11/12/2018. Shaping the Future Together UK R&D Leadership Community in the NHS. Agenda. Phase 2 Clinical Trials UK vs Global

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1 Shaping the Future Together R&D Leadership Community in the NHS Implications of Brexit for Clinical Research Agenda Commercial Clinical Trials in the Pharmaceutical Industry Priorities for Brexit Where are we now? Technical notices and guidance 27 th November 218 Dr Sheuli Porkess Deputy Chief Scientific Officer abpi.org.uk 1 abpi.org.uk 2 Phase 1 Clinical Trials vs Global Phase 2 Clinical Trials vs Global SOURCE: Cortellis Clinical Trial Intelligence from Clarivate Analytics, data accessed March April 217; data accessed December SOURCE: Cortellis Clinical Trial Intelligence from Clarivate Analytics, data accessed March April 217; data accessed December abpi.org.uk 3 abpi.org.uk 4 1

2 Phase 3 Clinical Trials vs Global Cardio-metabolic Trials vs Global Cardio-metabolic clinical trials vs Global SOURCE: Cortellis Clinical Trial Intelligence from Clarivate Analytics, data accessed March April 217; data accessed December SOURCE: Cortellis Clinical Trial Intelligence from Clarivate Analytics, data accessed March April 217; data accessed December This analysis focused on Cardiovascular & Metabolic trials only. Trials across multiple therapy areas were only included once. The therapy area in which they were included was determined by the trial s main purpose for study. abpi.org.uk 5 abpi.org.uk 6 Nervous System Trials vs Global Oncology Trials vs Global Oncology clinical trials vs Global SOURCE: Cortellis Clinical Trial Intelligence from Clarivate Analytics, data accessed March April 217; data accessed December This analysis focused on central nervous trials only. Trials across multiple therapy areas were only included once. The therapy area in which they were included was determined by the trial s main purpose for study. abpi.org.uk 7 SOURCE: Cortellis Clinical Trial Intelligence from Clarivate Analytics, data accessed March April 217; data accessed December This analysis focused on Oncology trials only. Trials across multiple therapy areas were only included once. The therapy area in which they were included was determined by the trial s main purpose for study. abpi.org.uk 8 2

3 Immune Disorder Trials vs Global Immune Disorders clinical trials vs Global Pharmaceutical Industry Perspective SOURCE: Cortellis Clinical Trial Intelligence from Clarivate Analytics, data accessed March April 217; data accessed December This analysis focused on Immune Disorder trials only. Trials across multiple therapy areas were only included once. The therapy area in which they were included was determined by the trial s main purpose for study. abpi.org.uk 9 abpi.org.uk 1 Why Brexit matters Why Brexit matters abpi.org.uk 11 abpi.org.uk 12 3

4 Timelines: The big picture ABPI Brexit Policy Priorities Securing the ability to trade and move medicines across borders. Securing regulatory cooperation An immigration system that allows companies to employ the best talent from around the world and the EU abpi.org.uk 12b Securing predictable funding and collaboration for scientific research abpi.org.uk 14 Working in partnership: Brexit Health Alliance What s the most important ask we have? Securing the ability to trade and move medicines across borders Securing regulatory cooperation Securing the ability to trade and move medicines across borders Securing predictable funding and collaboration for scientific research abpi.org.uk 15 abpi.org.uk 16 4

5 EU laws in force in the Where are we now? Government introduced the European Union (Withdrawal) Bill to Parliament to end the primacy of EU law in the on Brexit Day. This incorporates all EU legislation into law in one go. This will ensure the wiring of law works from day 1 of Brexit. The Bill also legislates for the Parliament to have a meaningful vote on the final Withdrawal Agreement. It finally became law in June 218 abpi.org.uk 17 abpi.org.uk 18 Where are we? Withdrawal Agreement The current text of the draft Withdrawal Agreement includes provision for a transition or implementation period. This would be a period between 29 March, 219 (when the formally leaves the EU) and 31 December, 22. This period is to ensure businesses and others can make necessary preparations. The full acquis of the EU will apply to the during this period, including free movement of people and the Single Market. However, the agreement of this transition period is dependent on the agreement of the Withdrawal Agreement which has not yet been agreed. abpi.org.uk 19 abpi.org.uk 2 5

6 MHRA Guidance Market access will not change during the implementation period. Firms can continue batch release testing and qualified person certification, with this being recognised by the EU and vice versa. Marketing authorisation holders and qualified persons, and qualified persons for pharmacovigilance can continue to be based in the and access EU markets. Manufacturing and distribution licences will continue to be recognised by the EU and vice versa, as will inspections. based firms can continue to apply for marketing authorisations via either the centralised or decentralised procedure Political Declaration on the future -EU relationship * ABPI, BIA and NHS Confed are calling for the following to be included in the text of the final Political Declaration on the future -EU relationship, so that patients can continue to benefit from cooperation on health security: To make specific reference to the importance of cooperating on the regulation of medicines. To make clear that the and EU will cooperate on protecting citizens from infectious disease and counterfeit medicines. To make clear that the and EU will agree closer collaboration on science and innovation abpi.org.uk 21 abpi.org.uk 22 Technical Notices - No Deal Technical notices, medicines supply Link to technical notices Link to guidance Link to RI portal Intention for these notices to give clarity to businesses and citizens to understand what they would need to do in no deal scenario. Government clear that this no deal scenario remains unlikely and that they are confident of securing a deal. There have been 4 batches of notices to date: the pharmaceutical industry featured prominently in the first batch. MHRA consultation on No Deal Statutory Instruments abpi.org.uk 23 abpi.org.uk 24 6

