POLICY & REGULATION
In its pilot, the EMEA will retain the a couple of years we will see a lot more of a lot of questions to be looked at, and based
emphasis on qualitative assessments but will these applications”, Mr Lönngren says. “This is on this we need to come up with some
also test out some quantitative evaluation one issue in our 2009 work programme.” new models.” The medical devices angle is
tools that could make decisions both more
an interesting one, because there have been
predictable and consistent with previous
growing workload a problem
suggestions that the European Commission
evaluations. This would allow industry and
These new responsibilities will only add to the
is looking at eventually having a single drug
assessors to hold more objective discussions
agency’s growing workload, which has already
and medical device agency for the EU. The
on the benefi t-risks of drugs.
been identifi ed as a problem. For example, in
commission has consulted on the revision
This will not necessarily be easy, says
recent years, the proliferation of committees
of the medical devices legislation and is now
Mr Lönngren. “Some people say that
has been putting an increasing strain on both
its own capacities and the ability of member
thinking about what proposals to make,
quantifi cation is diffi cult.” People within the
state agencies to spare enough staff to sit on
says Mr Lönngren, although he says, “I don’t
EMEA? “Well, there are different views on
all these bodies.
have any specifi c comment on this at the
this. We need to do a lot of research, and
As well as the committee that came
moment.”
see if we can come up with a concept that
with the paediatric regulation in 2007, the So how does he see the structure of the
could be useful. It could help to take decisions
EMEA will have a new advanced therapies agency and the EU regulatory system in a
about benefi t and risk, because you can easily
committee (CAT) in place from the start few years’ time? “I think we can work with
identify the parameters where there are
of 2009. And the European Commission
the existing architecture for a couple of years
disagreements.”
has proposed a new pharmacovigilance
or so, but we will need to revisit it. I think
Such an approach could also yield benefi ts
committee for the agency at some point in
in the post-authorisation phase. “If you can
it will come when the EU legislation is next
the future.
establish criteria and these change over time,
revised, based on the review of the EMEA in
you could say, OK, what is the magnitude of
2009. It all depends on what responsibilities
The EMEA will have a new
this change for the benefi t-risk assessment? It
the agency has in future.”
is very complex and we are just starting, but
advanced therapies committee
He says a good indication of likely
it is a priority for us.”
(CAT) in place from the start
developments will come from the
commission’s communication on the future
clinical trials
of 2009
of the EU single market for pharmaceuticals.
Another safety-related issue for the EMEA
[This was supposed to have been published
is clinical trials. With the trend towards
“Certainly this does not make it easier,” as part of the “pharmaceutical package” on
conducting more studies in emerging markets
says Mr Lönngren. “Business is becoming October 21st, but the package was delayed
in Asia and Latin America, the agency says
more complex, as are the relationships and
until the end of November so that some
it needs to ensure that they are in full
connections among the committees, and
“technical questions” could be addressed –
accordance with ethical standards equivalent
of course there will come a point where
Ed.]
to those in the EU clinical trial directive and
the system is so complicated that it will be
“Then we will know more or less where
the Declaration of Helsinki.
diffi cult to operate.”
we are going, and we can fi ne tune it and
The agency is seeing a “dramatic increase”
There is, he says, a need to take
then maybe run a public consultation in
each year in trials in countries like India,
a fresh look at the architecture of the
2009. At the end of 2009 we will see the
Taiwan, China, Singapore, the former Soviet
EU regulatory system. In fact, the process
results of the EMEA evaluation, then we
Union countries, and Latin America,
is already under way, with an independent
could put this together in a new road map –
Mr Lönngren says. He is also aware of
evaluation of the EMEA to be carried
a new long-term plan for the EMEA, similar
concerns raised about the ethics of trials
out in 2009 at the request of the
to our existing road map.”
conducted in these countries.
European Commission.
Overall, says the executive director, the
A major problem is how to inspect the
“It will be interesting to see the outcome
outlook is bright. “But you never know.
rapidly growing number of trial sites and
of the evaluation,” says Mr Lönngren, who
supervise the conduct and ethical standards
believes a whole range of aspects need
There could always be some drawback –
of studies. This has to be done on a selective
to be addressed. For example, whoever
for example the possibility that a centrally
basis. “We have to take a risk-based approach
does the assessment will need to look at
authorised drug could be involved in a major
because we don’t have the resources to do it
what work needs to be done centrally and
safety issue is increasing as the number of
any other way. We are starting to plan to have
what at national level, whether to maintain
such products rises.” Most of
the capacity to work outside the EU, so that
the current agency network, and how far
the safety problems so far have been
we can guarantee that clinical trials are up to
mechanisms like work-sharing should be
with nationally authorised medicines,
standard.”
brought into play.
he observes.
This is an area where more collaboration
“The fi nancing of the system is another
Just how many of the changes will take
is needed with agencies outside the EU,
issue. We need to match this against the
place during his tenure at the agency is
in countries where these trials are taking
growing complexity of the environment and
diffi cult to say. “My mandate runs out in
place, says Mr Lönngren. The EMEA has
the new science that is coming out. We need
2010, when I will have been here for 10
already established a contact point with
to look at the international environment with
years. I can’t have a contract beyond that.”
the authorities in India, and is planning
the future enlargement of the EU, and the
It is too early for him to say what he will do
similar moves in Asia-Pacifi c, Latin America
requirements in terms of new competences, then. In the meantime, “there is a lot more to
and countries in the Commonwealth of new product areas.”
do in two and a half years. Time is fl ying by.”
Independent States (CIS). It will also be important, he says, to see
So far the number of marketing how best to integrate the agency’s work with
authorisation applications submitted to disease management, preventive strategies, Ian Schofield is a principal analyst for
the EMEA that include data from trials in other interventions like surgery, the interface Informa Pharma.
emerging markets has been limited, “but in with medical devices, and so on. “There are
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