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Client Alerts 30 results
Client Alert | 15 min read | 08.20.25
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.
Client Alert | 16 min read | 08.13.25
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.
Client Alert | 11 min read | 08.06.25
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.
Client Alert | 6 min read | 07.30.25
The new EU “Pharma Package”: Global (Orphan) Marketing Authorization
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.
Client Alert | 4 min read | 07.23.25
The New EU “Pharma Package”: The Debate on Fiscal Import in the Supply Chain
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.
Client Alert | 8 min read | 07.16.25
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.
Client Alert | 9 min read | 07.09.25
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).
Client Alert | 4 min read | 06.30.25
Client Alert Series: The New EU “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.
Client Alert | 3 min read | 06.30.25
The New EU “Pharma Package”: Preparing for the Trilogues
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.
Client Alert | 6 min read | 07.25.24
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.
Client Alert | 3 min read | 07.02.24
The New Urban Wastewater Treatment Directive
New EU legislation is about to be adopted which will require pharmaceutical and cosmetics companies to pay water pollution costs. More specifically, it will oblige those companies to pay for the clean-up and removal of micropollutants from effluent water. In addition, it will increase the risk of pharmaceutical and other companies facing legal damage-to-health claims. The new EU legislation – called the (Recast) Urban Wastewater Treatment Directive (“New UWWTD”) – is expected to be formally adopted in Q3/4 of this year.
Client Alert | 4 min read | 06.26.24
Preparing for the U.S. BIOSECURE Act
Momentum is building for the US BIOSECURE Act, and it is becoming more and more likely that it will soon become law. It may significantly impact pharmaceutical and biotechnology companies and supply chains, particularly if they or their customers do business with the U.S. Federal Government. It is therefore important to prepare now to avoid potentially serious adverse effects.
Client Alert | 5 min read | 06.24.24
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.
Client Alert | 22 min read | 05.31.24
2024: An Overview of New and Upcoming Belgian and EU Laws and Regulations – UPDATED in May 2024
At the beginning of the year, we brought to your attention that a number of important Belgian and EU legislative changes are likely to have an impact in 2024: there are new laws that have been adopted and proposals that are expected to firm up into law.
Client Alert | 19 min read | 01.31.24
2024: An Overview of New and Upcoming Belgian and EU Laws and Regulations
A number of important Belgian and EU legislative changes are likely to have an impact in 2024. On the one hand, there are new laws that have been adopted and will start to bite, and, on the other, there are proposals that are expected to firm up into law.
Client Alert | 7 min read | 06.22.23
A New Patent System is Born in Europe
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.
Client Alert | 7 min read | 05.16.23
While fashion lovers throughout the European Union will surely be familiar with the pattern, the General Court held that luxury fashion house Louis Vuitton failed to demonstrate that its trademark checkerboard ‘Damier Azur’ pattern, had acquired distinctiveness through use throughout the European Union.
Client Alert | 6 min read | 05.04.23
Opening up the Long-Awaited EU Pharmaceutical Package
On April 26, 2023, the European Commission finally published its long-awaited EU Pharmaceutical Package. This Package introduces new draft legislation that would revise and replace existing EU pharmaceutical legislation in line with the Pharmaceutical Strategy for Europe, which was adopted by the EU on November 25, 2020.
Client Alert | 5 min read | 11.29.22
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.
Client Alert | 5 min read | 11.17.22
Unveiling the Complexity of the Belgian MedTech Legal Landscape
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.
