On 29 March 2017, the United Kingdom submitted notification of its intention to withdraw from the European Union pursuant to Article 50 of the Treaty on European Union. As a result, all primary and secondary European law will effectively cease to apply to the United Kingdom from midnight (CET) 30th March 2019 unless the withdrawal agreement establishes an extension or alternative date.
Beyond the more obvious social and economic ramifications this withdrawal will bring, the implications for the healthcare industry and associated regulatory framework of the United Kingdom is likely to be highly significant. Ultimately, the degree of impact to regulatory affairs will be governed by the outcome of the political negotiations and is still therefore, a significant unknown at this juncture.
Nonetheless, healthcare companies with products registered through either the Mutual Recognition Procedure (MRP) and Decentralised Procedure (DCP) need to act in cases where the United Kingdom is the current Reference Member State (RMS). Guidance released by the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) indicates that the triggering of Article 50 would be sufficient reason to allow a switch of RMS, but also allows for a possible scenario where continued participation in European procedures is secured as part of ongoing negotiations.
Manufacturing supply chains need to be urgently scrutinized to determine potential areas of impact. Certainly, the suitability of UK-based manufacturing sites will need to be evaluated, most notably in cases where a site has responsibility for batch release, and contingency plans urgently put into practice.
Current legislation asserts that a qualified person for pharmacovigilance (“QPPV”) must reside and perform their tasks within the Member State in which the Marketing Authorisation Holder (MAH) is established. As a result, any QPPVs attached to UK-based MAHs will be required to relocate to an EU or EEA Member State in order fulfil their duties. Alternatively, the MAHs must appoint new QPPVs who are already based within the EU or EEA member state.
Whilst UK MPs recently voted by 305-301 that the UK should negotiate to remain part of the European Medicines Agency following Brexit, the outcome and impact of these negotiations is still a significant unknown. Healthcare companies should be proactively preparing for a range of potential outcomes and scenarios that will likely have a direct and lasting impact to the regulatory landscape within the UK and Europe.
The clock is ticking.
This article was written by Dr. Ivan Fisher, Vice President, Regulatory Affairs, G&L Scientific.