Bristol-Meyers Squibb Company

This report provides an overview of Bristol-Meyers Squibb Company in Australia, including its functioning, applicable laws, and the impact of international treaties and conventions on its operations.

Running Head: Bristol-Meyers Squibb Company
BRISTOL-MEYERS SQUIBB COMPANY
Australian Perspective
System04128

Bristol-Meyers Squibb Company
Executive Summary
When it comes to pharmaceutical sector in Australia, the first name pops up in mind is
Bristol-Meyers Squibb Australia Pvt Ltd. It the one of the biggest and the oldest
biopharmaceutical operating from more than six decades in Australia. It has its headquarters
Mulgrave, Australia. This report will focus mainly on the functioning of the company, the
applicable laws, which the company have to follow, and the effect when they are not
followed. This report will also focus on the international treaties and convention which
impact the working of the Bristol-Myers Squibb Australia Company.
1 | P a g e

Bristol-Meyers Squibb Company
Table of Contents
Executive Summary...................................................................................................................1
About the Company...................................................................................................................3
Applicable Rules and Legislations.............................................................................................3
International Treaties and Conventions.....................................................................................7
Bibliography...............................................................................................................................9
2 | P a g e

Bristol-Meyers Squibb Company
About the Company
Bristol-Myers Squibb Company was incorporated in 1887 by William McLaren Bristol and
John Ripley Myers. Initially, it was a little assembling organization that sold medicines
straightforwardly to specialists. Considerably prior, in 1858, industry pioneer Dr Edward
Robinson Squibb framed a pharmaceutical organization that would in the long run bear his
name for a considerable length of time to come, ER Squibb and Sons. In 1989, Squibb and
Bristol Myers blended, framing the cutting edge organization that is presently known as
Bristol-Myers Squibb (Anon., 2019). It operates in Biopharmaceuticals (Anon., 2016). Its
headquarters is in New York and in Australia, it is known as Bristol-Myers Squibb Australia
Pvt Ltd with head office in Mulgrave, Australia (Anon., 2017). Bristol-Myers Squibb
Australia Pty. Ltd is private company with the owners are being from other nation. It has
23,700 employees worldwide (Anon., 2019) and 240 in Australia (Anon., 2017). It
distributes, imports and sells the pharmaceuticals products. The products are baraclude,
ceenu, daklinza, eliquis, etopophos and others. The government of Australia recognised the
company has an outstanding goodwill in the domestic and the global market for making sure
that safe, high standard and beneficial medicines are available on time.
Applicable Rules and Legislations
Bristol-Myers primarily deals in Biopharmaceuticals sector and its headquarter is in
Australia. Hence, Australian laws will be applicable. To give legal protection to public
health, government and administrators have to come up with laws, provisions and to
implement concerned authorities at apex level to make sure that the manufacturing, trading
and usage of medicines are in control and regulated properly and it is transparent to the public
as well (Anon., 2012). Some of the regulatory framework and agencies which supervise and
regulate, which are applicable on Bristol-Myers Squibb are-
Therapeutic Goods Act, 1989 - This Act gives the lawful necessities for purpose of trade,
production and sale of remedial products in Australian market. The act provides the necessary
needs regarding registration, posting and including prescriptions, medical administration and
organic items in Australian Register of Therapeutic Goods and other requirements of law
including labelling, promoting and appearance of the product. Different laws, provisions and
determinations are supporting the Act. This Act is a Commonwealth Act, which gives
particular single national system to control on therapeutic goods and assisting trade and
services among territories and the state. This helps both industries and the customers (Anon.,
3 | P a g e

