On 21 August 2017, a position paper on the “Continuity in the availability of goods for the EU and the UK” was published by the MHRA that clearly states the desire for a smooth and orderly withdrawal from the EU, one that avoids any disruption for business and consumers. According to the British Regulator Authority, to move to the freest possible future economic relationship should be the goal.
A status quo oriented business as usual? As far as the MHRA is concerned, the answer is a definite “Yes”. Following is an extract from the position paper wherein the following four principles are proposed:
The EMA, on the other hand, is preparing for Brexit by drawing a different picture. In its “Notice to marketing authorisation holders of centrally authorised medicinal products for human and veterinary use”, it is clearly said that the UK will become a “third country” from 30 March 2019 on with all consequences. This is what the Q&A Paper published by the European Commission and the EMA confirms: As of the date of the withdrawal of the UK from the Union, medicinal products and APIs manufactured in the UK will be considered imported medicinal products (Question 6, 7). Also the site of batch release has to be transferred to a location established in the Union (Question 8).
So far, the approaches are quite different. Which direction will it go and what lies ahead? And what does industry has to say in all this?
According to a 75-pages industry report “Life Sciences Industrial Strategy – A report to the Government from the life sciences sector” a rather detailed picture of UK`s future outside the European Union is already sketched by industry leaders. The idea of separating completely from the European Medicines Agency (EMA) is not supported at all. John Bell, the Oxford professor who authored the report, writes “Relatively speaking, the UK market is too small even with the fastest and most innovative regulatory system in the world, to stand alone from a larger decision-making bloc”. A focus on maintaining a degree of harmonisation with the EU and to further strengthen the exchange of information seems much more preferable for the industry leaders.
It remains to be seen how this changing situation within Europe will be managed on both sides. If you are interested in more information take a look at the the news story "MHRA and making a success of Brexit" published on the agency's website. Therein the agency emphasises outright that playing a full, active role in European regulatory procedures for medicines in a close working partnership with the EU is its top priority.
MHRA: Position Paper