2009-2010 - AESGP

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Source: Communication of the European
Commission on “Safe, Innovative and
Accessible Medicines: a Renewed Vision
for the Pharmaceutical Sector” of 10
December 2008
CuTTInG rEd TAPE
Some concrete progress towards ‘better regulation’ was made
with the new European variations system.
Regulation 1234/2008 on variations
was adopted in November 2008 and
came into force on 1 January 2010. It set
up a new variations system for centrally
authorised medicines as well as for medicines
authorised through the mutual recognition
and decentralised procedures.
It introduced new concepts such as the
‘do and tell’ notification, the possibility to
group variations in one submission, and
the work-sharing procedure which aims
at simplifying the whole system. Although
this is a notable improvement compared
with the previous framework, AESGP
regretted that the changes did not capitalise
more on the existing German or
Austrian systems for variations.
In another legislative step, the Commission
was empowered to extend the new
variations system to all marketing authorisations.
Although the last concrete phase
of the Regulation’s modification to include
nationally authorised medicines is not yet
completed, a majority of Member States
already apply the new rules to all medicines
in their territory.
The categorisation of variations, which
brings more flexibility to the system, was
laid out in a new guideline. Another guideline
clarified the details around the practical
application of the new procedure.
AESGP wishes to have the ad hoc group
that developed the new variation rules
monitor the early implementation stages
to ensure a fully harmonised – and hence
successful – variation system.
The reform of the variations regime was
part of a list of 10 fast-track actions to
reduce administrative burdens presented
by the European Commission in March
2008 to stimulate economic growth, and
fits into the Community’s framework programme
to reduce administrative burdens
for business by 25 percent by the year
2012.
BOOSTING INNOVATION
Reducing red tape is critical, but creating
incentives and the right environment to
support innovation is equally important.
In this context, AESGP participated in the
UK Ministerial Industry Strategy Group
(MISG) on widening access to medicines
in London on 3 December 2009. The
aim of this high-level strategic meeting
was to consider the development of a
streamlined reclassification model to deliver
wider access to medicines in the UK
and ultimately across Europe.
Through its interaction with EU or national
competent authorities, AESGP continues
to call attention to and educate about the
various benefits of self-care, but also to
emphasise the need to take account of
the sector’s specificities. At the European
Medicines Agency’s workshop on transparency
in October AESGP highlighted
the particularly competitive environment
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