PENAL CODE
CHAPTER II - CRIMES AGAINST INTRA-UTERINE LIFE

Article 142 (Non-punishable interruption of pregnancy)

1. The interruption of pregnancy by a physician, or under his/her supervision, in an official or officially recognised health establishment and with the consent of the pregnant woman is not punishable, when, in accordance with medical knowledge and experience,

a) It constitutes the only means of removing risk of death or serious and irreversible damage to the body or to the physical or mental health of the pregnant woman;
b) It is deemed necessary to prevent danger of death or serious and lasting injury to the body or to the physical or mental health of the pregnant woman, and is carried out within the first 12 weeks of pregnancy;
c) There are strong reasons to believe that the unborn child will be suffering from incurable serious illness or congenital malformation, and if the procedure is performed within the first 24 weeks of pregnancy, and the reasons are justified and proven by scanning or any other suitable means in accordance with leges artis, with the exception of unviable foetuses, in which case the pregnancy can be interrupted at any time;
d) The pregnancy results from a crime against sexual freedom and self-determination and the interruption is carried out within the first 16 weeks of pregnancy.

2. The circumstances which render the interruption of pregnancy non-punishable are confirmed through a medical certificate, written and signed before the intervention by a physician other than the one by whom, or under whose direction, the interruption is performed.

3. Consent is given:
a) Through a document signed by the pregnant woman, or on her behalf, and, whenever possible, three days prior to the date of the intervention; or
b) If the pregnant woman is under 16 or mentally incapable, then the document may be signed, respectively and in this order, by her legal representative, an ascendant or descendant relative, or, if these do not exist, by any collateral relatives.

4. If it is not possible to obtain consent under the terms of the previous number and the interruption of pregnancy is of an urgent nature, the physician has the power of decision relative to the situation resorting, whenever possible, to the opinion of other physician or physicians.

Article 148 (Injury to physical integrity through negligence)

1. Whosoever, through negligence, injures the body or health of another person, may be punished by a prison sentence of up to one year or by a penalty of up to 120 days.
2. In the circumstances envisaged in the previous number, the court may hand down the punishment when:
a) The agent is a physician exercising his/her profession and no illness or incapacity for work for more than 8 days results from the medical intervention; or
b) The injury does not result in the loss of capacity to work for more than 3 days.
3. If the action results in serious injury to physical integrity, the agent may be punished by a prison sentence of up to 2 years or a penalty of up to 240 days.
4. The criminal procedure depends on the complaint.

Article 149 (Consent)

1. Physical integrity is considered freely available for the purposes of consent.
2. To decide whether the injury to the body or health contradicts good practice, the motives and purposes of the agent and of the injured party shall be taken into account, as well as the means used and the predictable extent of the injury.

Article 150 (Interventions and medical and surgical treatment)

1. The interventions and treatments which, in accordance with the state of knowledge and experience of medicine, are deemed to be indicated and are carried out, in compliance with the leges artis, by a physician or other legally authorised person, with the intention of preventing, diagnosing, curing or minimizing any illness, suffering, injury or bodily fatigue, or mental disturbance, are not considered as injurious to physical integrity.
2. Those persons indicated in the previous number who, in view of the purposes therein described, carry out interventions or treatments in violation of the leges artis, thus creating serious risks to the life, body or health of the subject, may be punished with up to two years imprisonment or a penalty of up to 240 days, unless some other more severe punishment is applied under another legal provision.

(Terms of Law no. 65/98, of 2/9)

Article 156 (Arbitrary medical and surgical interventions and treatments)

1. Those persons mentioned in article 150 who, in view of the purposes therein referred to, perform interventions or treatments without the consent of the patient, may be punished with up to 3 years imprisonment or fine.
2. There is no punishment when consent:
a) Can only be obtained by means of a delay that would imply danger to life or serious injury to body or health; or
b) Is given for a certain intervention or treatment and a different one is carried out since the state of medical knowledge and experience has shown this to be the means to avoid danger to life, body or health;

and there are no circumstances which would safely lead to the conclusion that such consent would have been refused.

