As the director of regulatory affairs and QP services at The Wasdell Group, Colin Newbould is responsible for developing and implementing the company strategy to ensure world-class compliance, effective processes and customer satisfaction. Along with his position as director of QP services, he is also one of Wasdell’s QPs for certification to the European market. We asked for his views on what the worst and best case Brexit scenarios could be mean for contract services and the wider pharma industry.
What impact is Brexit likely to have on the current regulatory landscape in Europe?
There is a lot of uncertainty surrounding the impact that Brexit will have. It’s looking likely that in the case of a ‘hard’ Brexit, the UK will become a ‘third country’ operating under World Trade Organisation (WTO) rules. The upshot is that there could be significant changes for pharmaceutical companies in the UK and an upheaval of the current regulatory landscape.
For example, the UK currently manages 70% of all clinical trials QP certification for the EU, following Brexit we may no longer have access to the clinical trials portal. This would require the creation of separate clinical trials applications processes for the EU and the UK, as well as separate QP certification. This will increase the complexity, lead times and costs of running a clinical trial and could ultimately result in fewer studies being conducted in the UK and less drugs reaching the market.
There is also likely to be a significant impact on marketing authorisations as all UK centrally authorised products (CAPs) will need to be moved to the EU so that EU QP certification and QPPV can take place in the EU. This again will incur time, cost and resource in terms of manpower. Currently 37% of CAPs are held by UK-based companies and these products will also need to be reassigned to a legal entity in the EU which may not currently exist. Without a clear understanding of the full impact on CAPs, for example whether the UK will also need to grant UK licenses for CAPs, it will not be clear how much of an impact these variations will have on companies.
In addition to separate EU and UK batch certification, products will also need to be re-tested on importation unless the relevant regulatory bodies agree to grant mutual recognition agreements. This will demand more laboratory resource for method transfer and routine testing. And, where the UK manufactures active pharmaceutical ingredients, the MHRA may need to confirm these meet cGMP as per the ‘white list’. Then, referenced and retained samples will need to be stored in the EU.
Moving the marketing authorisation to another location will also require changes to packaging, labelling and patient information leaflets and this will coincide with implementing EU Falsified Medicines Directive compliance. The two together are likely to put regulatory departments under pressure so it’s vital that companies are prepared for these changes.
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. The impact within the EU may see delays in medicinal product approval, supply chain impact due to variation delays. Marketing Authorisation Holders (MAHs) may not vary licences which could see certain low volume markets not supplied.
It is worth understanding that the UK is a very significant importer of medicinal products from both the EU, but more importantly from third country medicinal products suppliers around the globe. Although this importation into the UK will have very little impact to the UK medicinal product availability, many of these products are subsequently exported into the EU. The UK is a net exporter of medicinal products into the EU market and without sensible rules and pragmatism significant harm could result to patients throughout the EU and UK.
Will Brexit impact the EU FMD regulatory changes?
The UK is committed to the implementation of the FMD regulations. The potential impact to the UK will be the access to the European Medicines Verification System (EMVS) which has been established and should guarantee medicines authenticity by an end-to-end verification.
There is a requirement for each member state to hold a National MVS, which is UKMVS in our country. The impact and consequences to how this will connect or not are not yet fully understood.
Has the EMA’s decision to move out of the UK had any immediate impact on the regulatory landscape? How can we expect this to evolve?
It was disappointing to see the action taken to relocate this agency so quickly before the clarity of Brexit was understood. There did seem to be other transitional options that could have been developed to leave the agency in place until the full extent of Brexit had been clearly defined. For example, a diplomatic arrangement could have been granted which may have helped smooth the significant turmoil of a full relocation.
The decision to move has already seen many people leave the agency which may have an impact on its ability to support all the necessary regulatory functions and implement the changes that will be required. Also, as the MHRA has traditionally been a significant support agency to the EMA, the ability of the EMA to support foreign inspections and licencing review will likely be impacted.
The UK has always had a strong development expertise and large pharmaceutical organisations have stated on the record that they will continue with this strategy. The medicines manufactured within the UK will continue to be made to the highest standards of GMP.
Are there any positive moves that can come out of the UK’s exit from EU? If so, what are they?
Yes, the UK is a large economy, with a strong and well respected regulatory history. Our industry is well established, and we are a significant exporter of medicine into the US and the rest of the world. The UK has previously held bilateral mutual recognition between the MHRA and FDA, so this could be a very significant opportunity and gateway for medicinal product supply chain growth. Where the UK supports global supplies, these may not change and could potentially grow depending on what complexity arise as we exit the EU.
What is the worst-case scenario for when Brexit finally occurs? How can companies mitigate these risks?
The worst-case scenario is that there is no agreement, meaning the immediate implementation of a ‘hard’ Brexit. It would be unlikely that all changes to licencing, legal entity generation and packaging would be completed in time and as such medicinal product supply chains would be immediately impacted. These delays could have wider impact on medicines in cold chain as they could become damaged and unsafe, which could potentially lead to rationing of critical medicines.
What (if any) trends have occurred where pharmaceutical contract providers have tried to mitigate risks associated with leaving EU? Have UK companies started to re-locate to the EU so they can continue to operate separately to UK?
Companies have adopted different approaches to create contingency plans. Some companies have developed joint ventures and co-location of premises in the EU. Other companies have looked to building a new facility and legal entity to provide continuity and contingency for their customers and markets. Due to the complexity of the manufacturing supply chains, not all operations can be moved, and more elaborate mechanisms will need to be developed.
As for the wider European contract services landscape, if the UK is no longer authorised to provide supply then the immediate impact will likely be a lack of capacity within the EU to meet the full demand. This may result in some short-term growth of the EU packaging industry as a result. Unless these strategic decisions have been made, many companies in the EU would be between two and five years away from delivering a full solution. Since we are building a global operation to fit the Brexit model at Wasdell, we expect this will be aligned without impact.
Raman Sehgal is founder of ramarketing