Summary: Report of the IBC on Updating Its Reflection on the Human Genome and Human Rights

[Read the full report here.]

“We are human because of the interplay of many biological, historical, and cultural determinants, which preserve the feeling of our fundamental unity and nourish the richness of our diversity. This is why the human genome is one of the premises of freedom itself and not simply raw material to manipulate at leisure. Scientific advancements in this field are likely to offer unprecedented tools against diseases. Therefore, it is crucial to acknowledge that these opportunities should never become the privilege of the few. What is heritage of humanity entails sharing both responsibilities and benefits.” (pg 4)

The report focused on these selected fields:

1. Direct-to-consumer genetic tests and non-health care related analysis;
2. Precision/personalized medicine;
3. Biobanks;
4. Non-invasive prenatal testing;
5. Emerging techniques for engineering gametes and editing the human genome.

Shortened Executive Summary

Five ethical principles and societal challenges have been addressed:

• Respect for autonomy and privacy: an individual’s genetic data are among the most “personal” data. They have to be protected;
• Justice and solidarity: genetics promises to offer an unprecedented contribution to improve health care. These advancements should be shared with society as a whole and with the international community; any discrimination has to be avoided;
• Understanding of illness and health: it might be emotionally relieving or, on the contrary, upsetting for an individual to know about his or her genetic endowment. At the same time, behavioral, social, and environmental determinants of health play a crucial role. Underestimation of the complexity of factors influencing health should be avoided;
• Cultural, social and economic context of science: globalization, access to information and growing pluralism strengthens the necessity of deeper reflection on the value, meaning, and direction of science as well as of a legal framework complying with the respect of fundamental human rights;
• Responsibility towards future generations: great and specific attention is required in the field of genome editing.

States and governments are called on to:

1. legally ban human cloning for reproductive purposes;
2. Agree on a moratorium on genome engineering of the human germline, at least as long as the safety and efficacy of the procedures are not adequately proven as treatments;
3. No one can act alone. Everyone must cooperate on a global standard;
4. Everyone needs to adopt non-controversial (as possible) rules, procedures and solutions, with regard to the issues of modifying the human genome and producing and destroying human embryos.
5. Adopt legislative and other measures, in order to:
   • quality-assurance around direct-to- consumer tests (including non-medical tests) to mitigate risks and avoid misuse;
   • organize health care systems so that precision medicine can be shared with all society, without inequality and discrimination;
   • develop trustworthy governance for biobanks and biobank security and harmonize the rules internationally;
   • ensure that genetic screening and NIPT comply both with the right to autonomous choices and the principles of non-discrimination and non-stigmatization and respect for every human being in her or his uniqueness.
6. Consider a revision of the existing UNESCO Declarations: the cogency of principles remains untouched; some applications could need updating.

The community of scientists and related regulatory bodies are called on to:

1. Strengthen communication internationally to update research and share information on the efficacy, safety, and consequences of new technologies;
2. Set high quality certification standards for service delivery;
3. Promote the use of genetic tests only for health purposes;
4. Renounce the pursuit of spectacular experiments that do not comply with the respect of fundamental human rights and universal normative ethical standards and of those with unproven efficacy and safety.

Media and educators are called on to:

1. Raise awareness and promote health/scientific literacy, to empower people to make conscious and responsible use of new technologies;
2. Avoid any sensationalism and encouragement of what is still a mere hope for a future to come, if not a deceptive promise;
3. Disseminate and strengthen the idea that scientific advancements in biomedicine entail responsibilities, which cannot be left only to market forces of demand and supply to define the line of what should be accepted and allowed.

Economic actors and for-profit companies are called on to:

1. Comply with principles and regulations that ensure the highest standard of qualityand safety for consumers and respect for privacy;
2. Refrain from circumventing restrictions in a particular country, in order to take advantage of weaker rules in other countries and maximize profit.

UDBHR principles: human dignity; autonomy and individual responsibility; respect for vulnerable people and personal integrity; privacy and confidentiality; equality, justice and equity; non-discrimination and non-stigmatization; respect for cultural diversity and pluralism; solidarity and cooperation; social responsibility for health; sharing of benefits; protection of future generations; protection of the environment, the biosphere and biodiversity.