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Law No. 184 Of 2 July 2015

Original Language Title: LEGE nr. 184 din 2 iulie 2015

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LEGE no. 184 184 of 2 July 2015 for approval Government Emergency Ordinance no. 77/2011 on the establishment of contributions to finance expenditure in the field of health and amending and supplementing Law no. 95/2006 on health reform
ISSUER PARLIAMENT
Published in OFFICIAL MONITOR no. 490 490 of 3 July 2015



The Romanian Parliament adopts this law + Article I Approval Government Emergency Ordinance no. 77 77 of 21 September 2011 on the establishment of contributions for the financing of expenditure in the field of health, published in the Official Gazette of Romania, Part I, no. 680 680 of 26 September 2011. + Article II Law no. 95/2006 on health reform, published in the Official Gazette of Romania, Part I, no. 372 of 28 April 2006, as amended and supplemented, shall be amended and supplemented as follows: 1. Article 2 (6) shall be repealed. 2. In Article 2, paragraph 8 shall be amended and shall read as follows: " (8) The responsibility for ensuring public health lies with the Ministry of Health, the county public health departments and the city of Bucharest and other specialized structures of the Ministry of Health, the National Insurance House Health, hereinafter referred to as CNAS, to specialized structures within ministries and institutions with their own health network, as well as to local public administration authorities. " 3. In Article 10, paragraph 3 shall be amended and shall read as follows: " (3) The Ministry of Health, through its own apparatus and through the county public health departments and the city of Bucharest, and the other ministries and institutions with its own health network, through the specialized structures, verify compliance public health regulations, and in the event of irregularities or non-compliance apply measures according to the law. " 4. In Article 11, letter b) is amended and shall read as follows: "b) other institutions and specialized structures of the Ministry of Health that carry out activities in the field of public health at national, regional, county and local level." 5. Article 15 is amended and shall read as follows: "" Art. 15. -The institutions and specialized structures of the Ministry of Health, which carry out activities in the field of public health at national, regional, county and local level, with legal personality, subordinated, coordinated or under the authority of the Ministry of Health, with the exception of CNAS and health insurance companies, shall be established, reorganized and abolished by Government decision. " 6. In Article 16, paragraph 2 shall be amended and shall read as follows: " (2) The members of the specialized committees referred to in par. ((1) lit. f) benefit from a monthly allowance of 10% of the allowance of the Secretary of State, which is granted in proportion to the number of actual participation in meetings. The travel expenses occasioned by the participation in the specialized committees are borne by the public institutions in which the persons are assigned or where they carry out activity through clinical integration. Travel expenses from other localities, occasioned by the participation in the specialized commission of family medicine, are borne by the Ministry of Health. The Organization and Functioning Regulation and the duties of the specialized committees shall be established by order of the Minister of Health. " 7. In Article 64, paragraph 3 shall be amended and shall read as follows: " (3) Doctors of general medicine referred to in art. 60 lit. d), which, on the date of Romania's accession to the European Union, hereinafter referred to as the EU, provide primary health care services in the health insurance system, can continue their activity under the same conditions after this date. " 8. Article 69 (2), letter b) shall be amended and shall read as follows: " b) the citizens of a Member State of the EU, of another State belonging to the European Economic Area, hereinafter referred to as the EEA, or of the Swiss Confederation, within the meaning of Article 3 (1) of the 370 370 para. ((1) lit. b) and art. 371 371 para. (1), formed in the profession in one of these states, which on January 1, 2007 were established on the territory of Romania and which, following the recognition of professional qualification, benefited, on this date, from the right of exercise within the national health insurance system of activities in the field of family medicine, without the title of family medicine specialist; " 9. Article 86 (1), letters b), t), u) and v) shall be amended and shall read as follows: " b) emergency integrated public assistance-assistance provided by state public institutions located in the structures of the Ministry of Health, the Ministry of Internal Affairs and/or in the structure of local public authorities, as well as the Special Telecommunications through the Directorate for Single Emergency Call 112. It includes all measures and activities