4. Specific regulations in Europe

• Risk management is increasingly viewed as necessary to continuously monitor, safeguard and even enhance the benefit-risk balance of a medicine  after market authorisation under real-world conditions. The risk minimisation activities should be proportionate to the risks and should not prevent the use of the medicine in appropriately selected patients.
• Risk management can be challenging and expensive, but is necessary and ultimately rewarding and reassuring. It allows trust to be built between companies and stakeholders (transparency).
• Risk management is increasingly becoming a cornerstone for sustainable market availability therapy
• Risk management is an opportunity to protect patients, avoid crisis, and enhance the knowledge about the products.

The recent additional monitoring process put in place across the EU is part of the EMA’s plan to strengthen medicine safety measures. The addition of the symbol ‘▼’ in package leaflets as well as in the SmPC aims to encourage reporting of adverse events from doctors but also from patients.

In this process as well as in the design of arisk management plan, patients are becoming key players in the continuous assessment of the benefit-risk balance of a medicine.