Pharma & Dominance

Foreword Dominance in the pharmaceutical sector: An overview of EU and national case law

As one of the most heavily regulated industries in the European Union, the pharmaceutical sector has historically been an area of focus for the European Commission and national competition authorities, which have relentlessly used antitrust enforcement as an instrument to help achieve the wider policy objective set for the sector: supporting patients’ access to innovative and affordable medicines. In a context where EU legislation regarding pharmaceuticals is currently under review as part of the Commission’s new Pharmaceutical Strategy for Europe, the sector remains under close scrutiny of competition authorities. In this article, we analyze the most recent developments across the European Union under Article 102 TFEU. While we still wait for the ECJ’s judgment in the Servier case, which creates notable uncertainty regarding the fate of the abuse of dominance allegation, these past 18 months the focus at the EU level seems to have shifted from pay-for-delay and excessive pricing cases to patent strategies (I.) and disparagement of competing drugs as an abuse of dominant position (II.). At the national level, excessive pricing remained at the center of attention, with the Leadiant case in several EU Member States and several appeal proceedings on-going in the UK (III.).

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Dechert (Paris)
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Dechert (Paris)
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Dominance

 The US FTC files an amicus brief outlining anticompetitive harm caused by improper Orange Book listings New
US Federal Trade Commission (FTC) (Washington)
United States 184 contributions 47043 visits
FTC Files Amicus Brief Outlining Anticompetitive Harm Caused by Improper Orange Book Listings* The Federal Trade Commission filed an amicus brief to address the anticompetitive harm that stems from improperly listed patents in the Food and Drug Administration’s (FDA) publication of “Approved (...)

The Canadian Competition Tribunal receives the first private abuse of dominance case alleging that not sharing a biologically equivalent drug’s sample with a company seeking to obtain regulatory approval constitutes abuse of dominance (Apotex / Paladin Labs)
McCarthy Tétrault (Toronto)
Canada 2 contributions 228 visites
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McCarthy Tétrault (Toronto)
Canada 1 contribution 52 visites
On September 29, 2023, Apotex Inc. (“Apotex”) applied for leave to the Competition Tribunal (“Tribunal”) under section 103.1 to bring an application under the abuse of dominance provisions of the Competition Act (the “Act”). Last year’s amendments to the Act (which we detailed previously) (...)

The UK Competition Appeal Tribunal upholds the Competition Authority’s decision and confirms the finding of excessive and unfair pricing of hydrocortisone tablets (Auden McKenzie / Actavis)
Van Bael & Bellis (Brussels)
Belgique 64 contributions 28943 visites
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Van Bael & Bellis (Brussels)
Belgique 163 contributions 56764 visites
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Van Bael & Bellis (Brussels)
Belgique 61 contributions 26499 visites
On 18 September 2023, the UK Competition Appeal Tribunal ( CAT ) confirmed in large part a decision of the UK Competition and Markets Authority ( CMA ) which on 23 July 2021 had imposed fines on several hydrocortisone tablet suppliers for, in addition to another infringement, charging (...)

The UK Competition Appeal Tribunal upholds a fine against a drugmaker for excessive pricing, for hiking prices over 10,00% (Auden / Actavis)
UK Competition & Markets Authority - CMA (London)
United Kingdom 410 contributions 105130 visits
CMA decision upheld in major drug price abuse case* Firms which raised prices for key medicine by over 10,000% from 70p to £72 have had their appeal against a CMA finding of excessive pricing rejected by the Competition Appeal Tribunal (CAT). The firms must now pay almost £130m in fines. (...)

The French Supreme Court allows follow-on damages action by the national health insurance fund in the wake of a major pharmaceutical company’s denigration strategy against rivals (CNAM / Sanofi)
Van Bael & Bellis (Brussels)
Belgique 64 contributions 28943 visites
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Van Bael & Bellis (Brussels)
Belgique 61 contributions 26499 visites
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Van Bael & Bellis (Brussels)
Belgique 163 contributions 56764 visites
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In a judgment dated 30 August 2023, the French Supreme Court rejected an appeal by Sanofi against the award of damages to the Caisse nationale d’assurance maladie des travailleurs salariés, the French national health insurance fund for employees ( CNAM ) (see, attached judgment). The damages (...)

