Public Law
Mahdi Moradi Berelian; Mohammad Ghsem Tangestani
Abstract
IntroductionIn recent decades, significant advancements in biomedicine have paved the way for the establishment of biobanks, serving as repositories for individual samples crucial in biological research. These samples are instrumental in identifying genetic diseases and developing appropriate treatments. ...
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IntroductionIn recent decades, significant advancements in biomedicine have paved the way for the establishment of biobanks, serving as repositories for individual samples crucial in biological research. These samples are instrumental in identifying genetic diseases and developing appropriate treatments. Nevertheless, a pivotal concern within the domain of public law revolves around how governments address the challenges posed by biobanks and institute the necessary regulatory frameworks. Different legal systems adopt different models of biobank governance. Some legal systems have enacted specific laws, while others have embraced a combination of self-regulation and general government rules. As biobanks continue to expand, a novel form of governance is emerging, wherein biobanks wield influence over political decisions. The present study aimed to examine how Iran’s legal system regulates biobanks and navigates the associated challenges, including the absence of a comprehensive act and the multiplicity of regulatory norms and bodies. These distinctive characteristics may have impacts on transparency, efficiency, accountability, and the establishment of clear-cut mechanisms for sample collection, sample access, and data protection. Focusing on Iran’s legal system, the study addressed the following research questions: What is the model for management of biobanks and their interactions with the government in the legal systems under study? What are the defining characteristics of the regulation of biobanks in Iran’s legal system? What challenges exist in this field, and what potential solutions can be proposed to address them?Literature ReviewPersian literature includes several articles that touch upon this topic, yet they neither provide a comprehensive examination of the regulatory model nor analyze the topic within the context of Iran’s legal system. Instead, they predominantly concentrate on the ethical challenges posed by biobanks.Materials and MethodsEmploying a descriptive–analytical research method, the study relied on library and Internet sources to offer a description of biobanks and delineate their characteristics and various types, while conducting an analysis of selected legal systems to identify models of biobank governance. As a case study, the research meticulously evaluated all laws and regulations pertaining to biobanks within Iran’s legal system. Drawing upon the results of a comparative analysis, it analyzed the regulatory model for biobanks in Iran as well as its challenges.Results and DiscussionThe advancements in biomedical knowledge and the establishment of banks for storing human tissue and genes represent significant achievements as well as challenges for the modern state. The challenges arisen from legal, ethical, security, and commercial considerations associated with the collection and storage of human samples, donor consent, and privacy and data protection all have elevated the regulatory role of the state to a new and specialized level. Traditional laws and rules (e.g., public law, civil law, private ownership, privacy and even penal norms) certainly fall short of providing adequate solutions to the challenges arising from biobanking. Biobanks should be considered as emerging and complex objects of state governance. To deal with this complexity, some governments have adopted a model of regulation in order to design a comprehensive legal framework inclusive of (non-)institutional mechanisms concerning the regulation of biobanking. The adoption of the model assumes large-scale, governmental management capabilities to strike a balance between public interests, individual rights, and commercial interests resulting from biobanking; create integration and transparency in biobanking; and ensure public accountability in this regard. Alternatively, some other governments have opted for decentralized monitoring of biobanks by relying on self-regulatory mechanisms that are mostly based on the norms and principles set by non-governmental institutions as well as a few governmental regulations. The decentralized, self-regulatory approach may lack transparency and public accountability but offer adaptability to the rapid transformations in biotechnology, avoiding issues related to macro-bureaucratic governmental management. In any case, effective governance of biobanks requires appropriate methods to address the multifaceted challenges.ConclusionThe establishment and development of biobanks have ushered in a new era of bio-politics, focusing on individual dissected body parts rather than the body as a whole. Biobanks actively shape biological policies, functioning as subjects of governance rather than passive objects. It seems that ensuring effective network governance and safeguarding public rights and interests require a delicate balance between integrated regulation through legislative norms and self-regulation mechanisms. Governments must strike this balance to play a pivotal role in navigating network governance and guaranteeing its essential functions. Relying solely on integrated regulation through legislative norms can result in an inflexible governance structure that struggles to adapt to changing nature of biomedicine and biobanking. However, certain aspects of biobanking activities must be regulated to ensure efficiency, secure public interests, and maintain accountability while incorporating self-regulatory mechanisms going on in the non-governmental sector.In Iran’s legal system, which is relatively young in the realm of biobanking with a history of less than two decades, biobank governance tends to align more with the model of governmental regulation. However, the Iranian legislator has not introduced specific regulations on banks of human samples. A set of laws, regulations, and documents established by various government agencies, primarily addressing banks of non-human samples, reflects a fragmented and mosaic-like regulatory framework. This approach has not delivered the anticipated benefits of large-scale, governmental management of biobanks, such as transparency, accountability, and the implementation of specific mechanisms related to collecting samples, safeguarding individual rights and privacy, and managing legal and ethical challenges.The legislative body is expected to define general principles and rules for collecting and using human samples, striking a balance between various competing interests. However, due to the specialized nature of the regulated field and limitations related to the legislator’s technical capacity, delving into intricate details may not be a reasonable expectation. It is essential to entrust the detailed regulation to executive statutes or independent specialized bodies.
