Europe: Regulatory Guidance, Advocacy, and Stakeholder Engagement

The Challenge

A global life sciences firm sought advocacy and regulatory guidance in a European nation whose pharmaceutical sector was experiencing rapid growth. Unexpected regulations posed challenges to our client, including delayed approvals for new medications and increased difficulties bringing products to market.

The Approach

ASG’s Europe team developed a strategy to strengthen relationships between our client and industry stakeholders.  We also worked to position the company as an industry leader prepared and willing to make its voice heard, both on its own and on behalf of the industry, on vital regulatory issues.

The Result

Our client received timely drug approvals, while securing pricing necessary to preserve economic viability for its product, and a commitment from the government to significantly increase budget allocation for certain classes of drugs in recognition of the health and cost efficiency benefits they offered. These outcomes, both benefiting our client, also brought value to the country through access to a range of new life-saving medicines for its citizens. Over time ASG provided additional support to effectively address similar issues in other markets, including Brazil, China, Saudi Arabia, South Africa, and Venezuela.