When the EU takes lessons from the other side of the Atlantic

By Zena Prodromou

EU regulatory law is an area in transition. The adoption of EC Regulation 1107/2009, replacing andrepealing Council Directives 79/11/EEC and 91/414/EEC comes as evidence of that the EU is still in seek of a legislative regime, that will allow for a fair balance to be stricken between two legitimate yet conflicting corporate interests: the proprietary interests of the original registrant on the one hand, and the applicant’s right to competition on the other. The current analysis shall review the legislative regime under the U.S. jurisdiction and shall distil lessons the EU could possibly take from the other side of the Atlantic.

The American view on Data Protection in the Field of Pesticides
I. Sketching the institutional framework
The Environmental Protection Agency (hereinafter “EPA”) is the federal entity largely responsible for regulating the sale and use of pesticides, and the allowable levels of such pesticides in or on food. In particular, EPA looks at the potential human and animal health risks as well as the environmental effects associated with the use of pesticides.
EPA’s authority and limits are contained in two core statutes, namely the Federal Insecticide,
Rodenticide, and Fungicide Act (FIFRA); and the Federal Food, Drug, and Cosmetic Act (FFDCA). In 1996 both statutes were amended by the Food Quality Protection Act (FQPA).
In addition to the EPA, the United States Department of Agriculture (hereinafter “USDA”) and the United States Food and Drug Administration (hereinafter “FDA”) set standards for the allowed level of pesticide residue.

II. Let’s talk about principles and procedures The novelty upon which the US system is based relates as to data that falls outside the exclusive use period1 or that has been afforded with compensable protection2.

Come these cases, no permission is required to cite related data so long as:
a) the composition and proposed uses of the “follow-on” or “me- too” applicant’s are
substantially similar to a previously registered product; and
b) the applicant offers, in writing, to compensate the data owner for using the data.
EPA does not require that the applicants actually pay compensation before obtaining a registration.
All that is necessary from EPA’s standpoint is for a follow-on applicant to certify that it has made all required compensation offers. Once a compensation offer is made, it is up to the parties to resolve any compensation dispute separately from EPA.
If the two companies are unable to reach a voluntary agreement on the amount of compensation owed, either party may initiate binding arbitration under the auspices of the American Arbitration Association (AAA) (FIFRA Arbitration rules at 29 C.F.R. Part 1440) to resolve the dispute.
EPA not being involved in resolving data compensation disputes, the time required to negotiate or arbitrate a dispute does not delay the “me- too” registration. This means that follow-on applicants typically can sell and earn profits on “me- too” products for several years before they actually pay any compensation. However, if a follow- on registrant fails to comply with a data compensation agreement or an arbitration award, the data owner may petition EPA to cancel the “me- too” registration.
The United States Supreme Court has twice upheld the constitutionality of the aforementioned data citation system on the occasion of Ruceklshaus v. Monsato Co3 and Thomas v. Union Carbide Agric. Prods. Co4.
In particular, the Supreme Court has found that “data sharing provisions {were} intended to
streamline pesticide registration procedures, increase competition and avoid unnecessary duplication of data- generation costs”5. What is more, the novel data protection scheme has been deemed as introducing “an added incentive beyond statutory patent protection for research and development of new pesticides”6.

Based on the above, the US system is premised upon the principles of time efficiency; flexibility; party autonomy and alternative dispute resolution, all of which seek to serve the interests of technological research and development as well as competition.
In an era whereby the EU is still trying to (re)shape its own policies on regulatory issues, the
aforementioned principles and mechanisms in support thereof could serve as inspiration towards the taking of a more targeted and concrete European stance. It remains to be seen, whether this will actually be the case…

Data sharing for studies involving vertebrate animals

By Panayota Boussis
Regulation 1107/20097 has strengthened the rules and the process as regards the placing of plant protection products on the market. Behind the stated intention of reaching a high level of protection of human health and environment, the new Regulation increases significantly – and maybe for some excessively – the standards that industry will have to meet in order to
commercialize its plant protection products. One of them is the prohibition of duplication of
studies concerning plant protection products on vertebrate animals, which involves a kind of
obligation for data holders of previous authorizations to share their data with new applicants for an authorization.

