Output of the European Medicines Agency policy on access to documents related to corporate documents

Transcription

1 09 February 2017 EMA/183710/ Output the European Medicines Agency policy on access to s related to corporate s Introductory remarks Aim the This needs to be read in conjunction with the following s: Regulation (EC) 1049/2001 the European Parliament and the Council 30 May 2001 regarding public access to European Parliament, Council and Commission s. European Medicines Agency policy on access to s (EMA/729522/2016). This, which contains guidance for the application Regulation (EC) 1049/2001 to corporate s held by the EMA, is not legally binding. For any not listed, access will be granted or refused in accordance with the principles outlined in the European Medicines Agency policy on access to s. It should also be noted that EMA has not listed all corporate s that it holds, but rather those for which it has received more requests, as well as the main corporate s which are available on its webpage. Therefore, this should be considered as 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone +44 (0) Facsimile +44 (0) Send a question via our website An agency the European Union European Medicines Agency, Reproduction is authorised provided the source is acknowledged.

2 a living which will be updated on a continuous basis taking into account further experience, as well as the legal interpretation Regulation (EC) 1049/2001 given by the European Court Justice. For s related to human and veterinary products, please refer to the Output the European Medicines Agency policy on access to s related to medicinal products for human and veterinary use (EMA/127362/2006, Rev. 1). This lists a number types which may be subject to requests for access to s. 1. Procurement related s These types have been classified according to the phase the procurement, as follows: 1.1. Documents in relation to the launch the procurement 1.2. Documents in relation to the submission and opening requests to participate 1.3. Documents in relation to the submission and opening tenders 1.4. Documents in relation to the evaluation tenders 1.5. Documents in relation to the award and signature contract or cancellation It should be noted that access to s and/or information concerning procurement s made by specific parties (candidates and/or tenderers) in the at different stages is regulated by the EMA Financial Regulation, making reference to Title V Financial Regulation (EU, Euratom) 966/2012 and Delegated Regulation (EU) 1268/2012. This refers to the general right access to s made under Regulation (EC) 1049/ Conflicts interest declarations 3. SOPs and WINs 4. Corporate s available on the EMA s website EMA/127362/2006 Page 2/15

3 Abbreviations CCI Commercial confidential information PPD Protection personal data R Releasable n-r n-releasable EMA/127362/2006 Page 3/15

4 Procurement Launch the procurement 39. Pre-information notice (PIN) Published on EMA website Yes t applicable t applicable 40. Justification for using a negotiated n-r before the is launched Art st t applicable 41. R after the is launched Yes t applicable t applicable Yes (PPD) 42. Contract notice Published on EMA website Yes t applicable t applicable Submission and opening requests to participate 44. List candidates who submitted a request to n-r until the deadline Art st Art (a) t applicable participate in a restricted or for receipt for tenders has competitive with negotiation or elapsed or until negotiated cancellation the EMA/127362/2006 Page 4/15

5 45. R after the deadline for receipt for tenders has elapsed or until cancellation the, except for the names natural persons or names firms identifying one or more natural persons Yes t applicable t applicable Yes (PPD) 46. Requests to participate Yes n-r until contract Art st t applicable 47. R after contract signature or cancellation Yes t applicable t applicable Yes (PPD and CCI) 48. Written record the opening requests to n-r before deadline for Art st Art. 4.1 (a) t applicable participate receipt tenders has elapsed or cancellation the EMA/127362/2006 Page 5/15

6 49. R after deadline for receipt tenders has elapsed or cancellation the Yes t applicable t applicable Yes (PPD) 50. Written record the evaluation requests to n-r contract Art st t applicable participate the 51. R after contract signature or cancellation Yes t applicable t applicable Yes (PPD and CCI) 52. Procurement s (notice, invitation to n-r launch Art st t applicable tender, tender specifications, terms EMA/127362/2006 Page 6/15

7 53. reference and draft contract) R after launch Yes t applicable t applicable Yes (CCI, including those cases where the exception on confidentiality Art. 153(1) the rules implementation the Financial Regulation applies) 54. Additional information, questions & answers n-r publication information or information made available to candidates or tenderers Art st Unfair treatment tenderers t applicable EMA/127362/2006 Page 7/15

8 55. R from publication or information made available to candidates or tenderers Yes t applicable t applicable Yes (CCI, including those cases where the exception on confidentiality Art. 153(1) the rules implementation the Financial Regulation applies) Submission and opening tenders 57. Received tenders Yes n-r contract signature Art st Art st indent t applicable 58. n-r after contract Art st Art. 4.1 (a) t applicable signature indent 59. Decision appointing the committees for the n-r contract Art st Art st t applicable opening and evaluation tenders indent EMA/127362/2006 Page 8/15

9 60. R after contract signature or cancellation Yes t applicable t applicable Yes (PPD, including the names the members the committee) 61. Written record the opening tenders R Yes t applicable t applicable Yes (PPD) Evaluation tenders 63. Declarations on the absence conflicts interest and confidentiality signed by the evaluators R Yes t applicable t applicable Yes (PPD, including names the members the committee) EMA/127362/2006 Page 9/15

