Insights

Brussels and Doha – April 1, 2024: The Legal 500 Europe, Middle East & Africa (EMEA) 2024 edition has recognized 16 practice areas and 11 lawyers in Crowell & Moring’s Brussels and Doha offices. The 11 individual lawyers received 18 total rankings across the 16 different practice areas.

In our seventh alert in this EU Pharma Package Series, we provided an analysis of the increasing focus on shortages of medicinal products in the EU and the prevention and mitigation measures as proposed by the EU institutions.

In our sixth alert in this EU Pharma Package Series, we provided an analysis of the history and interpretation issues for another highly debated topic: the “Bolar” exemption.

In our fifth alert in this EU Pharma Package Series, we provided an analysis of the background and ongoing legal debates regarding the concept of the global marketing authorization (GMA). We discussed in particular the missed opportunities in the Pharma Package to further codify and clarify the GMA, in view of its central role in determining the regulatory data protection (RDP) rights of a medicinal product.

An inescapable part of marketing your (non-food) products consists of managing the risks caused by defective and/or non-compliant products. To deal with the legal aspect of this risk, economic operators must take measures prior to putting their products on the market as well as once the product has been commercialized.

What impact will the new Urban Wastewater Treatment Directive really have on the pharma and cosmetic industries?

In Collaboration with the IBJDuring this webinar we will dive into the European Directive on pay transparency that entered into force in June 2024 and has to be transposed for June 2026 in all EU Member States. This European Directive has the ambition to strengthen the application of the principle of equal pay for equal work or work of equal value between men and women, for all employees in all sectors. The Directive brings significant new reporting obligations and assessment obligations on employers that the EU Member States will publish. How will you have to calculate the threshold to know if your company as an employer falls under the scope of the Directive? And what happens when there is a gap in the equal pay? What will you have to do as an employer? What kind of enforcement does the Directive foresee? Lastly, did you know that in the US there is an Equal Pay Act that has been in force since 1963? How has that statute been applied in the US and what are the differences and similarities with the European Directive? Our special US guest will teach us some interesting US-insights.