Chapter II - Re-use of certain categories of protected data held by public sector bodies (Art. 3-9)

Art. 3 DGA - Categories of data arrow_right_alt

This Chapter applies to data held by public sector bodies which are protected on grounds of:
1. commercial confidentiality, including business, professional and company secrets;
2. statistical confidentiality;
3. the protection of intellectual property rights of third parties; or
4. the protection of personal data, insofar as such data fall outside the scope of Directive (EU) 2019/1024.
This Chapter does not apply to:
1. data held by public undertakings;
2. data held by public service broadcasters and their subsidiaries, and by other bodies or their subsidiaries for the fulfilment of a public service broadcasting remit;
3. data held by cultural establishments and educational establishments;
4. data held by public sector bodies which are protected for reasons of public security, defence or national security; or
5. data the supply of which is an activity falling outside the scope of the public task of the public sector bodies concerned as defined by law or by other binding rules in the Member State concerned, or, in the absence of such rules, as defined in accordance with common administrative practice in that Member State, provided that the scope of the public tasks is transparent and subject to review.
This Chapter is without prejudice to:
1. Union and national law and international agreements to which the Union or Member States are party on the protection of categories of data referred to in paragraph 1; and
2. Union and national law on access to documents.

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Recital 10

The categories of data held by public sector bodies which should be subject to re-use under this Regulation fall outside the scope of Directive (EU) 2019/1024 that excludes data which is not accessible due to commercial and statistical confidentiality and data that is included in works or other subject matter over which third parties have intellectual property rights. Commercially confidential data includes data protected by trade secrets, protected know-how and any other information the undue disclosure of which would have an impact on the market position or financial health of the undertaking. This Regulation should apply to personal data that fall outside the scope of Directive (EU) 2019/1024 insofar as the access regime excludes or restricts access to such data for reasons of data protection, privacy and the integrity of the individual, in particular in accordance with data protection rules. The re-use of data, which may contain trade secrets, should take place without prejudice to Directive (EU) 2016/943, which sets out the framework for the lawful acquisition, use or disclosure of trade secrets.

Recital 11

This Regulation should not create an obligation to allow the re-use of data held by public sector bodies. In particular, each Member State should therefore be able to decide whether data is made accessible for re-use, also in terms of the purposes and scope of such access. This Regulation should complement and be without prejudice to more specific obligations on public sector bodies to allow re-use of data laid down in sector-specific Union or national law. Public access to official documents may be considered to be in the public interest. Taking into account the role of public access to official documents and transparency in a democratic society, this Regulation should also be without prejudice to Union or national law on granting access to and disclosing official documents. Access to official documents may in particular be granted in accordance with national law without imposing specific conditions or by imposing specific conditions that are not provided by this Regulation.

Recital 12

The re-use regime provided for in this Regulation should apply to data the supply of which forms part of the public tasks of the public sector bodies concerned under law or other binding rules in the Member States. In the absence of such rules, the public tasks should be defined in accordance with common administrative practice in the Member States, provided that the scope of the public tasks is transparent and subject to review. The public tasks could be defined generally or on a case-by-case basis for individual public sector bodies. As public undertakings are not covered by the definition of public sector body, the data held by public undertakings should not be covered by this Regulation. Data held by cultural establishments, such as libraries, archives and museums as well as orchestras, operas, ballets and theatres, and by educational establishments should not be covered by this Regulation since the works and other documents they hold are predominantly covered by third party intellectual property rights. Research-performing organisations and research-funding organisations could also be organised as public sector bodies or bodies governed by public law.

This Regulation should apply to such hybrid organisations only in their capacity as research-performing organisations. If a research-performing organisation holds data as a part of a specific public-private association with private sector organisations or other public sector bodies, bodies governed by public law or hybrid research-performing organisations, i.e. organised as either public sector bodies or public undertakings, with the main purpose of pursuing research, those data should also not be covered by this Regulation. Where relevant, Member States should be able to apply this Regulation to public undertakings or private undertakings that exercise public sector duties or provide services of general interest. The exchange of data, purely in pursuit of their public tasks, among public sector bodies in the Union or between public sector bodies in the Union and public sector bodies in third countries or international organisations, as well as the exchange of data between researchers for non-commercial scientific research purposes, should not be subject to the provisions of this Regulation concerning the re-use of certain categories of protected data held by public sector bodies.

