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

The Psychoactive Substances Act 2016: An Example of Poor Drafting and Unintended Consequences for Food?

The UK has enacted new legislation to address the issue of so-called ‘legal highs’ following a number of cases of paranoia, seizures, hospitalisation and even death after consumption of certain psychoactive substances.  The Psychoactive Substances Act 2016 (the “Act”) was granted Royal Assent on 28 January 2016.  It is expected to come into force on 6 April 2016.  The Act makes it an offence to produce, supply, offer to supply, possess with intent to supply, possess in a custodial institution, import or export psychoactive substances. Continue Reading

CMA Fines GlaxoSmithKline and Several Generic Companies £45 million for Delaying Market Entry of Generic Paroxetine in the UK

The CMA issued an infringement decision today fining GlaxoSmithKline (“GSK”) and two other pharmaceutical companies a total of £45 million for delaying market entry of generic versions of GSK’s blockbuster anti-depressant Seroxat (paroxetine) in the UK.

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Class Actions Finally Introduced into French Health Law

One year after France introduced class actions for French consumer and competition law cases (under Articles L.423-1 to L.423-26 and R. 423-1 to R.423-25 of the Consumer Code), the regime may soon also cover the healthcare sector.

After years of discussions and many unsuccessful attempts, recent public health scandals have bolstered a push for class actions in health-related cases.  The aim is to better compensate claimants and to deter wrongdoers.  On 17 December 2015 the National Assembly adopted the draft health reform law (Projet de loi de modernisation de notre système de santé), introducing new Articles L.1143-1 et seq. into the Code of Public Health regulating health-related class actions.  The rules are expected to take effect in … 2016. Continue Reading

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