Global Reporting Initiative

Organisation
The Sustainability Committee has the overall responsibility for the sustainability agenda, is the company’s highest authority with regard to environmental and bioethical issues. The committee works on behalf of Executive Management to ensure that Novo Nordisk’s interests and needs in regards to environmental, bioethical and occupational health and safety issues are met. The committee includes two members of Executive Management: Chief of Staffs (Chair) and the Chief Science Officer.

Policy
The committee is responsible for oversight of strategy, performance and compliance in relation to the - among others – environmental, bioethical and occupational health and safety policies, which refer to the UN Global Compact.

Goals
Novo Nordisk has an environmental strategy for 2012 to 2020 which will set ambitious, company-wide reduction targets. The strategy’s aspiration is to remain at the forefront of the pharmaceutical industry with regards to environmental responsibility, pursuing good practices and excelling in strategic areas. We want to achieve bold climate change targets and increasingly decouple environmental impact from growth.

Monitoring
Novo Nordisk has a number of internal environmental tools and guidelines in place to monitor the environmental impact of the company. One example is the monitoring that happens as part of our environmental management system, ISO 14001. In our Annual Report we report on how the company is performing in terms of our environmental footprint.

For more information about our environmental approach, click here.

Organisation
Labour issues are overseen by the Global People Board, which is responsible for overseeing strategy, performance and compliance in relation to the People Policy and the Health and Safety Policy. Both policies are part of the Novo Nordisk Way. The board’s mandate includes responsibility for:

• Labour relations
• Human rights (employees)
• Diversity and equal opportunities
• Occupational health and safety
• Training and education
• Employment.

The board is chaired by the executive vice president and chief of staffs, and consists of senior People & Organisation (human resources) professionals representing key geographies and functions in the company.Occupational health and safety (OH&S) is also subject to oversight by the Sustainability Committee. See also the environmental management approach disclosure above. 

Policy
The Novo Nordisk Way defines the overarching policy framework, in terms of business conduct, business in general, and specifically in terms of the management of labour issues (including its support for the Universal Declaration of Human Rights).

• The People Policy requires all employees to ensure equal opportunities for all.
• The Novo Nordisk Way also requires that all employees have a development plan that is reviewed annually by the employee and his or her manager.

Goals
Novo Nordisk’s overall labour-related goals are defined in the people priorities, which have been developed based on business needs and challenges throughout Novo Nordisk. At the global level, the primary focus of Novo Nordisk’s human resources management, as defined in our priorities, ensures that key capabilities are built and maintained within the company. These include recruitment; talent development; performance management; reward & mobility; and organisational design. Responsibility for defining and achieving specific performance goals are developed for regions and affiliates in order to ensure the local country context.

By 2011, the OH&S management system based on OHSAS 18001 includes all research and development and production facilities globally and headquarters operations. The plan calls for all Regions to have implemented the OH&S management system by end 2013. In addition, the production facilities including support functions have chosen to obtain an OHSAS 18001 certificate, meaning that Bureau Veritas Certification is conducting external OH&S audits on regular basis.
Furthermore our production sites have framed an ambitious plan to reduce ergonomic strain and to reduce the severity rate of occupational injuries in the coming years. 

Monitoring
Internal OH&S audits are regularly performed in the part of the organisation which has implemented the OH&S management system. The overall performance is generally of a high standard. When non-conformities are identified, preventive and corrective actions as well as other improvements are set in motion.
The OH&S management system is reviewed and the OH&S performance is evaluated on an annual basis by the management. This includes an annual management review of the OH&S management system OHSAS 18001 and an evaluation of the OH&S performance.

Organisation
Human rights issues are overseen by the following bodies within Novo Nordisk:

• General Human rights questions. Responsibility for human rights in general is anchored in the Sustainability Committee. This committee has the overall responsibility for the sustainability agenda in Novo Nordisk and oversees the implementation of the UN Global Compact principles and related commitments.
   
