Australia

Clarke, Julie; Jedličková, Barbora

doi:10.1007/978-3-319-55813-4_2

Julie Clarke⁵ &
Barbora Jedličková⁶

Part of the book series: LIDC Contributions on Antitrust Law, Intellectual Property and Unfair Competition ((LIDC))

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Abstract

The federal legislation covering both competition law and consumer law issues arising, or potentially arising, in the pharmaceutical industry in Australia is the Competition and Consumer Act 2010 (Cth) (the CCA). Competition law is primarily contained in Part IV.

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Notes

1.
The Act was previously named the Trade Practices Act 1974 (Cth). The Australian Constitution, the Commonwealth of Australia Constitution Act (1900), limits the extent to which the federal government can legislate. For that reason, states and territories enacted a ‘schedule’ version of the Part IV of the CCA, which contains core provisions on competition law. The CCA and the enacted schedule ensure a nationally consistent competition law.
2.
Part IV, Division 1 of the Competition and Consumer Act 2010 (Cth). This incorporates price-fixing, output restrictions, allocation of customers, suppliers or territories and bid rigging. This conduct is both a criminal offence and subject to civil penalties. Certain joint venture activity is excluded from the scope of the per se prohibition, but remains subject to the general prohibition against anticompetitive agreements in s 45.
3.
In Australia these are referred to as ‘exclusionary provisions’ and are per se prohibited where they involve an agreement between competitors having the purpose of preventing, restricting or limiting supply or acquisition to defined persons or classes of persons: ss 45 and 4D of the CCA. Joint ventures benefit from a limited competition defence: s 76C of the CCA.
4.
Unlike other forms of exclusive dealing, it is per se prohibited, but it is possible for the conduct to be ‘notified’ and receive immunity on public benefit grounds. This occurs when supply is made on the condition that goods or services are purchased from an unrelated third party (or there is a refusal to supply because of failure to agree to such a condition).
5.
It is not possible for conduct to be retrospectively authorised; approval must be provided in advance of the conduct occurring or it will contravene the Act notwithstanding any demonstrated public benefits.
6.
See also Sect. 2.1.2, below.
7.
There is one key exception; Australia has recently introduced ‘price signalling’ laws which currently apply only to the banking sector. However, where price signalling constitutes cartel conduct it will be captured. The specific price signalling laws will not be discussed further as they currently have no application outside the banking sector. Outside the core competition provisions in Part IV, there are some competition provisions specific to certain industries; most notably, the telecommunications industry.
8.
It provides that ‘[a] contravention of a provision of [Part IV] other than section 46, 46A or 48 shall not be taken to have been committed by reason of:
1. (a)
  the imposing of, or giving effect to, a condition of:
  1. (i)
    a licence granted by the proprietor, licensee or owner of a patent, of a registered design, of a copyright or of EL rights within the meaning of the Circuit Layouts Act 1989, or by a person who has applied for a patent or for the registration of a design; or
  2. (ii)
    an assignment of a patent, of a registered design, of a copyright or of such EL rights, or of the right to apply for a patent or for the registration of a design;
    
    to the extent that the condition relates to:
  3. (iii)
    the invention to which the patent or application for a patent relates or articles made by the use of that invention;
  4. (iv)
    goods in respect of which the design is, or is proposed to be, registered and to which it is applied;
  5. (v)
    the work or other subject matter in which the copyright subsists; or
  6. (vi)
    the eligible layout in which the EL rights subsist;
2. (b)
  the inclusion in a contract, arrangement or understanding authorizing the use of a certification trade mark of a provision in accordance with rules applicable under Part XI of the Trade Marks Act 1955, or the giving effect to such a provision; or
3. (c)
  the inclusion in a contract, arrangement or understanding between:
  1. (i)
    the registered proprietor of a trade mark other than a certification trade mark; and
  2. (ii)
    a person registered as a registered user of that trade mark under Part IX of the Trade Marks Act 1955 or a person authorized by the contract to use the trade mark subject to his or her becoming registered as such a registered user;
    
