life sciences

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

On March 11, 2023, the UK Government published its response (“Government Response”) to an independent review on equity in medical devices commissioned by the Department of Health and Social Care (“Review”).  The Government Response is not guidance nor policy rather it is intended to act as an action plan for tackling potential bias in the design and use of medical devices.  The Government Response fully accepts, and in turn makes a series of commitments in response to, the findings of the Review (which is broken down into 18 recommendations, 51 sub-recommendations, and 3 further calls to action).  Importantly, the Government “wholeheartedly agrees…that medical technology should be unbiased and equitable.” 

Bias in the medical device space, and within healthcare more broadly is (quite rightly) a topic of growing importance to governments, regulators and industry alike.  We set out some key points of interest from both the Review and the Government Response below.  We look forward to seeing more developments and guidance in this area going forwards given its significance to patients and the delivery of healthcare.  Continue Reading UK Government Outlines New Action to Tackle Biases in Medical Devices

In an earlier blog, we wrote that the German regulation of pharmaceutical pricing and reimbursement is one of the most complicated legal areas in the entire world of life sciences laws. With the new draft “Medical Research Act” (Medizinforschungsgesetz or MFG) that came out in…

Continue Reading Germany again to reform drug pricing and reimbursement laws – With “confidential reimbursements prices” that impede international reference pricing

Significant changes are on the horizon for clinical trials in Germany. At the end of January 2024, the German Federal Health Ministry has presented the draft for a “Medical Research Act” (Medizinforschungsgesetz or MFG). The draft bill proposes legislative amendments in several areas that span from…

Continue Reading Germany will revise laws for clinical trials with pharmaceuticals, medical devices and companion diagnostics – Overview of the “Medical Research Act”

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

The Holiday season of 2023 proved to be a busy one for innovative pharmaceutical companies in the UK and their legal and regulatory teams.

UK pharmaceutical companies are already number-crunching through two new price control systems for 2024 (please see our blog and audiocast).  In addition to the UK pricing regime changing, there are proposals to update advertising rules and the procedure for adjudicating upon advertising complaints.   

On 13 December 2023, the Association of the British Pharmaceutical Industry (“ABPI”) published proposals to update the 2021 ABPI Code of Practice for the Pharmaceutical Industry (“ABPI Code”) and the Prescription Medicines Code of Practice Authority (“PMCPA”) Constitution and Procedure (which sets out the procedure for adjudicating upon advertising complaints).  Companies have until 29 February 2024 to contribute to the consultation.

Many of the proposed changes to the ABPI Code are clarificatory in nature, but the planned changes to the complaints process may be of particular interest to in-house legal teams.  These changes are designed to make the PMCPA complaints process less formulaic and more flexible.  This could help manage relatively straightforward cases with greater efficiency, whilst also accommodating for cases which involve serious allegations and/or complex facts.  If implemented as proposed, the changes are likely to give PMCPA cases a more judicial or legalistic feel, particularly when it comes to case management.Continue Reading Consultation on Changes to the ABPI Code and UK Advertising Complaints Process

The German government is discussing a new Pharma Strategy with a number of reforms to improve the conditions for the pharmaceutical industry in Germany. Recently, the “Strategy Paper 4.0 – Improving the General Conditions for the Pharmaceutical Sector in Germany” (original title: Strategiepapier 4.0: Verbesserung der Rahmenbedingungen für den Pharmabereich in Deutschland – Handlungskonzepte für den Forschungs- und Produktionsstandort) became public that reportedly has the backing of the German Chancellor and the Federal Health Minister.

This strategy paper presents a range of measures to strengthen, among other things, pharmaceutical research and production in Germany and to improve the market access and pricing environment. These measures would have a significant impact for a multitude of players in the life sciences field. As such, the German government anticipates faster approvals for clinical trials, faster access to innovative medicines, more digitalization, greater supply security, a more investment-friendly environment and reduction of bureaucracy. Currently, and this is widely acknowledged by the government and most stakeholders, there is significant room for improvement in all of these areas.Continue Reading German Government pursues new Pharma Strategy with significant Reform Ideas

Roughly a decade ago, countries such as the USA and France introduced ground-breaking transparency and disclosure legislation under so-called “Sunshine Acts.”  Broadly speaking, such legislation made it mandatory for pharmaceutical companies to publish records of payments or other transfers of value made to healthcare professionals (HCPs) and healthcare organizations (HCOs).…

Continue Reading UK Government Consults on Proposals Mandating the Disclosure of Industry Payments to the Healthcare Sector