Legal Frameworks Applicable to Novo Nordisk

Running Head: Legal Aspect of International Businesses
Legal Frameworks Applicable to Novo Nordisk

Legal Aspect of International Businesses 1
Introduction:
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

Legal Aspect of International Businesses 2
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