    of a provision to the extent that it relates to the kinds, qualities or standards of goods bearing the mark that may be produced or supplied, or the giving effect to the provision to that extent’.
9.
ACCC, ACCC submission to the Productivity Commission Inquiry into Intellectual Property Arrangements in Australia (November 2015), p. 14. https://www.accc.gov.au/system/files/ACCC%20Submission%20-%20PC%20inquiry%20into%20IP%20arrangements%20in%20Australia%20-%2030%20November.pdf. Accessed 11 May 2016.
10.
I. Harper, P. Anderson, S. McCluskey and M. O’Bryan QC, Competition Policy Review: Final Report, March 2015, available at http://competitionpolicyreview.gov.au/final-report/. (‘Harper Report’).
11.
Harper Report, p. 109.
12.
Government Response to the Competition Policy Review, 2015, pp. 9–10. http://www.treasury.gov.au/~/media/Treasury/Publications%20and%20Media/Publications/2015/Government%20response%20to%20the%20Competition%20Policy%20Review/Downloads/PDF/Govt_response_CPR.ashx. Accessed 11 May 2016, p. 9; Productivity Commission, Intellectual Property Arrangements, Draft Report, Canberra, April 2016, pp. 22–23, 36, 385–393. http://www.pc.gov.au/inquiries/current/intellectual-property. (‘IP Draft Report’); Productivity Commission, Intellectual Property Arrangements, Final Report, Canberra, September 2016, Recommendation 15.1. (‘IP Final Report’).
13.
ACCC v Baxter Healthcare [2008] FCAFC 141.
14.
ACCC v Pfizer [2015] FCA 113 (Pfizer). See the discussion below.
15.
(6A) In determining for the purposes of this section whether, by engaging in conduct, a corporation has taken advantage of its substantial degree of power in a market, the court may have regard to any or all of the following:
1. (a)
  whether the conduct was materially facilitated by the corporation’s substantial degree of power in the market;
2. (b)
  whether the corporation engaged in the conduct in reliance on its substantial degree of power in the market;
3. (c)
  whether it is likely that the corporation would have engaged in the conduct if it did not have a substantial degree of power in the market;
4. (d)
  whether the conduct is otherwise related to the corporation’s substantial degree of power in the market.
  
  This subsection does not limit the matters to which the court may have regard.
(7) Without in any way limiting the manner in which the purpose of a person may be established for the purposes of any other provision of this Act, a corporation may be taken to have taken advantage of its power for a purpose referred to in subsection (1) notwithstanding that, after all the evidence has been considered, the existence of that purpose is ascertainable only by inference from the conduct of the corporation or of any other person or from other relevant circumstances.
16.
(4) In this section:
(a) a reference to power is a reference to market power;
(b) a reference to a market is a reference to a market for goods or services; and
(c) a reference to power in relation to, or to conduct in, a market is a reference to power, or to conduct, in that market either as a supplier or as an acquirer of goods or services in that market.
17.
Boral Besser Mansonry Ltd v ACCC (2003) 215 CLR 374, at [122].
18.
Harper Report, pp. 334–348.
19.
Harper Report, p. 348.
20.
ACCC v Pfizer [2015] FCA 113.
21.
Pfizer, at [110]; T. Faunce, Australian Competition and Consumer Commission v Pfizer: Evergreening and Market Power as Blockbuster Drug Goes off Patent, Journal of Law and Medicine 2015, p. 780.
22.
R. Jones, Pfizer Moves Aggressively to Maintain Lipitor Sales, Pharmaco Economics and Outcomes News (2012) p. 11.
23.
Pfizer, at [6] and [186]; ACCC, ‘Statement of Claim’, Submission in Pfizer (Federal Court Proceeding NSD 146/2014, 13 February 2014) at [60(d)].
24.
Pfizer, [6]; ACCC, ‘Statement of Claim’, Submission in Pfizer (Federal Court Proceeding NSD 146/2014, 13 February 2014) at [47]–[49].
25.
Pfizer, at [305].
26.
Pfizer, at [228]; ACCC, ‘Statement of Claim’, Submission in Pfizer (Federal Court Proceeding NSD 146/2014, 13 February 2014) at [33].
27.
ACCC, ‘Statement of Claim’, Submission in Pfizer (Federal Court Proceeding NSD 146/2014, 13 February 2014) at [44]–[46].
28.
Pfizer, at [220]–[225]; ACCC, ‘Statement of Claim’, Submission in Pfizer (Federal Court Proceeding NSD 146/2014, 13 February 2014) at [51].
29.
Pfizer, at [292]
30.
See T. Faunce, Australian Competition and Consumer Commission v Pfizer: Evergreening and Market Power as Blockbuster Drug Goes off Patent, Journal of Law and Medicine 2015, pp. 776–777.
31.
Pfizer, at [293].
32.
Pfizer, at [294]–[324]. Note that the ACCC did not claim s 46 was contravened in the form of predatory pricing, but rather that Pfizer’s rebate scheme was anticompetitive under s 46.
33.
Pfizer, at [357], [360].
34.
Ibid.
35.
Pfizer, at [413].
36.
Pfizer, at [231].
37.
There is no difference between determining the relevant market in the pharmaceutical industry in comparison with other industries.
38.
Pfizer, at [251].
39.
Pfizer, at [280]–[290]. The only company supplying atorvastatin in Australia during that period of time was Ranbaxy, which was allowed to launch its generic atorvastatin in Australia on 18 February and which also offered discounts on its product to pharmacies. See, Pfizer, at [271]–[272] and [289]; T. Faunce, Australian Competition and Consumer Commission v Pfizer: Evergreening and Market Power as Blockbuster Drug Goes off Patent, Journal of Law and Medicine 2015, pp. 772 and 775.
40.
See, eg, Boral Besser Masonry Ltd v Australian Competition and Consumer Commission (2003) 215 CLR 374 at [137]; Queensland Wire Industries Pty Ltd v Broken Hill Pty Co Ltd (1989) 167 CLR 177 at 189.
41.
Subsection 47(10) provides:
(10) Subsection (1) does not apply to the practice of exclusive dealing constituted by a corporation engaging in conduct of a kind referred to in subsection (2), (3), (4) or (5) or paragraph (8)(a) or (b) or (9)(a), (b) or (c) unless:
1. (a)
  the engaging by the corporation in that conduct has the purpose, or has or is likely to have the effect, of substantially lessening competition; or
2. (b)
  the engaging by the corporation in that conduct, and the engaging by the corporation, or by a body corporate related to the corporation, in other conduct of the same or a similar kind, together have or are likely to have the effect of substantially lessening competition.
Subsections 47(1) and (2) provide:
1. (1)
  Subject to this section, a corporation shall not, in trade or commerce, engage in the practice of exclusive dealing.
2. (2)
  A corporation engages in the practice of exclusive dealing if the corporation:
  1. (a)
    supplies, or offers to supply, goods or services;
  2. (b)
    supplies, or offers to supply, goods or services at a particular price; or
  3. (c)
    gives or allows, or offers to give or allow, a discount, allowance, rebate or credit in relation to the supply or proposed supply of goods or services by the corporation;
    
