When it takes an average of 17 years to develop an idea into a publicly available medical product, how can medical research charities show the difference they make?

This animation explains how charity-funded research can have an impact in one or more of five key areas: generating new knowledge, translating ideas into new products and services, influencing government policy, developing researchers, stimulating further funding and partnerships.

To find out more take a look at ‘Making a difference: Impact report 2017‘.

We’ve pulled together the best social media quotes, stats and comments from the BIA/MHRA conference which took place in London on Friday 14th July. Check out the event’s highlights here. #biamhraconference

Susie Middlemiss from Slaughter and May tells us about the latest developments in the creation of the Unified Patent Court and Unitary Patent system

The past few weeks have seen two significant developments in the process for setting up the Unified Patent Court (UPC). The UPC is a new litigation system established to enforce a new form of patent – the Unitary Patent (UP) – which will provide patentees with a single patent right enforceable across Europe. Before the new system can begin to operate, ratification of the UCP Agreement by the UK and Germany is required.

On Monday 26 June, the UK Parliament was presented with secondary legislation which is the final legislative step in the UK’s ratification process and will pave the way for the UK Government to formally ratify the Agreement. This step would appear to ease uncertainties which had developed following the Brexit referendum result and the General Election as to whether the UK would ratify the UPCA.

Meanwhile, the Chairman of the UPC Preparatory Committee confirmed in a statement that the opening of the UPC is likely to be delayed until early to mid-2018. This is significantly later than the original plan of having the court operational from December 2017. The delay is due to problems with ratification not just in the UK but also in Germany, where ratification has been postponed pending a judgment of the German Constitutional Court. There is little detail so far on the substance of this claim or the probability of its success.

Despite the delays and uncertainties, the current expectation is nevertheless that the UPC will come into operation within the next year and BIA Members should make preparations accordingly. Members should be aware that European patents and pending European patent applications will automatically be under the competence of the UPC unless an opt-out is registered by the patent owner. There will be a ‘sunrise period’ of at least three months prior to the opening of the UPC in which patent owners can register their opt-outs. Opting-out will protect the patent owner from an attack on their patent which could lead to it being lost across Europe. Whether the benefits outweigh the costs is likely to vary depending on the nature of each individual patent.

Patent owners should also be aware of the potential risk that the UK may leave the jurisdiction of the UPC following Brexit. The latest delays reduce the time available for when the UK could join pre-Brexit and could ultimately make it difficult for the UK to join which could have a knock-on effect on the viability of the system as a whole.

BIA members should seek advice on the best option for them. The BIA has also updated its guidance document to reflect the latest developments.

 

July is proving a busy month for the industry so far. Last week, the BIA was one of the signatories of an industry letter from UK and European bioscience trade bodies (AESGP, EFPIA, EuropaBio, Medicines for Europe, ABPI, BGMA, BIA and PAGB) to David Davis, UK Brexit Secretary and Michel Barnier, Chief EU Negotiator. The letter highlighted the importance of securing ongoing co-operation between the UK and the EU on medicines post-Brexit. In the letter, we argued that authorisations to market medicines should continue to apply for the sale of medicines in the UK and Europe following the UK’s departure from the EU. You can read more here (you will need a subscription to access the article). The full letter can be found on our website here. Our next Brexit Briefing Webinar is taking place on 19 July. You can register your place here.

We rounded off the week with the BIA/MHRA conference on Friday where it was great to see so many of you. Delegates heard from an array of expert speakers from across the industry on issues such as the Accelerated Access Review, personalised medicines and Brexit. Simon Stevens, Chief Executive Officer, NHS England opened the day and discussed taking medicines through regulatory approval, health technology assessment and faster adoption of innovative healthcare across the NHS for the benefit of patients. He credited the BIA as ‘the UKs thoughtful and impactful life science trade association’ and emphasised that the NHS is keen to work with industry to ensure patients get access to innovative treatments and outlined the challenges that the service faces in uptake of innovation.

Lord O’Shaughnessy, Parliamentary Under Secretary of State for Health, highlighted the government’s commitment to support and promote UK life sciences throughout the Brexit negotiations, outlining three key principles that must underpin any future relationship with the EU: first, patients must never be disadvantaged; second, the UK will continue to play a leading role promoting and ensuring public health – both in Europe and around the world; and third, industry must be able to get their products into the UK market as quickly and simply as possible, with the UK and Europe at the forefront of medical innovation.

The highlight of the day was Lord O’Shaughnessy’s announcement during his keynote address that innovative UK firms will benefit from a new package of support worth up to £86 million to help them develop real world medical breakthroughs that will help patients across the NHS.

These new building blocks for the UK life science innovation ecosystem will help UK small companies get their innovations into the NHS more quickly to benefit patients – something the BIA has long campaigned for. It will make the UK a more attractive location for starting and scaling life science businesses. Enabling smaller companies to access the Early Access to Medicines Scheme will be particularly helpful for small UK biotech companies. You can read more about Lord O’Shaughnessy’s keynote here and the government’s press release on the funding announcement here.