3. If, through gross negligence, the agent falsely represents the presupposition of consent, this may be punished by a prison sentence of up to 6 months or a penalty of up to 60 days.
4. The criminal procedure depends on the complaint.

Article 157 (Duty to explain)

For the purposes of the provision contained in the previous article, consent is only effective when the diagnosis and nature, range, magnitude and possible consequences of the intervention or treatment have been duly explained to the patient, unless that implies the communication of circumstances which, if the patient were to know about them, would endanger her life or would be deemed liable to cause serious harm to her physical or mental health.

Article 283 (Spreading of diseases, tampering with analysis or prescriptions)

1. Whomsoever:
a) Spreads contagious diseases;
b) As a physician or employee, nurse or laboratory worker, or person legally authorised to carry out examinations or keep supplementary records of diagnoses or medical or surgical treatment, provides in correct data or results; or
c) As a pharmacist or pharmacy employee, supplies medical substances different from those prescribed;

and thus endangers the life or poses serious risks to the physical integrity of others, may be punished by a sentence of 1 to 8 years imprisonment.
2. If the danger referred to in the previous number arises through negligence, the agent may be punished with up to 5 years imprisonment.
3. If the conduct referred to in no. 1 is of a negligent nature, the agent may be punished with up to 3 years imprisonment or with a penalty.

Article 284 (Refusal by physician)

A physician who refuses his/her professional help in case of serious danger to the life or physical integrity of another, which cannot be removed in any other manner, may be punished by a sentence of up to 5 years imprisonment.

Article 285 (Aggravation through outcome)

If the crimes referred to in articles 272, 273, 277, 280, or 282 to 284, result in death or serious injury to the physical integrity of another person, the agent may be punished with the penalty appropriate to the case, with the minimum and maximum limits being increased by one third.

Article 286 (Special attenuation of and exemption from punishment)

If, in the cases established in articles 272, 273, 277, or 280 to 284, the agent voluntarily removes the danger before significant injury is caused, the penalty may be specially reduced or dispensed with.

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CLINICAL TRIALS

Ministry of Health
Decree-Law no. 97/94
9th. April

Published in:DIÁRIO DA REPÚBLICA* - 1ST SERIES-A - No 83 - 9-4-1994

Article 1

Objective

1-The present diploma establishes the rules with which all clinical trials to be conducted on human beings should conform in order to guarantee both physical and mental integrity as well as the effectiveness and safety of medicines.
2-For the purposes of the present diploma, clinical trials are understood to include any systematic study involving medicines to be conducted on human beings, healthy or otherwise, with the purpose of investigating or checking the effects and/or studying their absorption, distribution, metabolism and excretion, in order to determine their effectiveness and safety.

Article 2

General principle

In any clinical trial, the individual welfare of the person should prevail over the interests of both science and community.

Article 3

Professional qualification

1-Clinical trials can only be carried out by physicians who have the appropriate scientific qualifications and research experience, especially in the area of the proposed clinical trial.
2-The scientific qualification referred to above, should be recognised by the ethics committee of the public health establishment or private practice unit, bearing in mind the type of test to be performed and the professional qualifications of the physicians in question.

Article 4

Requirements

1-Clinical trials should strictly observe recognised scientific principles and scrupulously respect the physical and mental integrity of those involved.
2-Clinical trials should be preceded by tests on animals, and can only be performed on humans when the results of tests on animals lead to the conclusion that the risks for the person being submitted to the test are proportional to the predicted benefits for that person.
3-Clinical trials can also be performed on healthy individuals when it is predicted that their physical and mental integrity are at no risk whatsoever.

Article 5

Authorised institutions

1-Clinical trials can only be performed in public health establishments, or duly authorised private health units, that have such material and human conditions as will guarantee the required scientific rigour and quality.
2-Trials including the use of medicines which, by their nature or because of the characteristics of the disease, may present a serious risk to the life or health of the patient, should be performed on patients admitted to health-care units which have the proper technical, material and human conditions to provide permanent monitoring of the trial and of the performance of surgical interventions which may be deemed necessary.

