Beyond science: ethical and societal considerations in the era of biogenic nanoparticles

2.1 Informed consent in medical applications

Informed consent is an ethical principle primarily used in healthcare and medicine. In essence, the principle of informed consent dictates that every patient must have sufficient information and understanding to make an informed decision regarding their medical treatment. Relevant information should include the benefits and risks associated with that particular form of therapy, the patient’s role in the treatment, alternative treatment options available to the patient, and the patient’s right to refuse that specific line of treatment [32].

The idea of informed consent varies from jurisdiction to jurisdiction. While developed countries place great importance on it, in developing and underdeveloped countries, it is generally a matter of discretion. With the advancement of BNPs in medical treatment, it becomes essential that not only is the patient informed about the general concept of the treatment, but also that they are aware that nanomaterials are being administered. There are suggestions that a patient be informed that the procedure uses NPs/BNPs, and that the small size may cause unique effects in their body [33]. Challenges to informed consent can arise when BNP-based therapeutics are administered in critical or emergency where patient comprehension time is limited, or when formulations are derived from indigenous plant materials that require both individual and community consent under traditional knowledge frameworks.

2.2 Intellectual property rights and access to BNP technology

Intellectual property rights are a set of intangible rights provided to persons for the creations of their intellect [34]. These rights motivate scientists to conduct more research by enabling them to access economic incentives. IPRs also address the issue of copying and credit snatching. For society, IPRs facilitate the dissemination of more creative works to the public, and each research project lays the groundwork for future research. The primary objectives of the Intellectual Property rights paradigm are to protect the rights of innovators, their products, research sponsors, inventors, and ultimately, the public at large. It also ensures the eradication of improper exploitation, abuse, and any contravention of the project’s intellectual assets. The paradigm also ensures that the environment and encouragements for research are augmented and which shall lead to the creation of new information. It also ensures that the benefits accumulating from all innovations and developments are reasonably and justifiably disseminated. And most importantly, it promotes interindustry linkages and stimulates research through the adoption and growth of innovative technologies, thereby creating opportunities for commercialization.

Four main theories offer the justification for IPRs. They are as follows-

1. The Natural Rights theory – English philosopher John Locke (the father of liberalism) proposed this theory. This theory posits that every person has a natural right to their own ideas. Every individual is entitled to the creation of his mind in the same manner as he is entitled to the ownership of the creation of his labour. Therefore, the fruits of a person’s labor should be legally protected and recognized as their property, whether tangible or intangible [35].

2. Utilitarian theory – Jerome Bentham and John Stuart Mill proposed that the objective of any policy should be the achievement of the greatest good for the greatest number [36]. This theory examines the economic success associated with the IPR regime. One significant drawback of the utilitarian approach to IPR is that it advocates monopoly, which poses a significant ethical challenge to IPRs, as we shall see in the following paragraphs.

3. The Reward theory – This theory supports rewarding individuals not only for the creation of their own labour but also for the benefits humanity derives from it. This theory, therefore, justifies exclusive rights over IPRs, taking into account specific moral and ethical considerations. Exclusive rights, according to this theory, are an expression of appreciation to the creator for doing more than what they are obliged to do for society [37].

4. The Personhood theory – The leading advocates of this theory are Hegel and Kant [38]. According to them, if a person’s artistic expressions are tantamount to their own personality, then such expressions deserve protection similar to the safety granted to the physical self of that person, because these expressions are, in a sense, a part of that physical person. Hegel propounds that IPRs protect and permit the development of one’s character, which ultimately extends to material things. Similarly, according to him, a copier of someone’s intellectual property is a thief who offers someone else’s spirit to the public [39].

It is the interplay of all the above-mentioned theories that has led to the creation of the present-day IPR Paradigm. While the considerations for IPR date back to the early days of the Gutenberg press, it was an international exhibition in Vienna in 1873 that led to the creation of the first international legal document in this sphere, the Paris Convention for the Protection of Industrial Property, in 1883. Thereafter, in 1893, the Bureaux for the Protection of Intellectual Property (BIPRI) were established. With the further advancement of the industrial and global world and the changes in the dynamics of the economy, various changes were desired in the international order governing IPRs. This was discussed by the world community at the Stockholm Convention of 1967, and as a result, the World Intellectual Property Organization was created to succeed BIPRI in 1970. WIPO today is the principal international organization dealing with IPRs. Its two main objectives are the promotion and protection of IPRs worldwide and ensuring organizational cooperation among the IPUs established by the accords administered by WIPO. The commercial aspect of IPRs is of utmost importance, and therefore, with the Inception of the World Trade Organization (WTO) after the agreement in Marrakesh, Morocco, in 1994, a need for a more holistic and sustainable international order regarding IPRs was recognized. This led to the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement in 1994 [40]. It is an international legal document binding upon all the member states of the WTO. The following IPRs are covered in the TRIPS Agreement-

1. Copyrights and related rights – These are a bundle of rights granted to the creators of literary, dramatic, and artistic works.