Bristol-Meyers Squibb Company
2019). Offences related to advertising by not following the rules and regulations carries a
penalty of A$12,600 per offence. The act includes following regulations-
 Therapeutic Goods Regulations 1990
 Therapeutic Goods (Medical Devices) Regulations 2002
 Therapeutic Goods (Charges) Act 1989
 Therapeutic Goods (Charges) Regulations 2018
Bristol-Meyers Squibb Australia is the leading company in the field of Biopharmaceuticals
and they need to strictly follow the provisions of Therapeutic Goods Act and its other
regulations. The act is directly applicable on the company. Non-compliance of the act can
lead to harsh penalties as mentioned above.
Medical Regulation Division- The Medicines Regulation Division assesses inquries to
support supply of new medicine in Australian market. This division is additionally in charge
of observing prescriptions affirmed for supply in Australia after they are available. This
division includes:
 Prescription Medicines Authorisation: It is responsible for assessing new physician
endorsed meds, prompting an endorsement or dismissal choice.
 Complementary and Over-the-counter Medicines: It is responsible for controlling
over the counter prescriptions just as corresponding medicines, which incorporate
conventional and homegrown drugs and nutrient and mineral enhancements.
 Scientific Evaluation: It is having duty to endorse applications to showcase organic
and nonexclusive prescriptions in Australian market. The Branch likewise gives
logical counsel to help the choices opt by the Medicines Regulation Division,
specifically assessing the hazardous and medicament science parts of remedial items
and give aptitude in the natural sciences.
 Pharmacovigilance and Special Access Branch: Oversight of drugs and antibodies to
guarantee as they keep up a proper dimension of value, wellbeing and viability
following getting in Australian commercial centre. This division likewise assesses and
approves some clinical preliminaries and extraordinary grant courses of action for a
wide range of remedial items (Anon., 2015).
4 | P a g e

Bristol-Meyers Squibb Company
The Bristol-Meyers Australia Pvt Ltd should introduce only those medicines in the market
which can be approved the said regulation. If company new medicine but it fails the criteria
under the act than the license or manufacturing of the medicine can be stopped.
Medical Devices and Product Quality Division - The Medical Devices and Product Quality
Division screens medicinal gadgets affirmed for sale in Australia and attempts to guarantee
domestic and global restorative products makers fulfil indicated guidelines. The Division
incorporates:
 Medicinal Devices Branch: Responsible for assessing restorative gadgets,
 Research centres Branch: Responsible for leading lab testing,
 Assembling Quality Branch :Responsible for investigation of assembling offices
(Anon., 2015)
When the Bristol-Meyers manufacture or imports goods from other countries in Australia
then they have to make sure that the products are meeting with the standards mentioned by
the division.
Regulatory Practice and Support Division: The Regulatory Practice and Support Division
give working administrative approach guidance as well as explicit help benefits guaranteeing
proficient, best use of administrative activities to the Health Products Regulation Group. The
Division incorporates:
 Branch of Administrative Services and Improvement
 Branch of Administrative Practice, Education and Compliance
 Branch of Administrative Engagement and Planning
Office of Drug Control: It controls and gives guidance on the trade fare and manufacturing
of handling medications to help Australia's commitments under the Narcotic Drugs
Conventions (Anon., 2015).
Competition and Consumer Act 2010- The Competition and Consumer Act 2010 contains
Australia's centre enactment for tending to hostile to focused lead. The main object of the
CCA is to update the welfare of Australians via the headway of competition and sensible
trading and game plan for purchaser security. The Act does this through an administrative
system that makes certain direct and rehearses unlawful, while guaranteeing that a situation
that encourages rivalry remains (Anon., 2019). When there is breach of the Australian
5 | P a g e

Bristol-Meyers Squibb Company
Consumer Law, second schedule of Competition and Consumer Act, 2010 is liable to cures
including orders, harms and compensatory orders. Moreover, financial punishments of up to
1.1 million Australian dollars for organisations and 220,000 Australian dollars for people can
be ordered.
Therapeutic Goods Advertising Code (TGAC) - The Complaints Resolution Panel (CRP)
evaluates breaks of the TGAC. On the off chance that the CRP discovers that a notice has
ruptured the Code, it can make a solicitation of the promoter/support yet has no capacity to
force any punishments. In the event that the solicitation is not agreed to, the CRP can
generate proposals to Head who arrange the back off promotion or the distribution of
withdrawal and revision. The panel can likewise suggest for request by secretary that a
promoter does not rehash distortions. In extraordinary instances, administrative activity to
expel the item from market might be vital (Anon., 2019).
Other regulatory authorities are-
 Personal Properties Securities Act 2009 (Anon., 2019)
 Goods and Services Tax Act 1999 (Anon., 2019)
 Levy Imposition Act 1998 (Anon., 2019)
 Agricultural and Veterinary Code Act 1994 (Anon., 2019)
 Privacy Act 1988 (Anon., 2019)
 Patents Act 1990 (Anon., 2019)- Federal Court of Australia held in Bristol-Myers
Squibb Company v Apotex Pty Ltd, that “Bristol-Myers Squibb Company (BMS) is
not the elite authorised of patent identifying with aripiprazole in the purview of the
conditions of permit allowed by Otsuka Pharmaceutical Co Ltd (Otsuka). Thus, BMS
is not having authorisation to sue Apotex Pty Ltd for encroachment of Otsuka patent”.
There should be restrictions of licensees to permit adequate to provide them remaining under
the Australian Patents Act. It need to be painstakingly audited and patent rights should be
allowed to them to guarantee they incorporate all misuse authorities, incorporating into
specific privilege to produce and to avoid of every single other gathering, in all fields of
utilization, including the patentee. If there is no elite permit, the licensee will not most likely
authorize rights related to patents against outsiders in own name (Anon., 2013).
6 | P a g e