Article 6

Protocol

1-The terms under which each clinical trial is conducted are laid down in a protocol, in which the respective objectives, conditions of performance and stages are established.
2-The protocol also includes the following items:
a) Names and addresses of the promoter, researcher responsible for the test and collaborators, and respective CVs;
b) Amount of fees to be paid to the researcher, as well as amounts in money or in kind, to be paid by the promoter to the establishments where the tests are performed, as compensation for the use of facilities;
c) Generic denomination of the medicine, its composition, and identification of the body which prepared the samples;
d) Name of the technical director responsible for the quality of medicines to be tested;
e) Type and definition of the clinical trial, the technique selected and its objectives;
f) Place and department where the clinical trial is to be conducted and respective duration;
g) Preview of the profile, admissibility criteria , number of participants and specifications of their diagnoses;
h) Precautions to be taken in conducting the trial and predicted adverse reactions.
3-The protocol is dated and signed by the promoter, and by the researcher responsible for the trial.
4-The identification of the subjects participating in the clinical trials, and respective proof of consent, are attached to the protocol.

Article 7

Authorisation

1-Prior authorisation from the administrative organ of the institution in which they are to be conducted is required, at the request of the promoter, with the following conditions being observed: .
a) In public health institutions and services, the favourable opinion of the ethics committee and director of the service where the trial is to be conducted is required;
b) In private health units, the favourable opinion of the ethics committee is required.
2-In those establishments or health units where an ethics committee does not exist, the performance of clinical trials cannot be authorised.
3-The authorisation application is added to the protocol and other documents justifying the objectives of the clinical trial.
4- This Authorisation will not be granted if the protocol does not include the items referred to in the previous article.
5-The promoter should communicate the authorisation, when granted, and the beginning of the trial, to the Instituto Nacional da Farmácia e do Medicamento [National Institute of Pharmacy and Medicines]. This communication should include a copy of the protocol.

Article 8

Ethics committees

1-The ethics committee has the power to decide on authorisation requests to hold clinical trials and is responsible for monitoring their respective execution, especially with respect to ethical aspects, and the security and integrity of those participating in the clinical trial.
2-In the exercise of the powers described in the previous paragraph, the entities involved should assess the following:
a) The qualifications and experience of the researcher and collaborators, bearing in mind the proposed trial;
b) The technical and support service conditions in which the trial is conducted;
c) Whether or not the protocol is appropriate to the objectives of the trial, taking into account the possible benefits and foreseeable risks;
d) Observance of ethical commitments undertaken through the protocol or resulting from norms, either national or international, which govern the running of clinical trials;
e) The emergence of reasons that may justify the suspension or revocation of the authorisation granted to hold clinical trials.

3-The composition, powers and mode of functioning of ethics committees are defined in a specific diploma.

Article 9

Information

1-The researcher is obliged to inform the subject participating in clinical trials, in a simple, intelligible and honest way, about the foreseeable risks, consequences and benefits, as well as about methods and objectives being pursued.
2-The researcher must also provide the subject participating in clinical trials with the following:
a) Names and addresses of the promoter, the researcher responsible for the test, and collaborators;
b) Name of medicine;
c) Name of the technician responsible for the quality of medicines to be tested;
d) Characteristics of the clinical trial, its duration and objectives;
e) Precautions to be taken when conducting the clinical trial and reactions predicted.
3-The subject participating in the clinical trial must also be informed of the civil liability regime in force.

Article 10

Consent

1-Consent to take part in clinical trials must be given freely, clearly stated and in writing.
2-Consent obtained without compliance with the previous article and of no. 1 above is considered void.
3-Consent shall be freely revocable at any time, without the participant incurring any obligation to compensate for losses entailed.
4-In cases of minors or subjects incapable of giving informed consent, the clinical trial can only be undertaken when there is a clear and direct clinical benefit for the subject.
5-In the case of minors or subjects incapable of giving informed consent, consent must be given by their legal representatives, without prejudicing the need to obtain consent from minors capable of understanding and manifesting their wishes..

Article 11

Confidentiality

All those taking part in clinical trials or who in any way learn about the holding of such trials, must not to disclose any such personal data as they might have had access to.