Hot off the press, we have just published our latest quarterly report ‘Influencing and shaping our sector’ which gives a round up of the work that the BIA has done for the sector in the second quarter of 2107. The report includes details of our work around Brexit, the government’s industrial strategy and raising the profile of the industry. You can read the full report here.

As the summer holidays approach, I’m sure many of you will be going away on holiday and I’d like to wish you a relaxing summer break. Looking forward towards the autumn, we have the UK Bioscience Forum on 12 October in London, and the Annual bioProcessUK Conference that will be held in Cardiff on 29-30 November. You can take advantage of early bird rates for the Forum here and for bioProcess here.

Grants can be an attractive option as they don’t always require repayments or equity stakes in return for funding. The eighth in our series of ‘Essential business tips’ looks at how to find the right grant for your business.

Tip 1 – Research your grant options
Tip 2 – Make sure you are eligible
Tip 3 – Prepare fully before applying
Tip 4 – Explore possible alternatives to grants

With the right combination of research, planning and determination, there’s every chance you’ll find a grant or suitable alternative to help you develop your business idea or grow your company.

NICE

Last Thursday, 40 senior representatives from the UK’s life science industry convened in London for the BIA’s seventeenth annual Parliament Day – a key day of engagement between BIA members and policymakers in Westminster and Whitehall.

Taking place less than a month after the snap general election and just two weeks after Brexit negotiations began, Parliament Day 2017 was an excellent opportunity for our members to engage with key figures from the new government and parliament and to make them aware of the sector’s priorities for Brexit and the upcoming Industrial Strategy and Life Sciences sector deal.

BIA’s report, Building something great: UK’s Global Bioscience Cluster 2016, published earlier this year, shows that financing of UK biotech remains strong. The UK retained its leading position in European biotech funding last year and has the strongest pipeline in Europe for future drug development. However, for the UK to become the third global bioscience cluster, closing the gap on Boston and San Francisco, this momentum must be maintained despite the current economic and political uncertainty. We provided each of the policymakers we met on Thursday with a briefing outlining how this could be achieved:

  • Prioritise public health and protect the sector in the ongoing Brexit negotiations. The BIA is seeking:
    • Regulatory cooperation with the EMA
    • Frictionless trade in goods and services
    • A quick, simple, consistent and cheap immigration system
    • Reassurances on EU funding
  • Deliver an effective Industrial Strategy and Life Sciences Industrial Strategy which supports SMEs
  • Achieve the ambitions of the Accelerated Access Review

Parliament Day 2

As well as attending various meetings throughout the day, our members also enjoyed a canapé lunch on the House of Lords Terrace, kindly hosted by Lord Willets.

Our thanks also go to specialist recruitment firm Ellwood Atfield, who very generously allowed us to use their gallery space, appropriately decorated with election paraphernalia, as our base for the day – an excellent location from which to access Parliament and Whitehall.

Given the unexpected outcome of the snap election, resulting in a Conservative minority government, the opportunity Parliament Day provides for BIA members to engage with backbench and opposition MPs, as well representatives from the Government, has renewed value. In total, our members met with 36 policymakers in 22 meetings on Thursday, strengthening the BIA’s relationship with key contacts across the political spectrum – a full list is provided below. The BIA will now follow-up with these contacts to make sure they are aware of the value of UK life sciences and are actively supporting the sector.

Civil Servants

Dr Ian Campbell Director – Health and Life Sciences Innovate UK
Dr Cheryl Case Deputy Director, International Team Department for Environment, Food & Rural Affairs
Kenny Chigbo Senior Policy Advisor: Science Workforce Department for Business, Energy and Industrial Strategy
Nicola Commander Senior Policy Adviser Office for Life Sciences
Tasha Niesen Senior Policy Manager Office for Life Sciences
Sir Andrew Dillon Chief Executive NICE
Ruth Froggatt R&D Tax Credits Policy Lead HMRC
Dr Hilary Glidden Chief Commercial Officer Life Sciences Organisation, Department for International Trade
Professor Sir Malcolm Grant Chairman NHS England
David Harris Patent Box Policy Lead HMRC
Lord Philip Hunt of Kings Heath Opposition Spokesperson for Health Labour Party
Jane James Patent Box Technical Lead HMRC
Holly Kelley-Weil Head of International Ecosystems Department for Environment, Food & Rural Affairs
Dr Zahid Latif Innovation and Supply Chain Specialist Life Sciences Organisation, Department for International Trade
Saira Madden Head of Investment Life Sciences Organisation, Department for International Trade
Dr Nicole Mather Director Office for Life Sciences
Wyndham North Head of Enterprise Investment HM Treasury
Professor Sir John Savill Chief Executive Medical Research Council
Dr Tony Soteriou Head of Research Infrastructure and Growth Department of Health
Joseph Spencer Policy Adviser: Enterprise Investment HM Treasury
Matthew Speers Chief Executive Officer Life Sciences Organisation, Department for International Trade
Dr Louise Wood Director of Science, Research & Evidence Department of Health
Tony Young National Clinical Director NHS England