10 64. Clarification requested from tenderers during Yes n-r contract Art st Art st t applicable evaluation and their replies indent the 65. R after contract signature or cancellation the Yes t applicable t applicable Yes (PPD and CCI) 66. Evaluation report a n-r contract the Art st t applicable 67. R after contract signature or cancellation the Yes t applicable t applicable Yes (PPD and CCI) Award and signature contract or cancellation 69. Award decision n-r adoption the decision Art st t applicable a For tenderers, a degree privileged access right is provided for in Article 113(2) the Financial Rules applicable to the general budget the Union (Regulation (EU, EURATOM) 966/2012 the European Parliament and the Council), which are applicable to the EMA as per Article 85.1 the EMA s Financial Regulation applicable to the budget EMA adopted by the Management Board on 15 January Those requests are therefore not dealt with under the provisions the Regulation (EC) 1049/2001 on Access to Documents, but under the relevant provisions the Financial Regulation. EMA/127362/2006 Page 10/15

11 70. R after adoption the decision Yes t applicable t applicable Yes 71. tification contract award to the successful n-r contract Art st t applicable tenderer the 72. R after contract signature or cancellation the Yes t applicable t applicable Yes (PPD and CCI) 73. Contract and its annexes Yes n-r contract the Art st st indent t applicable 74. R after contract signature or cancellation the Yes t applicable t applicable Yes (PPD and CCI) 75. tifications contract award to unsuccessful n-r contract Art st t applicable tenderer the 76. R after contract signature or cancellation the Yes t applicable t applicable Yes (PPD and CCI) EMA/127362/2006 Page 11/15

12 77. Decision to cancel the R from signature the decision and information to the tenderers b Yes t applicable t applicable 78. tification to tenderers cancellation R from the notification to Yes t applicable t applicable Yes (PPD) tenderers having been made 79. Award cancellation notice Published on EMA website Yes t applicable t applicable Conflict interest declarations 81. Conflict interest declaration for staff - For EMA management: Yes t applicable t applicable current published on EMA website For all other EMA staff: R 82. Conflict interest declaration for staff - previous R Yes t applicable t applicable Yes (PPD) 83. Conflict interest declaration for experts - current Published on EMA website Yes t applicable t applicable b As soon as the decision is taken it must be communicated to tenderers. EMA/127362/2006 Page 12/15

13 84. Conflict interest declaration for experts - previous R Yes t applicable t applicable Yes (PPD) 85. Conflict interest declaration for Committee and Management Board Members - current Published on EMA website Yes t applicable t applicable 86. Conflict interest declaration for Committee and Management Board Members - previous R Yes t applicable t applicable Yes (PPD) SOPs and WINs 88. SOPs and WINs current version Published on EMA website Yes t applicable t applicable 89. SOPs and WINs previous versions R Yes t applicable t applicable Corporate s available on the EMA s website 91. Annual report Published on EMA website Yes t applicable t applicable 92. Work programme Published on EMA website Yes t applicable t applicable 93. Annual Budget Published on EMA website Yes t applicable t applicable EMA/127362/2006 Page 13/15

14 94. Report on budgetary and financial management Published on EMA website Yes t applicable t applicable 95. Annual accounts Published on EMA website Yes t applicable t applicable 96. European Court Auditors final report on the annual accounts the European Medicines Agency Published on EMA website Yes t applicable t applicable 97. Agendas and minutes the Management Board Published on EMA website Yes t applicable t applicable 1 2 Refers to any the EMA produces, receives or has in its possession. Means any natural or legal person, or any entity outside the EMA, including the Member States, other EU or non-eu Institutions and Bodies, and third countries. Either Yes or to be filled in. Yes may/shall lead to a consultation exercise with the third party (cfr. policy for further details) with a view to assessing whether an exception listed in Article 4 Regulation (EC) 1049/2011 is applicable, unless it is clear that the shall or shall not be disclosed. 3 Refers to classification in one the following categories: Releasable (R) or n-releasable (n-r). In certain situations the s are published on the EMA website. If this is the case, this will be indicated. 4 Either access to be granted (Yes) or to be refused (); in case third-party consultation the granting or not access will depend on the outcome such consultation. 5 Only to be filled in if access to EMA s is refused by virtue application one the exceptions mentioned in Article 4 Regulation (EC) 1049/2001, i.e. by referring to: Article 4.1.(a) The Agency shall refuse access to a where disclosure would undermine the protection the public interest as regards public security, defence and military matters, international relations, the financial, monetary or economic policy the EU or a Member State. Article 4.1.(b) The Agency shall refuse access to a where disclosure would undermine the protection privacy and the integrity the individual, in particular in accordance with EU legislation regarding the protection personal data. EMA/127362/2006 Page 14/15

15 Article st indent The Agency shall refuse access to a where disclosure would undermine the protection commercial interests a natural or legal person, including intellectual property. Article nd indent The Agency shall refuse access to a where disclosure would undermine the protection court proceedings and legal advice. Article rd indent The Agency shall refuse access to a where disclosure would undermine the protection the purpose inspections, investigations and audits. Article st paragraph process. Access to a, produced, received or in possession the Agency shall be refused if disclosure the would seriously undermine the decision-making Article nd paragraph Access to a containing opinions for internal use as part deliberations and preliminary consultations within the Agency shall be refused even after the decision has been taken if disclosure the would seriously undermine the Agency s decision-making process. 6 7 Additional justification to be provided in order to further elaborate on the rationale for not providing access as per the reference to the exceptions mentioned in Article 4. Redaction EMA s will be carried out to remove any reference to commercial confidential information or to personal data. EMA/127362/2006 Page 15/15