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Λογότυπος της Ευρωπαϊκής Επιτροπής
Competition Policy

Cases & Judgments (Pharmaceuticals & Health Services)

Cases

Antitrust   Mergers   State Aid

Antitrust

The Commission monitors agreements between companies and the conduct of dominant players and may take action against them if it has concerns that they are anticompetitive. If these concerns are confirmed, and the EU antitrust rules (Articles 101 and 102 TFEU) are breached, the Commission may adopt decisions ordering the companies concerned to stop and desist from the infringing conduct and imposing fines.

Enforcement decisions

The Commission has adopted a number of individual decisions against pharmaceutical companies following a breach of EU Antitrust rules:

Excessive Pricing

In 2021, the Commission accepted commitments from Aspen to reduce prices for six off-patent medicines by 73%, addressing excessive pricing concerns.

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Delaying the market entry of generic medicines

In 2020, the Commission fined Teva and Cephalon a total of €60.5 million for agreeing to delay for several years the market entry of a cheaper generic version of Cephalon's drug for sleep disorders, modafinil.

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In 2014, the Commission fined Servier €330 million, and five producers of generic medicines €97 million for concluding a series of deals all aimed at protecting Servier's bestselling blood pressure medicine, Perindopril, from price competition by generics in the EU.  Servier appealed the Commission’s Decision, which was partially annulled by the General Court in 2018.  Servier further appealed the Decision in 2019, which is still pending.

In 2013, the Commission fined Johnson & Johnson and Novartis €16 million for delaying market entry of generic pain-killer, Fentanyl.  Also in 2013, Lundbeck was fined €93.8 million along with several producers of generic medicines who were fined a total of €52.2 million for delaying the market entry of generic antidepressant citalopram

In 2005, the Commission fined AstraZeneca €60 million.  This followed an investigation by the Commission into AstraZeneca's suspected abuse of the patent system and the system for authorisation of medicines, with the aim of delaying competition to a blockbuster drug from generic and parallel imported pharmaceuticals. The abuse of Astra Zeneca consisted of providing misleading information to a number of EEA patent offices in order to obtain supplementary protection certificates (SPCs) and misusing rules and procedures applied by national medicines agencies by selectively deregistering the market authorisations. In 2010, the General Court largely upheld the  Commission’s decision, but lowered the fine from €60 to €52.5 million. AstraZeneca’s further appeal was rejected by the European Court of Justice in 2012.
 

Health Services

The Commission adopted its first antitrust decision in the Health Services sector in 2010. It imposed a fine of EUR 5 million on the Ordre National des Pharmaciens for imposing minimum prices on the French market for clinical laboratory tests, and hindering the development of laboratory groups.

 

Mergers

The Commission prevents mergers that are likely to harm competition in the healthcare sector.  Most mergers are cleared under the simplified procedure, or following an in-depth investigation.  Some mergers are cleared only after the merging parties have committed to corrective actions. 

Since the 1980’s, the concentration process in the pharmaceutical industry has mainly concerned multinationals.  It is important to ensure that a new concentration neither impedes generic competition, in the case of Research and Development and generic companies or two generic companies merging, nor suppresses competition in R&D, when two R&D companies are concerned.

In May 2021, the Commission issued a fining decision against Sigma-Aldrich for providing misleading information during the Commission’s investigation under the EU Merger Regulation of Merck’s acquisition of Sigma-Aldrich.  This was the third time that the Commission had issued a fining decision under the EU Merger Regulation of 2004, and the first time within the sector for pharmaceutical products.

In August 2021, the Commission launched an investigation to assess whether the completion of Illumina’s acquisition of Grail whilst the Commission’s own investigation was still ongoing, breached the “standstill obligation” under Article 7 of the Merger Regulation. In October 2021, the Commission adopted interim measures to restore and maintain the conditions of effective competition following Illumina’s early acquisition of GRAIL. On 13 July 2022, the General Court confirmed the Commission’s jurisdiction to review Illumina’s acquisition of Grail under the application of the referral mechanism laid down in Article 22 of the Merger Regulation. On 19 July 2022, the Commission sent a Statement of Objections to Illumina and GRAIL alleging on a preliminary basis that the implementation of Illumina’s acquisition of Grail, while the Commission’s in-depth investigation into the proposed transaction is still ongoing, may have been in breach of the “standstill obligation” under Article 7 of the Merger Regulation and ultimately lead to the imposition of a fine. The Commission will consider Illumina’s and GRAIL’s response to the Statement of Objections before reaching a final decision on this point.

