Team:UNSW Australia/Human Practices/Law

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© 2018 UNSW Australia iGEM

Overview

The legal frameworks surrounding synthetic biology are critically important because they determine what type of research can be undertaken, by selecting for research that is both legally allowable and has potential commercial implications. However, scientists often fail to most effectively lobby for frameworks that support what their research actually needs, instead acquiescing to government policy that bows to vested commercial interests.

As a result UNSW iGEM 2018 has created a scientist’s guide to writing a policy proposal for government change, and written an example submission. We have also documented our discussions with various stakeholders in the process, such as normal scientists and the government departments who receive the submissions. UNSW iGEM 2018 also collaborated with other student organisations, including the UNSW Law Society.

UNSW iGEM 2018 discovered, as part of our foray into commercialisation, that patent law for pieces of genetic information is hard to comprehend from the scientific perspective. This is particularly important for scientists, as without patents, it can make commercialisation of their discoveries hard, and thus dis-incentivise funding of their research. It is further complicated by the international nature of research meeting individual countries’ patent law regimes.

Relevance

The legal sphere may seem divorced from the practice of science in the laboratory, but in reality, they are closely intertwined, with three key points of intersection.

Commercialisation The law can grant protection over ‘inventions’ made by scientists. The protection the law grants can then allow the invention to be commercialised, and incentivises companies to invest in research to get a competitive advantage in the market – without fear of unmitigated copying. The law aims to encourage and assist innovation, instead of stifling it, by allowing market forces (and the scientists) to capitalise on invention. It also means that the research with the most funding is typically the research which is the most potentially lucrative – research which can present solutions to problems (like cancer) that affect wealthier societies who can pay more for medicine. This is as opposed to research for diseases almost exclusively present in poorer nations (like dengue). Our team faced this issue – foundational technologies like the Assemblase system did not fit many of the grant opportunities that were available, being for things much closer to practical use. It did also mean we chose really practical enzymes for our model.

Accessibility & Availability The law’s protection comes with a stipulation that the protected invention is revealed to the public. As a result, the public has access to that idea once the protected timeframe is over. It also means that researchers can, in the future, build off that idea to have higher quality research, as well as the disclosure meaning that scientists may choose to stop research in a particular area, and refocus on another. However, that means that the law can render certain ideas inaccessible for a number of years. The challenge here is that science is built off of the research of others; and a period of years can truly stifle development and innovation. Our team faced issues surrounding the availability of the protein Spy Tag/Catcher system, because of its legal protection. However, these issues were avoided thanks to the research locations (and protection) being in two different jurisdictions.

Grants & Ethics Approval The legal ‘tick of approval’ is being introduced into grant applications within Australia, currently being part of grant applications in Europe. The grants the team received were not dependent on ethics approval of the research; however, we question whether they should be. The availability of grant money to fund the research also determines what projects can be undertaken – a project ineligible for grant money is far less likely to go ahead.