MPs

Hilary Benn MP Member for Leeds Central Labour Party
Tom Brake MP Member for Carshalton and Wallington and party spokesperson on Exiting the EU and International Trade Liberal Democrat Party
Jo Churchill MP Member for Bury St Edmunds

And PPS to Jeremy Hunt MP

 

Conservative Party
Anneliese Dodds MP Member for Oxford East and Shadow Treasury Minister

 

Labour Party
George Freeman MP Member for Mid-Norfolk Conservative Party
Chris Green MP Member for Bolton West Conservative Party
Kit Malthouse MP Member for North West Hampshire Conservative Party
Rt Hon John Spellar MP Member for Warley Labour Party
Dr Philippa Whitford MP Member for Central Ayrshire and party spokesperson for health Scottish National Party

Peers

Lord Sharkey Chair of Association of Medical Research Charities
Lord Hunt o/f Kings Heath Shadow spokesperson for health
Lord Haskel Deputy speaker
Lord Willetts Chief Executive of Resolution Foundation and BIA board member

Parliament Day 3

Parliament Day 4

Parliament Day 5

Parliament Day 7

Parliament Day 3

Last week we saw the work the BIA has put into advocacy with partners around Brexit starting to pay off with some fantastic news for our sector as for the first time UK government ministers championed continued collaboration with the EU on medicine regulation post-Brexit. Signed by Health Secretary Jeremy Hunt and Business Secretary Greg Clark, the letter to the FT highlighted that in order to secure industry investment “the UK would like to find a way to continue to collaborate with the EU”. You can read their full statement on the BIA website here.

This is a very positive step for the industry and I would like to thank all members for their continuing support as we navigate Brexit. The UK Government publicly communicating its full commitment “to continuing the close working relationship we enjoy with our European partners” is good news for patients, industry and investors in the UK and EU. Industry has responded with our own letter to the FT signed by AstraZeneca, European Medicines Group, GSK, Pfizer, Eisai Co, ABPI and the BIA. You can read the letter here. For the latest news on Brexit you can join our next Brexit briefing webinar will take place on 19th July. You can sign up here.

There will be more discussion and, I hope developments on the future of medicines regulation this week, at our joint BIA/MHRA Conference on Friday titled “Innovation in Life Sciences in a Changing and Dynamic Environment”.

Taking place this Friday 14th July, the event will feature keynotes from the UK government minister responsible for the MHRA Lord O’Shaughnessy and NHS Chief Executive Simon Stevens as well as senior industry experts and leading speakers from the MHRA. Last chance to join what is proving to be an extremely popular and timely event with over 250 industry peers and colleagues. Register here. This is the conference of the year on one of the hottest topics of this Brexit year in our sector.  I hope to see you there.

Another success last week was our annual Parliament Day where the BIA and our members had valuable meetings with MPs and officials across government. The day offers a fantastic opportunity for ministers, lords and civil servants to get hear first-hand the key issues for our industry and to build greater awareness of the UK biotech ecosystem. Lord Willetts also hosted us for a lunch in the House of Lords. Following this successful event, it was great to see so many of you at our Summer Reception on Thursday evening. Held at the IET, Savoy Place, the reception provided a great opportunity to unwind, network and enjoy the fantastic views. Many thanks to John Brennan the new Secretary General of EuropaBio, who travelled from Brussels to meet many of you.

As we are still part of the EU, Enterprise Europe Network is holding an event on how to write a successful application for European funding on Thursday 13th July in London. Experts will be available at the event to provide practical advice and support on project ideas and provide guidance to those requiring more investment to undertake market feasibility and technical development projects. You can find out more and register your place here. (On this occasion, I’m also interested to hear from members who are not prioritising this funding route – do drop me an email – has Brexit changed the dial for you? or have EU funding mechanisms not matched your needs? Perhaps you are going in the other direction – these grants are easier to access and more relevant so you are applying for the first time – any feedback would be welcome).

The next round of Brexit negotiations begins next Monday and we will continue to work with partners in the UK and at European level to ensure that the industries concerns remain a priority for the UK negotiating team.


Professor Sir Mark Walport, Chief Executive Designate of UK Research and Innovation, has given a speech outlining the vision, objectives and next steps in development for the organisation.

The speech was introduced by Professor David Cannadine, incoming President of The British Academy, and Jo Johnson MP, Minister of State for Universities, Science, Research and Innovation.