    on the condition that the person to whom the corporation supplies, or offers or proposes to supply, the goods or services or, if that person is a body corporate, a body corporate related to that body corporate:
  4. (d)
    will not, or will not except to a limited extent, acquire goods or services, or goods or services of a particular kind or description, directly or indirectly from a competitor of the corporation or from a competitor of a body corporate related to the corporation;
  5. (e)
    will not, or will not except to a limited extent, re-supply goods or services, or goods or services of a particular kind or description, acquired directly or indirectly from a competitor of the corporation or from a competitor of a body corporate related to the corporation; or …
42.
Pfizer, at [13] and [464].
43.
CCA, s 46.
44.
CCA, s 47.
45.
Since 2005 there have been 15 mergers informally reviewed by the ACCC, none of which were opposed and six not opposed subject to the provision of enforceable undertakings. Since 2010 there have been four not opposed and a further three not opposed subject to undertakings.
46.
See, for example, ‘Undertaking to the Australian Competition and Consumer Commission: given under section 87B of the Competition and Consumer Act 2010 (Cth) by GlaxoSmithKline Plc and Novartis Consumer Health Australasia Pty Ltd (accepted by the ACCC on 17 December 2014) para 2.10. http://registers.accc.gov.au/content/index.phtml/itemId/1183774/fromItemId/751043.
47.
These are known as s 87B enforceable undertakings; they cannot be imposed by the ACCC, but the ACCC may accept a written undertaking given by a party in relation to most competition and consumer matters under the CCA. If accepted any contravention of the undertaking can be taken to Court, which has considerable powers to make orders in respect of the contravention. This includes divesting any benefits obtained as a result of the contravention: s 87B(4) CCA.
48.
‘Pfizer Inc – proposed acquisition of Hospira Inc’ (ACCC Merger Register, Reference 57422).
49.
‘Pfizer Inc – proposed acquisition of Hospira Inc’ (ACCC Merger Register, Reference 57422).
50.
‘GSK Consumer Healthcare – proposed acquisition of GlaxoSmithKline plc and Novartis AG’ (ACCC Merger Register, Reference 55931).
51.
‘GSK Consumer Healthcare – proposed acquisition of GlaxoSmithKline plc and Novartis AG’ (ACCC Merger Register, Reference 55931).
52.
‘GSK Consumer Healthcare – proposed acquisition of GlaxoSmithKline plc and Novartis AG’ (ACCC Merger Register, Reference 55931). See also ‘Undertaking to the Australian Competition and Consumer Commission: Given under section 87B of the Competition and Consumer Act 2010 (Cth) by GlaxoSmithKline Plc and Novartis Consumer Health Australasia Pty Ltd’ (accepted by the ACCC on 17 December 2014).
53.
See, for example, Federal Trade Commission (US), ‘Novartis AG, In the Matter of (GlaxoSmithKline)’, 8 April 2015, available at https://www.ftc.gov/enforcement/cases-proceedings/141-0141-c-4510-c-4498/novartis-ag-matter-glaxosmithkline and European Commission, ‘Mergers: Commission approves both GSK’s acquisition of Novartis’ vaccines business and a consumer healthcare joint venture between GSK and Novartis, subject to conditions’, Press Release, Brussels, 28 January 2015, available at http://europa.eu/rapid/press-release_IP-15-3841_en.htm.
54.
Medicines Australia, Code of Conduct, 18^th edition, available at https://medicinesaustralia.com.au/code-of-conduct/code-of-conduct-current-edition/. See also ACCC, ‘ACCC authorises Medicines Australia code subject to strengthening individual reporting’ (ACCC Media Release, MR 66/15, 24 April 2015) and ACCC, ‘Medicines Australia Limited – Revocation and Substitution – A91436 – A91440’ (ACCC Authorisations and Notification Register, 24 April 2015), available athttp://registers.accc.gov.au/content/index.phtml/itemId/1179619/fromItemId/278039/display/acccDecision.
55.
K. Harvey, ‘Pharmaceutical industry code of conduct fails to find favour’, The Conversation, 22 August 2014, available at http://theconversation.com/pharmaceutical-industry-code-of-conduct-fails-to-find-favour-30404.
56.
There are additional consumer laws in some jurisdictions. In the case of both consumer and competition laws state and territory legislation extends their coverage beyond the constitutionally limited scope of federal laws.
57.
CCA, s 22.
58.
