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Desk study to review environmental risks from marketing GM veterinary and human medicines - CB02047

Description
Defra is expecting an increase in the number of marketing applications for live GMOs to be used in veterinary and human medicine. The environmental consequences, including impact on wider human health (i.e. not the patient), of marketing these GMOs must be assessed in accordance with the EU’s GMO deliberate release Directive (2001/18/EC). Any medicines that are derived products from GMOs do not lie within the scope of this legislation.

Defra would like to let a desk study to increase our understanding of the risks to the environment and wider human health that may be associated with the deliberate release of such GM medicines. The desk study will review the scientific literature, patents and regulatory databases to identify those live GM medicines (such as GM vaccines, gene therapies) that are in development and those that are close to, or pending, commercialisation (e.g., those in Phase III clinical trials).

The research will aim to highlight the gaps in our current understanding of future veterinary and human medicinal products consisting of live GMOs and the main environmental and human health issues for risk assessment and risk management.


Aims
- to provide a literature review and an assessment of current knowledge to increase our understanding on what the risks are for human health and the environment from live GM medicines. Specifically:

- the study should aim to review all aspects of developing technologies for GM veterinary and human medicines such as a description of the technology, any environmental hazards associated with it and a description of the likelihood and consequences – as described in 7.

- the study should also include an evaluation of industrial research effort in this area, which could be via searching patent applications and regulatory databases, as well as evaluation of papers in scientific journals and to provide information such as when/ if likely to be commercialised. The study should aim to address developments that are global-wide and not be restricted to developments in the EU.

- based on the findings from the literature review, to make recommendations for future research to inform risk assessment and risk management.

Project Documents
• Final Report : Review of the environmental risks from marketing GM veterinary and human medicines   (1063k)
Time-Scale and Cost
From: 2007

To: 2008

Cost: £54,962
Contractor / Funded Organisations
Atkins Environment
Keywords
Biotechnology              
Genetically modified food and crops              
GM Non-Food              
GM Risk Assessment              
Veterinary Medicines              
Fields of Study
Biotechnology and GMOs