EU Agrees Brexit Transition Period – But What Does It Mean For Pharma And The Regulators?
The EU has agreed to a Brexit transition period and adopted guidelines on its talks with the UK on their future relationship. But while the political agreement on the transition will give the life sciences industry some certainty, it is not yet a done deal and the regulatory implications are still unclear.
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Sarah Wollaston, chair of the Commons health committee, has asked the government to clarify its intentions for the relationship between the UK MHRA and the EMA during and after any Brexit transition period.
As Brexit uncertainty continues and a “no-deal” scenario remains a possibility, pharmaceutical companies need to be looking at issues such as the renegotiation of supplier contracts, the transfer of key regulatory roles, and the mapping of trade flows, says EFPIA’s president, Stefan Oschmann. Meanwhile, industry and healthcare organizations have drawn up a list of “crucial unanswered questions” that they say the Brexit negotiators must address.
The European Council’s draft guidelines on the future UK-EU relationship say that the UK, as a third country outside the EU single market, will not be able to participate in any EU agencies after Brexit, dashing hopes expressed by the government that the UK could have “associate membership” of the EMA. However, the UK BioIndustry Association remains optimistic that some form of regulatory cooperation can be negotiated in the interests of all stakeholders.