Only the Federal Court of Australia (or High Court on appeal) may hear competition law matters.
59.
The Australian Consumer Law is currently under review by Consumer Affairs Australia and New Zealand, with a report expected in March 2017; see Australian Consumer Law Review, available at http://consumerlaw.gov.au/review-of-the-australian-consumer-law/about-the-review/).
60.
Treasury Legislation Amendment (Small Business and Unfair Contract Terms) Act 2015 (Cth).
61.
Initially the threshold applies to contracts where the upfront price payable is $300,000 or less or $1m or less if the contract is for more than 12 months. The legislation currently applies only to unfair terms in standard form consumer contracts.
62.
Section 21 of the Australian Consumer Law contains the relevant prohibition and section 22 sets out a non-exhaustive list of factors that may be taken into account in assessing whether conduct was unconscionable. At the time of these proceedings the relevant prohibition was contained in s 22, but the substance of the prohibition was the same.
63.
See, for example, M. Bradley and H. Marshall, ACCC v Coles: Coles’s lucky day, Competition and Consumer Law News 2014 (June) p. 58 and A Merrett, ACCC signals strategic change in battle with supermarkets, The Conversation 6 May 2014, available at https://theconversation.com/accc-signals-strategic-change-in-battle-with-supermarkets-26288.
64.
At the time of the proceedings Coles was the second largest grocery retailer in Australia: Australian Competition and Consumer Commission v Coles Supermarkets Australia Pty Ltd [2014] FCA 1405 at para 1. The largest retailer is Woolworths. The ACCC has initiated separate proceedings against Woolworths alleging unconscionable conduct towards its suppliers: ACCC, ‘ACCC takes action against Woolworths for alleged unconscionable conduct towards supermarket suppliers’ (ACCC Media Release, MR 252/15, 10 December 2015).
65.
See, for example, M. Bradley and H. Marshall, ACCC v Coles: Coles’s lucky day, Competition and Consumer Law News 2014 (June) p. 58; A Merrett, ACCC signals strategic change in battle with supermarkets, The Conversation 6 May 2014. See also C. Beaton-Wells, Coles v ACCC: finding the balance between fair trading and competition, The Conversation (21 October 2014), available at https://theconversation.com/coles-v-accc-finding-the-balance-between-fair-trading-and-competition-33135.
66.
Australian Competition and Consumer Commission v Coles Supermarkets Australia Pty Ltd [2014] FCA 1405 at [202]. See also A. Merrett, ACCC signals strategic change in battle with supermarkets, The Conversation (6 May 2014).
67.
Australian Consumer Law, s 224.
68.
CCA, s 76.
69.
See, for example, Australian Competition and Consumer Commission v Coles Supermarkets Australia Pty Ltd [2014] FCA 1405 at [106].
70.
Australian Consumer Law, s 18.
71.
The consequences of listing and price-setting mechanisms are discussed further in Part IV.
72.
Apotex Pty Ltd (formerly GenRx Pty Ltd) v Les Laboratoires Servier (No. 2) [2008] FCA 607 at [3]–[7] (‘Apotex v Servier’).
73.
This is because the letter ‘a’ appears immediately before the brand name on the PBS schedule: see Apotex v Servier, at [5].
74.
National Health Act 1953 (Cth), s 103.
75.
Apotex v Servier. At the time misleading and deceptive conduct was prohibited under s 52 of the Act. This became s 18 of the Australian Consumer Law when that was introduced in 2009, but it remained, in substance, the same prohibition.
76.
For more detail see T. Faunce, New forms of evergreening in Australia: Misleading advertising, enantiomers and data exclusivity: Apotex v Servier and Alphapharm v Lundbeck, Journal of Law and Medicine 2008, p. 220 and Apotex v Servier.
77.
T. Faunce, New forms of evergreening in Australia: Misleading advertising, enantiomers and data exclusivity: Apotex v Servier and Alphapharm v Lundbeck, Journal of Law and Medicine 2008, p. 220. ACE refers to angiotensin-converting enzyme. See also Apotex v Servier, at [11].
78.
Apotex v Servier, at [13].
79.
Apotex v Servier, at [14].
80.
Apotex v Servier, at [17].
81.
Apotex v Servier, at [22].
82.
Apotex v Servier, at [22].
83.
There was evidence that, because of changes to packaging, dosages and labels, between old and new Coversyl, the switch had caused confusion amongst patients who had previously been taking the old Coversyl product: Apotex v Servier, at [22].
84.
Apotex v Servier, at [120].
85.
Apotex v Servier, at [102].
