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Raman Sehgal, ramarketing (Newcastle, UK).
Raman Sehgal talks to three industry leaders for their insights on the challenges faced across the life science sector and how the EMA needs to respond.
July 1, 2018 marked the start of the six-month countdown to the European Medicines Agency (EMA) 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.
Three industry leaders-Colin Newbould, director of regulatory affairs and QP services, Wasdell Group; Thomas Beck, Senior Vice President, Quality Management, Recipharm; and Paul Brooks, executive director, Regulatory Affairs Professionals Society (RAPS)-gave us their insights on the challenges faced across the life science sector and how the EMA needs to respond.
Thomas Beck: The initiatives shown by the UK government regarding a pragmatic approach to Brexit have not received any 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 March 30, 2019, as they will have been carried out in accordance with EU legislation, but little assurance has been given beyond that date.
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 county operating under WTO 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.
Beck: 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.
Newbould: 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.
Paul Brooks: Failing to reach a desirable outcome could be a significant problem for the UK pharmaceutical and medical device markets as it could potentially lead to a duplication of regulatory efforts if the processes and procedures for the UK and EU significantly diverge and/or don’t achieve mutual recognition. This could have serious consequences, including increased costs, time and resourcing for manufacturers. It is anticipated that most companies are implementing contingency plans, based on incomplete information, so that they are somewhat prepared should negotiations fail to align regulatory frameworks and clearance between the UK and EU.
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.
Beck: 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.
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.
Brooks: Clarity on the operational trade and regulatory post-Brexit environment is urgently needed. It remains unclear whether the UK will align its regulations and regulatory processes for pharmaceuticals and medical devices with those of the EU, with reciprocal acceptance by other EU Member States, and this is undermining future regulatory planning and confidence.
Newbould: 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.
Raman Sehgal is the founder of ramarketing (Newcastle, UK).