Upcoming Changes to Italy’s Biosimilar Landscape

On 28 November 2016, the Italian Chamber of Deputies approved the Draft Budgetary Law of 2017.  Among other things, the Draft Law introduces new rules on the substitutability of biologics and the procurement of biosimilars.

In particular, Article 59(11) of the Draft Law provides that:

  • two products enjoy a biosimilarity relationship only where this has been established by the European Medicines Agency (EMA) or the Italian Medicines Agency (AIFA);
  • the automatic substitution of an originator biologic with its biosimilars (and between biosimilars) is not allowed;

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The Court of Justice of the EU Adopts a Broad Interpretation of the Information on Emissions into the Environment that Authorities Must Disclose to the Public

Last week the Court of Justice of the European Union (“CJEU”) upheld a broad interpretation of the concept of “information that relates to emissions into the environment” that EU and Member State authorities (e.g., ECHA, EFSA, Commission, national environmental agencies) must disclose to the public.  According to the CJEU, the information that must be disclosed does not only relate to emissions from industrial installations, and must also include data allowing the public to: (i) know what is, or may be foreseen to be, released into the environment under normal or reasonable conditions of use of a product or substance; (ii) check the correctness of the assessment of the actual or foreseeable emissions on the basis of which product or substance is authorized; and (iii) understand the effect of those emissions on the environment.   This information must be disclosed to the public, upon request, even if it may affect the commercial interests of companies.

The CJEU’s decisions will have a significant impact on all companies that are required to submit regulatory filings to access the EU market under different EU legislation (e.g., REACH, Biocides, Plant Protection Products, Fertilizers, GMOs).  These companies must now assume that much of the data they submit may not be kept confidential.

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French Supreme Court upholds Sanofi’s generic denigration fine

In its 18 October judgment the French Cour de Cassation upheld the €40.6m fine imposed on Sanofi-Aventis (“Sanofi”) by the French Competition Authority (“FCA”) in May 2013 and affirmed the judgment of the Paris Court of Appeal. The FCA found that Sanofi abused its dominant position in violation of Art. 102 of the Treaty on the Functioning of the European Union (“TFEU”) and art. L.420-2 of the French Commercial Code by denigrating generic competitors of its drug Plavix on the French clopidogrel market.

In July 2008, Sanofi put in place a strategy intended to convince healthcare professionals of the differences between Plavix and soon to enter generic clopidogrel products. The strategy included representations that the generic drugs contained clopidogrel salts that differed from the Plavix salt and were not indicated to be used in combination therapy with aspirin for patients suffering from the Acute Coronary Syndrome (“ACS”).  Sanofi also encouraged doctors to indicate on their Plavix prescriptions that the drug was “not-substitutable” (except with Sanofi’s own generic Clopidogrel Winthrop). A large number of doctors did so.  In its communications, Sanofi stressed Plavix’s established efficacy and safety profile regarding the prevention of atherothrombotic events, which the newly entering third party generic drugs did not have.

The Court of Appeal upheld the FCA’s conclusion that Sanofi put in place a structured strategy aimed at denigrating competing generics, and that by going beyond merely stating objective differences between Plavix and the generic products it abused its dominant position. The FCA emphasised that only “significantly different properties” in terms of safety and efficacy could have justified the statements made by Sanofi.  To qualify as a generic the product need not contain the same salt provided that it has the same principle active ingredient and does not have a different safety and efficacy profile.  Nor must it be approved for all of the same indications.  The absence of the ACS indication for the competing generics reflected the fact that this indication continued to be protected by a complementary patent, not the different salts they contained.  Sanofi’s communications on why Plavix and the generic competitors were not substitutable were thus incomplete and misleading.

The Cour de Cassation found that Sanofi had abused its dominant position and foreclosed generic entry to the French clopidogrel market.  It concluded that Sanofi’s communications were cumulatively misleading and had a dissuasive effect.  Further, the court found that, as a result of the “non-substituable” reference that doctors were encouraged to include on Plavix prescriptions, the evolution of generic substitution was unusual (with Sanofi’s own generic systematically maintaining a market share by volume above 30%).

Finally, the Cour de Cassation rejected Sanofi’s claim that the fine imposed was unjustified and disproportionate.  It expressly affirmed the 50% uplift to the base used to calculate the fine, as a reflection of the economic strength of Sanofi-Aventis and the group to which it belonged.

Italy’s AGCM Fines Aspen EUR 5 Million for Excessive Pricing

The Italian Autorità Garante della Concorrenza e del Mercato (“AGCM”) has fined Aspen over €5 million for having abused its dominant position – in violation of Art. 102 of the Treaty on the Functioning of the European Union – by increasing prices of its anti-cancer drugs Alkeran (melphalan), Leukeran (chlorambucil), Purinethol (mercaptopurine) and Tioguanine (thioguanine) by up to 1,500%.  Aspen had previously acquired the rights to commercialise these drugs, internally referred to as the “Cosmos” drugs, from GlaxoSmithKline.  Aspen achieved the price increases by adopting an aggressive negotiating strategy with the Agenzia Italiana del Farmaco, including threating to stop the supply of the medicines on the Italian market (at the time, Aspen was the only company supplying these medicines in Italy).  Aspen was able to achieve price increases of between 300% and 1,500% (over the prior price).

In its analysis, the AGCM first defined the national markets using ATC5 classifications. In light of Aspen’s position in markets defined this narrowly, it concluded that Aspen held a dominant position on the various markets.