86.
Pharmaceutical patents review, Terms of Reference (IP Australia, 15 October 2012), available at https://www.ipaustralia.gov.au/about-us/ip-legislation/pharmaceutical-patents-review.
87.
Government statement on the Pharmaceutical Patent Review Final Report (2014), available at https://www.ipaustralia.gov.au/about-us/ip-legislation/pharmaceutical-patents-review. See also M. Summerfield, Pharmaceutical Patents Review Buried by Successive Governments, Patentology Blog (16 February 2014). http://blog.patentology.com.au/2014/02/pharmaceutical-patents-review-buried-by.html.
88.
D. Quilty, Evidence supports the pharmacy model, Pharmacy Guild of Australia (25 November 2015) in which Executive Director, David Quilty, claims the Harper Review’s recommendations on pharmacy deregulation were ‘deeply flawed and bereft of evidence’.
89.
Harper Report, p. 180.
90.
Harper Report, p. 179.
91.
See also Australian Government Department of Health 2014, Pharmacy Locations Rules Applicant’s Handbook, Canberra, available at http://www.health.gov.au/internet/main/publishing.nsf/Content/health-pbs-general-pharmacy-acpa-acpaintro.htm.
92.
Urbis, ‘Review of the Pharmacy Location Rules under the Fourth Community Pharmacy Agreement, Final Report’ (June 2010), p. 1, available at http://www.health.gov.au/internet/main/publishing.nsf/Content/health-pbs-general-pharmacy-acpa-index.htm/$File/review-report-fourth-pharmacy-location-rules.pdf.
93.
Harper Report, p. 48 and recommendation 14.
94.
Harper Report, p. 48 and recommendation 14.
95.
Harper Report, p. 181.
96.
Harper Report, p. 189.
97.
See, for example, Urbis, ‘Review of the Pharmacy Location Rules under the Fourth Community Pharmacy Agreement, Final Report’ (June 2010), p. 1. The National Commission of Audit also recommended ‘opening up the pharmacy sector to competition, including through the deregulation of ownership and location rules’: Australian Government 2014, Towards Responsible Government – The Report of the National Commission of Audit Phase One, Canberra, p. xlii. http://www.ncoa.gov.au/report/docs/phase_one_report.pdf.
98.
The Pharmacy Agreement expired 1 July 2015 (after the Harper Report was published). The sixth community pharmacy agreement was finalised in May 2015. It includes provision of approximately AU18.9 billion to community pharmacies for dispensing PBS medicines: 6^th Community Pharmacy Agreement.
99.
The Hon Sussan Ley MP, Minister for Health, Minister for Aged Care, Minister for Sport, ‘Press Conference updating on the 6^th Community Pharmacy Agreement’ (18 May 2015), available at http://www.health.gov.au/internet/ministers/publishing.nsf/Content/health-mediarel-yr2015-ley150518.htm. This is discussed further, below.
100.
Harper Report, p. 41.
101.
Harper Report, p. 112.
102.
Harper Report, p. 41, recommendation 6.
103.
Harper Report, p. 41, recommendation 7.
104.
Harper Report, recommendation 6.
105.
Australian Government, ‘Government Response to the Competition Policy Review’ (24 November 2015), available at http://treasury.gov.au/harperreview.
106.
Productivity Commission, ‘Intellectual Property Arrangements’, Public Inquiry (2015–2016), available at http://www.pc.gov.au/inquiries/current/intellectual-property. (IP Inquiry). See also ‘Pharmaceutical Patents – A Targeted Policy Prescription’ (Productivity Commission Fact Sheet), available at http://www.pc.gov.au/inquiries/currenrt/intellectual-property/draft/pharma-factsheet.pdf.
107.
Australian Government, ‘Government Response to the Competition Policy Review’ (24 November 2015).
108.
The Productivity Commission is an agency of the Australian Government which provides independent advice to all levels of Government. Its core function is to conduct public inquiries at the request of the Government.
109.
IP Inquiry. See also ‘Pharmaceutical Patents – A Targeted Policy Prescription’ (Productivity Commission Fact Sheet).
110.
IP Final Report.
111.
The Final Report was released by the Government in December 2016. At the time of writing the Government has not responded to the Report. A response was expected in April 2017.
112.
IP Final Report, recommendation 10.1. The Productivity Commission expressed concern that extensions of term (up to five years) for pharmaceutical patents had not attracted investment in research and development, as had been intended when they were introduced (page 285).
113.
