The MEB is halfway through the implementation of its Strategic Business Plan 2014-2018. The objectives in the area of patient-oriented evaluation have become an increasingly permanent part of the MEB’s day-to-day activities, as has the promotion of proper use of medicines and innovation. In 2016, the MEB invested heavily in cooperation with Dutch national practice and within the European network.
Cooperation with practice
Research conducted by NIVEL and initiated by the MEB showed that patients need easy-to-understand and accessible information about medicines, tailored to the individual patient. The official scientific product information and the patient information leaflet are regarded as the reliable source of information about medicines. The research paved the way for an improvement in the provision of information to patients.
The MEB also worked on improving the provision of information to patients in other ways. In 2016, marketing authorisation holders were asked to always mention the expiry date after opening on the labelling of OTC medicines.
The streamlining of information about medicines to prescribers continued with a new cooperation agreement between the MEB, Lareb, the National Health Care Institute, the Institute for Responsible Use of Medicines (IVM) and the Dutch Medicines Bulletin (Geneesmiddelenbulletin). The inclusion of news reports with safety information from organisations including the MEB (such as DHPCs) in the Pharmacotherapeutic Compass was secured in 2016. Users of the MEB Medicines Information Bank were also asked about their wishes. This can now be followed up.
The involvement of patient organisations became part of the primary assessment work of the MEB in 2016. More input on regulatory guidelines is requested on a regular basis. The interaction with doctors’ organisations was further defined through the MEB’s contributions to treatment guidelines. These contributions were incorporated in 9 NHG guidelines in 2016.
The MEB values the collaborations effected with NIVEL, IKNL and Santeon enabling the use of their databases with usage data for assessments. The Ministry of Health, Welfare and Sport has taken on a coordinative role with regard to registries. The MEB contributes in every possible way, such as more scientific research on registries.
EU Presidency
The Netherlands held the presidency of the European Council during the first half of 2016. An important theme for the MEB was to make new medicines available to patients efficiently and responsibly. The MEB focused on the early involvement of all stakeholders and responsible handling of uncertainties. In specific situations it is possible to issue a (provisional) marketing authorisation while the furnishing of proof still involves a high degree of uncertainty. This is subject to clear agreements on the generation of additional data after registration. Fitting in with this, the MEB will provide the chairman of the EMA with the task force on registries.
Under the Netherlands’ EU presidency, ‘Innovation and access to new medicines’ was included by the Heads of Medicines Agencies (HMA) as one of the priorities in the Multi-Annual Working Plan (MAWP). To consider this further, the ‘Task force on early access’ and the ‘Task force on big data’ were established and the Innovation Network was reviewed. The MEB participates in all of these groups. Furthermore, the MEB initiated the establishment of the Regulatory Optimisation Group in cooperation with the Health Products Regulatory Authority (HPRA).
Concrete steps were also taken with regard to two other EU presidency priority themes; the results were incorporated in plans laid down at European level. With regard to antimicrobial resistance, European agreements were made on availability and proper use of existing medicines (for both human and veterinary use) and on the development of new products.
The theme medicine shortages (human and veterinary use) was discussed on several occasions, including the HMA stakeholder meeting with pharmaceutical companies. In addition, the Task force on the Availability of Authorised Medicines for Human and Veterinary Use was established as one of the priorities in the MAWP.
