Abstract
This chapter provides an overview of the competition law implementation in the pharmaceutical sector in France. It outlines some regulatory specificities and reviews recent case law highlighting the French authorities and courts' approach to commercial denigration, interplay between competition and IP rights, online sales of medicinal products.
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Notes
- 1.
‘Concerted actions, agreements, express or tacit agreements or coalitions are prohibited, even through the direct or indirect intermediation of a company in the group established outside France, where they have the object or may have the effect of preventing, restricting or distorting the free competition in a market, particularly where they are intended to: 1° Limit access to the market or the free exercise of competition by other undertakings; 2° Prevent price setting by the free play of market forces, by artificially encouraging the increase or reduction of prices; 3° Limit or control production, opportunities, investments or technical progress; 4° Share markets or sources of supply’.
- 2.
‘The abuse of a dominant position by an undertaking or group of undertakings on the domestic market or a substantial part of the market is prohibited (...). This abuse may include a refusal to sell, a tie-in of sales or discriminatory terms of sale as well as the termination of established commercial relationships, for the sole reason that the partner is refusing to accept unjustified commercial terms. The abuse of the state of economic dependence of a client or supplier by an undertaking or group of undertakings is also prohibited, if it is likely to affect the functioning or structure of competition. This abuse may include a refusal to sell, tied selling or discriminatory practices mentioned in I of article L.442-6 or in product range agreements’.
- 3.
Competition Authority, Decision No. 13-D-11 of 14 May 2013, Plavix, relating to practices implemented in the pharmaceutical sector, para. 286.
- 4.
See, for example, the judgment of the Court of Cassation, Commercial Chamber, 15 June 1999, No. 97-15185; see also the Commission Decision, case COMP/A.37.507/F3 of 15 June 2005, AstraZeneca.
- 5.
Competition Council, Decision No. 07-D-09 of 14 March 2007, relating to practices implemented by GlaxoSmithKline France; see also Competition Authority, Decision No. 10-D-37 of 17 December 2010, relating to practices implemented on the market of cetirizine in tablets.
- 6.
Court of Cassation, Commercial Chamber, 15 June 1999, No. 97-15185, published in the French Official Bulletin.
- 7.
Competition Authority, Decision No. 13-D-11 of 14 May 2013, Plavix, paragraph 299: The Authority has thus considered that generics of the molecule of clopidogrel were direct competitors of the originator Plavix in particular because they are ‘compounds of the same active principle, have a report effectiveness/safety equivalent and can handle the same pathologies’.
- 8.
European Commission, case IV/M.950 of 4 February 1998, Hoffmann-La Roche/Boehringer Mannheim, para. 11.
- 9.
See for example: Competition Authority, Decision No. 10-D-02 of 14 January 2010, relating to practices implemented in the sector of heparin at low molecular weight, para. 55.
- 10.
European Commission, case IV/M.950 of 4 February 1998, Hoffmann-La Roche/Boehringer Mannheim, para. 17.
- 11.
Competition Council, Decision No. 01-D-07 of 11 April 2001, relating to practices implemented on the market of the pharmaceutical distribution.
- 12.
Competition Authority, Decision No. 09-D-17 of 22 April 2009, relating to practices implemented by the Regional Council of the Order of Pharmacists of Basse-Normandie.
- 13.
Competition Authority, Decision No. 13-D-21 of 18 December 2013, Subutex, relating to practices implemented on the French market in the high-dose buprenorphine marketed in city.
- 14.
Paris Court of Appeal, 26 March 2015, No. 2014/03330, Subutex, page 14.
- 15.
Paris Court of Appeal, 26 March 2015, No. 2014/03330, Subutex, page 13. This judgment was confirmed by the Court of Cassation, 11 January 2017, No. 15-17.134.
- 16.
Competition Council, Decision No. 05-D-72 of 20 December 2005, relating to practices implemented by various pharmaceutical companies in the area of parallel exports of drugs, paragraph 269.
- 17.
Competition Council, Decision No. 07-D-22 of 5 July 2007, relating to practices implemented in the sector of the distribution of pharmaceutical products, paragraph 100 (Decision quashed by the Paris Court of Appeal, 26 November 2008, No. 2007/13915, itself quashed by the Court of Cassation, Commercial Chamber, 2 February 2010, No. 08-70449).
- 18.
Article L.5123-1 of the Public Health Code: ‘Drugs and products referred to in article L.5121-8 may not be sold at a price higher than that resulting from the regulation of prices. The other drugs and products whose sales is reserved for pharmacists may not be sold at a higher price than that resulting from the tariff national pharmaceutical. […]’
- 19.
