It is no secret that Brexit will have a large impact on the pharmaceutical industry come March 2019 when the UK exits the EU. Since the UK voted to leave the EU on June 23, 2016, questions have been raised on the logistics of the transition, and how companies planning clinical trials in the EU will be affected. Where will the EMA be relocated to? How will the QP process be affected?
In the last quarter of 2017, more news regarding Brexit has been released, providing some answers for the clinical supply field. John Shillingford, 2017 Sherpa Summer Seminar speaker and independent consultant discusses these new developments and clarifies what questions we still need answers to. Spoiler alert: there’s a lot left unanswered.
From London to Amsterdam
On the 20th of November 2017, the European Medicines Agency (EMA) issued a press release announcing the move of the EMA from its London base to Amsterdam. The decision was taken by the EU27 member states in light of the UK’s intention to leave the EU by the 30th of March 2019. The Agency is working closely with the Dutch Government to ensure a smooth transition as they have only 14 months to complete the move and take up full operations.
During this transition, pharmaceutical companies will have to contend with a potential slowing of Agency Assessments while the move over the next 14 months is underway. Sponsor companies of clinical trials in the EU will need to be extra vigilant to ensure that this slow down does not delay the start of their clinical trials.
EMA Brexit Preparedness Plan Lays Out Priorities During Transition
How this move will affect the services of the EMA during this transitional period has been outlined in the EMA Brexit Preparedness Plan issued on the 13th of October 2017. This plan will be important to US pharmaceutical companies, as it sets out priorities to promote and maintain the Agencies International Product approval system, throughout this difficult move. It includes Business Continuity Plans (BCP) and separates the maintenance of services into 3 categories.
How this will affect pharmaceutical R&D and ongoing or planned clinical trials in Europe has yet to be fully understood. The EMA will release regular updates and advice must be to communicate with the Authorities when required.
Some critical remaining issues are:
- The maintenance of scientific assessment and advice services
- The maintenance of New Product Assessment and approvals
- Oversight and maintenance of Pharmacovigilance systems in the EU and EEA countries with the UK having left
- Oversight of the Qualified Person (QP) system for drug importation of Investigational Medicines and Drug Finished Product in the EU and EEA after the UK’s exit.
The UK’s Future Third Party Nation Status Has Far-Reaching Implications for U.S. Pharmaceutical Companies
The EMA’s 28th of November 2017 “Practical guidance for procedures related to Brexit for medicinal products for human and veterinary use within the framework of the centralised procedure” document clearly states that at the end of March 2019, the UK will be considered a Third Party Nation and subject to all EU requirements related to Drug Manufacturing and Importation of product into the EU27 countries.
Of particular note for US pharmaceutical companies using QPs residing in the UK - the EU is keeping their requirement that their QPs be a resident of an EU country. The UK has historically had a high proportion of EU QPs that will no longer be able to act as QPs for EU clinical trials. Naturally, there has to be methods and processes to minimise potential detrimental effects of the potential negation of the UK QP authority. Because these are currently unknown, it is recommended that any Company dealing with companies based in the UK undertake a detailed review of processes and take into account the likely outcome of Brexit.
In conclusion the UK and EU Brexit negotiation have just concluded the first round of the required discussions. Three main items have been agreed in principle and itemised in a document dated 8th December 2017:
- Protection of the rights of Union citizens in the UK and UK citizens in the Union;
- The framework for addressing the unique circumstances in Northern Ireland (maintenance of a soft border between North and Southern Ireland);
- The financial settlement between the EU and UK
The major concern for our industries is for the EU people living in the UK and those UK passport holders living in the EU. A number of these people work in the Pharmaceutical and support industries and they have been, understandably unsettled as to what the future holds for them and their families. Unfortunately, this anxiety has not been completely assuaged by the document –where you can read on Page 1 - that regarding the agreement they have reached in principle, this is so only under the terms of Paragraph 5:
- Under the caveat that nothing is agreed until everything is agreed, the joint commitments set out below in this joint report shall be reflected in the Withdrawal Agreement in full detail. This does not prejudge any adaptations that might be appropriate in case transitional arrangements were to be agreed in the second phase of the negotiations, and is without prejudice to discussions on the framework of the future relationship.
There is still much to resolve. The next round of Trade Talks is scheduled for April 2018 – time is short.
Get Your Clinical Trials Brexit-Ready
Sherpa Clinical Packaging’s global depot network includes depots throughout the (post-Brexit) EU and the UK. In 2017, our team managed clinical supply logistics in over 27 countries. Should you wish to Brexit-proof your clinical studies, set up a Buzz Session with Sherpa.
About John Shillingford, PhD
John Shillingford, PhD is an Independent Consultant whose career in the Pharmaceutical, Medical Device and CRO industries has stretched over 40 years. John has both lived and worked in a number of European Countries as well as the USA. He is now lives in Germany.
His wide experience of Drug and Medical Device Development in Europe and the USA has been acquired during the management of both Clinical and Data Operations for major Global Programmes.
John has held senior positions in Management, Clinical Operations and Project Management for, Aptiv Solutions, Averion International (a Medical Device Research Company), PRA International and Imform GmbH. Currently John is a researcher at the Clinical Research Foundation, a member of the Board of Orsus Medical Ltd, a UK based Medical Device Company and additionally continues to run a number of training courses.
John is available to support USA companies with their Development Projects in Europe and can be reached at:
Tel: 0049 174 190 7273 or 0049 6186 914 540
E mail: firstname.lastname@example.org
Have a question on how to manage your clinical supplies for your EU studies? Feel free to contact us.
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