Log in
The Ethics of Patenting DNA was a Nuffield Council on Bioethics Report by a working party of which Thomas Baldwin was a member with responsibility for providing the ethical framework for the report. The report was published in 2002 and its initial impact occurred in the 2002-2005 period; but it has had continuing impact during the current period on legal and political debates concerning the granting of patents on DNA sequences to pharmaceutical and biotechnology companies and to universities. More generally it continues to have a significant impact on policy formation in this much disputed area.
This case study describes both economic and healthcare benefits that have resulted from a new DNA (gene) sequencing technique known as SOLiD sequencing. Through the 1990s until the present, Cosstick (University of Liverpool since 1984) has both developed the synthesis and studied the properties of chemically modified DNA in which a single oxygen atom is replaced by sulfur; we have termed this a 3'-phosphorothiolate (3'-sp) modification. Chemically prepared DNA containing the 3'-sp modification is a key enabling component of the Applied Biosystems SOLiD DNA sequencing instrument which is able to produce extremely rapid, cost-effective and exceptionally accurate DNA sequence information. The impact of this very powerful sequencing technology extends beyond economic benefits as it has many healthcare applications which have impacted medical practice.
Hagan Bayley's research on nanopore sensing for DNA sequencing at the University of Oxford led to the formation of the spin-out company Oxford Nanopore Technologies Ltd (ONT) in 2005. Since 2008, ONT has raised £ 97.8M to support research and product development. This level of investment arises as a direct result of the pioneering technology ONT has developed, based on research in the UOA, which has the potential to revolutionise DNA sequencing and other single molecule analyses. ONT currently employs 145 people, nearly six times as many as in 2008, and was recently valued at $ 2 billion. Evidence from ONT was used in a 2009 House of Lords report on genomic medicine, demonstrating ONT's position at the forefront of this new technology.
[Key: Bold: text from REF guidelines; Bold italic/italic: emphasis; Superscript: references in sections 3 and 5]
Research by Chadwick has influenced research protocols and policies regarding the ethical consequences of collecting DNA for research. Her impact is most visible in the Personal Genome Project, and the work of the Nuffield Council on Bioethics, UN Food and Agriculture Organisation, Human Genome Project and H3Africa. Her contributions to discussions and documents resulted in changes to how consent is gained from DNA donors. In particular, the changes address important issues that she raised regarding the practicality and acceptability of the undertakings made in current consent protocols about confidentiality and the future use of data. Chadwick's underpinning research claims relate to the fact that genetic information, and the attendant genetic technology, are derived from, and significant to, populations as a whole. She maintains that biotechnological advances are changing our ethical values, particularly regarding conflicts between personal interests and large-group needs. For her, practical ethics cannot apply normative ethical concepts and theories arising from abstract philosophical reasoning. Rather, the conceptual and theoretical structures themselves must be developed through philosophical engagement with the scientific details of the project. Her collaboration with bodies responsible for the protocols of consent reflects a `bottom-up' moral philosophy rather than the traditional `top-down' theory-driven approach.
An AHRC and ESRC-funded Edinburgh research collaboration with the Argentinian Ministry of Science, Technology and Innovative Production (MOST), from 2007-2012, served as a key driver in the formation of regulatory structures, norms, knowledge and social understanding, helping to overcome state non-intervention in the regulation of regenerative medicine. As a direct result of engagement with the stakeholders in law/policy, medical and scientific communities, the research exposed a strong appetite for top-down legal intervention. This culminated in the first-ever model law presented by the MOST to the Argentine legislature (Congress) in 2013.
High-throughput genotyping has revolutionised the genome-wide search for associations between genetic variants and disease. Professor Sir Edwin Southern of the University of Oxford's Biochemistry Department invented the highly cost-effective array-based method of analysing genetic variation based on hybridisation between probes and samples on glass slides or `chips'. The spin-out company Oxford Gene Technology (OGT) founded by Southern in 1995 licenses the patent to manufacturers of `single nucleotide polymorphism (SNP) chips', including Illumina and Agilent, a global business exceeding $500M per year. Southern has continued to refine and extend this technology to increase its speed, efficiency and cost-effectiveness. This revolutionary technology has widespread applications such as prediction of individual risk, development of new drugs, provision of personalised treatments, and increased cost-effectiveness of clinical trials. Licence revenues fund R&D within OGT, and endow charitable trusts supporting primary school science education in the UK and crop improvement in the developing world.