On 26 May 2023 the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) announced it plans to introduce an international reliance route for the approval of medicinal products.  This shows the UK is now looking beyond the EU in its approach to recognizing foreign marketing authorizations.  The MHRA is “focused on providing

On April 27, 2023 the European Commission (“Commission”) released its proposal to introduce a single procedure for the granting of Supplementary Protection Certificates (“SPCs”) throughout the EU.  The changes are intended to complement the new unitary patent procedure that will enter into force on June 1, 2023.  The Commission intends the new unitary SPC to

Borderline issues arise when the regulatory classification of a product, for example, as a medicine, a medical device or a food supplement, is unclear.  Uncertainty about the regulatory status of a product under development, and consequently uncertainty as to what legal rules need to be followed, can have immense consequences for developers and innovators.  To

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 is a “public health emergency.” 

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 Procedure (“MRP”).  Chapter III of

The EU’s General Pharmaceutical Legislation amendment proposal, which was published on 26 April 2023 (“the Proposal”), is introducing new measures to regulate decentralized manufacturing, which is increasingly used for certain categories of medicinal products.  In particular, the Proposal introduces new obligations for manufacturers and for national competent authorities overseeing decentralized sites.  In this blog

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

The European Commission’s proposal to amend the EU’s general pharmaceutical legislation includes a new draft directive replacing Directive 2001/83/EC (the draft Directive) and a new draft regulation replacing Regulation (EC) No 726/2004, which will also incorporate the EU’s amended paediatric and orphan medicine rules (the draft Regulation).

Whilst the proposal maintains

As part of the EU’s General Pharmaceutical Legislation amendment proposal, published on 26 April 2023 (“the Proposal”), the European Commission (“Commission”) has introduced a series of measures aimed at securing the supply of critical medicinal products across the EU and at preventing shortages.  In particular, there are new obligations for Marketing Authorization Holders (“MAH”)

The latest draft pharmaceutical legislation published by the European Commission (“Commission”) is set to shake up the regulatory exclusivity protections available to innovator pharmaceutical companies operating in the EU (as discussed in further in our previous blog). As part of these developments, the Commission has clarified the concept of the Bolar exemption