TRANSPOSITIONS OF THE EU LEGISLATION FOR HEALTH PROFESSIONS CHALLENGES AND ACHIEVEMENTS

BACKGROUND The European Directives have been transposed in 2004 and in the first national legislative framework completely harmonized on EU legislation regarding the regulated health professions; It includes: - 2 Governmental Decisions introducing the minimum training requierements for the health professions and also the professional recognition criteria of these qualifications; - 4 professional law; - Subsidiary rules. It transposes- 9 European Directives regarding the training for the regulated health professions and their exercise the transposition of the new provisions regarding the regulated health professions introduced by the DC.nr.2005/36/EC.

THE TRANSPOSITION PROCEDURE Screening of existing national regulatory framework; Identification of the sensitive problems with national impact; The efective transposition of the European Directive(s); Adoption of the draft of the transposing national act; Notification to the European Commission the transposing national act.

SCREENING OF THE REGULATORY FRAMEWORK IN FORCE Identification of the national relevant legislation Setting up the conformity table including the legislation in force and the EU directive(s) Authorities in charge with the screening: Ministry of National Education- for the rules regarding the basic training for doctors, dentists, pharmacists, nurses responsible for general care and midwives; Ministry of Health- for the rules regarding the specialized training of doctors and dentists, the rules regarding the continuing medical education and professional recognition, and also for the rules regarding the exercise of the regulated health professions.

IDENTIFICATION OF THE TOPICS THAT MAY CONSTITUTE TRANSPOSITION PROBLEMS A working party will be set up including: experts from ministries in charge with transposition; representatives of the National House of Health Insurance; representatives of the professional bodies; representatives of the medical universities and post- secondary medical schools. The conformity table developed in the first stage will be analyzed by the working party. The sensitive issues and the modality of their transposition will be identified.

THE EFFECTIVE TRANSPOSITION OF THE EU LEGISLATIVE ACT The draft of the transposing national act is elaborated by the experts of the responsible in charge with transposition in collaboration with the experts from the Ministry of Foreign Affairs and the EU experts. The conformity tables are prepared including the EU directive(s) and the national transposing act.

PUBLIC DEBATE OF THE DRAFT OF THE NATIONAL TRANSPOSING ACT The draft of the national transposing act: is published on the initiator ministry's website for public debate is discussed with the professional bodies and social partners is send for analyzing to the advisors ministries (Ministry of Justice, Ministry of Labor, Family and Social Protection, Ministry of National Education, Ministry of Finance, Ministry of Foreign Affairs).

PUBLIC DEBATE OF THE DRAFT OF THE NATIONAL TRANSPOSING ACT The final form of the final draft is elaborated including the relevant comments received within the public debates. The conformity tables are revised accordingly. The final draft is approved by the initiator Ministry and it is sending for approval to the mentioned ministries.

THE DRAFT ADOPTION Depending on the type of legal act, the draft is adopted by the Parliament or by the Government and it will be published in the Romanian Official Journal, after the adoption of the national transposing act. The transposing national legislation is notified to the European Commission; It may be followed by the development of subsidiary rules necessary for the implementation.

THE DRAFT ADOPTION In Romania it was required the adoption of some subsidiary rules. For example: - The Government Decision on issuing the certificate of current professional status for doctors, dentists and pharmacists; - OMH no.36/2008 regarding the adaptation periods and aptitude tests applicable to the qualification titles recognized under provisions of article 10 of Directive nr. 2005/36/EC.

