What contributions are the Eastern and Central
European Member States making to the European Medicines Regulatory
Network (EMRN)?
This was the topic of the first session of the
Fifth Annual TOPRA Annual Symposium in Budapest which opened
yesterday. Professor Tamas Paal, current President of the Országos
Gyógyszerészeti Intézet (National Institute of Pharmacy) Operative
Board and former Director General, spoke candidly and directly
of the many pressures on National Medicines Authorities.
He stated
that they were always expected to have answers for politicians,
media and the Courts. Regulators are always expected to take
responsibility for the medicines used in the country, regardless
of what process by which they are approved or where the decision
was taken (CHMP, RMS, etc.).
Prof. Paal briefly commented upon
the strengths of the current system—namely the opportunity to
participate in international working groups and the Heads of Medicines
Agencies work. However he used most of his presentation to challenge
the conventional wisdom—he looked at the downsides of the integration
of processes across the EU and raised number of truly confounding
questions. For instance, what value to health outcomes does the
irrationally high increase of applications offer? Why are there
so many processes and possible routes by which a single compound
can achieve authorisation or extension? And finally, why in recent
years have we seen a dramatic increase in the number of graduates
who are managing processes instead of undertaking scientific
evaluation? These questions are ones for which the current framework
offers few answers. However, according to Prof. Paal, more thinking
needs to be done to mitigate these worrying trends of the current
arrangements. Failure to do so poses serious risk to both the
legitimacy of the overall system and public health, though, on
balance, he still sees that the pros sill outweigh the cons.
Dr.
Kristen Raudsepp, Director General of Ravimiamet (State Agency
for Medicine in Estonia), offered her views as the head of the
Agency in one of the EU’s smallest states. She discussed the
alignment of resources and motivations in agencies across the EU.
She portrayed three kinds of agencies—those with the resources
and motivation to participate; those with no resources but the
motivation; and those with resources but no motivation to make
a difference. She said that this is demonstrated by data on started
procedures in 2007/8. Of 30 potential agencies, only 12 were a
Reference Member State, with the majority doing no Mutual Recognition
Procedure or Decentralised Procedures at all. Despite having a
budget of only €2.5 million and 85 staff in total, her agency
continues to be very active, contributing where possible. Why is
it, she asked, that with more Member States now than before, resource
is a bigger issue than ever before? More Member States and the
nature of the procedures themselves should lessen workload, not
make it more burdensome.
Dr. Raudsepp advocated that the rules
be urgently reconsidered—they create unintended outcomes where
the hardest working competent authorities attract more work and
this discourages potential contributions from new participants.
Other presenters offered an industry perspective, finding their
own flaws in the current arrangements.
In concluding the session,
Prof. Paal stated that this had not been a negative session—rather
presenters offered a critical evaluation of a system that goes
some way to achieve its aims, but needs to be further refined
to make for more manageable workloads for agencies and, ultimately,
better outcomes for everyone
in the future.
The Symposium continues through Wednesday.
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