Delegated act

Act of general application that can be adopted if there is a delegation of power in a Regulation

• the delegated act cannot change the essential elements of the Regulation
• the Regulation must define the objectives, content, scope and duration of the delegation of power

Eg expansion of tasks of digital health authorities, modification of list of data categories to be made available by data holders for secondary use

Drafting process

• it is a commitment under the Interinstitutional Agreement on Better Law-Making that the European Commission consults experts designated by the Member States on draft delegated acts
• the European Commission thus prepares and adopts a delegated act after consulting expert groups, composed of representatives designated from each EU country
• as part of the European Commission’s better regulation agenda, citizens and other stakeholders can provide feedback on the draft text of a delegated act during a 4-week period
• once the European Commission has adopted the delegated act, the European Parliament and the Council generally have 2 months to formulate any objections; if they do not, the delegated acts enters into force

Implementing act

Act laying down detailed rules allowing the uniform implementation of the Regulation

Eg compliance of a third country national contact point to the requirements of MyHealth@EU, templates for data access application, data request and data permit

Drafting process

• before the European Commission can adopt an implementing act, it must consult a committee in which every EU country is represented
• the rules and procedures applicable to committees are set out in Regulation 182/2011; the committee will adopt its rules of procedure on the basis of standard rules of procedure which have been published in the Official Journal
• the committee enables EU countries to oversee the European Commission’s work as it adopts an implementing act; the committee is chaired by the European Commission but the European Commission does not take part in the vote
• as part of the European Commission’s better regulation agenda, citizens and other stakeholders can provide feedback on the draft text of an implementing act for 4 weeks before the relevant committee votes to accept or reject it
• the European Commission will take into consideration the conclusions and the opinion delivered by the committee