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

On 12 March, the European Commission adopted a proposal for a Delegated Regulation to amend Regulation (EC) No 1234/2008 as regards the examination of variations to the terms of marketing authorisations for medicinal products for human use.

Scientific and technological advancements have led to a rise in the number of requests for variations to marketing authorisations (MA) and have brought the need to revise the variations procedure to make it more efficient and adaptable to change, in particular in relation to biological medicinal products, vaccines and medical devices.

The proposal aims to make the variations procedure simpler, clearer and more flexible to be able to respond to scientific and technological progress, and to reduce administrative burden.Continue Reading European Commission proposal to amend the Variation Regulation for Medicines

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

In September 2023, the European Medicines Agency (EMA) relaunched its Policy 0070 on publication of clinical data for medicinal products for human use (the Policy). The Policy, as discussed in previous posts, is one of the Agency’s flagship public health initiatives focused on promoting the transparency of both EMA decision-making and clinical data, sharing of knowledge and use in future research.

While the Policy was adopted by the EMA back in 2014, it has been suspended since 2018 due to the EMA’s relocation to Amsterdam and COVID-19. During the COVID-19 pandemic, the EMA adopted exceptional transparency measures for centrally approved COVID-19 vaccines and treatments. This was deemed a success further showing the need for clinical data sharing and, thus, the need  for relaunching the Policy.Continue Reading EMA relaunches Policy 0070 on publication of clinical data for medicinal products for human use

We set out in a previous post that the UK Medicines and Healthcare products Regulatory Agency (MHRA) intends to introduce a new international recognition procedure (IRP) for medicinal products, whereby decisions taken in certain countries could be recognised by the MHRA to fast-track approval in the UK.

On 30 August 2023, the MHRA published detailed guidance on how it will use the IRP for medicinal products. The IRP will be open to applicants who have already received an authorisation for the same product from one of the MHRA’s specified Reference Regulators (RRs) in Australia, Canada, the European Union, Japan, Switzerland, Singapore and the United States. However, the MHRA retains the right to reject the IRP and conduct a full assessment if considered necessary.

This procedure will operate in parallel to the MHRA’s current national procedures, including the shortened 150-day timetable, offering applicants a range of authorisation routes depending on the status in other countries and type of application. The hope is that this will allow the MHRA to be able to use the decisions in other countries, while still being able to conduct its own assessment where necessary for the UK market.

The IRP will be available from 1 January 2024. However, until the Windsor framework is in place on 1 January 2025, discussed here, products falling within the scope of the EU Centralised Procedure can only be authorised in Great Britain (England, Scotland and Wales).Continue Reading New UK International Recognition Framework for Medicines

The European Commission published a Proposal for a Regulation on Packaging and Packaging Waste (the Proposed Regulation) to tackle the growing amount of packaging waste, the low levels of recyclability, and the re-use and uptake of recycled content. If adopted, the rules will apply to all companies involved in the packaging life cycle that place packaging and packaging waste in the EU internal market regardless of whether these companies are based in the EU.  While there are various exceptions for manufacturers of medicinal products and medical devices sectors, if adopted, the Proposed Regulation will require life sciences companies to make significant amendments to their current and future product packaging, with resulting cost impacts. We set out the key requirements and takeaways from the Proposed Regulation in our Advisory, and will continue monitoring and reporting on new developments as the legislative process evolves.

We have also prepared this helpful summary for your reference. Continue Reading Proposal for Revision of EU Legislation on Packaging and Packaging Waste

On 26 May 2023, the UK Medicines and Healthcare products Regulatory Agency (MHRA) announced plans to introduce new international recognition routes for medicines, whereby the MHRA can recognise decisions to authorise medicinal products taken in other countries so the MHRA can fast track approval in the UK. Further, on 4 July 2023, the MHRA published its Corporate Plan, 2023 to 2026 (Corporate Plan) outlining its four strategic priorities over the next three years, including to “deliver scientific and regulatory excellence through strategic partnerships” through, for example, collaboration with international regulatory partners.

The new international recognition routes will enable recognition of medicinal product approvals in Australia, Canada, the European Union, Japan, Switzerland, Singapore and the United States.

The aim is for these routes to be in place by the first quarter of 2024.Continue Reading New UK International Recognition Routes for Medicines   

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

On 17 November 2022, the Court of Justice of the European Union (CJEU) delivered its preliminary ruling in joined cases C-253/20 Impexeco NV v Novartis (Impexeco), and C-254/20 PI Pharma v Novartis (PI Pharma), finding that where a parallel importer affixes the trade mark of a branded reference medicinal product onto the packaging of a generic product, the brand owner may oppose the placing of that generic product by the parallel importer on the market of a Member State. Though the CJEU provides an exception to this general rule, the authors query whether the exception will ever apply.

Importantly, this case compares: (i) the rules on when a parallel import licence can be obtained (which is a regulatory question), and (ii) when rebranding can legitimately take place for such products (which is an IP question). As set out below, the need for “identicality” is not the same for these two considerations.Continue Reading Parallel imports: identicality of products when repackaging

On 18 November 2022, the European Medicines Agency (EMA) published a draft reflection paper (Paper) for public consultation on the criteria for the evaluation of new active substance (NAS) status for biological substances. The Paper provides guidance for applicants on the elements required for a successful NAS claim, including practical examples and a Q&A. This is an area of significant practical importance for pharmaceutical companies and the Paper is a key element to consider during the development of regulatory strategies for biological, biotechnology-derived and advanced therapy medicinal products (ATMPs).

Chemical active substances are excluded from the scope of the Paper, given they are already addressed in two previous reflection papers. The Paper builds on these reflection papers and provides guidance to applicants based on the EMA’s experience with biological products to date, and the current scientific thinking.

The public consultation on the Paper is open until 31 May 2023.Continue Reading Evaluation of New Active Substance Status for Biological Products in the EU