EU Legislation

On 18 December 2024, the European Commission published a proposed implementing regulation relating to pharmacovigilance (“PV”) requirements for human medicines marketed in the EU (“Proposal”), which will update European Commission Implementing Regulation (EU) 520/2012 (“Implementing Regulation”).  While the core PV requirements, including the obligation to establish and operate a PV system and the key reporting requirements, are set out in Regulation (EC) No 726/2004 and Directive 2001/83/EC, the Implementing Regulation provides detailed requirements on the performance of PV activities, including the need for a PV system master file (“PSMF”), more comprehensive requirements for the PV quality system, and detailed provisions relating to periodic safety update reports (“PSURs”). 

The proposed changes aim to harmonize the performance of PV activities by marketing authorization holders (“MAHs”), national competent authorities and the European Medicines Agency (“EMA”), and in some cases widen the scope of the Implementing Regulation’s PV requirements.  Other changes are clarificatory in nature.Continue Reading European Commission Consults on Update to Pharmacovigilance Rules

In an earlier blog, we had reported on an interesting litigation case concerning the legal scope of the market exclusivity right for orphan drugs in the EU. Meanwhile, there have been further developments in this court case and its key questions have now been referred to the European Court…

Continue Reading European Court of Justice requested to clarify the scope of the market exclusivity right for orphan drugs – German courts remain divided

On 10 April 2024, the European Parliament adopted its position on the Commission proposal to reform the core EU pharmaceutical legislation (see here and here).  In doing so, the European Parliament has met its ambitious timeline to adopt its position before the upcoming Parliamentary elections and marks a significant step in the legislative process. 

Parliament’s position comes less than a year since the Commission published its proposal, which consists of a new directive replacing Directive 2001/83/EC and a new master regulation replacing Regulation 726/2004, which will also consolidate the orphan and pediatric medicines regulations (see our prior EU Pharma Legislation Review blog series).  Many of Parliament’s amendments to the Commission proposal will be seen as improvements by the innovative industry, but there remain challenges and unresolved questions.

We provide below the top 8 takeaways for industry to consider during the next phase of the legislative process, which is a detailed review by the Council.Continue Reading European Parliament adopts its Position on EU Pharma Law Review: 8 Key Takeaways for Industry

The High Court has quashed decisions by the Food Standard Agencies in England, Wales and Scotland (“the FSAs”) that concluded that monk fruit decoctions are a novel food.  The Court ordered the FSAs to re-consider their position by assessing all of the evidence submitted to the FSAs on its own merits, rather than the FSAs’ previous approach of rigidly applying (non‑binding) European Union guidance.  The judgment is available here.  This case is the first of its kind in Great Britain and is relevant for individuals and companies considering whether or not their foods or food ingredients are novel under the GB novel food regime, which requires evidence of significant consumption of a food prior to 1 May 1997 to conclude the food is “non‑novel”, and not requiring a novel food approval. Continue Reading Food Standard Agencies in Great Britain unlawfully classified monk fruit as novel, High Court rules

The European Parliament and Council are currently negotiating the wording of a new Regulation establishing a Single Market emergency instrument (“SMEI”).  This new measure builds on the experience gained from the COVID-19 crisis and gives new powers to the Commission, in close cooperation with the Member States.  This blog briefly…

Continue Reading Single Market Emergency Instrument: Potential Impact on Medical Devices

Big news for manufacturers: the UK Government announced on 1 August 2023 that it will indefinitely recognize the EU’s product conformity assessment mark (the “Conformité Européenne” or “CE” mark), with respect to a range of manufactured goods placed on the UK market. 