Reinforcement of data sharing involving vertebrates animals
Regulation 1107/2009 contains provisions on data sharing which aim to avoid the duplication of studies concerning plant protection products on vertebrate animals. The concept of data sharing concerning studies involving vertebrates is though not a revolution since it was already foreseen in the previous directive8. The real innovation of the Regulation concerns rather the obligatory aspect of sharing.
In the previous legal framework, it was foreseen that if the applicant and the holder of previous authorizations of the same product could not reach an agreement on the sharing of data, Member States had the possibility to introduce national measures obliging the applicant and holders of previous authorizations located within their territory to share the data in order to avoid duplicative testing on vertebrate animals.
Regulation 1107/2009 goes now a step further and foresees that the failure to reach an agreement between the applicant and the data owner shall not prevent the competent authority of the Member State from using the test and study reports involving vertebrate animals for the purpose of the application of the prospective applicant.
This system introduced by Regulation 1107/2009 with the aim to avoid situations of refusal of data sharing (which by the past created situations of monopole) arises questions about its implementation.

Are negotiations on data sharing still necessary?
A first reading may give the impression that with the new Regulation, the situation is reversed and that under the new legal framework, the prospective applicants have an real interest that the negotiations on data sharing fail, since the failure to reach an agreement does not prevent the competent authority of a Member State from using the test and study involving vertebrate animals in order to complete their application. On the contrary, since the entry into force of Regulation 1107/2009, data holders have an evident interest to reach an agreement on data sharing with the prospective applicants in order to define themselves the amount of the costs of the study and avoid the involvement the competent national authority. Another issue arises with this provision: what happens to the negotiations in case of such an intervention from the national authority? Who defines the amount of the costs that the applicant has to pay in order to get access to the data?
In its article 62, paragraph 4, Regulation 1107/2009 draws the procedure – applicable EU-wide and not anymore Member-State by Member-State – in case of failure to reach an agreement on data sharing and foresees that in case that the national competent authority intervenes, the holder or holders of the relevant authorization shall have a claim on the prospective applicant for a fair share of the costs that the latest incurred. That implies that whether an agreement between the applicant and the data owner is reached or not, data can be used to the benefice of the applicant anyway. The latter does however not mean that the data owner will not receive compensation, but it will be his duty to claim it.
For this reason the amount of the claim should not be defined in advance and be fixed, but on the contrary, it would be wise to take into consideration the different elements that led to the failure of the negotiations between the prospective applicant and the data owner. A sort of “penalty” mechanism should be introduced and awards from arbitration or litigation should vary depending on the party responsible for the failure. Such a system could thus allow avoiding the Regulation being bypassed.

A prohibition of duplication of tests
Moreover, in order to guarantee the achievement of data sharing involving tests on vertebrates, Regulation 1107/2009 foresees means of pressure and provides in its article 62, par. 2 that “Member States shall not accept duplication of tests and studies on vertebrate animals or those initiated where conventional methods described in Annex II to Directive 1999/45/EC could reasonably have been used, in support of applications for authorisations. Any person intending to perform tests and studies involving vertebrate animals shall take the necessary measures to verify that those tests and studies have not already been performed or initiated”.
Does the Regulation really introduce a ban of duplication of tests and studies on vertebrate animals within the European Union territory or is it rather an obligation not to submit a dossier based on data from a new study involving the duplication of tests? Is it allowed to use the results of studies conducted in the framework of an application for the access to a market outside the European Union? A narrow interpretation of the provision would lead to the conclusion that all applicants should use the existing data and not perform their own studies on vertebrate. Although the pursued objective, i.e. the protection of vertebrates against unnecessary studies, is praiseworthy, it seems however completely disproportionate and far away from reality. The majority of companies operating in the field of plant protection products within the European Union are also active in other regions, where an authorization in order to put their products on the market is also needed. For this reason, it is more than probable that those companies have performed or need to perform their own studies with their own data in order to have a complete dossier to submit to the different authorities.
Require therefore from companies, which have their own data, to pay for an access to the data of the authorisations holders seems unconceivable. It was certainly not the intention of legislator.
However, even if it would have been the case, this situation is problematical for companies.

