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.