Independent Expert Advises EMA on Benefit/Risk Communication

An independent report released by the European Medicines Agency on May 31, 2011, highlighted a number of recommendations to aid the agency in its communication of the benefits and risks of medicines. The report was the conclusion to a one-year project conducted by Frederic Bouder, PhD, at the behest of EMA, aiming to provide detailed, evidence-based input by analyzing the expectations and attitudes of the agency’s stakeholders toward communication on medicines.

Tackling a number of questions, including how current communication channels build or undermine trust, how the risk communication process could be improved and how that process could bridge the gap between opposite views and expectations, the research studied a population that included regulators, industry and third parties (e.g., patient and consumer organizations, scientific opinion leaders, and medical and nonmedical journalists and editors).

Bouder created three case studies around Viracept, Acomplia, and Gardasil, and also conducted a cross-case analysis. The report concluded with four main recommendations:

• Establishing an external risk communication advisory board composed of experts the risk communication field. Parallels were drawn to a similar board already in place for the European Food Safety Agency.

• Forming a strategic view on what transparency means to enable a better response to stakeholders’ expectations and become more interactive in order to improve traditional information delivery.

• Being proactive in the involvement of patient organizations in sensitive issues, in particular where media coverage could escalate risk perception.

• Reviewing the format and timing of information delivery to target the audience and their needs more effectively. The report decried one-size-fits-all documents such as press releases for targeting neither experts nor the general public.

The agency has already started to implement some of the findings—evidence of its commitment to the five-year Road map to 2015 strategy.