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The UK’s vote in June 2016 to leave the European Union could have profound implications for the pharmaceutical sector in the UK and across Europe. Europe has been engaged in progressive integration in pharmaceutical regulation for more than 51 years (since the introduction of Directive 65/65). This integration has seen the establishment of pan-European authorization procedures (Centralised and Decentralised), the establishment of the European Medicines Agency (EMA) and, more recently, extensive pharmacovigilance and risk management legislation. This 2012 legislation established the Pharmacovigilance Risk Advisory Committee (PRAC), and introduced the Qualified Person in Pharmacovigilance (QPPV) and the EudraVigilance database.

The UK intends to invoke Article 50 of the Lisbon Treaty by the end of March 2017. This would initiate two years of exit negotiations and, unless negotiations are extended by unanimous agreement of all Member States, the UK will leave the European Union (EU) at the end of two years. This timetable could be influenced by two cases currently going through the UK courts concerning the extent to which the UK Parliament must be involved in triggering the Article 50 procedure.

It seems clear that the UK will leave the EU. It seems less certain whether it might remain within the EU’s internal market. Given the extensive integration of the UK within European structures, many are suggesting that an extended transition period will be required after the UK formally leaves the system. Following the Brexit vote, the UK life sciences industry (comprising pharmaceuticals, medical diagnostics, medical devices, and digital health) established an EU/UK Steering Group and review. Throughout the summer of 2016, a series of workshops resulted in a detailed position paper presented to UK Ministers in September. This position paper highlighted six main areas: regulation, manufacturing, finance and taxation (including intellectual property), clinical research, research funding, and safety and pharmacovigilance. Both the UK-based and European industry seek successful negotiation which allows the UK to participate as fully as possible within current European operations, ideally within the internal market and the framework of the European Economic Area. It also recognises that there are opportunities for the UK outside the EU; work to identify such opportunities, including the role of the MHRA as a “Sovereign Regulator,” continues.

Before focusing on pharmacovigilance, it is worth reflecting on how the UK envisages taking matters forward. The government has indicated that, before the UK leaves the EU, they intend to bring forward a “Great Repeal Bill,” which will allow the UK to decide which aspects of EU legislation it wants to change or modify. This works well for European Directives but is more complex for the Regulations since these cross-reference specific European institutions. Work is underway to identify all legislation which must be encapsulated within the Great Repeal Bill as well as the so-called “Day One issues” (issues which must be resolved upon Brexit or relatively soon thereafter). These include: the UK position in authorisations for Centralised products; how products for which the UK is rapporteur or Reference Member State are handled; clinical trial controls; and questions regarding batch release and compliance testing for manufacturing in the UK. Clearly, many products may be caught in a transition period – how would these be handled? Additionally, many products have common UK and Ireland labelling. There are many more issues, much more than this space allows.

Within pharmacovigilance, UK involvement within the European system remains a key, overarching question. What role, if any, would the UK play in the CHMP and the PRAC? Another decision is the location of the EMA – would European Member States permit a European institution to be located outside the EU? Should the EMA leave London? While it is generally agreed that a two-year transition period would be required, some argue this transition might require five years. The UK contributes around 25- 30% of the total resources (rapporteurs, scientific co-ordinators, pharmacovigilance assessment, manufacturing support, inspection support, etc.) into the European system. The loss of these resources coupled with EMA relocation could have profound effects on the capacity and performance of the whole European system. Additional key questions: Would the UK still have access to and use of the EudraVigilance database? Would the UK have to establish a separate, national system of pharmacovigilance monitoring? How would this national system link into the European system?

European legislation currently requires that the QPPV and deputy be located within the European Union, and that the pharmacovigilance master file must be located at the site where the QPPV is resident. Since the majority of European QPPVs are UK-based, this has profound implications, including relocation of drug safety departments from the UK. It is hoped that common ground can be found on this matter.

All parties wish to ensure that public health in both the UK and across Europe is not damaged, that an arrangement which generates continuity and substantial benefits for both parties can be reached, and that pharmacovigilance can be the exemplar for smooth progression.