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European Medicines Agency: Staying consistent in a turbulent time

Published on 12/06/17 at 11:44am

With Brexit looming, the future of the EMA headquarters in London has been cast in doubt. Pharmafocus spoke to Marie-Agnes Heine, Head of the Communication Department, and Juan García Burgos, Head of the Public Engagement Department, to discuss the medical communication role within the organisation and how the department is busier than ever.

When the referendum result was revealed, it wasn’t immediately clear what the fallout would be. Now, close to a year on, it is still a topic of considerable uncertainty. For the EMA, however, the decision had immediate ramifications – it had signed a 25-year lease on a building in Canary Wharf only a few years previously, but is obligated to remain in a country within the EU.

Since then, the headquarters has become the object of desire for just about every EU member state. More than 20 countries have vocalised their interest in accommodating the agency and it only takes a visit to the building itself to see why; experts convene here from all corners of the globe, while the vast array of meeting rooms host a wide-range of impactful discussions.

It is not hard to see how these meetings will generate ideas that shape the face of many different aspects of regulatory affairs. The UK must now be resigned to the loss of these experts but, beyond that, the same experts that work within the headquarters must confront the difficulty of managing their day-to-day activities whilst planning for the move ahead.

Could you explain the role of medical communications department and its writers?

MAH: Overall, medical writers are in the same boat as all scientific writers – they have to translate science into language that is understandable by all, including lay audiences. At EMA, these audiences include patients, healthcare professionals and academia. It is really important to get out of the jargon while not diffusing the facts – that’s the balance that a medical writer always needs to keep: to be simple, but also accurate when talking about scientific and often very complex issues.

JGB: I think that the figure of the medical writer in the pharmaceutical industry is slightly different because they often work on dossiers for submission, while here at EMA we are focusing more on information for the general public. We concentrate on the clarity and the quality of the information. Over the years, this has contributed to transform the face of the agency, in the sense that we produce a lot of scientific output but we make sure it is understandable by the general public.

Is processing information and delivering it to the public the biggest challenge for the communications department?

JCB: I think one of the biggest challenges may be recognition and visibility of their work. This role requires very specific knowledge, experience and skills to understand the science and the assessment process itself – then you must be able to communicate this in a simple and clear way. It is not that this role is not recognised, it is simply not always visible. Another important challenge is to keep a balance between scientific accuracy and simplicity, and to keep the experts content with the final text. Of course, as soon as you simplify, you are stretching the accuracy of the scientific content. Finding this balance is not always easy.

Is there a tension then between the aim of the experts and those tasked with conveying it to the public?

MAH: It is a negotiation, in the end. Experts are normally very keen to cover every little aspect and element of research – or assessment in our case – while, for the general public, certain elements are not as valid or as easy to understand. What they need is ‘the bigger picture’, and what the communication actually means for them. The scientists and experts here focus on the science itself and build their arguments to decide whether a medicine or product should get a positive recommendation or not.

For us in medical communications, it’s, ‘what does specific information mean for the healthcare professional or the patient, and what is the reasoning behind it?’ However, there are different levels, even between patient information and healthcare professional information, because there’s a different level of knowledge in the audience. For instance, the patient could be less knowledgeable on a particular medical subject and more likely to be influenced by a range of sources, whereas a healthcare professional will have very specific knowledge at a higher level than the patient. You need to cater to these different audiences and that’s the most important skill for a medical writer. This includes not only the facts that we are reporting on – because the facts can never change – but the language in which you are writing. You cannot use the jargon that the experts use – you have to translate this and make it accessible to these audiences.

You mentioned that patients are more likely to be influenced by a range of sources – is the variety of information available to patients and the public making medical communications more complicated?

JCB: In a way, society is becoming addicted to information and we consume more information than ever. I think that people are receiving information from all angles and it’s a challenge for everyone.

MAH: There’s a certain type of detailed information that the patient is not interested in, such as all the ins-and-outs of certain regulations. What we need to show is that the regulations that control the products that patients consume to treat their disease is of high-quality, effective and safe – these are the most important things for the patients. They also need to know that the experts who are looking at these medicines are independent, are highly qualified, and are examining all the available evidence on a product. Whether they want to know how many committees there are, how they work together and how often they meet – I think they aren’t as interested in that.

How do you manage to engage the patients in the information you are communicating – is digital media now playing a large role in this?

