COMMUNICATION TO THE COUNCIL,
THE EUROPEAN PARLIAMENT,
THE EUROPEAN COMMISSION
AND TO MEMBER STATES
30th September 2008
Common Position adopted by the Council with a view to the adoption of a Regulation of the European Parliament and of the Council concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC
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.
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.
President of AUDACE
Association des Utilisateurs et Distributeurs de l'AgroChimie Européenne
Association loi 1901 – Boîte Postale 27 – 41600 NOUAN LE FUZELIER – Président Monsieur Daniel ROQUES