In the field of basic training in health professions The implementation is done by the Ministry of National Education in partnership with: - The National Agency for Quality Assurance in Higher Education (ARACIS) - The National Agency for Quality Assurance in School Education (ARACIP) - The Universities of Medicine and Pharmacy - The health post-secondary schools. THE IMPLEMENTATION OF THE TRANSPOSING ACT PARTNERS OF IMPLEMENTATION

For example, ARACIP and ARACIS introduced between the accreditation criteria for medical education schools and universities, the minimum requirements provided by DC nr.2005/36/EC for the basic training of doctors, dentists, pharmacists, nurses responsible for general care and midwives. THE IMPLEMENTATION OF THE TRANSPOSING ACT PARTNERS OF IMPLEMENTATION

In the field of specialist training for doctors and dentists, the continuing medical education for regulated health professions and the exercise of these professions The implementation is done by the Ministry of Health in partnership with: The Universities of Medicine and Pharmacy; The professional bodies (the Romanian College of Doctors, the Romanian College of Dentists, the Romanian College of Pharmacists, Romanian Order of Nurses for General Care, Midwives and Nurses) which have to change their statute including the competence to award the right to exercise the profession after the directives implementation The National House of Health Insurance.

THE IMPLEMENTATION OF THE TRANSPOSING ACT SUPERVISION The authorities in charge with the supervision are: the Ministry of National Education and the Ministry of Health The Ministry of Health nominates - a state secretary as a member of the national councils of professional bodies - representatives in the administration boards of the subordinated health units and of the National House of Health Insurance.

THE IMPLEMENTATION OF THE TRANSPOSING ACT SUPERVISION Activities  Thematic controls carried out by the Ministry of National Education in post-secondary medical schools;  Periodically datas provided by the professional bodies, datas regarding the professional status of its members;  Statistic datas regarding the quality of health care services;  Public feed-back (claims, requests, etc.)

THE IMPLEMENTATION OF THE TRANSPOSING ACT IMPACT ON BASIC TRAINING IN HEALTH REGULATED PROFESSIONS The introduction of minimum training requirements provided by the directives: In case of dentists profession - dentist’s curriculum was modified by reducing the length of some disciplines which medicalized the profession (as: gynecology,infectious diseases) in favor of an increased number of clinical training hours to patient seat; In case of pharmacist profession: - rigorous distribution of clinical training hours per academic year;

In the case of nurse responsible for general care profession: - minimum training requirements for the university training have been introduced since 2003 and for post- secondary schools training, since 2007; - the training curriculum has been modified by introducing the missing disciplines stated in Annex V of DC no.2005/36/CE. In the case of midwife profession a new academic specialisation was introduced: - the specialisation of midwife, with 4 years length, graduated with the Diploma de Licenta. THE IMPLEMENTATION OF THE TRANSPOSING ACT IMPACT ON BASIC TRAINING IN HEALTH REGULATED PROFESSIONS

 Review of the Romanian medical, dental and pharmaceutical specialties Register and giving up the specialties such as General Stomathology and General Pharmacy;  Access to the training in the specialty of Oral and Maxillofacial Surgery for the doctors;  Review of the specialized curricula including a growing number of programs for competences and supra- specializations that could be accessed only by specialists doctors and dentists; THE IMPLEMENTATION OF THE TRANSPOSING ACT IMPACT ON SPECIALIZATION TRAINING OF DOCTORS, DENTISTS AND PHARMACISTS

THE IMPLEMENTATION OF THE TRANSPOSING ACT IMPACT ON CONTINUING MEDICAL EDUCATION  The Continuing Medical Education programs are credited by the professional bodies and their accomplishment represents a condition of annual renewal of the right to exercise the profession;  It is coordinated by the Ministry of Health and the professional bodies;  It is organized together with the Universities of Medicine and Pharmacy and other accredited partners;  The Ministry of Health organizes complementary studies programs for doctors, dentists and pharmacists in order to acquire new skills in accordance with the technical and scientific development in medical field, certified by “Atestat”.

THE IMPLEMENTATION OF THE TRANSPOSING ACT IMPACT ON THE EXERCISE OF REGULATED HEALTH PROFESSIONS  New health professions have been individualized: the profession of dentist and the profession of midwife;  It has been introduced the independent practice for all the regulated health professions. The professional is entitled to exercise as a self employer, if he is member of the professional body, is authorised to practice and if he is registered to the territorial administration of area where he resides.

