“A body of independent experts (the IBC) drafts the instrument with nonbinding advice and comment from government-appointed officials (the IGBC). The draft is then subject to negotiation and revision by government-appointed policy experts, after which it is ultimately submitted for acceptance or rejection by the General conference itself. Throughout the process, the procedural standard of acceptance is consensus.” (Snead 2009) [Emphasis added].

The UDBHR was the first international effort for a global approach to bioethics. Its preparation involved both governmental and non-governmental actors; with expertise in various disciplines such as bioethics, law, life sciences, and social sciences; and from as many as 191 member states of UNESCO. During the drafting stage, the IBC consulted widely, engaging with various stakeholders from and on multiple levels. On the global platform, through an Interagency Committee on Bioethics established by the UN Secretary-General, UNESCO led discussions on matters of common concern with other international bodies like the World Health Organization , World Trade Organization , and Food and Agriculture Organization . Regional experts were consulted, as were national bioethics experts from several countries. In addition, the IBC also engaged in dialogue with representatives of civil society organisations, different religious bodies and traditions, scientists and other experts through a major public symposium (Kirby 2008 and 2009). The result of such a multi-national, multi-cultural, multi-faceted collaborative effort was the identification of 15 basic principles that provide normative guidance not just for member states, but also for “individuals, groups, communities, institutions and corporations, public and private” (Article 2(b)). UNESCO achieved its aim of receiving “the broadest acceptance possible by public authorities, the scientific community and general public” (UNESCO 2003, p. 10), when the Declaration was adopted “unanimously, without any contrary votes or recorded abstentions” (Kirby 2008 and 2009). That all 191 member states endorsed the Declaration despite different religious and socio-cultural backgrounds, showed that UNESCO had managed to find some common grounds between nations, in order to set minimum standards for bioethics that are universally acceptable.

The first principle advocated in the UDBHR is respect for “human dignity, human rights and fundamental freedoms” (Article 3). Although this principle had long been established since the 1948 Universal Declaration of Human Right s (United Nations 1948), which is today widely regarded as the cornerstone of the international human rights system that emerged after the Second World War, the UDBHR was the first international instrument to comprehensively integrate international human rights law into the field of biomedicine. By broadening the scope of the respect principle from personal autonomy to human dignity, the UDBHR overcomes a shortcoming of previous bioethics documents, which seemed to accord respect only to autonomous persons. The UDBHR on the other hand, “includes the protection of those who are not yet, or are no more, morally autonomous (new-born infants, senile elderly, people with serious mental disorders, comatose patients, etc.)” (Andorno 2009). In addition to existing persons, the UDBHR also covers “future persons” as respect for human dignity requires that new challenging practices, such as reproductive cloning or germ-line interventions, do not result in the modification of basic human features or affect the integrity of the human species (Andorno 2009). The UDBHR does not precisely define “human dignity”, but one may gain a better understanding of the concept from the Universal Declaration of Human Rights, which recognised the “inherent dignity … and equal and inalienable rights of all members of the human family” (Preamble). It emphasises that dignity is an unconditional worth that every human being has regardless of their intellectual or moral abilities. Thus, every human being is entitled to fundamental rights and freedom, and they should be protected from any harm to their dignity even though they have consented to such acts.

Integrating the human rights framework into bioethics is meaningful because most basic human prerogatives are relevant to biomedical activities, for instance the rights to life, physical integrity, privacy and access to basic health care (Andorno 2007, 2009). There are fundamental rights and freedoms that are desirable to all human beings, regardless of ethnicity, gender, age, nationality or socio-economic status. The UDBHR identified some of these entitlements – for surely all persons must wish to be treated with due respect (Articles 3, 5, 8, and 9), be treated justly and equitably (Article 10), to enjoy the highest attainable standard of health (Article 14), and not be subject to discrimination and stigmatisation (Article 11). Hence, just like the Universal Declaration of Human Rights , the UDBHR is a proclamation of “the highest aspiration of the common people”. The UDBHR has also broadened the scope of bioethics to include considerations about the environment, biosphere and biodiversity (Article 17). It is no longer possible to advance science and technology without reflecting on the impact of our actions on our environment and other living beings. Hence, the UDBHR is indeed a universal instrument, for in addition to encouraging consideration for our fellow human beings, it also recognises the need to give due regard to other living beings that we share this earth with.

By focusing on common principles and shared values, the UDBHR established global standards that could be used by both developing and developed countries. As many of the UNESCO member states were lacking a well-developed bioethics infrastructure, the UDBHR was intended to address this gap by setting “universal ethical benchmarks” (Wolinsky 2006; ten Have 2006).

