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.
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
New Novel Foods Regulation: A Step Towards a Simpler and Faster Procedure?
A new Novel Food Regulation (EU) 2015/2283 (“Regulation”) was published in the Official Journal of the European Union on 11 December 2015. The Regulation aims to make it easier for food business operators to place novel foods and food ingredients on the EU market, while ensuring high level of consumer protection.
Under the Regulation, novel food is defined as food that has not been consumed to any significant degree in the EU before May 1997 (when the first novel food legislation entered into force). This can be newly developed, innovative food or food produced using new technologies and production processes as well as food traditionally eaten outside of the EU. The definition now also includes food consisting of engineered nanomaterials and derived from animal clones. The Regulation also makes it clear that insects can fall under the definition of a novel food. The Regulation introduces the following main changes: Continue Reading
