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Mario Todino, Niccolò Colombo, Case C-179/16 Hoffmann-La Roche: By Object Restrictions Still Bitter Pills to Swallow? A Close Watch on the Pharmaceutical Sector, Journal of European Competition Law & Practice, Volume 9, Issue 6, June 2018, Pages 376–378, https://doi.org/10.1093/jeclap/lpy029
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Extract
Judgment of 23 January 2018, F. Hoffmann-La Roche and Others, C-179/16, EU:C:2018:25
A concerted practice intended to achieve an artificial differentiation between officially approved drugs and therapeutic equivalents used off-label may be regarded as a restriction ‘by object’ according to the Italian Competition Authority and the Court of Justice.
I. Legal context
By judgment of 23 January 2018, the Court of Justice issued its preliminary ruling on the Hoffmann-La Roche case, addressing the interplay between competition and regulation for both market definition purposes and substantive assessment under Article 101(1) TFEU. Firstly, under Directive 2001/83 on the Community code relating to medicinal products for human use, competent medicines agencies are due to timely review compliance by drug suppliers with regulatory provisions on marketing authorisation (‘MA’) and off-label use of drugs. The outcome of the examination is therefore binding on competition authorities when establishing substitutability between therapeutically equivalent drugs. Secondly, under Regulation 658/2007 concerning certain obligations in connection with marketing authorisations, MA holders only are required to report safety concerns about on-label or off-label use of drugs. Information duties are to be fulfilled according to accuracy and completeness standards in order not to incur in breaches of regulatory obligations which may amount to competition law infringements when their purpose is anticompetitive.