The move is a significant reversal of the UK’s previous, post‑Brexit policy.  In a bid to separate the UK’s internal market from the European market, the UK promised to phase out CE marks for products marketed in England, Scotland and Wales (Great Britain or “GB”), and replace them with an equivalent “UKCA” mark.  However, the project suffered from numerous delays, and the UK repeatedly extended the deadline for transitioning from the CE mark to the UKCA mark, before the recent announcement that the UK will accept CE marks indefinitely.  Despite this change of policy, the UK has not abandoned the UKCA mark yet, and manufacturers may still choose to use it.  Even so, it is not obvious why a manufacturer would choose conformity assessment that is recognized only in the UK over (or even as well as) conformity assessment that is recognized across the UK and the EU.  What remains to be seen is whether differences between the UK and EU conformity assessment standards will lead to a kind of “forum shopping” by manufacturers. 

Also, and of significant importance for medical device manufacturers, the indefinite extension of CE mark recognition does not (at least currently) cover medical devices nor in vitro diagnostic medical devices (“IVDs”).  The Medicines and Healthcare products Regulatory Agency (“MHRA”) is separately consulting on international recognition of foreign approvals (including CE marks) in the medical device space.Continue Reading UK Government to Recognize CE Marks Indefinitely (other than for Medical Devices and IVDs)

Following the COVID-19 pandemic and the relatively slow approval of vaccines in the EU versus other key jurisdictions, as part of the EU’s General Pharmaceutical Legislation amendment proposal, published on 26 April 2023, the European Commission has proposed to introduce temporary emergency marketing authorizations (“TEMAs”) for use when there…

Continue Reading EU Pharma Legislation Review Series: Temporary Emergency Marketing Authorizations

The European Commission (the “Commission”) wants to “avoid unnecessary administrative and financial burdens for applicants and competent authorities.”  As such, the Commission’s proposal for a revised Directive on the Union Code Relating to Medicinal Products for Human Use (the “Directive”) retains the Decentralized Procedure (“DCP”) and Mutual Recognition…

Continue Reading EU Pharma Legislation Review Series: National MA Procedures Including the Mutual Recognition Procedure and Decentralized Procedure

As highlighted in our recent series of blog posts (please see our Inside EU Life Sciences blog series here), the European Commission has at long last published its proposal to overhaul EU legislation for human medicinal products. 

On 26 April 2023, the Commission published its proposal for a new human medicines directive (the “Proposed Directive”) to replace the current European Medicines Directive (Directive 2001/83/EC); as well as a regulation for centrally authorised medicines (the “Proposed Regulation”) to replace the current Regulation 726/2004. 

Medicines advertising and promotion rules are of key interest to pharmaceutical companies operating in the EU.  This blog looks into how the new legislative proposal might affect the advertising landscape, focusing on the Proposed Directive (whose advertising provisions also apply to products covered under the Proposed Regulation).

For those of you who are perhaps breathless from the suite of new proposals, advertising and promotion may appear to be one small area to exhale in relief.  However, some of the proposed changes may have significant practical implications, particularly for comparative advertising.

The headline news is that – for advertising – the Proposed Directive largely maintains the status quo.  It remains aligned almost entirely with the current framework, supplementing rather than revolutionizing current law. 

The evolutionary approach is unsurprising.  EU-level law is really only the “tip” of the proverbial “iceberg” when it comes to pharmaceutical advertising in Europe.  Many operational rules are nationally diverse, and found in national laws, codes and rulings.  Moreover, in practice, pharmaceuticals advertising is often largely governed and enforced through the self-regulatory system and self-regulatory codes, such as the Code of Practice of the European Federation of Pharmaceutical Industries and Associations (the “EFPIA Code”) and its various national incarnations.  The Explanatory Memorandum to the Proposed Directive suggests legislators have tried to avoid overhauling the intricate framework regulating advertising. Nevertheless, the Proposed Directive does make some changes to advertising rules.  Most are generally uncontroversial and/or “tidy ups”; but others may be more significant, particularly supplementing the definition of “advertising” and new provisions on comparative advertising. Continue Reading EU Pharma Legislation Review Series: Advertising Updates Reflect Evolution Rather than Revolution