20 Focus – Regulatory intelligence
An EFPIA view
of the consultation process
on proposed guidelines
An interview with Christine-Lise Julou, Director of Scientific, Technical
& Regulatory Affairs at the European Federation for Pharmaceutical
Industries and Associations (EFPIA), conducted by Phillip C Thornton,
on behalf of TOPRA’s regulatory intelligence SPIN group
Introduction
EFPIA’s Christine-Lise Julou invites, coordinates and presents responses
to public consultation papers regarding scientific and regulatory
matters. EFPIA represents the pharmaceutical industry through its direct
membership of 31 national associations and 40 leading pharmaceutical
companies. It interacts directly with the European Medicines Agency (EMA)
and with EU national agencies through the affiliated national associations.
EFPIA actively coordinates responses from its members to EU consultation
documents and prepares a structured and formal response. In the EMA
Road Map 2015, it is gratifying to note that industry stakeholders are
acknowledged and that previous contributions are recognised. Major
changes in the consultation landscape are not foreseen. However, the aim
is to continue to improve communication, so that the industry position can
be better understood by all stakeholders and not just the experts.
Q Is EFPIA given the opportunity to discuss scientific or regulatory
matters with the EMA or other regulatory authorities?
A Yes, EFPIA frequently participates in meetings with European
regulators to discuss scientific or regulatory matters.
These meetings take place in a variety of different contexts,
depending on the subject matter under discussion. For example,
EFPIA may be invited, together with other stakeholders, to participate
in workshops aimed at presenting and discussing new data, scientific
developments or procedures.
EFPIA may also have opportunities to discuss scientific or regulatory
matters during the development of new guidelines, for example, in
the context of the development of a concept paper proposing a new
guidance document, or in the context of a need to update an existing
guideline based on the emergence of new scientific data.
Q How does the consultation process work?
A EFPIA will draft or actively coordinate responses from its
members to most documents pertaining to scientific or regulatory
matters issued for consultation by EU regulators. This will involve
Regulatory Rapporteur – Vol 8, No 5, May 2011
alerting member companies to contribute, setting a date for
response and consolidation, and circulation of the consolidated
responses before submission of a formal response to the regulators.
The response will have to represent a consensus of the various EFPIA
members’ views.
Q Does EFPIA have opportunities to comment on draft guidelines
or guidance from competent authorities outside the EU?
A EFPIA may exceptionally submit comments on draft guidelines
from competent authorities outside the EU. However, providing
comments to agencies in territories outside the EU is normally
coordinated through local organisations. Many EFPIA members are
multinational companies and may submit comments via their local
offices through the local industry trade associations.
Q When and how does EFPIA interact with other industry associations?
A EFPIA represents the pharmaceutical industry operating in
Europe. Through its direct membership of 31 national associations
and 40 leading pharmaceutical companies it is able to interact
directly with the EMA and European Commission (for European
issues) and through the affiliated associations for national issues.
There are also opportunities for collaboration in areas such as
workshops with professional and training organisations, for
example, TOPRA or the DIA.
Q What regulatory intelligence measures are taken to keep
abreast of changes?
A The group at EFPIA will monitor websites, review scientific
articles, follow public debates (EU, national and international) and
read articles on general health matters to anticipate what may be
the next ‘hot potato’. This enables them to be aware of the next
impending topic concerning new technologies, new methodologies,
new concepts, safety, manufacturing, quality or environmental issues
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which may be of public concern. Media articles and public responses
can be a source of intelligence. EFPIA member networks also provide
feedback to the centre; this route is often very effective because the
members are actively monitoring all relevant areas. There is also a
need for monitoring for the longer term. However, identification of
topics and trends for the longer term becomes more of an art than a
science, a mixture of experience and initiative, but communication is
the key. With a large amount of information being fed into the system
there is a great need to filter and interpret to achieve an accurate
assessment of what the real priorities are.
Q What are the satisfying experiences in presenting industry concerns?
