throbber
31.5.2001
`
`EN
`
`Official Journal of the European Communities
`
`L 145/43
`
`REGULATION (EC) No 1049/2001 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
`of 30 May 2001
`regarding public access to European Parliament, Council and Commission documents
`
`THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
`EUROPEAN UNION,
`
`this Regulation as regards documents concerning the
`activities covered by those two Treaties.
`
`Having regard to the Treaty establishing the European
`Community, and in particular Article 255(2) thereof,
`
`Having regard to the proposal from the Commission (1),
`
`Acting in accordance with the procedure referred to in Article
`251 of the Treaty (2),
`
`Whereas:
`
`(1)
`
`(2)
`
`(3)
`
`(4)
`
`(5)
`
`The second subparagraph of Article 1 of the Treaty on
`European Union enshrines the concept of openness,
`stating that the Treaty marks a new stage in the process
`of creating an ever closer union among the peoples of
`Europe,
`in which decisions are taken as openly as
`possible and as closely as possible to the citizen.
`
`Openness enables citizens to participate more closely in
`the decision-making process and guarantees that
`the
`administration enjoys greater legitimacy and is more
`effective and more accountable to the citizen in a demo-
`cratic system. Openness contributes to strengthening the
`principles of democracy and respect for fundamental
`rights as laid down in Article 6 of the EU Treaty and in
`the Charter of Fundamental Rights of
`the European
`Union.
`
`The conclusions of the European Council meetings held
`at Birmingham, Edinburgh and Copenhagen stressed the
`need to introduce greater transparency into the work of
`the Union institutions. This Regulation consolidates the
`initiatives that the institutions have already taken with a
`view to improving the transparency of the decision-
`making process.
`
`The purpose of this Regulation is to give the fullest
`possible effect to the right of public access to documents
`and to lay down the general principles and limits on
`such access in accordance with Article 255(2) of the EC
`Treaty.
`
`Since the question of access to documents is not covered
`by provisions of the Treaty establishing the European
`Coal and Steel Community and the Treaty establishing
`the European Atomic Energy Community, the European
`Parliament, the Council and the Commission should, in
`accordance with Declaration No 41 attached to the Final
`Act of the Treaty of Amsterdam, draw guidance from
`
`(6) Wider access should be granted to documents in cases
`where the institutions are acting in their legislative
`capacity, including under delegated powers, while at the
`same time preserving the effectiveness of the institutions'
`decision-making process. Such documents should be
`made directly accessible to the greatest possible extent.
`
`(7)
`
`(8)
`
`(9)
`
`(10)
`
`(11)
`
`In accordance with Articles 28(1) and 41(1) of the EU
`Treaty, the right of access also applies to documents
`relating to the common foreign and security policy and
`to police and judicial cooperation in criminal matters.
`Each institution should respect its security rules.
`
`In order to ensure the full application of this Regulation
`to all activities of the Union, all agencies established by
`the institutions should apply the principles laid down in
`this Regulation.
`
`On account of their highly sensitive content, certain
`documents should be given special treatment. Arrange-
`ments for informing the European Parliament of the
`content of such documents should be made through
`interinstitutional agreement.
`
`In order to bring about greater openness in the work of
`the institutions, access to documents should be granted
`by the European Parliament,
`the Council and the
`Commission not only to documents drawn up by the
`institutions, but also to documents received by them. In
`this context,
`it
`is recalled that Declaration No 35
`attached to the Final Act of the Treaty of Amsterdam
`provides that a Member State may request the Commis-
`sion or the Council not to communicate to third parties
`a document originating from that State without its prior
`agreement.
`
`In principle, all documents of the institutions should be
`accessible to the public. However, certain public and
`private interests should be protected by way of excep-
`tions. The institutions should be entitled to protect their
`internal consultations and deliberations where necessary
`to safeguard their ability to carry out their tasks. In
`assessing the exceptions, the institutions should take
`account of
`the principles in Community legislation
`concerning the protection of personal data, in all areas
`of Union activities.
`
`(1) OJ C 177 E, 27.6.2000, p. 70.
`(2) Opinion of
`the European Parliament of 3 May 2001 (not yet
`published in the Official Journal) and Council Decision of 28 May
`2001.
`
`(12) All rules concerning access to documents of the institu-
`tions should be in conformity with this Regulation.
`
`WATSON LABORATORIES, INC. , IPR2017-01621, Ex. 1052, p. 1 of 6
`
`