Article L.162-16-4 of the Social Security Code.
- 20.
Article L.162-16-4 of the Social Security Code.
- 21.
In French: Services médico-économiques.
- 22.
Competition Authority, Opinion No. 13-A-24 of 19 December 2013, relating to the operation of the competition in the sector of the distribution of the medicinal product for human use in the city, paragraph 73.
- 23.
Competition Authority, Decision No. 13-D-11 of 14 May 2013, Plavix, confirmed on appeal.
- 24.
Competition Authority, Decision No. 13-D-21 of 18 December 2013, Subutex, confirmed on appeal.
- 25.
Paris Court of Appeal, 26 March 2015, No. 2014/03330 in Subutex; Paris Court of Appeal, 18 December 2014, No. 2013/12370 in the Plavix case.
- 26.
Competition Authority, Decision No. 13-D-11 of 14 May 2013, Plavix, paragraph 376: ‘Therefore, the dissemination of negative information, or even the instillation of a doubt on the intrinsic qualities of a drug may be sufficient to discredit immediately with health professionals. Indeed, if those wonder on its therapeutic efficacy or even on its safety, in reason of the submission that has been made or the answers that have been given to their questions in this regard, they will not take the risk to prescribe or deliver them’.
- 27.
Among these decisions refusing precautionary measures, one has resulted in sanction decision and one is still in progress. See Competition Authority, Decision No. 13-D-11 of 14 May 2013, Plavix; and Decision No. 13-D-21 of 18 December 2013, Subutex. These two decisions have been confirmed on appeal, but are the object of an appeal before the Court of Cassation. The Competition Authority sentenced Sanofi-Aventis for denigration imposing a fine of EUR 40.6 million, after the decision No. 10-D-16 which has rejected the requested provisional measures.
- 28.
A policy of low prices on a non-dominated market so as to deter the entry of rivals on the dominated market.
- 29.
Paris Court of Appeal, 8 April 2008, No. 2007/07008, confirmed by Court of Cassation, Commercial Chamber, 17 March 2009, No. 08-14.503.
- 30.
Competition Authority, Decision No. 14-DCC-61 of 25 April 2014, relating to acquisition of exclusive control of the companies Imarko ITS and Arkopharma ITS by Apharma SAS; and Competition Authority, Decision No. 13-DCC-187 of 10 December 2013, relating to the taking of exclusive control of Omnium Synerlab by the corporation 21 Centrale Partners.
- 31.
Competition Authority, Decisions No. 13-DCC-106 of 6 August 2013, relating to acquisition of exclusive control of Warner Chilcott plc by Actavis, Inc.; Competition Authority, Decision No. 10-DCC-191 of 20 December 2010, relating to acquisition of exclusive control of Théramex by Teva.
- 32.
Competition Authority, Opinion No. 13-A-24 of 19 December 2013, relating to the operation of the competition in the sector of the distribution of the medicinal product for human use in the city, paragraphs 569 and 722.
- 33.
Competition Authority, Opinion No. 13-A-12 of 10 April 2013, relating to a draft order of the Minister of Social Affairs and Health relating to good practices of dispensing of drugs by electronic means, paragraph 24.
- 34.
Competition Authority, Opinion No. 13-A-12 of 10 April 2013, paragraphs 101, 172 and 178.
- 35.
Competition Authority, Opinion No. 12-A-18 of 20 July 2012, on a draft decree relating to the supply of medicinal products for human use, paragraph 129.
- 36.
In a recent opinion (Opinion No. 16-A-09 of 26 April 2016 relating to two projects of Orders concerning electronic commerce of drugs), the Competition Authority issued a favourable opinion on two draft Orders in order to regulate online drug sales, believing that the obligations imposed on pharmacists by these projects are disproportionate to attain public-health objectives. Moreover, the new provisions, which add a large number of additional formalities with respect to the pharmaceutical analysis and counsel ‘do not appear justified on grounds of public health, specific to this particular mode of dispensing’ (paragraph 83). In addition, these additional constraints apply only to online Pharmacies, and are not applied to dispensatories, thus constituting a discrimination against online sale which may have heavy consequences ‘from a legal and economic point of view, but also on public health’ (paragraph 84). The Authority considers that these projects of orders will limit the attractiveness and competitiveness of the French offer face to those of foreign sites, with as important consequence, the risk to see the French patients using unauthorised sites, much more flexible in their use, and that could commercialise counterfeited drugs (paragraphs 87 to 89).