A It all depends on the case in question. Each matter has to be
presented in an entirely objective manner, in simple terms and free
from jargon. Being able to distil all the information into a concise,
factual presentation in an objective manner is very satisfying.
Some issues can be more important than others, so the EFPIA
advocacy has to remain focused. The comments deriving from
experienced commentators usually prove to be pertinent, whereas
those from technical experts, who may be used to presentations
exclusively to their peers, sometimes need additional refining. Overall
presentation, a logical structure and arguments supported by sound
rationale and evidence are critical. There is a greater probability
of success when an individual takes responsibility for drafting or
consolidating comments and, ultimately, greater satisfaction.
Q How do you foresee 2011 legislation in comparison with
previous years?
A The EU legislative process requires extensive consultation and
therefore tends to give more time for the legislator to reflect on the
appropriate response than national procedures. So the EU outlook is
always longer term rather than a single year. So far 2011 does not look
any different from other years.
Q How can industry improve how it makes comments?
A There is always a need for improvement: real information is
needed rather than hypothetical. In order to build a case and to
advocate a position, many facts need to be collected; we must
continue to work with the regulators to ensure that guidelines are
based on appropriate experience and solid data. Therefore the
industry position has to be based on strong evidence, appropriately
structured and well presented.
Q In the EMA Road Map 2015 it describes proposals for an
increased involvement of stakeholders in the preparation of new or
updated legislation and guidelines (eg, through workshops). How
do you think this will affect EFPIA and its industry associations?
A Will the Road Map bring changes? Probably; EFPIA has already
provided comments to the EMA on an early draft. One of the key
features of the agency’s interaction with stakeholders since its
establishment has been dialogue with the pharmaceutical industry.
Although the concept of preparing guidelines on medicines
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Focus – Regulatory intelligence 21
‘It is timely to strengthen the involvement
of stakeholders, in particular pharma,
academia, learned societies and patient
organisations, in the development process’
development in the fields of both human and veterinary medicines
has been in place for several years, it would seem timely to
strengthen the involvement of stakeholders (and in particular the
pharmaceutical industry, academia/learned societies and patients’
organisations) in this process, for instance by organising workshops
at a very early stage of guideline development, so that stakeholders
can actively contribute towards developing guidelines of the highest
quality in medical, regulatory and scientific thinking”.1
It is pleasing that industry stakeholders are acknowledged and that
previous contributions are recognised. It is important that this trusted
relationship continues when the number of stakeholders increases, and
their varied backgrounds bring different perspectives on issues.
Q Do you foresee any changes in the consultation landscape in the
coming years?
A Wait and see! The aim of EFPIA will be to continue to improve
contributions and to be understood by all stakeholders, not just
the experts; in fact to be understood by all parties. Interaction with
patient groups as highlighted in the Road Map and “Recognising
the added value of patients and consumers in benefit/risk
considerations”1 will become increasingly important and bring
new challenges.
About Christine-Lise Julou
In addition to her role at EFPIA, Christine-Lise Julou is a member
of the Steering Committee of the International Conference on
Harmonisation (ICH). After obtaining a doctoral degree in pharmacy,
Christine-Lise achieved a law qualification while working in industry,
eventually specialising in Health and then Business and Contract
Law. Christine-Lise has worked for Rhone-Poulenc Rorer (affiliates,
headquarters and joint ventures) and prior to joining EFPIA was
‘Pharmacien Responsable’ for various production sites and Global
Head of Regulatory Affairs for Aventis, with responsibility for
pharmacogenomics and new therapies. The main challenges in
her current area are to advocate the development of a regulatory
framework that fosters innovation and the safe and appropriate use
of medicinal products, while avoiding unnecessary bureaucracy.
References
1 Road Map to 2015. The European Medicines Agency’s contribution to
science, medicines and health. Adopted by the agency’s Management Board
on 16 December 2010. http://www.ema.europa.eu/docs/en_GB/document_
library/Report/2011/01/WC500101373.pdf (Accessed 26 January 2011).
Regulatory Rapporteur – Vol 8, No 5, May 2011