of a logistical, technical and medical nature, mainly intended to save and preserve life; ................................................................. t) Mobile emergency service, reanimation and discharge, hereinafter referred to as SMURD-integrated public intervention unit, of strategic importance, without legal personality, having in its structure integrated reanimation teams, specialized in providing emergency medical and technical assistance, as well as teams with paramedic staff, specialized in providing qualified first aid. SMURD operates within the emergency inspectorates, having as air operator the aviation structures of the Ministry of Internal Affairs, in collaboration with the county, regional hospitals and local public authorities; u) emergency reception unit, hereinafter referred to as UPU-section or clinical section located in the structure of a county, regional hospital or in the structure of hospitals belonging to ministries and institutions with own health networks, with staff own, specially prepared, designed for the triage, evaluation and emergency treatment of patients with acute conditions, who present themselves at the hospital spontaneously or who are transported by ambulances; v) emergency reception compartment, hereinafter referred to as the CPU-section in the structure of a city hospital, municipal or in the structure of hospitals belonging to ministries and institutions with own health networks, with their own staff, special prepared, designed for triage, evaluation and emergency treatment of patients with acute conditions, who report to the hospital spontaneously or who are transported by ambulances; " 10. In Article 93, paragraph (5 ^ 3) is amended and shall read as follows: " (5 ^ 3) Units and compartments of reception of emergencies within hospitals with emergency structures approved according to legal provisions, other than those provided in par. ((5), as well as the activities carried out in the emergency room, are financed from the budget of the Single National Health Insurance Fund and are included in the structure of the tariff on a solved case. " 11. In Article 146, paragraph 1 shall be amended and shall read as follows: "" Art. 146. -(1) The sampling of organs, tissues or cells from the living donor will be carried out with the opinion of the commission to endorse the donation from the living donor, constituted within the hospital where the transplant is carried out; this commission will assess the motivation donation and will control compliance with patients ' rights, according to the form approved by order of the Minister of Health. " 12. In Article 147, points 1 and 2 shall be amended and shall read as follows: " 1. is defined as a deceased donor without cardiac activity the person to whom the irresuscitable and irreversible cardiorespiratory arrest was found, confirmed in the hospital by 2 primary doctors. Confirmation of the deceased donor without cardiac activity is done according to the resuscitation protocol, according to the form model approved by order of the Minister of Health, except for unequivocal situations; 2. is defined as a deceased donor with cardiac activity the person at which the irreversible cessation of all brain functions was found, according to the brain death declaration protocol, according to the form model approved by order of Minister of Health 13. Article 150 is amended and shall read as follows: "" Art. 150. -Organ transplantation, tissues and cells of human origin are carried out with the written consent of the recipient, after he has been informed of the risks and benefits of the process, according to the form model approved by order of Minister of Health 14. In Article 151, paragraphs 1 and 3 shall be amended and shall read as follows: "" Art. 151. -(1) If the recipient is unable to express their consent, it may be given in writing by one of the family members or his legal representative, according to the form approved by order of the order. Health Minister ............................................................. (3) The situation described in par. (2) will be recorded by the chief section doctor and the patient's attending physician, in the form approved by order of the Minister of Health. " 15. Article 163 shall be repealed. 16. In Article 183, paragraph 7 is amended and shall read as follows: "" (7) During the execution of the management contract, the members of the steering committee shall enjoy a basic salary and other salary rights established according to the legal provisions in force, on which the insurance contribution is due state social, as well as health insurance contribution, in the quotas provided by law. That period shall constitute a contribution period and shall be taken into account when establishing and calculating the rights provided for by the legislation in force on the pension scheme. " 17. Article 209 (3) shall be amended and shall read as follows: "(3) The management of the fund is made, under the law, by CNAS and by health insurance companies." 