gauke-abzena_600_300Scotland’s key decision last week to stay as part of the union provides a stable foundation for ongoing research and business development in the biotech sector, and has been welcomed by members from across the UK. The vote removes previously articulated worries regarding funding for the UK bioscience research community as well as application of UK wide drug regulation and licensing. However, a vote for no is not a vote for the status quo. Now the devo-max plan will be implemented; the first step will be a Parliamentary debate introduced by former Prime Minister Gordon Brown MP, followed by the introduction of a Draft Scotland Bill in the new year. We’ll monitor progress of these developments to inform on implications for the sector. Tax incentives and rates for SMEs will be our first focus.

I’m delighted to tell you that we’ll be welcoming Treasury Minister Financial Secretary David Gauke MP to open our UK Bioscience Forum on 7 October 2014, taking place during European Biotech Week. The Minister’s speech and Q&A will be timely following our response last week to the Treasury’s consultation on tax-advantaged venture capital schemes and how they can best support growing businesses.

Not only is Mr Gauke the lead Minister for the key finance and tax issues that impact biotech businesses, but through recent site visits to BIA member companies such as Horizon Discovery and Abzena (pictured above) he has demonstrated his personal interest in and commitment to the sector. As HM Treasury considers how underlying tax regimes might change, this is a great chance to engage with government on how the fiscal framework can best support innovation and investment. Come to along to the UK Bioscience Forum and put your questions to him yourself.

With the political party conference season over the next few weeks the BIA team will be on the ground ensuring we can gather real-time insight on what policy will matter to our sector, as well as ensuring all the parties understand what makes a difference to members. We will be back in touch after the season to give you the low-down.

I was also delighted also to see that the MHRA have issued their first Promising Innovative Medicine (PIM) designation under the Early Access to Medicines Scheme (EAMS) we have worked to deliver for the sector. It’s been issued to US based company Northwest Bio. This could present the opportunity for UK patients to be amongst the first in the world to be offered personalised immune therapy for brain cancer and shows that the EAMS helps to attract clinical development to the UK. This also shows that it is open to all, and hopefully this will be the first PIM of many. On the European front, the Adaptive Licensing pilot project is also moving in the right direction. In the last couple of weeks the EMA confirmed that it has received and assessed 26 applications as part of its adaptive licensing pilot project. Seven of these have been selected for further discussion with the application. This news came as the EMA also published a useful Q&A document on the scheme. We anticipate a review from the EMA by the end of this year, after which the next steps will be set out.

For those of you interested in antimicrobial resistance (AMR) it was interesting to see US President Obama launching his multi-strategy attack on antibiotic resistance. The administration also is putting up $20m in a competition for the development of a rapid, point-of-care diagnostic test for healthcare providers to use to identify highly resistant bacterial infections. Like seeing the beginnings of speedy clinical trials for Ebola, it puts a spring in your step when action is taken to start tackling really important global challenges. And it was good of Professor Adrian Hill, Director of the Jenner Institute at the University of Oxford, leading the clinical trial application for the new Ebola vaccine, to put on record what the regulators were able to do – “What the MHRA did was remarkable. They were superbly efficient in fast tracking the approvals for this clinical trial, turning it round in under four days. It was crucial in being able to respond quickly to the great need seen in the Ebola outbreak in West Africa”.

Finally thanks to those of you who sponsored me as I did the 18 mile Carrots Nightwalk on Friday night for our charity partner of the year, Fight for Sight – it’s not too late to make a donation for this great cause. I’ll bring some pics of the event to the UK Bioscience Forum and look forward to seeing you there.

Best,

Steve