IP FInal Report, recommendation 10.1 and Finding 10.1. Currently data submitted to support regulatory approval is protected for a period of five years, during which any generic entrants must independently test and prove the safety of their pharmaceuticals: see ‘Pharmaceutical Patents – A Targeted Policy Prescription’ (Productivity Commission Fact Sheet). The PC noted in its draft report that there was no evidence patents do not provide sufficient protection on investment and that public availability of data could provide substantial health benefits and avoid costs of duplication.
114.
IP Final Report, draft recommendation 7.2.
115.
IP Final Report, draft recommendation 10.2.
116.
These are contained in s 51(3) of the CCA and were discussed in Part I.
117.
IP Final Report, p. 443.
118.
IP Final Report, p. 23 and recommendation 15.1.
119.
Department of Health, ‘Review of Pharmacy Remuneration and Regulation’, available at http://www.health.gov.au/pharmacyreview.
120.
See ACCC, ‘ACCC authorises Medicines Australia code subject to strengthening individual reporting’ (Media release MR 66/15, 24 April 2016), available at https://www.accc.gov.au/media-release/accc-authorises-medicines-australia-code-subject-to-strengthening-individual-reporting.
121.
Patents Act 1990 (Cth), ss 67 and 67; Patent Regulations 1991 (Cth), Div 6.
122.
Patents Act 1990 (Cth), s 70; Intellectual Property Laws Amendment Act 1998 (Cth). The extension can be opposed based on s 75. See, eg, Australia-United States Free Trade Agreement (signed 18 May 2004, entered into force 1 January 2005), Article 17.10; Agreement on Trade-Related Aspects of Intellectual Property Rights (Annex 1C to the Marrakesh Agreement establishing the World Trade Organization), 1864 UNTS 299 (entered into force 1 January 1995), Article 33.
123.
Alphapharm Pty Ltd v Lundbeck A/S [2014] HCA 42, at [57]–[58]; Revised Explanatory Memorandum for the 1998 Intellectual Property Laws Amendment Act, available at http://www.aph.gov.au/Parliamentary_Business/Bills_Legislation/Bills_Search_Results/Result?bId=r397.
124.
See, T. Faunce, Australian Competition and Consumer Commission v Pfizer: Evergreening and Market Power as Blockbuster Drug Goes off Patent, Journal of Law and Medicine 2015, pp. 780–786; S. Duckett, Australia’s Bad Drug Deal: High Pharmaceutical Prices (Grattan Institute, 2013). http://grattan.edu.au/wp-content/uploads/2014/04/Australias_Bad_Drug_Deal_FINAL.pdf.
125.
T. Harris, N. Gruen and D. Nicol, Pharmaceutical Patents Review Report, 2013, Canberra, pp. 29–30, available at https://www.ipaustralia.gov.au/about-us/ip-legislation/pharmaceutical-patents-review.
126.
T. Harris, N. Gruen and D. Nicol, Pharmaceutical Patents Review Report,2013, Canberra, available at https://www.ipaustralia.gov.au/about-us/ip-legislation/pharmaceutical-patents-review.
127.
IP Draft Report.
128.
National Health Amendment (Pharmaceutical Benefits Scheme) Act 2007 (Cth).
129.
T. Faunce, Australian Competition and Consumer Commission v Pfizer: Evergreening and Market Power as Blockbuster Drug Goes off Patent, Journal of Law and Medicine 2015, pp. 785–786; Thomas Faunce, Jimmy Bai and Duy Nguyen, ‘Impact of the Australia-US Free Trade Agreement on Australian Medicines Regulation and Prices’ (2009) J Gen Med 18, 24.
130.
It came into effect on 1 January 2005 and is available at http://dfat.gov.au/trade/agreements/ausfta/pages/australia-united-states-fta.aspx.
131.
See, S. Crosbie, The Limited Impact of Evergreening Practices In Australia, Journal of Law, Information and Science (2014–2015) p. 83.
132.
In situations where a patent is expiring but the owner of the patent or another company applies for a new patent.
133.
P. Drahos, B. Lokuge, T. Faunce, M. Goddard and D. Henry, Pharmaceuticals, Intellectual Property and Free Trade: the Case of the US-Australia Free Trade Agreement, Prometheus (2004) p. 250; see, also, R. Chesmond, Patent Evergreening in Australia after the Australia-United States Free Trade Agreement: Floodgates or Fallacy?, Flinders Journal of Law Reform (2006) p. 51.
134.
See the Patent Act 1990 (Cth).
135.
Foundation Ltd v Commissioner of Patents (1980) 1A IPR 261; National Research Development Corporation v Commissioner of Patents (1959) 102 CLR 252, at [265].
136.
Aktiebolaget Hassle v Alphapharm Pty Ltd [2002] HCA 59; 212 CLR 411.
137.
Merck & Co Inc v Arrow Pharmaceuticals Ltd [2006] FCAFC 91.
138.
Arrow Pharmaceuticals Ltd v Merck & Co Inc v [2004] FCA 1282, at [1].
139.
