As No-Deal Brexit Becomes More Likely, Drug Makers Warn of "Immediate Threat" to Patients

After the UK Parliament voted to reject Prime Minister Theresa May’s proposed Brexit deal with just weeks to go before the United Kingdom’s planned withdrawal from the European Union, the pharmaceutical industry has warned that a no-deal Brexit poses “tangible and immediate threats” to patient safety and public health.

That warning came from the European Federation of Pharmaceutical Industries and Associations (EFPIA) in a statement issued after May’s deal was voted down. EFPIA’s director general, Nathalie Moll, said in a statement that “Now is the time for policy makers in the [United Kingdom] and the [European Union] to put politics aside and put measures in place to prevent patients being harmed by the consequences of Brexit. In particular, from disruption to the supply of medicines including from transport delays at the border and where the development, manufacture, packaging, safety testing, and regulation of the medicine no longer benefits from mutual recognition.”

EFPIA called on negotiators to agree to a set of key actions to protect patients, such as exempting medicines and clinical trial materials from customs and border checks, coordinating fast-track lanes for the transport of medicines into ports, and potentially exempting active pharmaceutical ingredients from border checks to ensure that drug manufacturing can continue with limited disruption.

The Association of the British Pharmaceutical Industry (ABPI) also called on the UK government to bring clarity to the industry. In a statement, Mike Thompson, chief executive of ABPI, said, “We reiterate that ‘no deal’ would prove to be extremely challenging. With time running out, we hope Parliament will come together and quickly find a solution to the stalemate and reassure patients that medicines will not be disrupted come March 2019.”

Meanwhile, drug companies are making their own plans to avoid disruptions to the flow of medicines in the event of a no-deal Brexit. This week, Bloomberg reported that Novo Nordisk has begun to book air freight slots for its medicines so that insulin can be flown into the United Kingdom (which does not manufacture any of its own analogue or synthetic human insulin) if necessary. Fellow insulin maker Sanofi is currently testing alternative routes (from the Netherlands to the eastern coast and from France to the south) into the United Kingdom.

Even before embracing such options, drug makers had begun to stockpile their products after UK Health Secretary Matt Hancock advised that trade delays at the border could last for as long as 6 months. The specific drugs that are being stockpiled are not known, however; as The Guardian reported in December 2018, the UK government has demanded that pharmaceutical companies and organizations that are working in concert with the government to maintain supplies of their products sign nondisclosure agreements that prevent them from disclosing any details of their contingency plans.