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Hi5015-Legal Frameworks Applicable To Novo Assessment Answer



Novo Nordisk is the global healthcare corporation that operates its business in the pharmaceutical industry. The company has its headquarter based in Denmark. For over 95 years, the company has achieved leadership in diabetic care.  As per the recent data, it has employed almost 43100 people in 79 nations. It markets its pharmaceutical products in approximately 170 countries. Around 40% of the total staff of the company is hired for Denmark office and rest 60% of the staff hired in the rest of the world (IBIS World, 2017). The main products and services that the company is dealing in are: Diabetes Care medication as well as devices, Haemophilia & Bleeding Disorders, Obesity and Weight Management, Hormone Replacement Therapy and Growth Hormone Therapy. The company researches and develops a wide range of healthcare products that are unique designed to assist a broad gamut of health issues. The company was formed with the merger of two small sized Danish corporations called Novo and Nordisk (Novo Nordisk, 2018).

Novo Nordisk Australia

The company operates its business in Australia through its wholly owned subsidiary corporation Novo Nordisk Pharmaceuticals Pty. Limited. The subsidiary company’s headquarter is located in Sydney (Bloomberg, 2018). It was established in the year 1985 and is currently engaged in the business of marketing as well as distribution of the healthcare products and services that are designed and developed by its holding company Novo Nordisk A/S. Also, the company has a clinical trial development centre for the purpose of conducting trials for the new products. Currently, the company employees around 100 staff members in Australia (Pharma Boardroom, 2018).

Legal and Regulatory Frameworks applicable to Australian Subsidiary of Novo Nordisk

There are various acts and regulatory frameworks that are applicable on the companies that are operating their business in the pharmaceutical industry in Australia. The major piece of legislation that governs the pharmaceutical companies in Australia is named as Therapeutic Goods Act 1989. This act is in force to maintain the quality, safety, efficiency as well as timely provision of medical drugs and devices in the country. The framework is set up as the national control system for the medication products. The act is further supported by Therapeutic Goods Regulations as well as other state or territory legislation. Furthermore, there are two primary codes that govern the production and advertisement of medication products and services in Australia. Therapeutic Goods Advertising Code (TGAC) and the Australian Code of Manufacturing Practice for Therapeutic Goods (Australian Government, 2018). All the entities that are engaged in the business of medicine preparations in Australia are required to hold a certified license relevant to this particular field. Before any type of medication drug is marketed in Australia, it has to undergo an evaluation test by Therapeutic Goods Administration (TGA). The evaluation program of TGA covers both pre-market regulation processes as well as post market regulation processes (Wong, 2001). 

Further, the company has to adhere to the framework of corporate governance as per the requirements of Corporations Act, 2001. As the company has its headquarter based in Sydney, it has to comply with all the relevant rules and legislations that are applicable to the Australian entities (Novo Nordisk, 2018). As a part of corporate governance practices the company has to undertake various initiatives such as corporate social responsibility, sustainable reporting etc. (Schwartz, 2017) The company is committed to follow the triple bottom line principles in order to ensure that its business is conducted such a way that it is able to maintain the balance between its financial, social as well as environmental considerations. To adhere to these principles in the strict sense, the company has incorporated these principles in its Articles of Associations. Further, the company has to fulfil its commitments towards the Guiding Principles on Business and the Human rights as developed by United Nationals. These principles are given in the Protect, Respect and Remedy Framework of the country. Furthermore, the company along with its holding company is duly complying with the principles of UN global compact which is an initiative towards aligning business goals, policies and strategies with the main social and environmental principles such as human rights, labour protection, environmental safety, anti-corruption etc. Moreover, the company has to comply with the regulatory framework of integrated reporting. The said framework is developed by International Integrated Reporting Council (IIRC). It is intended to improve the quality of information provided by the company in addition to the financial information to the external parties who are concerned or associated with the company in direct or indirect capacity. Also, as a part of regulatory compliance, Novo Nordisk is fully committed to comply with the requirements of EFPIA Disclosure Code, 2018 (Novo Nordisk, 2018).