A. Christie, C. Dent, P. McIntyre, L. Wilson and D. Studdert, Patents associated with high-cost drugs in Australia (2013) PLoS ONE p. 1.
140.
A. Christie, C. Dent, P. McIntyre, L. Wilson and D. Studdert, Patents associated with high-cost drugs in Australia (2013) PLoS ONE p. 1.
141.
Such practices could potentially contravene s 45(2) of the CCA if proved that they substantially lessened competition.
142.
IP Final Report, pp. 285.
143.
Recommendation 10.2. There is no public mechanism for monitoring patent settlements in the pharmaceutical sector.
144.
IP Final Report, recommendation 10.2.
145.
An interlocutory injunction may be granted before the court makes a final order in circumstances where the applicant ‘might suffer irreparable injury for which damages will not be an adequate compensation if an injunction is not granted’ or ‘the public interest may be seriously affected’ and ‘the balance of convenience favours the grant of relief’: LexisNexis Australia, Encyclopaedic Australian Legal Dictionary.
146.
Abbot GmbH & Co KG v Apotex Pty Ltd (2009) 83 IPR 373.
147.
Abbot v Apotex, at [42].
148.
Alphapharm Pty Ltd v Wyeth [2009] FCA 945.
149.
Alphapharm v Wyeth, at [73]–[74].
150.
Alphapharm v Wyeth, at [111].
151.
Alphapharm v Wyeth, at [127].
152.
See, eg, Alphapharm v Wyeth, at [127]–[128], [131].
153.
See, eg, Abbot v Apotex, at [46].
154.
See, eg, Alphapharm v Wyeth, [131]; Sigma Pharmaceuticals (Aust) Pty Ltd v Wyeth [2009] FCA 595, at [58], [65]; Interpharma Pty Ltd v Commissioner of Patents [2008] FCA 1498, at [279]–[282].
155.
Australia-United States Free Trade Agreement 2004; Trans-Pacific Partnership Agreement 2015 (signed in February 2016), available at http://dfat.gov.au/trade/agreements/tpp/pages/trans-pacific-partnership-agreement-tpp.aspx.
156.
The Productivity Commission, ‘Study on Evaluation of the Pharmaceuticals Industry Investment Program’ (February 2003), available at http://www.pc.gov.au/inquiries/completed/pharmaceutical-investment, p. xxv; see, also, IP Draft Report, p. 271. However, the patent law changed in 2015 allowing the producers of generic drugs to export their drugs in very limited situations where public health problems in least developed countries require prompt attention. (IP Draft Report, p. 272.)
157.
IP Final Report, pp. 310-312.
158.
IP Final Report, p. 312.
159.
The Productivity Commission, ‘Study on Evaluation of the Pharmaceuticals Industry Investment Program’ (February 2003), available at http://www.pc.gov.au/inquiries/completed/pharmaceutical-investment.
160.
IP Laws Amendment Act 2015 (Cth).
161.
The primary reason for the introduction of this compulsory export licensing was the Australian obligation arising from the TRIPs Protocol.
162.
There are also a few specific situations under Chapter 12, Part 4, where the Commissioner of Patents can revoke a patent. These are if there was no entitlement to the patent, the invention is not a patentable invention or the patent was not obtained in the right way.
163.
The recent government inquiry into compulsory licensing summarised that there have been only a few applications across different industries; however, none of them were successful. The fact that these applications are costly and time consuming has led to this situation. Productivity Commission, Compulsory Licensing of Patents (2013, Inquiry Report No. 6). In this report, the Productivity Commission also considered mechanisms which would encourage voluntary licensing.
164.
See Australian Government, Pharmaceutical Benefits Scheme (PBS) Safety Net, available at https://www.humanservices.gov.au/customer/services/medicare/pharmaceutical-benefits-scheme-pbs-safety-net. When the threshold is met concession card holders receive all subsequent PBS prescribed drugs for free for the remainder of the year; general patients receive subsequent PBS prescribed drugs at the concessional rate.
165.
Sections 2A, 2B and 2C of the CCA. See, for example, ACCC v Baxter Healthcare [2007] HCA 38.
166.
The Crown in right of the Commonwealth is not, however, liable for pecuniary penalties or to be prosecuted for an offence: s 2A(3) CCA.
167.
ACCC v Baxter Healthcare [2008] FCAFC 141 (per Mansfield J), at [2].
168.
ACCC v Baxter Healthcare [2008] FCAFC 141 (per Mansfield J), at [5].
169.
ACCC v Baxter Healthcare [2008] FCAFC 141 (per Mansfield J), at [5].
170.
ACCC v Baxter Healthcare [2008] FCAFC 141 (per Mansfield J), at [5].
171.
