HI5015: Legal Aspects of AbbVie Inc. in Australia (T1 2019)

This report analyzes the legal framework affecting AbbVie Inc., a multinational biopharmaceutical company, in Australia. The report examines key legislation, including the Privacy Act 1988, Therapeutic Goods Act 1989, and Poisons and therapeutic goods act 1966, highlighting their impact on AbbVie's operations. It also explores the influence of various treaties, conventions, and agreements such as The Australia-United States Free Trade Agreement, Medicines Australia membership, International Federation of Pharmaceutical Manufacturers & Associations Membership and Ausbiotech, on the company's business practices. The report covers tax provisions, patent laws, and advertising regulations, providing a comprehensive overview of the legal environment in which AbbVie operates in Australia, and the importance of compliance with these laws and regulations.

Legal Aspects of International Trade and Enterprise
HI5015
Student’s Name
5/1/2019

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Executive Summary
Laws are an important part of every organization that affects it working in many ways
because the entity has to keep those laws in mind while performing its operations. The
situation becomes more critical in cases of multi-national companies as the company
has to comply with the laws of two different countries i.e. host country as well home
country. The presented report is developed on AbbVie Inc, which is a US-based
company, operating in Australia and many other nations too. Various laws of Australia
such as Privacy Act 1988, Therapeutic Goods Act 1989, Poisons and therapeutic goods
act 1966 and other rare applicable to the Australian operations of the company. In
addition to these laws, the business of the company also affects by the rules and
regulations that come out of different agreements signed by the government as well as
the company itself. AbbVie Inc signed membership of many organizations such as
Ausbiotech, International Federation of Pharmaceutical Manufacturers & Associations,
and Medicines Australia. Code of conduct and practices of these organizations are
applicableto AbbVie in addition to The Australia-United States Free Trade Agreement,
an international treaty that has ben developed between Australian and US government.

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Contents
Executive Summary...........................................................................................................1
Overview of the company..................................................................................................3
Legal Framework Affecting AbbVie in Australia................................................................3
Treaties, conventions and Agreements Affecting AbbVie in Australia..............................5
References.........................................................................................................................7

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Overview of the company
AbbVie Inc is an American company that has its headquarters in Illinois State of United
State. The company was founded in 2013 (Lerbinger, 2018). The business is a multi-
national company, which has its operations in nearly 70 countries including Australia.
AbbVie Inc is a Biopharmaceutical Company that is engaged in the healthcare industry.
This business is doing well in its operations and this can be evident by the fact that as
on 31 January 2019, the company had around 30000 employees worldwide
(Statista.com, 2019). If to talk about the level of operations of this company in Australia,
this is to state that the same provides employment to more than 300 people in Australia
(Abbvie.com.au, 2019a). Further company has seven places to work in Australia.
Company deals in many of the Pharmaceutical drugs that majorly includes Imbruvica
(ibrutinib), Norvir (ritonavir), Venclexta (venetoclax), Mavyret/Maviret and many others.
Legal Framework Affecting AbbVie in Australia
The company is required to comply with the provisions of United State law as the same
was incorporated there but as the company is a multinational company, it has to comply
with the laws of those countries also in which they are operating their business. In the
following part of various laws and regulations will be discussed which are applicable to
AbbVie Inc while operating in Australia. These laws are related to different subjects.
Privacy Act 1988:- The Company is required to comply with the provisions of this act. As
the name implies this law deal with the matter of privacy. Section 14 of the act is a
significant section, which outlines a number of privacy rights, which are also known as
information privacy principles. AbbVie Inc developed its privacy policy considering
provisions of the subjective privacy act. This policy briefs the manner in which this
company collects information of its customers and business partners in addition to the
manner of use (Abbvie.com.au, 2019b). Further privacy policy of the company also
highlights the incidents where the same can share personal information of its
stakeholders to third parties. This act affects the company as in day-to-day business
Operations Company need to consider the provisions of this law and breach with the
same can attract penalty from the federal government. As the company belongs to the
healthcare industry, the same is more likely to have personal health-related data of
patients and in this manner, Privacy Act 1988 limit the use of such information by the
company.
Therapeutic Goods Act 1989:- As mentioned above, the company is active in the
healthcare industry and therefore healthcare law of Australia is applicable to the same.
Therapeutic Goods Act 1989 is Australian legislation which provides a national system
of controls relating to safety, availability, quality, and efficacy (wherever necessary) of
therapeutic goods which are used in Australia irrespective of place of production. This
act further provides provisions related to labeling, advertising, and product appearance.
In addition to this law, Poisons Standard is also there which provide model provisions
related to labels and containers (Tga.gov.au, 2019). Further decisions related to the

