EARLY DIALOGUE IN EUROPE: PERSPECTIVES ON VALUE, CHALLENGES, AND CONTINUING EVOLUTION

Area of Science:

• Pharmaceutical policy
• Health technology assessment
• Regulatory science

Background:

• Early dialogue between pharmaceutical industry, regulatory agencies, and health technology assessment bodies (HTABs) is crucial for efficient drug development.
• Understanding stakeholder perspectives on current and future early dialogue processes is essential for optimization.

Purpose of the Study:

• To assess stakeholder views on past, present, and future early dialogue between the pharmaceutical industry, regulatory agencies, and HTABs in Europe.
• To identify facilitators and barriers to effective early dialogue processes.

Main Methods:

• Conducted eleven semi-structured interviews with experts from the pharmaceutical industry, European Medicines Agency, and Health Economics.
• Utilized open and axial coding of transcribed interviews to analyze findings on early dialogue value, challenges, timing, product suitability, and future perspectives.

Main Results:

• All participants recognized early dialogue as valuable for informing development and expediting patient access to new medicines.
• Key challenges identified include securing adequate resources within pharmaceutical companies and HTABs, and divergent requirements among national regulators and HTABs.

Conclusions:

• Pharmaceutical industry stakeholders view early dialogue as a vital tool for faster medicine delivery to patients through streamlined development.
• Mitigating identified challenges is necessary to establish a robust and sustainable mechanism for early dialogue.