Biotechnology Law at Greece
Greece's biotechnology legal framework is shaped by a combination of national legislation, European Union directives, and international agreements, with a focus on bioethics, biosafety, and emerging technologies. Here's an overview of the key components:
🇬🇷 National Bioethics and Technoethics Commission
Established by Law 2667/1998 and reorganized under Law 4780/2021, the National Bioethics and Technoethics Commission serves as an advisory body to the Greek government. It examines the ethical, social, and legal implications of advancements in biology, biotechnology, medicine, and genetics. The Commission's responsibilities include:
Formulating policy proposals and providing guidelines on related issues.
Representing Greece in international organizations.
Raising public awareness about biotechnological developments.
Participating in legislative drafting committees and delivering opinions on relevant provisions.
Coordinating national committees and organizing events on related topics
The Commission reports directly to the Prime Minister and operates under the General Secretariat of the Government .
⚖️ Legal Framework and Key Legislation
Law 1733/1987: This law addresses technology transfer, inventions, and technological innovation. It stipulates that patents cannot be granted for plant or animal varieties or biological processes for the production of plants or animals, except for microbiological processes or their products .
Law 4961/2022: This legislation regulates the utilization of emerging technologies, including artificial intelligence, the Internet of Things, unmanned aircraft systems, distributed ledger technologies, smart contracts, and 3D printing. It establishes obligations for public bodies and private entities involved in these technologies, aiming to promote digital transformation in Greece .
Law 4887/2022: Known as the "Greece Strong Development" law, it provides incentives for economic development, focusing on digital and technological transformation, green transition, and innovation. The law supports activities that contribute to environmental protection and sustainable development .
🧬 Biomedicine and Genetic Research
Oviedo Convention (Council of Europe): Greece has incorporated this convention into national legislation through Law 2619/1998, which addresses issues related to human rights and biomedicine .
Ministerial Decision ΔΥΓ/89292 (2003): This decision harmonized national legislation with EU Directive 2001/20, regulating human subject experimentation and clinical trials .
Law 2472/1997: This law protects personal data, including sensitive medical and genetic information, aligning with EU data protection standards .
🌱 Genetically Engineered (GE) Crops and Agriculture
Greece maintains a de facto ban on the cultivation and importation of genetically engineered (GE) crops. Since April 2005, the country has implemented a safeguard clause prohibiting the field release of MON 810 maize. Although a draft law to incorporate EU Directive 2015/412 and officially implement the cultivation opt-out clause has passed the public comment period, it is still awaiting governmental action .
🧬 Gene Therapies and Access Challenges
Despite advancements in gene therapies, Greece lacks a comprehensive legal framework to address the complexities of access to these treatments. Although over 500,000 patients have been diagnosed with rare diseases, there is no specific legislation governing gene therapies. The Personalised Cellular & Gene Therapies next to the Greek Patient (POCare) Model investment programme, launched in 2021, aims to improve access, but its results are yet to be fully realized .
🎓 Education and Research Opportunities
The University Center of International Programmes of Studies at the International Hellenic University offers a Master of Science (MSc) in Bioeconomy: Biotechnology and Law. This interdisciplinary programme provides knowledge and skills for those involved in public or private services dealing with biotechnological products and processes. It covers regulatory rules governing the production and promotion of biotechnological products, biosafety issues, and the management of biotechnological services .(
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