With bated breath: Examining the regulatory concerns in the uncertain political future

As pharma anticipates the forthcoming Brexit negotiations and future uncertainty, Stephie Castling, senior marketing executive from Denny Bros, examines the regulatory concerns coming to the fore in the industry.

As the country holds its breath over Brexit negotiations and an uncertain future, the pharmaceutical industry is understandably starting to ask questions. One of the current concerns is around the future of the EU’s Falsified Medicines Directive (FMD).

The directive has been on the table for a number of years now as a crucial way of preventing fake drugs getting through the system. In early 2016, the European Commission published a delegated regulation that enforces two safety features be placed on the packaging of most human medicines by no later than 9 February 2019. These two features are a unique identifier — namely a two-dimension barcode — and an anti-tampering device and both will guarantee the authenticity of medicine for the benefit of patients and businesses alike.

Prior to the Brexit vote, the progression towards compliance with this delegated regulation was going smoothly. My hope is that this will not change.

Earlier this year, we were hit with the news that the European Medicines Agency (EMA), the watchdog for approving and monitoring the safety of drugs across the continent, was preparing to leave London in the wake of Britain triggering the process to exit the EU — Article 50.

Uncertain times in one way, but our message is a far more certain one.

Is it still applicable?

Over the last few months, I have heard a few whispers questioning whether the EU FMD would still apply when Brexit negotiations are complete!

From our point of view, we shouldn’t be worrying about politicians around the table. The directive is still clear and makes perfect sense in the fight against counterfeiters. It is still relevant and should still be adhered to regardless of the political landscape.

My hope is that most companies will continue with the directive’s guidelines. Against that, our worry is that some won’t prioritise this as much as they should, that they will hide behind the Brexit negotiations and put off taking action until much nearer February 2019.

This would be wrong on so many levels.

With many solutions in the offering for companies to assist in regulatory compliance there really is no excuse for a last minute panic. At Denny Bros, for example, we provide a range of pharmaceutical labelling solutions that support compliance with the EU FMD, including tamper-evident labels and the ability to incorporate a unique serial number to identify and authenticate individual products.

The directive provides a perfect platform against fraudsters with the unique identification code logged onto a central database by the manufacturer and medicines verified at the point of dispensing across Europe.

It is obviously going to help companies, both in terms of profits — through a better inventory and the ability to streamline a product — but also, most importantly, it will prevent fakes from getting onto the market.

We shouldn’t be adopting a wait-and-see approach and I remain confident that the majority of companies will act now rather than wait for the future.

Challenges and concerns

Like with so many walks of life, Brexit will continue to pose challenges and concerns in the coming years.

For one, health secretary Jeremy Hunt has indicated that he expects that the UK will leave the EMA organisation — a move that has led some to believe it will have a detrimental effect on British pharma. However, that is an issue that may have to wait for another day with so many unanswered questions remaining about the UK’s future relationship with the EU.

Regardless of the future, the standards set out by the EMA should be adhered to for safety reasons and common sense business practice. The same very much applies to the EU FMD.