Further in the areas of data protection and security, the company is enforced by various binding laws. One of the major laws that is applicable to Novo Nordisk is the Data Protection Law. As Novo Nordisk operates as a pharmaceutical corporation which is indulged in the development, production and selling of healthcare products in the global market, it collects a wide range of personal data of its employees, contractors and other business parties which is subjected to the protection (Faunce, Bai & Nguyen, 2010). The binding corporate laws and rules form the basis of its compliance program in relation to data protection. The company is firmly committed to comply with all the applicable legislative rules and laws in order to maintain the high of degree and integrity of personal data. The said law does not permit the company to transfer any kind of personal data related to the parties associated with it, in any capacity, from outside Europe (Novo Nordisk, 2018). 

Last but not the least, the company has also entered into an advance price agreement with different nations and  is in process of entering into APAs with more countries to which it deals as a part of its pharmaceutical business. Novo Nordisk’s Tax policy is aimed at meeting its tax obligations in the responsible way. It has set out all the well-established subsidiaries shall comply with their tax obligations as per the tax laws of the countries in which they are operating. As a result of this, the company is under the obligation of paying income taxes at the rate of 30% for all the incomes generated by the Australian subsidiary of the company (Annual Report, 2017).

How compliance with these regulatory frameworks affects the company?

The compliance with all the above regulatory frameworks is mandatory for Novo Nordisk to sustain in the industry. These frameworks cover the provisions of non-compliance or breach of any rules and regulations. Therefore, in order to avoid the legal or regulatory interventions, the company is stringently committed to the due compliance with all the relevant laws and regulations applicable on it. Apart from legal consequences, another reason that encourages the company to work in accordance with all such rules as are applicable on it, is that these provisions are allowing the company to maintain the leading position in the entire industry as well as in the global market. The sustainability position of the company is also improved with the compliance with the corporate social responsibilities under corporation acts, 2001. Along with that, the compliance with all the laws and regulations enables Novo Nordisk to maintain a sound public image of its business in the market. 

Treaties, conventions or agreements that have impacted on the products or services of company

In order to protect the health of the consumers of products of Novo Nordisk and to safeguard the ecosystem from harmful chemicals, the company has started producing only those products or drugs that are environmental friendly in nature after the severe criticism from its stakeholders. The environmental regulators alleged that the enzymes that were developed by the company could cause severe skin allergies. It was alleged that the production and development processes of Novo Nordisk generates heavy dust that affects the health of different constituents of ecosystem. In response to all the allegations, the company started taking initiatives to improve the quality of its products as well as its production processes. As a result of this, the employees along with the managerial persons of Novo Nordisk participated to United Nations Conference on Environment and Development (UNCED) Earth Summit which was held in Rio de Janeiro. After attending the summit, it was realised by the company that environmental protection is quite important. Consequently, the company reinforced its commitment towards sustainable development. The company started to get its environmental report published which contained the necessary information regarding the resources consumed, quantum of emissions made in environment due its production processes. The environmental reports were followed by the integrated reports publishing by the company which contained sustainability report of the business along with the annual financial report (Novo Nordisk, 2017). The sustainability reporting has now become the most significant part of company’s corporate culture. To achieve sound sustainability reporting, the company has also accepted the Triple Bottom Line Philosophy so as to maximise the stakeholder’s value. Novo Nordisk has also supported the United Nations Convention on Biological Diversity in order to enhance its focus on sustainability. Also on the social front, company has agreed to value the socially integrated factors like human rights, environmental protection, labour protection etc. It had initiated the patient assistance program under which it provided medical assistance to the ones who did not have any medical insurance or medical assistance facility available from government. Novo Nordisk was the member of consortium formed for the purpose of allowance for the production of copies of the patented medicines in the situations of national emergencies. This agreement is recognised with the name of Trade Related Aspects of Intellectual Property Rights (TRIPS). However, the activists imposed heavy criticism for such production against patented rights. The company, thereafter, adopted a new pricing policy which was named as sustainable pricing. Under this policy the insulin was supplied at the price which was 20% of the original average price, to the poorest nations. 

