The European Court of Justice (the “Court”) has upheld the lawfulness of a Latvian law banning any advertising of medicinal products to the general public that encourages purchases by offering discounts and other special price offers, including reduced bundled pricing. The Court goes as far as saying that Member States must ban such advertising, even if not expressly prohibited by EU harmonising rules, where that is necessary to prevent the irrational use of medicines that…
In brief On 10 November 2022, the National Coordination Centre for Ethics Committees (“Centre”) published the updated versions of the “Contract for the performance of clinical trials on medicines,” the “Contract for the performance of independent clinical trials on medicines” and the “Contract for the performance of clinical investigations on medical devices that are not CE marked or CE marked but used outside their intended use.” Key takeaways In particular, the updates relate to: (i)…
Ukraine has adopted the new law on pharmaceuticals (“Law”) that fundamentally changes the regulatory framework for pharmaceuticals. The Law is largely based on EU laws, although certain provisions, including as regards parallel importation of pharmaceuticals and regulatory data protection, are not aligned with EU laws and may create hurdles for companies operating in the Ukrainian market. The Law will be enacted within 2.5 years after the expiry/lifting of martial law. In this video, we present these and…
In brief The Spanish Agency for Medicines and Health Products has streamlined the procedure for applying for the national code (NC) of centrally authorized medicinal products. In order to have more efficient management, this change has been included in a guide containing information on the documents required for the assignment of the NC. From now on it will be possible to send the NC application as soon as the final texts have been adopted by…
In brief On 25 October 2022 leading researchers and executives from some of the world’s pioneering drug and pharmaceutical companies came together at a Financial Times Live Webinar event to discuss “The Power of Clinical Trial Tokenisation”. Tokenisation of healthcare data is likely to be one of the next great innovations for developing life-saving drugs and treatments through the method of privacy-preserving record linkage (PPRL). This allows pharmaceutical companies to “tokenise” and link previously scattered…
In brief On 1 December 2022, Switzerland’s new Human Genetic Testing Act (HGTA) will enter into force. The new HGTA provides a comprehensive legal framework for all types of genetic testing (including direct-to-consumer genetic testing and lifestyle genetic testing) and implements stronger measures to protect privacy rights, prevent abuse of genetic data and ensure the quality of genetic tests and the interpretation of the results. As part of the comprehensive revision of the HGTA, the…
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 …