Art. 4 DGA - Prohibition of exclusive arrangements arrow_right_alt

Agreements or other practices pertaining to the re-use of data held by public sector bodies containing categories of data referred to in Article 3(1) which grant exclusive rights or which have as their objective or effect to grant such exclusive rights or to restrict the availability of data for re-use by entities other than the parties to such agreements or other practices shall be prohibited.
By way of derogation from paragraph 1, an exclusive right to re-use data referred to in that paragraph may be granted to the extent necessary for the provision of a service or the supply of a product in the general interest that would not otherwise be possible.
An exclusive right as referred to in paragraph 2 shall be granted through an administrative act or contractual arrangement in accordance with applicable Union or national law and in compliance with the principles of transparency, equal treatment and non-discrimination.
The duration of an exclusive right to re-use data shall not exceed 12 months. Where a contract is concluded, the duration of the contract shall be the same as the duration of the exclusive right.
The grant of an exclusive right pursuant to paragraphs 2, 3 and 4, including the reasons as to why it is necessary to grant such a right, shall be transparent and be made publicly available online, in a form that complies with relevant Union law on public procurement.
Agreements or other practices falling within the scope of the prohibition referred to in paragraph 1 which do not meet the conditions laid down in paragraphs 2 and 3 and which were concluded before 23 June 2022 shall be terminated at the end of the applicable contract and in any event by 24 December 2024.

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Recital 13

Public sector bodies should comply with competition law when establishing the principles for re-use of data they hold, avoiding the conclusion of agreements which might have as their objective or effect the creation of exclusive rights for the re-use of certain data. Such agreements should be possible only where justified and necessary for the provision of a service or the supply of a product in the general interest. This may be the case where the exclusive use of the data is the only way to maximise the societal benefits of the data in question, for example where there is only one entity (which has specialised in the processing of a specific dataset) capable of providing the service or supplying the product which allows the public sector body to provide a service or supply a product in the general interest. Such arrangements should, however, be concluded in accordance with applicable Union or national law and be subject to regular review based on a market analysis in order to ascertain whether such exclusivity continues to be necessary. In addition, such arrangements should comply with the relevant State aid rules, as appropriate, and should be concluded for a limited duration which should not exceed 12 months. In order to ensure transparency, such exclusive agreements should be published online, in a form that complies with relevant Union law on public procurement. Where an exclusive right to re-use data does not comply with this Regulation, that exclusive right should be invalid.

Recital 14

Prohibited exclusive agreements and other practices or arrangements pertaining to the re-use of data held by public sector bodies which do not expressly grant exclusive rights but which can reasonably be expected to restrict the availability of data for re-use that have been concluded or were already in place before the date of entry into force of this Regulation should not be renewed after the expiry of their term. In the case of indefinite or longer-term agreements, they should be terminated within 30 months of the date of entry into force of this Regulation.

Art. 5 DGA - Conditions for re-use arrow_right_alt

Public sector bodies which are competent under national law to grant or refuse access for the re-use of one or more of the categories of data referred to in Article 3(1) shall make publicly available the conditions for allowing such re-use and the procedure to request the re-use via the single information point referred to in Article 8. Where they grant or refuse access for re-use, they may be assisted by the competent bodies referred to in Article 7(1).

Member States shall ensure that public sector bodies are equipped with the necessary resources to comply with this Article.

