Introduction
Among the most striking scientific advancements of the 21st century is the rapid progress in biotechnology, particularly in the field of medicine. Technologies such as genetic engineering, personalized medicine, gene therapies, and AI-supported clinical decision systems offer more effective and individualized solutions in healthcare. However, they also raise complex ethical, social, and most importantly, legal challenges.
This article examines the legal implications of processing genetic data, the patentability of biotechnological inventions, the permissible limits of genetic interventions, and the legal responsibilities arising from personalized treatments, both under Turkish legislation and in light of international developments.
1. Legal Limits of Genetic Engineering
Genetic engineering involves the deliberate modification of an organism’s DNA. When such interventions target the human genome, legal systems evaluate them not only from a scientific perspective but also within the framework of human rights and bioethics.
- Article 23 of the Turkish Civil Code prohibits any intervention on a person’s bodily integrity without their explicit consent.
- According to Article 13 of the Oviedo Convention (Convention on Human Rights and Biomedicine), genetic interventions are only permitted for preventive, diagnostic, or therapeutic purposes, and not for altering the human genome for enhancement or eugenic purposes.
- Techniques such as CRISPR may not be applied without ethical committee approval and informed consent of the subject.
Thus, although scientifically feasible, genetic interventions are legally confined to a narrow and carefully regulated area.
2. Personalized Medicine: New Treatments, New Liabilities
Personalized medicine refers to treatments that are tailored to an individual’s genetic profile, biomarkers, and metabolic characteristics. Unlike traditional drug therapies, this approach requires targeted dosing and individualized strategies.
However, such precision in treatment also introduces new layers of legal responsibility:
- If a clinical decision-making algorithm fails, who is liable—the physician, the software developer, or the manufacturer?
- How are the patient’s genetic data stored, shared, and protected?
- Can a physician use genetic data to make non-therapeutic predictions?
These questions are addressed through data protection frameworks like Turkey’s Law No. 6698 on the Protection of Personal Data (KVKK) and the General Data Protection Regulation (GDPR) in the EU. Under these laws, genetic data is classified as “sensitive personal data”, and processing such data requires explicit consent and a valid legal basis.
3. Clinical Trials and the Role of Ethics Committees
The development of personalized medicines often requires clinical trials involving human participants. These trials are subject not only to scientific protocols but also to strict legal and ethical scrutiny.
In Turkey, the following legal instruments regulate clinical trials:
- Regulation on Clinical Trials
- Directive on the Working Procedures and Principles of Ethics Committees
- Regulations of the Turkish Medicines and Medical Devices Agency (TMMDA)
Accordingly, any research must obtain:
- Prior approval from an accredited ethics committee,
- Informed consent from all participants,
- Insurance coverage for potential risks,
- And comply with transparent reporting obligations.
Violations of these rules may lead to both civil and criminal liability.
4. Intellectual Property Law and Genetic Inventions
Another critical legal issue in biotechnology is the patentability of genetic materials and processes.
- Naturally occurring genetic sequences are not patentable.
- However, DNA sequences, proteins, or compounds created through a specific technical process—especially those used in personalized therapies—may be eligible for patent protection.
In Turkey, this issue is governed by the Industrial Property Law No. 6769, and internationally by treaties such as the TRIPS Agreement and the European Patent Convention (EPC).
While patent protection is essential to encourage innovation, it must be balanced with public health interests, including access to essential medicines and the application of compulsory licensing in emergencies.
Conclusion
Biotechnology offers promising solutions for the future of healthcare through individualized and effective treatments. However, its expansion is accompanied by complex legal, ethical, and societal risks.
Technologies such as genetic engineering and personalized medicine are only meaningful and sustainable if they are developed in accordance with legal legitimacy, ethical norms, and respect for fundamental rights.
The following legal pillars are especially critical in this context:
🔹 Protection of genetic and health data,
🔹 Ethical review of clinical research,
🔹 Allocation of medical liability,
🔹 Intellectual property rules for biotechnological innovations.
In the coming years, these areas will continue to challenge not only scientists and medical professionals but also lawmakers, legal practitioners, and regulatory authorities.
Therefore, the development of biotechnology law must be driven not only by legislative updates but also through interdisciplinary collaboration, academic insight, and public ethical discourse.
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