Human biosamples 

Human biosamples are biological samples such as tissue and blood, donated by patients or healthy individuals. For example, when patients undergo certain procedures, such as a biopsy or surgery, samples are removed for diagnostic or treatment purposes. Many patients give consent for a small amount of the sample to also be used in research.

Human biosamples are powerful tools to study human health and disease. Biosamples are supplied to Novo Nordisk from a range of public, private and not-for-profit organisations globally. The donation and legitimacy-of-use of human biosamples can have an impact on human rights, depending on how these biosamples have been obtained.

The biosample supply chain is often multi-organisational and multi-national. This complexity presents a risk that human rights may not have been respected along the entire supply chain.

Vulnerable groups or individuals, such as low-income groups, economic migrants, asylum seekers, refugees and homeless people, may be exploited and coerced into donating human biosamples. Commercial gain from human biosamples is banned in many countries; however, suppliers sourcing from many countries operate under different rules and regulations. Gaps remain in both international and national criminal law and enforcement relating to human biosamples. 

More information about human biosamples

 

Assessing risks

We identify risks using our human biosample supplier evaluation process. All evaluated and approved suppliers become bound by a contract to adhere to Novo Nordisk’s requirements with regards to human biosamples. Use of suppliers is monitored on a monthly basis. Those that are deemed unacceptable are removed from our approved supplier list and we do not conduct business with them. We encourage these suppliers to make the necessary changes to meet our requirements and, once evidence is received that they have done so, they are placed on our approved supplier list. 

News and media stories relating to ‘human body brokers’ - those who profit from illegitimate harvesting, supply and use of human biosamples - has raised the public’s interest in this topic. We monitor the media so that we are aware of any news stories involving our supply chain or the use of human biosamples in general.

 

Policies and governance

We have developed and implemented a human biosample governance framework in Novo Nordisk which includes:

  • Our Position Statement, which was updated in 2017
  • Global Procedures on Consent to Donation of human biosamples and on the Financial transaction relating to human biosamples
  • A global process for evaluation of suppliers of human biosamples, which was fully implemented in 2017
  • A pilot process for internal review and approval of activities involving human biosamples, which commenced in 2017
 

All documents and processes are supported by guidance and educational materials. In addition, R&D Management is supported by our Research and Development Bioethics Council and the specialist human biosample governance staff in the Global Research Bioethics and Compliance unit.

 

Performance

To further implement our human biosample governance framework described above, in 2017, we launched an internal procedure and an e-Learning course for Novo Nordisk’s research staff around the globe to ensure responsible sourcing of human biosamples. Over 85% of acquisitions of human biosamples by Novo Nordisk’s research staff conformed to the new global procedure.  

We evaluate our suppliers of human biosamples against human rights and other standards and they are given the opportunity to improve their performance. During 2017, we conducted another 15 supplier evaluations, bringing the total number of evaluated suppliers to 39. 29 are now listed as ‘acceptable suppliers’ to Novo Nordisk of human biosamples for use in research. As a result of our engagement, two thirds of our acceptable suppliers have taken actions to improve their performance, such as upgrading their approach to ensuring free and informed consent from donors or improving the working conditions for their staff.  

Additionally, we have an approach that reduces the number of suppliers and/or replaces suppliers with better suppliers. At the end of 2016, 101 usable suppliers existed. Currently, this number has been reduced to 62. 

 

Stakeholder engagement

Internally, we focus on stakeholders predominantly in the Global Research organisation. Communication channels include:

  • Attendance at and presentations to various management teams
  • Presentations to various departments/functions/project meetings
  • Updated information resource on intranet
  • e-newsletter

 

Our stakeholders are able to access up-to-date information regarding our responsible use of human biosamples through information on our website and brochure (available in print or online in English and Danish).

In addition, employees participate in various national and international fora.