Maintaining robust quality control standards is a key priority for any commercial industry – but for pharmaceutical manufacturers, it can literally be a matter of life and death. The medical sector is one of the most stringently regulated in the world, and drugmakers recognize the importance of these rules as a key cornerstone of the trust that patients and medical professionals place in their products.
As such, the looming Brexit deadline is likely to be seen as a pivotal moment by those operating in the sector. The prospect of the UK leaving the European Union, and the jurisdiction of the EU’s unified single market for medicine regulation, is creating considerable uncertainty for drugmakers. This is only furthered by the ongoing lack of clarity about the terms of the UK’s departure, and the timescales involved in transitioning over to a new regulatory framework.
For pharmaceutical companies based in Europe or that deal regularly with the EU and UK markets, this upheaval could be significant – which is why it has arguably never been more important for manufacturers to ensure their internal quality control methodologies are up to standard.
What are the regulatory implications of Brexit?
Since the UK officially commenced the process of withdrawing from the EU in March 2017, it has been clear that this will mean the UK drug market will move outside the jurisdiction of the European Medicines Agency (EMA); EU marketing authorization applications delivered via the EMA’s centralized procedure will no longer be applicable.
Several steps have already been taken to make this a reality – most notably, the relocation of the EMA headquarters from London to Amsterdam – but beyond that, the full regulatory implications of Brexit on medicine testing and approvals remain somewhat unclear. It is assumed that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), which currently works with the EMA as part of an EU-wide governance network, will become the sector's primary regulator in Britain. However, the details are yet to be confirmed about how this will work in practice.
The UK government has pledged to ensure that all medicines currently approved under EU law will have their status automatically upheld after Brexit, even in the event of a no-deal departure; but from that point onwards, the picture is less clear. On the one hand, various health organizations, medical professionals and pharmaceutical companies have expressed a clear preference for the UK to maintain regulatory alignment with the EMA on medicines, as they believe this would help ensure that patient safety and public health standards are upheld. Conversely, the British government has been keen for Brexit to provide an opportunity to apply UK-specific criteria to the regulation of drugs – for example, in determining which rare disease medicinal products qualify for orphan drug status.
What challenges will this pose for pharmaceutical testing?
Unless a so-called “soft Brexit” deal is passed, in which the UK maintains regulatory consistency with the EU even after its withdrawal, it seems likely that businesses should be expecting some degree of change to the drug testing and regulatory approvals process.
Inevitably, this process is likely to throw up challenges. At the very least, Brexit will mean that a significant amount of product labeling will need to be amended and updated to comply with new UK-specific requirements. In future, this regulatory divergence could increase further; companies may have to submit their medicines through two different approval processes in order to carry on trading in both the EU and UK.
At a time when pharmaceutical manufacturing is moving away from its past reliance on exclusive blockbuster drugs and towards a more varied manufacturing model, this could create substantial amounts of red tape. Many contract-based manufacturers produce multiple generic products using the same facilities and equipment, while others are stepping back from the one-size-fits-all therapy to explore personalized medicine approaches; both of these cases could potentially require rigorous testing of multiple products under two distinct regulatory frameworks.
The greatest worry remains that the UK will leave the EU without a withdrawal agreement in place, which could create significant confusion about how medicines should be approved and traded between the regions until a new working relationship can be established. In this instance, the concern would be that the lack of clarity may lead to a drop in standards, or create ambiguity that can be exploited by counterfeiters – especially if a no-deal Brexit creates a shortage and subsequent urgent demand for medical supplies.
Can tried-and-tested QC methods help to provide certainty?
Until the full details of the UK’s withdrawal approach have been finalized, it is difficult for companies to form specific expectations about what Brexit will bring. However, this is not to say it is impossible for them to prepare for change.
At a time when laws and industry conditions are changing in unpredictable ways, it has never been more important for pharmaceutical manufacturers to be able to rely on the robustness of their own internal quality assurance processes, regardless of external factors. As Brexit looms, it is therefore vital for drugmakers to make sure they are doing all they can to create the safest, purest medicines, using tried-and-tested methodologies that are proven to deliver the right results.
Elemental analysis is one of the most important examples of this, providing manufacturers with a reliable means of shoring up the microbial integrity of their therapies, and preventing cross-contamination between product batches. In particular, total organic carbon (TOC) analysis is widely accepted as a gold standard QC method by every major regulator, including the EMA and MHRA, highlighting its status as an essentially Brexit-proof investment.
TOC analysis is used as a screening parameter to identify carbon containing residues in vessels used in manufacturing, in order to check they have been properly cleaned and decontaminated between batches. By ensuring they are well-equipped with these capabilities, pharmaceutical companies will be guaranteeing that their drugs are being produced to an extremely high standard – thereby increasing their readiness for any post-Brexit regulatory requirements.
After all, major change and upheaval are often unwelcome factors in medicine, science and business alike – but they are also inevitabilities. Whatever the eventual outcome of Brexit, the best way for pharmaceutical manufacturers to prepare remains the same as always: to stay committed to the timeless principles of quality, purity and traceability in their products, and to embrace the methods that have been proven to deliver the right results.