Introduction The Department for Environment, Food & Rural Affairs (“DEFRA”) has announced a consultation regarding proposed changes to allergen labelling laws for food prepacked for direct sale in the UK. This follows the death of Natasha Ednan-Laperouse in July 2016, which was the result of an allergic reaction after consuming a baguette from Pret a Manger that contained sesame seeds. The coroner’s inquest in September 2018 found that Pret’s allergen labelling system was “inadequate”, as…

On October 22, 2018, the European Federation of Pharmaceutical Industries in cooperation with the Future of Privacy Forum and the Center for Information Policy Leadership organized a workshop entitled “Can GDPR Work for Health Research.”  In the first session, the workshop discussed the implications of the General Data Protection Regulation (“GDPR”) on clinical trials in the EU.  The second session was devoted to further use of health data for scientific research.  Among other things, this…

Over the past months, the Government has regularly  posted technical guidance notices on what it calls a “no deal” Brexit, i.e., a scenario in which the UK and the EU will not reach an agreement and the UK will become a third country on 29 March 2019.  The UK Government has now published four notices addressed specifically to UK food and beverage producers outlining its plans for a no-deal Brexit.  The notices emphasise that the…

This article was originally posted on our sister blog Global Policy Watch Introduction Health technology assessment (“HTA”) is a multidisciplinary assessment process that seeks to evaluate the added therapeutic value of health technologies (i.e., drugs, certain medical devices, medical treatments including surgical procedures, and measures for disease prevention and diagnosis) based on both clinical and non-clinical elements.  Until now, HTA has strictly fallen in the purview of EU Member States; they have cooperated among themselves…

The “Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity” is an international agreement which aims at sharing the benefits arising from the utilization of genetic resources in a fair and equitable way. It entered into force on 12 October 2014. The Nagoya Protocol imposes a complex set of multi-jurisdictional compliance obligations on businesses active in the pharmaceutical, food,…

By Dr. Dr. Adem Koyuncu, Covington & Burling LLP In the EU, drug companies are not allowed to publicly promote prescription-only medicines. As courts also apply a broad interpretation of the term “promotional”, nearly all public statements that mention a prescription drug are likely to be qualified as illegal advertising. In certain circumstances, this may be the case even if no drug is mentioned. But what should a drug company do if false statements…

On 4 January 2018, the European Commission published a draft implementing regulation laying down rules for the application of Article 26(3) of Regulation (EU) N° 1169/2011 of the European Parliament and of the Council on the provision of food information to consumers (“FIC”), as regards the rules for indicating the country of origin or place of provenance of the primary ingredient of a food where different to that given for that food (hereafter “Draft Implementing…