A key part of our business is marketing pharmaceutical products to doctors, hospitals and governments. Maintaining and building trust is key to sustaining our license to operate and innovate. This in turn requires that we operate ethically and with transparency in all aspects of our business, from conducting clinical trials to interactions with health care providers, patient organisations and other stakeholders.
An important part of business ethics relates to marketing practices. Novo Nordisk has procedures that guide how employees should interact with healthcare professionals.
All managers within sales and marketing must undergo e-learning on promotional activities. All employees have access to the e-learning from their workstations. The programme, offered in eight languages, is linked to the company's Balanced Scorecard, a strategic planning and management system.
We have a global procedure that ensures in-house legal counsel, regulatory expert reviews and approves marketing materials and activities. The review of promotional materials is documented in an electronic review system. The procedure, laying down the company's minimum requirements, also involves a secondtier review at the affiliate level to ensure compliance with local regulations in the market where materials will be used.
Off-label promotion is the practice of promoting drugs for a purpose outside the scope of the drug's approved label. This is illegal. If physicians judge it to be safe and effective they are allowed to prescribe approved medicines to treat conditions other that those approved. Novo Nordisk only promotes a use of our products for the therapeutic situation for which it is approved by the authorities in the countries we operate in.
Our core business is to help people, seeking to reduce suffering and improve health. Our commitment to patients is paramount. Engaging with patients and understanding their needs is an important part of how we work. However, it is the responsibility of local management to ensure that Novo Nordisk direct-toconsumer communication provides accurate, accessible and useful health information to patients. In countries where direct to consumer marketing is allowed, employees have to be trained according to local requirements.
Novo Nordisk may only engage in direct-to-consumer promotion in countries where this approach is legal. We only have a small direct-to-consumer marketing budget in the US and in International Operations, which is countries outside US, Europe and Japan/Oceania. In the remaining part of the organisation, Novo Nordisk is not permitted to do direct-to-consumer marketing by law, as Novo Nordisk's product portfolio is comprised of prescription products only.
Gifts and entertainment to healthcare professionals
The limit value and nature of gifts and entertainment to healthcare professionals (HCPs) must comply with the standard operating procedure or any applicable local laws and policies.
The guidelines include the following interaction with HCPs:
- social activities and entertainment: Stand-alone entertainment or social activities must not be provided to HCPs
- promotional aids and items of medical utility: Employees may provide or offer promotional aids or reminder items (gimmicks) and items of medical utility to HCPs and administrative staff in accordance with local laws and policies.
If permissible under local policy, any gimmicks must be of minimal value and relevant to the healthcare practice.
- Items of medical utility: Items of medical utility should be of modest value (in accordance with local policy), given only on an occasional basis, and beneficial to the provision of medical services and for patient care.
- Personal gifts: Employees are prohibited from giving, offering or promising to give gifts for the personal benefit of healthcare professionals (including, but not limited to, music CDs, DVDs, sporting or entertainment tickets, electronic items). Payments in cash or cash equivalents may not be offered to HCPs either directly or indirectly, except as compensation for bona fide consulting services.
- Cultural courtesy gifts: In some countries, if allowed under local law and in accordance with local policy, you may give an inexpensive gift not related to the practice of medicine on an infrequent basis to HCPs in acknowledgment of significant national, cultural or religious holidays.
The limit value for gifts vary from country to country taking into account local conditions and circumstance. In the US, gifts can be accepted up to a value of USD 86 per supplier/partner per year, while in Denmark the limit is DKK 500 per year.
Facilitation payments are minor payments made to a private or public official for the purpose of expediting or facilitating the performance by the official of a routine action. Novo Nordisk does not allow facilitation payments, no matter how small.
As an integrated part of the business ethics procedure, all relevant employees go through mandatory training on this and other ethics issues.
Pre-clinical and clinical research
Pre-clinical activities are entered into or conducted for scientific and development purposes, while clinical trials of medical products are performed for scientific and product development purposes in accordance with Novo Nordisk policies and procedures and local and international laws and regulations.
All payments to HCPs in relation to such activities must be within the Fair Market Value of the services provided, and may include re-imbursement only for reasonable expenses.
Phase IV trials and non-interventional studies
Phase IV trials and non-interventional studies must have a scientific or medical purpose and must never be used as a financial incentive or constitute an inducement to prescribe Novo Nordisk's products. There should always be a written study plan or a protocol which specifies the primary end points of the study.
Healthcare professionals participating in Phase IV trials or noninterventional studies may receive a fee for their services that are commensurate with the Fair Market Value for the services provided and may include re-imbursement for reasonable expenses.
For more information on our business ethics standards, training and reporting of misconduct see our business ethics page.