Article 12

Researcher remuneration

1-The payment of fees to the researcher is allowed, provided they are mentioned in the protocol, and without prejudice to the provision in the next point.
2-When the researcher is an employee or agent of the National Health Service, the civil service regime is applied.

Article 13

Recompense

1-The participation of subjects in clinical trials cannot, in any circumstances, be remunerated.
2-The previous point does not prejudice the reimbursement of such expenses or losses that the subject may have incurred through his/her participation in the tests.
3-When applied, and within the terms of paragraph 2 above, the reimbursement of expenses and losses, the respective amounts and justification should be communicated, periodically and in writing, to the ethics committee and to the body granting the authorisation.

Article 14

Insurance

1-The subject participating in the clinical trial has the right to be indemnified for damages, regardless of the guilty party.
2-In order to comply with the previous point, insurance must be taken out, at the promoter's expense.

Article 15

Promoter

1-The promoter is the person responsible for the promotion and financing of the clinical trial.
2-It is the promoter's duty:
a) To request authorisation from the administrative organ of the health establishment to hold clinical trials;
b) To propose a researcher, whose scientific qualifications and professional experience must be documented;
c) To provide the researcher with all relevant chemical-pharmaceutical, toxicological, pharmacological and clinical data to guarantee the safety of the medicine, as well as all the information required for the proper conduct of the trials;
d) To finance and make available to the researcher all the resources necessary for the proper conduct of the trials, especially medicines and equipment;
e) To assure the surveillance of the test by means of monitoring carried out under medical responsibility;
f) To assure the fulfilment of all duties to communicate and inform contained in the present diploma;
g) To present a final report to the administrative organ of the health establishment and to the Instituto Nacional da Farmácia e do Medicamento.

Article 16

Researcher

1-The researcher is the medical expert responsible for conducting and running the clinical trial.
2-It is the researcher's duty:
a) To assume the responsibility for holding trials, in accordance with the protocol signed jointly with the promoter, within the terms of the authorisation granted;
b) To inform and explain to the subjects participating in clinical trials, in accordance with Article 9;
c) To propose to the administrative organs of the health institution, once authorisation from the service director and promoter is obtained and after the ethics committee hearing, any alteration to the protocol which may result from partial data from the clinical trials; and to urge changes and the suspension of trials whenever reasons arise to justify such action;
d) To ensure the rigorous keeping of clinical records, the processing of all information gathered during the trials, and to compile the final report containing the assessment of the results obtained.
3-The researcher must also:
a) Take all appropriate measures in the case of serious or unexpected adverse reactions and report them immediately to the promoter, to the ethics committee, to the Direcção-Geral da Saúde [General Directorate of Health], to the Instituto Nacional da Farmácia e do Medicamento and to the respective administrative organ of the health establishment;
b) Report all trial results, whenever requested, to the Instituto Nacional da Farmácia e do Medicamento, to the administrative organ of the health institution, to the promoter, and to the monitor, so that those results can be analysed and the objectives confirmed;
c) Guarantee the confidentiality of all aspects of the preparation, conduct and finalisation of the trial, as well as of all information regarding the subjects participating;
d) Assume responsibility for the medical monitoring of the participants during and after the holding of trials, and to keep the head of the respective department informed of the progress of the trials.
4-The researcher may promote the holding of clinical trials provided he/she assumes, simultaneously, the responsibilities of promoter.

Article 17

Monitor

1-The monitor is the individual designated by the promoter to follow the clinical trial, report on its progress, check the information gathered, and to keep the promoter permanently informed.
2-The information to be given to the promoter specifically includes: the conditions required to conduct clinical trials, the information given to the whole research team, compliance with the protocol, and the process of gathering and recording data from the clinical trial.

Article 18

Suspension or revocation of the authorisation granted

1-The authorisation granted shall be suspended or revoked, according to the seriousness of the case, when the ethics committee hears that:
a) participant consent is missing or fraudulent;
b) cases of non compliance with the protocol have occurred;
c) continuation of the test would prove hazardous to the health of those taking part and, in particular, serious adverse reactions have occurred.
2-The suspension or revocation of the authorisation granted must be duly founded and reported to the Instituto Nacional da Farmácia e do Medicamento , to the head of the department, and to the promoter.