Pharmaceutical regulation

The life sciences sector encompasses companies in the fields of pharmaceuticals, biotechnology and medical technology that focus on the research, development and commercialisation of a wide range of products that have a medical application. Such products include pharmaceuticals (ie everything from over-the-counter painkillers to advanced therapies for treating diseases such as cancer or HIV), medical devices (eg plasters, syringes, heart stents, pacemakers, etc) and diagnostics. This subtopic provides an overview of pharmaceutical regulation in the EU.

In the EU, a large amount of the regulation originates from directives or regulations and is supplemented by guidance issued by the European Commission and by the European Medicines Agency (EMA), the decentralised agency of the EU responsible for the scientific evaluation, supervision and safety monitoring of medicines.

Regulation of medicinal products

Article 1(2) of Directive 2001/83/EC, the Pharmaceutical Code defines a medicinal product as a substance that is either:

•
presented as preventing or treating disease, or
•
used to correct or modify a physiological function by pharmacological, immunological or metabolic action, or to make a medical diagnosis

Practice Note: Introduction to the regulation of medicinal products—EU provides an

To view the latest version of this document and thousands of others like it, sign-in with LexisNexis or register for a free trial.

TAKE A FREE TRIAL

Latest EU Law News

EU Law weekly highlights—21 November 2024

This week's edition of EU Law weekly highlights includes analysis on the European AI Office’s draft General-Purpose AI Code of Practice, the Court of Appeal of the Unified Patent Court decision confirming its international jurisdiction, the judgment that 3D inhaler trade mark cannot be restored by Boehringer, the ruling that Ukraine border service cannot get an EU trade mark for its war slogan, Meta being fined €798m for tying marketplace ads to Facebook, and the role of acceptable use policies in AI, In addition, this week the 2025 EU annual budget was agreed, the Council of the EU adopted a regulation to shut down European Online Dispute Resolution platform, adopted a ban on forced labour products in Union market, and approved the certification framework for carbon removals, the European Parliament endorsed the postponement of the deforestation rules, the European Commission proposed a single digital portal for posted worker declarations, and the EU Cyber Resilience Act and EU Listing Acts were published in the Official Journal.

ECHA updates progress on PFAS restriction proposal evaluation

The European Chemicals Agency (ECHA) has issued a progress update on the evaluation of the per- and polyfluoroalkyl substances (PFAS) restriction proposal. ECHA and five European countries are reviewing over 5,600 comments received during consultation, identifying additional uses for assessment, and considering alternative restriction options beyond a full ban. The agency is evaluating the proportionality of these options for specific sectors, such as batteries and fuel cells, to inform the ongoing scientific committee evaluations.

A ‘Kwantum’ leap decision? Court of Justice on harmonising EU copyright protection for non-EU designs (Kwantum v Vitra)

IP analysis: In this decision, the Court of Justice’s weighed in on important principles and the EU-wide harmonisation of international copyright law. The Court of Justice confirmed the Advocate General (AG) Szpunar’s opinion that EU Member States do not have any discretion to limit EU copyright protection by applying the material reciprocity test enshrined in the Berne Convention, which provides that works of applied art originating in countries where they are only protected as designs (eg the US) may not, in other signatory countries eg Belgium and the Netherlands), also be granted copyright protection. In this context, the Court of Justice emphasised that a work shall enjoy protection under EU copyright law if it is ‘original’, regardless of its geographic origin within or outside the EU. The Court of Justice’s judgment can be expected to significantly impact the harmonisation of copyright laws within the EU, ensuring broader protection for works of applied art and potentially influencing future legislative developments. Written by Alexander Hofmann, attorney-at-law at Baker McKenzie Austria, and Marlies Kittinger, junior associate at Baker McKenzie Austria.

COP29 round-up—20 November 2024 (Urbanisation, Transport and Tourism)

On 20 November 2024, the tenth day of the 29th Conference of the Parties of the United Nations Framework Convention on Climate Change (COP29) focused on urbanisation, transport, and tourism, marking the first time the COP Presidency dedicated a day to tourism. The Presidency Stocktaking Plenary discussed several topics, including the new collective quantified goal on climate finance (NCQG). In addition, the UN Climate Change Executive Secretary, Simon Stiell, delivered a speech on nationally determined contributions (NDCs), and the COP29 Presidency launched declarations on tourism and urban resilience.