- 37.
See for example: Court of Cassation, Commercial Chamber, 23 April 2003, No. 00-17.166, in which Smithkline Beecham has assigned Lilly France for unfair competition for a comparative advertising alleged as denigrating; and Court of Cassation, Commercial Chamber, 22 March 2011, No. 10-17.814, in which the society Ferlux alleged to suffer for denigration acts implemented by a competitor of the company.
- 38.
Competition Authority, Opinion No. 13-A-24 of 19 December 2013, paragraph 461.
- 39.
Competition Authority, Opinion No. 13-A-24 of 19 December 2013, p. 11.
- 40.
Competition Authority, Decision No. 09-D-28 of 31 July 2009: The request for provisional measures has been rejected because of the lack of a serious and immediate damage to the complaining undertaking, to the general economy, to the concerned sector or to consumer’s interest.
- 41.
In French: Produits frontières. As for example pregnancy tests, liquid solutions for contact lenses, etc.
- 42.
Competition authority, Opinion No. 13-A-24 of 19 December 2013, paragraphs 712 to 729.
- 43.
Class actions are however very framed and complex to implement. Only consumer associations approved and represented at national level can initiate a procedure before civil courts. Furthermore, a class action cannot be introduced before a Competition authority’s decision, finding a breach of competition law, has become final on this point, which can lead to very long procedures.
- 44.
Article 184 of the Act No. 2016-41 of 26 January 2016 called ‘Modernisation of our health system’, codified in articles L.1143-1 to L.1143-22 of the Public Health Code.
- 45.
Codified in article L.1143-1 of the Public Health Code.
- 46.
Competition Authority’s News release of 16 May 2011 relating to the method of calculation of fines.
- 47.
Article L.464-2 of the French Code of Commerce.
- 48.
Article L.464-2, I of the French Code of Commerce. The proposals for commitments are generally followed by a market test (Publication of proposals of commitments on the site of the Authority in order to gather the comments of interested third parties), the authority then decides to accept and close the case or not. The Authority may also decide on a reduction in the fine, to encourage companies to propose commitments and to subscribe to compliance programs.
- 49.
For example: Competition Authority, Decision No. 13-D-21 of 18 December 2013, Subutex.
- 50.
Competition Authority, Opinion No. 13-A-24 of 19 December 2013, paragraph 529.
- 51.
Article L.464-2, I of the French Code of Commerce. In the case of non-compliance with an injunction, the Authority has the possibility to release a decision of sanction for non-compliance with an injunction, possibly accompanied by a penalty (article L.464-3 of the French Code of Commerce).
- 52.
Article L.464-1 of the French Code of Commerce.
- 53.
For example, in the case 07-MC-06 which concerned denigration, the Authority imposed on Schering-Plow, author of the alleged practices, to publish an article reaffirming the bioequivalence between the generic drugs and the originator, as well as the safety of the substitution, since the entrance of the generic on the market. The Authority has nevertheless several times rejected the requests for interim measures, not being met the necessary legal conditions, while pursuing the instruction on merits in order to qualify the practices. See for example the decision No. 09-D-28 of 31 July 2009, in which the Authority refuses to conclude at this stage, that very low prices, which sometimes confined to a sort of free-price, within the framework of a strategy of predation, and asses the absence of a serious and immediate damage to the interests protected by article L.464-1 of the French Code of Commerce, deciding to pursue the matter on merits. See also the Decisions 00-MC-16 of 7 November 2000, 02-MC-09 of 12 June 2002 and 02-MC-07 of 15 May 2002.
- 54.
Article L.464-2, I of the French Code of Commerce. Usualy it is an extract of the decision explaining the reasons for the finding of wrongdoing which is published. The costs are borne by the interested person.
- 55.
Codified in article L.5121-29 of the Public Health Code.
- 56.
In French: Agence nationale de sécurité du médicament et des produits de santé, or ANSM. See LEEM, press release of 20 May 2014: http://www.leem.org/sites/default/files/Dossier-de-presse-Atelier-presse-20-mai-2014_0.pdf;
The list of out-of-stock drugs is available on the site of the MSNA: see http://ansm.sante.fr/S-informer/Informations-de-securite-Ruptures-de-stock-des-medicaments.
- 57.
