Legal Aspects of International Trade Enterprise

Legal Aspects of
International Trade and
Enterprise
Running Head: AbbVie Inc 0
Student’s Name

AbbVie Inc 1
Executive Summary
Every business operates in a legal environment where different legislations and rules apply to
the same. The objective of this report is to develop an understanding of the legal framework
applicable to one of the companies of the USA named "AbbVie Inc". This is a multinational
company with a good number of employees and customers and laws of host county as well
as home country apply to the same. On the Australia operations of the company, different
laws of this nation become applicable which includes "Poisons and therapeutic goods act
1966", "The Therapeutic Goods Act 1989 & the Poisons Standard". "Tax and transfer pricing
laws", "Corporations Act 2001 (Cth)" and others. Further, apart from these domestic laws,
some other treaties, conventions, and agreements are also there which affect the selected
MNC. Such agreements include Membership Agreement with AusBiotech, Medicines
Australia, "The Australia-United States Free Trade Agreement", and others.

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Contents
Company Overview...........................................................................................................1
Legislative regulatory Framework......................................................................................2
"The Therapeutic Goods Act 1989 & the Poisons Standard"........................................2
“Poisons and therapeutic goods act 1966”....................................................................2
Privacy Act 1988.............................................................................................................2
Corporations Act 2001 (Cth)...........................................................................................3
Tax and transfer pricing laws.........................................................................................3
Treaties and conventions...................................................................................................3
The Australia-United States Free Trade Agreement......................................................3
Membership Agreement with AusBiotech......................................................................4
Membership Agreement with Medicines Australia.........................................................4
MOU between EPA and DAWR.....................................................................................4
References.........................................................................................................................6

AbbVie Inc 3
Company Overview
AbbVie Inc is a multinational company, which originally belongs to the United States and now
operating in around 70 countries that also include Australia. Headquarter of the company is
situated in North Chicago, USA (Wartofsky and Nostrand, 2016). The company is a
Biopharmaceutical Company and makes the life of people better by solving serious health
issues. As per figures presented by Forbes recently, the company employs nearly 30000
employees (Forbes.com, 2019). Out of these 30000 employees, 300 employees are getting
employment in Australia. As per the data available on the official website of the company, the
company serves its products in more than 175 countries (Abbvie.com, 2019). Every year 30
million and more people consume products of AbbVie to resolve their health-related issues. At
the global level, nearly 9000 employees of AbbVie are working in the area of research and
development to make a difference.
Legislative regulatory Framework
As mentioned above, the company originally belongs to the USA but operates in many other
countries. In such a way, laws of different nations also apply to the company in respect to the
operations of that nation. While working in Australia, AbbVie has to comply with a series of
Australia laws and legislations, which are mentioned as follow:-
"The Therapeutic Goods Act 1989 & the Poisons Standard"
This is a national act, which provides a "national system of control" in relation to safety,
quality and other aspects related to the use of therapeutic good in Australia irrespective of the
place of production. The act provides a classification of poisons and goods, which are,
mentioned in the poison's standards. These standards include provisions related to
containers and labels. Further, in addition to this, the act provides a framework that ensures
the adoption of a uniform approach regarding accessibility and availability as well as safe
handling of poisons in Australia. The provisions of the act are also applicable to the AbbVie
and affect its working, as the same has to plan the activities as per the standard approach.
“Poisons and Therapeutic Goods Act 1966”
This is the primary legislation for the companies working in the healthcare industry in New
South Wales State of the county. The act mainly regulates the supply and use of the
restricted substance, some dangerous drugs, and few therapeutic goods (Hattingh, Low, and
Forrester, 2013). The main motive of the act is to protect the health of NSW community
members. AbbVie has its operations in the subjective state and therefore has license under
the same. To check the manner in which the act affects operations of the company this is to
state that the company cannot use and supply those products, which are restricted under the
act, and has to act according to terms of license provided to the same under the act.
Privacy Act 1988
This is another important piece of legislation in Australia that needs to comply with by every
company operating in this country. The main objective of the act is to provide safeguards to
the personal information of patients and other stakeholders collected in the due course of
business. It is a federal level act that outlines the manner in which a business should handle
the personal information of others. The act applies to the AbbVie and also affect its working

