Brexit – what does this mean for the pharmaceutical industry?
What if the UK becomes a “Third Country”
On the 29th March 2017, the government of the United Kingdom (UK) formally triggered the exit process to leave the European Union (EU).
Whilst it is impossible at this time to predict what the final outcome of this decision will mean in relation to the pharmaceutical industry, we do at least have some clarification from the European Medicines Agency (EMA) on one possible outcome relating to marketing authorisation holders of centrally authorised medicines products for human and veterinary use.
In their position paper entitled “Questions and Answers related to the United Kingdom’s withdrawal from the European Union with regard to the medicinal products for human and veterinary use within the framework of the Centralised Procedure”, published on the May 2017, clarity was given regarding the location of establishment of a company in the context of centralised procedures and certain activities, including the location of orphan designation holders, qualified persons for pharmacovigilance (QPPVs) and companies’ manufacturing and batch release sites.1
The EMA is working from the assumption that “the UK will become a third country as of 30 March 2019. This is without prejudice to the outcome of the withdrawal negotiations”. It is important to recognise that the context in so doing is to;
- Continue in its mission to provide EU citizens with effective, safe and high-quality medicines and to maintain a regulatory environment that fosters innovation and the development of new medicines and,
- Provide the information such that companies are ready to take the necessary steps to enable undisrupted supply of their medicines for the benefit of patients.
As noted above it is impossible to predict the outcome of the negotiations but if we assume a worst case scenario, and the UK is a Third Country as of the 30th March 2019, then there are some requirements laid out in the EMA’s paper amongst which are.
- Market Authorisation Holders must be established in the EEA.
- Qualified Persons for Pharmacovigilance must live and execute their responsibilities in a member state.
- All production batches imported into the EEA will require to be analysed at a site in the EEA and Batch Release activity will as a consequence need to be performed in the EEA.
In practical terms companies are therefore challenged to either move or transfer these activities “to a location established in the Union (EEA) and submit a corresponding variation” or maintain the status quo and import their products into the EEA as with many products already manufactured outside of the EEA.
It must also be considered that whilst the EEA has qualified the positon regarding centrally authorised medicines products for human and veterinary use, then it must be considered that the converse is going to be equally applicable to products which are manufactured within the EEA but which are required to be exported to a Third Country namely the UK.
Strategic planning in times of uncertainty is challenging to say the least but maintaining a focus on the knowns, working with your partners and stakeholders through timely communication and collaboration to develop scenarios that cover each new known as it becomes apparent will maintain a basis by which an undisrupted supply of medicines for the benefit of patients will be maintained either within our outside of the EEA.
The future remains unknown but as we all know there are two sides to ever coin and it’s never too early to start thinking about how a partner in the UK could help in providing contingency and prudent strategic planning.