18. Article 213 (2), point d) shall be amended and shall read as follows: " d) execute a custodial sentence, be under house arrest or in pre-trial detention, as well as those who are in the execution of the measures provided for in art. 109, 110, 124 and 125 of Law no. 286/2009 on the Criminal Code, with subsequent amendments and completions, namely those that are in the period of postponement or interruption of the execution of the custodial sentence, if they have no income; " 19. In Article 291, after letter d) a new letter is inserted, letter e), with the following contents: "e) submit annually to the Government an activity report, as well as the plan of activity for the following year." 20. Title VIII "Health insurance", Chapter VII "Control", section 3 of Article 297 shall be repealed. 21. Article 316 is amended and shall read as follows: "" Art. 316. -Until the organization of the Arbitration Commission provided for in art. 298 and 299, disputes between healthcare providers, medicines and medical devices and insurance companies will be judged by the Central Arbitration Commission operating on top of CNAS, vested with the resolution of these disputes through the request for arbitrary. ' 22. In Title VIII, Chapter VIII "Liabilities and Sanctions", the title of Section 2 "Offences" shall be repealed. 23. In Article 331, paragraph 6 is amended and shall read as follows: " (6) The access of medical personnel to the information recorded on the national health insurance card will be established by the Methodological Norms for the application of the provisions regarding the national health insurance card provided in Title IX "European Card and National Health Insurance Card" of this Law. " 24. In Article 365, paragraph 1 is amended and shall read as follows: "" Art. 365. -(1) Contributions provided in art. 363 363 para. ((1) lit. a) and b) shall be transferred, at the time limit for the payment of excise duties provided for in the Fiscal Code, with subsequent amendments and completions, in collectors accounts opened in the structure of the budget classification, to the State Treasury. " 25. In Article 371, paragraph 1 shall be amended and shall read as follows: "" Art. 371. -(1) For the purposes of this Title, the term "doctors" of an EU Member State, of a State belonging to the EEA or of the Swiss Confederation shall designate, by assimilation, the doctors in the situations referred to in art. 370 370 para. ((1) lit. d) and f). " 26. Article 378 (2), point d) shall be amended and shall read as follows: " d) to doctors who meet the conditions laid down in art. 370 370 para. ((1) lit. c) and e). " 27. in Article 379, letter e) of paragraph 1 and paragraph 2 shall be amended and shall read as follows: "" e) by exception to lit. d), in case of temporary or occasional provision of services, doctors who meet the conditions provided in art. 370 370 para. ((1) lit. b), d) or f) must notify the Ministry of Health of the temporary or occasional provision of medical services on the territory of Romania and be registered during this period at the CMR. ((2) The citizens of a Member State of the EU, of a State belonging to the EEA or of the Swiss Confederation, established on the territory of Romania, as well as the doctors who meet the conditions laid down in art. 370 370 para. ((1) lit. c) and e) exercise the profession of doctor with the same rights and obligations as the Romanian citizen doctors members of the CMR. " 28. Article 398 is amended and shall read as follows: "" Art. 398. -As of the date of accession to the EU, the Romanian competent authorities will withdraw, temporarily or definitively, as the case may be, the documents 396 396 para. ((2) lit. c), issued to doctors who meet the conditions provided in art. 370 370 para. ((1) lit. a), c) and e), as well as doctors established in Romania who meet the conditions provided in art. 370 370 para. ((1) lit. b), d) and f), if they are subject to the sanctions provided by law with the suspension or prohibition of the exercise of the profession. " 29. In Article 404, paragraph 4 is amended and shall read as follows: " (4) CMR includes all doctors who meet the conditions laid down in art. 370 370 para. ((1) lit. a), c) and e), as well as the doctors established in Romania who meet the conditions provided in art. 370 370 para. ((1) lit. b), d) and f) and who exercise the medical profession under the conditions of this law. " 30. In Article 408, paragraph 1 is amended and shall read as follows: "" Art. 408. -(1) In order to exercise the profession of doctor, Romanian citizen doctors and citizens of an EU Member State, of a state belonging to the EEA or of the Swiss Confederation, established in Romania, as well as the doctors who meet the conditions provided in art. 370 370 para. ((1) lit. c) and e) have the obligation to register in the CMR. " 31. In Article 466, paragraph 2 is amended and shall read as follows: " (2) Physicians referred to in par. (1) and (1 ^ 1) the provisions of the Law no. 53/2003 -Labor Code, republished, with subsequent amendments and completions. " 32. In Article 484, paragraph 3 is amended and shall read as follows: " (3) Dental doctors referred