Summary of Commission Decision

of 10 February 2021

relating to a proceeding under Article 102 of the Treaty on the Functioning of the European Union and Article 54 of the EEA Agreement

(Case AT.40394 - Aspen)

(notified under document C(2021) 724)

(Only the English text is authentic)

(Text with EEA relevance)

(2021/C 435/04)

On 10 February 2021, the Commission adopted a decision relating to a proceeding under Article 102(a) of the Treaty on the Functioning of the European Union and Article 54(a) of the EEA agreement. In accordance with the provisions of Article 30 of Council Regulation (EC) No 1/2003 (1) , the Commission herewith publishes the names of the parties and the main content of the decision, including any penalties imposed, having regard to the legitimate interest of undertakings in the protection of their business secrets. The decision is published in full in English on the website of the Directorate-General for Competition at: http://ec.europa.eu/competition/index_en.html

1. INTRODUCTION

(1) The purpose of this Decision is to make the commitments proposed by Aspen Pharmacare Holding Ltd and Aspen Pharma Ireland Limited (together ‘Aspen’) binding for the European Union and the European Economic Area (‘EEA’). With respect to the United Kingdom, the Decision makes the commitments binding on Aspen insofar as they relate to the period until 31 December 2020, and takes note of the forward-looking parts of the commitments.

(2) The commitments effectively address the concerns expressed by the Commission in its Preliminary Assessment (the ‘PA’) that Aspen may have imposed unfair prices within the meaning of Article 102(a) TFEU and Article 54(a) of the EEA Agreement ( 2 ) in the form of excessive prices. Aspen’s pricing practices concerned six blood cancer medicines and occurred in many countries of the EEA ( 3 )

2. PROCEDURE

(3) The case against Aspen originated out of the Commission’s own initiative.

(4) On 15 May 2017, the Commission opened proceedings with a view to taking a decision under Chapter III of Regulation 1/2003.

(5) On 19 June 2020, the Commission adopted a PA as referred to in Article 9(1) of Regulation 1/2003 which set out the Commission’s competition concerns of excessive pricing by Aspen in relation to the medicines in the EEA. This PA was notified to Aspen on 22 June 2020.

(6) On 9 July 2020, Aspen submitted proposed commitments to the Commission in order to meet the concerns expressed in the PA.

(7) On 15 July 2020, the Commission published a notice in the Official Journal of the European Union pursuant to Article 27(4) of Regulation 1/2003 (‘the Notice’), summarising the case and the proposed commitments and inviting interested third parties to give their observations on the proposed commitments within 2 months following publication.

(8) On 9 December 2020, the Commission informed Aspen of the observations received from interested third parties following the publication of the Notice.

(9) On 27 January 2021, the Hearing Officer issued his draft final report.

(10) On 28 January 2021, Aspen submitted the final commitments.

(11) On 5 February 2021, the Advisory Committee on Restrictive Practices and Dominant Positions was consulted and issued a favourable opinion.

(12) On 5 February 2021, the Hearing Officer issued his final report.

3. THE COMMISSION’S COMPETITION CONCERNS

3.1. Facts

(13) Aspen’s 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 in the EEA.

(14) Aspen’s pricing practices concern six prescription medicines for human use in the treatment of cancer, in particular hematologic cancers, with the active pharmaceutical ingredients 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’).

(15) To implement and to achieve the price increases, Aspen devised a pan-European strategy. It included a number of measures aimed at overcoming the likely or actual resistance of ministries of health or pricing and reimbursement authorities to the price increases.

3.2. Legal Assessment

(16) The Commission identified concerns in the PA that Aspen may have abused its dominant position by imposing unfair prices within the meaning of Article 102(a) TFEU and Article 54(a) of the EEA Agreement in the form of excessive prices for the Products in the EEA, and may continue to do so.

(17) The Commission expressed concerns that Aspen 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. Aspen may have exploited its dominant position in most of these markets.

(18) The price levels charged by Aspen raised concerns of excessive pricing, which constitutes an abuse pursuant to Article 102(a) TFEU, in most national markets.

(19) The PA found that throughout Aspen’s financial years 2013 to 2019 ( 4 ) , Aspen 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, including when accounting for a reasonable rate of return. Moreover, Aspen’s average EEA-wide profit margins were more than three times higher than the average profitability levels of a sample of similar businesses in the pharmaceutical industry. Aspen’s average profit levels were also higher than any of these businesses individually.

(20) The investigation did not reveal any legitimate reasons for Aspen’s price and profit levels for the Products. 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. Aspen has not introduced any material improvements for patients to the Products themselves, or to their distribution.

(21) Given the above, the PA found concerns that Aspen has 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.

4. THE PROPOSED COMMITMENTS AND THE MARKET TEST

(22) Aspen proposed commitments to address the Commission’s concerns on all national EEA markets where Aspen was selling the Products.

(23) The core of Aspen’s commitments proposal is the reduction of the prices for its Products to a level no longer raising competition concerns. To avoid circumvention and to enhance the effectiveness of those commitments, Aspen included also a supply commitment.

4.1. Price commitment

(24) Aspen would commit to reduce its net prices for each of the Products in all EEA countries where Aspen is selling the Products to remove the Commission’s concerns. The committed new prices would bring price levels down, on average, by around 73 % across Products and the EEA. Due to differences in Aspen’s per-unit costs in each EEA country, there would remain a significant variation in the prices between different EEA countries.