AbbVie Inc 4
style because while collecting and keeping personal data of others, the company has to do it
according to the provisions of this act. The privacy policy developed and adopted by the
company reflects that the company is complying with the same. In addition, to name, address,
and contact number, the company has access to health-related information of people and in
this manner, it becomes more important to consider this act and to behave responsibly.
Corporations Act 2001 (Cth)
In Australia, the company is running its business under the structure of an Australian private
company named "AbbVie Pty Ltd" which is registered under the Corporations Act 2001
(creditorwatch.com.au, 2019). In this manner, the provisions of these corporations act apply
to the Australian operations of AbbVie Inc and affect the same. This act prescribes the
manner in which the affairs of an Australian company should be managed and regulates. It
also outlines the duties of directors, officers, and employees of Australian companies in
addition to the annual and other compliances of the same. The operations of AbbVie in
Australia are required to be conducted as per the provisions of these acts. The company has
to submit the accounts and other disclosures to the relevant authority as well as Australian
directors require behaving accordingly.
Tax and transfer pricing laws
Tax is an important element for the financials of every business that affects the overall
profitability of a business. Every company needs to pay a certain amount of its profits to the
government of that nation in the form of tax. The corporation tax rate in Australia is 30%
(taxsummaries.pwc.com, 2019). Further, every company working in Australia also has to deal
with the provisions related to transfer pricing while supplying the products to the other branch
of the same working in other countries. Here multi-national companies have to ensure that
they are dealing with arm's length price and are treating their other branches as a third party.
These rules and laws are very significant which affects the dealings of AbbVie as they have to
take care of the market prices, values, and tax rates while managing their financials and
profits during a particular period.
The above-mentioned rules apply to all the domestic companies of Australia and also to
AbbVie since it is operating in this nation.
Treaties and conventions
In addition to the above laws, some treaties and contracts are there which also affect the
company's working. Australia has signed some agreements with the government of the USA
that affect the working of MNCs of these two countries. Further Australia has also signed
some international treaties that need to be taken care of by businesses and lastly, this section
also includes those agreements that the company has developed with various parties.
The Australia-United States Free Trade Agreement
One of the leading agreements that have ever developed between these two countries such
as Australia and the US, is a Free trade agreement that influences companies of these
nations working in another one. The contract has been developed on 18 May 2004 (Moens
and Jones, 2013). The agreement is commonly known as "AUSFTA". The agreement was
developed 3with the intention to create and manage a trader relationship between parties.
The agreement consists of many provisions related to foreign investments,
telecommunication, environment, labor, electronic commerce and so on. Although the

