BIOETHICS: THE SUBJECT, PURPOSE AND OBJECTIVES OF THE HEALTH CARE SYSTEM. BIOETHICS OF BIOMEDICAL EXPERIMENTS. INTERNATIONAL DOCUMENTS ON BIOETHICS AND HUMAN RIGHTS.

Modern Biomedicine and Bioethical Movement

• Bioethics, while a modern term, is as old as medicine itself.

• The great humanist, a German doctor, missionary, theologian and musicologist Albert Schweitzer (1875 – 1965).

• Gradually his opinions and concepts became acknowledged, not only in Europe, but worldwide.

Modern Biomedicine and Bioethical Movement

• Van Rensselaer Potter (1911 – 2001 ), in 1971, justifying Bioethics, enhanced this point of view by saying: We must plead not for a moratorium on new knowledge, but a coupling of biological knowledge and human values.

Spectrum of Biological Risks

Three broad spheres of bioethics

• The first is academic bioethics, a sphere primarily focused on how theoretical and practical aspects of medicine affect considerations such as special obligations or responsibilities of clinicians, what is valuable, good, right, etc. in the biomedical context and how one might go about providing systematic accounts of such considerations.

Three broad spheres of bioethics

• The second is public policy and law bioethics, where concerns lies in how legal and extra-legal institutions can and should be involved in the regulation of clinical and research practices.

Three broad spheres of bioethics• The final sphere

is clinical ethics, and its focus is directly related to how the incorporation of bioethics into clinical practice can help to improve patient care.

International organisations• Council of Europe (1949)• Convention on Human Rights and Biomedicine• Steering Committee on Bioethics(CBDI)• European Conference of National Ethics Committees

(COMETH)• European Union• European Group on Ethics in Science and New Technologies

(EGE) The goals:• research control• clinical ethics consultation• political consultation• public discussion• educational tasks

Prominent ethical codes

• Hippocratic Oath (4th c BC)• Nuremberg Code (1947): issue of human experimentation• Declaration of Helsinki (1964) (WMA): issue of human

experimentation– First serious attempt of medical community to regulate itself

• Declaration of Geneva (1948)– Issued as a development on the Oath of Hippocrates

• CIOMS Guidelines (1993)– ‘International Ethical Guidelines for Biomedical Research

Involving Human Subjects’(CIOMS: the Council for International Organizations of

Medical Sciences)• Universal Declaration on Bioethics and Human Rights

(UNESCO; United Nations Educational, Scientific, and Cultural Organisation) (2005)

Bioethical methodologies

practical or applied ethics

principlism - the principles of autonomy, beneficence, nonmalfeasance, and justice

personalistic model of bioethics

Key Ethical Principles Video Principle of Beneficence Principle of Nonmaleficence Principle of the Common Good Principle of Distributive Justice Principle of Double Effect Principle of Human Dignity Principle of Informed Consent Principles of Integrity and Totality Principle of Religious Freedom Principle of Respect for Autonomy Principle of Respect for Persons Principle of Stewardship

Key Global

Biosecurity Principles

• Consolidate and reduce the number of unsecured pathogen collections globally

• Increase use of modern diagnostics to minimize biological risk

• Enhance global biosurveillance• Integrate human and animal

health systems.• Promote International Health

Regulations and capacity building

• Engage scientists to promote a culture of responsibility

• Complement efforts under the BWC, UNSCR 1540, IHR and other related international frameworks

The Way Ahead • Global security and public

health communitiesworking together to advance

common goals• Increase focus on emerging

biological threats– Infectious Disease– Surveillance and prevention

networks– Advanced Medical

Countermeasures / Diagnostics

– Support global security objectives as well as public

health objectives (e.g. WHO International Health

Regulations)

Biosecurity system components • Physical security• Personnel security• Material handling

and control measures

• Transport security• Information security• Program

management practices

Biological Dual-Use Research

• Biotechnology represents a ‘dual use’ dilemma in which the same technologies can be used legitimately for human betterment and misused for bioterrorism

WHO's primary responsibilities The primary function of WHO is to act in a coordinating role,

taking primary responsibility for:• Development of the Framework in collaboration with

stakeholders;• Setting of targets and indicators, and monitoring progress

towards achieving agreed WHO's primary responsibilities milestones and objectives;

• Identification and coordination of required resources to meet the objectives of the Framework;

• Identification and engagement of delivery partners, best suited to implement planned activities.