Biopharma industry urges MRA to mitigate risk of no-deal Brexit

Regulatory NewsRegulatory News | 19 June 2020 |  By 

The biopharma industry is urging the European Union to separate talks about post-Brexit regulatory cooperation from broader political negotiations. Groups including the European Federation of Pharmaceutical Industries and Associations (EFPIA) made the plea amid fears the collapse of free trade talks will force a hard split between the United Kingdom and EU regulatory regimes.
In a letter to senior EU officials, the six trade groups call for Brexit negotiators to prioritize the signing of a mutual recognition agreement (MRA) covering batch and import testing, good manufacturing practice (GMP) inspections and CE marking. The trade groups think an agreement could ensure medicines and medical devices continue to cross the UK-EU border with minimal delays.
The trade groups also requested “simplified and rational rules of origin, based on common, defined chemical, pharmaceutical and biotechnology processing activities, and smooth import clearance processes to avoid any disruption in the delivery of sensitive goods.”
In theory, the UK and EU are in favor of such outcomes. The EU tasked its negotiators with seeking “as close as possible a partnership” with the UK. Similarly, the UK government used its negotiating position to specifically express a desire to form an MRA spanning GMP certificates, pharmacovigilance and information sharing. But tying the regulatory to the broader trade negotiations means a sticking point unrelated to medicines could stop the UK and EU from forming an MRA that both think is in their interest.
EFPIA and its peers are asking the EU and UK to separate the discussions, allowing regulators in the EU and UK to work on an MRA that can come into force even if a broad trade deal does not.
The Transatlantic Trade and Investment Partnership (TTIP) provides a precedent for splitting off  regulatory considerations. During those negotiations, the US Food and Drug Administration and European Medicines Agency successfully completed an MRA despite the broader TTIP talks collapsing and failing to deliver a trade deal.
EFPIA’s actions are underpinned by concerns that the two sides will be unable to reach a free trade agreement. The talks are currently deadlocked as the EU wants the UK to maintain its standards, and the UK is unwilling to be tied to rules decided in Brussels.
Under the terms of the current transition period, the EU and UK need to sign off on an agreement by the end of the year. The negotiations are now around the halfway point, but the head of the European Commission Ursula von der Leyen warned this week that the two sides are “definitely not halfway through the work to reach an agreement.”
With the UK government consistently dismissing the prospect of asking for an extension, which must happen by the end of next month, von der Leyen sees a five-month window in which to wrap up the talks. In practice, there may be even less time. The UK government said this week that it “does not believe it makes sense for there to be prolonged negotiations into the autumn.”

The statement suggests that unless progress is made next month, when talks are set to intensify, or shortly thereafter the UK will stop negotiating and start preparing for a hard split from the EU.
EFPIA Letter


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