2. Geographical indicators – These are signs or symbols used to identify a product as having a particular geographical origin and significant market reputation.

3. Industrial design – It concerns the aesthetic and ornamental aspects of an article produced in any industry.

4. Trademarks – They are a combination of words, names, phrases, logos, symbols, designs, or images that are capable of ascertaining distinctiveness to the goods or services of one person from those of others.

5. Patent – It is an exclusive right granted for the invention of a product or a process which is novel, consists of an inventive step, and has industrial applicability.

6. Layout design of integrated circuits – These are the detailed plans used by manufacturers to fabricate integrated circuits.

7. Trade secrets – They are confidential information regarding a business that renders the enterprise a competitive edge over others.

The most critical IPRs concerning BNPs are patents. The main purpose of patenting is to promote innovation and scientific research, as it grants the patent holder exclusive economic rights [41]. To balance the interest, a person granted a patent must contribute to society’s further advancement in science and technology. This is achieved because he is required to publicly disclose the details of his invention and its intended use [42]. This scenario ultimately promotes competition and further research, which, in turn, benefits the scientific well-being of society [43]. For an invention to be granted a patent it has to meet the following five requirements: the subject matter of the invention must be patentable, the invention must have some utility, the invention must be novel, there must an inventive step or there should be no obviousness in the invention that is either the invention adds a feature to the already prevailing knowledge pool of practices or that a person who is skilled in that field must not find it to be obvious and that it should have the capability of being industrially applicable. The most important ethical question in patent law is what constitutes an invention. The following products or processes are widely regarded as not being inventions, and therefore they are not considered fit for Patent protection across the globe-

1. A frivolous invention.

2. An invention, the primary marketable use of which would be opposed to public order or ethics.

3. An invention that claims anything visibly conflicting with the well-recognized natural laws.

4. An invention the intended use of which will cause a serious threat or harm to humans, plants, animals, or the environment at large.

5. A mere discovery of a new form of a known material that does not result in the improvement of the usefulness of that known material.

6. A substance obtained by the mixing of other substances, resulting only in the accumulation of the properties of its components.

7. A method of agriculture.

8. A method of horticulture.

9. The mere arrangement or replication of known devices, each operating freely of the other in a well-established and known manner.

10. Any process for the curative, surgical, therapeutic, prophylactic, medicinal, diagnostic, or other treatment of human beings.

While at the outset, the IPR of a patent regarding BNPs may seem like a regular one, it poses some critical challenges. BNP novelties are always multidisciplinary in nature and function. These inventions encompass a broad range of disciplines, including chemistry, health, engineering, physics, biology, materials science, medicine, and various other scientific domains [44]. Therefore, a simple patent of a BNP requires a multidimensional approach so that its fruits can be enjoyed by society. Using rare or endangered organisms for nanoparticle synthesis may contravene biodiversity protection agreements, such as CITES. Ethical BNP research, therefore, requires sustainable sourcing, cultivation of microbial strains in controlled conditions, and compliance with conservation laws.

One of the significant ethical concerns regarding patents is the monopoly it grants to the patent holder for a specified period. While the scheme of the invention is publicly available, the patent holder can gain excessive economic advantage by licensing and authorising the use of the existing technology. This, in turn, may lead to a steep rise in the price of BNP, further restricting its affordability for a significant section of society. While BNPs in the field of cosmetics or other luxuries do not face this risk, BNPs in essential healthcare and agriculture certainly face a greater risk of social division in the event of extreme monopoly. It is therefore necessary that states regulate the Patenting of BNPs in a manner that ensures the poor section of society is not left behind. At the same time, the inventor and investor can reap the benefits of their labor and capital. This is done through the process of compulsory licensing, which ensures that the technology is available for the use of the public and that too at an affordable rate.

Although specific patent disputes on BNPs are scarce, comparable controversies exist in nanotechnology. For example, Arbutus Biopharma filed lawsuits against Moderna and Pfizer/BioNTech over patented lipid nanoparticle technologies. Likewise, the U.S. Supreme Court’s Myriad Genetics (2013) ruling established that naturally occurring materials cannot be patented, a principle directly relevant to biologically derived nanoparticles [45].

3.1 Public perception and acceptance of BNPs

BNPs have several advantages over chemically and physically generated nanoparticles. At the same time, the later ones tend to be more toxic, environmentally challenging, and unstable. They are, in most cases, inefficient in terms of energy and material use and require substantial capital investment [46]. BNPs, on the other hand, give a favourable option to these issues and are therefore considered superior [47].