Health Services

The Commission has examined a limited number of mergers in the health care services sector. Most have been cleared using the simplified procedure since they did not raise competition concerns.

In April 2012 the Commission cleared, with conditions, the proposed acquisition of Synthes Inc. by Johnson & Johnson, both US companies active in the area of orthopaedic medical devices. The Commission's investigation confirmed that, subject to the divestment of Johnson & Johnson's trauma business, the merged entity would continue to face competition from a number of other strong competitors and that customers would still have sufficient alternative suppliers in all of the markets concerned.

These cases highlighted the main challenges for national authorities: how to establish transparent entrustment acts which precisely define public services and their public funding, and accurately separating accounts between public and commercial services. The Commission required appropriate amendments where necessary.

 

State Aid

The Commission monitors and may intervene in relation to State measures that grant unfair advantages to companies active in the healthcare sector, thereby ensuring pharmaceuticals markets offer a level-playing field to companies. State aid investigations have also included a number of complaints lodged by private health service providers against their allegedly unfair treatment or against potential excessive compensation of publicly-owned hospitals.

The Commission has adopted a number of decisions allowing Member States to give aid in the field of pharmaceuticals. The aid has taken the form of tax exemptions or direct grants to enterprises in the framework of regional aid, allowing for investments in eligible regions which are lagging behind economically.

The Commission also examines cases involving possible state aid in the field of health insurance, in particular in countries with competitive health insurance markets.

The State Aid Temporary Framework

The State aid Temporary Framework and public support of research, testing and production of products relevant to fighting the Coronavirus outbreak was adopted on 19th March 2020 to enable Member States to use the full flexibility foreseen under State aid rules to support the economy in the context of the coronavirus outbreak.  On 3rd April 2020, the first amendment to the Temporary Framework increased the possibilities for public support for research, testing and production of products relevant to fight the coronavirus outbreak.

For a full list of Decisions adopted under the State Aid Temporary Framework, including those in the pharmaceuticals sector, see Coronavirus Decisions List.

To search further Commission Decision relevant to the pharmaceutical and healthcare sectors, please use the Case Search Tool.

 

Judgments

Delay of entry   Parallel trade

Delay of entry

General Court

Court of Justice

  • Case C-591/16 Lundbeck
    Judgment of the Court of 25 March 2021
  • Case C-614/16 Merck v Commission
    Judgment of 25 March 2021 (rectified by order of 3 September 2021)
  • Case C-601/16 Arrow Group and Arrow Generics v Commission
    Judgment of the Court of 25 March 2021
  • Case C-588/16 Generics (UK) Ltd, v. the Commission
    Judgment of 25 March 2021
  • Case C-586/16 Sun Pharmaceutical Industries and Ranbaxy (UK) v Commission
    Judgment of 25 March 2021 (rectified by order of 3 September 2021)
  • Case C-307/18 Generics (UK and Others
    Judgment of 20March 2020
  • Case C-457/10 P AstraZeneca v Commission
    Judgment of the Court of 6 December 2012
  • Cases C-207/03 and C-252/03 Novartis
    Judgement of the Court of 21 April 2005
  • Case C-36/03 Approved Prescription Services Ltd v Licensing Authority
    Judgement of the Court of 9 December 2004
  • Case C-106/01 Novartis Pharmaceuticals
    Judgement of the Court of 29 April 2004
  • Case C-316/95 Generics
    Judgement of the Court of 9 July 1997
  • Case C-238/82 Duphar BV and others v The Netherlands State
    Judgement of the Court of 7 February 1984

 

Parallel trade

General Court

  • Case T-574/14 European Association of Euro-Pharmaceutical Companies (EAEPC) v Commission
    Judgment of the Court of 26 September 2018
  • Case T-247/04 Aseprofar and Edifa v Commission
    Order of the Court of 19 September 2005

Court of Justice

Other

  • Case C-179/16 F. Hoffmann-La Roche and Others
    Judgment of 23/01/2018