Brexit And Cooperation: Insights From Danish Medicines Agency Head Thomas Senderovitz
Executive Summary
It was inevitable that Brexit would be the key theme of an interview with Danish Medicines Agency head Thomas Senderovitz earlier this year. The senior European regulator oversees one of the agencies that has taken on new staff to help deal with the impact, in drug regulatory terms, of the vote by the UK in June 2016 to leave the European Union. Senderovitz also chairs the management group of the EU Heads of Medicines Agencies network.
These are important times for European collaboration, says Thomas Senderovitz, head of the Danish Medicines Agency. On a macro level, the whole of the EU is being challenged, “amplified by Brexit,” and on a micro level, Brexit is causing a huge shift in dynamics and in the ability to deliver, he explains.
The situation regarding Brexit is extremely fluid and it is impossible to say what the UK’s future relationship with the EU will be when the country leaves the trading bloc on March 29, 2019. The same applies to the future relationship of the UK agency, the MHRA, with the EU pharmaceutical regulatory network. Among other things, Senderovitz talked about the preparations that two pillars of that network – the European Medicines Agency and the national competent authorities (NCAs) in the remaining 27 EU member states – are making for life without the UK.
Danish Medicines Agency head Thomas Senderovitz
Pink Sheet executive editor Maureen Kenny interviewed Danish Medicines Agency head Thomas Senderovitz soon after he was named chair of the management group of the EU Heads of Medicines Agencies network. Senderovitz talked about Brexit and his plans to make the HMA more effective. The following is a series of excerpts from the articles published in Pink Sheet following the interview.
Here’s some of what he had to say:
“We simply had to plan for a worst-case scenario. We were obliged [to do so] for the sake of our patients. We couldn’t just sit idle and say it may end up in a soft Brexit. It’s worse to have not prepared than to have over-prepared... It won’t be perfect on Day 1. I’m not saying it’s good, but if it goes to a hard Brexit, the MHRA will not be able to work on behalf of the EMA and the remaining 27 will be able to handle that for sure.”
“There will be challenges and it won’t be perfect, but we’ll manage... Will we lose something? For sure we will and it will take time to build up, but we are not going to be in a bad shape.”
Relocating Responsibilities
At EMA level, the agency has completed the reallocation to the EU27 member states of more than 370 centrally authorized drugs for which the UK was rapporteur or co-rapporteur, although the new rapporteurs and co-rapporteurs will only take full responsibility for the products at the end of March 2019. The MHRA still participates in EMA activities and will continue to do so until the UK withdraws from the EU, but UK representatives are no longer taking on any new rapporteurships or co-rapporteurships relating to the evaluation of new drug applications.
At the member state level, national agencies are having to take over from the UK the role of reference member state for thousands of products approved via the EU’s decentralized or mutual recognition procedures. Senderovitz says a significant number of national agencies, including his own, have taken on additional staff and invested additional resources to enable them to take on some of the work for which the UK was previously responsible. Some agencies have done what Senderovitz calls an “admirable job in staffing up.”
“We don’t have de facto numbers for what everyone has actually done… but we looked at what everyone was planning to do. And while to a certain extent it’s not clear yet whether everyone delivered, we could see from the plan that we would end up with numbers that could make up for the [withdrawal] of the MHRA.”
Capacity is one thing, but what about levels of expertise? “We will improve our expertise,” says Senderovitz. In terms of sheer numbers, though, he is in no doubt. “If you start adding up across the EU, we do not have a capacity issue.”
Soft Brexit Situation
What would happen if there is a soft Brexit and, ultimately, close regulatory alignment and the UK remains – or becomes again, depending on the timing – a part of the network?
“Let me be very frank. Everyone would have liked to be without Brexit. As a regulator, I would absolutely think it would be to everyone’s benefit if the UK could be deeply involved and remain in the collaboration... But there would have to be a changed balance. Many agencies including my own have significantly increased our staffing. It wouldn’t be fair if I had to go out and let people go because the UK now ends up being in the network. We’d have to find a way of solving that.”
“I am not talking for EMA, but if [the UK is] going to be engaged... then my view would be that the UK agencies would have to accept that they can’t have the same amount of work as before. It simply can’t happen... If we had to stop and rewind everything it would be a big challenge. It would require some interesting talks so let’s see what happens.”
Are national agencies doing enough to prepare for Brexit? “I have to assume people are doing everything they can,” Senderovitz says. But there is a caveat. They’re doing it, he says, “within the framework and with the resources they have.”
Bringing Smaller Countries Into The Fold
Senderovitz is a member of the EMA management board and was on the preparedness group at the EMA that designed the algorithms for how the UK portfolio would be distributed. There was, he says, “a really good debate” on how to bring more smaller countries more into the fold.
The challenge when redistributing the work was, and still is, “not to replace one UK with another UK,” but to spread that work more broadly and get more of the smaller countries “also activated and inside the process.”