The modality for granting the free right to practice has been changed in accordance with the EU provisions:  getting the specialist title for doctors and  getting the license for dentists and pharmacists; The practice authorisation for health regulated professions and the disciplinary liability of these professionals has been delegated by the Ministry of Health to the professional bodies. THE IMPLEMENTATION OF THE TRANSPOSING ACT IMPACT ON THE EXERCISE OF REGULATED HEALTH PROFESSIONS

The supervision of the exercise of these professions is done by professional bodies in collaboration with the Ministry of Health. In this regard a state secretary is appointed in the National Council of these bodies, as a full member. The professional conduct codes were reviewed and good professional practice guidelines were developed.

THE IMPLEMENTATION OF THE TRANSPOSING ACT CONCLUSIONS The implementation of the transposing act in the regulated health professions have led to: upgrading the professions; increased quality of medical services provided to population; increased patient safety; guarantee the right of free movement of Romanian professionals in the EU.

THE NEW PROPOSAL AMMENDING THE DC 2005/36/CE GENERAL ASPECTS The Professional Card- subject into discussions at professional bodies. The issuing procedure will be established along with the implementation of the new provisions; In our point of view, the exclusion of regulated health professions to the principle of partial access constitutes a benefit to professionals and patients; The alert mechanism constitutes a benefit by developing and clarifying the procedure followed by the Member States when a professional due to a disciplinary action or criminal conviction is no longer entitled to practice the professional activities, even temporarily.

THE IMPACT OF THE NEW DRAFT DIRECTIVE ON THE TRAINING OF DOCTORS, DENTISTS, PHARMACISTS, NURSES FOR GENERAL CARE AND MIDWIVES The implementation of the new skills and competences provided by the new directive proposal, for all regulated health professions; The length of basic professional training will not be affected as they were aligned with the EU rules in force. For example, for the basic training for doctors and dentists, the Government Decision nr.1477/2003 provides six years and 5500 hours; The transferable university credit system (ECTS) is mentioned on the Diploma Supplement since 2005 (the date of adoption of the Bologna Process);

THE IMPACT OF THE NEW DRAFT DIRECTIVE ON THE TRAINING OF DOCTORS, DENTISTS, PHARMACISTS, NURSES FOR GENERAL CARE AND MIDWIVES According to the Government Decision no. 1282/2007 and Government Ordinance no.18/2009, specialization courses performed in an another EU Member State by doctors, dentists and pharmacists who follow the training in the first or second specialty are recognized as specialist training. These provisions will be completed according to the new draft directive provisions. In the case of pharmacists were not imposed geographic restrictions or other kind of restrictions, in order to open new public pharmacies.

THE IMPACT OF THE NEW DRAFT DIRECTIVE ON THE TRAINING OF DOCTORS, DENTISTS, PHARMACISTS, NURSES FOR GENERAL CARE AND MIDWIVES The access to professional training of nurse responsible for general care and midwife is already conditioned by 12 years of general education; The professional training in midwifery is only done at higher education level, with a duration of 4 years.

THE IMPACT ON PROFESSIONAL QUALIFICATIONS RECOGNITION The specific acquired right for Romanian nurses for general care, was reviewed by amending the Article 33 (a) regarding the recognition of qualification titles of nurse responsible for general care obtained in Romania prior the accession by:  including two additional qualification titles attesting basic training by higher education;  decreasing the professional experience required, from 5 years of the last 7, to 3 years of the last 5 years. Bridging programs will be organized for holders of nurse responsible for general care qualification titles which are not provided by the DC.no.2005/36/EC and which are now recognized in another Member States under the general system provisions.

DR.NIMEREANU CRISTIANA BEATRICE Deputy General Manager GENERAL HUMAN RESOURCES DIRECTORATE AND CERTIFICATION ROMANIAN MINISTRY OF HEALTH