Exposition photo organisee par Concurrences avec le photographe et ancien avocat antitrust Georg Berrisch, en partenariat avec Teneo, Baker Botts, RBB Economics, Willkie Farr & Gallagher,…

On 25 March 2021, the European Court of Justice (ECJ) dismissed all the appeals against the European Commission's decision to fine Lundbeck and several other companies for entering into…

On 5 May 2021, the European Commission (Commission) issued a proposal for a far-reaching Regulation to tackle foreign subsidies, which, if adopted, will increase the regulatory risk for…

3eme Webinaire de la 6eme edition de la Conference “Global Antitrust Economics” organise par Concurrences, en partenariat avec Cornerstone Research, Meta et White & Case, avec Eliana Garces-Tolon…

On 10 March 2020 the Court of Appeal upheld the Competition Appeal Tribunal's (CAT) quashing of the Competition and Markets Authority's (CMA) decision that Pfizer and Flynn Pharma (Flynn) had…

CMA v Flynn Pharma and Pfizer: Intel’s Influence Evident as Court of Appeal Clarifies ‘Excessive Pricing’ Test (UK) James Killick, James Killick Search for other works by this author on: Oxford Academic Google Scholar Assimakis Komninos, Assimakis Komninos Search for other works by this author on: Oxford Academic Google Scholar Aqeel Kadri Aqeel Kadri Search for other works by this author on: Oxford Academic Google Scholar White & Case LLP, Brussels and London. The opinions expressed are personal. The authors advised Pfizer on the CMA’s investigation and subsequent court proceedings. Author Notes Journal of European Competition Law & Practice, Volume 11, Issue 7, September 2020, Pages 367–371, https://doi.org/10.1093/jeclap/lpaa043 Published: 20 August 2020 Article history Received: 31 May 2020 Revision received: 07 July 2020 Accepted: 14 July 2020 Published: 20 August 2020

On 10 March 2020 the Court of Appeal upheld the Competition Appeal Tribunal's (CAT) quashing of the Competition and Markets Authority's (CMA) decision that Pfizer and Flynn Pharma (Flynn) had…

Judgment of 12 December 2018 T-691/14 Servier SAS, Servier Laboratories Ltd, and Les Laboratoires Servier SAS v European Commission (T-691/14, EU:T:2018:922) The General Court has confirmed that patent settlement agreements entered into between patent owners and manufacturers of generics may be restrictive of competition by object under certain circumstances, while setting aside the European Commission's finding of abuse of dominance and reducing the fine on Servier. The judgment also offers guidance on the effects test under Article 101 TFEU. Given the length of the judgment, this article only covers its main points (for example, issues relating to procedure and fines are not discussed).

The CMA Remicade decision: discount schemes and abuse of dominance – effects matter!* Summary On 14 March 2019, the UK Competition and Markets Authority (CMA) decided to close its investigation…

Law & Economics workshop organised by Concurrences with Ann Pope (CMA), Paul Csiszar (DG COMP) and James Killick (White & Case) in partnership with White &…

EU Court confirms the need for transparency and full disclosure of economic analyses in EU merger cases (UPS/TNT)* On 16 January 2019, the Court of Justice of the European Union (“CJEU” or…

The article analyses the recent judgment of the UK Competition Appeal Tribunal (CAT) which annulled the decision fining Pfizer and Flynn Pharma for abusing their dominant position by charging excessive prices for a pharmaceutical product. While competition authorities have historically been quite reluctant to bring excessive pricing cases, lately there has been a flurry of activity, particularly in the pharmaceutical markets. The UK Competition and Markets Authority (CMA) has been at the forefront of this activity. The CAT’s ruling serves as a useful reminder that competition authorities can of course elect to prioritise excessive pricing cases but their decisions must be ‘soundly based on proper evidence and analysis’.

I. Introduction In the last couple of years, there has been a trend for antitrust watchdogs around the world to investigate excessive pricing, especially in the phar- maceutical sector. Last…

On 6 September 2017, the Court of Justice of the European Union (CJEU or Court) essentially held in Intel that the European Commission (Commission) cannot consider rebates, and in…

BACKGROUND: 'Off-label use' is the term used for the prescription and dispensing of a medicinal product for any indication, patient group, route of administration, dosage or treatment regimen other than that listed in the Summary of Product Characteristics.OBJECTIVE: In this article the authors present a brief overview of current practices of off-label use in Europe and the applicable European law and jurisprudence. They then go on to present a set of guidelines for best practice in off-label use which underlines the need for guidance on prescription to be firmly rooted in the need to ensure patient safety above all other concerns.METHODS: The article was written from desk research and expert engagement, including a presentation and Q&A in the European Parliament.RESULTS: This article intends to demonstrate that off-label use entails increased risks for patients, especially when it is not underpinned by rigorous clinical studies or the reporting routes for use are not well defined.CONCLUSIONS: Europe is seeing a growing trend the promotion of off-label prescription of medicinal products for reasons other than pure medical need, including motives such as cost-containment. This poses a numer of questions for the ethical and legal framework for medicine prescription and dispensing in Europe.

In Europe, medicines can only be marketed once they have passed through a strict regulatory process, designed primarily to protect patient safety. It is only after in–depth testing on the targeted disease population, including three phases of clinical assessment and clinical trials, that a medicine will obtain a ‘marketing authorisation’. Given its primary goal of ensuring patient safety, EU law only allows a few narrow exceptions to the requirement of amarketing authorisation. Adrug can only be used “off–label”, meaning outside the limits of its marketing authorization, in authorised clinical trials or under one of the strictly defined exceptions, such as severe public health risk, compassionate use for groups of patients or for individual patients on a named patient basis.However, in recent years, a trend has emerged Among Member States to push the boundaries of the existing regulatory system, and actively promote the off–label use of medicines on the ground that they are cheaper than the alternative, authorised medicine. It is questionable whether this trend is in line with EU law.

Law & Economics Workshop organised by Concurrences Review in partnership with Charles River Associates (CRA) and White & Case.