Biotechnology Law at Bahrain
Biotechnology Law in Bahrain is governed by a combination of national legislation, regulatory bodies, and international agreements. The legal framework addresses various aspects of biotechnology, including biosafety, intellectual property, and clinical research. Below is an overview of the key components:
🧬 Biosafety and Biotechnology Regulation
Committee of Health Laboratories and Biosafety (2017)
Established by the Supreme Health Council, this committee oversees the regulation of health laboratories and biosafety measures in Bahrain. It ensures compliance with safety standards in biotechnology research and practices.
National Health Regulatory Authority (NHRA)
NHRA is responsible for regulating healthcare services and ensuring public health safety. It oversees the licensing of healthcare professionals and facilities, including those involved in biotechnology-related activities.
🌱 Plant Variety Protection
Law No. 31 of 2021
This law, effective from December 10, 2021, provides protection for new plant varieties in Bahrain. It aligns with international agreements such as the UPOV Convention and the Cartagena Protocol on Biosafety.
🧪 Clinical Trials and Research
Clinical Trials Regulations (March 2021)
NHRA has established regulations for conducting clinical trials in Bahrain, ensuring that they adhere to international standards and ethical guidelines.
Stem Cell Research Regulations (2019)
Specific guidelines have been issued for clinical trials involving stem cells, addressing ethical considerations and safety protocols.
🌍 International Agreements
Cartagena Protocol on Biosafety
Bahrain is a party to this international agreement, which aims to ensure the safe transfer, handling, and use of living modified organisms resulting from modern biotechnology.
🏛️ Regulatory Bodies
Supreme Health Council
The Council plays a pivotal role in formulating health policies and regulations, including those related to biotechnology and biosafety.
National Health Regulatory Authority (NHRA)
NHRA enforces regulations concerning medical devices, clinical trials, and healthcare services, including those involving biotechnology.
📌 Summary
| Aspect | Regulation/Authority |
|---|---|
| Biosafety | Committee of Health Laboratories and Biosafety (2017) |
| Plant Variety Protection | Law No. 31 of 2021 |
| Clinical Trials | NHRA Clinical Trials Regulations (March 2021) |
| Stem Cell Research | NHRA Stem Cell Research Regulations (2019) |
| International Agreements | Cartagena Protocol on Biosafety |
| Regulatory Bodies | Supreme Health Council, National Health Regulatory Authority (NHRA) |
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