EFPIA response to the UK parliament’s decision to reject the Brexit withdrawal agreement and political declaration
EFPIA notes the UK parliament’s decision to reject the Brexit withdrawal agreement and political declaration. With the prospect of the UK leaving the European Union in a disorderly manner on 30 March 2019 without a deal, there are very real, tangible and immediate threats to patient safety and public health in both the UK and across Europe.
Speaking about the decision EFPIA Director General Nathalie Moll said “Now is the time for policy makers in the UK and the EU to put politics aside and put measures in place to prevent patients being harmed by the consequences of Brexit. In particular from disruption to the supply of medicines including from transport delays at the border and where the development, manufacture, packaging, safety testing and regulation of the medicine no longer benefits from mutual recognition.”
The research-based pharmaceutical industry has worked tirelessly to prepare contingencies for every scenario. Today, EFPIA would like to call on the negotiators to agree on a series of actions that need to be taken to protect patients including:
• The introduction of measures that will continue to recognise UK based testing at least until it can be transferred to the EU.
• Measures to enable the continued UK participation in key data sharing platforms that protect public health and medicines safety in Europe.
• Discussions between relevant authorities and the sector to co-ordinate contingency plans such as putting fast track lanes or priority routes for medicines into ports and airports.
• Medicines and clinical trial materials should be temporarily exempted from any new customs and borders checks.
• Enable paperwork and regulatory checks to be completed away from the physical border.
• The European Air Safety Authority (EASA) should recognise certificates issued in the UK to ensure that planes can continue to fly.
• Exploring the possibility of also exempting active pharmaceutical ingredients (API) and raw materials for medicines from border checks to ensure manufacturing of medicines continues with limited disruption.
The full list of actions needed have been published on the EFPIA website. Patients need policy makers to have an immediate and intense focus on regulation and supply of medicines in the post-Brexit relationship. We, along with many others in the healthcare community and across the life sciences sector, believe that an explicit commitment to securing long-term, extensive cooperation around the regulation of medicines and medical technologies is in the best interests of patients and public health.