In concluding that Aspen had abused its dominant positions, the AGCM applied a two-phase test, namely:

  1. as a first step, it assessed whether there was an excessive discrepancy between the manufacturing costs of, and the prices applied by Aspen for, the products, concluding that this was the case;
  2. as a second step, it assessed whether the prices applied by Aspen were excessive and unfair, taking into account a range of other factors, including the change in the prices over time, the lack of economic justification for the increases, the absence of any “extra economic” benefits for patients, the nature of the “Cosmos” drugs, the characteristics of the Aspen group and the damage (as a result of the increased cost) to the National Health Service.

Beyond the Aspen case, a number of other excessive pricing investigations by National Competition Authorities are currently on-going. For example, the UK’s Competition and Markets Authority (“CMA”) has recently pushed back for a second time the expected date of its final decision in its Pfizer/Flynn Pharma (“Flynn”) investigation (to November 2016).  The CMA is investigating whether Pfizer and Flynn abused their dominant positions in various UK markets by charging ‘excessive and unfair’ prices for phenytoin sodium capsules.  Pfizer allegedly charged between 8 and 17 times more for the drugs (at wholesale level) than it had charged for those same drugs at retail level before the deal, while Flynn charged between 25 to 27 times more for the products than Pfizer had charged at retail level.

French Pilot on Mandatory Country of Origin Labelling (COOL) for Dairy and Meat in Processed Foods

On 19 August 2016, France adopted Decree No 2016-1137 introducing mandatory country of origin labelling (COOL) for dairy and meat in processed foods.  The national measures strengthen the regulatory framework that exists at the EU level, which already imposes COOL requirements on specific foodstuffs, such as unprocessed and pre-packed swine, poultry, sheep and goat meat (Art. 26(2) of EU Regulation 1169/2011 of 25 October 2011), unprocessed beef and beef products (EU Regulation No 1760/2000 of 17 July 2000), fruit and vegetables, honey, etc.  After receiving the green light from the French State Council (“Conseil d’Etat”) and the European Commission, the trial period will now run for a period of two years, starting on 1 January 2017 until the end of 2018. Continue Reading

Italian Medicines Agency Publishes New Concept Paper on Biosimilars

Recently, the Italian Medicines Agency (AIFA) has published a new Concept Paper on Biosimilars.  The Concept Paper outlines the regulatory status of biosimilars in Italy as well as their importance for the Italian healthcare sector.

The new Concept Paper constitutes a revision of AIFA’s Position Paper on Biosimilars of 13 May 2013.  Overall, the Concept Paper does not differ significantly from the Position Paper of 2013.  In fact, both Papers indicate that it is for the physician to decide on a case-by-case basis whether to treat a patient with a biosimilar or with the innovative biologic.  They also exclude the automatic substitution between biosimilars and their originators. Continue Reading

Italian Administrative Court Finds That All Non-Prescription Medicines May Be Advertised to the Public

On 30 June 2016, the TAR Lazio, a lower Italian administrative court, found that all non-prescription medicines may be advertised to the public.  This ruling is of particular importance as until now the Italian Ministry of Health has interpreted the Italian medicines legislation as allowing the advertising to the public only of Over-the-Counter (OTC) products.

The judgment was triggered by a legal challenge brought by Kwidza Pharma GmbH and Chefaro Pharma Italia srl against a decision of the Italian Ministry of Health that denied the authorization to advertise to the public the non-prescription product “Bronchodual Sedativo e Fluidificante.”

As noted by the TAR Lazio itself, the court’s interpretation of the Italian rules is in line with the advertising rules of Directive 2001/83, which do not make any distinction between OTCs and other non-prescription products.

B2B or not B2B: Application of the NHCR to Business-to-Business Commercial Communications

On 14 July 2016, the Court of Justice of the European Union (CJEU) issued its decision in Case C-19/15 Verband Sozialer Wettbewerb v Innova Vital GmbH on the application of the Nutrition and Health Claims Regulation 1924/2006 (“NHCR”) to business-to-business (“B2B”) commercial communications.  The CJEU ruled that B2B communications that were promotional in nature came under the scope of the NHCR even though they are not specifically directed at “the final consumer”. Continue Reading

Court of Justice Rules That Genentech Must Pay Royalties to Sanofi

In its 7 July 2016 Genentech judgment (Case C-567/14), the European Court of Justice (“ECJ”) ruled that Genentech had to pay royalties to Sanofi-Aventis Deutschland under its licence agreement. The Paris Court of Appeal requested a preliminary ruling on whether the provisions of Article 101 of the Treaty on the Functioning of the European Union (“TFEU”) preclude the imposition of an obligation to pay a royalty for the use of a patented technology for the entire duration of a licence agreement, in the event that the patents protecting the technology are revoked.  The ECJ concluded that Article 101(1) TFEU does not preclude the imposition of a requirement to pay royalties, provided that the licensee is free to terminate the agreement by giving reasonable notice. Continue Reading

EMA Publishes Proactive Disclosure Guidance

On 2 March 2016, the European Medicines Agency (EMA) published guidance on aspects of the Agency’s proactive disclosure policy for clinical reports (Policy 0070).  The latest Proactive Disclosure Guidance can be found here and focuses on:

  • Procedural aspects of submitting clinical reports.
  • The anonymisation of clinical reports.
  • The identification and redaction of commercially confidential information (CCI) in clinical reports, i.e. the disclosure of information that is not in the public domain and may undermine the legitimate economic interest of the applicant.

The Guidance is accompanied by a number of annexes, including template cover letters, template anonymisation reports and process flowcharts. Continue Reading