Fiona Reekie (Janssen Research& Development) and Xavier Luria Oller (EMA) chaired a session looking at how critical decisions are made on new medicines and the role of patients.

Francesco Pignatti (EMA) summarised work done so far in the EMA project with centralised products in five European regulatory agencies aimed at improving transparency and consistency. Decision-making models will be applied to medicines where the benefit-risk is more difficult to determine while effects tables will become more common. Patients have been contributing to the regulator’s benefit–risk decision-making by sharing experiences and advising on the risks that they are prepared to accept; tending to accept more risk than regulators think they will.

Filip Mussen (Janssen Pharmaceutical Companies of Johnson & Johnson) illustrated how some companies are using structured processes, qualitative and quantitative, to facilitate and enhance benefit–risk decision making. Methods used range from NNT/NNH (numbers needed to treat/numbers needed to harm) to, eg, BRAT framework forest plots, prior to submission of an MAA. Different methods are resource intensive but help transparency. Patients can contribute to a company’s benefit–risk decision making through the use of patient reported outcomes in clinical trials, patient preference methods and through anecdotal evidence.

Isabelle Moulon (EMA) shared results from two surveys on the communication of benefit-risk in the context of an environment of increasing transparency. Consumers and health care professionals’ information expectations in this area are similar with a need to understand benefit-risk both at the population and individual level. Access to high quality information on medicines is key to this. The template for EPARs has been revised to address benefits, risks and uncertainties and an SmPC Advisory Board has been setup. The EudraSmPC webpage will be made public in 2012. The template for package leaflets has been revised to introduce information on the benefit of the medicine. Patients are regularly involved in the review of package leaflets, EPAR summaries and of communication on safety issues.

The new pharmacovigilance legislation will result in more transparency with, eg, the publication of all conclusions of assessments and decisions. The EMA communication strategy and transparency policies are under preparation and will build on the work done to date.

London 24 – 25 November 2011 – this meeting is an annual event organised by TOPRA with EMA and was held this year in the EMA building in Canary Wharf.

Notes to Editors

Media and interview enquiries:

Jenine Willis, TOPRA Publishiing
Telephone: +44 (0)20 7510 2560

The Organisation for Professionals in Regulatory Affairs (TOPRA)

TOPRA is the global organisation for Regulatory Affairs professionals and for those who have an interest in Regulatory Affairs in the healthcare sector. Current membership is drawn from over 40 countries and members worldwide are actively involved in delivering the services needed by busy regulatory specialists. Members are drawn from industry, the regulatory agencies and the consultancy community and work in all sectors including medical technologies, biotech, borderline products and pharmaceuticals.

Related content: