The explanatory memorandum of the George Act: liability for medical malpractice and the patient’s right to the truth, in memory of a friend.

The full text of the draft: The George Act (medical malpractice)

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

TO,

THE STANDING BUREAU OF THE SENATE

In accordance with the provisions of art. 74 para. (1) and art. 75 of the Constitution of Romania, republished, as well as with art. 92 para. (2) and (4) of the Regulation of the Senate, republished, we submit for debate and adoption the legislative proposal entitled “Act amending and supplementing Act no. 95/2006 on the reform of the health system and the Patients’ Rights Act no. 46/2003”.

Pursuant to art. 111 para. (1) of the Constitution of Romania, republished, we request that the Government be asked to communicate its point of view on this legislative proposal.

We likewise request that the opinions of the Legislative Council and of the Economic and Social Council be sought.

INITIATOR:

EXPLANATORY MEMORANDUM

At present, medical liability and the rights of the patient are governed by Act no. 95/2006 and by Act no. 46/2003 respectively, which provide a complex legislative framework for these subjects, sensitive in Romanian society.

In the context of the growing number of cases of medical malpractice and of the difficulties caused by the administration of treatments and medical devices without genuinely complete information being given to the patient, a clear regulation of responsibilities in the health sector is necessary, with a view to protecting patients and increasing transparency in this field.

It has thus been found that the present provisions are insufficient to cover all the aspects arising from civil and criminal liability in cases of malpractice, as well as the questions concerning the marketing and use of medicines and medical devices, which makes the amendment of the legislation necessary.

To this end, we set out briefly a series of critical problems faced by patients who consider themselves injured or wronged:

Lack of clarity as regards medical liability: cases of malpractice are difficult to prove, which leads to a large number of unresolved cases or of outcomes unsatisfactory for patients;

Lack of transparency in the doctor–patient relationship: patients are not always fully and correctly informed of the risks of treatments, and informed consent is perceived rather as a formality;

Lack of strict regulation of medical products: products are marketed and used which do not meet rigorous safety standards and which endanger the health of patients;

Discrimination against patients on the basis of accepting or refusing a treatment — a phenomenon requiring intervention in order to ensure equal treatment of all citizens.

This legislative proposal seeks to resolve the problems set out above, as follows:

Clarifying civil and criminal liability in cases of malpractice, including by establishing a presumption of malpractice where the damage appears within 72 hours of the medical or medical-pharmaceutical acts. Patients’ access to swift and equitable remedies in the event of damage is thereby facilitated;

Establishing the obligation of public or private health units to bear the costs where patients suffer long-term side effects as a result of medical acts. The obligation of the Ministry of Health to bear the damage caused by the adverse effects of compulsory or recommended vaccines is likewise established;

Regulating the marketing and use of medicines and medical devices, so as to prohibit the marketing or use of medicines, vaccines, medical devices and other pharmaceutical products for which complete clinical trials have not been carried out.

Among the principal effects which this legislative proposal will have upon the legislation in the field of health are:

Increased trust in the medical system: by providing a legal framework which clearly holds health units and medical personnel to account, patients will have greater confidence in the safety of the treatments offered;

A reduction in the number of malpractice cases: presuming malpractice in certain conditions and clearly regulating responsibilities will discourage negligent or intentional acts liable to endanger patients’ lives;

Improved access to justice for patients: by amending the procedures for establishing malpractice and the rules on the jurisdiction of the courts, injured patients will be able to obtain equitable legal remedies more swiftly;

Protection of public health by prohibiting the use of unsafe medical products lacking adequate clinical trials, which will prevent possible risks to patients’ health.

In the light of the aspects and arguments set out above, I ask you to note that this legislative intervention is necessary in order to improve the protection of patients and to increase transparency and responsibility in the health sector, in accordance with present needs and with citizens’ expectations of the public health system in Romania, and to support its adoption.

We state that, by the letter of submission, the Government was requested, pursuant to art. 111 para. (1) of the Constitution of Romania, republished, to communicate its point of view on this legislative proposal.

INITIATOR: