medicinal products

Subscribe to medicinal products via RSS

Introduction

On 4 June, EU Member States, meeting in the Council of the European Union (‘Council’), have agreed on a position on the pharmaceutical reform package.

This agreement was reached despite significant divergences between EU Member States in the preceding weeks. It marks a key milestone in the process for adoption of the EU revision of EU’s general pharmaceutical legislation, as it sets out the Council’s position for the trilogue negotiations to find a text agreeable to the Parliament and the Council, which can now begin.

The innovative pharmaceutical industry will welcome aspects of the Council’s adopted negotiating mandate as it provides greater certainty with regards to regulatory data protection and it lightens some of the obligations introduced in the European Commission proposal for reform of the EU pharmaceutical legislation adopted in April 2023 and the European Parliament’s position adopted on 10 April 2024 (see our detailed advisory). At the same time, the Council has adopted positions on some aspects of the proposals that could be seen as less favourable to industry.

We discuss some of the key provisions and changes in the Council’s adopted position below. This is, however, not covering all elements of the reform of the EU pharmaceutical legislation and the final outcome of the legislative process remains uncertain.Continue Reading Council of the European Union backs reforms to the EU Regulatory Framework for Medicinal Products

Do discount campaigns on prescription-only medicines (POMs) run by mail order pharmacies lure patients into consuming medicinal products? The European Court of Justice (CJEU) in the case of Apothekerkammer Nordrhein (C-517/23) has held that they do not.

Following on from the AG Opinion of Advocate General Szpunar, which we provided an update on earlier in the year, this case is the latest in a stream of cases on advertising practices involving DocMorris, a Dutch mail-order pharmacy that supplies medicines to end customers in Germany. The CJEU concluded that the discount campaigns regarding unspecified POMs do not fall within the definition of “advertising of medicinal products” (Article 86(1) Directive 2001/83) as the discount is implemented at the point of purchase of the POM.  The decision of which product to prescribe has already been taken by a doctor and all the patient is left to do is choose the dispensing pharmacy. As such, the Court held that the purpose of the discount campaign is not to encourage patients to purchase medicinal products. Rather, it is simply to attract them to a specific pharmacy.

The facts of the case are set out in our previous blog available here.Continue Reading An update from the European Court of Justice on discount campaigns run by mail order pharmacies

On January 1, 2025, new UK-wide arrangements for the supply of medicines came into effect on account of the “Windsor Framework.” The overarching aim is to secure the long-term stability of the supply of medicines to Northern Ireland (NI), ensuring that medicines will be available at the same time, and on the same basis, across…

Do discount campaigns on prescription-only medicines (POMs) run by mail order pharmacies lure patients into consuming medicinal products?

Advocate General Szpunar has opined that they do not. The opinion comes in the latest of a stream of cases on advertising practices involving DocMorris (Case C-517/23), a Dutch mail-order pharmacy that supplies medicines to end customers in Germany. The AG concluded that the discount campaigns regarding POMs do not fall within the definition of “advertising of medicinal products” (Article 86(1) Directive 2001/83) as the discount is implemented at the point of purchase of the POM.  The decision of which product to prescribe has already been taken by a doctor and all the patient is left to do is choose the dispensing pharmacy. As such, the purpose of the discount campaign is not to encourage patients to purchase medicinal products. Rather, it is simply to attract them to a specific pharmacy.Continue Reading When discount campaigns regarding prescription only medicines do not fall within the definition of advertising in the EU

Earlier this week, the EMA published its Reflection paper on the use of AI in the medicinal product life cycle. As set out in our previous blog post, the EMA’s draft reflection paper was published for consultation in July 2023, and following many months of review of the feedback collected from the relevant stakeholders, the Paper has now been published.  The Paper reflects the views of the EMA on the use of AI from drug discovery and non-clinical development, to clinical trials, manufacturing and post-authorisation. The Paper recognises the utility of AI in digital transformation and notes new risks that need to be mitigated to ensure patient safety and data integrity.Continue Reading EMA adopts reflection paper on the use of Artificial Intelligence (AI)

Following the outcome of the national election on 4 July 2024, on 17 July 2024, King Charles III gave a speech to the UK Parliament in which, as directed by the new Government, he outlined the key points of its legislative and policy agenda.

The agenda includes a Product Safety and Metrology Bill.  Some form of legislation to address UK product regulation was expected in order to take account of market developments and new technologies, such as online selling and AI.  We set out below a brief summary of the Bill.Continue Reading The King’s Speech: Product Safety and Metrology Bill

On 24 April 2024, the European Parliament formally adopted the Regulation on Standards of quality and safety for Substances of Human Origin (SoHo) intended for human application (the SoHO Regulation). On the same date, the European Commission published a Questions & Answers (Q&A) document on the SoHO Regulation. Then on 27 May 2024, the EU Council adopted the new rules. For the final step in the legislative process, the new Regulation is due to be published in the Official Journal shortly.