Conditions for re-use shall be non-discriminatory, transparent, proportionate and objectively justified with regard to the categories of data and the purposes of re-use and the nature of the data for which re-use is allowed. Those conditions shall not be used to restrict competition.
Public sector bodies shall, in accordance with Union and national law, ensure that the protected nature of data is preserved. They may provide for the following requirements:
1. to grant access for the re-use of data only where the public sector body or the competent body, following the request for re-use, has ensured that data has been:
  1. anonymised, in the case of personal data; and
  2. modified, aggregated or treated by any other method of disclosure control, in the case of commercially confidential information, including trade secrets or content protected by intellectual property rights;
2. to access and re-use the data remotely within a secure processing environment that is provided or controlled by the public sector body;
3. to access and re-use the data within the physical premises in which the secure processing environment is located in accordance with high security standards, provided that remote access cannot be allowed without jeopardising the rights and interests of third parties.
In the case of re-use allowed in accordance with paragraph 3, points (b) and (c), the public sector bodies shall impose conditions that preserve the integrity of the functioning of the technical systems of the secure processing environment used. The public sector body shall reserve the right to verify the process, the means and any results of processing of data undertaken by the re-user to preserve the integrity of the protection of the data and reserve the right to prohibit the use of results that contain information jeopardising the rights and interests of third parties. The decision to prohibit the use of the results shall be comprehensible and transparent to the re-user.
Unless national law provides for specific safeguards on applicable confidentiality obligations relating to the re-use of data referred to in Article 3(1), the public sector body shall make the re-use of data provided in accordance with paragraph 3 of this Article conditional on the adherence by the re-user to a confidentiality obligation that prohibits the disclosure of any information that jeopardises the rights and interests of third parties that the re-user may have acquired despite the safeguards put in place. Re-users shall be prohibited from re-identifying any data subject to whom the data relates and shall take technical and operational measures to prevent re-identification and to notify any data breach resulting in the re-identification of the data subjects concerned to the public sector body. In the event of the unauthorised re-use of non-personal data, the re-user shall, without delay, where appropriate with the assistance of the public sector body, inform the legal persons whose rights and interests may be affected.
Where the re-use of data cannot be allowed in accordance with the obligations laid down in paragraphs 3 and 4 of this Article and there is no legal basis for transmitting the data under Regulation (EU) 2016/679, the public sector body shall make best efforts, in accordance with Union and national law, to provide assistance to potential re-users in seeking consent of the data subjects or permission from the data holders whose rights and interests may be affected by such re-use, where it is feasible without a disproportionate burden on the public sector body. Where it provides such assistance, the public sector body may be assisted by the competent bodies referred to in Article 7(1).
Re-use of data shall be allowed only in compliance with intellectual property rights. The right of the maker of a database as provided for in Article 7(1) of Directive 96/9/EC shall not be exercised by public sector bodies in order to prevent the re-use of data or to restrict re-use beyond the limits set by this Regulation.
Where data requested is considered to be confidential, in accordance with Union or national law on commercial or statistical confidentiality, the public sector bodies shall ensure that the confidential data is not disclosed as a result of allowing re-use, unless such re-use is allowed in accordance with paragraph 6.
Where a re-user intends to transfer non-personal data protected on the grounds set out in Article 3(1) to a third country, it shall inform the public sector body of its intention to transfer such data and the purpose of such transfer at the time of requesting the re-use of such data. In the case of re-use in accordance with paragraph 6 of this Article, the re-user shall, where appropriate with the assistance of the public sector body, inform the legal person whose rights and interests may be affected of that intention, purpose and the appropriate safeguards. The public sector body shall not allow the re-use unless the legal person gives permission for the transfer.
Public sector bodies shall transmit non-personal confidential data or data protected by intellectual property rights to a re-user which intends to transfer those data to a third country other than a country designated in accordance with paragraph 12 only if the re-user contractually commits to:
1. complying with the obligations imposed in accordance with paragraphs 7 and 8 even after the data is transferred to the third country; and
2. accepting the jurisdiction of the courts or tribunals of the Member State of the transmitting public sector body with regard to any dispute related to compliance with paragraphs 7 and 8.
Public sector bodies shall, where relevant and to the extent of their capabilities, provide guidance and assistance to re-users in complying with the obligations referred to in paragraph 10 of this Article.

In order to assist public sector bodies and re-users, the Commission may adopt implementing acts establishing model contractual clauses for complying with the obligations referred to in paragraph 10 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 33(3).

Where justified because of the substantial number of requests across the Union concerning the re-use of non-personal data in specific third countries, the Commission may adopt implementing acts declaring that the legal, supervisory and enforcement arrangements of a third country:
1. ensure protection of intellectual property and trade secrets in a way that is essentially equivalent to the protection ensured under Union law;
2. are being effectively applied and enforced; and
3. provide effective judicial redress.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 33(3).

Specific Union legislative acts may deem certain non-personal data categories held by public sector bodies to be highly sensitive for the purposes of this Article where their transfer to third countries may put at risk Union public policy objectives, such as safety and public health or may lead to the risk of re-identification of non-personal, anonymised data. Where such an act is adopted, the Commission shall adopt delegated acts in accordance with Article 32 supplementing this Regulation by laying down special conditions applicable to the transfers of such data to third countries.

Those special conditions shall be based on the nature of the non-personal data categories identified in the specific Union legislative act and on the grounds for deeming those categories to be highly sensitive, taking into account the risks of re-identification of non-personal, anonymised data. They shall be non-discriminatory and limited to what is necessary to achieve the Union public policy objectives identified in that act, in accordance with the Union’s international obligations.

If required by specific Union legislative acts as referred to in the first subparagraph, such special conditions may include terms applicable for the transfer or technical arrangements in this regard, limitations with regard to the re-use of data in third countries or categories of persons entitled to transfer such data to third countries or, in exceptional cases, restrictions with regard to transfers to third countries.

The natural or legal person to which the right to re-use non-personal data was granted may transfer the data only to those third countries for which the requirements in paragraphs 10, 12 and 13 are met.

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Recital 12

The re-use regime provided for in this Regulation should apply to data the supply of which forms part of the public tasks of the public sector bodies concerned under law or other binding rules in the Member States. In the absence of such rules, the public tasks should be defined in accordance with common administrative practice in the Member States, provided that the scope of the public tasks is transparent and subject to review. The public tasks could be defined generally or on a case-by-case basis for individual public sector bodies. As public undertakings are not covered by the definition of public sector body, the data held by public undertakings should not be covered by this Regulation. Data held by cultural establishments, such as libraries, archives and museums as well as orchestras, operas, ballets and theatres, and by educational establishments should not be covered by this Regulation since the works and other documents they hold are predominantly covered by third party intellectual property rights. Research-performing organisations and research-funding organisations could also be organised as public sector bodies or bodies governed by public law.

This Regulation should apply to such hybrid organisations only in their capacity as research-performing organisations. If a research-performing organisation holds data as a part of a specific public-private association with private sector organisations or other public sector bodies, bodies governed by public law or hybrid research-performing organisations, i.e. organised as either public sector bodies or public undertakings, with the main purpose of pursuing research, those data should also not be covered by this Regulation. Where relevant, Member States should be able to apply this Regulation to public undertakings or private undertakings that exercise public sector duties or provide services of general interest. The exchange of data, purely in pursuit of their public tasks, among public sector bodies in the Union or between public sector bodies in the Union and public sector bodies in third countries or international organisations, as well as the exchange of data between researchers for non-commercial scientific research purposes, should not be subject to the provisions of this Regulation concerning the re-use of certain categories of protected data held by public sector bodies.

Recital 13

Public sector bodies should comply with competition law when establishing the principles for re-use of data they hold, avoiding the conclusion of agreements which might have as their objective or effect the creation of exclusive rights for the re-use of certain data. Such agreements should be possible only where justified and necessary for the provision of a service or the supply of a product in the general interest. This may be the case where the exclusive use of the data is the only way to maximise the societal benefits of the data in question, for example where there is only one entity (which has specialised in the processing of a specific dataset) capable of providing the service or supplying the product which allows the public sector body to provide a service or supply a product in the general interest. Such arrangements should, however, be concluded in accordance with applicable Union or national law and be subject to regular review based on a market analysis in order to ascertain whether such exclusivity continues to be necessary. In addition, such arrangements should comply with the relevant State aid rules, as appropriate, and should be concluded for a limited duration which should not exceed 12 months. In order to ensure transparency, such exclusive agreements should be published online, in a form that complies with relevant Union law on public procurement. Where an exclusive right to re-use data does not comply with this Regulation, that exclusive right should be invalid.

Recital 14

Prohibited exclusive agreements and other practices or arrangements pertaining to the re-use of data held by public sector bodies which do not expressly grant exclusive rights but which can reasonably be expected to restrict the availability of data for re-use that have been concluded or were already in place before the date of entry into force of this Regulation should not be renewed after the expiry of their term. In the case of indefinite or longer-term agreements, they should be terminated within 30 months of the date of entry into force of this Regulation.

Recital 15

This Regulation should lay down conditions for re-use of protected data that apply to public sector bodies designated as competent under national law to grant or refuse access for re-use, and which are without prejudice to rights or obligations concerning access to such data. Those conditions should be non-discriminatory, transparent, proportionate and objectively justified, while not restricting competition, with a specific focus on promoting access to such data by SMEs and start-ups. The conditions for re-use should be designed in a manner promoting scientific research so that, for example, privileging scientific research should, as a rule, be considered to be non-discriminatory. Public sector bodies allowing re-use should have in place the technical means necessary to ensure the protection of rights and interests of third parties and should be empowered to request the necessary information from the re-user. Conditions attached to the re-use of data should be limited to what is necessary to preserve the rights and interests of third parties in the data and the integrity of the information technology and communication systems of the public sector bodies. Public sector bodies should apply conditions which best serve the interests of the re-user without leading to a disproportionate burden on the public sector bodies. Conditions attached to the re-use of data should be designed to ensure effective safeguards with regard to the protection of personal data. Before transmission, personal data should be anonymised, in order not to allow the identification of the data subjects, and data containing commercially confidential information should be modified in such a way that no confidential information is disclosed. Where the provision of anonymised or modified data would not respond to the needs of the re-user, subject to fulfilling any requirements to carry out a data protection impact assessment and consult the supervisory authority pursuant to Articles 35 and 36 of Regulation (EU) 2016/679 and where the risks to the rights and interests of data subjects have been found to be minimal, on-premise or remote re-use of the data within a secure processing environment could be allowed.

