Draft Brexit Agreement Moves Forward on Shaky Ground

Regulatory NewsRegulatory News | 15 November 2018 |  By 

EU and UK negotiators on Wednesday advanced a draft agreement setting terms for the UK’s withdrawal from the EU in March 2019 and the two parties’ relationship during a 21-month transition period.
The agreement is being sent to the EU27 member states for consideration and must clear the UK Parliament before the negotiations can move to the next phase and avoid the possibility of a “No-Deal” scenario.
However, the deal appears to be in jeopardy after Brexit secretary Dominic Raab, work and pensions secretary Esther McVey and four other ministers resigned in opposition to the agreement after Prime Minister Theresa May’s Cabinet agreed to back the deal.
“I cannot in good conscience support the terms proposed for our deal with the EU,” Raab said on Twitter. In his letter of resignation, Raab sites his opposition to the customs “backstop” arrangement aimed at avoiding a hard border between Ireland and Northern Ireland.
Despite pushback, May defended the agreement saying she will see the deal through. “We agreed as a cabinet and as a government that the deal that we have is the right one to proceed with to go to the next stage of the negotiations,” she said.
Draft Agreement
While the draft agreement touches upon medicinal products and medical devices during the transition period, it does not spell out in detail what the EU and UK’s relationship will look like with regard to drug and medical device regulation long-term.
Exactly how the EU and UK will handle medicines and medical devices regulation beyond the transition period will be negotiated if the draft agreement is accepted by both parties.
The European Federation of Pharmaceutical Industries and Associations (EFPIA) Director General Nathalie Moll said the agreement’s “failure to contain an explicit reference to the importance of securing long-term, extensive cooperation around the regulation of medicines is not in the best interest of patients.”
However, the draft agreement does establish a single customs territory between the EU and UK during the transition period. The draft agreement also specifies under Annex V which EU regulations related to medicinal products, medical devices and substances of human origin will apply to the UK during the transition period.
Articles 44, 45 and 46 of the agreement also clarify that the EU and UK will continue to make information related to past and ongoing procedures for medicines and conformity assessments for devices available to one another.
Draft Agreement


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Tags: Brexit

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