A significant contribution of the UDBHR is the provision of guidance for transnational research (Article 21). The Declaration defined a set of minimum standards that all countries keen to conduct ethical scientific research could commit to, and outlined the roles and responsibilities of countries involved in transnational research. As an intergovernmental third party, UNESCO is in a unique position to ensure that while the international progress of science and technology are not unduly impeded, research participants worldwide are also properly protected. Hence, there is an underlying principle of global justice in the relevant articles; for example, Article 15(2) states that “[b]enefits should not constitute improper inducement to participate in research”. As more clinical trials are being conducted in developing rather than developed countries due to various reasons, such guidance will ensure that vulnerable groups are protected from excessive harm and exploitation. The UDBHR also calls for appropriate action on global issues such as global health, bioterrorism and illicit trafficking of human biological materials. UNESCO plays a crucial part in the promotion of science and technology internationally for the benefit of all of humankind, and the UDBHR is a commendable effort towards that purpose. What sets UDBHR apart as a truly universal instrument on bioethics is its promotion of the principle of solidarity and internal cooperation (Articles 13 and 24), which is further supported by its other principles of social responsibility (Article 14) and sharing of benefits (Article 15). Unlike traditional bioethics discourse, which tends to place the emphasis mainly on individual persons, the UDBHR also focuses on larger society and even the global community. The Declaration highlights the role that all sectors of society can play in ensuring the ethical conduct of biomedical research and clinical practice. Indeed, it is even stated that the UDBHR is intended “to guide the actions of individuals, groups, communities, institutions and corporations, public and private” (Article 2-b). The UDBHR calls on the principle of solidarity to unite individuals and states in achieving global goals, particularly the promotion of health and social development (Article 14-1). By identifying the protection of health and social development as a “central purpose of governments”, the goal is no longer mere moral persuasion but the subject of deliberate governmental policy (UNESCO Report on Social Responsibility and Health 2010). UNESCO member states that have adopted the Declaration have the obligation to protect citizens from health threats and social threats such as poverty or severe environmental degradation. Thus, bioethics is no longer just an academic field, as policy makers too are drawn into examining the issues related to medicine and life sciences.

Since “the enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being without distinction of race, religion, political belief, economic or social condition” (Article 14-2), health should not only be confined to national interests and responsibilities. Instead, social relationships beyond state boundaries, such as international trade and transnational research activities should be encouraged (UNESCO Report on Social Responsibility and Health 2010). International civil society organisations like UNESCO play an important role in overcoming geographical boundaries and promoting universal access to affordable, essential medicines for all human beings. In fact, the UDBHR urges states to “respect and promote solidarity between and among States, as well as individuals, families, groups and communities, with special regard for those rendered vulnerable by disease or disability or other personal, societal or environmental conditions and those with the most limited resources”(Article 24-3). It is also on the basis of solidarity that benefits obtained from scientific research and its applications should be shared with wider society and the international community, particularly with developing countries (Article 15). The benefits identified in the UDBHR – such as provision of new diagnostic and therapeutic modalities or products stemming from research, access to scientific and technological knowledge, and capacity-building facilities for research purposes – will reduce the time taken to discover prevention measures and treatments for diseases as well as reduce the number of people to be involved in clinical trials. For example, benefit sharing will help many Asian countries cope with curable infectious diseases that they are still struggling with, as well as the new series of infectious diseases such as Avian Flu and SARS that have hit the continent (Bagheri 2011). In today’s globalised world, where air travel makes it easy for people (together with the diseases that they may carry) to move across continents quickly, it is clearly advantageous for international cooperation in order to prevent transnational transmission. Therefore, infectious diseases are a global problem, the eradication of which is not exclusive to developing countries only. Furthermore, by sharing benefits, for instance in the form of resources, the number of clinical trials that need to be conducted will be reduced. This would lead to a decrease in the number of people needed for trials, which in turn will help to reduce the rate of exposure to harm and exploitation. Indeed, benefit sharing is necessary to attain the universal aim of good health for all of humankind.

Underlying the principle of solidarity is a sense of “connectedness”, and it implies at the very least “the willingness to take the perspective of others seriously”, which Gunson has suggested is a kind of “weak solidarity” that is more suited to inclusion in universal documents such as UDBHR (Gunson 2009). This is distinct from “strong solidarity”, as it merely requires that one listen and assess whether a particular cause is worthy of allegiance and does not require action in support of specific goals or political causes. Strong solidarity simply would not be feasible in universal instruments because it would require that all nations involved actually be supportive of all possible projects. Nevertheless, the principle of solidarity, whether weak or strong, implies unity and a sense of belonging; and as advocated in the UDBHR, it emphasises “the interconnectedness of humanity” (Gunson 2009), a kind of global solidarity among all human beings.