LONDON – The life sciences industry exhaled sharply and prepared to labor over the fine print in 1,246 pages of text after the EU and U.K. reported they had agreed a post-Brexit trade deal on Christmas Eve. The U.K. has said it will take a light touch, at least initially, with implementation of new border controls taking place in three stages up to July 30, 2021. The EU has not said what its approach will be.

LONDON – The pharmaceutical industry exhaled sharply and prepared to labor over the fine print in 1,246 pages of text after the EU and U.K. announced they had agreed a post-Brexit trade deal on Christmas Eve. The EU/U.K. Trade and Cooperation Agreement means the risk of a crash-out Brexit on Dec. 31 is over, and there will be no tariffs or quotas on the import and export of goods.

Device makers may see privacy legislation in California and other U.S. states as a source of regulatory balkanization, but that very same problem is cropping up in the international arena. In addition to the European General Data Protection Regulation (GDPR), privacy requirements are popping up in Brazil and elsewhere, and Eric Bowlin, a partner at Deloitte Risk & Financial Advisory, told attendees on a virtual symposium that the best approach might be to base a compliance program on general principles.

LONDON – As the last scheduled talks on the future EU/U.K. trading arrangements got underway on Sept. 29, the pharmaceutical industry across Europe issued an urgent plea for medicines to be spliced out of the contentious negotiations. In a joint statement, the U.K. and European industry organizations called for a mutual recognition agreement (MRA) to prevent the need for retesting of medicines imported from the EU to the U.K., in the event there is no deal.

LONDON – With just four months to go until Brexit is activated, the start of September finally saw the med-tech industry get official guidance on the licensing regime for medical devices in the U.K. once the Medicines and Healthcare Products Agency (MHRA) becomes the standalone regulator Jan. 1, 2021.

LONDON – While the pandemic raged, Brexit was simmering on the back burner, but now as infections wane, the industry is turning its attention back to being ready for the U.K. cutting ties with the EU at the end of December.

LONDON – The European Commission (EU) is pulling the plug on implementation of the Medical Devices Directive (MDR) on May 26, to free up resources and expertise as countries across Europe struggle to deal with the COVID-19 crisis.

LONDON – The U.K. life sciences sector has stepped into “a new reality” following publication of the government’s negotiating mandate on the future trading relationship with the EU. “Plan A is no longer on the table,” said Steve Bates, chief executive of the Bioindustry Association, who has spent three long years lobbying for a favorable deal for the industry.

PERTH, Australia – With the Brexit split now official, Australia’s Therapeutic Goods Administration is trying to figure out the impact to its life sciences industry and the new trade relationships that will take effect after the transition period ends.