The amendment is worded as follows: ‘If the shortage is not linked to any technical or quality reason, the pharmaceutical company must have the obligation to produce and provide those. If the shortage is linked to technical problems or if the product no longer has the quality required, there is an obligation for the company to correct the problems in a given period. Pending the return too normality, the production of the drug, being faulty the active principle or the pharmaceutical formulation, can be entrusted to a third party in order to ensure the necessary supply’. This amendment was intended to allow the MSNA to impose to a company that decided to suspend the marketing of a drug, to produce it.
- 58.
See Senate, Session of 29 September 2015: http://www.senat.fr/seances/s201509/s20150929/s20150929008.html; the co-rapporteur indicated that the ‘obligation to produce and provide, as well as the new possibility to entrust a third party the production of drugs which pose problems, in the field of property law. The risk, in effect, is that the State is obliged to compensate the pharmaceutical company due to the obligations it imposes upon him, which is certainly not the objective sought by the authors of the amendment’.
- 59.
Delivery of pharmacies in the twenty-four hours and detention of a stock of two weeks including at least nine tenth of pharmaceutical specialties actually marketed in France.
- 60.
Competition Authority, Opinion No. 13-A-24 of 19 December 2013, paragraph 618.
- 61.
Competition Authority, Opinion No. 13-A-24 of 19 December 2013, p. 11.
- 62.
Competition Council, Decision No. 07-D-22 of 5 July 2007, relating to practices implemented in the sector of the distribution of pharmaceutical products, paragraph 99.
- 63.
Competition Council, Decision No. 07-D-22 of 5 July 2007, paragraph 100.
- 64.
Competition Council, Decision No. 07-D-22 of 5 July 2007, paragraph 99.
- 65.
Competition Authority, Opinion No. 12-A-18 of 20 July 2012, paragraph 130.
- 66.
In French: Direction générale de la concurrence, de la consommation et de la répression des fraudes, or DGCCRF.
- 67.
See Ministry of the Economy, DGCCRF: http://www.economie.gouv.fr/dgccrf/lapplication-loi-anti-cadeaux-dans-secteur-sante.
- 68.
Article R.5121-8 of the Public Health Code.
- 69.
Article L.162-16 of the Code of Social Security.
- 70.
Article 50 of the Act No. 2008-1330 of 17 December 2008 on social security funding for 2009 and article L.5125-23 of the Public Health Code.
- 71.
Article L.5125-23 of the Public Health Code.
- 72.
Article 33 of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) provides that ‘[t]he term of protection available shall not end before the expiration of a period of twenty years counted from the filing date’.
- 73.
In French: Autorisation de mise sur le marché, or AMM.
- 74.
Competition Authority, Opinion No. 13-A-24 of 19 December 2013.
- 75.
Competition Authority, Opinion No. 13-A-24 of 19 December 2013.
- 76.
European Commission, case COMP/AT. 39226, Lundbeck, 19 June 2013.
- 77.
European Commission, case COMP/AT.39685, Johnson & Johnson, 10 December 2013.
- 78.
Competition Authority, Opinion No. 13-A-24 of 19 December 2013, paragraph 343.
- 79.
Competition Authority, Decision No. 10-D-37 of 17 December 2010.
- 80.
Court of Cassation, Commercial Chamber, 12 December 1995, Meteorological Directorate.
- 81.
For example, Court of Cassation, Commercial Chamber, 21 October 1997, Chambre syndicale des pharmaciens du Maine-et-Loire in which the Court of Cassation has considered, with regard to mutual societies that ‘the legal regime of mutual societies, such as the non-profit character of their activity, is not of a nature to exclude them from the scope of application of the Ordinance of 1 December 1986, when they implement, as in the present case, marketing of medicinal products, a production, distribution and services activity’.
- 82.
Competition Council, Decision No. 01-D-07 of 11 April 2001, relating to practices implemented on the market of the pharmaceutical distribution.
- 83.
ECJ, joined cases C-180/98 and C-184/98, Pavel Pavlov v Stichting Pensioenfonds Medische Specialisten, 12 September 2000, ECLI:EU:C:2000:428.
- 84.
Competition Council, Decision No. 06-D-36 of 6 December 2006, relating to practices implemented by Imagerie Médicale du Nivolet.
- 85.
Competition Council, Decision No. 06-D-05 of 15 March 2006, relating to practices implemented in the sector of medical transport of emergency in ‘Doubs et le Jura’.
- 86.
Competition Council, Decision No. 99-D-01 of 5 January 1999, relating to practices implemented by Disty medical club.
- 87.
Competition Council, Decision No. 05-D-43 of 20 July 2005, relating to practices implemented by the Departmental Council of the National Order of the dentists of Puy-de-Dome and the National Council of the National Order of the dentists.
