With the European Medicines Agency (EMA) relocating to Amsterdam before 29 March 2019, Pf sought the views of industry leaders to discuss the impact of Brexit and this relocation on pharma in the UK.
Paul Brooks, Executive Director, Regulatory Affairs Professionals Society (RAPS)
David Hukin, Head of Pharmacovigilance, Quanticate
Colin Newbould, Director of Regulatory Affairs and QP services, Wasdell Group
Impact of Brexit:
What are the current regulatory implications of Brexit?
Paul Brooks: Clarity on the operational trade and regulatory post-Brexit environment is urgently needed. It remains unclear whether the UK will fully align its regulations and regulatory processes for pharmaceuticals and medical devices with those of the EU, with reciprocal acceptance by other EU Member States (pre and post market), and this is undermining future regulatory planning and confidence.
UK agencies, including the Medicines and Healthcare products Regulatory Agency (MHRA), have been proactive in helping the industry negotiate this tricky landscape. They have, historically, been very visible in Europe, ensuring that EU regulations have been pragmatic, favourable to innovation and forward-looking while protecting patient interests. All stakeholders have benefitted from MHRA’s engagement in Brussels. The absence of MHRA’s perspective on future EU regulation negotiations could also leave a vacuum in available regulator expertise that will certainly be noticed.
David Hukin: One of the key considerations for the pharma industry when it comes to the impact of Brexit is pharmacovigilance (PV). The current situation is that, from 30 March 2019, PV activities which must take place in an EU member state (or other EEA territory) will no longer be able to be conducted in the UK.
On 17 July 2018, Parliament voted on an amendment tabled by Phillip Lee MP to require the Government to negotiate an agreement with the EU for the UK to participate in and align with Europe on medicines regulations and framework.
The Government opposed this amendment, however Parliament voted in its favour. This is significant for PV and access to medicines in general as it could mean the UK remains much more tightly aligned to the EU than in other areas. What that means regarding the licensing of medicines and alignment/cooperation
on a range of PV factors is still unknown.
Colin Newbould: 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.
What would happen if the UK became a ‘third country’?
Colin Newbould: 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 country operating under World Trade Organisation rules, which could have significant repercussions for the pharmaceutical industry, particularly with regards to the regulatory landscape.
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.
How will pharma businesses operate in a post-Brexit Europe?
Colin Newbould: 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 current good manufacturing practice standards as an absolute minimum. We are currently actively engaging with our customers to ensure as little impact on their supply chains 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.
David Hukin: There is very little time to prepare for what the pharmaceutical industry will look like post-Brexit and it is likely that it will affect companies and sponsors at a wider business level. As we move forward, it is vital that the industry carefully monitors output from the EMA and UK MHRA to guide their strategy. The concerns surrounding Brexit and its impact on the wider industry mean that it will be all too easy for companies to take their eye off the ball when it comes to ensuring they meet the new PV regulations, so it is vital that departments ensure the necessary changes are made.
The Parliamentary vote to remain part of the EMA is a promising sign that this could be simpler than previously thought.
We trust that the ongoing talks between the UK and EU will be constructive and keep patients at the forefront of discussions, ensuring access to new medicines is not delayed and the huge efforts towards PV harmonisation, improving patient safety, are not undone. However, it is possible that the UK will walk away from the negotiating table with no deal and no arrangements, transitional or otherwise, for the continued cooperation on the regulation of medicines and PV.
Paul Brooks: Currently, there are too many variables to be able to accurately predict what the future holds for UK pharmaceutical and medical device companies post-Brexit. It is similarly difficult to forecast what the wider economic and logistical impacts will be on the pharmaceutical and medical device industries within the UK and the EU, as well as manufacturers outside the EU and UK wishing to place products onto the UK market and via the UK into Europe.
Manufacturers with strong regulatory resources, intelligence and structure will be much better prepared to navigate the changing regulation landscapes, and these well-prepared companies will, no doubt, position themselves as the most competitive in the market.
As the healthcare product industry is not able to fully prepare for all the possible outcomes of Brexit as it stands, it’s imperative that it realises the increasing importance of its regulatory workforce in monitoring, influencing (where possible), interpreting developments, preparing contingency plans and reacting by delivering successful regulatory strategies.
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