TERMS OF REFERENCE

 Realization of a legal analysis aimed at analyzing the national legislative environment in relation to bioethics

1. Context

Bioethics is conceptualized as a response to ethical problems and societal questions raised by progress in biology, medicine and health. These developments bring into play the fundamental ethical principles such as the dignity of the human being, their autonomy, the inviolability and the unavailability of their body, their personal data, etc. This need to ensure the protection of these principles is today recognized worldwide.

The extent of the ethical issues posed by uncontrolled medical-scientific research practices has given rise to a universal awareness of the need to impose legal safeguards on these practices to guarantee respect for the fundamental rights of the individuals with regard to applications of biology and medicine. Since the Nuremberg Code enunciated in 1947, a series of international instruments and texts have followed one another to constitute the framework of the international system of protection of humans against the dangers of scientific progress which could upset or alter their fundamental rights. This has led several countries to integrate the standards and norms of bioethics into their internal legislation.

Morocco adheres to the main existing instruments related to human rights, in this case those related to bioethics and the right to health. At the national level, reflection on bioethics was initiated at the beginning of the 1980s thanks to a gradual awareness, in medical and university circles, of the need to raise awareness of bioethics with a view to institutionalizing it. This aim has led to the creation of ethics committees within the faculties of medicine and University Hospital Centers (CHU). Alongside this academic and scientific movement, a gradual implementation of the regulations governing the biomedical field has started, in particular regarding areas of research, organ donation and transplantation, and assisted reproduction, among others.

The National Human Rights Council, through its missions of prevention, protection and promotion of human rights, by virtue of law 76-15 concerning its reorganization, supports the promotion of the principles of bioethics and its institutionalization. And it is with this aim in mind that it is carrying out a study which draws up the inventory of bioethics both in health practices and biomedical research and in the legislative, institutional and academic fields, and with the objective of supporting its advocacy in favor of strengthening respect for the rights of patients and participants in biomedical research and for human identity in general.

The program of the analysis will be based on a certain number of activities which revolve around two key components:

1. Producing a survey report regarding progress based on two questionnaires, relating respectively to ethics committees and to the teaching of bioethics. The questionnaires are intended for public and private healthcare institutions, training institutions in the fields of health, life sciences and social sciences, research institutions, etc.
2. The analysis of the legislation governing biomedical medical practices and research, potentially limited by ethical and bioethical dimensions.

Under this second component, a reflection seminar was organized at the CNDH on December 3, 2022, focusing on the legislative framework and the ethical and human rights issues in health and biomedical research. This seminar specifically addressed the laws governing biomedical research, assisted reproductive technology, organ donation, blood donation, as well as the draft law on the protection of individuals with mental illnesses, in order to identify their shortcomings in light of bioethical issues.

Building on the discussions held during this workshop, it is necessary, within the framework of the current consultation, to engage in legal expertise to identify the means to ensure the establishment of bioethics and its institutionalization in the field of health and research.

2. Objective and consistency of the expert mission

• Aim and objectives of the mission

The purpose of the mission is to carry out an analysis of the national legislative framework governing medical and biomedical practices and research in terms of guarantees of the principles of bioethics and human rights, as recognized by the relevant normative reference in the matter.

The CNDH will rely on the results of this expertise to formulate, within the framework of the final report of the study, an opinion on the existing legal structure and issue recommendations in favor of a consecration of the principles of bioethics and the rights of human beings in health-related practices and research involving human beings.

• Consistency of the mission

Based on the reference framework governing bioethics, including in particular the Universal Declaration on Bioethics and Human Rights[1], and in the light of good practices in this area, the work will consist of the following:

• Produce a collection of the main legal texts governing medical practices and biomedical research at the national level, as well as any other relevant regulations. These texts must also include, in particular, the laws that were the subject of reflections within the framework of the aforementioned workshop organized by the CNDH in December 2022;
• Examine the harmonization of the texts of laws, thus identified, in particular in relation to the reference system of human rights and international standards in the field of bioethics;
• Identify legal loopholes and their consequences on the institutionalization of bioethics and their impact on respect for human rights;
• Based on the conclusions of the analysis, propose legislative and institutional measures to strengthen the incorporation of bioethics in medical practices and biomedical research, as well as in the training programs for healthcare professionals.

3. Deliverables

The deliverables to be submitted as part of this mission are:

1. An initial report including a methodological analysis detailing the approach, the stages, the means proposed, the justification of the methodological choices, the chronogram detailing the progress of the mission, its different phases, the data sources, and the structure of analysis and the final report.
2. An interim report presenting the main texts constituting the universal repository of bioethics, and a synthesis of good legislative practices at the international level in terms of the consecration of bioethics. This report includes the collection of legal texts relevant to the national level governing of the fields concerned by bioethics.
3. A final report presenting the elements of the study, the results of the analysis and the resulting proposals. This report will be the subject of a restitution and validation workshop with the CNDH. The report should include an executive summary and a synthetic PP presentation.

The deliverables will be written in French and provided in 4 copies in paper and electronic format.

4. Duration of consultation

The mission is scheduled for an estimated duration of 40 working days, spread over a period of two months (excluding delivery validation times). This period will begin from the date of signing the contract.

5. Consultant Profiles

Carrying out the tasks required by the consultation requires proven skills in terms of legal analysis, a good knowledge of health law and confirmed knowledge in the fields of bioethics and human rights.

The team in charge of carrying out the study should be composed of:

An international consultant (Team Leader),

• Graduate degree in legal sciences, or in equivalent fields,
• Consistent experience in the fields related to the subject of the expertise,
• Experience in analysis in the field of bioethics and health in general;
• Expertise in areas related to international human rights law, right to health, health law
• In-depth knowledge of the issues related to bioethics and the international standards that govern them and of the international environment of the jurisdiction of bioethics;
• experience in leading teams of consultants

A national senior legal consultant having in particular:

• A higher degree (minimum Master’s degree or equivalent) in law;
• Substantial experience in legislative / legal studies and analyzes
• A perfect knowledge of the Moroccan health system, national legislation governing the health sector and biomedicine, and health law;
• Good knowledge of national and international standards in human rights and bioethics;
• Very good writing and reporting skills.

[1] Universal Declaration on Bioethics and Human Rights | UNESCO