Glyn Edwards on BBC Breakfast

Last Friday the government finally announced its plans for an Early Access to Medicines Scheme and the introduction of a Promising Innovative Medicine (PIM) designation. I have discussed elsewhere that the proposals have some positive and progressive elements, some disappointing news and aspects which will require further detail. With this in mind, in partnership with the ABPI, we are will hosting a “one stop shop” half day explainer event on 28 April in London where the whole sector can hear the detail from the policymakers, and discuss how to make a success of this.

Also last week we published a report – “Very rare diseases, complex issues” – examining the future evaluation of ultra-orphan medicines in the UK. The research and development of treatments for rare and very rare diseases (orphan and ultra-orphan drugs), which affect 1 in 17 of the population, is a critical undertaking. Ensuring patients can access those new medicines is no less so. Given the high costs of developing a drug, and the very small patient populations found within the UK for any one rare condition how do we ensure equitable patient access at a cost that is acceptable to the tax payer? The report comes at a critical time, with the National Institute of Health and Care Excellence (NICE) – which now has the remit for evaluating very rare diseases (or highly specialised technologies (HSTs)) – preparing for a full consultation on how the new framework should look..

The Financial Conduct Authority (FCA) has outlined how it would regulate crowdfunding in the UK from April this year. In our sector, crowdfunding could offer the opportunity to create a more direct link between medical research and development and the ultimate end users. We continue to believe that the introduction of Citizens’ Innovation Funds (CIFs) would provide a tax incentive to support individuals’ investment into innovation in the UK. With the regulatory regime now established for crowdfunding, the policy debate should continue to examine how best to involve the public with UK innovation and the investment landscape looks set to evolve further.

This week we will watch the Chancellor’s Budget with interest and hoping that he addresses some of our calls. I plan to use my webinar on 27 March to inform members how the Chancellor’s decisions affect our sector.

The Labour Party has asked Mike Wright, Executive Director at Jaguar Land Rover, to examining how they can create the right environment for long-term growth in advanced manufacturing and related businesses in the UK. Mike is seeking evidence from a range of companies, individuals and organisations with experience of supporting, developing, operating, and investing in manufacturing in the UK. Last week I mentioned that the BIA, alongside ABPI, were supporting the Medicines Manufacturing Industry Partnership and I believe this work will be able to feed into the review. If you are interested in contributing to the BIA response please contact Rob Winder asap as the review closes this month.

It is great news to see that tomorrow Circassia will float on the London Stock Exchange in the UK’s largest biotech IPO. I hope this will encourage investors to take a look at the pipeline of innovative UK companies in our sector that are considering IPOs in the near future. EP Vantage has published an overview of the last year in pharma and biotech. Their report shows that last year was a good year for biotech marked by surging company valuations in the US and the opening of the IPO window. As well as increasing M&A deal values, buoyant licensing activity and sustained venture capital investment. It’s free so do read it.