BAKGRUNN (fra kommisjonsdirektivet)

(1) The harmonised minimum training requirements for the professions of nurse responsible for general care, dental practitioner and pharmacist are currently set out in Articles 31, 34, and 44 of Directive 2005/36/EC as well as in points 5.2.1, 5.3.1 and 5.6.1 of Annex V to that Directive. 

(2) In its 2011 Green Paper on the modernisation of Directive 2005/36/EC, the Commission acknowledged the need to modernise the harmonised minimum training requirements in different phases. 

(3) In the context of the amendment of Directive 2005/36/EC through Directive 2013/55/EU of the European Parliament and of the Council, national authorities, academic institutions and professional organisations indicated that the professions covered by Title III, Chapter III of the Directive have significantly evolved since their minimum training requirements were harmonised. 

(4) While Directive 2013/55/EU reviewed to a certain extent the harmonised minimum training requirements for the professions of nurse responsible for general care, dental practitioner and pharmacist, no substantial changes were made to the training programmes listed in points 5.2.1, 5.3.1 and 5.6.1 of Annex V to Directive 2005/36/EC or to the list of knowledge and skills to be acquired during training laid down in Articles 31(6), 34(3) and 44(3) of that Directive. 

(5) Instead, Article 21(6) of Directive 2005/36/EC, as amended by Directive 2013/55/EU, provided the Commission with delegated powers to introduce, in accordance with its Article 57c, updates to the minimum training requirements in order to adapt them to generally acknowledged scientific and technical progress to reflect the evolution of Union law directly affecting the professionals concerned. 

(6) The Commission has assessed whether the minimum training requirements for the professions of nurse responsible for general care, dental practitioner and pharmacist, as set out in Directive 2005/36/EC, should be updated in light of generally acknowledged scientific and technical progress. 

(7) To assist the Commission in its assessment, three studies have been carried out. The aim of those studies was to explore the developments of training requirements for the professions of nurse responsible for general care, dental practitioner and pharmacist in all Member States and European Free Trade Association States (EFTA States). For that purpose, data was collected at Union and national level through desk research and targeted stakeholder consultations. The data collection focused on several developments in training requirements at national level: (i) scientific and technical advancements affecting the professions of nurse responsible for general care, dental practitioner and pharmacist; (ii) training programmes as well as knowledge and skills that go beyond the minimum training requirements laid down in Directive 2005/36/EC and that reflect any adaptation to scientific and technical advancements. 

(8) A comparative assessment of the data collected was carried out during the studies. It focused on developments in and commonalities between training requirements across all Union Member States and EFTA States in light of generally acknowledged scientific and technical progress. For that purpose, a working definition of ‘generally acknowledged’ scientific and technical progress was created, consisting of scientific and technical advancements that have been noted in at least 16 Member States and EFTA States. 

(9) The results of the studies were presented to relevant stakeholders during workshops and meetings of the group of coordinators for the recognition of professional qualifications. Based on the feedback received, the conclusions of the studies were drafted, suggesting updates to the minimum training requirements set out in Directive 2005/36/EC in respect of training programmes as well as knowledge and skills. 

(10) The study on nurses responsible for general care identified the following generally acknowledged scientific and technical advancements in training programmes in Member States and EFTA States that were not represented or not sufficiently represented in the current minimum training requirements set out in Directive 2005/36/EC: person-centred care theory, management theory applied to nursing, evidence-based practice, e-health, and technical innovations related to healthcare and nursing methods. 

(11) The study on dental practitioners identified the following generally acknowledged scientific and technical advancements in training programmes in Member States and EFTA States that were not represented or not sufficiently represented in the current minimum training requirements set out in Directive 2005/36/EC: implantology, gerodontology, interprofessional collaborative care, dental public health – community oral health, practice management, genetics and genomics, immunology, regenerative medicine/dentistry and digital technology in dentistry. 

(12) The study on pharmacists identified the following generally acknowledged scientific and technical advancements in training programmes in Member States and EFTA States that were not represented or not sufficiently represented in the current minimum training requirements set out in Directive 2005/36/EC: biopharmaceutical technology and biotechnology, genetics and pharmacogenomics, immunology, clinical pharmacy, pharmaceutical care, social pharmacy, epidemiology and pharmacoepidemiology, pharmacy practice, inter- and multidisciplinary collaboration, pathology and pathophysiology, health economics and pharmacoeconomics, information technology and digital technology. 

(13) In accordance with the Joint Political Declaration of 28 September 2011 of Member States and the Commission on explanatory documents, Member States have undertaken to accompany, in justified cases, the notification of their transposition measures with one or more documents to explain the relationship between the components of a directive and the corresponding parts of national transposition instruments. With regard to this Directive, the legislator considers the transmission of such documents to be justified. 

(14) Directive 2005/36/EC should therefore be amended accordingly,