The UK Competition Appeal Tribunal upholds the Competition Authority’s decision to fine a pharmaceutical company and its former owners for excessive pricing (Advanz Pharma / Hg Capital / Cinven)
Van Bael & Bellis (Brussels)
Belgium 32 contributions 6134 visits
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Van Bael & Bellis (Brussels)
Belgique 61 contributions 26499 visites
On 8 August 2023, the UK Competition Appeal Tribunal (“CAT”) delivered its judgment upholding the decision by the UK Competition and Markets Authority (“CMA”) against pharmaceutical company Advanz Pharma and its former owners Hg and Cinven (jointly, “Advanz”) for excessive pricing (see VBB on (...)

The UK Competition Appeal Tribunal upholds the Competition Authority’s decision to fine 3 drugmakers for excessive and unfair pricing of a critical medicine (Advanz / Cinven/ HgCapital)
Van Bael & Bellis (Brussels)
Belgique 64 contributions 28943 visites
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Van Bael & Bellis (Brussels)
Belgique 61 contributions 26499 visites
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Van Bael & Bellis (Brussels)
Belgique 163 contributions 56764 visites
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On 8 August 2023, the UK Competition Appeal Tribunal ( CAT ) unanimously upheld a decision of the UK Competition and Markets Authority ( CMA ) which in July 2021 had imposed fines totalling more than £101 million on Advanz Pharma ( Advanz ) and two previous private equity owners, Cinven and (...)

The UK Competition Appeal Tribunal rejects a challenge to an excessive pricing fine which came after the sole producer of a drug for thyroid hormone deficiency hiked prices by over 1,000% over a ten-year period (Advanz Pharma / Hg Capital / Cinven)
UK Competition & Markets Authority - CMA (London)
United Kingdom 410 contributions 105130 visits
CMA defeats legal challenge in medicine pricing case* The Competition Appeal Tribunal has unanimously upheld the CMA’s decision condemning a pharmaceutical supplier for excessive pricing of medicines sold to the NHS. The Competition and Markets Authority (CMA) welcomes today’s landmark (...)

The UK Competition Appeal Tribunal dismisses appeals against the Competition Authority’s findings of abuse of dominance relating to excessive pricing investigation concerning liothyronine tablets market (Advanz Pharma / Hg Capital / Cinven)
Herbert Smith Freehills (Brussels)
Belgium 121 contributions 74416 visits
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Herbert Smith Freehills (Brussels)
Belgique 22 contributions 7390 visites
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Herbert Smith Freehills (London)
Royaume-Uni 3 contributions 1964 visites
The UK Competition Appeal Tribunal has dismissed appeals against the CMA’s finding of abuse of dominance relating to excessive pricing of liothyronine tablets. The judgment provides further detail on the application of the excessive pricing test, and follows the Court of Appeal’s approach in (...)

The Italian Regional Administrative Tribunal of Latium upholds the Competition Authority’s finding that a pharmaceutical company abused its dominant position by charging excessive prices for an orphan drug (Leadiant)
Municipality of Cagliari
168 contributions 134417 visites
An Italian administrative court confirms the condemnation of a pharmaceutical company for charging excessive prices on an orphan drug* Introduction In Leadiant the Italian Competition Authority (ICA) found a pharmaceutical company, Leadiant, guilty of violating Article 102 TFEU for (...)

The Dutch Competition Authority maintains findings of excessive pricing against medicine supplier but reduces the fine imposed (Leadiant)
Van Bael & Bellis (Brussels)
Belgique 64 contributions 28943 visites
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Van Bael & Bellis (Brussels)
Belgique 61 contributions 26499 visites
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Van Bael & Bellis (Brussels)
Belgique 163 contributions 56764 visites
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Autoriteit Consument & Markt, the Dutch competition authority ( ACM ), announced on 11 July 2023 that it had considered the objections raised by Leadiant against its earlier decision of 1 July 2021 finding Leadiant guilty of an abuse of dominant position in the form of excessive prices (...)

