Development and execution of decisions
The Medicines Evaluation Board (MEB) is an independent administrative body. The MEB is supported by a secretariat: the Medicines Evaluation Board Agency (MEB Agency). The MEB Agency prepares and implements the MEB's decisions.
The MEB Agency deals with approximately 20,000 cases annually. The MEB is unable to take all the decisions itself.
Based on a decision's importance, the MEB has therefore stipulated in mandate regulations the level at which the preparations and the final decision-making for a case may take place, such as when a new active ingredient or a new indication is concerned. Approximately 5% of cases are discussed in this way with the chair or in an MEB meeting. Most of the 20,000 cases the MEB Agency receives annually are prepared and dealt with by the authorised officer.
The MEB's Authorisation and Signature Table states who is authorised to handle which decisions at the time of final decision-making: the case manager (authorised officer), the vice-secretary, the (second) secretary, or the chair/vice-chair.
The MEB holds a monthly plenary meeting as well as a monthly non-plenary meeting and further meets as often as necessary. At the meetings, the MEB takes decisions on the approval of medicinal products, the withdrawal, suspension or amendment of marketing authorisations, medicinal product monitoring, and the policy to be pursued.
During the MEB meeting:
- employees of the MEB Agency present the MEB with the dossiers they have evaluated, after which the MEB decides on granting new marketing authorisations, amending, suspending or withdrawing marketing authorisations, medicinal product monitoring, and policy.
- the MEB adopts positions on procedures being processed at the European level.
- current cases are discussed concerning medicinal products/monitoring, regulatory directives and developments in the national and EU medicinal products chain.
The MEB Agency's Executive Management is responsible for ensuring that the MEB Agency makes careful preparations for the MEB's decision-making and for ensuring that the MEB's decisions are properly implemented. The MEB's secretary – who is also director of the MEB Agency – is the contact person for this.
The MEB endeavours to take decisions by consensus. If this is not possible, votes are cast. The opinions and voting proportions are shown in the report.
The MEB publishes the reports of its meetings on its website, thereby keeping the public, health care professionals and stakeholders as fully informed as possible. The published report describes the recommendations, opinions and decisions adopted on the day of the meeting. The final decision on a medicinal product may differ from an opinion adopted by the MEB at an earlier stage.
The relevant passages in the report remain confidential until a decision on a procedure has been taken. The passages previously recorded are added to the report after a procedure or a case has been concluded. Commercially confidential information, for instance on production processes, and data which can be traced to individuals, such as personal and patient data, are never disclosed/published.
An overview is provided below of the control mechanisms that contribute to integrity and responsibility in decision-making and implementation:
The MEB’s performance of its duties is laid down by law
The MEB performs its duties on the basis of the Dutch Medicines Act. The General Administrative Law Act requires decisions passed by the MEB to have a statutory basis. This also applies to decision-making on matters such as granting marketing authorisation for a medicinal product as well as the policy to be pursued. Without a statutory basis decision-making is invalid.
The MEB’s internal organisation is governed by law, management regulations and mandate regulations
The MEB’s internal organisation is regulated in the Dutch Medicines Act, the management regulations and mandate regulations. The management regulations and the mandate regulations have been approved by the Minister.
The MEB's powers are jointly vested in all its members
The law, management regulations and mandate provide that all of the MEB's powers must be exercised jointly by all its members, unless the MEB has resolved that powers may also be exercised on the basis of a mandate. The decisions are decisions of the MEB.
The MEB may also take decisions outside meetings
The MEB has also mandated the chair to take decisions outside a meeting. This means that the MEB is always able to act quickly in the event of serious health risks arising.
Option for consultations with stakeholders
Two related levels of dialogue are recognised in the MEB's contacts:
- Discussions with representatives of marketing authorisation holders, consumers and patients, and physicians/pharmacists
- An advisory council and other advisory committees in which meetings are held about a given topic.
Each of these types of consultations contributes in its own way to responsible management and careful decision-making by the MEB.
Independent support in medicinal product monitoring following marketing authorisation
The MEB evaluates and monitors the efficacy and potential health risks of medicinal products throughout their entire life cycle. This ensures continual comprehensive evaluation and monitoring. Experts who are not directly responsible for the initial application for a medicinal product's authorisation provide support for the monitoring of adverse event, in order to guarantee the independent formation of an opinion, also after a medicinal product's authorisation.