Brexit, quo vadis?

Almost 100 years after the Republic of Ireland left the United Kingdom, dividing the island in two parts, this question still is on the political agenda in Europe. The major hurdle to a Brexit deal remains the border between Northern Ireland (part of U.K.) and the Republic of Ireland. As I look at it today less than 20 days before the final Brexit date as declared by the British prime minister, the chances to reach an agreement accepted by everybody before the final Brexit data are still low, let alone obtaining approval by the British Parliament, the European Council, and the governments involved.

Without a deal, the prime minister, by law, is forced to ask for an extension of the negotiation period. The big unknown is what the EU will decide: Will it be willing to grant the U.K. extra time to work on an agreement? My best guess is that another extension will be granted.

For the pharmaceutical industry and the supply of medicinal products and medical devices, U.K.’s Medicines and Healthcare products Regulatory Agency has done a lot of work to prepare for the situation after Brexit. MHRA has given guidance on the transfer of central approvals into national approvals, how to continue doing clinical trials in the U.K., the import and export of active pharmaceutical ingredients, and many more aspects. Unless an unexpected and unorganized Brexit happens by Oct. 31, it looks like the Brexit shock to the pharmaceutical industry should not be as big as feared six months ago on March 29, which was when Brexit initially was to have occurred.

What can we expect in the event Brexit finally happens?

The best case will be an organized Brexit with sufficient processes and guidance to safeguard the interest of the people and the pharmaceutical industry in U.K. and EU. This will also ensure a sufficient supply of drugs, an organized import and export of medicinal products and devices, and continuity for clinical trials. This is especially what moderate members of the parliaments in the U.K. and the EU want to achieve.

The British government recently was forced to publish its study on the worst case scenario, called Operation Yellowhammer. While Brexiteers consider this to be a far too negative and dystopic scenario, many scientists consider it realistic. The study implies that there will be shortages for medicinal products, medical devices, and food products like vegetables and fruits — exactly the situation moderates want to avoid.

I still believe and hope that the best case scenario will prevail and the U.K. will leave the EU in an organized and friendly manner.

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