The necessity to strengthen the legal framework on plant protection products reflects that the
previous legislation relying on a voluntary approach and a mandatory negotiation between data owner and applicant has not reach the expected results, i.e. avoiding the duplication of studies involving vertebrates. A constraint element was needed to achieve this objective.
However, Regulation 1107/2009 having as main purpose the protection of vertebrates remained vague on that point in order to cover as much situations as possible. This provision however requires definitely an interpretation or at least guidance lines. Otherwise the intervention of the European Court of Justice will appear to be needed in order to clarify the provision concerned.

Plant Protection Products and Competition: the concept of abuse of dominant position through regulatory procedure

By Damien Thavard
The Plant Protection Products (PPP) business is all about authorisations and regulatory procedures. In this way, the AstraZeneca case law, establishing the possibility of abusing a
dominant position through regulatory procedure and in particular through authorization procedure, is quite interesting, especially regarding the confirmatory data scheme and the datasharing requirements set out by Regulation 1107/2009.

Abuse of dominant position and Plant Protection Products market
According to settled case law, the dominant position referred to in Article 102 TFEU relates to a position of economic strength enjoyed by an undertaking which enables it to hinder the maintenance of effective competition on the relevant market by allowing it to behave, to an appreciable extent, independently of its competitors, customers and, ultimately, consumers9. Unlike a monopoly or a quasi monopoly situation, such a position does not preclude some competition, but enables the advantaged undertaking, if not to determine, at least to have an appreciable influence on the conditions under which that competition will develop, and in any case to act largely in disregard of it and without suffering any adverse effects as a result of its attitude10.
In a domain close to the PPP field, the pharmaceutical market, the determination of a dominant
position will involve an in-depth analysis of the competition, which means that not only market shares will be taken into consideration but also “various factors relating, principally, to the importance of intellectual property rights and other rights of a regulatory nature, to the advantages associated with firstmover status, to the relevance of price as a parameter of competition, to the relevance of the presence of monopsony purchasers and of regulated price systems, and to the relevance of research and development investment, promotional activities and financial resources”11.
But as Article 102 TFEU states, being in a dominant position is not illegal per se. Indeed, this Article forbids only the abuse of a dominant position: “Any abuse by one or more undertakings of a dominant position within the internal market or in a substantial part of it shall be prohibited as incompatible with the internal market in so far as it may affect trade between Member States”. So, in order for the behavior of a company to be judged as illegal in respect to Article 102, the company has to be in a dominant position, and its behaviour has to constitute an abuse of this position.

According to the case-law “The concept of abuse is an objective concept relating to the behaviour of an undertaking in a dominant position which is such as to influence the structure of a market where, as a result of the very presence of the undertaking in question, the degree of competition is weakened and which, through recourse to methods different from those which condition normal competition in products or services on the basis of the transactions of commercial operators, has the effect of hindering the maintenance of the degree of competition still existing in the market or the growth of that competition”12.
An abuse of a dominant position could result from various behaviours; it could be the refusal to supply raw materials in order to protect one’s own manufactured products13, or an obligation on or promise by buyers to obtain all or most of their goods from an undertaking in a dominant position14.
The behaviour leading to an abuse has not even to be faulty15; it is sufficient in this regard that it modifies the structure of the market.
A particular way to abuse a dominant position is to use a regulatory mechanism to this effect. Indeed, the Tribunal has decided that the use of a regulatory procedure in order to prevent or complicate the entry of a competitor in the market constitutes an abuse: “Whilst the fact that an undertaking is in a dominant position cannot deprive it of its entitlement to protect its own commercial interests when they are attacked (Case T 65/89 BPB Industries and British Gypsum v Commission [1993] ECR II 389, paragraph 69), it cannot use regulatory procedures in such a way as to prevent or make more difficult the entry of competitors on the market, in the absence of grounds relating to the defence of the legitimate interests of an undertaking engaged in competition on the merits or in the absence of objective justification”16.
In other words, it is forbidden for a company in a dominant position to use a regulatory procedure in order to prevent other companies from entering the market or to make this entry more onerous.
This type of abuse is particularly interesting in a domain as regulated as the PPP field. Indeed, the continuation of competition in a market relating to PPP is tied to the continuation of authorisations either of a substance competing with another, or of products competing with others. In this field there are in fact two types of competitions. The R&D competition, in which R&D companies compete with each other by developing new substances and new formulations aiming at the same use; in this case the substances and resulting products are patented, and there are no particular competitions issues at the authorisation level. The other competition relates to R&D versus Generics competition; here the competition field relates to non-patented substances, and authorization becomes a competition issue. Indeed, R&D Companies have often all the data necessary to get their authorisation, while the Generics Companies have to generate these data, yet. At this point, competition issues could arise because the R&D industry, due to its earlier involvement in the authorisation process, can gain market power trough regulatory procedures.

