On the 29th of March 2017 there were 2 major events happening – well, at least from my point of view. The UK had triggered the famous Article 50 and I was at the maternity ward with signs of early labour. Thankfully baby decided to come later, but what a day it was!
Since welcoming the new addition to the family I have had to settle with looking in to the regulatory world from the outside whilst juggling the usual scenarios that come with having a baby and a young child at home. Returning to work in April 2018 therefore left me with some catching up to do!
The team in Panacea was absolutely fantastic in supporting me. I was asked to join our Brexit team, a group dedicated to review and interpretation of any information on Brexit from both sides of the table, and the impact they will bring to our business and our clients. The group shared the information gathered so far at the time and the updates and changes just kept on coming! One thing I have really enjoyed is our monthly brainstorming session where we try to find answers to the challenges ahead with the scarce information available – at least at the time. Since a huge component in Brexit is related to regulatory affairs, I’d like to think I have helped us come up with solutions to the already identified issues. How we can best serve our clients is a common theme to our discussions but also to have a balanced approach. We all felt the ticking clock but knew it was not the time to be opportunistic, or make rash (and sometimes radical) decisions. Our aim was to be prepared but without panic. Knowing what needed to be done and when, but being patient to wait for further information while we could.
In the beginning we only had a guide from Europe, who had a somewhat simpler task in the sense that it didn’t have to adapt its legislation, the definite feel of a clock ticking and very little information from the UK who had a much harder task. A blank piece of paper may be filled with a lot of possibilities, but it also carries a burden of uncertainties a lot of work to be completed. Then came the glimmer of hope of the interim period that would give the healthcare sector a very welcome breathing space, but the shadow of the huge caveat of it being dependent on a ratified deal between UK and EU dampened the excitement. Now the MHRA have published its guidance on a hard Brexit and we now know both possible outcomes. Whilst in April this year, it appeared that some MAHs could afford to have a plan with actions on hold, now it’s time to roll up the sleeves and prepare for 29th of March 2019. It is time to prepare for the worst case scenario.
If there is a deal, essentially nothing changes until December 2020. In reality MAHs and regulatory agencies would have until December 2020 to prepare for the inevitable changes ahead.
If there is no deal, European law remains the same and on the 30th of March 2019 the United Kingdom will be considered a third country. This means anything produced in the UK will be considered an ‘import’ in the Union. UK established companies can no longer be MAHs or orphan designated holders for MAs in EU/EEA. Likewise QPPVs for MAs in the EU/EEA can no longer be based in the UK nor can the PSMF be located in the UK for these MAs. Pharmaceutical companies will have to reconsider their batch release arrangements and the list goes on from GMP certificates to sourcing of medicines to bioequivalent studies – including which product can be considered the reference medicinal product for an abridged application.
The UK has taken a pragmatic approach to Brexit. Their ‘hard Brexit’ guidance is aimed at making the transition as smoothly as possible. Having said that, there is nothing smooth about the process. The changes needed are profound, there’s simply no way to avoid this.
With so many variables the ability to remain flexible and be able to act quickly (without panic) will be required from MAHs. Having a well thought out plan considering possible scenarios and importantly recognizing what we still do not know and what can be done about it will ensure companies can act when needed, optimizing resources and ensuring business continuity. With busy regulatory teams this can be hard to achieve and this is one area Panacea can help with. Perhaps you might just want some help the with creation and submission of Variations, or a review of your strategy; we can be as little or as much involved in your Brexit plan as you wish. As daunting as it sounds the next couple of years can also be an exciting opportunity for new relationships and creative solutions.
Please contact Clarisse.Ceotto@panacea.im for further information.