The Chinese State Administration for Market Regulation fines a pharmaceutical company for engaging in resale price maintenance (Zizhu Pharma)
Hogan Lovells (Beijing)
Chine 81 contributions 21116 visites
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Hogan Lovells Fidelity (Shanghai)
9 contributions 2471 visites
On 29 May 2023, China’s antitrust authority – the State Administration for Market Regulation (“SAMR”) – published the decision against Zizhu Pharma on its webpage. The company was fined by SAMR’s Beijing branch for engaging in resale price maintenance (“RPM”), the antitrust lingo for (...)

The Mexican Competition Authority initiates an abuse of dominance investigation in the market for the distribution and commercialization of scopolamine
Mexican Competition Authority (Mexico City)
Mexico 140 contributions 30549 visits
Cofece initiates investigation in the market for the distribution and commercialization of scopolamine in national territory* The Investigative Authority has indications of possible absolute monopolistic practices in the market for this active ingredient used in the manufacture of medicines. (...)

The Canadian Competition Authority enters into a consent agreement with a nuclear pharmaceutical company to address competition concerns with its contracting practices in the radiopharmaceutical industry (Isologic)
Canadian Competition Bureau (Gatineau)
Canada 84 contributions 11808 visites
Competition Bureau reaches agreement with Isologic to protect competition in healthcare* The Competition Bureau announced today that it has entered into a consent agreement with Isologic Innovative Radiopharmaceuticals Inc. (Isologic) to address competition concerns with its contracting (...)

The Belgian Competition Authority imposes a fine of €2.7M for abuse of dominance on a pharmaceutical company (Novartis)
Belgian Competition Authority (Brussels)
Belgium 122 contributions 24507 visits
The Belgian Competition Authority imposes a fine of EUR 2 782 808 on Novartis for abuse of dominant position* The Competition College of the Belgian Competition Authority has on 23 January 2023 imposed a fine of EUR 2,782,808 on Novartis Pharma SA en Novartis AG (hereafter Novartis) for the (...)

The Belgian Competition Authority imposes a €2.7M fine on a pharmaceutical company for abusing its dominance by misleading healthcare professionals about the effectiveness of a generic drug competitor (Novartis)
Van Bael & Bellis (Brussels)
Belgique 61 contributions 26499 visites
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Van Bael & Bellis (Brussels)
Belgique 163 contributions 56764 visites
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Van Bael & Bellis (Brussels)
Belgique 64 contributions 28943 visites
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As if on cue, the Belgian competition authority announced on 24 January 2023 new significant developments with regard to their enforcement activities in the pharmaceutical sector. The Belgian Competition Authority (BCA) indicated that it had imposed a fine of EUR 2,782,808 on Novartis for (...)

The Spanish Competition Authority fines the maker of an orphan medicine to treat a rare metabolic disorder €10.25M for imposing excessive prices (Leadiant)
Van Bael & Bellis (Brussels)
Belgique 64 contributions 28943 visites
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Van Bael & Bellis (Brussels)
Belgique 163 contributions 56764 visites
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Van Bael & Bellis (Brussels)
Belgique 61 contributions 26499 visites
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On 14/11/2022, the Spanish Competition Authority (CNMC) imposed a fine of EUR 10.25 million on Leadiant because that firm was found to have abused its dominant position by applying excessive prices for chenodeoxycholic acid, an orphan medicine indicated for the treatment of patients afflicted (...)

The Spanish Competition Authority fines a drugmaker €10.25M for excessive pricing of a drug for the treatment of cerebrotendinous xanthomatosis (Leadiant)
Callol, Coca & Asociados (Madrid)
Spain 170 contributions 47331 visits
XCT is an ultra-rare metabolic disease affecting 200-250 diagnosed patients in Europe of which around 50 are in Spain. XCT has been based on an active principle denominated CDCA. Leadiant has been the only provider of CDCA based pharmaceuticals in Spain since 2010. The investigation was (...)