Bristol-Meyers Squibb Company
International Treaties and Conventions
Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS
Agreement) - The TRIPS (Agreement on Trade-Related Aspects of Intellectual Property
Rights) of World Trade Organisation has incredibly influenced worldwide biopharmaceutical
guideline. Excursions are an endeavour to decrease holes in manner-licensed innovation.
Rights are ensured everywhere and to bring them under regular global principles;
nevertheless, the implications of the understanding's arrangement on licenses caused worries
in creating nations. In light of those worries, at the Doha Conference in 2001, WTO members
received a unique attestation-known as Doha Declaration- problems identified with ‘TRIPS’
and general wellbeing. The revelation insists that the “TRIPS Agreement” ought to be
executed in manners that ensure general wellbeing and elevate access to medicines. Driven
by the expansion of worldwide exchange pharmaceutical items and the consequent
multifaceted nature of specialized regulations identified with prescription security and
quality, a few initiatives have been set up to advance the harmonization of universal
pharmaceutical rules and guidelines by government organisation at national and international
level (Anon., 2019).
International Conference on Drug Regulatory Authorities- It is sorted out by World
Health Organisation, the International Conference on Drug Regulatory Authorities star vide
authorities from medication administrative specialists from all World Health Organisation
participant nations with a gathering for chipping away at quality participation and
coordinated effort. From 1980, the yearly gatherings are held to advance the trading of data.
Furthermore, it gives a stage to create global accord on pharmaceutical guideline. The
meetings are for discussion that collect all medication government experts, does not value
more to their associations’ course of advancement. The said authority is successful in
managing government experts on way of harmonization of guideline that can upgrade the
protection, viability and kind of prescriptions (Anon., 2019).
International Conference on Harmonisation- In this conference, there was discussion on
necessities for registration of pharmaceuticals for human use. It is a task to unite
administrative specialists and specialists from the biopharmaceutical business of the United
States, Europe and Japan to talk about logical as well as specialized parts of item enlistment.
The reason for existing is to advance correlation in utilization of specialized rules and
necessities for latest item registration to lessen the duplication of and encourage the
assessment of testing did amid the innovative work of latest medications. Balancing
7 | P a g e

Bristol-Meyers Squibb Company
conserves assets and expands the accessibility of new meds, while keeping up administrative
commitments to defend the items. Albeit proposed for new products, ICH rules are likewise
being utilized to enrol existing items. The rules, formally delivered by and for ICH part
nations, mirror the specialized abilities of their well-created administrative offices and
pharmaceutical ventures. In this manner, various nations should keep in mind their nearby
situations before trying to apply rules and provisions of ICH. Be that as it may, the ICH rules
do finish up effecting all attempts, especially when they identify with the quality details of
restorative items covering conventional medications, the prerequisites for which change
significantly crosswise over nations (dim 2004). WHO, with its eyewitness status on the ICH
guiding board of trustees, is relied upon to go about as a connection among “ICH and non-
ICH nations” and to scatter data to non-ICH nations. The ICH has additionally settled a
worldwide united bunch that expert bits ICH rules by going about as a data asset for non-
members (Grimm, 1998).
Narcotic Drugs Convention- This Convention plans to battle tranquilize maltreatment by
facilitated worldwide activity. Two types of mediation and control cooperate. To start with, it
tries to restrain the ownership, use, exchange, dissemination, import, fare, assembling and
creation of medications only to medicinal and logical purposes. Second, it battles medicate
dealing through universal collaboration to stop and debilitate sedate dealers (Anon., 2019).
8 | P a g e

