OPINION NO. 129/CNECV/2024 - JOINT CNECV/CEIC OPINION ON THE ETHICAL ASPECTS OF CLINICAL RESEARCH IN EMERGENCY SITUATIONS (EXECUTIVE SUMMARY)

The National Ethics Council for Life Sciences (CNECV) and the Ethics Commission for Clinical Research (CEIC) have approved a joint opinion on the possibility of carrying out clinical trials on medicines and clinical studies on medical devices in emergency situations, taking into account the direct application the Portuguese legal framework of the European regulations in the fields of clinical trials and medical devices.

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Opinion no. 128/CNECV/2024 on the ethical aspects of the use of psychedelics in healthcare (EXECUTIVE SUMMARY)

Psychedelic substances refer to a group of substances defined by the subjective effects induced by their consumption, namely cognitive, perception, sense, meaning, and identity alterations. The scarcity of studies on the validity and efficacy of these substances for therapeutic use points to the need for further research before the standardised implementation of the use of psychedelics in clinical practice.

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Opinion 127/CNECV/2024 on the proposal for a Decree-Law aimed at ensuring the application of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices (Executive Summary)

The present opinion was prompted by a request addressed to the National Council of Ethics for Life Sciences (CNECV) by the Board of Directors of INFARMED - National Authority of Medicines and Health Products, I.P., for the Council's reflection and recommendation on the proposal for a Decree-Law aimed at ensuring the application of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices.

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OPINION 126/CNECV/2023 ON THE DRAFT LAW REGULATING LAW NO. 90/2021 OF 16 DECEMBER - AMENDING THE LEGAL REGIME APPLICABLE TO SURROGATE PREGNANCY (Executive Summary)

The present opinion was prompted by a request addressed to the National Council of Ethics for Life Sciences (CNECV) by the Office of His Excellency the Minister of Health. The Council assessment and opinion was requested on the Draft Decree-Law that regulates Law no. 90/2021, of 16 December, which amends the legal framework for medically assisted procreation (MAR), approved by Law no. 32/2006, of 26 July (LPMA), concerning the legal framework for surrogate pregnancy.

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Opinion 125/CNECV/2023 concerning sexual convertion therapies (Executive Summary)

The Committee for Constitutional Affairs, Rights, Freedoms and Guarantees of the Portuguese Parliament addressed to the CNECV a request for an opinion on the ethical aspects of Draft Bill no. 699/XV/1 (PAN), which provides for the criminalization of practices aiming at changing, limiting or repressing sexual orientation, gender identity or expression, and promoting the study of these practices in Portugal and the guarantee of support and response mechanisms, and Draft Bill no. 707/XV (PS), which prohibits offensive practices against LGBT+ people through so-called sexual conversion therapies.

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Opinion 124/CNECV/2023 on the protection of intimacy within the school context (Executive Summary)

The Parliamentary Standing Committee on Constitutional Affairs, Rights, Freedoms and Guarantees has sent the National Council of Ethics for the Life Sciences (CNECV) a request for an opinion on the assessment, in ethical terms, of Draft Bill no. 705/XV/1ª (CHEGA political party) - Reinforcing the protection and privacy of children and young people in the spaces of intimacy within a school context.

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Opinion 123/CNECV/2023 on Off-Label use of medicines - Ethical implications

The off-label use of medicinal products is a common therapeutic practice in any healthcare system. The CNECV’s opinion provides an analysis of the technical reasons justifying the off-label use of medicinal products, as well as the ethical and legal implications thereof, and makes the corresponding recommendations.

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Opinion 122/CNECV/2023 on the draft decree-law regulating Law No. 90/2021 of 16 December, which alters the legal regime applicable to gestational surrogacy (Executive Summary)

The National Council of Ethics for the Life Sciences (CNECV) unanimously approved, at its 276th Plenary Meeting held on 21 April, Opinion No. 122/CNECV/2023 on the draft decree-law that regulates Law No. 90/2021 of 16 December, which alters the legal regime applicable to gestational surrogacy. The present opinion was prompted by a request addressed to the Council as a matter of urgency by His Excellency the Minister of Health.

