Global equity considerations in synthetic biology access

Introduction

Global equity considerations in synthetic biology access refer to the legal, ethical and economic principles governing fair access to synthetic biology technologies, research facilities, scientific knowledge and commercial benefits across different countries and communities. Synthetic biology involves the design and development of biological systems for applications in healthcare, agriculture, environmental protection, energy and industrial manufacturing.

These technologies may help produce affordable medicines, improve agricultural productivity, develop sustainable materials and address environmental challenges. However, access is not equally distributed. Wealthier countries generally possess stronger research infrastructure, specialised laboratories, skilled professionals and greater investment capacity. Developing countries may face financial, technological and regulatory barriers.

Therefore, global equity requires that synthetic biology innovation should benefit humanity broadly rather than remain concentrated among technologically advanced countries and private corporations.

International legal framework

1. Convention on Biological Diversity, 1992

The Convention on Biological Diversity (CBD) establishes three important objectives: conservation of biological diversity, sustainable use of its components and fair and equitable sharing of benefits arising from genetic resources.

These principles are relevant to synthetic biology because research may involve biological resources obtained from different countries. The CBD recognises the importance of national sovereignty over natural resources and supports equitable arrangements concerning access and benefit-sharing.

2. Nagoya Protocol, 2010

The Nagoya Protocol establishes an international framework for access to genetic resources and fair benefit-sharing arising from their utilisation.

It encourages appropriate access permissions, mutually agreed terms and benefit-sharing arrangements. Benefits may include monetary payments, technology transfer, research collaboration, training and sharing of scientific results.

However, its application to digital sequence information (DSI) requires careful distinction. DSI is not automatically treated as a physical genetic resource under every provision of the Protocol. Separate multilateral developments have emerged under the CBD.

3. Cartagena Protocol on Biosafety, 2000

The Cartagena Protocol governs the safe handling, transport and use of living modified organisms resulting from modern biotechnology that may adversely affect biodiversity.

It supports developing countries by recognising the importance of biosafety assessment, information exchange and national decision-making. Its scope is limited to living modified organisms covered by the Protocol, rather than all synthetic biology products.

4. Sustainable Development Goals

The United Nations Sustainable Development Goals provide an important policy foundation for equitable access to synthetic biology.

In particular:

Goal 3 promotes good health and well-being.

Goal 9 supports industry, innovation and infrastructure.

Goal 10 focuses on reducing inequalities.

Goal 17 encourages international partnerships.

These goals support cooperation in research, technology transfer and affordable access to scientific innovation.

Major equity considerations

1. Unequal access to research infrastructure

Synthetic biology requires specialised research facilities, trained scientists, advanced equipment and institutional funding. Wealthier countries can invest more heavily in these resources, while developing countries may struggle to establish comparable research systems.

International cooperation, shared research facilities and scientific training programmes can reduce these inequalities.

2. Intellectual property and patent protection

Patents provide incentives for innovation by granting exclusive rights over qualifying inventions. However, extensive patent restrictions may increase licensing costs and make important technologies difficult to access.

The WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) establishes minimum international intellectual property standards. Its Article 31 provides conditions under which governments may authorise certain uses of patented inventions without the patent owner's consent.

Equitable governance should balance innovation incentives with public-interest considerations, particularly in healthcare and essential agricultural applications.

3. Access to genetic resources and benefit-sharing

Developing countries possess significant biological diversity and may provide genetic resources used in scientific research. Equity requires that benefits arising from their utilisation should be shared in accordance with applicable legal obligations.

Such benefits may include:

Financial compensation and benefit-sharing payments.

Scientific training and institutional development.

Technology transfer and research partnerships.

Access to relevant research findings.

Participation in commercial and scientific opportunities.

4. Digital sequence information

Synthetic biology increasingly relies on digital sequence information derived from genetic resources. Researchers may use such information without physically collecting biological samples.

This creates challenges for traditional access and benefit-sharing systems. CBD decisions have consequently developed a multilateral mechanism for benefit-sharing from DSI, including the Cali Fund established following COP16 in 2024.

The mechanism seeks to ensure that benefits arising from the use of DSI contribute to conservation and sustainable development.

Indian legal and regulatory framework

India has several laws and policies relevant to equitable access to synthetic biology.

The Biological Diversity Act, 2002, as amended in 2023, provides a framework for regulating access to biological resources and associated benefit-sharing. Its requirements depend on the identity of the applicant, the nature of the resource and applicable statutory exemptions.

The Patents Act, 1970, governs patent protection for qualifying inventions. Sections 3 and 4 identify categories of subject matter that are not patentable, while Section 3(j) excludes plants and animals in whole or any part thereof, other than microorganisms, including seeds, varieties and species, and essentially biological processes for production or propagation of plants and animals.

The Environment (Protection) Act, 1986, and the 1989 Rules regulate specified activities involving hazardous microorganisms and genetically engineered organisms.

India's scientific policy framework should also promote research collaboration, affordable innovation, institutional capacity-building and responsible commercialisation.

Relevant case laws

There is no direct Indian Supreme Court judgment comprehensively addressing global equity in synthetic biology access. However, several decisions establish relevant legal principles.

1. Divya Pharmacy v. Union of India (2018)

The Uttarakhand High Court considered benefit-sharing obligations under the Biological Diversity Act. The decision is important for understanding equitable sharing of benefits arising from commercial utilisation of biological resources.

2. Novartis AG v. Union of India (2013)

The Supreme Court interpreted Section 3(d) of the Patents Act, 1970. The judgment demonstrates the importance of preventing inappropriate patent extensions while maintaining legitimate incentives for pharmaceutical innovation.

3. Entertainment Network (India) Ltd. v. Super Cassette Industries Ltd. (2008)

The Supreme Court examined compulsory licensing principles under copyright law. Although not a biotechnology case, its discussion of balancing private intellectual property rights with public access provides a useful comparative principle.

4. K.S. Puttaswamy v. Union of India (2017)

The Supreme Court recognised privacy as a fundamental right. This principle is relevant when synthetic biology research involves genetic information, biological samples and identifiable personal data.

5. Vellore Citizens' Welfare Forum v. Union of India (1996)

The Supreme Court recognised the precautionary principle and polluter-pays principle. These principles support responsible governance where synthetic biology applications may create environmental risks.

Challenges and recommendations

Major challenges include unequal research funding, expensive patented technologies, limited scientific infrastructure, regulatory differences and insufficient participation of developing countries in international decision-making.

To address these problems, governments and international organisations should:

Promote affordable licensing and responsible technology transfer.

Strengthen research institutions in developing countries.

Improve access to scientific education and training.

Establish transparent benefit-sharing arrangements.

Encourage international research partnerships.

Develop appropriate governance for digital sequence information.

Ensure that environmental and public-health safeguards apply consistently.

Conclusion

Global equity in synthetic biology access is essential to ensure that scientific progress benefits countries and communities regardless of their economic capacity. International instruments such as the Convention on Biological Diversity, Nagoya Protocol and Cartagena Protocol provide important foundations for equitable and responsible biotechnology governance. Indian legislation, particularly the Biological Diversity Act and Patents Act, also contributes to this framework. Judicial decisions such as Divya Pharmacy and Novartis demonstrate the importance of balancing commercial rights with public interests. Ultimately, fair access requires technology transfer, capacity-building, responsible intellectual property protection and equitable sharing of scientific and economic benefits.