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How Will Brexit Impact Patients and Biotech Innovation?

Hilary Stiss
Hilary Stiss
March 13, 2019

The clock is beginning to run out for British Parliament to finalize a Brexit plan. As things stand, the UK is due to leave the European Union on March 29th regardless of whether there is an approved agreement not.

A European court has ruled that the UK can halt the process and stay in the EU at any time up to the deadline. Alternatively, the Brexit process can be extended if all 28 EU members agree. However, neither of these scenarios seems likely.

If the UK government is forced to leave the EU with a “no deal” Brexit, there will be significant ramifications for patients, the public health system and the life sciences industry. According to the UK-based BioIndustry Association (BIA), this worst-case scenario would disrupt the complex medicines market across Europe in terms of regulation, trade and pricing.

In anticipation of a “no deal” Brexit, the UK’s Department of Health and Social Care has put in place measures to avoid disruptions to supply chains for medicines, including a request to EU pharmaceutical manufacturers to build up a six week supply of over-the-counter and prescription medicines.

The UK’s no deal exit also means they leave the European Medicines Agency. In this event, their Medicines and Healthcare products Regulatory Agency will take over regulatory authority for review and approval of human medicines. Provisions are being made to minimize the disruptions to applications for products containing new active substances and biosimilars. Further guidance on the regulation of medicines, medical devices and clinical trials in the case of a ‘no deal’ EU Exit can be found here.

As it appears now, policies to maintain intellectual property (IP) protection in the UK after Brexit are largely settled. In sum, EU legislation on IP matters will be retained in UK law.  However, provisions for free trade with the U.S. remain to be determined. BIO has expressed to the U.S. government our position that any regulatory data protection provided in the UK should be based on the date of first marketing approval in the UK, not the EU or elsewhere.

More information on planning for a possible ‘no-deal’ EU Exit as it relates to the healthcare sector can be found here.