• Human rights issues related to our research and development are handled by the R&D Bioethics Council, which covers all bioethical issues related to human, animal, and environmental ethics. The Council makes recommendations for Sustainability Committee’s approval on bioethical issues, strategies, targets and action plans related to research and development.
   
• Employees’ human rights: responsibility for oversight of these issues is anchored in the Global People Board. See Labour Principle 3-6 for more information on the People Board.
   
• Human rights in the supply chain are overseen by the Procurement Committee.
   
• Human rights in relation to global health issues are the responsibility of the Health Policy Committee, which is mandated by Executive Management to deal with global health policy issues and to coordinate the company’s efforts.

Policy
The Novo Nordisk Way is the foundation of the values-based management system in Novo Nordisk. It explains who we are, where we are going, and what we care about. One priority item in the Novo Nordisk Way is the essential of ‘treating everyone with respect’. This implies that we seek to demonstrate respect in all aspects of our business from consistent global standards for conducting clinical trials to clear non-discrimination guidelines.

Providing a link from Novo Nordisk Way, a set of policies has been defined on how we operate our business. For our external stakeholders, each policy gives information about principles that guide our decisions. They cover 13 key areas that are of relevance to our business. Internally, for our staff, the policies provide high level guidance on basic principles on how we will conduct our business.

Each policy is owned by an internal board or committee, which operates with a mandate from Executive Management. The policies are applied throughout the organisation in operational procedures.

Goals
Beyond our donations to the World Diabetes Foundation, our approach to expanding access builds on the right to health and aligns with the UN Millennium Development Goals (MDG), which offers a common vision for tackling some of the major challenges facing the world by 2015.

Over the next decade, our emphasis will be on areas selected because of their ability to have an impact on current and future generations, with a long-term impact consistent with our role as a sustainable business. Our areas of emphasis support three of the UN Millennium Development Goals.

• treating children with type 1 diabetes
• confronting diabetes in pregnancy
• building partnerships and capacity through donations to support World Diabetes Foundation and differential pricing

For more information on access to health, click here.

Monitoring

• Facilitation (see the section Novo Nordisk Way) is a specific follow-up method that is unique to companies in the Novo Group. It is used to provide systematic and validated documentation of the levels of compliance with all aspects of the Novo Nordisk Way, including the human rights commitment.
   
• Access to health:  Each year Novo Nordisk measures and reports: how many Least Developed Countries purchase insulin sold under the differential pricing policy; how many activities have been conducted; and how many healthcare professionals and people with diabetes have received training.
   
• Our Responsible sourcing programme works to ensure that human rights are systematically integrated into purchasing decisions. All purchasers are trained in human rights and associated ILO Convention requirements that form the basis of the programme’s standards. How well the standards are met is assessed through audits, with a focus on suppliers in countries with known challenges in working conditions. Human rights included in the Responsible Sourcing programme concern: wages and benefits, working hours, health & safety, child labour, forced labour, discrimination, disciplinary measures, and privacy.
  

Organisation

• The Business Ethics Board is the formal body for driving the preparation of the Business Ethics Policy and procedures as well as outlining the implementation programme. It is a cross-functional group with representatives from across the business, chaired by the executive vice president and chief of staffs. The committee addresses business ethics in the context of all aspects of the business, including R&D, production, sales and marketing, sourcing and public policy engagement.
   
• A Business Ethics Compliance office in Headquarters supports and monitors the company’s Business Ethics Policy and procedures and manages training covering anticorruption, conflicts of interest, promotion of pharmaceutical products, and interaction with healthcare professionals, suppliers and intermediaries.
   
• The External Relations Board coordinates and aligns global public policy engagement activities in terms of strategic direction and ethical conduct.
   
• The Sustainability Committee, which is responsible for the sustainability agenda, aims to secure implementation and development of Novo Nordisk’s sustainability strategy.

