Assessment of the impact of policy and regulatory changes on a company’s pipeline​

Situation

Our client, a leading pharmaceutical company, faced uncertainty due to the European Commission’s revision of the General Pharmaceutical Legislation (GPL). This revision, part of the Pharmaceutical Strategy for Europe, proposed changes to the EU incentives framework affecting all medicines, including those for rare diseases and pediatric indications.​

Outcome

We undertook a detailed analysis to clarify the potential effects of these legislative changes for our client. Our method comprised:​

Exposure Analysis: ​
We actively assessed the company’s exposure to the regulatory shifts. Our team compiled the company’s pipeline overview, charted the imminent policy alterations, gauged their impacts, and calculated these impacts across each pipeline asset and category.

Impact Model:
We evaluated the impact on the pipeline assets’ value using a risk-adjusted Net Present Value (rNPV) model. This evaluation painted a comprehensive picture of the cumulative effect of various revision scenarios and underscored the significance of distinct revision components.

We equipped the client with in-depth insights and a solid framework to assess the legislative changes’ repercussions. This empowered the company to adjust their internal R&D and commercial strategies and to sharpen their advocacy initiatives.​

Our analytical work played a pivotal role in navigating the client through the revised EU incentives framework’s intricacies. With our expert report, the client grasped the legislative changes’ implications on their product pipeline, aiding them in strategic planning and advocacy stances. Our bespoke two-step solution ensured the client was prepared to tackle the legislative updates and to counter potential business risks proactively.​

Private Client