Therapeutic Goods Administration, Australian Register of Therapeutic Goods, available at https://www.tga.gov.au/australian-register-therapeutic-goods.
172.
S. Mitchell, N. Tyacke, S. Uthmeyer, K. O’Brien, R. Singh, E. Mallon, R. McMaster and A. Parker (DLA Piper), Medicinal product regulation and product liability in Australia: overview (2016), Practical Law, Thomson Reuters, available at http://uk.practicallaw.com/0-500-7384.
173.
National Health Act 1953 (Cth) s. 85AD.
174.
S. Mitchell, N. Tyacke, S. Uthmeyer, K. O’Brien, R. Singh, E. Mallon, R. McMaster and A. Parker (DLA Piper), Medicinal product regulation and product liability in Australia: overview (2016), Practical Law, Thomson Reuters, available at http://uk.practicallaw.com/0-500-7384.
175.
National Health Act 1953 (Cth) s 85B.
176.
Memorandum of Understanding between the Australian Government and Medicines Australia 2010 (September 2010), available at http://www.pbs.gov.au/info/industry/useful-resources/memorandum. See also s 99ACB National Health Act 1953 (Cth)
177.
S. Mitchell, N. Tyacke, S. Uthmeyer, K. O’Brien, R. Singh, E. Mallon, R. McMaster and A. Parker (DLA Piper), Medicinal product regulation and product liability in Australia: overview (2016), Practical Law, Thomson Reuters, available at http://uk.practicallaw.com/0-500-7384.
178.
Agreed as part of the 6^th Community Pharmacy Agreement. See further Australian Government, PBS Access and Sustainability Package including the Sixth Community Pharmacy Agreement, available at http://www.pbs.gov.au/info/general/pbs-access-sustainability-package.
179.
The dispensed price for medicines supplied by approved hospital authorities is determined by the Minister under ss 98C(1)(a) and 99(4) of the National Health Act and associated regulations.
180.
Australian Government, The Pharmaceutical Benefits Scheme: PBS Frequently Asked Questions, available at http://www.pbs.gov.au/info/general/faq.
181.
Ibid.
182.
See, for example, S. Dunlevy, Prescription medicine row: ‘There is always one or two who will do the wrong thing’ (news.com.au, 22 December 2015).
183.
The Hon Sussan Ley MP, ‘Discount PBS prescriptions start today’ (Media Release, 1 January 2016).
184.
Australian Government, Guarantee of Supply, Pharmaceutical Benefits Scheme website, available at http://www.pbs.gov.au/info/industry/listing/elements/guarantee-of-supply.
185.
National Health Act 1953 (Cth), s 99AEB.
186.
National Health Act 1953 (Cth), s 99AEA.
187.
National Health Act 1953 (Cth), ss 99AEC(2) and 99AED(2) set out the full criteria for classifying products as guaranteed brands of guaranteed items.
188.
National Health Act 1953 (Cth), s 99AEC(2)
189.
National Health Act 1953 (Cth), s 99AED(2). See also Australian Government, ‘Guarantee of Supply’ Pharmaceutical Benefits Scheme website, available at http://www.pbs.gov.au/info/industry/listing/elements/guarantee-of-supply.
190.
National Health Act 1953 (Cth), s 99AEC(3) and 99AED(3). This is the ‘guaranteed period’. See also Australian Government, Guarantee of Supply, Pharmaceutical Benefits Scheme website, available at http://www.pbs.gov.au/info/industry/listing/elements/guarantee-of-supply.
191.
The responsible person is the registered person or corporation that supplies the particular brand of medicine on the PBS National Health Act 1953 (Cth), ss 84 and 84AF.
192.
National Health Act 1953 (Cth), s 99AEE.
193.
National Health Act 1953 (Cth), s 99AEG(1)(2).
194.
National Health Act 1953 (Cth), s 99AEH.
195.
National Health Act 1953 (Cth), s 99AEG(3).
196.
The value of a penalty unit is set out in the Crimes Act 1914 (Cth) s. 4AA and is currently set at AUD 180. It is subject to indexation.

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Deakin Law School, Deakin University, Geelong, VIC, Australia
Julie Clarke
TC Beirne School of Law, The University of Queensland, St Lucia, QLD, Australia
Barbora Jedličková

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Pranvera Këllezi
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Bruce Kilpatrick

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Clarke, J., Jedličková, B. (2017). Australia. In: Kobel, P., Këllezi, P., Kilpatrick, B. (eds) Antitrust in Pharmaceutical Markets & Geographical Rules of Origin. LIDC Contributions on Antitrust Law, Intellectual Property and Unfair Competition. Springer, Cham. https://doi.org/10.1007/978-3-319-55813-4_2

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