“We were quite strong on how we should make sure that smaller countries who hadn’t had many rapporteurships would also be involved, maybe for simpler assessments, like generic assessment, which wouldn’t require a full-scale set-up like you’d need for a complex assessment,” Senderovitz notes.
A new balance perhaps, but only to a certain degree. Some countries will still be bigger and the bigger countries to a large extent will take on more of the newly available work than their smaller counterparts. “It’s not wrong, it’s a fact of life. It would be a surprise if they didn’t move to strengthen their position,” he says.
Becoming more involved is one thing, but Senderovitz says it is naïve to expect that scientific expertise will ever be spread equally across the member states. “Let’s be clear. You will never have small countries with the same ability to build expertise like Germany, for instance. It’s never going to happen. Let’s not fool ourselves that we’ll have exact same distribution across every member state. I don’t even think that’s a smart idea.” It makes more sense, he says, to work towards there being more clusters of regulatory excellence than to try to build “a full-scale set of expertise” in every single country across Europe.
Specialization is already happening to a certain extent. No single country can master all areas or will have access to all expertise and all necessary data, Senderovitz says. “Even the big countries… can’t do everything by themselves. Even the US Food and Drug Administration cannot solve everything by itself.”
Making more of the HMA
Senderovitz took on the role of chair of the HMA management group in March 2018. Among other things, he thinks group could do a better job of supporting the network of EU NCA heads that the management group co-ordinates and oversees, with a view to making it more effective and efficient.
The EU NCAs have an “immense responsibility towards patients in Europe and beyond” to make sure they have the best possible network, he says. For that to happen, Senderovitz believes that “first and foremost we need to look at the very raison d’être of the management group and permanent secretariat [to ensure] we facilitate HMA as an institution to the best possible extent.”
More broadly, the HMA network as whole needs to ask itself some fundamental questions. Are we on the right track? Is our vision the right vision? Are we too ambitious? Are we under ambitious? Do we try take on too much? Who are our stakeholders? Are we able to achieve what we set out to deliver?
The Danish agency head notes the complexity of the make-up of the EU medicines regulatory network. There is the European Commission, the EMA, “which depends so much on the expertise of the member states,” and the NCAs, “each of us with our national hat on, if you may, with different agendas, different priorities, different political set-ups and different cultures.”
The HMA works well but there is room for improvement, Senderovitz says.
“I don’t want to go into detail here, but I do think we run the risk of wanting to achieve too much and solve all the problems of the world and at the end of the day we might solve none. I’m exaggerating here but it’s the same for anyone working with a strategy… everything seems meaningful but possibly we don’t have the bandwidth to solve everything. We have to be very clear on how we achieve what we have to achieve and then on which other points [we will have to say] we can’t solve these, at least not in the form of HMA, as one organization.”
Senderovitz notes the huge shifts taking place in areas such as science and technology. It was, he accepts, a challenge for regulators to keep up with scientific advances such as CAR T-cell therapies and CRISPR gene editing technology. At the same time, he observes, there are other big, important themes that are not limited to innovations in science. These include availability of medicines across the European network, substandard and falsified medicines – “which is increasingly challenging us” – and cybersecurity. “I wanted to bring to the table [the idea that] we need to work very hard to find common ground amongst all the member states and to take care of this very important collaboration and make sure it’s ready for the future.”
The EMA cannot solve it all by itself, Senderovitz says, particularly not now when it’s struggling to cope with the huge changes brought about by the UK’s decision to leave the EU.
The EMA expects to lose at least a third of its 900 or so employees as result of its forced relocation from London to Amsterdam when the UK withdraws from the EU at the end of March 2019. The agency is having to divert considerable resources to enable it to focus on addressing the implications of Brexit and the move. To safeguard its core activities relating to drug evaluation and oversight, the EMA has been forced to scale back many of its non-core activities.
“We have to get this to work together,” he says. “I feel an obligation and I also feel a passion for it.” Senderovitz stresses the “completely voluntary and non-binding” nature of the HMA. There’s no formal obligation to work together but “we all think it’s very important we can act and speak on certain areas as one. In other situations, we can’t speak as one. It’s about finding the common ground,” he emphasizes.
At HMA level, he’s clear that more focus is needed:
“If we have big strategies and fine thoughts, we need to be able to execute them. If we decide we want to go in a particular direction, we need to be able to deliver... We’re definitely going to be much clearer, more transparent and more focused.”
“Even smaller countries with fewer resources should feel empowered and engaged as well. How do we do that? I don’t have all the answers but I for sure have questions.”
Turning to the question of stakeholders, Senderovitz says an official stakeholder strategy is required. “You can’t really work as a regulatory system if you don’t have deep, deep collaboration with and listen to stakeholders. I think we can do better.”
This article is part of the Outlook 2019 series – an annual collection provided exclusively to subscribers of Informa Pharma Intelligence publications.
Other articles in this series with Thomas Senderovitz: