Chương VIII Luật khám bệnh chữa bệnh 2023: Áp dụng kỹ thuật mới, phương pháp mới trong khám bệnh, chữa bệnh và thử nghiệm lâm sàng trong khám bệnh, chữa bệnh

Chapter VIII

APPLICATION OF NEW TECHNIQUES OR METHODS AND CLINICAL TRIALS IN HEALTHCARE

Section 1. APPLICATION OF NEW TECHNIQUES OR METHODS IN HEALTHCARE

Article 92. New healthcare techniques or methods

1. New techniques or methods are those techniques and methods that are applied for the first time in Vietnam.

2. New techniques or methods shall comprise the following:

a) New techniques or new methods that are researched in Vietnam or abroad;

b) New techniques or new methods that are available for use with the consent of competent authorities in foreign countries.

Article 93. Conditions for application of new techniques or methods in healthcare

1. In order to apply for permission to use a new healthcare technique or method, a medical establishment shall be required to satisfy the following conditions:

a) Their operating license itemizes professional activities for which that new technique or method is suitable;

b) Their physical infrastructure, medical equipment, staff and other conditions meet the requirements for application of that new technique or method.

2. A new technique or method shall be applied as follows:

a) The medical establishment prepares the proposal for permission to apply that new technique or method;

b) The Ministry of Health reviews or decentralizes authority to consider granting permission to experiment on that new technique or method;

c) After completing the experimentation stage, the medical establishment integrates experimentation results into the application for the acceptance testing conducted by the Ministry of Health;

d) If the acceptance testing result is satisfactory, the Ministry of Health shall be responsible for issuing written permission to apply that new technique or method.

3. The Government shall elaborate on this Article.

Section 2. CLINICAL TRIALS IN HEALTHCARE

Article 94. Clinically trialed objects

1. New healthcare techniques or methods.

2. Medical equipment that is ranked highly above-average or high in the risk rating adopted by the Government before being registered for free sale in Vietnam.

Article 95. Conditions of participants in clinical trials in healthcare

1. Persons who meet the professional requirements of a clinical trial of new technique or method, medical equipment in use in medical examination and treatment activities (hereinafter referred to as clinical trials) and voluntarily participate in clinical trials.

2. In order to participate in a clinical trial, the participant who is a person who loses his/her capacity to perform civil acts, has impaired cognition or difficulties in behavior control or limited capacity to perform civil acts; the minor patient shall be required to seek the consent from his/her representative or guardian under civil law.

3. If the participant in a clinical trial is the one specified in clause 2 of this Article above; a pregnant or lactating woman, the research profile shall need to clarify reasons for recruitment and proper actions for protection of the participant, unborn babies or the infants who are being breast-fed by the mother participating in the clinical trial.

Article 96. Rights and obligations of participants in clinical trials

1. A participant in a clinical trial shall reserve the following rights:

a) Have access to full and accurate information about the clinical trial and potential risks before the clinical trial is initiated;

b) Receive any compensation for any damage caused by the clinical trial;

c) Have the confidentiality of his/her personal information relating to the clinical trial protected;

d) Gain exemption from any liability when unilaterally terminating his/her participation in the clinical trial;

dd) File complaints, denunciations or take legal actions against any violation of laws committed by entities or persons whose new techniques, methods or medical equipment need to be clinically trialed.

2. Participants in clinical trials shall be obliged to comply with the instructions specified in the approved clinical trial profiles.

Article 97. Rights and responsibilities of entities and persons whose new techniques or methods need to be clinically tested

1. Entities and persons whose new techniques or methods need to be clinically tested shall have the following rights:

a) Designate any body meeting facility and personnel requirements to conduct clinical trials;

b) Retain full ownership of clinical trial results.

2. Entities and persons whose new techniques or methods need to be clinically tested shall have the following rights:

a) Compensate participants in clinical trials for any risk that may arise during the process of conduct of clinical trials in accordance with laws;

b) Enter into written contracts for clinical trials with testing bodies;

c) Have legal liability for quality and safety of new technique, method or medical equipment that they hand over for clinical trials.

Article 98. Rights and responsibilities of testing bodies

1. Testing bodies shall reserve the following rights:

a) Take steps in accepting conduct of clinical trials in accordance with law;

b) Import and purchase chemicals, reference materials, specimens of medications and medical equipment needed for a clinical trial;

c) Use findings from a clinical trial in accordance with entities and persons whose new techniques, methods or medical equipment need to be clinically tested.

2. Testing bodies shall assume the following responsibilities:

a) Take responsibility for the completeness, accuracy and reliability of clinical trial findings;

b) Bear responsibility for the safety of clinical trial participants and compensate them for any risk that they may incur through the testing body’s fault in accordance with laws;

c) Ensure authenticity and objectivity during a clinical trial.

Article 99. Principles and authority of approval of clinical trials

1. Clinical trials shall be performed before application of a new technique or method, or marketing authorization of a medical device, except in the case of exemption from clinical trials or exemption from certain phases of a clinical trial.

2. A clinical trial shall be conducted only after the profile of that clinical trial has passed the scientific and ethical evaluation by the Ethics Committee on Biomedical Researches referred to in clause 3 of this Article, and after it is approved in writing by the competent authority.

3. Ethics Committee on Biomedical Researches is an independent committee set up to protect the rights, safety and health of the participants in clinical trials.

4. Conduct of clinical trials, scientific and ethical evaluation of the clinical trial profiles and approval of clinical trials shall adhere to the following basic principles:

a) Respect, protect and uphold the self-determination rights of participants in clinical trials;

b) Ensure that research interests should prevail over risks incurred during clinical trials;

c) Ensure equal benefits and responsibilities; make sure that risks are evenly distributed among clinical trial participants;

d) Assure implementation of clinical trial stages and compliance with good practice in testing new techniques, methods or clinical testing of medical devices as instructed by the Minister of Health.

5. The Government shall elaborate on the followings:

a) Clinical trial stages;

b) Cases of eligibility for exemption from clinical trials or certain of clinical trial stages;

c) Requirements of new techniques, methods or medical equipment to be clinically trialed;

d) Requirements of the testing body;

dd) Application package, procedures and processes for a clinical trial;

e) Establishment of the Ethics Committee on Biomedical Researches.