INTRODUCTION TO THE LEGAL SYSTEM OF MOZAMBIQUE
The Republic of Mozambique has a civil law legal system where legislation is the primary source of law. Therefore case law does not have the binding authority as in common law systems and are not considered a primary source of law.
Mozambique is a democratic rule of law State with foundation on separation and interdependence of powers, according to the Constitution of 16 November 2004, a third post-independence constitution adopted, which further strengthened individuals rights and the independence of the courts. The supreme law of the country is the Constitution (2004). Thus, legislation found to be contrary to the provisions of the Constitution shall be subject to nullification. Mozambique is a unitary State, which respects the principles of autonomy of local authorities.
Title III of the Constitution (Articles 35 to 95) provides with Fundamental Rights, Duties and Freedoms. It ensures the equality of all before the law, the right to life and to physical and moral integrity and to not be subject to torture or to cruel or inhuman treatment, the right to privacy, and the duty to defend and promote health.
According to article 43 of the Constitution, the constitutional principles in respect of fundamental rights shall be interpreted and integrated in harmony with the Universal Declaration of Human Rights (1948) and with the African Charter of Human and Peoples, Rights (1981).
In terms of International Law, only validly approved and ratified International treaties and agreements shall enter into force in the Mozambican legal order once they have been officially published and while they are internationally binding on the Mozambican State. Norms of international law shall have the same force in the Mozambican legal order as have infra-constitutional legislative acts of the Assembly of the Republic and the Government, according to the respective manner in which they are received.
In Mozambique there is a science and Technology Ethics Code, a general Law, approved by the Council of Ministers (Decree n° 71/2007, of 24 December) which according to article 2, it applies to all areas where scientific investigations occurs, including those that involves ethical aspects on human lives. Thus, one can say that there is general law regulating health research and the protection of research participants, which address the basic principles of health research likely Respect to persons (consent, confidentiality), Beneficence and Justice.
This Ethics Code does not explicitly refer to the Declaration of Helsinki (2008), although it comprises its basic principles for research. Mozambique is not part of the Declaration yet, as the Country National medical Councils in the process of becoming a member of the World Medical Association. Nevertheless, the country has a relatively good record in ratifying international and regional human rights instruments without reservation; Notwithstanding, it applies the principles of the Declaration of Helsinki as customary international law, the same applies to CIOMS International Ethical Guidelines 2002 and WHO Operational Guidelines for Ethics Committees (2000) and ICH- Good Clinical Practices (1996).
Thus, the evaluation of biomedical research protocols is regulated in general by the Science and Technology Ethics Code, which applies to any scientific research including research involving humans. This regulation covers requirements for ethics review and approval, beneficence, participant consent and procedures for ethics commissions or committees.
There is no specific law on research involving human beings . However the National REC (CNBS– Comité National de Bioética para Saúde) applies international principles derived from the Declaration of Helsinki and others, such as CIOMS, ICH-Good Clinical Practices, etc. There are also national requirements scattered in various laws applying to different sectors of health and the protection of human rights, such as Civil Code, Penal Code, Family and Minors Law, Code of Professional Conduct of Medical Doctors.
The Order dated 21st May 2002 of the Minister of Health established the National Research Ethics committee (REC) involving human beings (CNBS – Comité National de Bioética para Saúde), whereas the main responsibility, among others is to regulate, guarantee respect for ethical principles and review and approval of health research protocols.
At the administrative level, as per Article 2 of the Decree of the President of the Republic N˚17/2005 of 31st March, the Ministry of Science and Technology (MTC) is responsible for the development, implementation and evaluation of government policy in science and Technology and the coordination of all scientific research in the country, including in the Health sector. That is why the Scientific Council for Health is based at this Ministry, where the areas of interest for research are defined.
In addition, the Ministry of Health is responsible for the implementation of health policy in Mozambique; according to Article 1 of the Decree of the President n˚11/95 of 29 December. Article 2 nº 3 (a) of this decree, indicates that the Ministry of Health has other duties including to promote and to fulfil clinical, biomedical and epidemiology research according to the national priorities. From these two Presidential Decrees, one can assume that both Ministries have to work in collaboration, however the regulation and definition of areas of Scientific research are mainly at the Ministry of Science and Technology, as set by article 4 of the Decree of the President of the Republic N˚17/2005 of 31st March.
There is an Ethics Council of Scientific Investigation Activities (CEAIC), presided by the Ministry of Science and Technology, which is the highest organ for management of ethics on activities for scientific investigation. The CEAIC coordinates and monitors all activities on scientific research and technology development.
The CEAIC has the following mandate:
- Monitors the implementation and evaluation of the Science and Technology Ethics Code in the country;
- Advisory board to the Government on issues related to ethics of scientific investigation that may put public health at risk as well as national security and the environment;
- Coordinates the creation and update of adequate ethics rules to the Mozambican context;
- “Gives opinions on the creation and regulation of rules of procedures of specific ethics committees, such as RECs.
- Constitution of the Republic, 2004, Art. 1, 3, 6, 7, 8 & 18
- Science and Technology Ethics Code, Decree n° 71/2007, of 24 December. Preamble, Art. 2, 4, 6, 7, 8, 9, 12 & 13.
- Order of Minister of Health (2002) establishing the National Research Ethics Committee (CNBS) involving human beings.
- Decree of the President of the Republic N˚17/1995 of 31st March, defining the Powers of the Ministry of Science and Technology. Art. 2 & 4
- Decree of the President n˚11/1995 of 29 December, defining the Powers of the Ministry of Health. Art. 1, 2 nº3 (a)