This could be a suitable arrangement for the re-use of pseudonymised data. Data analyses in such secure processing environments should be supervised by the public sector body, so as to protect the rights and interests of third parties. In particular, personal data should be transmitted to a third party for re-use only where a legal basis under data protection law allows such transmission. Non-personal data should be transmitted only where there is no reason to believe that the combination of non-personal data sets would lead to the identification of data subjects. This should also apply to pseudonymised data which retain their status as personal data. In the event of the reidentification of data subjects, an obligation to notify such a data breach to the public sector body should apply in addition to an obligation to notify such a data breach to a supervisory authority and to the data subject in accordance with Regulation (EU) 2016/679. Where relevant, the public sector bodies should facilitate the re-use of data on the basis of the consent of data subjects or the permission of data holders on the re-use of data pertaining to them through adequate technical means. In that respect, the public sector body should make best efforts to provide assistance to potential re-users in seeking such consent or permission by establishing technical mechanisms that permit transmitting requests for consent or permission from re-users, where practically feasible. No contact information should be given that allows re-users to contact data subjects or data holders directly. Where the public sector body transmits a request for consent or permission, it should ensure that the data subject or data holder is clearly informed of the possibility to refuse consent or permission.

Recital 17

The intellectual property rights of third parties should not be affected by this Regulation. This Regulation should neither affect the existence or ownership of intellectual property rights of public sector bodies nor limit the exercise of those rights in any way. The obligations imposed in accordance with this Regulation should apply only insofar as they are compatible with international agreements on the protection of intellectual property rights, in particular the Berne Convention for the Protection of Literary and Artistic Works (Berne Convention), the Agreement on Trade-related Aspects of Intellectual Property Rights (TRIPS Agreement) and the World Intellectual Property Organization Copyright Treaty (WCT), and Union or national intellectual property law. Public sector bodies should, however, exercise their copyright in a way that facilitates re-use.

Recital 21

Appropriate safeguards should also be considered to be implemented where, in the third country to which non-personal data is being transferred, there are equivalent measures in place which ensure that data benefit from a level of protection similar to that applicable by means of Union law, in particular with regard to the protection of trade secrets and intellectual property rights. To that end, the Commission should be able to declare, by means of implementing acts, where justified because of the substantial number of requests across the Union concerning the re-use of non-personal data in specific third countries, that a third country provides a level of protection that is essentially equivalent to that provided by Union law. The Commission should assess the necessity of such implementing acts on the basis of information provided by the Member States through the European Data Innovation Board. Such implementing acts would reassure public sector bodies that re-use of data held by public sector bodies in the third country concerned would not compromise the protected nature of that data. The assessment of the level of protection afforded in the third country concerned should, in particular, take into consideration the relevant general and sectoral law, including on public security, defence, national security and criminal law, concerning access to and protection of non-personal data, any access by the public sector bodies of that third country to the data transferred, the existence and effective functioning of one or more independent supervisory authorities in the third country with responsibility for ensuring and enforcing compliance with the legal regime ensuring access to such data, the third country’s international commitments regarding the protection of data, or other obligations arising from legally binding conventions or instruments as well as from its participation in multilateral or regional systems.

The existence of effective legal remedies for data holders, public sector bodies or data intermediation services providers in the third country concerned is of particular importance in the context of the transfer of non-personal data to that third country. Such safeguards should therefore include the availability of enforceable rights and of effective legal remedies. Such implementing acts should be without prejudice to any legal obligation or contractual arrangements already undertaken by a re-user in the interest of the protection of non-personal data, in particular industrial data, and to the right of public sector bodies to oblige re-users to comply with conditions for re-use, in accordance with this Regulation.

Recital 22

Some third countries adopt laws, regulations and other legal acts which aim to directly transfer or provide governmental access to non-personal data in the Union under the control of natural and legal persons under the jurisdiction of the Member States. Decisions and judgments of third-country courts or tribunals or decisions of third-country administrative authorities requiring such transfer of or access to non-personal data should be enforceable where they are based on an international agreement, such as a mutual legal assistance treaty, in force between the requesting third country and the Union or a Member State. In some cases, situations may arise where the obligation to transfer or provide access to non-personal data arising from a third country law conflicts with a competing obligation to protect such data under Union or national law, in particular with regard to the protection of the fundamental rights of the individual or of the fundamental interests of a Member State related to national security or defence, as well as the protection of commercially sensitive data and the protection of intellectual property rights, including contractual undertakings regarding confidentiality in accordance with such law. In the absence of international agreements regulating such matters, the transfer of or access to non-personal data should be allowed only if, in particular, it has been verified that the third-country’s legal system requires the reasons and proportionality of the decision or judgment to be set out, that the decision or judgment is specific in character, and that the reasoned objection of the addressee is subject to a review by a competent third-country court or tribunal, which is empowered to take duly into account the relevant legal interests of the provider of such data.

Moreover, public sector bodies, natural or legal persons to which the right to re-use data was granted, data intermediation services providers and recognised data altruism organisations should ensure, where they sign contractual agreements with other private parties, that non-personal data held in the Union are accessed in or transferred to third countries only in accordance with Union law or the national law of the relevant Member State.

