By Steve Mann, Director of External Regulatory Affairs, Nelsons
To say the world has changed over the last couple of years might just be the understatement of the century — but as we begin to emerge from the shadow of COVID-19, into a trading environment as difficult as we’ve ever had to deal with, an old specter is looming large on our regulatory radar. COVID-19 has certainly taken center stage since I wrote an article for AAHP in 2020, but the topic of that particular piece (the UK’s departure from the EU) has been lurking in the shadows ever since — resurfacing occasionally and causing a stir between lockdowns and social restrictions.
At the previous time of writing, the UK had, in fact, already left the EU and was transitioning towards its own national, legislative framework. Despite that, very little had actually changed. A rift was seemingly forming in the English channel, separating the UK from the Regulations and Directives coming out of Brussels — but the transition process would take time, and any changes weren’t going to kick in overnight. So, it was going to take a couple of years before we would really know how the EU and UK regulatory frameworks could be disentangled and what businesses would need to do to comply. A couple of years later, things aren’t all that much clearer.
The regulatory framework for homeopathic drugs has been long established in the EU. Sure, its ride has been a little bumpy on occasions, and its implementation and interpretation across the EU Member States hasn’t always been consistent. But a framework nevertheless exists and, for all intents and purposes, works the same way in both the UK and the EU. Homeopathic drugs require pre-market approval before commercialization, and there are two regulatory pathways: one with label indications and one without. Requirements for Good Manufacturing and Distribution Practice also apply to homeopathic drugs, and to a lesser extent, Good Pharmacovigilance Practice as well (depending on the type of drug you market). But whilst there are specific requirements that homeopathic drugs and manufacturing facilities must meet, they are also tied into the broader web of regulations, directives, and other requirements that govern the pharmaceutical industry as a whole. Nobody was ever under any illusions that to disentangle the UK from all this was going to be straightforward. The only viable option during transition was to simply pick up all the EU legislation and transpose it directly into UK law. That caused several issues to emerge quite quickly.
One of the first was centered around the EU requirements for Qualified Persons — both in terms of Product Quality and Pharmacovigilance. For all batches of drugs released to the EU market, homeopathic or otherwise, they must be released by Qualified Person (QP) who must reside in the EU. So, before Brexit, a UK company could manufacture homeopathic drugs in the UK and release them for sale throughout the EU via their UK based QP. After Brexit, those same products can only be sold in the EU if they are released by QP who resides in the EU. So, a UK QP can no longer release products for sale in the EU, meaning a second batch release process must take place within the EU, increasing cost, complexity, and adding to the regulatory burden. Similar requirements apply to Qualified Persons for Pharmacovigilance (QPPV) — a drug manufacturer must retain the services of a QPPV, and they must reside in an EU Member State if you export any drugs into the EU. So many companies were faced with employing additional Qualified Persons and duplicating processes and procedures to meet both UK and EU requirements for their drug products.
Politics has, of course, had a significant role to play as well, and especially with the territory of Northern Ireland (NI). Quite bizarrely, both UK and EU requirements apply in this region of the UK, which creates a great many practical problems in the day-to-day running of a business. Whilst common sense is beginning to prevail for some requirements, the search for pragmatic solutions to many of the legislative conundrums still continues, and these will only increase as and when the UK and EU legislative frameworks diverge and evolve.
Political pressure is also mounting to deliver the promises outlined in the government’s Brexit manifesto. One of the drivers behind the Brexit process was that the UK would be able to enjoy greater freedom from EU regulation. But if the UK is to set its own rules and requirements, what does this mean for businesses who export products into the EU — they will have two different sets of requirements to meet, rather than one? And what might happen in the future as EU regulations evolve and change? Will this leave UK products in a position of non-compliance?
As organizations analyzed their businesses in preparation for Brexit, whether UK or EU based, many began to realize that the legislative web surrounding them was more complex than they previously thought. The volume of legislation and regulation specifically for homeopathy in the UK and EU is, in the grand scheme of things, relatively brief. There are both pros and cons to this, but at least it makes it fairly straightforward to track. What is much more difficult is keeping abreast of every other piece of legislation that can potentially have an impact on your business, either directly or indirectly. Whilst we tend to focus on GxP fields of activity, Brexit analysis and preparedness workstreams have shown us that the legislative web extends way beyond this.
As we entered the Brexit process, there was concern about how changes to the rules and regulations governing homeopathy could impact the industry. Quickly, the focus changed to encompass GxP activities as a whole, and how future changes here may result in collateral damage. That process has evolved yet further to encompass end-to-end business activities and to examine the legislative web through a more holistic lens. That can be a very valuable and enlightening exercise, irrespective of whether your organization is based in the UK, EU, or elsewhere. But it’s also a significant undertaking, and one which small- and medium-sized businesses may struggle to complete.
A collaborative approach across industry, not just regionally and nationally, but also internationally, to gather and disseminate “regulatory intelligence” is perhaps long overdue. The more complex that global regulation becomes, the better prepared we will be as an industry to manage the regulatory environment of the future.