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LEGAL FRAMEWORK

On September 7, 2005 the Decree stating the creation of the National Bioethics Commission as a deconcentrated agency was published in the Official Journal of the Federation. However, such agency has a background dating back to 1989, as a result of the interest that came up around Bioethics at international level, with the creation of a study group for this subject at the core of the General Public Health Council which on September 30, 1992, became the National Bioethics Commission, according to the agreement made by the Public Health Commission, mainly to address transcendental issues like biomedical research, health care and the environment.

At that moment, the National Bioethics Commission was installed in the ancient Cloister of Saint Paul, occupied by Hospital Juárez-Centro of Mexico City, with its mission and vision being: “The best knowledge of universal cultures, the reality regarding the protection of life, the respect for human rights, the reality in terms of life protection, respect for human rights regarding freedom, health, welfare, and exercising solidarity for equity and justice.”

In 1993, the Internal Regulations of the Commission were drafted with the involvement of twelve work committees set up by professionals of diverse disciplines, summoned for such purpose. Bioethics was spread and promoted since the publication of the National Bioethics Commission Bulletin, the organization of three international (1994, 2000 and 2003) and national congresses (consecutive from 1997 to 2003), as well as multiple work meetings, sessions, conferences and forums.

As an outcome of the acknowledgement to its work and the social significance of its role, on October 23, 2000, the National Bioethics Commission obtained the permanent character through a presidential agreement, which granted the Commission a greater consistency and paved the way to a broader performance for its impact over the public and private sectors.

Under this new framework, its purpose was redefined as follows: “The National Bioethics Commission shall have the aim of promoting the study and observance of ethical values and principles for the exercise of health care, as well as health research”.

This meant a change in the Commission’s direction, mostly focused on providing medical services and research. Within the same Agreement it was established that the National Bioethics Commission was created by the principal officers of the main health institutions, such as: The Secretariat of Health itself, the Mexican Social Security Institute, the Institute for Security and Social Services for State Workers, the National Commission for Medical Arbitration, among others, with the suggestion of asking the rectors of the public and private universities to join, and the director of the National Council for Science and Technology.

On February 27, 2003, an initiative of the National Bioethics Commission, the National Health Council, integrated by the Health Ministers of the Federal Government and the thirty two federal entities, agreed that “a Bioethics Commission will be created in each state.”

In October 2002, the Bioethics Code for Health Personnel was issued, in response to what was established in the Presidential Agreement which stipulated: “To spread among society and professionals, technicians and health assistants, the principles and values that must govern in the exercise of their activity.”

On July 20, 2004, the National Institute of Genomic Medicine was created; for such reason, on August 2, 2004, the Presidential Agreement abrogating the Agreement for the lining up of the National Commission for the Human Genome (CONAGEN, by its acronym in Spanish) was published. In this sense, the National Bioethics Commission took over and incorporated the reflections on the ethical aspects of the human genome.

DECREE FOR THE CREATION OF THE DECONCENTRATED AGENCY DENOMINATED NATIONAL BIOETHICS COMMISSION.

On September 7, 2005, by Presidential Decree, published by the Official Journal of the Federation, the National Bioethics Commission was created as a deconcentrated agency, hierarchically subordinated to the Secretariat of Health, with technical and operational autonomy. It is worth quoting that, the Universal Dictionary of Parliamentary Terms in its second edition defines deconcentrated agency as follows:

I. Deconcentrated agencies are administrative units to whom a central agency transmits part of its functions, with the aim of approaching the provision of a service to the user and decongest power. Actually, deconcentrated agencies are part of central agencies, because they are created to comply with powers that correspond to their competence.

II. Regarding the implementation of deconcentrated agencies, there are two approaches: First, there is the regional idea, that is to say, that functions are withdrawn to certain geographical locations of a country; secondly, with an attributive character, referring only to deconcentrate powers. Among the advantages granted to deconcentrated agencies, the doctrine contemplates the following: the administrative action is faster and more flexible when decongesting the activity; it causes the approach between the authorities and individuals, because the agency can know the problems closer and it boosts the efficiency of subordinated agencies by granting them accountability for certain matters.

It is relevant to establish the difference between deconcentrated and decentralized agencies; the first ones are subordinated to a central one, while the second depends directly on the Executive Power; deconcentrated agencies can be legal entities and have their own heritage or not, while decentralized are always legal entities; regarding powers, those of deconcentrated agencies are limited and the powers of decentralized agencies are autonomous. In overview, in both cases, deconcentration and decentralization try to be separated from the center.

POLITICAL CONSTITUTION OF THE UNITED MEXICAN STATES

The legal nature of the administrative deconcentrated agencies comes from article 90 of the Political Constitution of the United Mexican States, which specifies that the Congress is responsible for issuing the organic law in which businesses of the administrative order are distributed among State Secretariats, as immediate dependent agencies of the Federal Executive Power.

ORGANIC LAW OF THE FEDERAL PUBLIC ADMINISTRATION

Thus, the Federal Public Administration Organic Law establishes in its article 17, that, in order to comply with the most effective assistance and the efficient dispatch of the matters within its competence, the State Secretariats will be able to have administrative agencies hierarchically subordinated to them, and such agencies shall have specific powers in order to resolve on the matter and within the territorial jurisdiction determined for each case, in accordance with the legal applicable provisions.

