Interview: Nathalie Bere, European Medicines Agency

Nathalie Bere offers an overview of her work supporting engagement with patients and consumers at the European Medicines Agency, and highlights how far the Agency has come in integrating patients into its activities.

Nathalie Bere offers an overview of her work supporting engagement with patients and consumers at the European Medicines Agency, and highlights how far the Agency has come in integrating patients into its activities.

Can you tell us about EMA and your area of work?

The European Medicines Agency (EMA), located in London, UK, has a coordinating role for the evaluation and supervision of medicines developed by pharmaceutical companies for use across Europe.

My role is to support the Agency’s engagement with patients and consumers via a large network of European patient and consumer organisations. This includes the management of the Agency’s Patients and Consumers Working Party (PCWP). 

My work involves not only daily interaction with patients, but also developing and monitoring the scope of their involvement within the various Agency activities, and ensuring that their voice can be heard throughout the lifecycle of a medicines’ evaluation, wherever it may be of benefit.

How did you become involved in this field?

Totally by chance! I joined the Agency 17 years ago in an interim position, in a different role. This evolved into a more permanent position, and over the years I held several different roles, gaining more knowledge and qualifications along the way. Finally, as the Agency‘s engagement with patients was expanding, 6 years ago I had the opportunity to take this role, and the rest, as they say, is history!

Can you tell us about the recent EMA Patients’ and Consumers’ Working Party (PCWP) training session and meeting? What is the purpose of the meeting, and what do you hope the outcomes will be?

The session is an annual training day organised for all of our eligible patient organisations. The training session explains how the Agency works and covers the key opportunities for patients to be involved in our activities. For example, explaining the meetings that patients may be invited to participate in and looking at the different types of documents produced by the Agency that patients may be asked to review.

The meeting allows us to provide feedback on activities patients have been involved in during the year, and also to provide general medicine-related information of mutual interest. We also shared information on the EMA’s plans for improving its communications, on its collaboration with health technology assessment (HTA) agencies and the new adaptive licensing project. Additionally, we discussed our ongoing pilot project relating to the publication of risk management plan summaries, as well as the vaccines project ADVANCE.

This meeting is a vital platform for the exchange of information between the EMA and European patient organisations.

How do you see the role of patients and consumers in EMA activities developing in the future? 

The role of patients in the EMA has grown since its creation in 1995, and a mutually beneficial relationship has developed over the years. Patients are now an integral part of the Agency’s work; they are involved in a wide range of EMA activities beginning early in the medicines development stage, lasting through the evaluation phase, and continuing once it is authorised. 

In the future we would like to look at how to further reach out to patients across Europe and to find the best ways to collect and use the wealth of knowledge and experience they possess. We would also like to expand our contacts with individual patients to increase the network of patients available and interested in working with us.

During the past few years there has been a significant increase in patient participation and we are committed to further strengthening this involvement.

What do you enjoy most about your work?

One aspect that is very rewarding is finding patients with a specific disease/condition to participate in an EMA activity, who can then share their real-life experience and knowledge of living with the disease and to see how they make an important contribution to the overall ‘scientific discussion’.

Our team also has the unique position of interacting with a variety of groups at the Agency, and this view of the overall process is not only interesting but provides a good opportunity to increase the involvement of patients, healthcare professionals and other experts in procedures.

What are you most proud of in your career?

I feel very privileged to have been able to evolve and grow within the Agency, and to have contributed to the current systems and structure in place to facilitate patient involvement.

Is there anything else you’d like to share with our readers?

I would recommend that readers go to the EMA website, specifically to the Partners and Networks tab, and look at the Patients and Consumers’ area and all the documents and videos available there.

Next year represents an important milestone for medicines in Europe. Not only is the EMA celebrating its 20th birthday but 2015 is also the 50th anniversary of the EU pharmaceutical regulation. EMA will mark this double anniversary year with events on a monthly basis including an 20th anniversary book and conference. So stay tuned!

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