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classification of poisons and drugs are also mentioned under poison standard
schedules.
Poisons and therapeutic goods act 1966:- This legislation is state legislation of
Australia, which is applicable to the companies registered in NSW state of the country.
As the company established its business in NSW state, therefore this act is applicable
to the same. Company has received licensed under this act to supply poisons and
substances. AbbVieis obliged to comply with the provisions of this act while operating in
Australia.
Therapeutic Goods Advertising Code (No.2) 2018:- AbbVieis liable to act according to
the provisions of this act while advertising its therapeutic goods in Australia. In Such a
situation, authority ensures that advertising is conducted in a manner, which supports
informed health care choices. The further act ensures that advertising promotes the
proper use of therapeutic goods by reducing their misuse, underuse. Here this is
necessary to mention that during advertising its products, AbbVie has to follow the rules
and regulations in a mandate manner. Further, certain therapeutic goods are mentioned
under this act where price information is not required to be given in advertising
(Legislation.gov.au, 2018).
Tax provisions:- Company is required to consider tax provisions of the nation. In order
to do companies’ profits from its Australian operations are subject to a 30% tax rate. In
addition to the tax rate, another important aspect is transfer pricing. Australian tax
officers have rules related to transfer pricing. First, this is to state that as per these rules
any company which has operations in other countries as well are required to use arm’s
length methods for such pricing. This can be understood in a way that in cases of
transfer of business assets from one branch to another, another branch should be
treated as a strange/outsider. These laws are applicable to the AbbVie and affect its
business, as the company has to divide its profits under various taxes such as Capital
Gain Tax, Company tax and Goods and Service Tax (Austrade.gov.au, 2019).
Patents Act 1990:- In order to discuss Australian laws applicable to AbbVie Inc., laws
related to intellectual property is also required to have a look upon. In Australia Patents
Act 1990 is there to protect the interest of innocent parties in cases of infringement of
the patent. AbbVie Inc. is involved in many kinds of drug development. In such a
situation, the company is required to apply for the patent of its products. This provides
additional security to the same. The other side of the coin is also required to be a review
that is a liability. By the virtue of this act, AbbVie Inc. can face heavy penalties in those
cases where the same uses patent registered in the name of others without their
consent. Such acts are considered as an infringement of the trademark.
In order to conclude this part of the report, this is to state that all the above-mentioned
laws and regulations are applicable to AbbVie that affect its working in many ways.
Compliance with these laws are necessary and mandatory and not complying with the
same can create many issues to the same such as penalty and fines for the company.
Here this is to state that the above-mentioned laws are not inclusive everything and in

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addition to these laws certain other laws are also there. For instance corporate
governance regulations 2018 and consumer law of Australia. These laws protect the
interest of different stakeholder of the company and regulate the behavior of AbbVie Inc
in Australia.
Treaties, conventions and Agreements Affecting AbbVie in Australia
Above-mentioned part outlined laws of Australia applicable to Abbive Inc. Now, this part
will be focused on those agreements and treaties that apply to the company. These
treaties and agreements affect the working of the company in Australia. This is to inform
that some treaties and agreements have entered into by the government of respective
nations i.e. United States and Australia, and in some of the contracts company, itself
entered into. These treaties and agreements are mentioned hereunder:-
The Australia-United States Free Trade Agreement: - This agreement was developed
between the governments of Australia and the United States as on 18 May 2004
(Moens and Jones, 2013). Further, the same came into effect as on 01 st January 2005.
This agreement influence behavior of US companies operating in Australia and provide
the provisions related to environment, labor, transparency and many other aspects. It
has been reviewed that this agreement has very fewer provisions in favor of US-based
companies. For instance, there is no clear provision in relation to a situation where an
American company faces disputes with Australia. This is just an example but overall
too, the subjective Free trade agreement seems to be more beneficial for Australian
businesses working in the US rather than US businesses working in Australia.
Medicines Australia Membership: - Being a biopharmaceutical company, the same
developed a membership agreement with Medicines Australia. This organization
provides membership to those companies that invent, developed and supply innovative
vaccines and medicines to Australian society. Companies develop a membership
agreement with this organization as the same offers many benefits to them. In addition
to benefits, some liabilities are also there for member companies. The organization has
a mandatory code of conduct, adherence of which is necessary for all the members
(Kilcoyne, Ambery and O'Connor, 2013). Being a member of this organization, the code
is also applicable to AbbVie Inc. The code is known Medicines Australia Code of
Conduct Edition 18 and the same came into effect as on 16th May 2015. This code
influences the operations of the company, as the company has to comply with the same
in a mandatory manner. The code states the manner and other provisions related to the
promotion and advertising of prescription medicines and members, companies need to
consider the same when planning its promotional activities.
International Federation of Pharmaceutical Manufacturers & Associations Membership:-
This association targets and represented research-based pharmaceutical associations
and companies globally and popularly known as IFPMA (Ifpma.org, 2019). In this
manner, it is clear that this is a local organization/association of Australia. Similar to
Medicines Australia, this association also has its code of conduct which applies to all
the member companies. Once a company became a member of this organization, the

