Now we have just passed the six-month marker (1 July) until the European Medicines Agency (EMA) moves from its current location in London to Amsterdam, as a result of Brexit, we gauge industry response to this change…
Brexit opinion
Here, we speak with Colin Newbould, director of regulatory affairs and QP services, Wasdell Group, and Thomas Beck, senior vice president, Quality Management, Recipharm, to learn their opinions on the relocation and the potential impact this and Brexit may have on both the EU and the UK.
“The beginning of July marks the start of the six-month countdown to the EMA’s relocation of its operations to Amsterdam. Worryingly, there remains little guidance or clarity from the EMA as to the implications of the move, and Brexit, on the pharma industry,” said Beck.
“The initiatives shown by the UK government regarding a pragmatic approach to Brexit have not received any pragmatic response from the EMA which remains firm in its hard-Brexit approach. While this political game continues, most likely driven by the discussion of the fees the UK will have to pay to remain a member in the EMA, the industry is trying to plan and prepare, but with all the uncertainty it is far from optimal for patients.
“The EMA’s recent guidance documents may have confirmed that the findings of good manufacturing practice (GMP), good clinical practice (GCP) and pharmacovigilance inspections are expected to be valid for inspections carried out before 30 March 2019, as they will have been carried out in accordance with EU legislation, but little assurance has been given beyond that date.
“The best outcome is that a mutual recognition agreement is maintained between the EU and UK, meaning there will be limited to no immediate regulatory changes. The worst-case scenario, where no agreement is reached, may result in medicine shortages, which is extremely concerning.
“Treating the UK as a ‘third country’ post-Brexit also has the potential to create additional layers of complexity that manufacturers will have to adapt to if they are not already familiar with third-party importation practices.
“The challenge needs to be faced in a pragmatic way and details need to be confirmed and communicated as a matter of priority or patients across the UK and EU could suffer.”
“There is a lot of uncertainty surrounding the full impact of Brexit. Should the government press ahead with a ‘hard’ Brexit, it is likely the UK will become a third county operating under WTO rules which could have significant repercussions for the pharmaceutical industry, particularly with regards to the regulatory landscape,” stressed Newbould.
“The most obvious implication would be the requirement for EU and UK batch certification. For a product to be certified for the EU market it would potentially need to be retested on importation from the UK, unless the relevant regulatory bodies agree to grant mutual recognition agreements. Likewise, the UK may need to grant licenses for exported products. Implementing any additional measures to incorporate these requirements could have a noticeable effect on lead times, necessary resource and as a result overall cost.
In addition, the impact of the MHRA leaving the EU could result in significant divergence in approaches to medicine regulation. For many years the UK has not only been a very strong and well-respected agency within the EU, it has also supported the inspection activities of the EMA regularly. It is important that the industry takes the time to fully understand the potential impact of Brexit so as not to put undue pressure on regulatory departments and ensure it is well prepared for all the ramifications of leaving the EU.
“At Wasdell we have invested a lot of time into developing a strategic approach to Brexit that will allow us to continue working at a global level and continue to meet EU cGMP standards as an absolute minimum. We are currently actively engaging with our customers to ensure as little impact on their supply chain as possible. We already have short, medium and long-term plans in development to incorporate safety stock, change contractual derogated responsibilities, move customers to alternative importation sites where necessary and prepare our new facility in Ireland ahead of it becoming our EU headquarters.
“It is also worth mentioning that Brexit is creating opportunities as well, for example it has become vital that businesses review the complexity of their regulatory filing process and their supply chains, which ultimately could help to improve operations in the long run. Providing companies take a well-thought-through, strategic approach to Brexit they should be able to minimise any potential impact on supply.”