INTERNAL REGULATIONS OF THE HEALTH SECRETARIAT

Pursuant to the aforementioned, article 2, letter C, fraction XI Bis, of the Internal Regulations of the Health Secretariat, foresees that the National Bioethics Commission is a deconcentrated agency that assists the Health Secretariat on the settling of its affairs, and number 36 of the same regulation establishes for the effective assistance and efficient dispatch of the matters within its competence, that the Health Secretariat will have deconcentrated agencies hierarchically subordinated and such agencies will be entitled to have operational, technical, and administrative autonomy, and, in every case, they must comply with the legal applicable provisions, including internal regulations issued by the Health Secretariat.

Also, it is mentioned that the administrative deconcentrated agencies and their principal officers will have competence and powers granted by the internal regulations, as well as the ones foreseen by the law, regulation or legal instrument that creates or regulates them, and in the agreements of the Secretary’s delegation of powers. Likewise, it is stated that, in accordance with the relative provisions, the Secretary is entitled to review, reform, modify or revoke the resolutions made by the deconcentrated agencies.

Article 37 of these Regulations, explains the competences of the deconcentrated agencies of the Secretariat: planning, programming, organization, management, control and assessment of the functioning of their assigned administrative units, subject to the guidelines established by the law, regulation, decree, agreement or legal instrument or more that governs them, that establishes such guidelines.

It is also mentioned that such agencies will have an Internal Council presided by the Secretary of Health or the person appointed by him/her, and the settlement, functioning and competences of the Council will comply with what the provisions that govern them or that the agreements pronounced by the Secretary have established. In this respect, it is important to point out that in the case of the National Bioethics Commission, this figure is precisely the Council, presided by the Commissioner, -who also acts as the head of the Commission- pursuant to the Third article of the Decree which created it

Furthermore, article 38 of the Internal Regulations of the Secretariat of Health mentions the generic powers that the principal officers of the deconcentrated agencies hold.

GENERAL HEALTH LAW

It must be mentioned that the 14th of December 2011, as a result of the sensitivity and engagement of several members of the Congress of the Union, both representatives and senators, the Decree for the addition of article 41 Bis and the reform of article 98 of the General Health Law was published in the Official Journal of the Federation, which states the obligation of having Hospital Bioethics and Ethics Research Committees in the health care establishments of the public, social or private sector of the national health system, which will be subject to the criteria established by the National Bioethics Commission is stated.

AGREEMENT FOR THE ISSUE OF GENERAL PROVISIONS FOR THE INTEGRATION AND FUNCTIONING OF HOSPITAL BIOETHICS AND RESEARCH ETHICS COMMITTEES AND THE ESTABLISHMENT OF HOSPITAL UNITS THAT MUST INCORPORATE THEM, PURSUANT TO THE CRITERIA ESTABLISHED BY THE NATIONAL BIOETHICS COMMISSION

In compliance with the Third TRANSITORY article of the Decree for the addition of article 41 Bis and the reform of article 98 of the General Health Law, this Commission, along with the General Coordination of Legal Matters and Human Rights of the Health Secretariat, the Federal Commission for Protection against Sanitary Risks, and the Federal Commission of Regulatory Improvement formulated for the issue of the Agreements from which General Provisions for the Integration and Functioning of the Hospital Bioethics and research ethics Committees are issued, the Hospital Units that incorporate them are established, pursuant to the criteria established by the National Bioethics Commission, which were published on October 31, 2012.

REGULATIONS OF THE GENERAL HEALTH LAW IN TERMS OF THE PROVISION OF HEALTH CARE SERVICES AND HEALTH RESEARCH

It should be warned that with the aim of adapting the regulations in force, this Commission is currently processing and promoting before the General Coordination of Legal Matters and Human Rights of the Secretariat of Health, a reform proposal to the General Health Law Regulations in terms of Provision of Health Care Services and Health Research, which are basically focused on two subjects: standardizing the term Committee instead of Commission and encouraging the register of the Research Ethics Committees before this deconcentrated agency; the aforementioned has the aim of complying with the content of the Second TRANSITORY article of the decree of December 14, 2011 through which articles 41 bis and 98 of the General Health Law are reformed and added.

In accordance with these normative adaptations and legal reforms, the Council of the Commission has agreed on adapting and modifying its own Creation Decree to be pursuant to the new attributions and functions required to foster the bioethics culture and therefore, responding to the needs of society in the framework of modernization of the Federal Public Administration, ratified resolution by the Secretary, as well as by the Internal Control Committee and Institutional Performance. Accordingly, the agreement shall go together with the Internal Regulations of the Secretariat of Health.

Likewise, this reform has been considered as an opportunity area detected by the Commission and guaranteed by the Secretariat of Health in the Diagnosis Report about organic structure, internal processes and the operation expenses of Agencies and Entities of the Federal Public Administration in the framework of the fulfillment of the provisions of the Decree that establishes the measures for the efficient, transparent and effective use of public resources, and the budgetary discipline actions in the exercise of public expense, as well as the modernization of the Federal Public Administration

From this perspective, the National Bioethics Commission responds to the aim of setting up an efficient normative framework that favors the organization of collegiate bodies specialized on the analysis, deliberation and support when making decisions regarding bioethical dilemmas and issues that come up during clinical practice, research with human beings and teaching in the health care area; as well as supporting the assessment processes and certification of biomedical research and health protocols; thus, consolidating the work of bioethics in the establishments intended for health care and research on human beings–including higher education or purely research institutions–of the public, social and private sectors, taking over its ruling character over the performance of such work bodies, straightening its normative nature and its performance as consultative agency.


Última modificación :
Viernes 22 de Noviembre del 2013 por Centro del Conocimiento Bioético
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