Assessing a medicine
When a new medicine is offered to the European Medicines Agency (EMA), two countries within the CHMP are designated to assess the drug, Hans explains. "One country is appointed rapporteur and the other co-rapporteur. These countries take the lead in the whole evaluation process. If the Netherlands operates as rapporteur, the Dutch Medicines Evaluation Board will assess the product and write an assessment report. This report and that of the co-rapporteur is shared with member states, for them to comment on. The CHMP takes into account all the comments and then decides if the balance between the efficacy and the harmful effect of the medicine turns out to be positive or negative. If everyone or the majority argues that the efficacy outweighs the harmful effects we will issue a positive recommendation to the European Commission, if not, the recommendation will be to not grant the medicine access to the European Market.”
The European Medicines Agency has several committees for the registration of all types of medicinal products. "They all give advice to the CHMP. For example, the PRAC is the committee that deals with risks and side effects. We discuss and decide on our recommendation to the European Commission with all these side reports in mind. The CHMP is therefore the final element in the decision-making process for these committees.”
The role of the European Medicines Agency
Hans: “The European Medicines Agency facilitates and safeguards this process. The agency does not take part in the decision making, but creates the optimal environment for it.”
Harmonization of medicines
The CHMP also ensures harmonization of medicines that are already available in Europe. Hans explains what this entails: "Harmonization is important for the safe use medicines. The various European countries used to have their own regulations and market allocations. As a consequence medicines, their prescription and package leaflets could differ from one country to another. The CHMP tries to put an end to that by coming to an agreement between member states.”
CHMP and pharmaceuticals manufacturer
When a medicine is being developed the CHMP provides scientific advice for manufacturers. "We inform them how to optimalize the development process of a medicine in order to create a better way of demonstrating that a drug actually works. This advice may relate to the scientific content of the dossier and/or the application procedure to be followed.” Hans explains that the CHMP partly manages special working groups for this purpose.
Hans concludes by telling us what he likes about his work at the CHMP: "You make a concrete positive contribution to medicine and you indirectly improve the life of a patient."
Want to read more? Click here for an interview with Frank Verheijen and Emiel van Galen of the Dutch Medicines Evaluation Board about their relationship with EMA.