Bristol-Meyers Squibb Company
Bibliography
Anon., 2012. Pharamaceutical legislation and regulations. [Online] Available at:
https://www.msh.org/sites/msh.org/files/mds3-ch06-legislation-mar2012.pdf [Accessed 3
May 2019].
Anon., 2013. Licence to pill: exclusive or not? Bristol-Myers Squibb Company v Apotex Pty
Ltd. [Online] Available at: https://s3.amazonaws.com/documents.lexology.com/29a23cfd-
09cc-4245-ad8e-94eab61b9bca.pdf [Accessed 3 May 2019].
Anon., 2015. Medical Devices and Product Quality Division. [Online] Available at:
http://www.health.gov.au/internet/main/publishing.nsf/Content/medical-devices-and-product-
quality-division [Accessed 3 May 2019].
Anon., 2015. Medicines Regulation Division. [Online] Available at:
http://www.health.gov.au/internet/main/publishing.nsf/Content/medicines-regulation-division
[Accessed 3 May 2019].
Anon., 2015. Regulatory Practice and Support Division. [Online] Available at:
http://www.health.gov.au/internet/main/publishing.nsf/Content/regulatory-practice-and-
support-division [Accessed 3 May 2019].
Anon., 2016. Bristol-Myers Squibb Company. [Online] Available at:
https://s21.q4cdn.com/104148044/files/doc_financials/annual_reports/2016/2016-Form-10-
K.pdf [Accessed 3 May 2019].
Anon., 2017. Bristol-Myers Squibb Australia Pty Ltd - Profile Company Report Australia.
[Online] Available at:
https://www.ibisworld.com.au/australian-company-research-reports/wholesale-trade/bristol-
myers-squibb-australia-pty-ltd-company.html [Accessed 3 May 2019].
Anon., 2017. Key Facts. [Online] Available at: https://www.bms.com/au/about-us/key-
facts.html [Accessed 3 May 2019].
Anon., 2019. A New Tax System (Goods and Services Tax) Act 1999. [Online] Available at:
https://www.legislation.gov.au/Details/C2014C00008 [Accessed 3 May 2019].
Anon., 2019. Agricultural and Veterinary Chemicals Code Act 1994. [Online] Available at:
https://www.legislation.gov.au/Details/C2011C00557 [Accessed 3 May 2019].
Anon., 2019. Bristol-Myers Squibb. [Online] Available at:
https://www.forbes.com/companies/bristol-myers-squibb/#769137e46184 [Accessed 3 May
2019].
Anon., 2019. International Conference of Drug Regulatory Authorities. [Online] Available
at: https://www.who.int/medicines/areas/quality_safety/regulation_legislation/icdra/en/
[Accessed 3 May 2019].
9 | P a g e

Bristol-Meyers Squibb Company
Anon., 2019. Patents Act 1990. [Online] Available at:
https://www.legislation.gov.au/Details/C2017C00045 [Accessed 3 May 2019].
Anon., 2019. Personal Property Securities Act 2009. [Online] Available at:
https://www.legislation.gov.au/Details/C2014C00273 [Accessed 3 May 2019].
Anon., 2019. Privacy Act 1988. [Online] Available at:
https://www.legislation.gov.au/Details/C2014C00076 [Accessed 3 May 2019].
Anon., 2019. Single Convention on Narcotic Drugs, 1961. [Online] Available at:
https://www.unodc.org/unodc/en/treaties/single-convention.html [Accessed 3 May 2019].
Anon., 2019. Superannuation Supervisory Levy Imposition Act 1998. [Online] Available at:
https://www.legislation.gov.au/Details/C2010C00454 [Accessed 3 May 2019].
Anon., 2019. The Competition and Consumer Act 2010. [Online] Available at:
https://www.aph.gov.au/Parliamentary_Business/Committees/Senate/Former_Committees/
foodprocessing/foodprocessing/report/c03 [Accessed 3 May 2019].
Anon., 2019. Therapeutic Goods Act 1989. [Online] Available at:
https://www.tga.gov.au/about-australian-therapeutic-goods-legislation [Accessed 3 May
2019].
Anon., 2019. Therapeutic goods advertising code. [Online] Available at:
https://www.tga.gov.au/publication/therapeutic-goods-advertising-code [Accessed 3 May
2019].
Anon., 2019. Trade-Related Aspects of Intellectual Property Rights. [Online] Available at:
https://www.wto.org/english/docs_e/legal_e/27-trips_01_e.htm [Accessed 3 May 2019].
Anon., 2019. Working Together For Patients. [Online] Available at:
https://www.bms.com/au/about-us.html [Accessed 3 May 2019].
Grimm, W., 1998. Extension of the International Conference on Harmonization Tripartite
Guideline for Stability Testing of New Drug Substances and Products to Countries of
Climatic Zones III and I. Drug Development and Industrial Pharmacy, 24(4).
10 | P a g e