Competition issues at the substance level
At the active substance level, an issue relating to competition can be seen through the prism of the so-called “confirmatory data” mechanism. Indeed, Article 6 (f) of the Regulation (EC) No 1107/2009 puts in place an interesting mechanism; Article 6 focuses on conditions and restrictions that can be laid down besides the authorisations of an active substance. The subsection (f) of this Article establishes that the “submission of further confirmatory information to Member States, the Commission and the European Food Safety Authority, (the Authority), where new requirements are established during the evaluation process or as a result of new scientific and technical knowledge” can be a condition imposed upon an authorisation. It is really interesting to notice that since 2006 this mechanism has been largely used in the authorisation process; in fact 90% of authorisations make use of the
confirmatory data requirement.
Even more interesting is the fact that the authorisations state in one form or another that “the notifier (at whose request (the substance) was listed in Annex I)” or “the applicant” should submit the requested confirmatory data before a certain date. This means that only the primo-applicant can submits this confirmatory data.

Confirmatory data and power over the marketing of a substance
In practice, it means that the primo applicant gains a marketing power over an active substance.
Indeed, the continuation of the active substance’s inclusion in Annex I remain in his hands. He is given the power, by not submitting the requested confirmatory data, to withdraw an active substance from the market. This power over the market does not necessary lead to dominance. Indeed, this simple administrative power is not the sole factor to be taken into account when it comes to dominance, as it has been seen; but the competition on a particular PPP market is often tied to the continuation of the authorisation of an active substance.
The situation is more problematic in case the primo-applicant, who has to submit confirmatory data for the continuation of the authorisation, is also in a dominant position on this market. According to case-law, an undertaking in a dominant position cannot be disentitled of protecting its own commercial interests, if attacked, and of taking such steps as deemed reasonable to protect its interests; however, the purpose of such behaviour cannot be to strengthen one’s dominant position and to abuse it17. This basically means that an undertaking in a dominant position cannot adopt the same course of action as any other undertaking.
In the particular situation looked at, the fact that an undertaking in a dominant position on the
relevant market does not submit confirmatory data could be seen as a way to strengthen its
dominant position, by evicting potential or actual competition through this regulatory procedure; this is considered an abuse of the dominant position. The more obvious instance for not submitting the data is that the notifier has, in the meantime, developed a new patented substance with the same purpose that the one for which confirmatory data are required.

Competition issues at the product level
Another interesting issue relates to the product authorisation. In order to obtain an authorisation, an applicant has to demonstrate that he has access to a complete dossier relating to the active substance his product is based on. To do so, a company can either generate its own data, or prove it has been authorised, through a letter of access, to use a protected study deemed necessary for the authorisation, owned by another company. This mechanism is really interesting when merged with the data-sharing obligation set out by Regulation 1107/2009.

