Challenge

The Giurgiulesti port of Chișinău in Moldova is an important strategic hub for all shipping to the black sea. It is a high EU political strategic value with regard to neighboring Russia.

In Moldova, we were faced with the task of steering tough EU diplomatic entanglements, in a direction that secured justice for our Azerbaijani client. The client was an important investor in Moldova. His interests in the Moldovan port which also involved huge EBRD investments had been compromised by an EU national.
Our client had sought a solution in Moldovan courts. After a freezing order in his favour was miraculously lifted, in the context of public statements from EU officials, he was concerned about the rule of law, independence of judiciary and the respective safety of his assets in this potential EU member state – and reached out to our team.

Strategy

The strategy was a bold venture into the multi-layered external relations boundaries that have been blurring due process. We reminded the EU that it had an obligation to uphold the rule of law in a potential EU accession country even if the result geopolitically would favor potentially Russian interests.

Results

The EU was ultimately content with making a neutral statement that did not implicate its integrity. It resulted in substantive justice for the client, and created a more positive relationship with the EU institutions.

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

Our client Heel leading manufacturer of homeopathic medicinal products dedicated in research, dealt with a non-suitable regulatory environment. Existing requirements as applied by national authorities did not honor investments in scientific research. Alber & Geiger faced a European Commission reluctant for legislative changes and differing Member State approaches.

Strategy

The strategy co-ordinated legal, ethical, medical and scientific concepts into coherent arguments. It showed the European Commission and the EU institutions but also relevant national competent authorities more broadly, the particularities of homeopathic medicinal products, as well as their effectiveness and safety and the different national approaches in the EU Member States.

Results

Ultimately our strategy allowed our client to enter into a constructive dialogue with relevant national authorities. Alber & Geiger followed the maxim that sometimes less regulation is more, reflecting the priorities of our clients’ industries.