to in par. (1) may be anticipated in advance, upon request, under the conditions provided by the legislation in force on the pension system, if they meet the conditions of contribution period provided by law for the early pension or for the partial early pension. " 33. In Article 548, paragraph 2 shall be amended and shall read as follows: " (2) Dental doctors referred to in par. (1) and (1 ^ 1) the provisions of the Law no. 53/2003 , republished, with subsequent amendments and completions. " 34. In Article 565, paragraph 3 is amended and shall read as follows: " (3) Pharmacists referred to in par. (1) may be anticipated in advance, upon request, under the conditions provided by the legislation in force on the pension system, if they meet the conditions of contribution period provided by law for the early pension or for the partial early pension. " 35. In Article 592, the introductory part of paragraph 1 shall be amended and shall read as follows: "" Art. 592. -(1) The college council shall have a number of members in proportion to the number of pharmacists registered in the college on the date of the elections, as follows: " 36. In Article 640, paragraph 2 shall be amended and shall read as follows: " (2) Pharmacists referred to in par. (1) and (1 ^ 1) the provisions of the Law no. 53/2003 , republished, with subsequent amendments and completions. " 37. In Article 669, paragraph 2 shall be amended and shall read as follows: "(2) On the list of experts you can register any doctor, dentist, pharmacist, nurse/midwife at least 8 years old in the specialty, with the opinion of CMR, CMDR, CFR and OAMGMAMR." 38. In Article 683, paragraph (1 ^ 1) is amended and shall read as follows: " (1 ^ 1) The National School of Public Health, Management and Improvement in the Sanitary Area of Bucharest, hereinafter referred to as SNSPMPDSB, operates as a public law institution with Romanian legal personality, fully financed by its own income in the coordination of the Ministry of Health, and academic coordination is established by Government decision. SNSPMPDSB operates on the basis of economic management and financial autonomy, calculates the amortisses and leads the bookkeeping in economic mode. " 39. In Article 700, paragraphs 3 and 5 shall be amended and shall read as follows: " (3) After a drug has received an initial marketing authorisation, according to par. ((1), any concentrations, pharmaceutical forms, administration routes and additional forms of presentation, as well as any variations or extensions, must be authorized separately in accordance with paragraph 1. ((1) or included in the initial marketing authorisation; all such marketing authorisations shall be regarded as belonging to the same global authorisation, in particular for the purpose of applying the provisions of art. 704 704 para. ((1) and of art. 852. ................................................................ (5) The authorization provided in par. (1) it is also necessary for the generators of radionuclides, kits (kits), radionuclide precursors and industrial manufactured radiopharmaceuticals. " 40. In Article 788, paragraph 11 is amended and shall read as follows: " (11) The travail of the samples taken and the cost of the analyses carried out shall be borne according to 823 823 para. ((1 ^ 7) lit. b). " 41. In Article 823, paragraph 9 is amended and shall read as follows: "" (9) If the result of the inspection referred to in par. ((1 ^ 7) lit. d) show that the marketing authorisation holder does not comply with the system of pharmacovigilance, as described in the pharmacovigilance system standard, and the provisions of the head. X of this Title, ANMDM signals these deficiencies to the Marketing Authorisation Holder and gives it the opportunity to comment. In this case, ANMDM informs the other Member States, the European Medicines Agency and the European Commission. Where appropriate, the ANMDM shall take the necessary measures to ensure that the marketing authorisation holder is subject to effective, proportionate, preventive sanctions. " 42. Article 862 is repealed. 43. Article 863 is repealed. 44. In Article 864, paragraph 1 is amended and shall read as follows: "" Art. 864. --(1) This Title establishes the general framework for facilitating access to safe and high-quality cross-border healthcare and promotes cooperation in the field of healthcare between Romania and the EU Member States. " 45. in Article 865, points h), j) and k) of paragraph 1 and letter f) of paragraph 2 shall be amended and shall read as follows: "h) Title XVII" Medicine ", art. 695-861 of this law. .............................................................. j) approval of standards on selection and evaluation of tissue and cell donor, alert systems and emergency procedures, qualification of personnel from tissue and cell banks, quality system, import and export of tissues and human cells, relations between tissue and cell banks and third parties, of the Methodological Norms for the application of Title VI "Perform the sampling and transplantation of organs, tissues and cells of human origin