After Brexit, will patients get the medicines they need?
Since the UK public voted to leave the European Union, the potential impact on our healthcare systems has begun to loom large. For most sectors, the issues around Brexit are economic. But medicines are different. As the research-based pharmaceutical industry, the medicines we make improve the quality of life, often save the lives of patients in the UK and across Europe. For us, the primary concern around Brexit has always been patient safety and public health, in particular the uninterrupted supply of medicines to patients in the 27 EU Member States and the United Kingdom.
The scale of the task should not be underestimated, around 1 billion packs of medicines cross the UK-EU border each year. That’s around 45 million per month from the UK to the EU and 37 million in the other direction. As the long-running political uncertainty around the future relationship between the UK and the EU continues, our industry has committed to planning for every outcome.
In practice it has meant companies preparing in earnest for a “no deal” scenario. Every company, has made changes to product supply chains as a consequence of Brexit. This includes stockpiling medicines, duplicating drug testing, transferring licences and making plans to ship drugs to and from the EU on ferries leased by the UK government via six new port routes. Medical isotopes for cancer treatment and other supplies with a short shelf life may be transferred by plane in what is one of the biggest supply-chain logistics challenges our industry and our health service partners have ever faced.
Despite these intensive preparations, leaving under a no deal, without a transition period would overnight take the UK out of a regulatory, patient safety, medicines supply and clinical research framework that has taken decades to evolve. Whatever the actions taken by our industry, getting medicines to patients involves a wide range of actors from regulatory bodies to transport companies, wholesalers to governments.
Considering the urgency and the importance of medicines to all our health, we have been concerned by a certain lack of focus, outside of our industry, on protecting medicines supply. We have witnessed positive action in areas such as fisheries, transport and financial services but more needs to be done to protect public health and the supply of medicines to patients.
There are some key actions that should be taken immediately. Despite companies’ best efforts, where the transfer of medicines testing from the UK to the EU cannot be completed by the 30 March 2019, then the EU and its Member States should allow the use of medicines currently quality tested in the UK. Similarly, medical devices used in conjunction with medicines that currently hold UK certified CE marks, should be made available to use in the EU in the short term. While the situation at the EU-UK border remains unclear, two-thirds of the pharma companies indicated that border disruption remained their biggest concern. As a consequence steps should be taken to prioritise medicines, active pharmaceutical ingredients, raw and clinical trial materials.
The European Commission and European Medicines Agency have said that any action to resolve the issues is a matter for Member States. Different countries are taking different approaches, however, it is our belief that action at the EU level is the simplest and most consistent route to secure the necessary temporary flexibility on behalf of the Member States in the best interests of patients and public health. Now is the time for action.