`

`L 145/44
`
`EN
`
`Official Journal of the European Communities
`
`31.5.2001
`
`(13)
`
`(14)
`
`(15)
`
`(16)
`
`(17)
`
`the right of access is fully
`In order to ensure that
`respected, a two-stage administrative procedure should
`apply, with the additional possibility of court proceed-
`ings or complaints to the Ombudsman.
`
`Each institution should take the measures necessary to
`inform the public of the new provisions in force and to
`train its staff to assist citizens exercising their rights
`under this Regulation. In order to make it easier for
`citizens to exercise their rights, each institution should
`provide access to a register of documents.
`
`Even though it is neither the object nor the effect of this
`Regulation to amend national
`legislation on access to
`documents, it is nevertheless clear that, by virtue of the
`principle of loyal cooperation which governs relations
`between the institutions and the Member States, Member
`States should take care not
`to hamper the proper
`application of this Regulation and should respect the
`security rules of the institutions.
`
`This Regulation is without prejudice to existing rights of
`access to documents for Member States, judicial authori-
`ties or investigative bodies.
`
`In accordance with Article 255(3) of the EC Treaty, each
`institution lays down specific provisions regarding access
`to its documents in its rules of procedure. Council
`Decision 93/731/EC of 20 December 1993 on public
`access to Council documents (1), Commission Decision
`94/90/ECSC, EC, Euratom of 8 February 1994 on public
`access to Commission documents (2), European Parlia-
`ment Decision 97/632/EC, ECSC, Euratom of 10 July
`1997 on public access to European Parliament docu-
`ments (3), and the rules on confidentiality of Schengen
`documents should therefore, if necessary, be modified or
`be repealed,
`
`HAVE ADOPTED THIS REGULATION:
`
`Article 1
`
`Purpose
`
`(b) to establish rules ensuring the easiest possible exercise of
`this right, and
`
`(c) to promote good administrative practice on access to docu-
`ments.
`
`Article 2
`
`Beneficiaries and scope
`
`Any citizen of the Union, and any natural or legal person
`1.
`residing or having its registered office in a Member State, has a
`right of access to documents of the institutions, subject to the
`principles, conditions and limits defined in this Regulation.
`
`to the same principles,
`The institutions may, subject
`2.
`conditions and limits, grant access to documents to any natural
`or legal person not residing or not having its registered office
`in a Member State.
`
`This Regulation shall apply to all documents held by an
`3.
`institution, that is to say, documents drawn up or received by it
`and in its possession, in all areas of activity of the European
`Union.
`
`4. Without prejudice to Articles 4 and 9, documents shall
`be made accessible to the public either following a written
`application or directly in electronic form or through a register.
`In particular, documents drawn up or received in the course of
`a legislative procedure shall be made directly accessible in
`accordance with Article 12.
`
`Sensitive documents as defined in Article 9(1) shall be
`5.
`subject to special treatment in accordance with that Article.
`
`This Regulation shall be without prejudice to rights of
`6.
`public access to documents held by the institutions which
`might follow from instruments of international law or acts of
`the institutions implementing them.
`
`Article 3
`
`Definitions
`
`The purpose of this Regulation is:
`
`(a) to define the principles, conditions and limits on grounds
`of public or private interest governing the right of access to
`European Parliament, Council and Commission (hereinafter
`referred to as ‘the institutions’) documents provided for in
`Article 255 of the EC Treaty in such a way as to ensure the
`widest possible access to documents,
`
`For the purpose of this Regulation:
`
`(a) ‘document’ shall mean any content whatever its medium
`(written on paper or stored in electronic form or as a
`sound, visual or audiovisual recording) concerning a matter
`relating to the policies, activities and decisions falling
`within the institution's sphere of responsibility;
`
`(1) OJ L 340, 31.12.1993, p. 43. Decision as last amended by Decision
`2000/527/EC (OJ L 212, 23.8.2000, p. 9).
`(2) OJ L 46, 18.2.1994, p. 58. Decision as amended by Decision 96/
`567/EC, ECSC, Euratom (OJ L 247, 28.9.1996, p. 45).
`(3) OJ L 263, 25.9.1997, p. 27.
`
`(b) ‘third party’ shall mean any natural or legal person, or any
`entity outside the institution concerned,
`including the
`Member States, other Community or non-Community insti-
`tutions and bodies and third countries.
`
`WATSON LABORATORIES, INC. , IPR2017-01621, Ex. 1052, p. 2 of 6
`
`

