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

A US Fortune 500 chemical company approached Alber & Geiger seeking regulatory and advocacy support over a European Union proposal that would have classified Titanium Dioxide as a cat.2 suspected carcinogen by inhalation. Such a decision would have affected our client’s revenue and increased risk of similar regulatory measures in the other jurisdictions across the globe.

Strategy

With the experts opinion from the ECHA’s Risk Assessment Committee delivered to the European Commission, our team quickly embarked on a campaign aimed at highlighting the broader ramifications of classification on other EU policies and beyond Titanium Dioxide.

We pursued a strategy that put the spotlight on loss of consumer choice, impact on jobs and EU competitiveness as well as cost to downstream users. Alber & Geiger also broadened the issue to include political considerations and other players. On top of the European Commission, in particular DG Envi and DG Grow and the Member States’ Competent Authorities, we reached out to the Permanent Representations of the Member States as well as select Members of the European Parliament.

Results

Our advocacy helped thwart the original carcinogen classification that would have harmed our client. Through active engagement at the regulatory and political level, we helped find a suitable compromise for our client, which was then mirrored in the European Commission amended proposal.

Instead of outright carcinogen labelling on Titanium Dioxide, the European Commission changed its position by agreeing for classification to apply to Titanium Dioxide in powder form, only on the level of manufacture and without carcinogenicity labelling in the end products.

Challenge

Within a climate of instigated political fear in the USA for China’s corporations, Huawei was starting to have a credibility problem in the EU, despite adherence to EU standards and a strong commitment to Europe. Huawei’s reputation and thus business development being at risk over its products’ cyber security concerns, Alber & Geiger was called to mitigate these concerns and build support in Europe.

A major focus was the 5G rollout under the EU toolbox in several European member states. The respective European cybersecurity strategy conflicted with the bilateral corporation agreement several EU member states had signed with the United States on cybersecurity, especially targeting Chinese suppliers like Huawei.

Strategy

Alber & Geiger targeted key Members of the European Parliament in all relevant committees and across the political spectrum, to emphasize Huawei’s commitment to Europe, adherence to EU standards and contribution to the European economy through leading products and services, jobs creation and investments in research and development. In that context we established an alternate strategy with the European Commission and related EU agencies to show that Huawei is fully integrated in the EU market and successful for business reasons only.

Results

Our engagement demonstrated to EU law makers that there was no Chinese government involvement in Huawei’s business strategies, let alone any cyber security issue with Huawei’s devices. By doing so, we advanced Huawei’s business interests in Europe.