Mandatory data sharing
The first data-sharing mechanism relates to studies involving vertebrates and is fully mandatory. This mandatory data sharing laid down by Article 62 of Regulation 1107/2009 is not a revolution, since the previous directive was already covering this issue. The main innovations relate to the strengthening of the mandatory aspect of the sharing.
This aspect is reinforced in two ways. In the first place, this sharing has become fully mandatory and not only strongly recommended, since “Member States shall not accept duplication of tests and studies on vertebrate animals”. It means that national authorities will not accept the production of duplicated studies involving vertebrates, when it comes to authorising a product. It is the responsibility of the applicant to verify if such a study already exists and to initiate negotiation with the study owner. The second point relates to the failure to reach an agreement. Indeed, in case of failure, the national authority will be allowed to use the protected study anyway, putting the data owner in a position in which he can claim compensation for the use of its protected data before arbitrary formation or national courts.
In the first place, it has to be remembered that the obligation to negotiate does not in itself put the data owner in a dominant position. Indeed, it is depends on other factors, although, since national authorities will not accept duplicated studies, being the owner of protected data relating to vertebrates study secures a strong position.
The second point to look at is the question as to whether or not the foreseen remedies will impede the abuse of a dominant position. Indeed, Article 62, paragraph 4, determines the procedure in case of failure to reach an agreement, applicable EU-wide and no longer on national level. According to this Article, “The failure to reach agreement, as provided in paragraph 3, shall not prevent the competent authority of that Member State from using the test and study reports involving vertebrate animals for the purpose of the application of the prospective applicant”. It basically means that whether or not an agreement is reached between the applicant and the data owner, data are going to be used to the benefit of the applicant. The first guess is that the abuse of a dominant position is therefore impossible.
Nonetheless, for a dominant undertaking, an abuse through this mandatory sharing is still possible.
Even if a refusal to share will not eliminate the competition, it is still possible to use the mechanism of protracting the negotiation, in order to delay the entry of a competitor in the market. The Court had the occasion to state that protracting negotiation, in the granting of licenses, constitutes an abuse, if the undertaking is in a dominant position18. Therefore, even if the existence of efficient remedies reduces the possibility of abusing a dominant position through this procedure, this type of abuse is not completely annihilated.

Mandatory negotiations for data-sharing
It seems, though, that competition issues are more likely to arise in cases of data sharing of other studies. Indeed, the other interesting innovation of Regulation 1107/2009 is the extension of data sharing to all studies. To summarize this procedure determined by Article 61, the applicant, before carrying out any test relating to an active substance, a safener, a synergist or an adjuvant, has to check if there are already authorisations granted for one or more products incorporating substances the product he wish to apply for is based on. If it is the case, the applicant has to convince the competent authority that he is willing to apply for an authorisation of a product containing such a substance.
Once the applicant persuades the competent authority, the latter provides him with a list of
authorisation holders for products using these substances. Thereafter, it is to the applicant and the authorisation’s holder(s) to negotiate in order to reach an agreement for sharing the data needed by the applicant. This negotiation, according to the regulation, has to be carried out in a fair, transparent and non-discriminatory way.
Moreover, it has to be noted that no remedies are foreseen if the negotiations fails. In this case, the applicant would have to run his own trial, after having been in a long negotiation process for obtaining these data. According to the regulation he cannot skip this new procedure by running these tests prior to the negotiation. This entire administrative process is under the final decision of the owner of the protected data. In case of completely different products, or when there are a lot of data owned by various actors, it does not seem to be a problem. When a single owner of protected data negotiates with an applicant willing to place on the market a product directly competing with the product for which the study was made in the first place, it seems more problematic.
That is probably the reason for the Parliament to try to introduce the additional ruling that: “Such an agreement may be replaced by submission of the matter to an arbitration board and acceptance of the arbitration order. In an endeavour to ensure that the costs of sharing the information are determined in a fair, transparent and non-discriminatory way, the Commission may, in accordance with the regulatory procedure referred to in Article 79(3), adopt cost-sharing guidelines based on those principles”. This addition, by amendment 204, was justified by the fact that “In order to minimise unnecessary duplication of tests, it is necessary to put in place arbitration- and cost-sharing mechanisms that could help applicants and holders of authorisation to reach an agreement. These provisions have also been introduced in the REACH Directive”

Among others, this amendment was deemed “not acceptable, as the legislative procedure would be too demanding for such technical provisions that need to be continuously updated”19. Even though this explanation is not convincing, as a matter of fact, in the final trialog conciliation, this amendment has disappeared.
If we go back to the hypothesis in which an applicant wishes to compete with a product of the data owner’s, it can be seen that the applicant is obliged to ask the data owner to share data with him before beginning any tests. If the data owner plays for time, he will delay the entry into the market of the new competitor for the duration of this negotiation time. If he is in a dominant position in the market for this type of product, according to the case law of the ECJ, he is abusing its position, since, as already seen, protracting the proceedings for the grant of licenses “undeniably constitutes an abuse”20.
The situation is even worse in the case of renewal of authorisation of a product. Even if the dataprotection is shorter (only 30 months), the renewal of an authorisation is delimited by tight deadlines.
If a competitor gives the competent authority a new study deemed necessary to obtain a renewal of an authorisation, the data owner could protract the negotiation for sharing data in order to exhaust the deadline. Consequently, he would simply expel a competitor from the market, which is an anticompetitive behaviour and constitutes an abuse of dominant position, if the data owner is in a dominant position.
The dominance over the relevant market can also be seen as putting a reinforced obligation on the undertaking in a dominant position negotiating with a newcomer on the market. Indeed, if the said negotiation does not succeed because it has not been carried in a “fair, transparent and nondiscriminatory way”, it could be considered as more than a simple non-compliance with the Regulation but also as an abuse of the dominant position.
In conclusion, it can be said that the notion of abuse of a dominant position through regulatory procedure, as laid down by the AsrtraZeneca case – still under appeal before the ECJ – is a very interesting new way of apprehending competition in largely regulated market fields such as the PPP field.

