UK life science backs May's plan to remain part of EMA
BIA welcomes the Prime Minister’s announcement today that the UK will seek to explore with the EU, the terms on which the UK could remain part the European Medicines Agency, abide by the rules of the agency and make an appropriate financial contribution.
BIA CEO Steve Bates said: “It’s good to see the PM articulating the practical dynamics of our industry of the future, when she said in her speech that ‘membership of the European Medicines Agency would mean investment in new innovative medicines continuing in the UK, and it would mean these medicines getting to patients faster as firms prioritise larger markets when they start the lengthy process of seeking authorisations.’
“Her language reflects the work that the BIA has undertaken on regulatory cooperation since before the referendum, as well as the desire of patient, NHS Confederation and European coalitions. The PM also stated that it would also be good for the EU because the UK regulator assesses more new medicines than any other member state.'
Mr Bates added:
“It is good to see the PM’s recognition of the importance of ‘ensuring that these products only need to undergo one series of approvals, in one country.’ The PM has also listened to BIA members who have consistently made the case that ‘it is strongly in their interest to have a single set of regulatory standards that mean they can sell into the UK and EU markets.’
“There is much work to be done but this is a positive step forward on the future of medicines regulation.”
Notes to editors:
Ed Sexton, Communications and Media Relations Manager, BIA
Patient Safety/public health systems
Regulatory cooperation on medicines between the UK and EU is important for patient safety – both as for UK patients and those in the EU27. The PM’s suggested approach is a win, win – as important for the EU as it is for the UK. With 82 million patient packs travelling between the UK and EU each month, it is vital that teams on both sides of the channel make patient safety a priority.
As a recent publication from a European industry/patient coalition pointed out:
“diseases know no borders, and as many of Europe’s health and demographic challenges are shared, we call for a framework to be put in place between the EU and the UK post-Brexit to ensure that there is knowledge sharing to strengthen public health and to support the response to public health threats.”
It also highlighted that “The UK has the highest number across the EU of phase I clinical trials, those testing a new drug or treatment for the first time, and the second highest number of phase II and phase III clinical trials. It has also the highest number of trials across the EU for both rare and childhood diseases.
And: “There are over 1500 clinical trials being conducted in multiple EU member states that have a UK-based sponsor and over half of these trials are scheduled to continue beyond March 2019.”
The safest systems are those that have the most reliable information fed into it and taking out a large chunk of it is not the best way forward for the EU, or the UK. As the Brexit Health Alliance (of which BIA is a member) recently highlighted, the UK’s “MHRA contributes to up to a third of the EU’s pharmacovigilance work. Similarly, in 2016, the UK alone contributed 23.4 per cent of all national competent authority reports (NCARs) submitted to EU members, demonstrating that the UK is a significant partner in the continued health of both UK and EU patients.”
“The loss of data from a country that has a large population (the UK) and the valued reporting capacity of the MHRA would have an impact on the effectiveness of safety reporting across the EU, but also the loss of access to European data and reporting would clearly impact the UK’s ability to map trends in safety of devices and medicines.”
A Brexit Health Alliance press release also highlighted “that up to 120,000 prostate cancer patients throughout Europe could be affected if Brexit negotiations fail to find a solution for future cooperation between the UK and the EU on regulation and trade of medicines and medical devices.” And “The future of research into new medicines and medical technologies could also be affected. Around 750 UK-led clinical trials including multiple EU member states could be at risk if there is no plan on how to approve and manage these multi-national trials with European partners after March 2019.”
The BIA is pleased that the UK Government has listened to our long campaign on the benefits of regulatory cooperation for medicines. Prior to the referendum, the BIA took an early stance on this issue. In March 2016 the BIA responded to the House of Commons Science and Technology Select Committee's inquiry on EU regulation of the life sciences. The BIA argued strongly that the integrated European regulatory framework for clinical research and development of new, innovative medicines was a key enabler of the strength of UK life sciences. The BIA highlighted that this effective system was built by regulators and legislators over the course of a generation, with UK influence and input at its core. The BIA was the only life sciences trade association to make this case in person at the oral sessions conducted by the Science and Technology Select Committee.
In the lead-up to the Referendum vote, the BIA community was active and vocal in stating the benefits of a harmonised approach across Europe to the regulatory framework for clinical research and development of new, innovative medicines, participating at events across the UK and stating that view in the media.
In September the BIA/ABPI/PwC report called for “ A common regulatory framework with Europe”. And stated that “The single regulatory system provides the scale and certainty required to bring innovative, effective and safe medical technologies to UK patients quickly.”
This is also the UK government’s preferred outcome, as set out by the Health and Business Secretaries in a letter to the FT in July 2017.
Regulatory cooperation for medicines is a complex issue and the devil is in the detail – however it is vital to get it right. BIA represents the broadest base of biotech/pharma in the UK from SMEs through to multinationals, we will continue to make the case for cooperation and make our expertise available for everyone.
We continue to work closely with the UK government, the MHRA and partner organisations across the EU 27 Member States towards that goal.
Reports for further information:
Brexit Health Alliance
About the BIA
Established over 25 years ago at the infancy of biotechnology, the BioIndustry Association (BIA) is the trade association for innovative enterprises involved in UK bioscience. Members include emerging and more established bioscience companies; pharmaceutical companies; academic, research and philanthropic organisations; and service providers to the bioscience sector. The BIA represents the interests of its members to a broad section of stakeholders, from government and regulators to patient groups and the media. Our goal is to secure the UK's position as a global hub and as the best location for innovative research and commercialisation, enabling our world-leading research base to deliver healthcare solutions that can truly make a difference to people's lives.
For further information, please go to www.bioindustry.org and twitter.com/BIA_UK