Prime Directive

Stuart Pritchard December 19, 2017

 

 

 

Senior Marketing Executive at Denny Bros, STEPHIE CASTING, looks at the potential threat Brexit poses to medicine safety…

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. 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 February 9th, 2019. These two features were a unique identifier – namely a two-dimension barcode – and an anti-tampering device, and both would guarantee the authenticity of medicine for the benefit of patients and businesses alike. This was all progressing smoothly until the Brexit vote. My hope is that this will not change.

SAFETY SENSE

Last month 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. Uncertain times

You can never be too safe when to comes safeguarding against falsified medicines

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

Over the last few months, I have heard a few whispers about whether the Falsified Medicines Directive would still comply when 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 save taking action until much nearer February 2019. This would be wrong on so many levels, as 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.

FEND OFF FAKES

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

EU regulations for medicines will help defeat counterfeiters

remain confident that the majority of companies will act now rather than wait for the future.

At Denny Bros, we provide a range of pharmaceutical labelling solutions that support compliance with the Falsified Medicines Directive regarding packaging for prescription drugs and high risk over-the-counter medicines. These include tamper-evident labels and the ability to incorporate a unique serial number to identify and authenticate individual products.

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. But that is for another day, with so many unanswered questions remaining about the UK’s future relationship with the EU.

PHARMA’S FUTURE

Regardless of the future, the standards set by EMA should be adhered to for safety reasons and common sense business practice; the same very much applies to the Falsified Medicines Directive.

www.dennysbros.com