European Medicines Agency: Breaking Down the Firewalls between the Regulator and Payer Communities

Hans-Georg Eichler, Senior Medical Officer at the European Medicines Agency (EMA), joins Pharma IQ to discuss the potential impact of the pharmaco-vigilance legislation, and the top priorities of the EMA over the next 12 months. To watch the full video interview go to European Medicines Agency's Hans-Georg Eichler: Top Priorities to 2015

Pharma IQ: What are the most important upcoming legislations and trends that the agency will face in this year and the coming years?

First and foremost I would cite the pharmacovigilance legislation, which will have a significant impact on the way we look at drugs. What is behind that is we have learned, over time, that the growth curve of knowledge on a drug doesn’t stop at the time when we licence it, and we have successfully moved, in the past, from passive pharmacovigilance to active pharmaco-vigilance. We have successfully put in place risk management plans, and the next logical step in the evolution of looking at post-licensing safety, but also efficacy of drugs, is the pharmaco-vigilance legislation, which will give us, the regulators, together with the industry, a stronger role to look into the real-life effectiveness of drugs. How does a drug pan out once it reaches the market? What do we observe in terms of its effectiveness, which is real life as opposed to efficacy which is clinical trials? And how does it perform in terms of safety. That is clearly the top.

I would also cite in that context, still, the paediatric legislation. While it is not entirely new - it’s been enacted a few years ago – we are still on a learning curve and it has been successfully implemented but we are now refining it. We are doing this, together with the industry, to see how can we best apply this new tool in practice.

Pharma IQ: What are the EMA’s top priorities in the next 12 months?

There are several, and we have laid them out in a document that we call the Roadmap to 2015. I would cite, as a top priority, our way of doing benefit-risk assessment. This is the core business of any regulatory agency. We have to balance, in the interest of patients, the benefits that they would hopefully reap and the risks that a patient could incur and we have been doing this, with some success, for the past decade since drug regulatory agencies were created. But we do recognise that perhaps there are better ways to do it: ways where we could more formally look at what are the benefits, what are the weights and the importance of benefits, what are the risks, and what is the importance of risks in the eye of a patient? So that is what we are currently exploring, and we’re hoping to complete a long-term project by the end of next year.

Absolutely. I would say one of the key developments that has happened within the EMA was that we have torn down the firewalls between ourselves, the regulatory community, and the payers’ community. You need to understand that Europe is characterised by universal solidarity-based healthcare systems. So we face payers of healthcare who will be looking at the drugs that we have authorised, and they will reassess them.

It is important for all stakeholders - patients, but also industry - that we share a common view of the merits and the value of a drug. When I say value, I do not mean financial value because we as regulators don’t look at economics and financial value. But we need to speak a common language between regulators and payers about, for example, what is an appropriate end-point in a clinical trial. How do you way a certain risk versus a certain benefit? And we have started this dialogue. We have engaged with the payers. We are now dispensing joint scientific advice to industry to enable them to design a drug development programme that will meet the information needs of both the regulators and the payers at the same time. And we’re now starting a dialogue on the evidentiary standards that our two communities have with a view to harmonising those.

Interview conducted by Andrea Charles.

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