In brief The Social Security Financing Bill for 2023 (“Draft Bill”) was introduced on 26 September 2022. It is currently being debated in parliament and is expected to be voted on by the end of 2022. Some of its proposed measures have a potential strong economic impact on health industries and concerns are being raised. In more detail In the context of a permanent increase in the volume of medicines reimbursed by the social security…
Impact on medicines and medical devices In brief Medicines and medical devices are subject to the EU’s general product liability rules, including the EU’s Product Liability Directive (PLD). The European Commission’s proposal for a new PLD seeks to make the PLD fit for purpose in the 21st century and address challenges faced by those who have suffered damage to claim compensation. In doing so, the Commission has expanded the scope of the PLD so that…
In brief On 6 October 2022, Advocate General Medina issued an Opinion in three joined appeal cases brought by the European Commission, the EMA and Biogen against Pharmaceutical Works Polpharma. The opinion touches on the concept of global marketing authorization (GMA), and on the principle of mutual recognition of scientific assessments carried out by Member States authorities and EU institutions. In depth This is the first case related to the question of whether an authorized fixed combination…
In brief At the end of September, the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) published a long-awaited Note for Guidance to assist their member companies with their use of social media and digital channels. The guidance aims to set out the areas that companies should consider when communicating on social media and other digital channels, and builds on existing guidance, including the Principles …