Product stewardship
Product stewardship is a product-centred approach to environmental protection. It encourages companies to adopt life-cycle thinking and requires all stakeholders – from manufacturers to distributors and consumers – to reduce the environmental impact of products. Reducing the environmental impact of Novo Nordisk’s products can be done in a multitude of ways, such as reducing use of toxic substances, designing for reuse and recyclability, and creating take-back programmes for products.
Increasingly, there is a trend to close the loop on the product life cycle by placing responsibility for safe and environmentally sound disposal of products on the manufacturers. Governments are introducing legislation to ensure environmentally sound disposal of products at the end of their life by making producers responsible for the products following use and disposal.
For Novo Nordisk product stewardship comprises the active pharmaceutical ingredients (API) in the products as well as the administration devices and packaging.
Pharmaceuticals
Pharmaceuticals in the environment are an issue which is especially relevant for Novo Nordisk's oestrogen-related hormone products (HRT). When pharmaceuticals are administered to patients, some of the active pharmaceutical ingredients (API) may not be completely metabolised in the body. The non-metabolised pharmaceuticals are excreted through the urine and to minor extent via the faeces and released into the sewage system and usually transported to a waste water treatment plant that remove most of the pharmaceutical residues from the water phase. However, extremely low concentrations of pharmaceuticals may pass through the waste water treatment plant and be discharged to a water recipient. Despite low concentrations in the purified waste water, effects have been observed for highly potent pharmaceuticals like oestrogens on aquatic organisms e.g. by causing feminisation of fish.
Novo Nordisk acknowledges that HRT products have unwanted side effects in nature and has as a responsible company prepared an issue management plan comprising the following activities, which are completed by 2004:
- Perform ecotoxicological effect studies on oestrogens (17β-estradiol and its primary metabolite estrone) to provide the ecotoxicological data necessary for environmental risk assessment of Novo Nordisk’s HRT products according to OECD guidelines.
- Share our knowledge about ecotoxicological properties of oestrogens with environmental authorities and other interested stakeholders.
- Prepare a binder with facts about environmental impacts of HRT products for marketing purpose.
- Environmental audit of the production facilities of our suppliers of oestrogens.
The ecotoxicological effect studies on oestrogens, which are performed by the Danish research institute “DHI, Institute for water and environment”, were finalized in 2003 and include the following studies:
- Growth inhibition test on the alga Pseudokirchneriella subcapitata
- Life cycle test on the crustacean Acartia tonsa
- Early life stage test on Zebra fish
- Nitrification inhibition test with activated sludge
- Reproduction test on the earth worm Enchytraeus albidus
- Biodegradation tests comprising closed bottle test and activated sludge test
For more information please contact Novo Nordisk’s corporate environmental department, External Environment.
EnviroProcess
Producing pharmaceuticals will always impact the environment. To ensure environmental focus at an early stage of the developing process, a focus group called “EnviroProcess” under the Environment & Bioethics Committee is working with environmental assessments in R&D.
The tools for environmental assessments consist of a checklist, an environmental profile and a prioritized action plan. The tools focus on the use of energy, water and chemicals as well as waste and other emissions. The environmental assessments will be integrated in the development processes in R&D.
In addition to the environmental assessments in the developing projects, a part of R&D - called CMC API Production - is implementing Environmental Management according to ISO 14001 and will be certified in 2008.
Devices and packaging
Another issue relating to product stewardship is the safe and environmentally sound disposal of pre-filled devices used for injection of e.g. insulin and growth hormone. Novo Nordisk’s diabetes strategy focuses on upgrading patients from human insulin to modern insulins and to pre-filled devices such as FlexPen®. As a responsible company, it is important to develop strategies to ensure safe and environmentally sound disposal of these pre-filled devices.
The Device Green Team
The Device Green Team was established as a competence group in 2004 as a result of a workshop on innovation. The group has participants from ongoing projects and from Regulatory Affairs, Packaging & Devices, and Device Materials & Characterization. The Device Green Team has a mandate and objectives to look at legislation, materials, electronics and processes.
Since its inception, the Device Green Team has developed four tools:
- Tools 1 and 2 contain environmental information for a large number of polymer materials used in the device industry. It includes for example information on the energy content, the emission of gases (CO2, NOx/SOx) and other relevant information.
- Tool 3 includes MECO analysis (Material, Energy, Chemicals and Other issues) for the same materials. This tool is useful for identifying the environmental ‘hot spots’.
- Tool 4 is a template developed for use as a frame for environmental documentation in a development project from idea phase to pilot production. It has been used with success in development projects.
In order to facilitate considerations for reducing environmental impacts in projects, the Device and Packaging Development Manual has been updated with respect to environmental issues.
In 2007 assistance was given to four development projects and one launched product. The Device Green Team has taken part in the project on implementation of the REACH regulation (Registration, Evaluation, Authorisation of Chemicals) in Novo Nordisk.
This page has been reviewed by PricewaterhouseCoopers as part of its assurance of Novo Nordisk’s non-financial reporting. Please refer to Audit and assurance for a full description of the conclusions and the nature of assurance offered.