Art. 6 DGA - Fees arrow_right_alt

Public sector bodies which allow re-use of the categories of data referred to in Article 3(1) may charge fees for allowing the re-use of such data.
Any fees charged pursuant to paragraph 1 shall be transparent, non-discriminatory, proportionate and objectively justified and shall not restrict competition.
Public sector bodies shall ensure that any fees can also be paid online through widely available cross-border payment services, without discrimination based on the place of establishment of the payment service provider, the place of issue of the payment instrument or the location of the payment account within the Union.
Where public sector bodies charge fees, they shall take measures to provide incentives for the re-use of the categories of data referred to in Article 3(1) for non-commercial purposes, such as scientific research purposes, and by SMEs and start-ups in accordance with State aid rules. In that regard, public sector bodies may also make the data available at a discounted fee or free of charge, in particular to SMEs and start-ups, civil society and educational establishments. To that end, public sector bodies may establish a list of categories of re-users to which data for re-use is made available at a discounted fee or free of charge. That list, together with the criteria used to establish it, shall be made public.
Any fees shall be derived from the costs related to conducting the procedure for requests for the re-use of the categories of data referred to in Article 3(1) and limited to the necessary costs in relation to:
1. the reproduction, provision and dissemination of data;
2. the clearance of rights;
3. anonymisation or other forms of preparation of personal data and commercially confidential data as provided for in Article 5(3);
4. the maintenance of the secure processing environment;
5. the acquisition of the right to allow re-use in accordance with this Chapter by third parties outside the public sector; and
6. assisting re-users in seeking consent from data subjects and permission from data holders whose rights and interests may be affected by such re-use.
The criteria and methodology for calculating fees shall be laid down by the Member States and published. The public sector body shall publish a description of the main categories of costs and the rules used for the allocation of costs.

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Recital 25

Public sector bodies should be able to charge fees for the re-use of data but should also be able to allow re-use at a discounted fee or free of charge, for example for certain categories of re-use such as non-commercial re-use for scientific research purposes, or re-use by SMEs and start-ups, civil society and educational establishments, so as to provide incentives for such re-use in order to stimulate research and innovation and support undertakings that are an important source of innovation and typically find it more difficult to collect relevant data themselves, in accordance with State aid rules. In that specific context, scientific research purposes should be understood to include any type of research-related purpose regardless of the organisational or financial structure of the research institution in question, with the exception of research that is being conducted by an undertaking with the aim of developing, enhancing or optimising products or services. Such fees should be transparent, non-discriminatory and limited to the necessary costs incurred and should not restrict competition. A list of categories of re-users to which a discounted fee or no charge applies, together with the criteria used to establish that list, should be made public.

Art. 7 DGA - Competent bodies arrow_right_alt

For the purpose of carrying out the tasks referred to in this Article, each Member State shall designate one or more competent bodies, which may be competent for particular sectors, to assist the public sector bodies which grant or refuse access for the re-use of the categories of data referred to in Article 3(1). Member States may either establish one or more new competent bodies or rely on existing public sector bodies or on internal services of public sector bodies that fulfil the conditions laid down in this Regulation.
The competent bodies may be empowered to grant access for the re-use of the categories of data referred to in Article 3(1) pursuant to Union or national law which provides for such access to be granted. Where they grant or refuse access for the re-use, Articles 4, 5, 6 and 9 shall apply to those competent bodies.
The competent bodies shall have adequate legal, financial, technical and human resources to carry out the tasks assigned to them, including the necessary technical knowledge to be able to comply with relevant Union or national law concerning the access regimes for the categories of data referred to in Article 3(1).
The assistance provided for in paragraph 1 shall include, where necessary:
1. providing technical support by making available a secure processing environment for providing access for the re-use of data;
2. providing guidance and technical support on how to best structure and store data to make that data easily accessible;
3. providing technical support for pseudonymisation and ensuring data processing in a manner that effectively preserves the privacy, confidentiality, integrity and accessibility of the information contained in the data for which re-use is allowed, including techniques for the anonymisation, generalisation, suppression and randomisation of personal data or other state-of-the-art privacy-preserving methods, and the deletion of commercially confidential information, including trade secrets or content protected by intellectual property rights;
4. assisting the public sector bodies, where relevant, to provide support to re-users in requesting consent for re-use from data subjects or permission from data holders in line with their specific decisions, including on the jurisdiction in which the data processing is intended to take place and assisting the public sector bodies in establishing technical mechanisms that allow the transmission of requests for consent or permission from re-users, where practically feasible;
5. providing public sector bodies with assistance in assessing the adequacy of contractual commitments made by a re-user pursuant to Article 5(10).
Each Member State shall notify the Commission of the identity of the competent bodies designated pursuant to paragraph 1 by 24 September 2023. Each Member State shall also notify the Commission of any subsequent change to the identity of those competent bodies.

