The George Act: the liability of medical staff for malpractice, the patient’s right to full information and access to the medical file.

The explanatory memorandum: Explanatory memorandum — The George Act

Full translation of the draft. The Romanian text remains the authoritative one.

THE PARLIAMENT OF ROMANIA

SENATE — CHAMBER OF DEPUTIES

ACT

amending and supplementing Act no. 95/2006 on the reform of the health system and the Patients’ Rights Act no. 46/2003

The Parliament of Romania adopts this law

Art. I — Act no. 95/2006 on the reform of the health system, republished in the Official Gazette of Romania, Part I, no. 652 of 28 August 2015, as subsequently amended and supplemented, is amended and supplemented as follows: → the reasons

1. In article 653, paragraph (5) is amended and shall read as follows: → the reasons

“(5) The civil liability regulated by this law does not remove the incurring of criminal liability, where the act which caused the damage was brought about by acts or omissions committed with direct or indirect intent, or with advertent negligence, by medical personnel in breach of the laws, procedures and medical protocols, and constitutes an offence according to law.”

2. In article 653, after paragraph (5), a new paragraph (6) is inserted, reading as follows: → the reasons

“(6) Malpractice is presumed where the damage to the patient appears within 72 hours of the medical or medical-pharmaceutical acts causing damage to the patient and there are reasonable suspicions that a causal link exists between the damage suffered and the medical or medical-pharmaceutical act. In such cases, the Commission for monitoring and professional competence for malpractice cases shall draw up a report within 7 days of notification and shall adopt a decision on the case within no more than 30 days of the date of notification, in accordance with the procedure laid down in article 679 et seq. of this law.”

3. In article 655, after paragraph (2), three new paragraphs (3)–(5) are inserted, reading as follows: → the reasons

“(3) Public or private health units are obliged to bear in full the costs of treatment, of surgical interventions and all other medical expenses of patients who are victims of medical malpractice and who suffer side effects or infirmity for a period longer than 20 days as a result of the medical or medical-pharmaceutical acts administered by their medical personnel. The prior informed consent of the patient does not exonerate from the liability regulated by this paragraph. The liability of the public or private health units does not exonerate the medical personnel involved in the medical act, who shall be held jointly and severally liable.

(4) The Ministry of Health is obliged to bear in full the costs of treatment, of surgical interventions and all other medical expenses of patients who suffer side effects or infirmity for a period longer than 20 days as a result of the administration of the vaccines that are compulsory or recommended under the National Vaccination Programme, as well as of the other vaccines that are compulsory or recommended in endemic situations or in periods of epidemic and pandemic. The prior informed consent of the patient does not exonerate from the liability regulated by this paragraph.

(5) The provisions of paragraphs 3 and 4 of this article are applicable to all patients who suffer damage following medical or medical-pharmaceutical acts. The existence of the damage shall be established and certified at any time, upon request, by the Commission for monitoring and professional competence for malpractice cases, irrespective of the moment when the medical or medical-pharmaceutical act causing the damage was performed. The decision of the Commission is subject to the procedure laid down in article 684 of this law.

4. Article 687 is amended and shall read as follows: → the reasons

“Art. 687

The court competent to settle the disputes provided for in this law is the tribunal — civil section — in whose territorial jurisdiction the patient victim of the alleged malpractice has his domicile, or the tribunal — civil section — in whose territorial jurisdiction the alleged act of malpractice took place.”

5. After article 704, a new article 704¹ is inserted, reading as follows: → the reasons

“Art. 704¹

(1) Medicines or medical devices for which the manufacturer offers no guarantees and no demonstrably viable remedies against adverse effects may not be marketed or used, nor may such medical treatments be applied.

(2) The marketing or use of medicines, vaccines, medical devices and other pharmaceutical products for which complete clinical trials have not been carried out in accordance with the methodology laid down by law is prohibited.”

6. In article 811, paragraph (1) is amended and shall read as follows: → the reasons

“Art. 811

(1) For the purposes of this chapter, advertising for medicines means information by direct contact (the ‘door-to-door’ system), as well as promotion intended to stimulate the prescription, distribution, sale or consumption of medicines; advertising for medicines shall be carried out exclusively through:

— advertising for medicines addressed to persons qualified to prescribe or distribute medicines;

— visits by medical representatives to persons qualified to prescribe medicines;

— the supply of samples.”

Art. II — The Patients’ Rights Act no. 46 of 21 January 2003, published in the Official Gazette of Romania, Part I, no. 51 of 29 January 2003, as subsequently amended and supplemented, is amended and supplemented as follows: → the reasons

1. Article 4 is amended and shall read as follows: → the reasons

“(1) The patient has the right to be informed of the medical services available and of the manner of using them.

(2) Medicines, medical devices and other therapeutic means may be administered and applied to Romanian citizens only after obtaining the patients’ written consent, following prior and mandatory information given on the basis of the leaflets provided by the manufacturer of the medicines proposed, medical emergencies excepted.”

2. After article 36², a new article 36³ is inserted, reading as follows: → the reasons

“Art. 36³

No citizen may be discriminated against, positively or negatively, as a result of accepting or refusing a treatment or a medical device. Discriminating against a citizen as a result of accepting or refusing a treatment or a medical device constitutes an offence and is punished in accordance with the criminal laws.”

This law was adopted by the Parliament of Romania, in compliance with the provisions of art. 75 and art. 76 para. (2) of the Constitution of Romania, republished.

President of the Senate — President of the Chamber of Deputies