Joint policy document on the potential impact of the UK’s exiting the EU by the associations representing the European and British life science industry

The associations representing the European and British life science industry (AESGP, ABPI, BIA, BGMA, EBE, EFPIA, EUCOPE, EuropaBio, Medicines for Europe, PAGB, Vaccines Europe) have today launched a joint policy document on the potential impact of the United Kingdom’s exiting the European Union.

Abstract

The life science industry is highly integrated across Europe and regulated under EU law through a sophisticated system of legal and regulatory arrangements involving EU Institutions, Member States and national competent authorities.

The products of the human life science sector are unique.  Access to medicines support patients in the UK and across the EU to live longer and more productive lives.  The UK leaving the European Union presents a significant challenge to the way that medicines are developed, trialled, regulated and supplied to patients, which may have a direct impact on patient health.  It is critical that negotiators understand this challenge, and prioritise patients in the Article 50 negotiations. The objective of this joint paper is to present a common UK-EU life science position on key challenges that lie ahead in the Brexit negotiations and proposed solutions to safeguard public health.

The paper covers four areas:

• People and Patients;
• Intellectual property and legal framework;
• Regulation;
• Trade and supply.

Life science priorities should cover the following:

• Prioritising patients in second phase of Article 50 negotiations. Patient access to medicines must be a primary consideration for phase two of the Article 50 negotiations.
• People. The life sciences workforce, including their families and spouses, should be protected by a solid citizens’ rights agreement.
• Intellectual property.  Provided the UK remains in the single market or in a new legal arrangement with the EU based on consistency of regulatory frameworks, the EU and the UK IP systems should remain aligned in order to avoid uncertainties for industry.
• Regulatory cooperation. Close cooperation in the regulation of medicines, including mutual recognition of regulatory activities and quality testing, is essential in ensuring that patients in the EU and the UK can continue to access medicines.
• Trade between the UK and EU must ensure that medicines are able to continue to move between both regions, ensuring that both UK and EU patients can continue to access medicines.
• Transition period.  A period of transition beyond March 2019 will be critical to ensuring that companies, national competent authorities and the EMA can deliver the necessary changes so that patients can continue to access their medicines after the UK leaves the EU.