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Recital 26

In order to provide incentives for the re-use of specific categories of data held by public sector bodies, Member States should establish a single information point to act as an interface for re-users that seek to re-use that data. It should have a cross-sector remit, and should complement, if necessary, arrangements at the sectoral level. The single information point should be able to rely on automated means where it transmits enquiries or requests for re-use. Sufficient human oversight should be ensured in the transmission process. For that purpose existing practical arrangements such as open data portals could be used. The single information point should have an asset list containing an overview of all available data resources including, where relevant, those data resources that are available at sectoral, regional or local information points, with relevant information describing the available data. In addition, Member States should designate, establish or facilitate the establishment of competent bodies to support the activities of public sector bodies allowing re-use of certain categories of protected data. Their tasks may include granting access to data, where mandated under sectoral Union or national law. Those competent bodies should provide assistance to public sector bodies with state-of-the-art techniques, including on how to best structure and store data to make data easily accessible, in particular through application programming interfaces, as well as make data interoperable, transferable and searchable, taking into account best practices for data processing, as well as any existing regulatory and technical standards and secure data processing environments, which allow data analysis in a manner that preserves the privacy of the information.

The competent bodies should act in accordance with the instructions received from the public sector body. Such an assistance structure could assist the data subjects and data holders with management of the consent or permission for re-use, including consent and permission to certain areas of scientific research where in keeping with recognised ethical standards for scientific research. The competent bodies should not have a supervisory function, which is reserved for supervisory authorities under Regulation (EU) 2016/679. Without prejudice to the supervisory powers of data protection authorities, data processing should be carried out under the responsibility of the public sector body responsible for the register containing the data, which remains a data controller as defined in Regulation (EU) 2016/679 insofar as personal data are concerned. Member States should be able to have one or more competent bodies, which could act in different sectors. The internal services of public sector bodies could also act as competent bodies. A competent body could be a public sector body assisting other public sector bodies in allowing re-use of data, where relevant, or a public sector body allowing re-use itself. Assisting other public sector bodies should entail informing them, upon request, about best practices on how to fulfil the requirements laid down in this Regulation such as the technical means to make a secure processing environment available or the technical means to ensure privacy and confidentiality where access to re-use of data within the scope of this Regulation is provided.

Art. 8 DGA - Single information points arrow_right_alt

Member States shall ensure that all relevant information concerning the application of Articles 5 and 6 is available and easily accessible through a single information point. Member States shall establish a new body or designate an existing body or structure as the single information point. The single information point may be linked to sectoral, regional or local information points. The functions of the single information point may be automated provided that the public sector body ensures adequate support.
The single information point shall be competent to receive enquiries or requests for the re-use of the categories of data referred to in Article 3(1) and shall transmit them, where possible and appropriate by automated means, to the competent public sector bodies, or the competent bodies referred to in Article 7(1), where relevant. The single information point shall make available by electronic means a searchable asset list containing an overview of all available data resources including, where relevant, those data resources that are available at sectoral, regional or local information points, with relevant information describing the available data, including at least the data format and size and the conditions for their re-use.
The single information point may establish a separate, simplified and well-documented information channel for SMEs and start-ups, addressing their needs and capabilities in requesting the re-use of the categories of data referred to in Article 3(1).
The Commission shall establish a European single access point offering a searchable electronic register of data available in the national single information points and further information on how to request data via those national single information points.

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Recital 26

In order to provide incentives for the re-use of specific categories of data held by public sector bodies, Member States should establish a single information point to act as an interface for re-users that seek to re-use that data. It should have a cross-sector remit, and should complement, if necessary, arrangements at the sectoral level. The single information point should be able to rely on automated means where it transmits enquiries or requests for re-use. Sufficient human oversight should be ensured in the transmission process. For that purpose existing practical arrangements such as open data portals could be used. The single information point should have an asset list containing an overview of all available data resources including, where relevant, those data resources that are available at sectoral, regional or local information points, with relevant information describing the available data. In addition, Member States should designate, establish or facilitate the establishment of competent bodies to support the activities of public sector bodies allowing re-use of certain categories of protected data. Their tasks may include granting access to data, where mandated under sectoral Union or national law. Those competent bodies should provide assistance to public sector bodies with state-of-the-art techniques, including on how to best structure and store data to make data easily accessible, in particular through application programming interfaces, as well as make data interoperable, transferable and searchable, taking into account best practices for data processing, as well as any existing regulatory and technical standards and secure data processing environments, which allow data analysis in a manner that preserves the privacy of the information.

