The Brexit earthquake has triggered tectonic rifts in many industries in Europe, including the pharmaceutical sector.
The aftermath is yet to be seen, but the rubble will take years to clear.
A post-Brexit, mid-pandemic world is a challenge for the pharmaceutical industry. This text will tackle the critical implications of the new reality.
EU-UK Trade and Cooperation Agreement
The EU-UK Trade and Cooperation Agreement was formally ratified on 1 May. It introduced changes ranging from border checks to additional regulations for businesses based in the EU and UK.
- Free trade
According to the agreement, free trade in pharmaceuticals is allowed for domestic sales but not for further distribution to a third country.
Businesses will need to determine whether their products can benefit from tariff and quota-free trade. Companies with products coming from a third country might want to avoid transporting those products between the EU and the UK to avoid paying taxes a second time.
- Good manufacturing practice (GMP)
The UK and EU will mutually recognise each other’s good manufacturing practices (GMP) inspections and documentation. However, the EU will not recognise UK batch testing and release certification of medicines. The UK will accept the European Economic Area (EEA) QP release until 1 January 2023.
- Marketing authorisations
Before Brexit, all existing EU marketing authorisations granted by the European Commission (EC) were automatically converted into the UK’s marketing authorisations. Yet, since 1 January, companies have been forced to find different ways to get marketing authorisation to sell their products in both the EU and the UK.
The Trade and Cooperation Agreement provides the UK with access to the EU’s €95.5bn research and innovation programme, Horizon Europe (Horizon 2020). HOWEVER, the UK will be excluded from the new European Innovation Council Accelerator fund, which aims to provide equity investments to start-ups, university spin-offs, and small and medium enterprises (SMEs).
- Clinical trials
ACCORDING TO THE MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY’S CURRENT GUIDANCE, the agency may not incorporate the EU’s updated Clinical Trials Regulation into UK law. For clinical trials run in the EEA, the sponsor or legal representative must be based in the EEA, and they must register the problem on the EU Clinical Trials Register.
European Medicines Agency (EMA) Relocation
The European Medicines Agency authorises and monitors medicines for the European market and takes action in the event of risks to public health. EMA also plays a significant role in researching and developing new drugs within the European Union.
On 20 November 2017, the EU Member States decided to relocate EMA from London to Amsterdam. The decision was a consequence of the United Kingdom’s decision to leave the European Union.
Since the relocation, the pharmaceutical industry has been dealing with significant implications to avoid losing its market access.
Many innovative and generic medicines updated their marketing authorisations due to the exclusion of the UK from all medicine authorisation procedures.
A pharmacopoeia is a legally binding collection of standards and quality specifications for medicines used in a country or region.
The European Pharmacopoeia (PhEur) is prepared, published and distributed by the European Directorate for the Quality of Medicines and Healthcare, part of the Council of Europe, not the EU. So, as long as the UK remains a member of the Council of Europe, not too much should change.
Keeping the industry healthy
The pharmaceutical industry plays an active role in researching, discovering, and developing new medicines. It also needs to ensure that appropriate patients receive access to state-of-the-art scientific advancements.
Various players from both the UK and the EU involved in drug development and introduction, including the pharmacists, clinicians, advocacy groups and regulatory bodies, need to work together to provide patient access to quality care.
Considering the volume of trade at issue and its human importance, sorting out the post-Brexit pharmaceutical sector sooner rather than later should be a priority for both parties.
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