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agreement does not affect day to day dealings of AbbVie whenever it comes to investing in
Australian operations, the same has to consider and follow the rules of this agreement.
Membership Agreement with AusBiotech
AusBiotech is a life science organization of Australia, which works for the favor of the "life
science industry" of this nation. Belonging to the related industry, AbbVie also signed a
membership agreement with this organization and currently is a proud member of the same.
The organization has its guidelines and rules, which apply to all its members, and therefore
the affairs and operations of AbbVie are likely to be affected by the same. One of the
important way in which the respective agreement affect AbbVie is the code of the conduct of
AusBiotech that is required to be accepted and complied by all the members. In conjunction
with the same, the code ensures that all the members are committed to the industry and in
their operations, adhere to the provisions set out under the code. As already mentioned this
code is applicable in a mandatory manner and therefore AbbVie needs to pay additional
attention to the same.
Membership Agreement with Medicines Australia
As the company is a biopharmaceutical company, the same is engaged in the practices of the
development of new medicines and vaccines. Medicines Australia is an organization, which
represents the discovery-driven pharmaceutical industry of Australia and supports those
companies, which invent and supply innovative medicines (Bryant, Knights, Rowland, and
Darroch, 2018). Since AddVie also manufactures such medicines, which prevent disease and
help the nation in developing healthy communities hence the same has entered into a
membership agreement with "Medicines Australia Membership". The organization provides
many advantages to businesses. AbbVie falls under category one member of this
organization. However, Medicines Australia also has some policies, which outline the liability
of its members. There are different codes, which apply to members of Medicines Australia.
For instance, being a member of this organization AbbVie has to comply with a transparent
code of the same where it has to require reporting the payments made to healthcare
professionals (abbvie.com.au, 2019). It is a mandatory compliance for AbbVie. In addition to
this, to ensure transparency in the affairs of member companies, Medicines Australia makes
the changes in policies and laws regularly and AbbVie has to do accordingly. Further, the
code of conduct consists of the provisions related to the new products, product information,
medical educational material and so on, which also needs to comply with. By this method, this
membership agreement affects the working and reporting requirements of AbbVie.
MOU between EPA and DAWR
It found that the USA and Australia have almost similar concerns regarding the environment
and therefore "the united states environmental protection agency" has entered into a
memorandum of understanding with "the Australian Government Department of Agriculture
and Water Resources on water cooperation" (DAWR). The DAWR is responsible for
developing national water policy and implement the same for Australia (epa.gov, 2016).
AbbVie being a responsible enterprise focus on land and water conservation. In this manner,
while planning the activities, the company looks after the national policies, which are
influenced by subjective MOU. This MOU indirectly affects AbbVie rather than influencing it
directly.
The above-mentioned treaties and agreements are some of the major ones but it does not
mean that they are exclusive. There are also some other agreements and conventions that

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affect products and services of AbbVie Inc., for instance, Australia has signed many other
international treaties related to human rights, sustainability, and other subjects. To comply
with the goals of these treaties, the Australian government develops different policies and
regulations for business on a timely basis, which also affect the products and service of
AbbVie.
Conclusively this is to state that AbbVie is doing well in Australia, as it became a member of
some of the leading industrial organizations and getting benefits of these memberships. The
company is complying with various Australian legislations as well as treaties and conventions.

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References
Abbvie.com. (2019) People. Passion. Possibilities. [online] Available
from:https://www.abbvie.com/our-company.html [Accessed on 19/12/2019]
abbvie.com.au. (2019) Transparency. [online] Available from:https://www.abbvie.com.au/our-
company/transparency.html [Accessed on 19/12/2019]
Bryant, B., Knights, K., Rowland, A., and Darroch, S. (2018) Pharmacology for Health
Professionals. Australia: Elsevier Health Sciences.
Corporations Act 2001 (Cth)
creditorwatch.com.au, (2019) Summary Information. [online] Available
from:https://creditorwatch.com.au/credit/profile/48156384262/ABBVIE-PTY-LTD [Accessed
on 19/12/2019]
epa.gov. (2016) Memorandum Of Understanding. [online] Available
from:https://www.epa.gov/sites/production/files/2016-03/documents/
signed_epa_dawr_mou_2016_508.pdf [Accessed on 19/12/2019]
Forbes.com. (2019) AbbVie. [online] Available
from:https://www.forbes.com/companies/abbvie/#22aefbac510f [Accessed on 19/12/2019]
Hattingh, L., Low, J., S. and Forrester, K. (2013) Australian Pharmacy Law and Practice.
NSW: Elsevier Health Sciences.
Moens, G. and Jones, R. (2013) International Trade and Business Law Review, Volume 10.
Oxon: Routledge.
Poisons and Therapeutic Goods Act 1966
Privacy Act 1988
taxsummaries.pwc.com. (2019) Australia Corporate - Taxes on corporate income. [online]
Available from:http://taxsummaries.pwc.com/ID/Australia-Corporate-Taxes-on-corporate-
income [Accessed on 19/12/2019]
The Therapeutic Goods Act 1989
Wartofsky, L. and Nostrand, D., V. (2016) Thyroid Cancer: A Comprehensive Guide to Clinical
Management. USA: Springer.