Regulatory Focus™ > News Articles > 2019 > 1 > Updated: UK Parliament Rejects Brexit Agreement as EFPIA Warns of Threats to Patient Safety

Updated: UK Parliament Rejects Brexit Agreement as EFPIA Warns of Threats to Patient Safety

Posted 16 January 2019 | By Zachary Brennan 

Updated: UK Parliament Rejects Brexit Agreement as EFPIA Warns of Threats to Patient Safety

EU biopharmaceutical industry group EFPIA on Tuesday said that the UK parliament’s decision to reject the Brexit withdrawal agreement, by a vote of 432 to 202, and political declaration increases the prospect of the UK leaving the EU in a disorderly manner on 30 March 2019.

The UK's Brexit committee said Wednesday that the government must come up with a decision by Monday, 21 January at the latest on what it proposes to do next. The committee said that there are four options:

1. To hold another vote on the draft Withdrawal Agreement and Framework for the Future Relationship.

2. To leave the EU with no deal on 29 March, with no agreement on future relations in place in and with no transition/implementation period.

3. To call on the government to seek to re-negotiate the deal to achieve a specific outcome, be it a variation of the terms of the separation set out in the Withdrawal Agreement or providing clarity about the end state of future relations as set out in the Political Declaration.

4. In addition to these policy choices about the UK’s future relationship, Parliament could decide to hold a second referendum to allow the British people to decide either which kind of Brexit deal they want or whether they wish to remain in the EU.

Without a deal, the group said, “there are very real, tangible and immediate threats to patient safety and public health in both the UK and across Europe.”

EFPIA Director General Nathalie Moll noted the possibility of a “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.”

EFPIA is calling 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 recognize UK-based testing at least until it can be transferred to the EU.
  • Measures to ensure the continued UK participation in data sharing platforms that protect public health and medicines safety in Europe.
  • Discussions between relevant authorities and the sector to coordinate contingency plans such as putting fast track lanes or priority routes for medicines into ports and airports.
  • Top exempt medicines and clinical trial materials from any new customs and borders checks.
  • Enable paperwork and regulatory checks to be completed away from the physical border.
  • 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 Association of the British Pharmaceutical Industry (ABPI), the trade group representing the branded pharmaceutical industry in the UK, added: "The focus of pharmaceutical companies is on making sure that medicines and vaccines get to patients whatever the Brexit outcome. This includes stockpiling and duplicating manufacturing processes here and in Europe. We continue to work as closely as possible with Government on no deal planning.

“But we reiterate that ‘no deal’ would prove to be extremely challenging. With time running out we hope Parliament will come together and quickly find a solution to the stalemate and reassure patients that medicines will not be disrupted come March 2019.”

In addition to EFPIA and ABPI, MedTech Europe, the industry group for medical devices, explained how Brexit is not just a UK issue.

"The situation should be considered extremely urgent for Europe as 30-40% of medical technologies have been certified and provided via a UK notified body, consequently there is a concrete risk that such products would stop being distributed immediately putting both patients and hospitals into a very critical situation," the group said.

Article updated on 1/16/19 with more from the UK Brexit Comittee, ABPI and MedTech Europe.

Categories: Regulatory News

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