Facilitation and Regulation of Research and Development Involving Human Genetic Databanks. Australia's medical biotechnology research feeds into our biotechnology industries, with flow-on benefits for national health and prosperity. Realisation of these benefits is contingent upon community protection and public trust. An effective and appropriate regulatory regime is a foundation requirement. This project aims to shape a national regulatory framework for human genetic databanks that both facili ....Facilitation and Regulation of Research and Development Involving Human Genetic Databanks. Australia's medical biotechnology research feeds into our biotechnology industries, with flow-on benefits for national health and prosperity. Realisation of these benefits is contingent upon community protection and public trust. An effective and appropriate regulatory regime is a foundation requirement. This project aims to shape a national regulatory framework for human genetic databanks that both facilitates research and maintains highest ethical standards. By examining the balance between facilitation and regulation, assessing existing law reform proposals, making recommendations for further reform, and placing this analysis in the international context, this project will significantly benefit the nation and the research community. Read moreRead less
Reforming the regulatory environment for innovative health technologies. This project aims to comprehensively map the regulatory pathways that innovative health technologies must navigate from the laboratory to the clinic, and to identify areas of over and under regulation. Pathways for innovative procedures, medicines and devices will be analysed in three cutting edge case studies - genome editing, biologic medicines and bio-printing - with particular focus on therapeutic goods registration and ....Reforming the regulatory environment for innovative health technologies. This project aims to comprehensively map the regulatory pathways that innovative health technologies must navigate from the laboratory to the clinic, and to identify areas of over and under regulation. Pathways for innovative procedures, medicines and devices will be analysed in three cutting edge case studies - genome editing, biologic medicines and bio-printing - with particular focus on therapeutic goods registration and patents. Doctrinal, qualitative and iterative research methods will be used. The primary intended outcome is a set of recommendations to assist policy makers in ensuring consistency of regulatory policy and practice, thereby supporting innovation and safe clinical translation, for the benefit of all Australians.Read moreRead less
Legal and Ethical Regulation of the Use and Commercialisation of Human Biological Material. The Australian government has a policy of promoting expertise in genomics. An essential ingredient of research and development of the genomics industry is access to human biological material. A clear regulatory framework is required, consistent with national ethical principles. There is lack of clarity, legally and ethically, in relation to ownership (including derivative claims), consented and un-consent ....Legal and Ethical Regulation of the Use and Commercialisation of Human Biological Material. The Australian government has a policy of promoting expertise in genomics. An essential ingredient of research and development of the genomics industry is access to human biological material. A clear regulatory framework is required, consistent with national ethical principles. There is lack of clarity, legally and ethically, in relation to ownership (including derivative claims), consented and un-consented use, contracts, conflict of interest and benefit sharing in human biological material, including regenerative tissue. Clarification will facilitate ethical research and commercialisation. These issues will be analysed systematically with recommendations for Australia consistent with international standards.Read moreRead less
Co-operative intellectual property management and technology transfer for the Australian biotechnology industry. The Australian biotechnology industry rests on a framework of internationally competitive research and should be well placed to capture a significant share of expanding global markets. However, existing intellectual property (IP) management strategies do not make the most of this potential because they raise barriers to much-needed co-operation among industry players. By developing an ....Co-operative intellectual property management and technology transfer for the Australian biotechnology industry. The Australian biotechnology industry rests on a framework of internationally competitive research and should be well placed to capture a significant share of expanding global markets. However, existing intellectual property (IP) management strategies do not make the most of this potential because they raise barriers to much-needed co-operation among industry players. By developing and refining new co-operative IP management models in an Australian context, this project offers direct economic benefits (more efficient industry structures), improved social and economic benefits (better and cheaper biotechnology products and services), and an opportunity for Australia to take the lead in developing innovative approaches to IP management.Read moreRead less
The innovation pool in Australian biotechnology: assessing strategies for fostering innovation through patenting and patent pooling. The current patent system was designed for a very different research environment than that in which the global biotechnology industry operates. Rather than facilitating innovation there is evidence that the system can unduly restrict R&D. Patent pooling is being promoted internationally as a way to facilitate innovation. However, potential pitfalls are also recogni ....The innovation pool in Australian biotechnology: assessing strategies for fostering innovation through patenting and patent pooling. The current patent system was designed for a very different research environment than that in which the global biotechnology industry operates. Rather than facilitating innovation there is evidence that the system can unduly restrict R&D. Patent pooling is being promoted internationally as a way to facilitate innovation. However, potential pitfalls are also recognised, and work is underway to develop appropriate regulation. Australia cannot afford to be left behind: urgent consideration must be given to the desirability of patent pooling and the regulatory changes that are required to allow it to function in the national interest. The proposed research will provide the data necessary to make informed decisions on this critical issue. Read moreRead less
Material Transfer Agreements and Open Science in the Genome Era. Research paradigms are changing rapidly in the Genome Era. Open access databases are increasingly popular and are required by public funding agencies. The role of material transfer agreements (MTAs) in this open access era is not clear. This project aims to assess the extent to which MTAs facilitate exchanges of biological materials between organisation in Australia and internationally. The project will assess whether MTAs are refl ....Material Transfer Agreements and Open Science in the Genome Era. Research paradigms are changing rapidly in the Genome Era. Open access databases are increasingly popular and are required by public funding agencies. The role of material transfer agreements (MTAs) in this open access era is not clear. This project aims to assess the extent to which MTAs facilitate exchanges of biological materials between organisation in Australia and internationally. The project will assess whether MTAs are reflecting the open data access movement or maintaining traditional closed proprietary practices. The project will make policy, ethical and legal recommendations for the development of MTAs to promote exchange of materials nationally and internationally and to facilitate the developing collaborative research culture. Read moreRead less