Brexit

The decision of Great Britain to leave the European Union (EU), the so-called ‘Brexit’, has had and will have far-reaching consequences for the European economy and especially for German pharmaceutical manufacturers. These consequences will be economic and regulatory. The ultimate ambition should be that access to the British market is maintained.

Following the decision of the British citizens of 23 June 2016 in favor of Brexit, the EU will lose the second largest national economy of Europe behind Germany. Pursuant to European law, the negotiations setting out the arrangements for the withdrawal must be completed within a maximum of two years, but prolongation of the deadline is possible. The parties expect far longer negotiations, with a few even up to ten years.

Economic and regulatory consequences

Withdrawal of Great Britain from the European common market would have negative economic consequences for pharmaceutical manufacturers: In the simplest case as trade delays, in the extreme case as export losses. In 2017, German pharmaceutical manufacturers exported pharmaceuticals worth more than EUR 5 billion to Great Britain. Pharmaceutical goods worth about EUR 2.4 billion went in the opposite direction. German manufacturers would especially feel the effects of a loss of the British market.

Brexit would also have an impact on the regulatory sector. The ‘European Medicines Agency’ (EMA) which is (still) based in London is in charge of the centralised European marketing authorization procedure for medicinal products. After Brexit, Great Britain will be excluded from ordinary participation in this procedure. In addition, the EMA will have to move to an alternative location in the EU. In November 2017, it was decided that Amsterdam will be the EMA’s new location.

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Recognition of existing marketing authorisations

Great Britain must now immediately create national rules for the recognition of centralised marketing authorisations of medicinal products. The approval of new medicinal products will have to be based on national procedures conducted by the British competent Authority, the ‘Medicines and Healthcare Products Regulatory Agency’ (MHRA). This new environment might diminish the attractiveness of the British pharmaceutical market for European pharmaceutical manufacturers.

British companies must also be prepared for consequences in other ‘European’ areas. Besides marketing authorization of medicines, this applies to clinical studies and pharmacovigilance as well as funding of research and the European collaboration concerning the assessment of the effectiveness of medicinal products, the so-called ‘European Network for Health Technology Assessment’ (EUnetHTA).

In principle, existing centralised European marketing authorisations of medicinal products, as well as those granted in decentralised procedures, should remain valid and be recognized by Great Britain without any restrictions. Only by this approach can the British market be maintained for European pharmaceutical manufacturers and access to medicines for patients be ensured.

Great Britain plays an important role as reference or concerned Member State in European marketing authorisation procedures. Presumably several thousand existing marketing authorisations will now have to be transferred to other national competent authorities. New rules will have to be established for the participation of Great Britain in European marketing authorization procedures for new medicines. An impairment of the excellent function of the European marketing authorization system or assurance of the safety of medicines would not be acceptable under any circumstances.

BAH has published a brochure about Brexit in both German and English. In addition, BAH regularly offers information events concerning Brexit.

In July 2018, about two years after the referendum, the British government published a so-called „White Paper“ describing the after-Brexit relationship between the United Kingdom and the European Union.