CliveDix_600300

In a new format to our usual Annual Lecture, last Thursday’s “An Evening With Clive Dix” was a fantastic opportunity to hear from one of our sector’s great entrepreneurs. Interviewed by his long term colleague and friend Brenda Reynolds, our very own Piers Morgan for the evening, it was great to hear Clive give a candid review and insight into his career in the industry – it’s one occasion where I have to say you needed to be there to get the insight, as a closed door event with no reporting led to a frank and personal perspective being openly shared. We think it worked as a format and look out for further events like this in future.

Two key policy events to look out for this week. The Queen’s Speech this Wednesday will announce the key pieces of legislation we can expect over the next couple of years. A higher education bill has been widely-trailed in the newspapers this morning and will include provisions to allow the creation of a new body to oversee the Research Councils and Innovate UK. The new body, expected to be called UK Research and Innovation (perhaps a clue about whether the plan is to roll Innovate UK into the new body), is intended to provide greater coordination between research funders but a Government statement says that they will maintain their identities and delegated budgets. A white paper setting out more detail has been published today and we will engage these developments over the coming months on the sectors behalf.

Jim O’Neill’s Review on Antimicrobial Resistance is expected to be published on Thursday. BIA members from large to small have been actively engaged in the policy making process here and I expect to see continued comment from all sides on the final report. It’s good to see UK policymakers and companies playing a leading role in shaping a globally vital discussion that will move swiftly to the World Health Assembly and Organisation and G20. We are particularly interested in developing new incentive models for drug discovery and development and it seems likely the review will suggest delinked incentives, pay or play provisions and priority review vouchers as models to be explored.

Information on the Early Access to Medicines Scheme including its principles and operational guidance developed by the stakeholder task group was published last week. You can download the document, ‘Early access to medicines scheme (EAMS): how the scheme works’, here. EAMS was one of the key topics discussed at our recent BIA MHRA joint conference – pictures from the day are now up on the blog along with a brief summary of the highlights, which you can visit here.

The European Medicines Agency (EMA) has published a report summarising the experience with its small and medium-sized enterprise (SME) initiative over the last ten years. It’s great to see that in terms of geographical distribution the UK remains the top country in Europe for SMEs from 2011 to 2015. It’s a key reason why it is important the Agency remains in London and continued to engage with the BIA and its members.  The initiative started in December 2005 when the SME Regulation came into force and the SME Office was established to address the needs of the smaller businesses in the pharmaceutical development ecosystem. To support SMEs throughout all stages of medicines’ development, EMA’s SME Office provides active regulatory, financial and administrative support to registered SMEs. The new report emphasizes the importance of SMEs in pharmaceutical innovation and draws attention to the trends observed in the past ten years.

On events, there’s now just over a week left to register for the 8th European Conference on Rare Diseases & Orphan Products (ECRD 2016), taking place in Edinburgh from 26 – 28 May 2016. The ECRD, organised by the European Organisation for Rare Diseases (EURORDIS) and co-organised by the Drug Information Association (DIA), unites all stakeholders of the rare disease community across all rare diseases and countries: patients, healthcare professionals and researchers, industry, payers, regulators and policy makers. ECRD 2016 will bring together over 80 speakers and more than 800 participants, covering six themes from the latest research, to developments in new treatments, to innovations in healthcare, social care and support at the European, national and regional levels. Find out more here.

Finally, last Friday marked the 2nd anniversary of the launch of the Concordat on Openness on Animal Research. I’d recommend taking a look though #ConcordatOpenness for some fantastic examples of the work being done by the UK bioscience community to maximise openness and communication on this important issue. A great result and effort over the past two years.

Best

Steve