The EU’s Pharmaceutical Reform Package

A. The current framework

The current pharmaceutical legislative framework essentially comprises the following main instruments:

• Directive 2001/83/EC, which codified all existing provisions in force on the sale, production, labelling, classification, distribution and advertising of medicines for human use in the European Union
• Regulation (EC) No 726/2004, which introduced a centralised authorisation procedure for medicines (alongside existing national procedures), reinforced monitoring procedures (pharmacovigilance), and established the European Medicines Agency
• Regulation (EC) No 141/2000, which set out criteria for classifying certain medicines as “orphan drugs” (for the prevention, diagnosis and treatment of rare conditions) and provided incentives for their research, development and marketing
• Regulation (EC) No 1901/2006, which enacted provisions to encourage research into paediatric medicines, guarantee that most of them receive a specific authorisation for use in paediatric populations, and ensure that accurate and helpful information on such medicines is available
• Regulation (EC) No 1394/2007, which established the Committee for Advanced Therapies within the European Medicines Agency, and set out a framework for authorising, supervising and monitoring advanced therapy medicinal products within the Union

These legislative enactments did much to harmonise pharmaceutical law across the European Union; however, there is no doubt that the legislation was in need of revision, consolidation and modernisation in order to ensure that the Union continues to guarantee a high level of public health.

B. The aims of the reform

With this in mind, on 26 April 2023 the European Commission adopted a proposal for a new Directive and a new Regulation, to update and replace the existing framework. Its more specific aims in doing so were to:

• Ensure that patients have timely and equitable access to safe, effective and affordable medicines (a “Single Market” for medicines) across the EU
• Continue to offer an innovation-friendly environment for research, development and production of medicines in the Union
• Reduce the administrative burden for the authorisation of medicines so that they can be approved faster and reach patients more quickly
• Strengthen availability of medicines, regardless of where in the EU the patient resides
• Combat antimicrobial resistance (AMR)
• Enhance the environmental sustainability of medicines

C. What is in the pharmaceutical package?

The proposal adopted by the Commission comprises three instruments: a Directive, a Regulation, and a Council Recommendation that will replace the existing framework.

Let’s take a brief and very simplified look at what a Directive, a Regulation and a Council Recommendation actually are, before going into their specific provisions in more detail.

• A Regulation is a type of EU legislation that is automatically binding on all Member States. It does not need to be “transposed” (more on that later).
• A Directive is a type of EU legislation that sets out objectives for EU Member States. It needs to be “transposed” into national legislation; that is, each Member States needs to put together its own laws in order to fulfil the objectives in a Directive. There is a set date in each Directive by which transposition needs to take place.
• A Recommendation is not binding, but sets out views and suggestions.

In the pharmaceutical package, the proposed legislative acts are as follows:

• The Directive lays down the requirements for authorisation, monitoring, labelling and regulatory protection, placing on the market and other regulatory procedures for all medicines authorised at EU and national level
• The Regulation enacts specific provisions (in addition to those in the Directive) for medicines authorised at EU level, and specifically the most innovative ones. It provides a framework for the European Medicines Agency and also includes rules for dealing with critical shortages and the supply of critical medicines in a coordinated manner.

In subsequent blog posts, we will look at specific elements of the reform.

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*Please note that the content of this blog series is for informational purposes only and does not constitute legal advice. Visitors to this blog should not act upon the information on this website, or decide not to act based upon the information on this website, without first seeking appropriate professional counsel from an advocate licensed to practise in the reader’s jurisdiction.