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Opinion 121/CNECV/2023 on the Draft Bill no. 24/XV/1 - Approves the Mental Health Law and amends the related legislation (Executive Summary)

The National Ethics Council for Life Sciences (CNECV) unanimously approved, on 23 March, during its 275th Plenary Meeting, Opinion 121/CNECV/2023 on the Draft Bill no. 24/XV/1 - Approves the Mental Health Law and amends the related legislation. The CNECV highlights as relevant to the assessment of this topic the importance of informing and guaranteeing citizens the right to prospectively declare their will regarding treatments and other procedures related to their health to be considered if they lose the capacity to express it, and that such information is accessible to professionals directly involved in the provision of care.

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Opinion 120/CNECV/2022 on on self-determination of gender identity, gender expression and the right to protection of sexual characteristics within the school environment (Executive Summary)

The Parliamentary Committee on Constitutional Affairs, Rights, Freedoms and Guarantees has sent the National Council of Ethics for the Life Sciences (CNECV) a request for an opinion with the object of assessing, in ethical terms, both the Draft Bill No. 332/XV/1 (PS) - Establishes the framework for issuing administrative measures that schools must adopt for the purposes of implementing Law No. 38/2018, of 7 August, and Draft Bill No. 359/XV/1 (BE) - Strengthening the guarantee of the exercise of the right to self-determination of gender identity, gender expression and the right to protection of sexual characteristics in schools.

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Opinion 119/CNECV/2022 on Voluntary Termination of Pregnancy (Executive Summary)

The National Council of Ethics for the Life Sciences (CNECV) received from the Parliamentary Standing Committee of Constitutional Affairs, Rights, Freedoms and Guarantees a request for an opinion concerning Draft Bills no. 953/XIV/3 and no. 954/XIV/3 on voluntary termination of pregnancy. With the dissolution of the Parliament, the initiatives lapsed and, with them, the object of the request. Nevertheless, the CNECV considered that it should issue an opinion on the subject on its own initiative, given the relevant ethical, as well as medical, legislative, and social issues raised.

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Opinion 118/CNECV/2022 on Bill no. 95/XV/1 - mandatory referendum on the decriminalisation of medically assisted death (Executive Summary)

The National Council of Ethics for the Life Sciences (CNECV) was asked for an opinion on Bill no. 95/XV/1 (CHEGA political party) on the compulsory holding of a referendum on medically assisted death (also referred to as medical assistance in dying – MAID). Although the Bill falls within the scope of medically assisted death, its main question refers to the requirements of mandatory holding of a referendum to change the legal status of central matters constitutionally consecrated as fundamental rights, in this case, the right to life.

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Opinion 117/CNECV/2023 on ethical requirements for public interest decision making in Life Sciences (Executive Summary)

The decision-making processes of public interest, at both governmental and institutional level, are particularly demanding in the current context of pluralistic and egalitarian societies, deserving a thoughtful reflection. In contemporary democratic societies, built on the respect for Human Rights, it is recognised that public policies aim to formulate a standard for civic action, while respecting the plurality of individual values and the diversity of community values.

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Opinion 116/CNECV/2022 on Bills 5/XV/1 (BE), 74/XV/1 (PS) and 83/XV/1 (PAN), regulating the conditions under which medically assisted death is not punishable and amending the Penal Code (Executive Summary)

The National Council of Ethics for the Life Sciences (CNECV) approved in its Plenary Meeting on June 9, 2022, in response to the request of the Parliamentary Standing Committee on Constitutional Affairs, Rights, Freedoms and Guarantees, the Opinion No. 116/CNECV/2022. 116/CNECV/2022 on Bills no. 5/XV/1 (BE), no. 74/XV/1 (PS) and no. 83/XV/1 (PAN), regulating the conditions under which medically assisted death is not punishable and amending the Penal Code.

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Opinion 115/CNECV/2022 on the Draft Regulatory Act of Law No. 90/2021, of 16 December, which further amended the legal regime of medically assisted procreation regarding gestational surrogacy (Executive Summary)

The National Council of Ethics for the Life Sciences (CNECV) approved, on 25 May 2022, Opinion No. 115/CNECV/2022 on the Draft Regulatory Act of Law No. 90/2021, of 16 December, which further amended the legal regime of medically assisted procreation in terms of gestational surrogacy.

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