Regulatory Divergence: The Burden of Brexit?

Editor's Note: This article was published in Pharmaceutical Technology Europe's January 2019 print issue. 

With the deadline for the United Kingdom’s exit from the European Union rapidly approaching, the intricacies and complexities of the break-up between the regions are becoming more apparent. For the pharmaceutical industry, in particular, there have been numerous concerns raised about the impact of Brexit and the potential ramifications of a ‘worst-case’ scenario outcome (1). 

Under the current system, all members of the EU benefit from universal access to any European qualified person (QP) to sign-off and release a medicinal product to the European market. However, after 29 March 2019 this situation may change.

To assess the potential issues facing QPs both in the UK and Europe, Pharmaceutical Technology Europe spoke with Colin Newbould, director of regulatory affairs and QP services at The Wasdell Group, about the role of the QP and the impact of Brexit in more detail.

The QP and Brexit

PTE: Could you briefly run through the key aspects of the role of a QP?

Newbould: The QP’s role is defined by several pieces of legislation:

• Article 51 of Directive 2001/83/EC for Medicinal Products 

• Article 13 of Directive 2001/20/EC for Investigational Medicinal Products

• Eudralex, Volume 4, Annex 16, Section 1.7.

This should include the manufacturing sites of the starting materials and packaging materials for the medicinal product and any other materials deemed critical through a risk assessment of the manufacturing process.

PTE: What would be considered the ‘best-case’ Brexit scenario for a QP in the UK and for those in the EU?

Newbould: In the best-case scenario, there needs to be parity recognition between the UK and the EU for QPs when it comes to their authority, legal status, and qualification. This would ensure that batches can be released between the UK and EU without further auditing being required. Ultimately, this will negate any risk of delay or shortage in drug delivery.

PTE: What would be the ‘worst-case’ Brexit scenario?

Newbould: Any regulatory divergence will result in additional auditing throughout supply chains for products being shipped between the EU and UK. There’s a risk of a reduction in standards and increased variability within EU as a significant proportion of QP certifications for the EU are currently provided from the UK. Seventy percent of clinical trials are managed through the UK, as a result EU QPs will be less familiar with the standards and requirements associated with them. Losing access to this expertise will be a blow for the EU.

In the longer-term and on a more practical level, there will be issues around experience as QPs may have to familiarize themselves with entirely new requirements and there will no doubt be some scepticism as any new requirements bed-in. Potentially, QPs could find themselves unknowingly acting illegally as they aren’t familiar with new requirements. 

As it stands, there remains a lack of clarity in this area.

QP certifications and resources

PTE: Currently the UK manages a significant proportion of QP certifications for the EU. Has there been any/realistic advice from either the UK government or the EMA on how this work will be covered if UK QPs are no longer recognized in the EU post-Brexit?

Newbould: This is still largely unknown. There is some clarity for specific roles such as Qualified Person Responsible for Pharmacovigilance (QPPV) who must be a resident in the EU. Certain member states have indicated they will recognize UK QPs if they are named on a licence in practice-however, it remains to be seen if the EU and UK will agree to this at a regulatory level. 

PTE: Do you anticipate there may be a rebalance of the talent pool of QPs within the UK and EU post-Brexit?

Newbould: There has always been a shortage of talent in the QP space, so any rebalance will not be simple or quick.

Relocation of EMA

PTE: Does the relocation of the EMA impact QPs directly or has this had wider regulatory implications?

Newbould: The EMA is anticipating that it will lose almost a third of its staff in relocating to Amsterdam, which will no doubt have a knock-on effect on the resources available and ability to cope with routine activities. There are already discussions of suspending or reducing activities, including work on developing and updating guidelines, beyond that which was originally proposed to ensure core activities continue unaffected. 

The implication is a short-term slowdown in the development of new regulations. 

Reference

1. PharmTech, “Prioritizing Pragmatism in Face of a ‘no-deal’ Brexit,” pharmtech.com, 20 November 2018.  

Article Details

Pharmaceutical Technology Europe Vol. 31, No. 1 January 2019 Pages: 44–45  

Citation

When referring to this article, please cite it as F. Thomas, “Regulatory Divergence: The Burden of Brexit,"

Pharmaceutical Technology Europe

31 (1) 2019.