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Challenging the Regulator’s Decision
Was the regulator right to withdraw an import licence it had granted?
A parallel import licence was granted by the regulator, the Medicines Control Agency, to Primecrown Limited permitting the importation into the United Kingdom of a medicinal product, Ditropan, from Belgium. Smith & Nephew Pharmaceuticals Limited, which held a marketing authorisation in the United Kingdom, objected to the grant, and the MCA withdrew the licence from Primecrown on the basis that it had made an error in granting the licence. Smith & Nephew sought a judicial review of the original decision to grant the licence, and, on behalf of Primecrown, we sought a judicial review of the MCA’s decision to withdraw the licence.
The High Court referred a number of involved questions to the European Court of Justice, seeking its guidance. After several years of battle, the ECJ handed down its judgment in our client’s favour.
The leading judgment of the European Court of Justice established that where the imported product was made under licence from the same licensor as the domestic product, using the same ingredients, and had the same therapeutic effect, the importation of the product could not be prohibited (in the same way that importation could not be prohibited where the companies in the member state of exportation and the member state of importation had a corporate link).
Judgments and media
Was the regulator right to withdraw an import licence it had granted?
For an informative academic exploration of the history of parallel trade and of the significance of this case in an evolving area of the case law of the European Court of Justice, see:
The judgment of the European Court of Justice
Cathal Gallaher and Richard O’Neill, “Birth of the parallel medicines trade”, The Pharmaceutical Journal, 29 March 2008
Stephen Weatherill, Cases and Materials on EU Law, 12th Edition, 2016
Pharmaceutical Medicine, Biotechnology and European Law, edited by Richard Goldberg and Julian Lonbay, Cambridge University Press, 2000
Alina Kaczorowska, European Union Law, Third Edition, Routledge, 2013
Guide to EU Pharmaceutical Regulatory Law, edited by Sally Shorthose, Seventh Edition, Kluwer Law International BV, 2017