COMMUNICATION
TO THE COUNCIL,
THE
EUROPEAN PARLIAMENT,
THE
EUROPEAN COMMISSION
AND
TO MEMBER STATES
30th September 2008
By our total implication and our constant participation
in all the works realised with the aim of the adoption of this project
Regulation we demonstrated the interest which users and distributors of plant protection products
have in the conditions in which these products are and will be put at their disposal.
In the objective of a larger harmonisation wished by
The common position adopted by the Council on August
20th, 2008, radically modifies this article by an article 52 which:
·
Conflicts with the most recent and constant jurisprudence of the ECJ and
restricts considerably the scope of application of article 28 EC to plant
protection products.
·
·
Misses the target of total harmonisation.
And so:
1- The
imported products would henceforth be considered identical to reference
products if ( article 52 §3 –c ) :
<< ( … ) they are either
the same or equivalent in ( … ) packaging
size, material or form
( … ) >>.
It is indisputable that such a
criterion of identity was always considered by the Court as being
disproportionate and amounting to a measure having equivalent effect to a
quantitative restriction within the meaning of article 28 of the Treaty.
Besides the extensive
jurisprudence on this matter in the area of human medicine, none of the
judgments relating to plant protection products (C-100/96 – C-260 and 261/06 –
C-201/06) allow for such a condition of identity of the packaging including
when it is mitigated by the option < < or equivalent > > obviously not applicable in the case at
hand because a 5 litres packaging will never be equivalent to a 10 litres
packaging as for its < < dimension
> > or its < < form >
>.
Without saying it clearly, the
Council definitely pursued the objective to forbid any possibility of
repackaging the imported product by the holder of the import authorisation.
However, by such wording, it
also firmly forbade the free movement of a product which, although identical in
all its constituents, would be originally presented in packages of different
dimensions and forms in different member States without having been necessarily
repackaged by the importer.
All that manufacturers would
have to do is conceive a specific packaging in every national market to
partition the community market as they please, hence making parallel business
impossible.
It seems to us that, if such a
limitation was definitively confirmed, it would so exclude plant protection
products from the founding principles originating in articles 28 - 30 of the
Treaty, that these would have to be modified to take into account this
extraordinary agrochemical exception.
As for the repackaging of
imported products, we have been so convinced that the practice contributes to
fraud and counterfeiting that AUDACE has constantly alerted the national and
community authorities over the last 10 years where this has come to its notice.
However, we do not believe
that the solution decided on by the Council is acceptable for its purpose of
stamping out fraud and counterfeiting, as it so contradicts the
EU Treaty and the
jurisprudence of the Court.
Basically, the community law
recognises the legitimacy of repackaging by a parallel importer once
repackaging is necessary - so that
the imported product can have market access in the
Our opinion is that it would
be enough to forbid formally any repackaging from the moment that, on its
application for import authorisation, the importer does not demonstrate the
necessity of carrying it out in conditions which could not affect the original
state of the product contained in the packaging (c.f. : ruling C-348/04 of April 26th, 2007).
A priori, nothing would go
against the fact that this solution and the conditions of its application be
harmonised between member states.
2- The
imported products would be considered identical to reference products if (article 52 § 3 – a) << ( … ) they have been manufactured by the same company or by
an associated undertaking or under licence according to the same manufacturing
process >>.
This unacceptable condition of
common origin clearly arises from a simplistic reading of the judgment C-201/06
of February 21st, 2008 from which the Commission had based that for lack
of common origin products are also considered identical if << they are found to have
either the same specification or specifications under the procedure referred to
in Article 37 >> (Commission project Regulation March 11th,
2008 - article 49bis - § 3 - b).
Now, it emerges effectively
from the Court decision that in case of different origins, the national
authorities can always use for the imported product the safety and the efficacy
evaluation performed for the reference
product if this use presents no risk to public health and if products have no
significant differences for the purpose of assessing their safety and their
efficacy although they were made by two different companies.
The Court added that there is
no reason relating to the protection of public health which precludes that rule
from being applicable to plant protection products inasmuch as the Community
legislation applicable to that area seeks to ensure a high level of protection
of human health
This is in particular the case
of products containing active substances registered on annex I of the directive
91/414/EEC and for which the comparative examination of the formulation does
not require the application of the procedure provided for in the article 10 of
the directive for the mutual recognition of MA.
We add that this was precisely
the position which
Besides, we consider that
abandoning this alternative is hardly in accordance with the principle of
mutual recognition of the MA granted by one
3- << The procedure for granting a
parallel trade permit is interrupted from the day the request for information
is sent to the competent authority of the Member State of origin until the
complete information required is delivered to the competent authority of the
Member State of introduction. >> (article 52 - § 2 – 3rd
sentence).