- 88.
Competition Council, Decision No. 07-D-09 of 14 March 2007.
- 89.
Competition Council, Decision No. 99-D-01 of 5 January 1999.
- 90.
Competition Council, Decision No. 97-D-18 of 18 March 1997, relating to the practices identified in the sector of the portage of medications in the home.
- 91.
Competition Authority, Decision No. 09-D-17 of 22 April 2009.
- 92.
Court of Cassation, Commercial Chamber, October 1997, House association of pharmacists in the Maine-et-Loire.
- 93.
Court of Cassation, Criminal Chamber, 25 November 1992, No. 91-83.512.
- 94.
Competition Council, Decision No. 93-D-20 of 8 June 1993 on the Referral presented by the European Confederation of Independent Workers’ Defence.
- 95.
Competition Authority, Decision No. 14-D-12 of 10 October 2014, relating to practices implemented in the sector of the supply of health data by the National Health Insurance Fund for Salaried workers and the GIE SESAM-Vitale.
- 96.
Competition Authority, Decision No. 10-D-24 of 28 July 2010, relating to practices implemented by the National Fund of Family Allowances.
- 97.
Competition Council, Decision No. 01-D-62, relating to the provision of medical devices by some CPAM.
- 98.
Competition Council, Decision No. 01-D-55 of 21 September 2001, relating to practices implemented on the market of the additional reimbursement to the sickness insurance.
- 99.
Court of Cassation, Criminal Chamber, 21 October 1997, No. 95-14.457; Court of Cassation, Commercial Chamber, 12 March 2002, No. 00-11.638.
- 100.
Only if the competition authority has not yet ruled on the practice in question.
- 101.
Article R.4235-65 of the Public Health Code.
- 102.
Competition Council, Annual Report for 2008, thematic study ‘Competition Law and Health’, p. 124.
- 103.
A separate statute for export wholesale distributor is provided for by the Code of public health in article R.5124-2, 7°. Contrary to the wholesaler-distributor, the export wholesale distributor is not subject to the public service obligations to which are instead submitted wholesalers-distributors.
- 104.
Competition Council, Decision No. 05-D-72 of 20 December 2005, paragraph 270.
- 105.
Competition Council, Decision No. 07-D-22 of 5 July 2007, paragraph 100.
- 106.
ECJ, case C-322/01, Deutscher Apothekerverband, ECLI:EU:C:2003:664.
- 107.
Directive 2011/62/EU of 8 June 2011, amending the Directive 2001/83/EC of 6 November 2001 on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products.
- 108.
Order No. 2012-1427 of 19 December 2012, concerning the strengthening of the security of the drugs supply chain, to the frame of the sale of drugs on the Internet and to the fight against the adulteration of drugs.
- 109.
Article L. 5121-5 of the Public Health Code.
- 110.
Competition Authority, Decision No. 08-D-25 of 29 October 2008, relating to practices implemented in the sector of the distribution of cosmetic products and of bodily hygiene sold on pharmaceutical advice; confirmed by the Court of Cassation, Commercial Chamber, 24 September 2013, CDS and other v Pierre Fabre, No. 12-14.344.
- 111.
Competition Authority, Opinion No. 13-A-12 of 10 April 2013; and Competition Authority, Opinion No. 16-A-09 of 26 April 2016.
- 112.
Competition Authority, Opinion No. 16-A-09 of 26 April 2016.
- 113.
Competition Authority, Decision No. 13-D-11 of 14 May 2013, Plavix.
- 114.
Competition Authority, Decision No. 13-D-21 of 18 December 2013, Subutex.
- 115.
Competition Authority, Decision No. 13-D-21 of 18 December 2013, Subutex.
- 116.
Article L.4211-1 of the Public Health Code.
- 117.
Competition Authority, Opinion No. 13-A-24 of 19 December 2013.
- 118.
Competition Authority, Opinion No. 13-A-24 of 19 December 2013, paragraphs 712 to 745.
- 119.
Consumer Affairs Act No. 2014-344 of 17 March 2014.
- 120.
Competition Authority, Opinion No. 13-A-24 of 19 December 2013, paragraph 727.
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Eskenazi, L. et al. (2017). France. In: Kobel, P., Këllezi, P., Kilpatrick, B. (eds) Antitrust in Pharmaceutical Markets & Geographical Rules of Origin. LIDC Contributions on Antitrust Law, Intellectual Property and Unfair Competition. Springer, Cham. https://doi.org/10.1007/978-3-319-55813-4_6
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