Policy
Our Business Ethics Policy sets direction and states that bribery and corruption are unacceptable. It also commits Novo Nordisk to adhere to the principles of the UN Convention against Corruption. It is backed by four procedures for ethical business conduct.

Goals
The Business Ethics Compliance Programme is anchored in the Balanced Scorecard, against which individual managers’ performance is measured. Goals focus on training, implementation of and adherence to procedures.

Monitoring
It is important for Novo Nordisk to have mechanisms in place that enables the organisation to promptly detect problems and undertake corrective actions. The internal audit function plays a critical role in assessing adherence to the company’s business ethics policy. We conduct specific business ethics audits, which include on-site visits, during which our auditors interview local management and employees to assess knowledge of our business ethics procedures and how effectively those procedures are being implemented. Business ethics audits are conducted by a group of specialists with deep understanding of business ethics.

Organisation
Pharmacovigilance is the science and activities relating to detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. At Novo Nordisk, the chief responsibility for pharmacovigilance within the company is undertaken by International Product Safety (IPS), whose responsibilities include involvement in any emerging drug safety-related concern; provision to authorities of safety information; and review of safety reports, new safety information and complaints.

The vice president of IPS reports to the senior vice president of Quality. IPS is organised according to three key processes:

• Customer complaint handling
• Safety case handling
• Safety surveillance.

In order to be in compliance with procedures for handling adverse events and safety information, Novo Nordisk has several Safety Committees that review safety of specific products. In order to protect the safety of clinical trial participants, Novo Nordisk may initiate external independent Data Monitoring Committees.

The global regulatory affairs function obtains and maintains the market authorisations for all products and is responsible for all product labelling.

See also our position on counterfeit medicines

Goals
Ensuring patient safety is one of the most important commitments a pharmaceutical company makes in the delivery of its products and devices. It is also an aspect of company activities which is highly regulated. Novo Nordisk has long had policies and processes and a comprehensive Quality system in place to minimise any safety risks connected with the use of its products and devices. The Quality Mindset is part of the Novo Nordisk Way as Essential 10 states: “We never compromise on quality and business ethics.”

Policy
Novo Nordisk has long had policies and processes and a comprehensive Quality system in place to minimise any safety risks connected with the use of the company’s products and devices. It is our policy to take early contact with authorities and to be proactive in addressing any safety issues that arise. We strive to be open and transparent in our communication about the safety of our products. In adhering to high standards in both the manufacturing of products and their safe use by patients, Novo Nordisk is overall in high compliance with regulatory demands, as reflected by the outcomes of recent inspections.
Novo Nordisk subscribes to the WHO Ethical Criteria for Medicinal Drug Promotion. Furthermore, the company’s policies and procedures are in accordance with the principles of industry codes of practices, such as the PhRMA, EFPIA, IFPMA, JPMA marketing codes. Novo Nordisk does not have specific policies regarding consumer privacy.

Monitoring
Novo Nordisk has procedures, systems and processes in place to ensure that safety information on all serious adverse events is entered into a global Novo Nordisk safety database. This activity comes under the broad heading of pharmacovigilance.

This work is supported by hundreds of people throughout the Novo Nordisk organisation. Subsidiaries in the local markets are required to report serious adverse events within 48 hours and non-serious adverse events on a weekly basis, unless otherwise agreed.

See also Safety and quality for more reported data.

Organisation
Socioeconomic dimensions of performance are managed as part of the agendas in several boards and committees, including Health Policy Committee, Sustainability Committee, External Relations Board and Global Finance Board. The committees have representation from Executive Management, corporate and regional senior management.

Policy
Novo Nordisk strives to conduct its activities in a financially, environmentally and socially responsible way. This commitment is made in the company’s Articles of Association and in the Novo Nordisk Way. For us, being economically viable mean managing the business in a way that ensures corporate profitability and growth, while seeking to make a positive economic imprint in the community.

