this process and have not been party to the development of the proposal.

R&D tax credits ahead of the Spring statement

A few weeks ago, there were reports in the Financial Times (£) about possible cuts to SME R&D tax reliefs.  A letter signed by 100 BIA member companies has helped us engage with government at the highest levels on this. While the content of the Chancellor’s statement on Wednesday is closely guarded, I would be highly surprised to see cuts to the SME R&D tax credit scheme announced this week, but this is an issue the BIA will continue to engage in.  If you would like further information on our campaign please contact our Head of Policy and Public Affairs, Dr Martin Turner.

BIA submission to the MHRA consultation on proposals for legislative changes for clinical trials

This consolidated BIA response was developed with input from our Regulatory Affairs Advisory Committee and submitted using the online survey providing our comments in response to questions raised in the MHRA consultation document on proposals to update the current UK clinical trials legislation, the Medicines for Human Use (Clinical Trials) Regulations 2004, as amended. Thanks to all who inputted for your expert insight. This process will provide the opportunity to design an outward looking, world-class regulatory environment for clinical trials to support the development of new innovative medicines and ensure that the UK retains and grows its reputation as world leading base for life sciences, in line with the ambitions of the Life Sciences Vision.

EMA Management Board elects new Irish chair

The management board of the European Medicines Agency has elected Lorraine Nolan as its new chair for a three year period. Many BIA members will remember Lorraine giving the keynote speech at our joint Regulatory conference with the MHRA in 2019 as the Chief Executive of the Irish Health Products Regulatory Authority, and it’s great to see someone with expert insight into the challenges of Northern Ireland and with a strong working relationship with the UK sector taking up the role.

Feedback from PULSE

Our annual programme for up-and-coming life sciences entrepreneurs took place last week, marking our fifth year of PULSE. A selective cohort of aspiring entrepreneurs and first-time CEOs were invited to the Francis Crick Institute for an intensive three-days of workshops, talks and interactive exercises, interspersed with networking opportunities with experts and investors from our BIA community. This programme continues to provide a fantastic platform for attendees to practise relevant skills, share ideas and build connections with industry experts and their peers alike. The BIA innovation map is there to support the next generation of life science entrepreneurs, please take a look and we welcome feedback to help us expand and improve this vital tool.

Shared Commitments’ set out priority actions for genomics initiatives across the UK

The UK government, Welsh and Scottish Governments and Northern Ireland published on Friday a series of commitments to improve outcomes for patients through better genomic testing and access to clinical trials. The new Shared Commitments for the first time set out priority actions across the UK and are part of wider plans to improve healthcare through genomics - the study of genes and DNA. David Atkins, the BIA’s representative on the National Genomics Board, said: “SMEs are a vital part of the UK’s existing strength in genomics. Fostering the right environment and developing a workforce for these companies is key to achieving the ambition of Genome UK.”

The invasion of Ukraine remains the pressing concern in many conversations I have with members. Common issues arising include how best to support humanitarian efforts, business continuity and supply concerns, and how the operation of sanctions will affect companies. Most companies have their own plans in place, but I am interested to learn if members see value in a sector wide sharing of thinking on this most difficult of issues. As ever member feedback will guide my thinking.

 

 

Steve Bates OBE
CEO, BioIndustry Association

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