The use of gene technology in biomedical research and the use of genetically modified organisms (GMOs) in the production of pharmaceuticals offer substantial benefits to the quality of products, the environment and opportunities for the identification of new treatment concepts for patients. It is expected that gene technology can help solve many health issues of today but it is also recognised that gene technology causes concerns to many people.
Novo Nordisk uses gene technology and GMOs in biomedical research and the production of pharmaceuticals. The GMOs are handled under closed and contained conditions.
Novo Nordisk´s position
- Nordisk believes that the contained use of gene technology is an important tool in the identification and production of pharmaceuticals for patients. These pharmaceuticals could not otherwise be provided in sufficient quantity or quality.
- Novo Nordisk only uses GMOs in the lowest risk category for production and the final products do not contain GMOs.
- Novo Nordisk will use production strains without antibiotics resistance genes whenever technically possible and practically feasible.
- Novo Nordisk recognises the concern about emission of GMOs to the environment and secures a minimal discharge of GMOs in our waste streams in compliance with regulation.
- Novo Nordisk supports the proper regulation of the use of gene technology and the principle that public concerns are adequately addressed.
- Novo Nordisk applies the Precautionary Principle in the use of gene technology by conducting risk assessment prior to use.
- Novo Nordisk will actively participate in the development of relevant international standards.
- Novo Nordisk supports transparency and openness in relation to the use of gene technology and continues to report publicly on our use of the technology.
The application of gene technology enables Novo Nordisk to produce a variety of biological active proteins: various types of insulin for the treatment of diabetes, hormones for the treatment of growth deficiencies, and blood clotting factors for the treatment of haemophilia and severe loss of blood.
Novo Nordisk products do not contain GMOs or gene fragments
This is due to the fact that these are separated from the final products in the purification process following the fermentation process. Labels on our products inform our customers that GMOs are used in the production process.
The GMOs in use for research and production at Novo Nordisk are mainly microorganisms (i.e. bacteria and fungi) and mammalian cells.
For production, Novo Nordisk uses GMOs in the lowest risk category where there is no known risk to humans or to the environment. In research Novo Nordisk strives to use the lowest possible risk category of GMOs.
In the case of an accidental release of GMOs for production from Novo Nordisk there is no known risk to humans and the surrounding environment. The GMOs are designed in such a way that they can only poorly survive outside in the environment.
Novo Nordisk´s main usage of GMOs is in Denmark. Novo Nordisk must, as all other companies in Denmark, obtain approval before starting any kind of experiment or production involving GMOs. In Denmark, the approval is given by the National Working Environment Authority and in the case of production also by the Danish Forest and Nature Agency. Outside Denmark Novo Nordisk operates under the high standards of the company in addition to local regulations on GMOs.
The GMOs undergo a thorough risk assessment
The potential risk to employees and the environment during normal procedures as well as in the case of accidents or spills is carefully considered. The laboratory or production facilities where the GMOs are handled must also be approved by the authorities before use. All GMOs are handled under contained conditions and by trained personnel according to approved procedures.
Contained use of approved GMOs for research and production in Novo Nordisk is based upon approximately 25 years of risk assessments and safety records. No damage to human health or the environment has ever been recorded. Field surveys have not shown living GMOs in the surrounding soil. Nevertheless, Novo Nordisk continuously aims at eliminating and reducing uncertainties and at developing additional precautionary approaches.
No emission of antibiotic resistance genes
The use of antibiotic resistance genes as markers in GMOs could be a reason for concern. Over the years, many studies and control measures have shown that Novo Nordisk’s production using GMOs harbouring antibiotic resistance marker genes does not contribute to dissemination of antibiotic resistance.
Novo Nordisk treats its waste so as to eliminate living recombinant organisms and functional DNA.
Even so, it has been decided that, whenever technically possible and practically feasible, all new production strains will be developed without genetically engineered antibiotic resistance marker genes as a precautionary approach in response to public concerns.
Novo Nordisk is responsive to public concerns
As the debate on GMOs develops Novo Nordisk will continuously try to respond to the concerns of society through open communication and dialogue and by integrating these concerns into our daily decision-making.
Novo Nordisk has a very limited use of raw materials of GMO-origin
The pharmaceutical products from Novo Nordisk are based on the use of GMO. The raw material used is selected based on the quality specifications and the process demands.
Novo Nordisk is currently monitoring our use of raw material of GM-origin in production, and the use will be limited to raw materials approved by the EU authorities to be produced in or imported to EU.