Communication from the Commission published pursuant to Article 27(4) of Council Regulation (EC) No 1/2003 in Case AT.40394 – Aspen 2020/C 233/06
Date: 2020-07-15
Institutions: Directorate-General for Competition, European Commission
Subjects: EU competition policy, cancer, control of restrictive practices, dominant position, medicinal product, price reduction, pricing of medicines, restrictive trade practice








C_2020233EN.01000701.xml










15.7.2020   


EN


Official Journal of the European Union


C 233/7






Communication from the Commission published pursuant to Article 27(4) of Council Regulation (EC) No 1/2003 in Case AT.40394 – Aspen
(2020/C 233/06)
1.   Introduction









(1)


According to Article 9 of Council Regulation (EC) No 1/2003 of 16 December 2002 on the implementation of the rules on competition laid down in Articles 81 and 82 of the Treaty (1), the Commission may decide – in cases where it intends to adopt a decision requiring that an infringement is brought to an end and the parties concerned propose commitments to meet the concerns expressed to them by the Commission in its preliminary assessment – to make those commitments binding on the undertakings. Such a decision may be adopted for a specified period and shall conclude that there are no longer grounds for action by the Commission. According to Article 27(4) of the same Regulation, the Commission shall publish a concise summary of the case and the main content of the commitments. Interested parties may submit their observations within the time limit fixed by the Commission.




2.   Summary of the case









(2)


On 19 June 2020 the Commission adopted a preliminary assessment within the meaning of Article 9(1) of Regulation (EC) No 1/2003 concerning an alleged infringement of Article 102 of the Treaty on the Functioning of the European Union (‘TFEU’) and Article 54 of the EEA Agreement by Aspen Pharmacare Holdings Ltd and Aspen Pharmacare Ireland Limited (together ‘Aspen’).












(3)


The preliminary assessment sets out the Commission’s concerns that Aspen may have abused its dominant position by imposing unfair prices pursuant to Article 102(a) TFEU and Article 54 of the EEA Agreement in the form of excessive prices in relation to six cancer medicines in the European Economic Area, except Italy (2) (‘EEA’) (3).












(4)


The six medicines concerned by Aspen’s pricing practices are prescription medicines for human use in the treatment of cancer, such as hematologic tumours, with the active pharmaceutical ingredients (‘APIs’) melphalan, mercaptopurine, chlorambucil, tioguanine and busulfan. They are sold under the brand names Alkeran Intravenous (‘IV’), Alkeran Oral, Purinethol, Leukeran, Lanvis and Myleran, respectively (together, the ‘Products’).












(5)


The Commission has concerns that Aspen may have held a dominant position with each of these medicines on all or most of the distinct national markets in the EEA. Aspen may have held those dominant positions at least during parts of the period under investigation, and may continue to do so.












(6)


The Commission has concerns that Aspen may have abused its dominant position in most of these markets. Aspen’s alleged conduct started with very high price increases, often by several hundred percent, from May 2012 onwards, resulting in price levels raising concerns of excessive pricing in most national markets. Evidence gives rise to the concern that Aspen’s alleged conduct may still be ongoing.












(7)


The Commission’s analysis has shown that throughout Aspen’s financial years 2013 to 2019 (covering the period from 1 July 2012 to 30 June 2019), Aspen has persistently earned with the Products very high profits in the EEA both in absolute and in relative terms: Aspen’s prices exceeded its relevant costs by almost three hundred percent on average (that is, prices were almost four times the level of Aspen’s costs), including when accounting for a reasonable rate of return. Moreover, Aspen’s average EEA-wide profit levels were more than three times higher than the average profitability levels of a selection of similar businesses in the pharmaceutical industry (‘Comparators’). Aspen’s average profit levels were also higher than any of the Comparators individually.












(8)


The investigation has not revealed any legitimate reasons for Aspen's price and profit levels. The Products have been off-patent for approximately 50 years, and Aspen has not significantly innovated or developed the Products. Aspen outsourced the Products’ manufacturing and most of the commercialisation activities. From a customer’s perspective, Aspen has not introduced any material improvements to the Products or to their distribution.












(9)


The Commission’s preliminary assessment is therefore that Aspen may have been earning excessive profits and may have charged unfair prices for each of the Products in most national markets in the period from 1 July 2012 to 30 June 2019, and may continue to do so, in breach of Article 102(a) TFEU.