Data confidentiality in the pesticide authorization process in the EU.

By Manon Steibel
This article deals with the rules applicable under Regulation n° 1107/2009 of the European
Parliament and of the Council of 21 October 2009 concerning the placing of plant protection
products on the market in relation to access and confidentiality of documents in the pesticide
authorisation process in the European Union.

Plant protection products (hereafter “PPP”) or pesticides are chemical formulations containing an active substance and other ingredients. They are important for the protection of plants and crops in agriculture, horticulture, forestry and gardening. Active substances, which are chemicals used in PPP and which are the essential component enabling the PPP to protect the plant against insects or fungi, are approved at EU-level. However, the PPP containing these substances are authorised at MS level.
Until 2009, the legislation in place in the EU with regard to PPP was Directive 91/414/EEC. In 2001, the Commission submitted a progress report on Directive 91/414 to the Council and Parliament which concluded that a reform of the legislation was necessary in order to address certain identified needs and weaknesses. In this context, Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of PPP on the market was adopted.
The Regulation confirms the European Commission’s great commitment to increase the level of health and environmental protection, whilst seeking to harmonise the placing of PPP on the market.
Indeed, contrary to the previous legal instrument chosen – a directive -, a regulation is binding in its entirety and directly applicable in all Member States.
The Regulation includes specific provisions with regard to data protection and data confidentiality.
These specific provisions are covered in Articles 59-63 of the Regulation. Under the Regulation, “data protection” means the temporary right of the owner of a test or study report to prevent it being used for the benefit of another applicant and applies to test and studies reports on the active substance, safener or synergist, adjuvant and the plant protection product. However, when submitting an application for the approval of an active substance or for an amendment to the conditions of an approval, some information shall be considered as business information and shall be kept confidential.
This data confidentiality is even more important when the pesticide authorisation process includes an access right to information with respect to the public. At EU level, there is a general tendency that more and more documents or information are made available to the public. The pesticide authorisation process is no exception to this rule. Nevertheless, this legitimate interest should prevent misuse and unfair competition. Regulation 1107/2009 contains important new provisions on data confidentiality and public access. In this respect, it could be interesting to analyse the provisions of the Regulation21.
The new provisions’ scope on data confidentiality and public access In accordance with the provisions of Regulation n° 1107/2009, an application for the approval of an active substance or for an amendment to the conditions of an approval is submitted by the producer to the Member State, which is called the Rapporteur Member State (hereafter “RMS”). The application shall be accompanied by two dossiers containing all the information available to enable the assessment of the potential effects of the PPP on human and animal health, and the possible impact on the environment. One must first submit a comprehensive dossier on the substance, including full information on the nature and composition of the substance, details of tests carried out on crops and plants, safety data and means of detection but also the name of their owner and the name of the institute, which has carried out theses studies to a RMS22. The information provided may be protected by a confidentiality clause if it constitutes an industrial or trade secret, provided certain conditions are satisfied.
As before, when submitting an application, the applicant may request certain information including certain parts of the dossier to be kept confidential. Upon a request for access to information, the RMS shall decide what information is to be kept confidential23. Regulation 1107/2009 includes important changes from its predecessor (Directive 91/414) regarding the procedure for data confidentiality. The current regulation contains a positive list of data, which are in principle regarded as confidential. Under Directive 91/414, all data was confidential unless otherwise specified. In accordance with Article 63 of the new Regulation, only commercial business interests and specific documents are per se kept confidential. The disclosure of the following shall normally fall in those categories:
•    The method of manufacture
•    The specification of impurity of the active substance except for the impurities toxicologically, eco toxicologically or environmentally relevant
•    Results of productions batches of the active substance including impurities
•    Methods of analysis for impurities in the active substance as manufactured
•    Links between a producer or importer and the applicant or authorization holder
•    Information on the complete composition of a PPP
•    Names and addresses of persons involved in testing on vertebrate animals.