BNPs have established a significant presence within the nanotechnology community. However, various ethical concerns have arisen in the field of BNPs [48]. These moral concerns will be dealt with later in this article. At this juncture, it is essential to note that if these ethical concerns are not addressed, the general trend of accepting BNPs may face a significant challenge ahead. It is therefore necessary for the scientific community to address these public concerns. Apart from the above, certain misconceptions have also cropped up regarding BNPs and their use. Toxicity to the body, environmental harm, and disease caused by the use of BNPs in agriculture are among the critical misconceptions that need to be debunked. This can only be achieved if an efficient dialogue is established between the scientific community and the public at large, and the benefits of BNPs are efficiently advertised amongst the masses (Figure 2). The European Union mandates explicit nano-labeling in cosmetics and novel foods, requiring the term ‘(nano)’ after each ingredient name. In contrast, the U.S. FDA provides guidance encouraging detailed nanoparticle characterization but does not require consumer-level labeling. Other regions, such as Japan and China, follow similar advisory rather than mandatory disclosure approaches.

Figure 2:

Public perception and acceptance model for biogenic nanoparticles (BNPs). Scientific acceptance directly affects the public’s perception of the issue. Public trust, influenced by transparency and historical experiences, also plays a crucial role. Effective communication strategies are pivotal in bridging gaps and mitigating misconceptions, ultimately leading to the successful adoption of BNPs.

Favourable public perception is of great importance to BNPs. Firstly, they are essential scientific tools, and their applicability benefits both humanity and the environment. Secondly, their development requires significant capital investment, and if these investments face commercial risk, further development of this field may be impeded.

3.2 Bridging the gap between developed and developing nations

Since the end of the Second World War, the entire globe has worked diligently to establish a universal commercial system, connecting countries through trade and the exchange of ideas. Globalization, therefore, is one of the most outstanding achievements of human civilization. Many international organisations have been established to ensure that this global commercial order operates smoothly and that every participant can express their concerns. The United Nations Organization, the World Bank, the International Monetary Fund, and the World Trade Organization have played a vital role in this regard since their inception.

One of the key considerations of the global commercial order is that economic prosperity and development should not be restricted to the rich and developed nations. The development should be sustainable, and even the poorest countries must be assisted in their journey toward prosperity. The GATT and the WTO Agreement ensure that all members treat each other similarly and that domestic products and MFN products receive the same treatment.

There must be a constant sharing of technological knowledge between developed nations and their developing and underdeveloped counterparts, so that every human on this planet can witness the marvels that we, as a species, have achieved. As previously discussed, BNPs are a boon for the environment [47], and in the current era of global warming and climate change, we must employ every mitigating strategy to prevent or at least slow the rate of climate change. Environmental change is not a local phenomenon; it is a global issue. Pollution in one corner of the world has a dramatic effect on the climate in another part of the world, in the other hemisphere. Therefore, to ensure environmental restoration, developed countries must develop a plan to aid other countries in combating this scenario using BNPs.

3.3 Socioeconomic implications of BNPs

The advancement of technology is often linked with a reduction in employment numbers. However, BNPs paint a very different picture. They have, of late, been associated with job creation and prosperity. The entire BNP paradigm has created a demand for skilled technicians, researchers, scientists, managers, and investors. They have altogether made a new avenue for employment.

Additionally, BNPs have very far-reaching economic implications. The most significant of these can be observed in agriculture (Table 3). BNPs are now being utilized to enhance crop yield [49], improve disease and drought resistance [4], 50], and enable biofortification and nutrient enrichment. This is a bane for farmers and for populations deficient in nutrients.

4.1 Current regulatory landscape for BNPs

To understand the regulatory framework for BNPs, we must address the broader regulatory framework and marketing of Nanoparticles (Figure 3). Nanoparticles, as we know, have become an integral part of various industries, ranging from robotics and communication to agriculture and medicine. Therefore, they must be covered under an umbrella of regulations. Their economic importance makes their regulation a matter of utmost importance in the international context. It is pertinent to note that, at present, there is no holistic international framework (applicable to all countries alike) to regulate biogenic nanoparticles [63]. However, a few government bodies and groups have established rules and laws to define and regulate the use of nanoproducts [64]. We will provide a detailed examination of the regulatory frameworks for nanomaterials in various countries later in this article.

Figure 3:

An overview of the paths of nanomaterial synthesis to its marketing.

4.2 Need for adaptive and stringent regulatory measures

Every citizen is considered to have a social contract with their state. For the smooth running of things, the state must fulfill its promise of general protection to its citizens and create a system of law and order, which in turn sends a signal of well-being to the masses. In modern times, with commerce having gone global, various states must come together to form an international system of law and order that can address specific issues uniformly worldwide. On this path, with the Inception of the United Nations, the international community has come together and worked hard to create a global order in which the fundamental human rights of each individual are protected. These Human rights can be personal, political, social, cultural, and economic. It is the duty of the United Nations and its members to uphold the definition of these rights and to protect their citizens from their violation. For this purpose, the UN has adopted various conventions to enumerate and define these rights. According to Article 13 of the UN Charter, “The contracting parties state their desire to promote: ‘economic and social advancement’ and ‘better standards of life’.” This forms the basis of the discussion surrounding the regulatory framework of newer technologies that impact the economy, development, health, and other aspects of our civilization. Articles 7 and 12 of the International Covenant on Economic, Social, and Cultural Rights (ICESCR) are also noteworthy in this regard [63].

