FratiniVergano’s latest issue of Trade Perspectives© is published
The first article addresses the publication in the EU Official Journal of Regulation (EU) 2019/933 of the European Parliament and of the Council of 20 May 2019 amending Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products. Regulation (EU) 2019/933, which will enter into force on 1 July 2019 and will introduce an exception for export purposes and for stockpiling to the protection granted to an original medicine by a so-called Supplementary Protection Certificate (hereinafter, SPC). The exception is an important measure to the benefit of EU-based manufacturers of biosimilar and generic medicines, who will soon be entitled to manufacture a biosimilar or generic version of a medicine that is still covered by an SPC. The article first provides some background on biosimilar and generic medicines, as well as on the SPC. The article then describes the rationale behind the introduced exceptions and the related legislative process in the EU. The article concludes that with respect to patent protection, a balance must be found between the interests of patent holders and the development of biosimilar and generic medicines, take greater public health considerations into account.
The second article addresses the adoption of the new Section 25704 Exposures to Listed Chemicals in Coffee Posing No Significant Risk’ into Title 27 of the California Code of Regulations by the California Office of Environmental Health Hazzard Assessment (OEHHA). Section 25704 provides that the exposure to chemicals in coffee that are created by and inherent in the processes of roasting coffee beans or brewing coffee, including acrylamide, does not pose a significant risk of cancer. First, the article provides an overview of the recent developments in the US regarding acrylamide in food. Second, the article provides details of a 2018 ruling by the Superior Court of the State of California for the County of Los Angeles, which had required the placing of cancer warnings on coffee products sold by certain companies in California. The article then reviews the decision by the OEHHA to adopt the new Section 25704 exonerating coffee from a significant risk of cancer, which is supported by the federal US Food and Drug Administration (FDA). The article concludes that stakeholders in the food industry should continue to closely monitor any development relating to acrylamide, as further changes to the current rules could be expected in the US and beyond.
The third article analyses the PHYCOMORPH European Guidelines for a Sustainable Aquaculture of Seaweeds (PEGASUS) report that was released on 9 May 2019 by the European Commission’s Joint Research Centre (JRC), as well as a team of international experts. The report analysed the current EU policy framework for seaweed aquaculture, identifying challenges, including regulatory hurdles, and how they could be solved to benefit from this resource in a sustainable way. The article concludes that from a regulatory perspective, harmonisation in the EU, in particular in the field of food contaminants, should be carefully monitored by stakeholders and that adequate legal advice, inter alia, on health claims and the authorisation of novel foods, including traditional foods from third countries, should be sought.