`

`31.5.2001
`
`EN
`
`Official Journal of the European Communities
`
`L 145/45
`
`Article 4
`
`Exceptions
`
`The institutions shall refuse access to a document where
`1.
`disclosure would undermine the protection of:
`
`(a) the public interest as regards:
`— public security,
`— defence and military matters,
`— international relations,
`— the financial, monetary or economic policy of
`Community or a Member State;
`
`the
`
`(b) privacy and the integrity of the individual, in particular in
`accordance with Community legislation regarding the
`protection of personal data.
`
`The institutions shall refuse access to a document where
`2.
`disclosure would undermine the protection of:
`— commercial interests of a natural or legal person, including
`intellectual property,
`— court proceedings and legal advice,
`— the purpose of inspections,
`investigations and audits,
`
`unless there is an overriding public interest in disclosure.
`
`Access to a document, drawn up by an institution for
`3.
`internal use or received by an institution, which relates to a
`matter where the decision has not been taken by the institu-
`tion, shall be refused if disclosure of the document would
`seriously undermine the institution's decision-making process,
`unless there is an overriding public interest in disclosure.
`
`Access to a document containing opinions for internal use as
`part of deliberations and preliminary consultations within the
`institution concerned shall be refused even after the decision
`has been taken if disclosure of the document would seriously
`undermine the institution's decision-making process, unless
`there is an overriding public interest in disclosure.
`
`As regards third-party documents, the institution shall
`4.
`consult the third party with a view to assessing whether an
`exception in paragraph 1 or 2 is applicable, unless it is clear
`that the document shall or shall not be disclosed.
`
`to
`the institution not
`A Member State may request
`5.
`disclose a document originating from that Member State
`without its prior agreement.
`
`If only parts of the requested document are covered by
`6.
`any of the exceptions, the remaining parts of the document
`shall be released.
`
`The exceptions as laid down in paragraphs 1 to 3 shall
`7.
`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 covered by the exceptions relating to privacy or
`commercial interests and in the case of sensitive documents,
`
`the exceptions may, if necessary, continue to apply after this
`period.
`
`Article 5
`
`Documents in the Member States
`
`Where a Member State receives a request for a document in its
`possession, originating from an institution, unless it is clear
`that the document shall or shall not be disclosed, the Member
`State shall consult with the institution concerned in order to
`take a decision that does not jeopardise the attainment of the
`objectives of this Regulation.
`
`The Member State may instead refer
`institution.
`
`the request
`
`to the
`
`Article 6
`
`Applications
`
`Applications for access to a document shall be made in
`1.
`any written form,
`including electronic form,
`in one of the
`languages referred to in Article 314 of the EC Treaty and in a
`sufficiently precise manner to enable the institution to identify
`the document. The applicant is not obliged to state reasons for
`the application.
`
`If an application is not sufficiently precise, the institution
`2.
`shall ask the applicant to clarify the application and shall assist
`the applicant in doing so, for example, by providing informa-
`tion on the use of the public registers of documents.
`
`In the event of an application relating to a very long
`3.
`document or to a very large number of documents, the institu-
`tion concerned may confer with the applicant informally, with
`a view to finding a fair solution.
`
`The institutions shall provide information and assistance
`4.
`to citizens on how and where applications for access to docu-
`ments can be made.
`
`Article 7
`
`Processing of initial applications
`
`An application for access to a document shall be handled
`1.
`promptly. An acknowledgement of receipt shall be sent to the
`applicant. Within 15 working days from registration of the
`application, the institution shall either grant access to the docu-
`ment requested and provide access in accordance with Article
`10 within that period or, in a written reply, state the reasons
`for the total or partial refusal and inform the applicant of his
`or her right to make a confirmatory application in accordance
`with paragraph 2 of this Article.
`
`In the event of a total or partial refusal, the applicant
`2.
`may, within 15 working days of receiving the institution's
`reply, make a confirmatory application asking the institution to
`reconsider its position.
`
`WATSON LABORATORIES, INC. , IPR2017-01621, Ex. 1052, p. 3 of 6
`
`