Goals
We constantly strive to achieve competitive business results so that we can build a sustainable business. Strong business growth combined with productivity improvements in manufacturing, administration and corporate functions has in recent years enabled Novo Nordisk to increase investments in research and development as well as strengthening our presence in the marketplace to be well-positioned for continued, sustainable growth.

A vital part of our socioeconomic work addresses the economic implications of the diabetes pandemic in developed and developing countries. The disease hits doubly by impeding people’s productive abilities as well as being costly to treat and to provide care for. We believe that investing in health can free up resources for other social development purposes. This is particularly relevant for diabetes, where many studies - including several conducted by Novo Nordisk - show that the cost of not treating diabetes is much greater than the cost of proper treatment. With healthcare spending rising faster than GDP in many countries, governments are looking for ways to reduce direct healthcare costs. Socioeconomic calculations provide evidence that investing in proper disease management reduces costs to both individuals and society due to fewer complications, higher productivity and increased quality of life.
For more detailed information on Novo Nordisk’s economic performance in 2011, see the section Socioeconomics.

Monitoring
Novo Nordisk continually monitors its financial performance, and reports this on a quarterly basis.
Looking beyond direct economic impact, we are working with many policymakers and other influential stakeholders to advocate a more sustainable approach to tackling the diabetes pandemic. This means an increased focus on preventative measures, better education, earlier diagnosis and earlier, more effective treatment to delay the onset of complications.

The Changing Diabetes Barometer is an initiative that identifies best practices for the prevention and management of diabetes. The Barometer provides a set of quality indicators defined by international guidelines including targets for blood glucose, blood pressure, weight control and lipids. It also measures quality of life experienced by patients and direct and indirect healthcare expenditures. By creating more transparency, it is the aim to give policy-makers and healthcare providers the best possible basis for making informed decisions about improving health outcomes while bringing down total costs.

See the section Support and advocacy.

The need for an effective risk management system is essential in the pharmaceutical industry as it faces increasing challenges due to the global economic outlook, affecting the industry’s ability to finance innovation of new therapeutic medicines. 
Novo Nordisk has developed a dynamic approach to risk management to ensure that key risks are effectively identified, assessed and managed so they will not affect the company's ability to achieve our business objectives.

We define risk in continuation of our business goals: Risks are events and developments that could reduce our ability to meet our overall objectives.
This definition of risk includes:

• financial and non-financial risks
• risks at all points in the value chain-from discovery and development through to sales and marketing
• not just risks to short-term financial objectives but also impacts on reputation, sustainability and of course people.

The assessment of risks has a time frame spanning three years ahead from the present date. Long term risks (ten years) are assessed once annually as part of the strategic planning process.

See the current list of risks in the Annual Report.

Risk management set-up
Executive Management has established a dedicated Risk Management Board of senior executives representing all key business activities and selected support functions. Chaired by the chief financial officer, it reports to Executive Management and the Board of Directors. The Risk Management Board meets at least four times a year.

It sets the strategic direction and challenges for risk management, and analyses the risk and control information generated by the individual business areas. This process helps to reduce blind spots and consider potential cross-functional impacts. In quarterly reports to Executive Management and the Board of Directors, risks are assessed and quantified in terms of potential financial impact and reputational damage. For each risk the potential impact is specified, as are mitigating actions.

The Risk Office is the secretariat of the Risk Management Board. It drives and consolidates risk reporting from discovery and development, through manufacturing and logistics, to marketing and sales. In addition, risks related to support functions such as regulatory, business development, finance, legal & IT and people & organisation are included. This is done in consultation with relevant Novo Nordisk committees, boards and management groups.

* Corresponding principle in United Nation Global Compact

* Corresponding principle in United Nation Global Compact

* Corresponding principle in United Nation Global Compact

* Corresponding principle in United Nation Global Compact

* Corresponding principle in United Nation Global Compact

* Corresponding principle in United Nation Global Compact