The competent bodies should act in accordance with the instructions received from the public sector body. Such an assistance structure could assist the data subjects and data holders with management of the consent or permission for re-use, including consent and permission to certain areas of scientific research where in keeping with recognised ethical standards for scientific research. The competent bodies should not have a supervisory function, which is reserved for supervisory authorities under Regulation (EU) 2016/679. Without prejudice to the supervisory powers of data protection authorities, data processing should be carried out under the responsibility of the public sector body responsible for the register containing the data, which remains a data controller as defined in Regulation (EU) 2016/679 insofar as personal data are concerned. Member States should be able to have one or more competent bodies, which could act in different sectors. The internal services of public sector bodies could also act as competent bodies. A competent body could be a public sector body assisting other public sector bodies in allowing re-use of data, where relevant, or a public sector body allowing re-use itself. Assisting other public sector bodies should entail informing them, upon request, about best practices on how to fulfil the requirements laid down in this Regulation such as the technical means to make a secure processing environment available or the technical means to ensure privacy and confidentiality where access to re-use of data within the scope of this Regulation is provided.

Art. 9 DGA - Procedure for requests for re-use arrow_right_alt

Unless shorter time limits have been established in accordance with national law, the competent public sector bodies or the competent bodies referred to in Article 7(1) shall adopt a decision on the request for the re-use of the categories of data referred to in Article 3(1) within two months of the date of receipt of the request.

In the case of exceptionally extensive and complex requests for re-use, that two-month period may be extended by up to 30 days. In such cases the competent public sector bodies or the competent bodies referred to in Article 7(1) shall notify the applicant as soon as possible that more time is needed for conducting the procedure, together with the reasons for the delay.

Any natural or legal person directly affected by a decision as referred to in paragraph 1 shall have an effective right of redress in the Member State where the relevant body is located. Such a right of redress shall be laid down in national law and shall include the possibility of review by an impartial body with the appropriate expertise, such as the national competition authority, the relevant access-to-documents authority, the supervisory authority established in accordance with Regulation (EU) 2016/679 or a national judicial authority, whose decisions are binding upon the public sector body or the competent body concerned.

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Recital 15

This Regulation should lay down conditions for re-use of protected data that apply to public sector bodies designated as competent under national law to grant or refuse access for re-use, and which are without prejudice to rights or obligations concerning access to such data. Those conditions should be non-discriminatory, transparent, proportionate and objectively justified, while not restricting competition, with a specific focus on promoting access to such data by SMEs and start-ups. The conditions for re-use should be designed in a manner promoting scientific research so that, for example, privileging scientific research should, as a rule, be considered to be non-discriminatory. Public sector bodies allowing re-use should have in place the technical means necessary to ensure the protection of rights and interests of third parties and should be empowered to request the necessary information from the re-user. Conditions attached to the re-use of data should be limited to what is necessary to preserve the rights and interests of third parties in the data and the integrity of the information technology and communication systems of the public sector bodies. Public sector bodies should apply conditions which best serve the interests of the re-user without leading to a disproportionate burden on the public sector bodies. Conditions attached to the re-use of data should be designed to ensure effective safeguards with regard to the protection of personal data. Before transmission, personal data should be anonymised, in order not to allow the identification of the data subjects, and data containing commercially confidential information should be modified in such a way that no confidential information is disclosed. Where the provision of anonymised or modified data would not respond to the needs of the re-user, subject to fulfilling any requirements to carry out a data protection impact assessment and consult the supervisory authority pursuant to Articles 35 and 36 of Regulation (EU) 2016/679 and where the risks to the rights and interests of data subjects have been found to be minimal, on-premise or remote re-use of the data within a secure processing environment could be allowed.

This could be a suitable arrangement for the re-use of pseudonymised data. Data analyses in such secure processing environments should be supervised by the public sector body, so as to protect the rights and interests of third parties. In particular, personal data should be transmitted to a third party for re-use only where a legal basis under data protection law allows such transmission. Non-personal data should be transmitted only where there is no reason to believe that the combination of non-personal data sets would lead to the identification of data subjects. This should also apply to pseudonymised data which retain their status as personal data. In the event of the reidentification of data subjects, an obligation to notify such a data breach to the public sector body should apply in addition to an obligation to notify such a data breach to a supervisory authority and to the data subject in accordance with Regulation (EU) 2016/679. Where relevant, the public sector bodies should facilitate the re-use of data on the basis of the consent of data subjects or the permission of data holders on the re-use of data pertaining to them through adequate technical means. In that respect, the public sector body should make best efforts to provide assistance to potential re-users in seeking such consent or permission by establishing technical mechanisms that permit transmitting requests for consent or permission from re-users, where practically feasible. No contact information should be given that allows re-users to contact data subjects or data holders directly. Where the public sector body transmits a request for consent or permission, it should ensure that the data subject or data holder is clearly informed of the possibility to refuse consent or permission.

Data Governance Act (DGA)