Europe and the supply of innovative medicines: why it matters

One of the standout features of the ‘no-deal’ Brexit debate has been the focus on the impact on supplies of medicines and medicinal products. This includes everything from chemical compounds and investigational medicinal products (IMPs) for clinical research through to short shelf-life medicines made on the continent. The debate has been a continuous battle between those outlining the possible impact on patients’ lives while struggling to quantify the extent of the impact.

Some areas of concern

Innovative medicines, such as new cancer treatments, are expected to be amongst those to see trade delays in a ‘no deal’ scenario on October 31. More than 1 in 4 clinical trials funded by Cancer Research UK, for example, involve at least one other European country, and this is even higher for rare and children’s cancers. The suggestion is that the most vulnerable patients could face the biggest impact.
With its hand forced by Parliament, the British Government published its heavily redacted “Operation Yellowhammer”, reams of guidance and impact assessment on a possible no deal scenario for exiting the European Union. The document, published in August of this year, states that “the reliance of medicines and medical products’ supply chains on the short straits crossing make them particularly vulnerable to severe extended delays.” The document also went on to say that “three-quarters of medicines come via the short straits.” That’s a significant portion of medicines and products coming into the UK that could be disrupted by abandoning customs arrangements – a particular concern when a few days could mean the difference between life and death for some patients.

For the UK’s healthcare industry, it is also the ability to conduct clinical research as much as the supply of ready-approved medicines that worries many. The UK has played a vital role in the development of new EU-wide legislation for clinical research which sought to make it easier and more expeditious to conduct studies across Europe. Now the UK risks losing its eminence in Europe, meaning it will take longer to bring innovative medicines to market. There could be a loss of investment in the UK as pharmaceutical companies look to place their studies in cost-effective and predictable environments with minimal barriers for entry into the marketplace.

Making health care a priority

As the Government has ramped up its rhetoric over the likelihood of a ‘no deal scenario’ in the last few months, medical charities and bodies have kept a close eye. In August, the Royal Pharmaceutical Society, along with 16 other health organisations – including other royal colleges, the British Dental Association and Kidney Care UK – signed a letter calling for healthcare to be a primary concern for no-deal preparations in order to minimise the consequences previously outlined. “We are simply unable to reassure patients,” the letter states, “that their health and care won’t be negatively impacted by the UK’s exit from the EU.” As stated by others such as Cancer Research UK, the letter again cites the risk of delays at the border, causing reduced access to life-saving medication and medical devices.

Moreover, since the Brexit ‘deadline’ was pushed from March to October, our healthcare system now faces embracing a no deal Brexit just a matter of weeks before the winter and flu season begins. If the Government has failed to prepare sufficiently for these risks, there is a concern in the healthcare sector that it may place great and unnecessary pressure on care delivery.

Many in the healthcare and research sectors are aware of the challenges posed by a no deal Brexit, however, they feel that the Government will not listen to their concerns. Many suggest that whatever happens with Brexit, the outcome will be the same no matter what they do. Nonetheless, if the Government is going to prioritise healthcare in a post-Brexit world, it needs to hear the voice of the sector. Those whose businesses are due to be impacted significantly by any Brexit scenario ought to be engaging with Government now to make sure its concerns are considered in the months and years ahead.

See more articles by Ian Perrin