It’s all happening in the device space. Further to the European Commission’s meeting we discussed last week on the proposed three-year extension to the transition period under the Medical Devices Regulation (EU) 2017/745 (MDR), the EU Medical Device Coordination Group (MDCG) has now published guidance clarifying the use of the non-compliance procedure under Article 97 of the MDR.

Under Article 97, competent authorities can temporarily allow devices that do not comply with the MDR to continue to be placed on the market if they do not present an unacceptable risk to the health or safety of individuals or to public health.

Continue Reading New Guidance on the Application of Article 97 of the MDR to Legacy Devices Certified under the MDD or AIMDD

The European Commission intends to extend the transition period under the Medical Devices Regulation (EU) 2017/745 (MDR) for an additional three years. The proposal comes among concerns with the number of devices yet to transition to the MDR, along with rising costs of re-certification and extended time periods for assessment. It is estimated that around 23,000 certificates of conformity for EU medical devices have not yet transitioned, which will expire on May 26, 2024 (if not before). Low notified body capacity is a key contributing factor for the transition delays.

Continue Reading European Commission Announces Intention to Introduce Three-Year Extension to the MDR Transition Period

On the 27 October 2022, the Court of Justice of the EU (“CJEU”) issued a preliminary ruling  regarding the definition of foods for special medical purposes (“FSMP”).  The CJEU held that for a food product to be classified as an FSMP, it must cover the increased or specific nutritional requirements caused by the disease.  It is not sufficient that the product counteracts the disease or alleviates its symptoms, as that would blur the lines between foods and medicinal products. 

1. Background to the Dispute

This ruling arose in the context of an action brought by Verband Sozialer Wettbewerb e.V. (“VSW”) against Orthomol pharmazeutische Vertriebs GmbH (“Orthomol”) regarding two Orthomol products classification as FSMPs.  This action was brought before the Landgericht Düsseldorf (Regional Court, Düsseldorf, Germany) at the first instance and was then appealed to the Oberlandesgericht Düsseldorf (Higher Regional Court, Düsseldorf, Germany) which then referred the case to the CJEU for a preliminary ruling. 

Continue Reading CJEU clarifies the Food for Special Medical Purposes Definition

The German regulation of pricing and reimbursement of pharmaceuticals is probably one of the most complicated legal areas in the entire world of life sciences laws. Now, the German government is adding another layer of complexity to the existing rules.

On 20 October 2022, the German Parliament has accepted the draft Act for the Financial Stabilization of the German Statutory Health Insurance System („GKV-FinStG“). The new act was subject to month-long controversial discussions within and outside of the Parliament and affected stakeholders. This was due to the fact that the new rules will affect almost all players within the healthcare system, including the health insurers, doctors, hospitals, pharmacies and, especially, the pharmaceutical industry. The new law encompasses significant cost-containment measures as the German healthcare system faces increased costs while, at the same time, the system suffers from a reduced inflow of funds.

Continue Reading Germany significantly tightens Drug Pricing and Reimbursement Laws

The UK has reaffirmed its commitment to leading the way in regulatory innovation in software as a medical device (“SaMD”) and artificial intelligence as a medical device (“AIaMD”).  On 17 October 2022, the UK Medicines & Healthcare products Regulatory Agency (“MHRA”) published its Guidance on “Software and AI as a Medical Device Change Programme – Roadmap.”  It builds on the Government response to consultation on the future regulation of medical devices in the UK and follows on from the Software and AI as a Medical Device Change Programme, which was published in 2021.  The MHRA has provided deliverables, which map out a course for change to the regulation of this sector.

Continue Reading Change is Coming for Software and AI Medical Devices in the UK

The Medical Device Coordination Group (“MDCG”) has published a new position paper (MDCG 2022-14) acknowledging the significant and urgent lack of capacity of EU notified bodies.  It acknowledges the risk that this could lead to many existing and new medical devices and in vitro diagnostic medical devices (“IVDs”) not undergoing timely conformity assessments under Regulation (EU) 2017/745 (the “MDR”) or Regulation (EU) 2017/746 (the “IVDR”) (together, the “Regulations”)).  In turn, this could mean patients miss out on access to, potentially, lifesaving medical devices and IVDs.  As such, the MDCG has suggested actions for mitigating such challenges.  Importantly, there is a focus on flexibility and pragmatism.

Continue Reading Notified body capacity needed! MDCG proposals recognize need to increase notified body capacity to ensure device availability

On 28 September 2022, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) and European Federation of Pharmaceutical Industries and Associations (EFPIA) published joint guidelines concerning the use of social media and digital media channels by pharmaceutical companies (Joint Digital Guidelines).  IFPMA  and EFPIA are umbrella trade bodies for the innovative pharmaceutical industry on the global and European stages, respectively.

The Joint Digital Guidelines are timely.  Digital communications and the use of social media have become hot compliance topics for the pharmaceutical industry, both in Europe and globally.  Actors in the healthcare world increasingly use digital communication channels; many clinicians, patients and patient organizations actually prefer to receive content digitally.  With more content comes higher compliance risk.  Digital communications, particularly over social media, can spread fast across borders and are often publicly accessible. 

It is no surprise that a very significant number of pharmaceutical advertising cases in European markets now concern digital channels or social media.  This certainly reflects our experience; and this is an area where our pharmaceutical advertising experts are continually advising clients.

Continue Reading IFPMA and EFPIA Publish New Joint Guidance Note on Social Media and Digital Channels

On 1st August 2022, the Italian Competition Authority (“AGCM”) published its decision where it ruled that the NutriScore labelling must be discontinued in Italy because it deceives consumers.  The authority further held that products meant for the French market, where the NutriScore is allowed, and which are distributed also on the Italian market may keep the NutriScore labelling provided that this is sufficiently substantiated.    

Continue Reading NutriScore Halted In Italy As Italian Competition Authority Deems It Misleading

On 14 July 2022, the European Commission published a proposal for a Regulation on “substances of human origin” (“SoHO”) intended for human application.  The proposed Regulation is intended to replace the existing and largely outdated Directives on SoHO, respectively on Blood and on Tissues and Cells.  These sets of rules govern the sourcing and use of starting materials for innovative therapies, such as blood, tissues and cells.  Pharmaceutical companies active in the manufacturing of advanced therapy medicinal products (“ATMPs”) are therefore well advised to closely monitor the developments surrounding the proposed Regulation.

Continue Reading European Commission to Harmonize Rules on the use of Substances of Human Origin

On 31 May 2022, the Italian Parliament approved Law 62/2022, also known as the Sunshine Act.  The Sunshine Act entered into force on 26 June 2022.  However, it will become fully enforceable once the Ministry of Health sets up the Public Register where companies will have to disclose their data and issues the necessary implementing acts.  This means that realistically the new transparency system will not be operational before 2023.  Nonetheless, it is critical that companies operating in Italy make sure that they are ready when the time comes.  Here, we outline some of the key features of the new Sunshine Act and the steps that companies could take in preparation.

Continue Reading The New Italian Sunshine Act: What Companies Should Know And How To Get Ready