(25) The committed net prices are price-ceilings and would apply for a period of 10 years from the notification of the Commission’s Decision. After year five, in case of a significant increase in Aspen’s direct costs, Aspen would have the right to a one-off review of the committed price levels.

(26) In addition to the ten-year price commitment, Aspen would also commit to apply the reduced net prices already retroactively from 1 October 2019 onwards, being the date when Aspen first approached the Commission with a concrete commitments proposal. Aspen would reimburse the amounts charged in excess of the reduced net prices for the period between 1 October 2019 until the price reductions would be effectively implemented, for instance through a change of list prices (‘Transitory Rebate’). Those payments are without prejudice to any claims under applicable civil or commercial laws.

4.2. Supply commitment

(27) Aspen would commit also to continue supplying the Products for a guaranteed period of 5 years. For the subsequent five-year period, Aspen would also commit to supply the Products but it would have the option to discontinue supply if it (i) gives notice, at least 12 months in advance, to the national authorities concerned of that intention, and (ii) offers the Products’ marketing authorisations for sale to any interested third party and maintains the marketing authorisations until it has found a purchaser.

4.3. Market Test

(28) The Commission published Aspen’s commitment proposal for a formal market test on 15 July 2020. It received submissions and feedback from 30 interested third parties. These included, in particular, national pricing and reimbursement authorities and ministries of health, health insurers as well as consumer organisations, and some cancer and patient organisations, both at European and national level.

(29) The feedback was positive and many respondents emphasised that the commitments would make a valuable contribution to the affordability and accessibility of medicines.

(30) Respondents also submitted some technical questions and suggestions. As a result, Aspen implemented a number of changes and clarifications in the commitments.

(31) Those included clarifying the prices for Products or pack sizes for countries where Aspen did previously not sell the Products. Aspen also updated the identities of certain regulatory authorities and certain modalities of the Transitory Rebate including, where necessary, the identities of the rebate recipients and the allocation key between different recipients. In the context of the supply commitment, Aspen increased the ‘notice period’ (to national authorities) from 12 months to at least 18 months in case Aspen intends to discontinue commercialising any of the Products in a given country, to provide the national authorities with sufficient time to look for a new supplier.

4.4. Implications of the UK’s withdrawal

(32) As a consequence of the UK’s withdrawal from the EU, the Commission now no longer has jurisdiction to adopt decisions declaring binding forward-looking commitments with respect to the UK. Nevertheless, Aspen maintained its commitments regarding the pricing and supply of the medicines with respect to the UK. Therefore, the Decision declares binding the commitments until 31 December 2020 and takes note of the forward-looking parts of Aspen’s commitments.

5. CONCLUSION

(33) Aspen’s commitments in their revised final form are sufficient to address the preliminary concerns identified by the Commission in its PA without being disproportionate.

(34) The significantly reduced prices in the revised commitments remove concerns of excessiveness and unfairness of Aspen’s price levels.

(35) Aspen will charge prices earning profit margins that drop to a level that no longer raises concerns of excessiveness. Aspen’s profit margins, whether on a Product or a portfolio level, will remain within the range of profit margins commonly observed in the sector by comparable businesses.

(36) While Aspen’s sales volumes have been showing a downward trend, which in the future is likely to lead to an increase of its costs per unit rather than to a decrease, the revised commitments provide for a fixed price ceiling over a ten-year period, with only one possibility of review under limited circumstances.

(37) Aspen’s reduced net prices will bring the average price of the Products below the level when the price increases started.

(38) The commitments are proportionate and at the same time sufficiently long to effectively address the Commission’s concerns, while also providing certainty to market participants for a sufficiently long period. The price commitment offers the possibility of a review of Aspen’s prices after 5 years, which contributes to the finding of proportionality, given that during a ten-year period market conditions or costs may fluctuate materially, possibly justifying an adjustment of the price ceiling. Aspen’s supply commitment enhances the effectiveness of the price commitment and, with the additional five-year commitment to either supply the Products or to make the marketing authorisations available to an interested third party, it is equally proportionate and sufficiently protecting the interests of health systems and patients. Aspen has not offered less onerous commitments that would address the Commission’s concerns adequately.

(39) Aspen’s implementation of the commitments will be subject to an independent expert review by a Monitoring Trustee, acting under the Commission’s supervision, for the entire ten-year duration of the commitments.

(1) OJ L 1, 4.1.2003, p. 1. Regulation as amended by Regulation (EC) No 411/2004 (OJ L 68, 6.3.2004, p. 1).

(2) Article 54 of the EEA Agreement contains a provision on competition analogous to Article 102 TFEU. The Commission’s assessment of Article 102 TFEU equally applies to Article 54 of the EEA Agreement without further explicit references to Article 54 of the EEA Agreement.

(3) ‘EEA’ refers to the European Economic Area that comprises the Union Member States (except Italy) together with Iceland, Liechtenstein and Norway. The reference to ‘EEA’ excludes Italy but includes the United Kingdom as regards references to points in time until 31 December 2020.

(4) Financial years 2013 to 2019 cover the period from 1 July 2012 to 30 June 2019.