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same has to comply with the code of conduct prescribed by this for member companies.
AbbVie Inc is also a member of this organization and is liable to comply with the code of
practice developed by IFPMA.
Ausbiotech:- This is a life science organization. It represents its member companies and
works in the best interest of Australian Life Science industry. The organization has
around 3000 members at present AbbVie is also a member of this organization and is
entitled to receive many benefits such as networking and business promotions. Again,
the organization has its code of conduct for the member, which is applicable to them in
a mandatory manner. This code stipulates the commitment of member companies
towards the industry. AbbVie in its operations is required to consider the provisions set
out under this code. As per one of the requirements of this code, AbbVie is liable to
develop regulatory risk management plans in order to ensure compliance with all the
relatable conditions. Further company has to ensure that the developed and
commercialized by this carries high standards of quality and safety. As this code
consists of many rules and regulations, it is far clear that it affects the working of the
company as not matching with the required/standard criteria can cancel out its
membership and business can face loss.
In addition to the above, many other agreements and treaties are also there affect the
working of the company. For instance, Australia has a membership of many
international organizations such as United Nations, World Trade Organization (WTO),
Organization for Economic Cooperation and Development (OECD) and so. These
organizations put many obligations to their member countries. Businesses are an
important part of every economy and in this manner, a country while setting its targets
considers organizations. Australia signed various treaties with these organizations in
respect to labor, environmental and human rights standard. In order to meet the
standards set out by international organizations, the country put some obligations and
standards on its business that affect working of the same. The business of AbbViealso
affects from these standards.
To conclude this part of the report, this is to state that the national treaties are
mandatory to AbbVieby default but rest of the legal requirements such as compliance
with various codes became applicable because of the membership agreements signed
by this company with different organizations.

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References
Abbvie.com.au. (2019a) Make Possibilities Real. [Online] Available at:
https://www.abbvie.com.au/careers.html?trackingSelection=Yes [Accessed on 01st May
2019].
Abbvie.com.au. (2019b) Privacy Policy. [Online] Available at:
https://www.abbvie.com.au/privacy.html#_when-we-share-your-information [Accessed
on 01st May 2019].
Austrade.gov.au. (2019) Australian business taxes. [Online] Available at:
https://www.austrade.gov.au/International/Invest/Guide-to-investing/Running-a-
business/Understanding-Australian-taxes/Australian-business-taxes [Accessed on 01st
May 2019].
Ifpma.org. (2019) IFPMA in Brief. [Online] Available at: https://www.ifpma.org/
[Accessed on 01st May 2019].
Kilcoyne, A., Ambery, P. and O'Connor, D. (2013) Pharmaceutical Medicine. United
Kingdom: OUP Oxford.
Legislation.gov.au. (2018) Therapeutic Goods Advertising Code (No.2) 2018. [Online]
Available at: https://www.legislation.gov.au/Details/F2018L01524 [Accessed on 01st May
2019].
Lerbinger, O. (2018) Corporate Communication: An International and Management
Perspective. USA: John Wiley & Sons.
Moens, G. and Jones, R. (2013) International Trade and Business Law Review, Volume
10. Oxon: Routledge.
Statista.com. (2019) AbbVie's number of employees between 2013 and 2019* [Online]
Available at: https://www.statista.com/statistics/417023/employees-of-abbvie/ [Accessed
on 01st May 2019].
Tga.gov.au. (2019) The Therapeutic Goods Act 1989 & the Poisons Standard. [Online]
Available at: https://www.tga.gov.au/therapeutic-goods-act-1989-poisons-standard
[Accessed on 01st May 2019].