The Spanish Competition Authority fines a pharmaceutical company €10.25M for selling its orphan drug for the treatment of a rare disease at an excessive price (Leadiant)
Spanish Competition Authority (CNMC) (Madrid)
Spain 143 contributions 31825 visits
The CNMC fines the pharmaceutical company Leadiant 10.25 million for selling its orphan drug for the treatment of a rare disease at an excessive price.* The company has abused its dominant position as the holder of the only medicine available in Spain for the treatment of a rare disease: (...)

The US FTC files an amicus brief challenging the abuse of the FDA’s "orange book" listing procedures which allow companies to automatically block the entry of generic drugs for 30 months (Jazz Pharmaceuticals / Avadel CNS Pharmaceuticals)
US Federal Trade Commission (FTC) (Washington)
United States 184 contributions 47043 visits
FTC Amicus Brief Challenges Abuse of FDA “Orange Book” Listing Procedures to Block Drug Competition* The Federal Trade Commission filed an amicus brief with the U.S. District Court for the District of Delaware in the case of Jazz Pharmaceuticals v. Avadel CNS Pharmaceuticals. The Brief (...)

The Spanish Competition Authority fines a pharmaceutical company €39M for filing unjustified lawsuits with the goal of delaying the entry of rivals into the market for female contraceptive rings (Merck Sharp & Dohme)
Spanish Competition Authority (CNMC) (Madrid)
Spain 143 contributions 31825 visits
The CNMC fines pharmaceutical company Merck Sharp and Dohme 39 million euros for abuse of a dominant position in the market for vaginal contraceptive rings* In 2017, the company took unjustified legal action against its competitor Insud Pharma under the pretext of protecting its patent. With (...)

The Spanish Competition Authority imposes sanctions on a pharmaceutical company for misusing litigation strategies regarding patents (Merck Sharp & Dohme)
Herbert Smith Freehills (Brussels)
Belgium 121 contributions 74416 visits
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Herbert Smith Freehills (Madrid)
Espagne 22 contributions 31757 visites
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Herbert Smith Freehills (Madrid)
Espagne 12 contributions 2192 visites
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On 21 October 2022, the Spanish National Markets and Competition Commission (CNMC) imposed a €38.9 million fine on pharmaceutical company Merck Sharp and Dohme (MSD) for abusing its dominant position in the Spanish market for contraceptive vaginal rings. In particular, the CNMC concluded that (...)

The Spanish Competition Authority fines a maker of female contraceptive products for abuse of dominance through vexatious litigation tactics (Merck Sharp & Dohme De España / MSD Human Health)
Marcos Araujo Boyd Law Practice
3 contributions 686 visites
n 21 October 2022 the Spanish CNMC imposed a fine of 38.9 million EUR on MERCK SHARP & DOHME DE ESPAÑA, S.A. and its parent company MSD HUMAN HEALTH HOLDING, B.V. (hereafter jointly ‘MSD’) for abusive practices in the Spanish market of contraceptive rings. Their breach consisted in having (...)

The Spanish Competition Authority holds that patent litigation could be a form of abuse of dominance and imposes a €38.9M fine on a biopharmaceutical company for filing a patent suit aimed at harassing a competitor (Merck Sharp & Dohme)
Marcos Araujo Boyd Law Practice
3 contributions 686 visites
On 21 October 2022 the Spanish CNMC imposed a fine of 38.9 million EUR on MERCK SHARP & DOHME DE ESPAÑA, S.A. and its parent company MSD HUMAN HEALTH HOLDING, B.V. (hereafter jointly ‘MSD’) for abusive practices in the Spanish market of contraceptive rings. Their breach consisted in having (...)

The EU Commission sends a Statement of Objections to the developer of a multiple sclerosis medication over misuse of the patent system and disparagement of a rival (Teva)
Allen & Overy (Munich)
Allemagne 2 contributions 158 visites
On 10 October 2022, the European Commission (EC) sent a Statement of Objections to Teva Pharmaceutical Industries Limited and Teva Pharmaceuticals Europe BV (Teva). The EC has provisionally found that Teva abused its dominant position in the market for the treatment of multiple sclerosis by (...)