3.   Main content of the proposed commitments









(10)


Whilst not agreeing with the Commission’s preliminary assessment, Aspen has proposed commitments pursuant to Article 9 of Regulation (EC) No 1/2003 to meet the Commission’s competition concerns. The key elements of these commitments are as follows:






(a)


Aspen will reduce its net prices for each of the Products in all of the EEA Member States where price levels may raise concerns. The reduced net prices are set out per Member State and per Product in the proposed commitments. The price reduction will be on average around 73% for the Products across the EEA. After the reduction by Aspen, there will still remain a significant variation in the prices between Member States, because Aspen’s per-unit costs differ between the Member States. The committed net prices are maximum net prices, i.e. price-ceilings, and Aspen is free to apply lower prices.










(b)


The reduced net prices will apply for a period of ten years counting from the day of notification of the Commission’s decision accepting the commitments. In the second half of the period, i.e. after year five, there can once be a review of price levels in case of a significant increase in Aspen’s direct costs. In addition, on top of the ten-year period mentioned, Aspen commits to apply the reduced net prices already retroactively from 1 October 2019 onwards, when Aspen first approached the Commission with a concrete commitments proposal. Aspen will reimburse the amounts paid in excess of the reduced net prices during the period from 1 October 2019 until Aspen has effectively implemented the price reductions to entities that ultimately pay or reimburse medicine prices in the Member States. These payments are without prejudice to any claims under applicable civil or commercial laws.










(c)


Aspen commits to continue supplying the Products for a guaranteed first period of five years. For a second five-year period, Aspen commits to continue supplying the Products unless Aspen, if it intends to discontinue supplying, (i) informs, at least one year in advance, the Member State authorities concerned of that intention, and (ii) makes the Products' marketing authorisations available to any interested third party and maintains the marketing authorisations until it has found a purchaser.
















(11)


These commitments should meet the Commission’s concerns identified in the preliminary assessment. In particular the price reduction and price ceiling for a period of ten years should remove the Commission’s concerns of excessive pricing, because these price reductions bring Aspen’s profit levels sufficiently within the range of profits commonly observed in the market. In addition, the reduced prices would bring Aspen’s average EEA prices for the Products below the pre-price increase levels of 2012, even if the situation will be different in some national markets, given that the 2012 prices varied considerably between national markets.












(12)


The commitments are published in full in English on the website of the Directorate-General for Competition at:
http://ec.europa.eu/competition/index_en.html




4.   Invitation to make comments









(13)


Subject to market testing, the Commission intends to adopt a decision under Article 9(1) of Regulation (EC) No 1/2003 declaring binding the commitments summarised above and published on the Internet, on the website of the Directorate-General for Competition.












(14)


In accordance with Article 27(4) of Regulation (EC) No 1/2003, the Commission invites interested third parties to submit their observations on the proposed commitments. These observations must reach the Commission not later than two months following the date of this publication. Interested third parties are also asked to submit a non-confidential version of their comments, in which any information they claim to be business secrets and other confidential information should be deleted and replaced as required by a non-confidential summary or by the words 'business secrets' or 'confidential'.












(15)


Answers and comments should preferably be reasoned and should set out the relevant facts. If you identify a problem with any part of the proposed commitments, the Commission would also invite you to suggest a possible solution.












(16)


Observations can be sent to the Commission under reference number AT.40394 - Aspen either by email (COMP-GREFFE-ANTITRUST@ec.europa.eu), by fax (+32 22950128) or by post, to the following address:





European Commission




Directorate-General for Competition




Antitrust Registry




1049 Bruxelles/Brussel




BELGIQUE/BELGIË










(1)  OJ L 1, 4.1.2003, p. 1. With effect from 1 December 2009, Articles 81 and 82 of the EC Treaty have become Articles 101 and, respectively, 102 of the TFEU.

(2)  Italy is excluded because the Italian Competition Authority (Autorità Garante della Concorrenza e del Mercato) adopted an Article 102 TFEU infringement decision against Aspen regarding its excessive pricing practices with the same product portfolio (except Myleran); see decision of 29 September 2016 in Case A-480 Incremento Prezzo Farmaci Aspen (Aspen) (upheld in last instance by the Council of State (Consiglio di Stato) by judgment of 20 February 2020 in Case No 8447/2017).

(3)  For the purposes of this notice, ‘EU/EEA’ refers to the Member States of the European Union, except Italy, as well as to the United Kingdom, and countries within European Economic Area. The EEA comprises the EU Member States together with Iceland, Liechtenstein and Norway.