This allowed the cross subsidizing of company’s product. Further, the company became the signatory of UN Global Impact which was the platform created with the motive of promotion of sound corporate principles and learning (Harvey et. al., 2008). The aim of this initiative was to combat diabetes pandemic. In 2004, company’s management practices were certified to ISO standards. In year 2005, Novo made an initiative to launch its ‘Changing Diabetes’ platform for its brands. After huge preparation and assessment processes, Novo Nordisk entered into one more agreement in year 2006 with the World Wildlife Fund for Nature (WWF). This agreement allowed the company to become the 10th member of Program of Climate Savers. The participating corporations of the said program were supposed to cutback the emission of carbon dioxide gases in open environment through their operations. As a result of which, Novo had set the aim of reducing the emission of CO2 by absolute 10% by the end of 2014. It has shifted to the renewable sources of production. Moreover, the company had also made an investment of $ 20 million to initiate a campaign called global energy efficiency campaign. The agreement that was entered by Novo with WWF required it to not put reliance on the carbon offsets or buying of power from the current renewable resources. In order to achieve the set benchmark in regards to CO2 emission the company had to join hands with the giant most energy company of Denmark viz. DONG Energy. Novo pledged to deploy the money savings that were achieved through the energy saving measures, in acquisition of green energy which was produced by DONG Energy. With all these initiatives, the company evolved as the leading insulin producer across the globe with around 50% of the market share. The company was also recognised as the world’s most sustainable country by one of the famous business magazines viz. corporate knights (Rao & Purkayastha, 2017).

Impact of such agreements on the products and services of Novo Nordisk:

The agreements have allowed the company to improve the quality of its products and services by adoption of such production processes that promotes the pollution free environment. The medical products of the company were therefore recognised as safe and harmless to the health of the consumers. These factors ultimately enhanced the overall demand of Novo’s products and services in market and therefore it achieved the competitive advantage over its rival firms.


Australian Government, 2018. How therapeutic goods are regulated in Australia. Available from: Accessed on 30.08.2018.

Bloomberg, 2018. Company Overview of Novo Nordisk Pharmaceuticals Pty. Limited. Available at: Accessed on 30.08.2018.

Faunce, T., Bai, J. and Nguyen, D., 2010. Impact of the Australia—US free trade agreement on Australian medicines regulation and prices. Journal of Generic Medicines, 7(1), pp.18-29.

Harvey, K.J., Korczak, V.S., Marron, L.J. and Newgreen, D.B., 2008. Commercialism, choice and consumer protection: regulation of complementary medicines in Australia. Medical Journal of Australia, 188(1), p.21.

IBIS World, 2017. Novo Nordisk Pharmaceuticals Pty Limited - Profile Company Report Australia. Available from: Accessed on 30.08.2018.Novo Nordisk, 2017. Annual Report. Available from: Accessed on 30.08.2018.

Novo Nordisk, 2018. Corporate Governance.  Available from: Accessed on 30.08.2018.

Novo Nordisk, 2018. Personal Data Protection.  Available from: Accessed on 30.08.2018.

Novo Nordisk, 2018. Transparency Disclosures.  Available from: Accessed on 30.08.2018.

Novo Nordisk, 2018. Who we are? Available from: Accessed on 30.08.2018.Pharma Boardroom, 2018. Novo Nordisk – Australia. Available at: Accessed on 30.08.2018.Rao, A.S. and Purkayastha, D., 2017. Embedding sustainability at Novo Nordisk: the compassion vs. competitiveness dilemma. In Case Studies in Sustainability Management (pp. 22-45). Routledge.

Schwartz, M.S., 2017. Corporate social responsibility. Routledge: Germany.

Wong, E., 2001. Regulation of Medicines in Australia. Available from: Accessed on 30.08.2018.


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