UK Research and Innovation will be formed in April 2018, bringing together the Research Councils, Innovate UK and a new body, Research England. The organisation’s ambition is to be the best research and innovation agency in the world.

Richard Turner, who leads FTI Consulting Life Sciences practice, tells us about a new publication from the Medicines Manufacturing Industry Partnership showcasing the attractiveness of the UK for medicines manufacture.

The UK has created a very favourable tax environment for innovation and commercialisation. To help communicate this to potential investors in the UK, the Medicines Manufacturing Industry Partnership – a collaboration between the BIA, ABPI and government – has produced a Fiscal Paper setting out the case for the UK as the location of choice for Medicines Manufacture.

In the past, UK companies would locate elements of the supply chain across two or more territories in order to access more competitive tax rates and incentives.  The UK tax landscape has changed in recent years to present a much more compelling case for retaining the entire supply chain from development through to manufacture in the UK.  The tax benefits include:

  • Tax rates – The current corporation tax rate is 20% regardless of the size of the business and will reduce to 17% by 2020.
  • Patent box – Tax on profits attributable to qualifying patented technologies is reduced to 10%.
  • R&D relief  – Available to all companies undertaking qualifying R&D activities inc manufacturing for clinical development
  • Tax losses – These can be carried forward indefinitely and offset against future profits and therefore shelter taxable income arising after product launch.

There can be further efficiency through the lower cost of compliance with reduced cross border transactions and product flow.

More recently, the US administration has issued proposals to improve its tax competitiveness given its headline federal tax rate of 35%.  At the time of writing, it is understood that the original proposals are likely to be diluted if and by the time they are legislated and that the overall package is likely to be tax neutral.

In summary, not only should a UK company which develops and manufactures in the UK enjoy a long term effective tax rate of 11%-13% it will receive substantial R&D tax credits along the way of up to 33p/£. For further details please see the MMIP’s Fiscal Paper with a more concise summary in the Fiscal Guide.​

I’m looking forward to seeing many of you at Parliament Day and at our Summer Reception on Thursday where I know your expertise and face time with policy makers will enhance the associations ability to influence in the corridors of power.

Following our trip to San Diego for BIO, last week featured more travel for me as I started the week attending the excellent AstraZeneca Exchange event in Cambridge, before travelling to Brussels for EuropaBio’s National Association Councils and Board meetings. As Brexit negotiations get underway, it is more important than ever for us to continue constructive dialogue with our European partners and I was glad to be able to put across our latest thinking to the other EU member states present. I was also glad to be able to meet with John Brennan, the new Secretary General of Europabio, and I’m delighted that he’s accepted my invitation to join us at our Summer Reception this week – do please introduce yourselves and make John welcome. If you’ve not booked It’s the last opportunity to book so do get registered for what looks set to be a great evening.

Brexit inevitably dominates policy discussion, but the early focus the sector has given to what type of Brexit is required to ensure minimal disruption and maximum opportunity is certainly paying off. It was a key agenda item at last week’s Ministerial Industry Strategy Group, which was well attended at both Secretary of State and Ministerial level across the Department of Health and the Department for Business, Energy and Industrial Strategy. This week I am also attending the John Bell’s Life Sciences Industry Strategy Board meeting, which also present a great opportunity to influence a robust Industrial Strategy for our sector, now more important than ever in the context of Brexit.

Parliament Day has a packed schedule of meetings with Ministers, Parliamentarians and key officials for us to voice our views on Brexit and other key issues. The shape of the new government is coming into focus with Ministerial responsibilities now mostly confirmed. Check out our new guide to the government for more detail at: http://www.bioindustry.org/document-library/bia-guide-to-the-government/. Last week saw key Queens Speech votes in parliament – which ensures we are not facing the prospect of an immediate election, but did confirm that Jeremy Corbyn would 3 line whip his Labour MPs to vote down an amendment backing staying in the EU single market. Fifty Labour MPs defied Jeremy Corbyn’s orders and backed single market membership in a vote on Thursday, including Cambridge MP Daniel Zeichner, who left the shadow Labour team and returned to the backbenches as a result.

The latest MMIP newsletter has been released and you can read the text on the BIA website.

Finally, I wanted to update you on some significant news here at the BIA. Laura Collister has accepted a new role at the BIA as Brexit Lead. This new role reflects the strategic importance of Brexit to the BIA and Laura will lead, develop and implement a comprehensive strategy for Brexit including advocacy, campaigns and issues management as well as devising and leading significant member communications across all channels. Laura has already been leading on this issue for the BIA for the last year whilst providing maternity cover for Pamela Learmonth. Pamela has recently returned from maternity leave and with Pamela back in post as Director of Public Affairs and Communications and Laura continuing at the BIA as Brexit Lead, I am confident that we have a strong team in place to represent your interests at a critical juncture in UK politics.

Best,

Steve