EFPIA notes the postponement of the UK Parliament’s debate on the Brexit withdrawal agreement and political declaration which outline the terms of the UK’s exit from the European Union. In the meantime, the research-based pharmaceutical industry continues to prepare contingencies for every scenario.

EFPIA Director General Nathalie Moll said “While for most sectors the issues are primarily economic, for the healthcare sector the primary concerns are patient safety and public health. A disorderly exit from the EU by the UK has very real and tangible consequences for patient safety and public health in both the UK and across Europe. We hope that politicians in the UK take this into consideration when the vote occurs.”

There is no doubt that from the healthcare sector’s perspective a transition period is critical, as it provides some time for companies to continue to adapt to new regulatory requirements, manufacturing and supply issues including customs arrangements to ensure an uninterrupted supply of medicines to patients. The transition period would also allow multi-national companies with international workforces in the UK and the EU to manage the implications for staff.

The scale of the task should not be underestimated; around 45 million packs of medicines leave the UK destined for patients in Europe every month with 37 million packs heading the opposite way.  In total that is around 1 billion packs of medicine crossing the border between the UK and the EU each year.  Given the uncertainty around the process of voting on the withdrawal deal and the terms of the UK’s future relationship with the EU, our industry has invested heavily in ensuring that companies are prepared for every eventuality.

As part of those contingencies, today EFPIA has shared with the Commission and Member State Capitals a series of actions to be taken in order to protect patients and public health in the event of a no deal scenario, including:

• The introduction of measures that will continue to recognise UK based testing at least until it can be transferred to the EU.
• The introduction of 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.

Following publication of the Withdrawal Agreement and Political Declaration, we were encouraged by the commitment in the Political Declaration to a “free trade area combining deep regulatory and customs cooperation”and the additional reference to explore “the possibility of cooperation of United Kingdom authorities with Union agencies such as the European Medicines Agency (EMA)”. 

Nathalie Moll went on to say “Our hope is that a deal is agreed and then immediate and intense focus is given to 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.”