The SoHO Regulation aims to introduce new and innovative measures to help ensure that high standards of safety and quality for SoHO are maintained across the EU and that SoHO activities are appropriately regulated.  A key goal is to facilitate cross-border exchanges and access to SoHOs across the EU, while ensuring high levels of health for donors, recipients and offspring from medically assisted reproduction. A more harmonised approach to the regulation of SoHO across the EU is envisaged, which will be welcomed by industry. However, Member States may still diverge and include more stringent measures under their national laws. The extent to which one Member State’s authorisation of a SoHO Entity, SoHO establishment or SoHO preparation is really “EU wide” therefore remains to be seen. Furthermore, the success of the SoHO Regulation is reliant upon cooperation and coordination between Member States, including the use of the SoHO Platform and seeking opinions from the SoHO Coordination Board on borderline issues. This will require continuous contact between Member States and a good understanding of the ever-developing and innovative uses of SoHOs. Guidance accompanying the new rules, as well as what measures need to be put in place from the outset, will need to be informative, clear and proportionate for the SoHO Regulation to make the differences it is intended to achieve.Continue Reading European Parliament adopts Regulation on substances of human origin (SoHO)

Members of the European Parliament (MEPs) have voted overwhelmingly in favour of the pharmaceutical reform package following a debate on 10 April.

The vote is a key step in the passage of the new Directive and Regulation, which together form the EU’s revisions to the General Pharmaceutical Legislation (GPL). These revisions are part of the overall EU pharmaceutical strategy that was announced by the European Commission in November 2020, with the core GPL amendments proposals published in April 2023.

With the vote, the European Parliament has now endorsed the position adopted by the Environment, Public Health and Food Safety Committee on 19 March 2024. The Committee had amended the Commission’s proposal in several respects. Overall, the Parliament’s amendments are aimed at encouraging and fostering more innovation in the EU, and industry will be pleased that some of its core concerns have been addressed, although significant areas of uncertainty remain.

The adoption of the package is likely to be delayed by the European Parliament elections in June this year. The reforms will be taken up by the new Parliament after the elections, and so it is difficult to see any agreement being reached before 2026.

Below is a summary of the Parliament’s position in some of the key area. This summary is, however, not exhaustive but rather highlights topics that have been subject to increased interest for industry and extensive discussions in the European Parliament.Continue Reading European Parliament backs reforms to the EU Regulatory Framework for Medicinal Products

In a previous blog post, we discussed the UK government’s proposed changes to the regulatory framework governing clinical trials. Marking the start of this legislative change is a new notification scheme for the lowest-risk clinical trials (the scheme), published on 12 October 2023. The scheme is based on the proposal set out in the Medicines and Healthcare Regulatory Agency’s (MHRA) consultation earlier this year, which was supported by 74% of respondents.

The scheme allows for the processing of eligible clinical trials by the MHRA in less than 14 days, instead of the statutory 30 days. The scheme currently only applies to clinical trial authorisation (CTA) applications for Phase 4 and certain Phase 3 clinical trials deemed as low risk, and provided they meet the MHRA’s eligibility criteria, set out below. Initial “first in human” Phase 1 or Phase 2 trials and clinical trial amendment applications will not be eligible.

The scheme aims to reduce the time taken to get lowest-risk clinical trials up and running, to give UK patients quicker access to potentially life-saving medicines, without undermining patient safety. The MHRA encourages clinical trial sponsors to use the scheme for all eligible trials and estimates that this will include 20% of UK initial clinical trial applications.Continue Reading UK clinical trials – new notification scheme for lowest-risk clinical trials

On 27 February 2023, an agreement in principle was reached by the UK and EU, known as the Windsor Agreement, relating to post-Brexit trade issues in Northern Ireland (NI). The principles are expected to be approved shortly by the EU-UK Joint Committee. The UK Government and the EU institutions will then enact legislative measures to make the necessary amendments to their laws. 

Following Brexit, from 31 January 2020, the UK is no longer subject to EU single-market rules or the EU legislative framework. However, under the EU-UK Withdrawal Agreement’s Protocol on Ireland and Northern Ireland, NI continues to follow EU rules. This is to avoid customs checks between NI and the Republic of Ireland. In practice, this means that medicinal products on the market in NI must be authorised in line with the EU regime, which no longer applies in Great Britain. This causes difficulties for companies marketing their products in the UK, as different authorisations, following different rules, apply in different parts of the UK. It also means that patients have access to different products in GB or NI.

The current agreement covers a number of sectors, and in relation to medicines, the aim is to simplify supply between GB and NI, and ensure that only one authorisation is needed and one set of rules needs to be followed within the UK. However, much detail still needs to be published so that companies can fully understand the impact of the changes on their medicines supply chains.Continue Reading The Windsor Agreement and supply of medicinal products in Northern Ireland