EMA’s Dr. Hans-Georg Eichler

,,Regulatory Science has a huge importance. Regulation is essentially the space where science meets regulation. There is often a dispute of what shall take precedence. It is pretty clear that the law and regulation have to follow science, and not the other way around. Mother Nature doesn’t care much about regulations and legislation; she does as she pleases. And so, we have to follow biology, and have to follow science. Seen from that perspective, I would say that Regulatory Science should be the guiding star for regulatory actions that we all take.’’

Small country, impressive contribution

,,The MEB has done admirable work. That is largely due to their strategy of having a strong link with academia. I would say the MEB has been strong in all the disciplines of Regulatory Science. That is from the conceptual stage, coming up with new ideas, all the way to the stage of implementation into every day regulatory practice. This is a result of the MEB’s strong presence in the European Regulatory Network. And the MEB has also done a lot of work on impact-assessment: we implemented this intervention; now what has been the impact on public health? There is no doubt that the MEB makes a very relevant contribution to the European Regulatory Network. And given the fact that the Netherlands is a comparatively small country, this is an impressive contribution.‘’

Collaborate while maintaining various roles

,,The formal role that the EMA has is to provide coordination of the Member State expertise in terms of administrative, technical and scientific coordination. We have taken a very strong interest in Regulatory Science. That is why we have started or have contributed to a number of initiatives ourselves, like ENCePP*, many IMI** projects or Horizon 2020*** projects. Our role is to facilitate and catalyse collaboration across Europe and to help implementation of regulatory science findings.

I think it is hugely important to strengthen knowledge and competence between regulators, academia and industry. I understand that the collaboration on science projects and the collaborative space between academia and regulators is widely accepted. There is some hesitation by some groups, with regard to collaboration between regulators and industry, for the obvious reasons of a possible conflict of interest. I strongly believe that science is universal and we should collaborate, with clear processes that allow us to maintain our various roles and clear boundaries of responsibilities. I think what the MEB has done is quite admirable in the sense of how they act with dual contracts for some of their staff. There is a number of people who have a contract with the Dutch regulator and with academia. In the Netherlands, this seems to work well and it might be a useful model for other regulatory agencies.’’

Big shoes

,,I would describe the effort of Christine Gispen-de Wied (former MEB Scientific Programme Manager) and Bert Leufkens (former MEB Chairman) in building a programme and an infrastructure on Regulatory Science for the MEB as a complete success. Just look at the number of publications which have come out and the number of ideas they have developed and changes they have instigated. So, this is successful. And how do we all benefit from this? Knowledge and science is fortunately contagious. Someone comes up with a new idea, presents new data, etc. so that everybody can benefit from it. There is a direct and immediate benefit from these projects for the EMA and the entire European Network.

I have known Christine for at least ten years. And we have had many fruitful exchanges, we discussed projects and she and Bert Leufkens came up with many ideas for PhDs or other projects. We hosted people here from the MEB to do work in collaboration with the EMA. It has been a long and fruitful relationship. I would like to say to Christine: job well done and big shoes to fill for her successor. Of course, she is leaving a gap. Clearly, there will be a next generation to fill that gap. Given the great environment, which Christine has helped establish, it will be exciting to witness what that generation will bring.’’

Key topics: real world data, quality and patient voice

,,I would argue that Regulatory Science is a broad spectrum of scientific sub-disciplines. But if you ask me what are the key topics that will keep us busy over the next years, I would venture to name a few.

The obvious one I think that everybody talks about is: how can we glean useful information for regulation from what is widely called ‘real world data’. How can we integrate information of the data that come out of everyday clinical practice, be it insurance claims, be it electronic health records, other data? How can we put that to use to enable robust regulatory decisions? This is a challenge on the technical, on the legal, and on the scientific methodology level.

We are seeing new challenges with advanced therapy medicinal products, gene products and cell based products, that are not as comparatively simple as the small drugs of old. So, there we have many challenges how to ensure the quality and consistency of these products. That is a new -I would almost say- discipline or subdiscipline within Regulatory Science that has been coming to the fore over the past five or ten years.

A very different emergent domain of Regulatory Science is how we deal with the patient voice. Can we quantify and incorporate patient preferences into the regulatory decision-making? How are patients willing to trade benefits for harms? Are patients willing to accept a given level of uncertainty? These are not trivial challenges and I think we are only at the starting point of a learning curve on how to handle this new input.’’

The Brexit effect

,,Given the Brexit situation right now, and that we will likely lose a considerable volume of expertise as the UK will leave us, I think it is very important that the Member States will hopefully pick up and rise to the task and see that the European network will not suffer.

We cannot predict at this stage what exactly will be the relationship between the EMA and the European Regulatory Network on the one hand and the UK on the other hand. This is a subject of debates to come in the near future. What is not in doubt, is that the UK has made a major contribution to the European network, and to the workings of the European Regulatory System. So, if that falls away, others will have to pick up. We would hope that the European Member States, all 27, will rise to the challenge, including the Netherlands.’’

*Coordinated by the EMA, the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) brings together expertise and resources in pharmacoepidemiology and pharmacovigilance across Europe.

**Innovative Medicines Initiative (IMI) Research projects: A Public-Private Partnership (PPP) involving the pharmaceutical industry represented by the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the European Commission.

***Horizon 2020: The EU Research and Innovation programme for 2014-2020.