q3-2016-updateSince our last update in July there have been a number of major developments in life sciences policy and in politics more widely. In this edition we have provided a key section focusing on Theresa May’s Government, Industrial Strategy and Brexit, and we also celebrate the Chancellor’s commitment to re-fill the Biomedical Catalyst scheme – a very welcome result after years of advocacy by BIA and our members!

Download the report in full here, and read on for a summary of the key topics covered in this edition.

The May Government, industrial strategy and Brexit – The last few months have seen significant change in the political landscape following the outcome of the EU Referendum. We now have a new Prime Minister, new Government, new Whitehall department and a new policy focus. Our latest update examines the work of the UK EU Life Sciences Transition Programme including next steps, BIA engagement with the newly re-structured Government, the renewed focus on industrial strategy and how it links to Brexit, and medicines regulation in the context of the UK leaving the EU.

Commitment to refill the Biomedical Catalyst – The Government has committed to fund the Biomedical Catalyst for the rest of this Parliament following a long-fought campaign by the BIA. The Chancellor, Philip Hammond MP, used his speech at the Conservative Party conference on 3 October to formally announce the £100 million investment in life science companies. The Government said in a statement that the BMC will provide grant support to ensure that “emerging disruptive healthcare technologies in disease prevention, earlier diagnosis and tailored treatments are delivered to market”. The programme will offer funding in 2017, 2018, 2019 and 2020 to support varying stages of technical and commercial development from feasibility studies through to proof of concept and early clinical trials.

Party conference insights – The BIA had a presence at four political party conferences this year. We hosted private roundtable meetings with the Conservatives and Labour and attended the Liberal Democrats and Scottish National Party conferences. The focus of the roundtable meetings was on maintaining the UK’s world-leading position in the life sciences after Brexit. As in previous years, the BIA partnered with the AMRC, BIVDA and ABPI to deliver the events and invited a range of stakeholders from academia, the NHS and our memberships to meet with MPs and policy makers. Our update also covers the key announcements from the conferences for the life science sector.

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UN report on global access to medicines and landmark declaration on AMR – The United Nations (UN) published a report on access to medicines written by a high-level panel of experts. The International Council of Biotech Associations, of which BIA is a member, published a response to the report which you can read in full in our update. It was also announced at the United Nations General Assembly that 193 countries had signed a landmark declaration agreeing to combat antimicrobial resistance as a matter of priority.

PRIME scheme six months on – The BIA has played an active role in influencing the development of PRIME, representing the views of member companies. As of 6 October 2016, 64 applications to the EMA’s PRIME scheme had been received. We have seen high levels of interest in PRIME from BIA member companies and we are pleased that a number of our members’ products have been accepted onto it.

Adaptive pathways: where are we today? – On 3 August the EMA published a final report on the experience gained during its pilot project on adaptive pathways. The EMA received 62 applications with oncology accounting for a third of the total submissions; 18 were selected for in-depth face-to-face meetings with the participation of other stakeholders. At the end of the pilot, six applications had progressed to parallel regulatory HTA scientific advice and one to scientific advice with EMA. The EMA will now explore the adaptive pathways approach further in the context of parallel scientific advice with HTA bodies – more details in our update.

Download Influencing and shaping our sector: BIA update July – October 2016 for details on the above topics and more.

lobbyingTo learn more about BIA’s policy, public affairs and regulatory affairs work, see our previous quarterly policy updates, our consultation responses, or email Martin with any questions.