The Swiss Competition Authority carries out a dawn raid at the premises of a pharmaceutical company which causes it to drop its Intellectual Property infringement court actions against a competitor (Novartis / Lily)
Van Bael & Bellis (Brussels)
Belgium 32 contributions 6134 visits
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Van Bael & Bellis (Brussels)
Belgique 64 contributions 28943 visites
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Van Bael & Bellis (Brussels)
Belgique 163 contributions 56764 visites
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As we have previously reported (Van Bael & Bellis Life Sciences News and Insights, 15 September 2022), on 13 September 2022, the Swiss Competition Authority carried out an inspection at the premises of Novartis Pharma AG ( Novartis ). In parallel, Novartis received a request for (...)

The Swiss Competition Authority initiates an investigation against a pharmaceutical company due to possible unlawful use of a patent to reduce competitive pressure in the market
Swiss Competition Commission (Bern)
Suisse 18 contributions 635 visites
COMCO: Investigation on use of patents* Bern, 15.09.2022 - The Swiss Competition Commission (COMCO) has opened an investigation against a Swiss pharmaceutical company concerning a possible unlawful use of a patent to reduce competitive pressure. On September 13, 2022, COMCO opened an (...)

The Swiss Competition Authority initiates an investigation against a pharmaceutical company based on the allegations concerning refusal to supply products to a Swiss pharmaceutical wholesaler on more favourable terms
Swiss Competition Commission (Bern)
Suisse 18 contributions 635 visites
COMCO: Relative market power in healthcare* Bern, 16.08.2022 - The Competition Commission (COMCO) has opened a new investigation. A pharmaceutical company is alleged to have refused to supply products to a Swiss pharmaceutical wholesaler on more favorable terms abroad. If relative market (...)

The US Court of Appeals for the Tenth Circuit upholds a District Court decision dismissing a case alleging exclusionary practices on the grounds that consumer welfare is unaffected and a demonstrable intention to exclude in some situations is legitimate (Sanofi-Aventis / Mylan)
Hausfeld (San Francisco)
États-Unis 3 contributions 211 visites
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Hausfeld (San Francisco)
États-Unis 1 contribution 103 visites
On July 29, 2022, the Tenth Circuit affirmed the grant of summary judgment to defendants by the District of Kansas in an important, albeit at times misguided, monopolization opinion. The antitrust claim by Sanofi-Aventis U.S., LLC against Mylan, Inc. and Mylan Specialty, LP, arose from (...)

The UK Competition Authority fines two pharmaceutical firms €70M for charging excessive prices to the National Health Service (Pfizer / Flynn)
Cleary Gottlieb Steen & Hamilton (London)
Royaume-Uni 21 contributions 22448 visites
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Cleary Gottlieb Steen & Hamilton (London)
Royaume-Uni 2 contributions 568 visites
The UK Competition and Markets Authority (CMA) last week fined pharmaceutical companies Pfizer and Flynn £63 million and £6.7 million for engaging in excessive pricing. In the CMA’s view, the companies charged unfairly high prices for Phenytoin capsules, a genericised anti-epilepsy drug, in (...)

The UK Competition Authority fines two pharma companies £70M for overcharging the National Health Service (Pfizer / Flynn)
UK Competition & Markets Authority - CMA (London)
United Kingdom 410 contributions 105130 visits
£70 million in fines for pharma firms that overcharged NHS* After reassessing part of the case, the CMA has found that Pfizer and Flynn abused their dominant positions to overcharge the NHS for a life-saving epilepsy drug. Pharmaceutical companies Pfizer and Flynn fined £63 million and £6.7 (...)

The EU Court of Justice AG Kokott proposes that the Court should set aside the ruling of the General Court and declare that the pay-for-delay agreements concluded by a pharmaceutical firm constituted an abuse of dominance (Servier)
European Court of Justice (Luxembourg)
Luxembourg 332 contributions 111410 visits
Marketing of perindopril: Advocate General Kokott proposes that the Court of Justice should rule that all agreements concluded by the Servier group with generic pharmaceutical companies constituted restrictions of competition by object and that it should set aside the General Court’s findings (...)

