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EFPIA Calls for "Maximum Alignment" Between UK and EU Pharma Laws


  The European Federation of Pharmaceutical Industries and Associatiobs (EFPIA) today published results of a survey underlining the sheer scale and importance of the medicines issues that must be addressed as part of the Brexit discussions in order to protect public health.   Commenting on the survey, EFPIA Director General, Nathalie Moll said: “For life saving and life improving medicines, the EU and UK cannot afford to wait any longer to ensure that the necessary cooperation on medicines is in place from the day the UK leaves the EU.”
  The survey highlights that medicines used by patients across Europe have integrated supply chains, which include the UK, and states that:
  • over 2,600 final products have some stage of manufacture based in the UK
  • 45 million patient packs are supplied from the UK to other EU-27/EEA countries each month   • over 37million patient packs are supplied from the EU-27/EEA to the UK each month.
  In this context, 45% of EFPIA members expect trade delays if the UK and Europe fell back to WTO rules. To prevent these delays, critical for patients to access their medicines, the EU and UK should agree a comprehensive agreement that ensures maximum alignment between EU and UK pharmaceutical laws.
  In addition, over 12,000 centrally authorized Marketing Authorizations (MAs) for medicines will require a separate MA in the UK in order for the medicine to be prescribed to patients. Approximately 17% of centralized MAs are held in the UK.
  There are over 1500 clinical trials being conducted in multiple EU member states that have a UK-based sponsor. Over 50% of these trials are scheduled to continue beyond March 2019. The figures, from the EFPIA survey, underline the importance of scientific research collaboration between the UK and EU. Scientific collaboration strengthens the EU’s global position in life sciences, attracting global life science investment to the EU.
  Nathalie Moll added: “Even in the context of the Brexit negotiations, where all sectors are looking for clarity on the future, it is important to recognize that the medicines sector is different. The medicines we make impact directly on peoples’ health.” She went on to say, “Securing ongoing cooperation on medicines regulation between the UK and EU is the best way of ensuring that patients across Europe continue to have access to safe and effective medicines.”
  A summary of the EFPIA survey results is available here.