Product Liability 2009 - Arnold & Porter LLP

Lovells LLP The EU General Product Safety Regime
market conditions, consumer behaviour, or modes of distribution of
the product, but any discrepancies must be capable of ready
justification.
For the same reasons, the flow of information during the course of
the corrective action must be controlled. Some national authorities
may raise questions or request further information about the risk or
the proposed action. The nature of such responses in each Member
State should be carefully managed to ensure a consistent flow of
information.
Get the balance right
When making initial notifications to authorities about a potential
product risk or proposed corrective actions, the authorities will need
sufficient information to enable them to determine the adequacy of
the producer’s proposed actions. However, the provision of too
much detail can result in misunderstandings and can prompt
unnecessary inquiries from authorities, with the risk that the taking
of corrective action can be delayed, particularly if the information
is highly technical and needs to be translated.
Maintain good relations with the authorities
Complications can, and regularly do, arise in pan-European recalls
when the authorities take inconsistent views of the way in which the
potential risk ought to be dealt with. This can become particularly
problematic if some authorities are not satisfied with corrective
actions proposed by the producer or distributor. It is often
necessary to enter into negotiations with local authorities in an
effort to satisfy them that the steps proposed, which are also being
undertaken in other countries, are appropriate to deal with the
perceived risk. This is why it is important to ensure a good
relationship with local authorities from the outset.
Since the Directive came into force, national safety authorities have
become more experienced in dealing with product risks notified to
them, and are becoming much more interventionist in relation to
how corrective action should be handled in their countries.
Generally, however, if the local authorities can see that the recall
action is being undertaken carefully and professionally and that the
producer or distributor is willing to be open and prompt in its
communications with the authorities, there is much less risk that the
authorities will seek to substitute their judgment for that of the
producer or distributor.
Protect confidential information
One of the difficulties with the Directive is that, unlike in the US, it
is not possible to ensure that information given to the authorities
will remain confidential (see the section on “Information sharing”
ICLG TO: PRODUCT LIABILITY 2009
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above). Indeed, the authorities are given the power and
encouragement to make such information available to the public
unless it is covered by “professional secrecy”, which is taken, in at
least some countries, to mean trade secret. This is an important
consideration when deciding precisely what information to provide
to the authorities. In certain situations it may be possible to agree a
mechanism to protect confidential information, for example, where
its release could put the producer or distributor in breach of their
legal obligations in other countries.
Guidance For Pan-European Notification
(Assuming Single Notification Procedure Not
Adopted)
1. Develop a master “notification pack”
Select language for documents in master pack: this will
usually be English.
Get the right balance of information, having regard to:
legal obligations of disclosure;
confidentiality concerns; and
the need to provide adequate information about the
risk and proposed corrective action, but not so much,
and not presented in such a way, as to lead to
unnecessary questions from authorities.
Emphasise the international scope of action to minimise the
risk of an individual national authority seeking to modify
proposed strategy.
2. Line up a network of experienced local counsel in each
country
Select local counsel with relevant experience and expertise.
Brief local counsel to be ready to respond when necessary.
Request advice from local counsel on any particular
requirements of national authorities.
3. Prepare to notify national authorities
Send notification pack to local counsel for translation.
Ensure local counsel can be contacted and are available to
notify national authorities as soon as instructed.
4. Notify national authorities simultaneously using local
counsel
Maintain centralised control over responses to enquiries
from national authorities. Ensure consistency of information
provided to national authorities (allowing for differences in
the level of detail).
Acknowledgment
The authors would like to acknowledge the assistance of their
associate, Claire Taylor, a member of Lovells’ product liability
practice.
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