The French Supreme Court rejects an appeal by a pharmaceutical company which alleged that a €21M fine imposed by the Competition Authority was erroneous (Janssen-Cilag)
Dechert (Paris)
France 48 contributions 71884 visites
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Dechert (Paris)
France 20 contributions 24452 visites
On 1 June 2022, the French Supreme Court (the “Supreme Court”) entirely dismissed the appeal of Janssen-Cilag (“Janssen”) and its parent company Johnson & Johnson against a judgment of the Paris Court of Appeal (the “Court of Appeal”) of 11 July 2019 in the Durogesic® case. However, this (...)

The French Supreme Court agrees with the Paris Court of Appeal’s decision reducing a €25M fine to €21M for abuse of dominance by obstructing the entrance of generic drugs onto the market (Janssen-Cilag)
Van Bael & Bellis (Brussels)
Belgique 61 contributions 26499 visites
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Van Bael & Bellis (Brussels)
Belgique 163 contributions 56764 visites
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Van Bael & Bellis (Brussels)
Belgique 64 contributions 28943 visites
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On 1 June 2022, the French Supreme Court (Cour de cassation) upheld the judgment of the Paris Court of Appeal, which in turn largely upheld the 2017 decision of the French Competition Authority (FCA) to impose fines of EUR 25 million on Janssen Cilag and its parent company Johnson & (...)

The Italian Competition Authority fines a drug manufacturer €3.5M for charging excessive prices to the National Health Service for a life-saving drug (Leadiant)
Italian Competition Authority (Rome)
Italy 72 contributions 19349 visits
A524 - ICA fines Leadiant 3,5 million euros for abusing its dominant position* The Italian Competition Authority (ICA) found that since June 2017 Leadiant has charged the Italian NHS unfairly excessive prices for the sale of a life-saving drug. Similar proceedings were conducted by (...)

The Italian Competition Authority fines a pharmaceutical company for charging excessive prices for an orphan drug (Leadiant)
Municipality of Cagliari
168 contributions 134417 visites
The Italian Competition Authority (ICA) has recently closed an Article 102 TFEU enquiry against a pharmaceutical company in the Leadiant case with an infringement decision. The ICA found that Leadiant, had abused its dominant position by charging highly disproportionate prices for a drug (...)

The Chinese SAMR fines a national pharmaceutical company $1.4M for resale price maintenance (Geistlich Trading)
AnJie Broad Law (Beijing)
Chine 15 contributions 1948 visites
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AnJie Broad Law (Beijing)
Chine 44 contributions 12633 visites
Beijing AMR fines Geistlich Trading (Beijing) over monopoly agreement* On 28 February 2022, the State Administration for Market Regulation (SAMR) published an administrative penalty decision against Geistlich Trading (Beijing) Co Ltd for engaging in monopoly agreements of resale price (...)

The Dutch Competition Authority ceases an investigation into a pharma company after it promises to halt potentially abusive discounting of an arthritis drug (Pfizer)
Netherlands Authority for Consumers & Markets- ACM (The Hague)
Pays-Bas 212 contributions 36841 visites
Drug manufacturer Pfizer to discontinue its steering pricing structure for Enbrel following discussions with ACM* Drug manufacturer Pfizer will no longer persuade hospitals in the Netherlands into purchasing anti-rheumatic drug Enbrel through its discount schemes. Pfizer has informed the (...)

The Italian Competition Authority closes its investigation into resale price maintenance in the market for probiotics following commitments from the alleged transgressor (SOFAR)
Portolano Cavallo (Milan)
Italie 63 contributions 10441 visites
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Portolano Cavallo (Milan)
Italie 36 contributions 7165 visites
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University of Bologna (Bologna)
Italie 1 contribution 91 visites
In May 2021, the Italian Competition Authority (AGCM or ICA) launched an investigation into restrictions on resale prices that a pharmaceutical company, SOFAR, was alleged to have imposed upon its distribution network for a probiotic product (Enterolactis Plus). In Europe, agreements or (...)