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  1. Services
  2. Healthcare & Pharmaceutical Law
  3. Healthcare Regulation
  4. Compliance
  5. Bioethics Law

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Compliance

Bioethics Law

Is there a separate bioethics law?

No — the core is in the patients' rights law: Articles 31-34 and 26.

What is prohibited in genetics?

Discrimination on grounds of heritage, non-therapeutic testing, changing the descendants' genome and sex selection without medical necessity.

When is consent unnecessary?

When anonymous information and anonymised material are used.

When is sex selection admissible?

Only where it is necessary to prevent a hereditary disease linked to sex — the exception of Article 34.

5 min·...

Bioethics law does not exist in Georgia as a separate statute — its codified core lies in the Law on Patients' Rights: the genetic block in Articles 31 to 34, and research consent in Article 26. Foreign bioethics frameworks are not the Georgian reference — the page is carried by the Georgian law.

The prohibition of genetic discrimination

Article 31 is the foundation of the block: discrimination against a person on grounds of genetic heritage is prohibited. This norm covers every sphere in which a decision about a person is taken — from employment to insurance — and the first test of bioethics law is precisely this prohibition: no decision may rest on genetic heritage.

The conditions of genetic testing

Article 32 defines testing: testing that reveals a disease-determining gene or determines a genetic predisposition to a disease is admissible only where its aim is the protection of the patient's health or scientific research connected with the protection of health. For any other aim — identification or classification, for instance — testing is inadmissible under the law, and this list is closed.

Gene modification and sex selection

Article 33 regulates the boundary of intervention: an intervention intended for the modification of a human gene is admissible only for the purposes of diagnosis, treatment or prevention and if it does not involve changing the genome of the patient's descendants. Article 34 gathers the sphere of artificial conception: the use of artificial conception methods for the purpose of sex selection is prohibited, except where the prevention of a sex-linked hereditary disease is necessary. Thus two clear boundaries of bioethics law are opened: the therapeutic aim and the inviolability of the descendants' genome; the choice of sex is prohibited, medical necessity is admitted.

Research consent

Article 26 regulates the research block: the informed consent of the patient is necessary for the patient's use as an object of study, and this consent precedes the use. Questions connected with patients in receipt of support and minor patients are regulated by a separate law. Consent is not necessary only in two cases: where information existing in the medical documentation is used for study purposes that gives no possibility of identifying the patient; or material received in the process of treatment and diagnosis whose anonymity is ensured. Anonymity is here the gateway of use — as long as identification is possible, consent is necessary.

Practical application in two sectors

In the research sector these five norms read as a single workflow. The first step — establishing that the object of the research is genetic data: in that case the aim of testing must fit the two admissible aims of Article 32. The second step — checking the protocol against Articles 33 and 34: where the research involves an intervention or artificial conception, the aim must be therapeutic and the descendants' genome must remain untouched. The third step — the choice between consent and anonymisation under the conditions of Article 26: identifiable data require informed consent, anonymous data do not. And finally — Article 31 controls the use of the results as well: genetic information obtained through research cannot become a discriminatory ground for any decision.

In clinical practice the same norms are written as the frame of the conversation with the patient: the physician determines a genetic test only for the protection of health, obtains prior consent for research use, and refuses what contradicts the law — sex selection, non-therapeutic modification, classification based on heritage. Such a frame frees the patient's trust within the boundaries of the law.

The practical summary of these five norms is a system of four control points: the purpose of every genetic test must be fixed in advance and fit the two admissible purposes of Article 32 — the protection of the patient’s health or scientific research connected with that protection; a modification intervention must stay within the clinical frame — diagnostics, treatment, prevention — leaving the genome of the descendants outside it; artificial fertilization methods for the purpose of sex selection are prohibited, and the sole exception is the necessity of preventing a hereditary disease linked to sex; and research use operates only through two lawful channels — informed consent or complete anonymization. Both the planning of a study and the building of a position in a dispute stand on these control points: naming the violated point precisely brings the dispute from the side of a general prohibition down to a specific norm.

Frequently asked questions

Below are the questions most frequently raised about bioethics law.

Does a separate bioethics law exist?

No — the core is in the Law on Patients' Rights: Articles 31 to 34 and Article 26.

When is genetic testing admissible?

Only for the protection of health or health-related research — under Article 32.

May the descendants' genome be changed?

No — under Article 33 modification is admissible only for diagnosis, treatment or prevention, without changing the descendants' genome.

When is consent for research unnecessary?

Only for anonymous information and material whose anonymity is ensured — under Article 26.

When is sex selection admissible?

Only where it is necessary to prevent a hereditary disease linked to sex — the exception of Article 34.

How We Help on Legal.ge

The specialists of Legal.ge draft bioethics documents on the basis of Articles 31, 32, 33, 34 and 26: forms of the conditions of testing, documentation of consent and rules for the anonymisation of research material. Submit a request on this page and receive the bioethical framework of your research or practice.

Updated: ...

Legal basis:

  • პაციენტის უფლებების შესახებ
  • ჯანმრთელობის დაცვის შესახებ

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