Article 7 provides a deeper understanding of the denotation of the right to just and favourable working conditions, as discussed in other UN documents. “Favourable conditions of work” include terms of remuneration as well as “safe and healthy working conditions” [65]. Article 12 clearly and concisely addresses the issue of health. It is perhaps the strongest of all human rights instruments regarding the explicit right to protection against “occupational disease” and protection for “industrial hygiene.” The aforementioned international conventions and principles, therefore, impose a duty on states, both domestically and internationally, to formulate a robust regulatory framework for BNPs that is adaptable to emerging technological advancements. This is necessary because, over time, BNPs will not only affect individuals but also play a greater role in reshaping the economic and social paradigms of the world at large. There must be a mechanism to ensure that new technological advancements in BNPs are communicated globally efficiently and that both developed and developing nations do not fall behind in this regard.

4.3 Ethical considerations regarding the use of artificial intelligence in BNP development

The growth of Artificial intelligence has not been met by a proportional advancement in regulations and protocols, which poses a challenge regarding fairness in the development and deployment of BNPs as well [66]. The ethical and responsible deployment of advanced technologies, such as biogenic nanoparticles, necessitates a multidimensional approach that encompasses privacy protection, transparency, accountability, and robust governance structures. In the context of artificial intelligence (AI), privacy-preserving techniques, including differential privacy, federated learning, and homomorphic encryption, are crucial for safeguarding sensitive personal and health-related data throughout the research and application lifecycle [67]. Responsible deployment also necessitates transparency in methodological practices and decision-making processes, as well as active bias detection to ensure equity and mitigate risks to vulnerable populations. Inclusive stakeholder engagement, which involves experts, regulators, and the public, is crucial to building trust and promoting ethical oversight. The adoption of international regulatory standards, ethical codes of conduct, iterative risk assessments, and independent audits will ensure ongoing compliance with rapidly evolving policies and regulations. Integrating transparency, fairness, and privacy in AI development requires a comprehensive ethical framework that mitigates bias, promotes accountability, and respects data protection across global contexts. There is a need for routine audits, fairness-aware algorithms, clear documentation, diverse teams, and international collaboration to harmonize ethical AI standards for trustworthy and equitable AI systems [68].

4.4 Case studies of regulatory approaches in different regions

In this section, we will examine the various statutory and non-statutory measures taken by international organizations and multiple countries worldwide to establish a global framework for the regulation of Nanoparticles and their regulation in their respective territories [69].

4.5 Recommendations for improving regulatory oversight

BNPs in particular and Nanotechnology in general are a novel phenomenon. As we saw earlier in this article, there is a lack of specific agencies and instruments, both globally and locally, to regulate nanoparticles. One of the main reasons is that nanoparticles have found roles in various aspects of human life, and it is impractical to develop a single framework that regulates all aspects of human civilization. Therefore, the current situation demands better coordination. The existing procedures for nanomaterials, such as REACH in the European Union, need to be integrated into existing frameworks [70]. Various standardization agencies need to develop a globally standardized testing protocol for nanomaterials and uniform guidelines to assess the environmental effects of nanoparticles and other safety concerns [71]. Safer principles need to be incorporated into the development of nanomaterials so that they can be engineered with lower toxicity without compromising functionality [72]. Additionally, stakeholders in the field of BNPs, including industrial leaders, regulators, and researchers, should participate in the decision-making process to promote transparency and foster consensus. Nevertheless, there is an excellent opportunity to integrate societal, legal, and ethical considerations into the regulatory framework, ensuring that the ethical and responsive governance of nanotechnology is addressed [73]. In India, a clear lack of a robust framework regulating BNPs is evident. To ensure optimal output, a regulatory framework for biogenic nanoparticles in India should involve a coordinated approach among key regulatory agencies. The Bureau of Indian Standards (BIS) should develop technical standards addressing nanoparticle synthesis, quality control, and safety. The Indian Council of Medical Research (ICMR) must lead health risk assessments and safety evaluation protocols. The Food Safety and Standards Authority of India (FSSAI) should regulate the use of food and nutraceuticals, ensuring labelling and consumer protection. Stakeholder engagement, pilot regulatory testing, and legal enforcement mechanisms must be established to ensure compliance and address public health concerns [74]. International collaboration and alignment with global standards are crucial for robust governance and innovation.