for therapeutic purposes" of this Law, and Title VI " Perform of organ, tissue and tissue sampling and transplantation human origin for therapeutic purposes ", art. 141-164 of the present law, of the Rules on the establishment of the professional training standard of the person designated for the quality assurance of human tissues and/or cells processed and/or used for therapeutic purposes and the establishment of the Agency National Transplant; k) recognition of diplomas and professional qualifications for regulated professions in Romania, appointment of the institution to automatically recognize the documents proving the qualification acquired abroad, outside the education system, Romanian citizens or citizens of the EU Member States and of the EEA States, the approval of the mandatory minimum criteria for authorisation and accreditation for higher education institutions in the fields of medicine, dental medicine, pharmacy, nurses, midwives, veterinary medicine, architecture as well as for colleges of general practitioners, for basic training, recognition of the qualification of a veterinarian and the regulation of aspects relating to the exercise of the veterinary profession and of diplomas and professional qualifications for regulated professions in Romania, the approval of the procedure for attestation of qualification-training and professional experience-acquired in Romania, outside the national education system, by Romanian citizens who want to carry out activities, independently or as employees, in the territory of an EU Member State, on the regime of qualifications in the professions of doctor, dentist, pharmacist, general and midwife nurse, acquired outside the borders of Romania, approval of the Methodology for the organization and conduct of the adaptation internship, of the aptitude test, as well as establishing the status of persons referred to art. 40-42 of Government Decision no. 1.282/2007 for the approval of the rules on the recognition of diplomas, certificates and titles of doctor, dentist, pharmacist, nurse generalist and midwife, issued by a Member State of the European Union, by a State of The European Economic Area or the Swiss Confederation, with subsequent additions, which follows the compensatory measure for professional recognition in Romania, the recognition of the qualification of veterinarian and the regulation of certain aspects on the exercise of the profession of veterinary surgeon; Title XII ' Exercise of the profession of Physician. Organization and functioning of the Romanian College of Physicians ", art. 370-467, Title XIII " Exercise of the profession of dentist. Organization and functioning of the College of Dental Physicians in Romania ", art. 468-552, and Title XIV " Exercise of the profession of pharmacist. Organization and functioning of the Romanian College of Pharmacists ", art. 553-641 of this Law; approval of the rules on the recognition of diplomas, certificates and titles of doctor, dentist, pharmacist, general nurse and midwife, issued by an EU Member State, by a State belonging to EEA or Swiss Confederation; on how to carry out the preparation by residency in the specialities provided by the Nomenclature of medical, medical-dental and pharmaceutical specialties for the healthcare network, as amended and subsequent additions; approval of the Nomenclature of medical specialties, medical-dental and pharmaceutical for the healthcare network, with subsequent amendments and completions; on the organization of medical, medical-dental and human pharmaceutical postgraduate education and education medical and pharmaceutical postgraduate; recognition of diplomas and professional qualifications for regulated professions in Romania; on the exercise of the profession of general medical assistant, of the profession of midwife and of the profession of assistant medical as well as the organization and functioning of the Order of Nurses Generalists, Midwives and Nurses of Romania; organization of the activity of judicial and extrajudicial technical expertise; authorization of forensic experts who may be recommended by the parties to participate in the making of surveys forensics; organization and exercise of the profession of architect; approval of the Methodological Norms on the organization and exercise of the architectural profession; recognition of diplomas and professional qualifications for regulated professions in Romania; ................................................................... f) Regulation (EC) No 593/2008 of the European Parliament and of the Council of 17 June 2008 on the law applicable to contractual obligations (Rome I), Regulation (EC) No 864/2007 of the European Parliament and of the Council of 11 July 2007 on the law applicable to non-contractual obligations (Rome II) and other EU rules on private international law, in particular the rules related to the jurisdiction of courts and law applicable. ' 46. In Article 868, the introductory part of paragraph 1 shall be amended and shall read as follows: "" Art. 868. -(1) In addition to CNAS, the National Contact Point is