Where does all this data from medicines come from?
"Licence holders are required to provide us with various types of information. For example, they must enter adverse drug reaction data into a European database (Eudravigilance). So we have a huge amount of data. This information is provided by patients or doctors and can range from headaches to very serious liver problems. We call this spontaneous reporting. This information is then shared with national authorities such as the Medicines Evaluation Board or with pharmaceutical companies. These data are all entered in Eudravigilance and are constantly analyzed and monitored. In addition, pharmaceutical companies are required to submit files in which they provide an overview of what has happened to their product over a certain period of time. This is called a periodic safety update report. How often a report like this must be submitted depends on how long the product has been on the market. For example, if the product has only been on the market for a short time, the manufacturer must provide an overview every six months. We assess these files. We also evaluate risk management plans in which pharmaceutical companies indicate how they may carry out further research and in which way they try to minimize risks.”
What is the role of the European Medicines Agency?
"You need a lot of data for pharmacovigilance. When you cooperate within Europe you can coordinate this, but to do this properly, you need good administrative and scientific support. This is where EMA comes in, because this organization monitors these periodic safety update reports. EMA ensures that the European database is up-to-date and easily accessible to everyone. Once a medicine is centrally registered, it has access to the entire European market. It is therefore very important to have an organization that coordinates this. For example, if a package leaflet text needs to be changed, EMA ensures that this is done immediately throughout Europe. Another example is that EMA coordinates scientific research that has to be done by several pharmaceutical companies. We recently concluded an important procedure whereby more than 400 companies had the same medicine in their product package. It is very difficult if all these companies have to do a joint study. In such a situation, EMA can carry out such a study.”
What do you think about EMA coming to the Netherlands?
"Mixed feelings. On the one hand, I am proud of it. I think it is very good for the Netherlands. We are giving a huge boost to developments in the pharmaceutical industry. Of course it is easier for me to go to Amsterdam for a meeting than to travel to London. On the other hand, I think it's a big change for the people who work for EMA. They have to change their lives and move to another country. That must not always be easy to do.”
Read also the interview with Frank Verheijen and Emiel van Galen about their relationship with EMA. Frank and Emiel work at the Medicines Evaluation Board.