BSI Policy & Public Affairs Update
6 August - 14 August
A number of companies and societies raise concerns over medicine stockpiling
As reports come in about the possibility of a no-deal Brexit – whereby the UK leaves the EU without a finalised trade or customs deal – multiple pharmaceutical companies such as Sanofi, Pfizer and Astra Zeneca, as well as the NHS, have revealed they are stockpiling medicines in order to ensure their availability following the UK exit from the EU in March.
In response to these reports, the Royal Pharmaceutical Society has released a statement concerning the availability and stockpiling of medicines imported from the EU.
President of the RPS, Ash Soni, said:
“Patient health is paramount and we agree with the Government that patients in the UK and across the EU should continue to be able to access the best and most innovative medicines.
“Without a negotiated deal, risks of the UK’s withdrawal from the EU include delays in patients accessing medicines, a concern widely recognised across the healthcare sector.
“With some medicines manufacturers now talking about contingency plans to stockpile medicines in the absence of a negotiated deal, we are engaging with regulators and the NHS about their plans to minimise any potential disruption to the medicines supply chain.
EMA to further temporarily scale back and suspend activities in preparation for Brexit
The European Medicines Agency (EMA) has announced that it will release the next phase of its ‘Business Continuity Plan’ by 1 October 2018. The plan outlines reductions in key activities in order to cope with significant staff losses following its move from the UK to Amsterdam in March 2019, whilst safeguarding its ability to evaluate and supervise medicines.
Reduced activities include:
Collaboration at international level: this will be temporarily scaled back to focus primarily on product-related requests and supply-chain integrity.
Development and revision of guidelines: these will be temporarily limited to those guidelines that address an urgent public/animal health need or are necessary to support and facilitate preparations for Brexit;
Holding of non-product-related working parties: this will be temporarily reduced as a consequence of the scaling back of guideline development or revision.
Programmes and projects: activities in relation to project governance will be reduced in line with the reduction/suspension of projects.
Organisation and attendance at stakeholder meetings: these will be limited to Brexit-related interactions.
Clinical data publication: the launch of new procedures will be temporarily suspended as of 1 August 2018.
New allergy-prevention guidelines for infants
The British Society for Allergy & Clinical Immunology (BSACI) Paediatric Group and the Food Allergy Specialist Group (FASG) of the British Dietetic Association (BDA) have released new guidelines to UK Healthcare Professionals on preventing food allergy in higher risk infants. The guidelines are based upon recent recommendations from Public Health England’s Scientific Advisory Committee on Nutrition (SACN). These recommendations are:
Babies should be exclusively breastfed for around the first six months of life
Solid foods can be introduced at around six months
Foods containing peanut and hens' eggs can be introduced at six months because delaying this might increase the risk of food allergy
The new guidelines include the advice to introduce potentially allergenic foods into the infant diet in order to reduce the risk of the development of a food allergy.
Science Minister publishes annual investment in research and development figures
In line with the Industrial Strategy’s aims of increasing Research and Development (R&D) spending to 2.4% GDP by 2027, Science Minister Sam Gyimah MP, has published the annual Allocations Booklet which highlights the biggest ever increase in R&D funding in 40 years. The publication outlines how increases in R&D funding has been allocated to:
UK Research and Innovation (UKRI)
The UK Space Agency
Public Sector Research Establishments
Science Minister Sam Gyimah said:
“We want the UK to lead on new ideas and technologies and have committed to supporting our businesses and world-leading innovators by taking measures to ensure 2.4% of GDP will be spent on research and development by 2027.
The publication of the Allocations Booklet spells out how we will ensure the benefits of this funding is felt across the science, research and innovation landscape; paving the way for disruptive businesses, entrepreneurs and researchers to flourish, boosting our economy and creating the high-value jobs of tomorrow”.
HM Treasury announces £780m backing for British innovation
The Chancellor of the Exchequer, Philip Hammond MP announced that world-leading researchers and entrepreneurs in Britain will receive an extra £780m in funding from the Government.
Funding will be spread across all regions of the UK and will be focused on the expansion of ‘catapult centres’. These private entities fuel innovation by working closely with Innovate UK, part of UKRI, to remove barriers to innovation by strengthening industry-academia links, maintaining open-access cutting-edge facilities for the use of SMEs and helping to build ecosystems within research companies which are conducive to innovation.
Dr Ian Campbell, Interim Executive Chair of Innovate UK, said:
“Today’s significant announcement means our world-class network of catapults can build on their success and continue helping thousands of businesses across the UK to undertake innovative R&D. This long-term investment will mean the catapults can help deliver the Grand Challenges of the Industrial Strategy in their sectors and help the UK achieve its ambition to raise investment in R&D to 2.4% of GDP by 2027.”