Participation and invited lecture of the UNESCO Chair in Trieste (November 30 - December 1, 2016) at the Joint Research Center of the European Commission and the ICGEB - JOINT EXPERT MEETING ON GENOME EDITING AND RELATED TECHNOLOGIES: SCIENTIFIC AND REGULATORY CONSIDERATIONS.
This international meeting was meant to contribute to the development of an international consensus in regard to genome editing.
Genome editing and related technologies: scientific and Regulatory considerations
"Genome editing" is a recent technology that can be considered as ultramodern
microsurgery on genes. It is an innovative technology that is booming in molecular
biology laboratories; in 2015 experts considered it the "breakthrough of the year" and,
given its precision, low costs and ease of use, it has become the model of the
"democratisation of science".
Genome editing helps us to understand complex biological processes and can - for
example - be used to directly correct genetic disorders in affected tissues and cells to
cure diseases that cannot be treated (easily) with traditional therapies.
Genome editing can also be used to modify, correct or add new and valuable traits in
animals or plants, for example. These are the major providers of nutrition for the world
population and any improvement in nutritional value and resilience would be welcome
in many species. Successful proof of concept applications have already been reported in
pig, goat and cattle as well as in several agricultural crops, such as mildew induced
resistance in wheat.
The ease of use, accuracy and efficiency of genome-editing tools has led to their broad
adoption in research, as well as to proof of concept applications in gene therapies
involving non-reproductive (somatic) cells.
It is also possible to deploy genome editing in human germline cells (sperm and eggs) as
well as in early embryos. Many stakeholder groups are debating this issue, which, for
some, remains a line not to be crossed whereas for others it provides possibilities for
improving the human condition through the repair of deleterious genetic mutations.
The precise effects of genetic modification on an embryo may be unknown until after
birth and this raises concern about unintended effects that may not surface for years.
In general, there are serious concerns regarding the ethical and safety implications of
human germline cell research. There is also concern on the negative impact this could
have on important work involving the use of genome-editing techniques in nonreproductive
cells and thus on genome-editing work in general.
When genome editing (and related technologies) is applied to living cells, the result
often leads to the creation of a novel organism, capable of replicating. These organisms
may be placed on the market as products, or as parts of products, that may be novel
and are unknown to society.
It is standard practice, before these products are placed on the market, or before they
are released into the environment, that a risk assessment is carried out.
The situation with regard to genome editing appears similar to the issue of genetically
modified organisms where certain techniques applied to living, replicating organisms
may result in genetically modified products that are risk assessed on a case-by-case
basis before they are released into the environment or placed on the market.
However, there has been no decision yet as to whether products resulting from genome
editing should be treated in the same manner as GMOs or whether another regulatory
framework is to be applied.
The proposed workshop aims to bring together stakeholders from academic, industrial
and governmental organisations and will have the following format:
- Section one: The technology involved and its future developments
- Section two: Present and future innovations and their potential impact on society (health, agriculture, industry, …)
- Section three: Ethical concerns
- Section four: Possible role of the regulator.
A final, fifth section will be dedicated to formulating conclusions and recommendations.
- Anticipate the technology landscape and the associated expected
- Create a Directory of possible hazards associated with the application of the
- Provide an evaluation of related ethical concerns
- Establish a Catalogue of policy options