Introduction
On 16 December 2025, the European Commission (“Commission”) published its Proposal for a Regulation on establishing a framework of measures for strengthening the Union’s biotechnology and biomanufacturing sectors particularly in the area of health (“Biotech Act”) (see here). The Proposal follows a public consultation held between
Continue Reading European Commission Adopts Proposal for the Biotech Act
This is one in a series of Inside EU Life Sciences blogs on the European Commission’s (“Commission’s”) latest proposal for a European Biotech Act.
On 16 December 2025, the Commission announced a proposal to introduce a new draft Regulation (“Proposed Regulation”) aimed at boosting the EU’s competitiveness in the biotech
Continue Reading European Biotech Act: Potential new extension for supplementary protection certificates (SPCs) for ATMPs and biotechnology medicinesIn a landmark judgement, the Higher Regional Court of Cologne has set new standards for pharmaceutical advertising with influencers. First, a key point from the decision is that the court qualifies paid influencers as agents of the drug company with respective consequences for the company (discussed below). Second
Continue Reading Influencer Marketing – German court sets new Guardrails for Pharmaceutical Advertising on Social Media
At just after 5 am on 11 December 2025, the EU Parliament and the Council reached agreement on a new directive and a new regulation that will result in a major update to the EU’s pharmaceutical laws. Progress towards these new rules began in 2016 and are the result of
Continue Reading EU Announces Political Agreement on Pharma Law ReviewGermany has taken another step to improve the conditions for pharmaceutical research & development in Germany. Now, the Federal Government has adopted the “Standard Contractual Clauses” for pharmaceutical clinical trial agreements. In this blog, we discuss what the new standard clauses cover and how they will affect clinical trials in
Continue Reading Germany enacts Standard Contractual Clauses for pharmaceutical clinical trial agreements – Changes for medical device studies also on the horizon
On 30 January 2025, the UK Government announced the re-launch of the Innovative Licensing and Access Pathway (“ILAP”) for medicines.
The ILAP is an “end-to-end” access pathway offering a unique opportunity for a medicine’s developer to engage with: (i) the UK’s medicines regulator – the Medicines and Healthcare products Regulatory Agency (“MHRA”); (ii) England’s HTA body – the National Institute for Health and Care Excellence (“NICE”); and (iii) and the National Health Service (“NHS”) (together the “ILAP Partners”). By providing medicines developers with joined-up, co-ordinated and tailored guidance from the ILAP Partners, from the early stages of clinical development, the ILAP scheme hopes to accelerate the time to market for innovative and transformative medicines and drug-device combinations.Continue Reading Re-Launch of UK’s Innovative Licensing and Access Pathway (“ILAP”)
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 dividedThe European Union has just published a new (recast) Urban Wastewater Treatment Directive (“UWWTD”) in the EU’s official journal. The UWWTD imposes important new Extended Producer Responsibility (“EPR”) obligations that will have a significant financial and administrative impact on companies marketing human medicines and cosmetic products in the
Continue Reading The EPR Obligations of the New Urban Wastewater Treatment Directive: Key Questions and Next Steps for Member States
Those of us who advise on medicines advertising issues have been waiting for much of 2024 for the Association of the British Pharmaceutical Industry (“ABPI”) together with its self-regulatory body for pharmaceutical advertising, the Prescription Medicines Code of Practice Authority (“PMCPA”), to publish the new Code of Practice for the Pharmaceutical Industry (“ABPI Code”). On 23 September 2024, the suspense finally lifted, with the publication of the ABPI Code 2024 (available here). The 2024 ABPI Code replaces the previous version from 2021.
The new ABPI Code incorporates an updated PMCPA Constitution and Procedure, which sets out the procedure for adjudicating upon advertising complaints.
The ABPI initially proposed, and consulted upon, updates to the ABPI Code from December 2023 to February 2024 (please see our previous blog post discussing these proposals here). The 2024 ABPI Code includes most of the changes that were proposed and consulted upon, usually with only minor changes to wording. The PMCPA has issued summaries of the changes to the Code and Constitution, which can be found here and here.
The main headline is that the new ABPI Code is very similar to its predecessor. The consultation received over 3,000 comments, with many commentators calling for more extensive changes than those proposed. The ABPI appears to have resisted these calls, preferring evolution over revolution.
The changes take effect on 1 October 2024. However, a transitional period will operate from 1 October 2024 to 31 December 2024, during which time no material or activity will be regarded as breaching the ABPI Code if it fails to comply with the new requirements of the 2024 version. The 2024 ABPI Code will come into full force on 1 January 2025. Notably, though, the PMCPA will begin operating in accordance with the new Constitution and Procedure from 1 October 2024, including the legalistic elements and abridged complaints procedure discussed below.
Of the (relatively few) changes, what should legal and compliance teams take note of?
The new PMCPA Constitution and Procedure makes changes to the process for investigating and adjudicating upon advertising complaints. These changes aim to enhance the flexibility and efficiency of the complaints process. They include: (i) powers for the PMCPA to issue case management directions; and (ii) a new abridged complaints procedure that could apply in certain cases. The changes will likely result in a more legalistic feel to PMCPA proceedings. If the PMCPA notifies a company of a complaint, it may be beneficial to involve legal teams early in the process.
By contrast, changes to a company’s compliance obligations under the new ABPI Code are relatively modest. The updates are generally clarificatory in nature. Some changes essentially consolidate and codify into the Code principles that already exist in guidance and previous PMCPA cases. An example of this is how companies fulfill their obligation to maintain high standards. There is now more detail on this point in the Code, pulling together concepts from various cases.
There are also new rules permitting the use of QR codes to provide access to prescribing information in certain cases.Continue Reading New ABPI Code and PMCPA Constitution and Procedure Published