7 Medicines Supply Contingency Programme Alongside MHRA Technical Notices, the DHSC have announced the above Programme The Programme is intended to support the Government request of pharmaceutical companies to stock-pile an additional 6 weeks supply of medicines sourced from or via the EU/EEA. Clinical Trials Implementation Period, No Deal Implementation Period No Deal The EU Clinical Trial Regulation (EU CTR) is expected to be clinical trial applications will continue to be implemented during 22. If it does not come into force during authorised by MHRA and ethics committees. The will the implementation period, law will remain aligned with parts continue to participate in multi-national trials of the EU CTR legislation. Two elements that the would not be able to implement on its own are the use of a shared MHRA will improve processes to enable closer working central IT portal and participation in the single assessment with ethics bodies, allowing a single application and single model. Both need a negotiated /EU agreement, regarding national decision in the. Initial pilot work has already involvement post the implementation period started and would continue to be developed post-exit. The Programme has included a letter to both: Pharmaceutical Companies requesting additional stockpile and booking of additional pre-wholesaler capacity or alternative air-freight arrangements NHS advising no local stockpiling required Additionally, pharmaceutical companies have been provided with a Response Template for completion as to no-deal Brexit preparedness per product abpi.org.uk 25 The s access to networks, information systems and databases will continue on current terms Whatever happens, the is committed to offering a competitive service for clinical trial assessment covering: regulatory approval from MHRA, services from HRA, ethics services, NIRH and the NHS Market access will not change and there will be import testing of intermediates. batch testing release of Investigational Medicinal Products (IMPs) will also be recognised in the EU and vice versa. There will be acceptance of batch release and qualified person testing. Transparency provisions will, we hope, be aligned with those operating in the EU. How a system would be developed, will be the subject of consultation. ABPI is working to preserve the position of sponsor or their legal representative to be based in the EU or EEA. We anticipate it will be necessary to have an individual based in the, with overall responsibility for the trial. More details to come. Organisations running clinical trials, need to consider their supply chains for Investigational Medicinal Products (IMPs) ahead of 29/3/19. Trials using IMPs from or via the EU/EEA will need to assure supplies in the event of any possible border delays abpi.org.uk 26 Clinical Trials Implementation Period, No Deal (cont d) Notice on Clinical Trial Supplies Implementation Period No Deal The will continue to accept batch testing of The s access to networks, information systems and IMPs manufactured in EU and EEA states. There databases will continue on current terms will be no change to the current arrangements for batch testing of IMPs manufactured in third countries. The same approach will apply to QP certification of licensed medicines Whatever happens, the is committed to offering a These arrangements will continue until the competitive service for clinical trial assessment government considers any further change necessary. covering: regulatory approval from MHRA, services ABPI is committed to working with industry from HRA, ethics services, NIRH and the NHS ahead of any changes outlined in the technical notice impacting supply chains and manufacturing processes. We want at least two years of notice for the introduction of any changes, to allow industry to fully prepare for their implementation. There will be acceptance of batch release and qualified person testing. There will be import testing of intermediates. batch testing release of investigational medicinal products will also be recognised in the EU and vice versa. MHRA 12 th October We would encourage organisations running clinical trials in the to consider their supply chains for IMPs ahead of the 29th March 219. Clinical Trials that use IMPs which come from or via the EU/EEA will need to ensure appropriate arrangements to assure supplies in the event of any possible border delays that may arise in the short term in the unlikely event of a no-deal Exit that we reach March 219 without agreeing a deal with the EU. It may be necessary to start making any contingency arrangements ahead of the 29th March 219 to provide assurance to trial participants and for the trials. abpi.org.uk 27 abpi.org.uk 28 7

8 Horizon 22: government underwrite guarantee In 216, the Chancellor announced that the government will guarantee funding for competitively bid for EU projects submitted before the leaves the EU, including Horizon 22 projects. This guarantee covered all successful bids submitted by participants before the exits the EU, for the full duration of the projects 2. In July 218, the Treasury announced an extension of this guarantee, in a nodeal scenario, to provide funding until the end of 22 for successful bids where organisations are involved. What s next? abpi.org.uk 29 abpi.org.uk 3 ABPI recommendations to members Prepare for all scenarios Understand company s own processes Understand implications for suppliers / partners / vendors Read all regulatory announcements from EMA, CMDh, MHRA Read Technical Notices on no deal Read Guidance on Implementation Period Companies to continue to discuss individual portfolios with MHRA Any company decisions should be informed by company s own legal advice Shaping the Future Together R&D Leadership Community in the NHS Implications of Brexit for Clinical Research 27 th November 218 Dr Sheuli Porkess Deputy Chief Scientific Officer abpi.org.uk 31 abpi.org.uk 32 8

9 References 1. Source: a) Cortellis Clinical Trial Intelligence from Clarivate Analytics, data accessed March April 217; data accessed December 217. b) Notes: Data was collected from Cortellis Clinical Trial Intelligence, Clarivate Analytics using the following criteria: trial start date (1st January st December 216), phase (I, II, III), and country (,,,,,,,,, and ). Only trials related to pharmaceutical drug development and molecular/biological entities were included. Only commercial trials were included. Collaborative trials were only included if one or more partners were a commercial organisation. All therapeutic areas were included in this analysis abpi.org.uk 33 9