However, companies can also claim for confidentiality of documents in their dossier if they believe it would undermine their commercial interests including company know-how. For example, commercial interests may include benefit considerations; product registration strategies; direct comparison with competitive products; details of work conducted to establish the mode of action; the sensitivity of target tests, and the most appropriate anti-resistance strategy. The new regulation provides that this claim for confidentiality must be supported by verifiable evidence showing that disclosure might undermine commercial interests or protection of privacy and the integrity of the individual24. The MS is competent to assess the confidentiality request and to decide which data has to be kept,confidential. After receiving a decision on the admissibility of the application from the RMS, the applicant must immediately submit the dossier including confidential data to the other Member States, the European Commission and the European Food Safety Authority (hereafter “the
Regulation 1107/2009 contains provisions on what can be made public in the future, excluding any information in respect of which confidential treatment has been requested and justified pursuant to Article 63. The Authority provides access to the draft assessment report submitted by a designated RMS for the EU peer review of existing and new active substances used in PPP26. Henceforth, for new active substances reviewed under Regulation 1107/2009, the Authority makes the “summary dossiers” publicly available (Article 10 of Regulation). The Authority also makes both applications and “summary dossiers” for renewal of approval reviewed under that Regulation available to the public (Article 16 of Regulation). Normally, any confidential information justified on the basis of Article 63 is
excluded from this disclosure. However, pursuant to articles 10 and 16, in case of an overriding public interest, confidential information will be disclosed.
Critical aspects of the new regulation Many obscure points from the new regulation regarding confidentiality aspects deserve closer attention.
First of all, at national level, when the RMS assesses the confidentiality, there is a positive list of data, which are in principle regarded as confidential. However, as mentioned above, companies can also claim for confidentiality of documents by providing verifiable evidence showing that disclosure might undermine their commercial interests. But the terms employed in Regulation 1107/2009 “verifiable evidence” are vague and can be confusing. This ambiguity confers on the RMS a broad discretion, enabling it to refuse the justification provided by the applicant in his confidentiality request. However, the disclosure of sensitive information can have a considerable impact on commercial interests, and potential competitors can obtain sensitive commercial data. Therefore, the owner of such information should be given the opportunity to comment on a disclosure decision before it is taken
and to seek legal redress, if necessary. An amendment concerning this legal issue was proposed by the European Parliament in its position adopted at first reading on 23 October 2007 with a view to the adoption of the Regulation of the European Parliament and of the Council, concerning the placing of PPP on the market. The proposed amendment provided that “An opportunity to comment shall be given to the applicant before the competent authority adopts a decision as to the confidentiality of the data, which shall be binding on all MS, the Authority and the Commission. The decision, which must be notified to the applicant, shall contain an adequate justification. The applicant shall have the right to challenge such decision in court before it is implemented, with a view to having the assessments and decision made by the competent authority by the court and to preventing disclosure of the data in question”. The adoption of this amendment would have allowed fixing this legal issue, since a European regulation is directly applicable in all its elements and in all MS. Whatever the RMS; the applicant would have had a legal basis on which to challenge the contested decision before the competent court. Likewise, in case of a request for access to information, the RMS would have had to decide what data should be kept confidential. However, the amendment was finally rejected. In some Member States this may result in the applicant not having automatically access to court to challenge the contested decision. In France, according to a ministerial decree of October 201227, the minister of Agriculture is competent to assess confidentiality request. Its decision is an administrative act, which may be challenged before an administrative court. However, the Charter of fundamental rights of the EU recognises the right to an effective remedy and to a fair trial. According to article 47 of the Charter, “Everyone whose rights and freedoms guaranteed by the law of the Union are violated has the right to an effective remedy before a tribunal in compliance with the conditions laid down in this Article.” The provisions of the Charter are implemented in Member States together with EU law.
However, as mentioned above, the applicants must submit their dossier including confidential
information to the other MS; for this reason, another issue, which arises under this Regulation, is whether the decision on confidentiality of the RMS is binding on all MS.