MAH: I think, overall, this change in media is important at different levels. It is crucial for us to actually convey our message, but definitely also to engage more with our audiences. Social media, as you know, provides many platforms for engagement. We cannot stay apart because we are committed to transparency and we involve patients in our decision making. We consult them, listen to them and really take their views into consideration. We need platforms for that, and therefore social media is really important for us, but also for the patients themselves, and for the healthcare professionals.

Social media allows a person with a rare disease to find someone else who has the same disease, to exchange knowledge and personal experiences. They can also join forces to put pressure on companies to develop new treatments. On the other hand, there is also the flipside of social media as there is a huge amount of information but a lack of validation. The people who read certain information don’t know if the writer is a reliable source. As a regulator and authoritative source for medicines, we provide unbiased and reliable information on the medicines marketed in Europe. However, we have to compete with other sources of information – partly from companies, people who share their personal experiences, and from non-scientists. For instance, the so-called ‘anti-vaxxers’, who promote vaccine hesitancy based on articles with allegedly scientific results that have long since been debunked, amplify the wrong information through the internet. This can cause parents in Europe to not immunise their children against vaccine-preventable childhood diseases. This is something that we have to take into account. We try to counter these unreliable messages, but it is not easy when some of the ‘fake news sources’ have so many more resources than we do.

Who is supporting you in this role?

MAH: We rely a lot on the national competent authorities because we work within a regulatory network composed of the European Commission, the Member States and EMA. They have the capability to engage with their audiences in their native languages, which is something we don’t do to the same extent. Within the network, we try to make sure that consistent messages are shared across the whole system and can reach everyone who is interested in the information.

What is your plan for moving into social media in the future?

MAH: We are currently working on a social media strategy to see which channels to use more or which to use less or not at all. We’ve started to see a trend where there are mergers and acquisitions, which means that you need to be very selective when deciding where to put your resources. We are also in the situation where we will have to move, and so there are a lot of resources going into the preparation of moving to make sure our operations are not disrupted. We have to prepare a lot for that, even as far as thinking of data centres that will have to move. We also have a lot of extra communications to do because people are interested in knowing how the move will impact our work. There are a lot of question marks for ourselves – we are not involved in the process of the selection of the location of our new premises. Plus, so far we are not getting any new staff to deal with the extra work. This means that we have to focus on core business and prioritise work and resource allocation. This also means that tasks that are viewed as less important will have to wait.

JCB: The aim is to continue to ensure that operations remain as smooth as possible. We have a very clear mandate that we have to deliver. We have to make sure that everything is prepared in the system to cope with this move, and we are trying to streamline our operations to ensure that resources are also available for the move itself. In terms of information and communication, at the moment we need to continue our normal operations because once we evaluate a medicine, we have the obligation to communicate the outcome of such assessment. This is not something we are thinking of compromising – our core activities will have to continue. For now, it’s too early to know what will happen, so we just continue to deliver.

The move of the EMA headquarters will be a huge challenge. What will change and how do you plan to adapt?

MAH: I think what is clear is that we are going to relocate and we need to prepare for the worst case – the worst case, for us, is that the UK will become a so-called ‘third state’ as of 30 March, 2019. That’s what we need to prepare for – if things are different afterwards then it’s a little bit easier, but that’s where we are.

JCB: There is a clear direction that we need to continue to deliver, and that means fulfilling our mission to protect public health.

MAH: This cannot be disrupted. What is really interesting is that due to this big discussion – relocation, Brexit and so on – it becomes more visible how important regulation really is. The benefit to the patient and the European citizen is very clear in the case of EMA. There are many players who work together to actually ensure that medicine development continues unhampered. Medicines regulation is now becoming very visible and people are now taking much more interest in this.

JCB: Just to give you an example of the situation, a company wanting to market a new medicine in the EU via EMA has to apply for marketing authorisation. This process takes some time, and we cannot compromise this – we cannot put the evaluation on hold and say, ‘when we have relocated, we will continue’, as this would result in EU patients having later access to this new medicine. At the moment, we are working to ensure that there is no impact on the time needed to evaluate marketing authorisation applications. We are working to ensure that marketing authorisations applications, if successful, are evaluated on exactly the same timelines.

MAH: We are working to ensure we do not jeopardise patients’ health and that we continue to deliver our core activities. This needs preparation. We look at everything we do and remain focused on our core activities.

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