THE PRINCIPLE OF JUSTIFICATION

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1 THE PRINCIPLE OF JUSTIFICATION AND ITS RELATION WITH RADIOLOGICAL INFORMED CONSENT IN THE CONTEXT OF EU LAW Legal Adviser at the Instituto Superior Técnico / Campus Tecnológico e Nucler, Lisbon University Proteção Radiológica na Saúde, September 2013, Lisboa, Portugal

2 CONTENTS Introduction Principle of Justification Principle of Justification in Council Directive 97/43/Euratom and the new EU BSS Radiological Informed Consent Conclusions 2

3 3 INTRODUCTION

4 INTRODUCTION What is the meaning of justification? What is the principle of justification? Who is covered by the principle of justification? Who is obliged to implement the principle of justification? Who is protected in terms of law by the principle of justification? If the principle of justification is not applied, what can be done? Which are the consequences? Legal or Moral consequences? Are there differences between justification and informed consent? 4

5 5 PRINCIPLE OF JUSTIFICATION Considering risks and benefits

6 PRINCIPLE OF JUSTIFICATION 6

7 PRINCIPLE OF JUSTIFICATION (2) Based on philosophical considerations and developed by international organizations: No practice should be adopted unless its introduction produces a positive net benefit. Requirement 36 - International BSS 7

8 PRINCIPLE OF JUSTIFICATION (3) It is applied in all radiation exposures: Medical exposure, which is mainly the exposure of patients as part of their diagnosis or treatment; Occupational exposure, which is the exposure of workers incurred in the course of their work, with some specific exclusions; and Public exposure, which comprises all other exposures of members of the public that are susceptible to human control. 8

9 PRINCIPLE OF JUSTIFICATION (4) 9

10 PRINCIPLE OF JUSTIFICATION (5) ICRP Recommendations presents different Levels of Justification for medical exposure: Level 1: Justification of use of radiation in medicine The use of radiation is accepted as doing more good than harm. Level 2: Justification of a defined radiological procedure It is necessary to consider if the radiological procedure will improve diagnosis or provide necessary management information for the benefit of those exposed. Level 3: Justification of a procedure for an individual patient All individual medical exposures should be justified in advance, taking into account the specific objectives and the characteristics of the patient. 10

11 PRINCIPLE OF JUSTIFICATION (6) IAEA, under article III (A) (6) of its Statute, establishes or adopts standards of safety for protection of health and minimization of danger to life and property; The Safety Fundamentals Principles (SF-1): Principle 4: Justification of facilities and activities Facilities and activities that give rise to radiation risks must yield an overall benefit. International Basic Safety Standards - Interim Edition General Safety Requirements Part 3 (GSR part 3): The application of the justification principle to medical exposures requires a special approach. (pg ) 11

12 PRINCIPLE OF JUSTIFICATION (7) 12

13 PRINCIPLE OF JUSTIFICATION (8) International BSS Requirement 37: Justification of medical exposures: Relevant parties shall ensure that medical exposures are justified. (pg , etc.) Medical exposures shall be justified by weighing the expected diagnostic or therapeutic benefits that they yield against the radiation detriment that they might cause, with account taken of the benefits and the risks of available alternative techniques that do not involve medical exposure. Generic justification of a radiological procedure shall be carried out by the health authority in conjunction with appropriate professional bodies, and shall be reviewed from time to time, with account taken of advances in knowledge and technological developments. The justification of medical exposure for an individual patient shall be carried out through consultation between the radiological medical practitioner and the referring medical practitioner, as appropriate, with account taken, in particular for patients who are pregnant or breast-feeding or paediatric, of: 13

14 PRINCIPLE OF JUSTIFICATION (9) International BSS Requirement 37: Justification of medical exposures: Relevant parties shall ensure that medical exposures are justified. (pg , etc.) (a) The appropriateness of the request; (b) The urgency of the procedure; (c) The characteristics of the medical exposure; (d) The characteristics of the individual patient; (e) Relevant information from the patient s previous radiological procedures. 14

15 15 PRINCIPLE OF JUSTIFICATION IN COUNCIL DIRECTIVE 97/43/EURATOM Considering risks and benefits European context

16 PRINCIPLE OF JUSTIFICATION IN COUNCIL DIRECTIVE 97/43/EURATOM Ø Directive 97/43/Euratom (MED Directive): Refers to the health protection of individuals against the dangers of ionizing radiation in relation to medical exposure. Structured: 15 Articles Definitions; Scope; Justification, optimization, Responsibilities, Procedures, Equipment, Training, Inspection Supplements Council Directive 96/29/Euratom and lays down the general principles of the radiation protection of individuals in relation to the medical exposure (Article 1 (1)). Adopts the ICRP s Recommendations and the Safety Standards of IAEA. 16

17 PRINCIPLE OF JUSTIFICATION IN COUNCIL DIRECTIVE 97/43/EURATOM (2) o Directive 97/43/Euratom Article 1 (2) (a) the exposure of patients as part of their own medical diagnosis or treatment; (b) the exposure of individuals as part of occupational health surveillance; (c) the exposure of individuals as part of health screening programmes; (d) the exposure of healthy individuals or patients voluntarily participating in medical or biomedical, diagnostic or therapeutic, research programmes; (e) the exposure of individuals as part of medico-legal procedures. 3. This Directive shall also apply to exposure of individuals knowingly and willingly helping (other than as part of their occupation) in the support and comfort of individuals undergoing medical exposure. 17

18 PRINCIPLE OF JUSTIFICATION IN COUNCIL DIRECTIVE 97/43/EURATOM (3) Article 3 (1) Justification 1. Medical exposure referred to in Article 1 (2) shall show a sufficient net benefit, weighing the total potential diagnostic or therapeutic benefits it produces, including the direct health benefits to an individual and the benefits to society, against the individual detriment that the exposure might cause, taking into account the efficacy, benefits and risks of available alternative techniques having the same objective but involving no or less exposure to ionizing radiation. In particular: (a) - all new types of practices involving medical exposure shall be justified in advance before being generally adopted, - existing types of practices involving medical exposure may be reviewed whenever new, important evidence about their efficacy or consequences is acquired. (b) all individual medical exposures shall be justified in advance taking into account the specific objectives of the exposure and the characteristics of the individual involved. If a type of practice involving a medical exposure is not justified in general, a specific individual exposure of this type could be justified in special circumstances, to be evaluated on a case-by-case basis. ( ) Project of Article 54 (1) New EU BSS Justification 1. Medical exposure shall show a sufficient net benefit, weighing the total potential diagnostic or therapeutic benefits it produces, including the direct benefits to health of an individual and the benefits to society, against the individual detriment that the exposure might cause, taking into account the efficacy, benefits and risks of available alternative techniques having the same objective but involving no or less exposure to ionising radiation. 2. Member States shall ensure that the principle defined in paragraph 1, is applied and in particular that: (a) new types of practices involving medical exposure are justified in advance before being generally adopted; (b) all individual medical exposures are justified in advance taking into account the specific objectives of the exposure and the characteristics of the individual involved. (c) if a type of practice involving a medical exposure is not justified in general, a specific individual exposure of this type can be justified, where appropriate, in special circumstances, to be evaluated on a case-by-case basis and documented. 18

19 PRINCIPLE OF JUSTIFICATION IN COUNCIL DIRECTIVE 97/43/EURATOM (4) Article 5 (1) Responsibilities Project of Article 56 (1) (c) Responsibilities The prescriber as well as the practitioner shall be involved as specified by Member States in the justification process at the appropriate level. the referrer and the practitioner are involved, as specified by Member States, in the justification process of individual medical exposures; 19

20 PRINCIPLE OF JUSTIFICATION IN COUNCIL DIRECTIVE 97/43/EURATOM (5) Article 3 (3) Prohibition and Article 14 (1) Project of Article 106 If an exposure can not be justified, it should be prohibited. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 13 May They shall forthwith inform the Commission thereof. The Member States shall lay down the rules on penalties applicable to infringements of the national provisions adopted pursuant to this Directive and shall take all measures necessary to ensure that they are implemented. ( ) 20

21 PRINCIPLE OF JUSTIFICATION IN COUNCIL DIRECTIVE 97/43/EURATOM (6) Decree-Law 180/2002 of 8 of August transposes Council Directive 97/43/Euratom; The Principle of justification is foreseen in the Article 4 (a); The practitioner has the duty to justify (Article 11 (2)), taking in consideration all information provided by the prescriber (Article 11 (4)); According to the Article 12 the practitioner has to take into consideration the risks and benefits of the exam or treatment; All new types of practices involving medical exposure shall be justified in advance by a favourable opinion of the National Commission for Ethics (Article 12 (4)); Decree-Law 180/2002 does not establish a fine for the failure to justify the use of ionizing radiation. 21

22 22 RADIOLOGICAL INFORMED CONSENT A particular case of informed consent

23 RADIOLOGICAL INFORMED CONSENT A valid informed consent requires: Capacity of the patient: Capacity is reduced in the cases of minors, elderly and mentally ill; Information: Diagnostic; Prognostic; Plan or objective of the treatment; Secondary effects; Risks and benefits. Consent: Free; On time. 23

24 RADIOLOGICAL INFORMED CONSENT (2) Who informs the patient?? 24

25 RADIOLOGICAL INFORMED CONSENT (3) What? How much? How? Treatment; Secondary effects; Alternative techniques, etc Based on a probabilistic criteria and on advances of scientific knowledge. Difficulties to understand the terminology: find equivalents. 25

26 RADIOLOGICAL INFORMED CONSENT (4) Information/Communication: Adequate, complete and previous information to the patient is essential in a system of shared responsibilities; Provides a better awareness and control of the risks; Helps the patient to better deal with secondary effects; Shows possible alternatives to the proposed intervention; Protects the patient when ionizing radiation is used; Allows the patient to take part in the decision making process. 26

27 RADIOLOGICAL INFORMED CONSENT (5) A hard dialogue: Specific and complex physical terminology; Difficulties of the patient in understanding the relationship between exposure and its beneficial effects; Difficulties to estimate risks concerning the application of ionising radiation; Biological basis of the treatment is complex and full of uncertainties. A transparent communication is essential! 27

28 28 CONCLUSIONS

29 CONCLUSIONS What is the meaning of justification? What is the principle of justification? Who is covered by the principle of justification? Who is obliged to implement the principle of justification? Who is protected in terms of law by the principle of justification? If the principle of justification is not applied, what can be done? Which are the consequences? Legal or Moral consequences? Are there differences between the justification and the informed consent? 29

30 THANK YOU VERY MUCH FOR YOUR ATTENTION! 30

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