Secondly, as mentioned above, Regulation 1107/2009 requires the Authority to make several types of documents available to the public, such as the summary dossier for a new active substance, the draft assessment report, the Authority Conclusion and the application for the renewal of the approval. The documents are made available in accordance with the EU legislative framework.
In case of a new application or a renewal of the approval of an active substance, the Authority makes a “sanitised” version of the summary dossiers publicly available, without delay, when the RMS has accepted the confidentiality claim. Pursuant to Articles 12 § 1 and 2, the applicant will be given two weeks to request that certain parts of the draft assessment report are kept confidential and another two weeks to screen the Authority conclusion before it is made available to the public. In respect to all these availabilities to the public, usually the RMS decides on confidentiality request first. But, it happens that the Authority evaluates a new confidentiality claim and takes a decision on its acceptability, in particular concerning the availability of the draft assessment report and the Authority conclusion.
Therefore, the Authority has a discretionary power to assess such claims. The applicant should have the possibility to challenge the contested decision before a court. However, the Authority (EFSA) is a decentralised agency of the EU which was established by European Regulation n°178/2002 of the European Parliament of 28 January 2002; this Regulation laid down the general principles and requirements of food law, established the European Food Safety Authority and laid down procedures in matters of food safety. The legal issue that may arise is whether such decision of the Authority can be challenged under article 263 of TFEU. According to Article 47 of Regulation No 178/2002 it seems that the legislature intended to make only actions for damages brought against EFSA, such as contractual and non -contractual liability subject to review by the Court of Justice. This legal issue was discussed in the case Dow Agrosciences Ltd against EFSA28 in which the applicant brought an action for annulment of the EFSA opinion on the assessment of the active substance haloxyfop-R” on the basis of the fourth paragraph of Article 230 EC (now 263 TFEU). The defendant, supported by theCommission, pleaded the inadmissibility of the application for annulment. In support of its objection of inadmissibility, EFSA submitted that Article 230 EC did not contain any reference to Acts of European agencies or bodies other than the institutions mentioned in that provision. EFSA couldn’t therefore be regarded as one of the institutions mentioned in Article 230 EC and its opinion in relation to the assessment of the active substance haloxyfop R was not a measure that could be contested under that Article. The General Court rejected the action for annulment as inadmissible because of the nature of the Act, which was an opinion, regardless of the statute of the Agency.
However, the new Article 263 TFEU provides that the European Court of justice shall also review the legality of acts of bodies, offices or agencies of the Union intended to produce legal effects vis-à vis third parties. Therefore, an act of the Authority that may produce legal effects vis-à-vis third parties may be challenged before the Court. However, the disclosure of confidential information by the Authority may affect commercial interests of a producer. For this reason, an action for annulment may be brought against such decision before EU courts.
Finally, apart from the specific provisions of Regulation 1107/2009 regarding public access to
information, a third party (potential competitor) on its own initiative may make a request for
documents of the European Institutions on the basis of Regulation 1049/2001 of the European Parliament and of the Council of 30 May 2001, which could lead to the distortion of the competition.
Although the latter Regulation applies to documents of the European Parliament, Council and
Commission, the Authority laid down, in its internal rules, by a decision concerning access to
documents, practical arrangements for implementing confidential rules and provisions applicable to access to documents in conformity with Regulation 178/200229. In this regard, it should be noted that Regulation 1049/2001, although merely regarding public access to the European institutions, recognises the obligation, as acknowledged by the European Court of Justice, to protect business secrets. Indeed, according to articles 4 § 2, 4, 6 and 7, Regulation 1049/2001provides that:
“2. The institutions shall refuse access to a document where disclosure would undermine the protection of:
4. As regards third-party documents, the institution shall consult the third party with a view to assessing whether an exception in paragraph 1 and 2 is applicable, unless it is clear that the document shall or shall not be disclosed (…)
6. If only parts of the requested documents are covered by any of the exceptions, the remaining parts of the document shall be released.
7. The exceptions as laid down in paragraphs 1 to 3 shall only apply for the period during which protection is justified on the basis of the content of the document. The exceptions may apply for a maximum period of 30 years. In the case of documents.”

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