`

`L 145/46
`
`EN
`
`Official Journal of the European Communities
`
`31.5.2001
`
`for example in the event of an
`In exceptional cases,
`3.
`application relating to a very long document or to a very large
`number of documents, the time-limit provided for in paragraph
`1 may be extended by 15 working days, provided that the
`applicant is notified in advance and that detailed reasons are
`given.
`
`Failure by the institution to reply within the prescribed
`4.
`time-limit shall entitle the applicant to make a confirmatory
`application.
`
`Article 8
`
`Processing of confirmatory applications
`
`A confirmatory application shall be handled promptly.
`1.
`Within 15 working days from registration of such an applica-
`tion, the institution shall either grant access to the document
`requested and provide access in accordance with Article 10
`within that period or, in a written reply, state the reasons for
`the total or partial refusal. In the event of a total or partial
`refusal,
`the institution shall
`inform the applicant of
`the
`remedies open to him or her, namely instituting court proceed-
`ings against the institution and/or making a complaint to the
`Ombudsman, under the conditions laid down in Articles 230
`and 195 of the EC Treaty, respectively.
`
`for example in the event of an
`In exceptional cases,
`2.
`application relating to a very long document or to a very large
`number of documents, the time limit provided for in paragraph
`1 may be extended by 15 working days, provided that the
`applicant is notified in advance and that detailed reasons are
`given.
`
`Failure by the institution to reply within the prescribed
`3.
`time limit shall be considered as a negative reply and entitle the
`applicant to institute court proceedings against the institution
`and/or make a complaint to the Ombudsman, under the rele-
`vant provisions of the EC Treaty.
`
`Article 9
`
`Treatment of sensitive documents
`
`Sensitive documents are documents originating from the
`1.
`institutions or the agencies established by them, from Member
`States, third countries or International Organisations, classified
`‘SECRET’ or ‘CONFIDENTIEL’
`in
`as ‘TRÈS SECRET/TOP SECRET’,
`accordance with the rules of the institution concerned, which
`protect essential interests of the European Union or of one or
`more of its Member States in the areas covered by Article
`4(1)(a), notably public security, defence and military matters.
`
`Applications for access to sensitive documents under the
`2.
`procedures laid down in Articles 7 and 8 shall be handled only
`by those persons who have a right to acquaint themselves with
`those documents. These persons shall also, without prejudice
`to Article 11(2), assess which references to sensitive documents
`could be made in the public register.
`
`Sensitive documents shall be recorded in the register or
`3.
`released only with the consent of the originator.
`
`An institution which decides to refuse access to a sensi-
`4.
`tive document shall give the reasons for its decision in a
`manner which does not harm the interests protected in
`Article 4.
`
`5. Member States shall take appropriate measures to ensure
`that when handling applications for sensitive documents the
`principles in this Article and Article 4 are respected.
`
`The rules of the institutions concerning sensitive docu-
`6.
`ments shall be made public.
`
`The Commission and the Council shall inform the Euro-
`7.
`pean Parliament regarding sensitive documents in accordance
`with arrangements agreed between the institutions.
`
`Article 10
`
`Access following an application
`
`The applicant shall have access to documents either by
`1.
`consulting them on the spot or by receiving a copy, including,
`where available, an electronic copy, according to the applicant's
`preference. The cost of producing and sending copies may be
`charged to the applicant. This charge shall not exceed the real
`cost of producing and sending the copies. Consultation on the
`spot, copies of less than 20 A4 pages and direct access in
`electronic form or through the register shall be free of charge.
`
`If a document has already been released by the institution
`2.
`concerned and is easily accessible to the applicant, the institu-
`tion may fulfil its obligation of granting access to documents
`by informing the applicant how to obtain the requested
`document.
`
`Documents shall be supplied in an existing version and
`3.
`format (including electronically or in an alternative format such
`as Braille, large print or tape) with full regard to the applicant's
`preference.
`
`Article 11
`
`Registers
`
`To make citizens' rights under this Regulation effective,
`1.
`each institution shall provide public access to a register of
`documents. Access to the register should be provided in elec-
`tronic form. References to documents shall be recorded in the
`register without delay.
`
`For each document the register shall contain a reference
`2.
`number
`(including, where applicable,
`the interinstitutional
`reference), the subject matter and/or a short description of the
`content of the document and the date on which it was received
`or drawn up and recorded in the register. References shall be
`made in a manner which does not undermine protection of the
`interests in Article 4.
`
`immediately take the measures
`The institutions shall
`3.
`necessary to establish a register which shall be operational by
`3 June 2002.
`
`WATSON LABORATORIES, INC. , IPR2017-01621, Ex. 1052, p. 4 of 6
`
`

`

`31.5.2001
`
`EN
`
`Official Journal of the European Communities
`
`L 145/47
`
`Article 12
`
`Direct access in electronic form or through a register
`
`The institutions shall as far as possible make documents
`1.
`directly accessible to the public in electronic form or through a
`register
`in accordance with the rules of
`the institution
`concerned.
`
`In particular, legislative documents, that is to say, docu-
`2.
`ments drawn up or received in the course of procedures for the
`adoption of acts which are legally binding in or for the
`Member States, should, subject to Articles 4 and 9, be made
`directly accessible.
`
`3. Where possible, other documents, notably documents
`relating to the development of policy or strategy, should be
`made directly accessible.
`
`4. Where direct access is not given through the register, the
`register shall as far as possible indicate where the document is
`located.
`
`(c) directives other than those referred to in Article 254(1) and
`(2) of the EC Treaty, decisions other than those referred to
`in Article 254(1) of the EC Treaty, recommendations and
`opinions.
`
`Each institution may in its rules of procedure establish
`3.
`which further documents shall be published in the Official
`Journal.
`
`Article 14
`
`Information
`
`take the requisite measures to
`Each institution shall
`1.
`inform the public of
`the rights
`they enjoy under
`this
`Regulation.
`
`The Member States shall cooperate with the institutions
`2.
`in providing information to the citizens.
`
`Article 13
`
`Administrative practice in the institutions
`
`Article 15
`
`Publication in the Official Journal
`
`In addition to the acts referred to in Article 254(1) and
`1.
`(2) of the EC Treaty and the first paragraph of Article 163 of
`the Euratom Treaty, the following documents shall, subject to
`Articles 4 and 9 of this Regulation, be published in the Official
`Journal:
`
`(a) Commission proposals;
`
`(b) common positions adopted by the Council in accordance
`with the procedures referred to in Articles 251 and 252 of
`the EC Treaty and the reasons underlying those common
`positions, as well as the European Parliament's positions in
`these procedures;
`
`(c) framework decisions and decisions referred to in Article
`34(2) of the EU Treaty;
`
`(d) conventions established by the Council in accordance with
`Article 34(2) of the EU Treaty;
`
`(e) conventions signed between Member States on the basis of
`Article 293 of the EC Treaty;
`
`(f) international agreements concluded by the Community or
`in accordance with Article 24 of the EU Treaty.
`
`As far as possible, the following documents shall be
`2.
`published in the Official Journal:
`
`The institutions shall develop good administrative prac-
`1.
`tices in order to facilitate the exercise of the right of access
`guaranteed by this Regulation.
`
`establish an interinstitutional
`shall
`institutions
`The
`2.
`committee to examine best practice, address possible conflicts
`and discuss
`future developments on public
`access
`to
`documents.
`
`Article 16
`
`Reproduction of documents
`
`This Regulation shall be without prejudice to any existing rules
`on copyright which may limit a third party's right to reproduce
`or exploit released documents.
`
`Article 17
`
`Reports
`
`Each institution shall publish annually a report for the
`1.
`preceding year including the number of cases in which the
`institution refused to grant access to documents, the reasons
`for such refusals and the number of sensitive documents not
`recorded in the register.
`
`(a) initiatives presented to the Council by a Member State
`pursuant to Article 67(1) of the EC Treaty or pursuant to
`Article 34(2) of the EU Treaty;
`
`(b) common positions referred to in Article 34(2) of the EU
`Treaty;
`
`At the latest by 31 January 2004, the Commission shall
`2.
`publish a report on the implementation of the principles of this
`Regulation and shall make recommendations,
`including,
`if
`appropriate, proposals for the revision of this Regulation and
`an action programme of measures
`to be taken by the
`institutions.
`
`WATSON LABORATORIES, INC. , IPR2017-01621, Ex. 1052, p. 5 of 6
`
`

`

`L 145/48
`
`EN
`
`Official Journal of the European Communities
`
`31.5.2001
`
`Article 18
`
`Application measures
`
`Each institution shall adapt its rules of procedure to the
`1.
`provisions of this Regulation. The adaptations shall take effect
`from 3 December 2001.
`
`2. Within six months of the entry into force of this Regula-
`tion, the Commission shall examine the conformity of Council
`Regulation (EEC, Euratom) No 354/83 of 1 February 1983
`concerning the opening to the public of the historical archives
`of
`the European Economic Community and the European
`Atomic Energy Community (1) with this Regulation in order to
`
`ensure the preservation and archiving of documents to the
`fullest extent possible.
`3. Within six months of the entry into force of this Regula-
`tion, the Commission shall examine the conformity of the
`existing rules on access to documents with this Regulation.
`
`Article 19
`Entry into force
`This Regulation shall enter
`into force on the third day
`following that of its publication in the Official Journal of the
`European Communities.
`It shall be applicable from 3 December 2001.
`
`This Regulation shall be binding in its entirety and directly applicable in all Member States.
`
`Done at Brussels, 30 May 2001.
`
`For the European Parliament
`The President
`N. FONTAINE
`
`For the Council
`The President
`B. LEJON
`
`(1) OJ L 43, 15.2.1983, p. 1.
`
`WATSON LABORATORIES, INC. , IPR2017-01621, Ex. 1052, p. 6 of 6
`
`

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