Insights

In this ninth and final alert in our weekly series on the EU Pharma Package, we consider the proposals of the European Commission, European Parliament and the Council of the EU as regards the advertising of medicinal products and we conclude by suggesting various ways in which pharmaceutical companies can already prepare for the upcoming changes.

In this eighth alert in our weekly series on the EU Pharma Package, we continue our overview of initiatives with respect to security of supply and shortage prevention and mitigation. Our last alert looked at how the Pharma Package seeks to address these issues. However, the Pharma Package does not exist in isolation, and in this alert we will discuss the interplay between its measures and those contained in other important EU initiatives such as the proposed Critical Medicines Act (CMA), and the Medicinal Countermeasures Strategy and the EU Stockpiling Strategy.

In this seventh alert in our weekly series on the Pharma Package, we will discuss the increasing focus on shortages of medicinal products in the EU and the prevention and mitigation measures as proposed by the European Commission, the European Parliament and the Council of the EU.

In this sixth alert in our weekly series on the EU Pharma Package, we focus on the proposals of the European Commission, European Parliament and Council of the EU for another topic with a highly debated scope and with diverging interpretations across EU Member States: the “Bolar” exemption.

In this fifth alert in our weekly series on the EU Pharma Package, we will delve into the global marketing authorization (GMA) concept which has largely remained untouched in the legislative proposal – aside from an important introduction of the notion of a GMA for orphan medicinal products. We will discuss the missed opportunity to codify existing case law and provide further clarification in this respect.

In our first alert in this weekly series on the EU Pharma Package, we provided some important background and general information about the status of the Pharma Package and how the trilogues work. In the second alert, we discussed the proposed changes to regulatory data protection. Our third alert delved into the different proposals of the European Commission, Parliament, and the Council regarding the transferable exclusivity voucher (TEV) for priority antimicrobials.

In our first alert in this weekly series on the EU Pharma Package we provided some important background and general information about the status of the Pharma Package and how the trilogues work, and in the second alert we discussed the proposed changes to regulatory data protection.

In our first alert in our new weekly series on the EU Pharma Package, we provided some important background and general information about the status of the Pharma Package and how the trilogues work. In this second alert, we will discuss the respective positions of the European Commission, the European Parliament and the Council of the European Union with respect to one of the most debated and anxiously anticipated topics on the table, the regulatory data protection (RDP).

On June 4, 2025, after nearly two years of intense debate and negotiation between the 27 EU Member States, the Council of the European Union adopted its position on the proposed overhaul of the EU general pharmaceutical legislative framework known as the new Pharma Package.

On June 4, 2025, after nearly two years of intense debate and negotiation between the 27 EU Member States, the Council of the European Union adopted its position on the proposed overhaul of the EU general pharmaceutical legislative framework known as the new Pharma Package.

On September 3, 2024, the EU Court of Justice overturned the first-instance judgment of the EU General Court, which had held that the European Commission could review transactions that fall below EU and Member States' merger control thresholds through referrals by national competition authorities under Article 22 of the EU Merger Regulation (Case C-611/22 P, Illumina v Commission).

The EU Institutions are currently adding the finishing touches to the new Packaging & Packaging Waste Regulation (“PPWR”) which is expected to be adopted in Q4 2024 or Q1 2025. While many companies are fully preoccupied with preparing for other EU legislation (e.g. the Deforestation Regulation) – companies will ignore the PPWR at their peril. The PPWR contains a host of ambitious legal targets and requirements – which industry will find it difficult to achieve in practice. And the deadlines to comply – are perhaps even more challenging. Companies will need to start preparing for the EU PPWR now, to avoid serious problems – including supply-chain disruption, penalties and litigation – in the future.

The EU legal and policy framework regarding critical medicines and medicine shortages is rapidly changing.  In the past 12 months alone, there have been numerous developments: from the ‘Non-Paper’; to the Communication on ‘Addressing medicine shortages’; and the launch of the Critical Medicines Alliance.  In the next 12 months, there is likely to be similar developments – including a possible draft proposal for a ‘Critical Medicines Act’.  As the new regulatory framework becomes clearer, pharma companies will need to understand it, and prepare for the impact it will have.

The Judgment of the Brussels Court of Appeal is the latest development in the saga in Belgium where a Belgian parallel importer, PI Pharma NV, imported a generic Sandoz product from the Netherlands, repackaged and rebranded them, and placed them on the Belgian market alleging they were a Novartis’ originator product.

Unitary Patents are being granted and the Unified Patent Court is up and running as of June 1, 2023.  Since the 1970’s, there have been attempts at establishing a unitary European patent that would cover multiple European countries and would be enforced by a single court system.  This type of system is in contrast to the system known since 1973 of granting European Patents by the European Patent Office (EPO) and validating the European Patent in designated European countries, wherein each validated patent is enforced in the national court associated with the validated patent.

On November 17, 2022, the European Court of Justice (ECJ) issued four important decisions (here) relating to parallel imports of branded products within the internal market of the European Union (EU). This is a complex topic at the crossroads of free movement of goods and trademark enforcement in the EU.

The Belgian regulatory framework for medical devices is highly complex, and the already dense legal landscape was recently added to by the adoption of two new Belgian royal decrees: the Royal Decree of 25 September 2022 relating to performance studies involving in vitro diagnostic medical devices and the Royal Decree of 13 September 2022 amending and repealing various provisions regarding in vitro diagnostic medical devices.

On May 3, 2022, the European Commission published a proposed regulation (the “EHDS Proposal”) for the establishment of a European Health Data Space (or “EHDS”). This is the first proposal for establishing domain-specific common European data spaces following the European strategy for data and an important step in building a European “Health Union”.