Regulatory Science: investing in the quality of our work

Our mission is to provide scientifically sound assessments of medicines. We are continuously evaluating our assessment methods in order to ensure that we can continue to carry out our mission in the future.

To do so, we need to have the relevant scientific knowledge in house. That is not something that every regulatory authority has, but we made a conscious decision to have this knowledge in house. This does not always have to provide immediate results. It is primarily a strategic choice.

Different rationale

At almost every board meeting, we discuss one or two dossiers where we ask ourselves whether the rationale and arguments brought forward are acceptable and for which the standard statistics do not work. We deal with ‘Personalised Medicines’, i.e. targeted medicines  through genetic testing. But the groups on which these are tested are becoming increasingly smaller. And if you can predict whether something works, does it still make sense to work with control groups? Is it ethically correct to withhold a treatment from a group of persons? This forces us to reflect more deeply on such matters. This is also the case of the information uncontained in the SmPc, for example in the area of Gender Specific Pharmacology.

By far, most of the medicines used in the Netherlands are generic medicines. There can be as many as 30 to 40 generic versions available for a particular medicinal product. Are they all biologically equivalent to each other and can they simply be substituted without any further consideration? The Regulatory Science Programme has researched this matter. As it turns out, this is possible in most cases. This information is very relevant for patients who, temporarily or for a longer period of time, do not have access to their medicine or, for whatever reason, are switched from one generic medicine to another.

A new reality

With Regulatory Science, we search for responsible methods to deal with the new reality, such as ‘Real World Data’. We are used to work with data and we carry out clinical research within the framework of all the relevant rules and regulations. But the patient may at times find other things important, and that information is becoming more freely available. That is also true of ‘Big data’. In the future, our information will expand, for example with heart rate and blood pressure. This is generated by devices such as smart phones and watches or other sources that we have not yet used in our work. That can provide medically relevant information from a huge group of people. The added value of the Science Programme consists of researching which qualified methods exist or are needed to meet the challenges of the future in a structured and sound manner, and how we at the MEB can weigh various arguments and considerations in this regard. And in doing so, we involve all the parties concerned, including the persons carrying out the treatments as well as the patients being treated.

Science is not bounded by national borders

Many of our PhD candidates are involved in the latest developments at the EMA. But science is not bounded by the national borders in Europe or by Europe itself. The topics are universal in nature. The Netherlands plays an active role and is looking to collaborate with other countries that do the same. But the group of active players is rather small. The University of Utrecht is an authority in this area, and we collaborate very closely with them. It’s of critical importance to maintain links to scientific organisations in the world and to know what is happening in the world around us. You need to know who is doing what, where the blind spots are located and what should be given priority.