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Brexit, Medicines, and Trials: A Report from the U.K.

by Imogen Cheese

Several members of my family live in mainland Europe and join huge numbers of British expats concerned about how Brexit will impact their daily lives. My father, who takes a daily medication to treat his prostate cancer, fears the potential impact on reimbursement and therefore his long- term survival.

Here in the U.K., there have been rumblings for some time about stockpiling medications and the possibility of a shortage of supply as the borders and import/export regulations change. The U.K. government launched plans to fly in emergency supplies and have drawn up risk scenarios for drug rationing. The slow drip-feeding of this information through the media has caused great concern and anxiety for the patient community.

With the final decision about what type of Brexit we will have, which is still very much under debate, and with the deadline looming closer, the supply of drugs has already become a problem. There are now over 85 common drugs in short supply across the U.K., and the price of hundreds of other key drugs have increased exponentially to meet with the demand.

Some pharmacists have reportedly contacted the National Health Service (NHS) in England with grave concerns about the impact of missed treatments for many of their patients. There are cynics who claim the increased costs are merely opportunism and pessimists who declare that the current state of the drug supply is the tip of the iceberg. They say that within months it won’t be common drugs that the U.K. will face supply issues with, it will be cancer treatments and even the supply of drugs for clinical trials.

Over the last year, I have had several conversations with colleagues discussing how best to manage the impact of Brexit upon clinical trials. I know of several studies that have been delayed while awaiting the decision. Other clients have expressed fears of increased costs with the supply of trial materials in and out of the U.K. and how this affects the placement of study sites.

The final closure last month of the European Medicines Agency offices in the U.K. was a monumental event as the industry witnessed the departure of colleagues and friends moving to Amsterdam. The 1,000 people who worked at the EMA offices faced relocation or job changes, which impacted their lives and those of their immediate families. Local businesses face the loss of income generated by the 36,000 regulators and scientists that would visit the EMA annually, a painful long-term impact on the U.K. economy. To many, this felt like a backward step in progress and collaboration.

Cancer Research UK published an advisory report last year to the U.K. government that covered all aspects of the potential risk of a hard Brexit, from staff shortages and drug supply to research collaboration. In 2017, there were 823 applications for commercial trials of medicines in the U.K. Eighty percent of clinical trials are global, so it is in the long-term interest of medical research and the patient community for the effect of Brexit to be both short lived and where possible, negated.

I sit in a unique position of working within the industry and therefore understanding the commercial risks and impacts of Brexit and also the more personal and emotional position as a patient and advocate.

Patients fear stagnation in clinical research. With international cooperation comes progress and great strides forward in the development and bringing to market of new innovative treatments. Will the disjointing effect between the U.K. and the EU have a detrimental impact on clinical research?  Will the impact of Brexit cause so much undue bureaucratic red tape that patients in the U.K. will have to wait longer than our counterparts on the continent to obtain access to trials, treatments, and new drugs?

The most likely scenario is that there will be a significant impact no matter the outcome of Brexit. There will be delays, new systems, processes and laws which need to be created, absorbed into policy, and adjusted to. This will not be an overnight process and there simply is no way to fully prepare for these eventualities. We can already feel the shift in recruitment and the already overstretched NHS bracing itself for the harsh negative impact.

In a recent article, David Meek, CEO of Ipsen, warned that leaving the EU will affect the buying power and position of the U.K. government to obtain the same prices and supply levels of key approved drugs as we may have historically accepted. While the frustration resulting from chaos importing and exporting supplies might be short-lived, the potential longer-term ramifications that will directly impact patients continue to unfold.

At Imperial, with our existing clients, we work to put contingencies in place. This includes ensuring sites are adequately stocked, where possible, to ensure no delays or impact to studies. We work with Brexit risk assessors in each client’s organisation to set up processes unique to them that help us manage their supply and stock effectively. Our flexibility and the immediate responsiveness of the Imperial marketplace is part of our process designed to help mitigate concerns over such delays.

The ongoing attempts to mitigate risk and prepare for all potential eventualities is challenging, and the patient community are grateful for all attempts to minimize the storm that’s heading our way.

Brexit has created further anxiety for patients that may already feel hopeless and lost in the system. While treatments and care pathways may be like the light at the end of the tunnel for so many, the tunnel seems longer now. We might end up as the greatest victim in this turf war, yet the irony is that as patients we exist in a constant bubble of uncertainty as our survival plays out in front of us on a daily basis, so we might actually be better able to navigate this drama than most. Patient vulnerability is both our weakness and strength, and we already anticipated a fight… because every day we live one.

In the last week, the drama continues to unfold, with questions raised over a possible second referendum. Whatever the outcome, patients will be affected, and I will follow up after Brexit.

 

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