established and operates, as a structure without legal personality, hereinafter referred to as PNC, with the following tasks: " 47. After Article 873 ^ 1 a new article is inserted, Article 873 ^ 2, with the following contents: "" Art. 873 873 ^ 2. -(1) Administrative procedures for access to cross-border healthcare and reimbursement of cross-border healthcare granted in another Member State are based on objective and non-discriminatory criteria which are necessary and proportionate to the objective pursued. (2) The administrative procedures referred to in par. ((1) are easily accessible and information on such a procedure shall be made available to the public at the appropriate level. Such a procedure shall enable the processing of requests objectively and impartially. " 48. In Article 874, after paragraph (1 ^ 1), a new paragraph (1 ^ 2) is inserted, with the following contents: " (1 ^ 2) By exception to the provisions of par. ((1), pensioners and their family members residing in the territory of another EU Member State and for which, according to Regulation (EC) No 883/2004 and al Regulation (EC) No 987/2009 , Romania is responsible for the reimbursement of the costs of healthcare, benefits on the territory of Romania of medical assistance provided under the health insurance system under the same conditions as if pensioners and their family members would reside in Romania, except: a) healthcare which, according to Directive 2011 /24/EU ,, is subject to prior authorisation in the EU Member State of residence, for pensioners and their family members who have established their residence in that Member State and where that Member State has opted for a refund of fixed amounts; b) healthcare provided in accordance with the head. I of Title III of Commission Implementing Regulation (EU) No 883/2004 ; c) the services provided in art. 864 864 para. ((3) of this Title. ' 49. In Article 875, paragraph 1 is amended and shall read as follows: "" Art. 875. -(1) In a situation where health insurance companies do not approve insurance claims for reimbursement of cross-border healthcare consideration, they are required to communicate it to them in writing, indicating the legal basis, in the term provided for in the methodological norms approved by Government decision. " 50. In Article 876 (1), point c) is amended and shall read as follows: " c) is provided by a healthcare provider who, on a case-by-case basis, could generate serious and specific concerns about the quality or safety of care, with the exception of health care subject to EU law that ensures a minimum safety and quality in the EU. " 51. In Article 879, paragraph 1 is amended and shall read as follows: "" Art. 879. -(1) The Ministry of Health, as coordinator of the Internal Market Information System (IMI), and CMR, CMDR, CFR and OAMGMAMR, as competent authorities for the purposes of Regulation (EU) No 1.024/2012 , make available to the NCP and to the authorities of other Member States, on request, free of charge, information on the right of practice of health professionals in evidence for the purposes of cross-border healthcare. " 52. Annex no. 14 14 is repealed. + Article III Points 47 and 48 of Article II transpose art. 7 7 para. ((2) lit. b) and art. 9 9 para. ((1) and (2) of Directive 2011 /24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients ' rights in cross-border healthcare, published in the Official Journal of the European Union, L series, no. 88 of 4 April 2011, p. 45-65. + Article IV Throughout the whole Law no. 95/2006 on health reform, with subsequent amendments and completions, the words " Law no. 571/2003 " and " Law no. 571/2003 on the Fiscal Code "is replaced by the phrase" Fiscal code ", and the phrases" Government Ordinance no. 92/2003 on the Fiscal Procedure Code 'and' Government Ordinance no. 92/2003 " are replaced by the phrase "Fiscal procedure code". + Article V On the date of entry into force of this Law, the Government Emergency Ordinance no. 68/2014 on the modification and completion of certain normative acts, published in the Official Gazette of Romania, Part I, no. 803 of 4 November 2014, art. VI and the reference to the transposition of art. 7 7 para. ((2) lit. b) and art. 9 9 para. ((1) and (2) of Directive 2011 /24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients ' rights in cross-border healthcare, published in the Official Journal of the European Union, L series, no. 88 of 4 April 2011, p. 45-65. + Article VI Law no. 95/2006 on health reform, published in the Official Gazette of Romania, Part I, no. 372 of April 28, 2006, with subsequent amendments and completions, as well as with the amendments and completions brought by this law, will be republished in the Official Gazette of Romania, Part I, giving the texts a new numbering. This law was adopted by the Romanian Parliament, in compliance with the provisions of art. 75 75 and art. 76 76 para. (2) of the Romanian Constitution, republished. CHAMBER OF DEPUTIES PRESIDENT VALERIU-STEFAN ZGONEA SENATE PRESIDENT CĂLIN-CONSTANTIN-ANTON POPESCU-TARICEANU Bucharest, July 2, 2015. No. 184. -----