Challenge

Alber & Geiger assisted West Pharmaceutical, a US corporation and world market leader in medical devices, paving the way for PFAS ban exemptions for their products. The intention was to prevent disruptions in the supply of certain medical devices, where the medicinal products are inseparably connected with the devices, like it is the case with the diabetes pen or with vaccines prefilled in containers and syringes.

Strategy

Our team engaged in a multifaceted approach to safeguard the interests of the medicinal and medical devices. We provided strategic input during the consultation period with the European Chemicals Agency (ECHA), highlighting the unique needs and safety considerations of specific medical devices. This was followed by an extensive outreach to stakeholders within the European Parliament, the European Commission, and the EU member states. Our efforts focused on educating decision-makers about the indispensable role of PFAS in medicinal products and medical devices and the potential supply chain risks posed by a PFAS ban.

Results

Our advocacy efforts led to a pivotal development in the regulatory landscape on medical devices. Our targeted approach opened the door to potential derogations of several years for specific medical applications where there is substantial evidence that viable alternatives to PFAS do not exist. This ensures that essential medical devices remain available and effective, safeguarding patient care and industry stability.

Challenge

Alber & Geiger was engaged by Xiaomi, the best-selling phone manufacturer in the EU to fend off against initiatives in the member states’ that could spill-over into the European Union. Our team was called in to provide strategic support, monitoring and analysis of ongoing EU policy initiatives and member states cybersecurity reports that had the potential to affect Xiaomi’s business in Europe.

Strategy

Alber & Geiger engaged on a plethora of issues, including EU-China relations, cybersecurity, right to repair, cyber resilience act, corporate sustainable due diligence, sanctions as well as the digital markets act, by providing high-end analysis and advise on content and engagement with the European Institutions, including the European Parliament and the European Commission. We also helped compile language to assist Xiaomi in addressing European Parliament concerns on the need to protect consumers from Chinese mobile phones by highlighting Xiaomi adherence to EU GDPR standards and norms.

Results

We were able to learn firsthand of ongoing EU initiatives in the Commission or in the European Parliament affecting Xiaomi, and quick to provide analysis and message to advocate vis-à-vis the institutions. Alber & Geiger addressed the concerns raised in reports, letters and policy initiatives. This approach enabled us to protect the image of Xiaomi, and its position in the European market.

Challenge

The Gauselmann Group, one of the largest producers and operators of games of chance in Europe, called on Alber & Geiger when faced with a number of threatening gambling regulations in Germany, Austria, Hungary, Netherlands, Romania, Serbia, Slovakia and the Czech Republic. Alber & Geiger had to convince the European Commission to make a counterintuitive political risk in confronting a powerful Member State, Germany and concurrently convince the European Commission that our interpretation would stand up to CJEU scrutiny.

Strategy

Given the limited scope of directly ascertainable EU competence, the strategy employed an abstracted analytical formula to show that the various regulations were legally incoherent. It demonstrated that the laws of the Member States contradicted their own main goals on a substantive level. It utilized the jurisprudential architecture of the CJEU in lieu of their crystallization.

The multifaceted strategy also incorporated an economic dimension. Concurrently, the same technique allowed us to demonstrate that the money laundering directive could not arbitrarily encompass all the gambling operators without distinction of risk volume and activity.

Results

Ultimately, we managed to convince the European Commission to act. Its omission to launch infringement proceedings had been rebuked. Alber & Geiger was able to safeguard fundamental liberties and freedoms by bringing EU instruments into a new field and challenging archaic but powerful structures. We were also able to hold the scope of the money laundering directive back, establishing a distinction between casinos and other gambling operators.