network

In its strategic business plan for 2005–2009 the Medicines Evaluation Board sets out a clear and ambitious goal:

“In the coming years, the MEB aims to maintain its position as one of the top 5 EU medicines agencies.”

In this way the MEB links its operations to a strong position in the Netherlands and in Europe. It aims to further develop into a truly authoritative centre of excellence for medicinal products. To achieve this goal, the MEB has concentrated more attention than hitherto on a number of specific areas of special interest and has forged alliances with universities and other centres of expertise in these areas.

Dutch network
The MEB has a collaborative agreement with the Pharmacoepidemiology Department of Utrecht University (UU) in the field of pharmacovigilance and aims to extend this alliance to include the universities of Rotterdam (Erasmus MC) and Groningen (UMCG). On the basis of this collaboration, the MEB now plays a prominent role within Europe in the assessment of risk management plans (RMPs) for medicinal products.

In the field of oncology the Board has for some time been cooperating with the Dutch Cancer Institute (NKI) in Amsterdam, while collaborative agreements have been concluded with diabetes centres at the VU University Medical Centre in Amsterdam and St Radboud UMC in Nijmegen.

Collaborations are being discussed with Utrecht University in the fields of psychiatry, neurology and vaccines. To strengthen the assessment of medicinal products for children, the MEB has set up a group of specialists in paediatric medicine.
This alliance is stimulating a fruitful exchange of information and knowledge between the organisations, allowing for an even better assessment of the balance between the risks and efficacy of medicinal products.

In addition, many of the clinical assessors are also working as specialists at a university hospital, meaning that their knowledge and personal networks remain up-to-date.

European network
The European system for the marketing authorisation of medicinal products is unique in the world. In the year under review, the European Union still consisted of 25 Member States. In 2007 there will be 27, each with its own experience, medical culture and expertise. In order to consolidate these resources as far as possible, the regulatory authorities have built up a network comprising the competent authorities of all EU Member States, which receives assistance and support from the European Medicines Agency (EMEA). Thanks to this network, national regulatory authorities are able to share the workload and exploit each others’ expertise to the full.

Patient and consumer organisations
The MEB maintains contact with consumers/patients through patient and consumer organisations. The MEB has been organising six-monthly meetings with patient and consumer organisations twice a year since 2004 at which information is exchanged and discussions held. These organisations greatly appreciate being kept up to date on information about new developments in medicines. For the MEB this exchange is important because the contact with the organisations provides a good insight into the use of medicines. Topics of discussion include the package leaflet, repeat prescriptions, over-the-counter medicines (medicines available without a prescription) and medicines for children. Reports of this meeting can be found in the news section and in documents of meetings with patient organisations.

Co-ordination group for Mutual recognition and Decentralised procedures (CMD)
Within the network, the marketing authorisation agencies cooperate in several different ways. Via the Co-ordination group for Mutual recognition and Decentralised procedures (CMD human/veterinary) the nationally responsible agencies cooperate in assessing medicinal products. Ms Truus Janse-de Hoog is, on behalf of the Netherlands, chair of CMD (human) and Ms Sandra Kruger is a member. For the centralised procedure, medicinal products are assessed by the European scientific committee (CHMP/CVMP). Within this committee, the reporter and co-reporter coordinate the nationally available expertise for a European assessment. EMeA primarily has a supportive role in this area. On behalf of the Netherlands, Dr Barbara van Zwieten is a member of CHMP, and Prof. Pieter de Graeff is an acting member.

Committee for Orphan Medicinal Products (COMP)
The Committee for Orphan Medicinal Products (COMP) operates in a similar manner. Each country is also represented by a member in the group, who, together with the coordinator from EMeA is responsible for assessing whether a certain product can be awarded the status orphan medicinal product. Dr Bettie Voordouw is, on behalf of the Netherlands, a member of COMP.

Scientific Advice Working Party (SAWP)
As Members of the Scientific Advice Working Party (SAWP) are chosen on the basis of expertise. Not all 27 EU countries are represented, Dr Christine Gispen-de Wied and Dr Hans Ovelgönne are the Dutch members of the SAWP. 

No agency has all of the requisite expertise in-house and few regulatory authorities can provide the highly specialised knowledge that is needed in order to resolve every problem directly. However, the European network ensures that the available knowledge is consolidated, and that each Member State makes its own contribution. The Netherlands plays an important role in Europe by actively participating in the network and through its efforts on many committees. The Netherlands is also represented on the Pharmacovigilance Working Party, the Quality Working Party and the Safety Working Party. 

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