By this statement, the
aforementioned demand of information would arise from a systematic practice and
no longer from an alternative offered by the Court (C-100/96) and proposed by
the Commission in that << The Member State of introduction may seek
information from the Member State of origin if it has no other way of
establishing whether the plant protection product is identical (…)
>> (project of March 11th, 2008 - article 49bis - § 2 - 3rd
sentence).
Besides, << Member
States shall on request provide each other with the information necessary to
assess identically within 10 working days of receiving the request
>> (article 52 - § 2 - 2nd sentence).
Since the council removed the
obligation which that << The Member State of
introduction shall inform the applicant of this request >> (project of March 11th,
2008 - article 49bis - § 2 - last sentence), this period of 10 days would not bind
the authorities legally in favour of the applicant who could not add it up any
more to the period of 45 workdays as the Commission had suggested it (March
11th, 2008 - article 49 encore - § 2 - 5th sentence).
Perfectly consistent with this
new statement, the common position adopted by the council removes purely and
simply the alternative to the effect that << The parallel trade permit shall be granted automatically if the Member
State of introduction has not adopted an explicit decision on the request
within the period (...) >> of 45 workdays.
In so doing, the processing of
the applications for parallel import authorisation would remain subjected to
vague deadlines, left only to the will of national competent authorities and
giving no rights to the applicant.
The current differences in the
processing of these applications between member states would continue with
ensuing distortions.
The objective of harmonisation
pursued by the Regulation would not thus be achieved.
4- << The information requirements may be
amended or completed and further details and specific requirements shall be
established in case of application for a plant protection product for which a
parallel trade permit has already been granted and in case of an application
for a plant protection product for a personal use in accordance with procedure
referred to in Article 79(4) >> (article 52 - § 4 - last
sentence).
Most confusingly, this
statement would add an inexplicable will not to harmonise the procedures
relating to applications for successive import authorisations and import
authorisations for own use, over which the Court nevertheless precisely ruled
on November 08th, 2007 in the joined cases C-260 and 261/06 and for
which the Commission had suggested specific procedures corresponding to the
stipulations of the aforementioned ruling (project of March 11th,
2008 - article 49bis - § 6 - b and 6 - c)
The reference to article 79 §
4 on comitology, which refers itself to articles 5bis, 7 and 8 of Decision
1999/468/EC amended, laying down the procedures for the exercise of implementing
powers conferred on the Commission means considering that the questions
concerning successive applications for import and applications for own-use
would not be essential within the meaning of the 3rd recital of the
Decision amended on July 17th, 2006 when, as a matter of fact, they
were precisely the object of a response by the Court within the framework of a
reference for a preliminary ruling and that this response ought to lead to a
complete harmonisation.
5- The common
position adopted by the Council does not retain that << The applicant for a first parallel trade
permit may demonstrate by means of all available and accessible information
that the plant protection product intended to be introduced is identical in
terms of paragraph 3, 4 and 5 to the reference product (...) >> (Commission project of March
11th, 2008 - article 49bis - § 7).
Henceforth, the applicant
would thus be deprived of any possibility of appeal further to a decision of
refusal.
Contrary to all expectations the Commission
communication to the European Parliament of September 22nd, 2008
seems to confirm these new provisions, which would have taken into account <
< the judgment of the Court of Justice
in more recent Cases > > and which contradicts so clearly the project
of March 11th, 2008.
We consider that in this state of the common position
adopted by the Council the question arises whether member States trust each
other, their national competent authorities that are responsible for granting
MA of reference products and more generally, the community authorities in
charge of the implementation of Directive 91/414/EEC in the process of being
amended.
On the other hand, if the Regulation were to be
confirmed in this condition, the question would not arise again about whether
users and distributors of plant protection products, as well as consumers of
our agricultural productions, would understand why a product authorised in a
member State could not be authorised in another one because it puts at great
risk public health and the environment.
Indeed beyond any commercial and economic
consideration, it is because of these two fundamentals of first the credibility
of our community and national regulations and second the certainty that they
are implemented properly at all decision-taking levels that we seek the
revision of this common position adopted by the Council on August 20th
of this year.
D ROQUES
President of AUDACE
· The sustainable use of plant protection products
· A regulation to replace directive 91/414/EEC
· A strong generic competition for a sustainable agriculture and an innovative dominant industry
· PPP imports by users, farmers and amateur gardeners, within the limit of their personal needs
· PPP parallel imports by professional traders - distributors
AUDACE
Association des Utilisateurs et Distributeurs de l'AgroChimie Européenne
Association loi 1901 – Boîte Postale 27 – 41600 NOUAN LE FUZELIER – Président Monsieur Daniel ROQUES
Téléphone : 02.54.96.88.13 – Télécopie : 02.54.88.41.84 – Internet : http://www.audace.org – E-mail : roques.audace@club-internet.fr