MEB and Dutch Heart Foundation to collaborate on making medicines available to the patient more quickly
Scientific advice from the MEB improves and speeds up the development of medicines
The Medicines Evaluation Board (MEB) is going to collaborate with the Heart Foundation. This collaboration is intended to advance the development of medicines and to make these new medicines available to the patient more quickly and easily.
Due to unfamiliarity with the regulations on the granting of authorisation for medicines, the translation and development of research into medicines can sometimes be unnecessarily slow. This means that new medicines reach the patient much later, or sometimes not at all. This process could be speeded up if the MEB, with its correct and up-to-date knowledge, were to give scientific advice at an early stage. This collaboration means that researchers at the Heart Foundation will receive advice on the optimal applicability and the feasibility of the research.
MEB chairman Prof. Ton de Boer explains: “Larger companies are familiar with the regulations on the granting of authorisation for medicines. But new medicines are often developed by academic centres or small pharmaceutical companies and they often do not know the regulations. This means that research into medicines often has to be repeated unnecessarily, or that the medicines do not reach the clinic. Research into medicines could be speeded up if these parties were more familiar with the medicines authorities such as the MEB. Ultimately, it benefits the patient.”
Floris Italianer, Director of the Heart Foundation, adds: “The financing of outstanding scientific research is one of the most important activities in our quest to trace cardiovascular diseases at an earlier stage, and to be able to improve treatment. We are focusing on translating the results of research to the clinic or health care practice as quickly as possible; we want people with cardiovascular disease to receive the best possible treatment. This is the reason that since 2016 it has been obligatory for our researchers to work with a committee of users. They advise on how research results can be practically applied to the patient as quickly as possible. The collaboration with the MEB is the next step in this process. The MEB’s advice enables our researchers to design their research in an even more goal-oriented and efficient way."
Customised scientific advice
In order to promote renewal and fast access to medicines, in 2015 the MEB began a pilot to provide customised scientific advice. This is a low-threshold form of advising that is aimed at start-up companies. These are small businesses and academic groups that work on the development of medicines. However, requests for customised advice concerning the development of innovative medicines, the marketing authorisation of medicines that are used off-label and the authorisation of a new use for an existing medicines (Drug Rediscovery) are also granted. In general, the advice will primarily concern the early phase of development (i.e. pharmaceutical or pre-clinical aspects, phase 1 clinical research). In addition, the MEB offers the opportunity of providing organisation-wide advice together with the National Health Care Institute and/or the Central Committee on Research Involving Human Subjects (CCMO). This gives parties the opportunity to sit down at the table with all governmental partners involved in the development of medicines.