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Australian Health Review Australian Health Review Society
Journal of the Australian Healthcare & Hospitals Association
RESEARCH ARTICLE (Open Access)

Does generic entry lower the prices paid for pharmaceuticals in Australia? A comparison before and after the introduction of the mandatory price-reduction policy

Jean Spinks A C , Gang Chen B and Lara Donovan A
+ Author Affiliations
- Author Affiliations

A Centre for Health Economics, Monash University, Clayton, Vic. 3800, Australia. Email: lara.donovan@bms.com

B Flinders Health Economics Group, Flinders University, Daw Park, SA 5041, Australia. Email: gang.chen@flinders.edu.au

C Corresponding author. Email: jean.spinks@monash.edu

Australian Health Review 37(5) 675-681 https://doi.org/10.1071/AH13024
Submitted: 7 August 2012  Accepted: 19 August 2013   Published: 28 October 2013

Journal Compilation © AHHA 2013

Abstract

Objective We investigated the relationship between the number of generic medicines and pharmaceutical prices over time in Australia.

Methods A dataset was utilised containing 76 items for 4 years (2003–2007) on the national subsidy scheme – the Pharmaceutical Benefits Scheme (PBS) – for which a generic brand is available. The PBS price was used as the dependent variable, and the number of generics available the key explanatory variable. The ordinary least-squares estimator was adopted for estimation. In the robustness analysis, an instrumental-variables method was used to account for potential endogeneity.

Results Results suggested that the effect of increased generic medicine sellers on reducing the prices paid for generics is marginal but statistically significant.

Conclusions It is suggested that structural changes to the way generic prices are determined needs to be reconsidered by the Australian government if the policy aim of using increased ‘competition’ to lower prices is to be maximised.

What is known about the topic? There is scant empirical evidence that supports the notion that increased generic availability for pharmaceuticals, in heavily price-regulated markets such as Australia, has a significant effect on lowering the prices paid over time. Despite this, Australia has adopted a policy that promotes increased generic ‘competition’ as a means of controlling prices, without establishing if this policy has, or is likely to be, successful in the longer term.

What does this paper add? Using longitudinal data from Medicare Australia, this paper quantifies the relationship between the number of branded and generic items of a given drug molecule and formulation, and prices paid over time, controlling for other explanatory variables.

What are the implications for practitioners? The results suggest that although increased generic entry may lower prices over time in the Australian context, the price reduction gained is likely to be very small. Therefore, whilst generic entry should be encouraged, it is important not to assume that this price-lowering effect is realised without question and that the magnitude of such an effect is comparable with other price-regulated countries.

Additional keywords: competition, cost containment, generic pharmaceuticals, generic pricing, Pharmaceutical Benefits Scheme (PBS).


References

[1]  Puig-Junoy J. Impact of European pharmaceutical price regulation on generic price competition: a review. Pharmacoeconomics 2010; 28 649–63.
Impact of European pharmaceutical price regulation on generic price competition: a review.Crossref | GoogleScholarGoogle Scholar | 20515079PubMed |

[2]  Danzon PM, Chao LW. Cross-national price differences for pharmaceuticals: how large, and why? J Health Econ 2000; 19 159–95.
Cross-national price differences for pharmaceuticals: how large, and why?Crossref | GoogleScholarGoogle Scholar | 1:STN:280:DC%2BD3M%2FgsVGmuw%3D%3D&md5=13d81118461b56dd2da300d33a1aeec3CAS | 10947575PubMed |

[3]  Caves RE, Whinston MD, Hurwitz MA. Patent expiration, entry, and competition in the U.S. pharmaceutical industry. Brookings Pap Econ Act 1991; 1–66.

[4]  Grabowski HG, Vernon JM. Brand loyalty, entry, and price competition in pharmaceuticals after the 1984 Drug Act. J Law Econ 1992; 35 331–50.
Brand loyalty, entry, and price competition in pharmaceuticals after the 1984 Drug Act.Crossref | GoogleScholarGoogle Scholar |

[5]  Grabowski HG, Vernon JM. Longer patents for increased generic competition in the US: the Waxman–Hatch Act after one decade. Pharmacoeconomics 1996; 10 110–23.
Longer patents for increased generic competition in the US: the Waxman–Hatch Act after one decade.Crossref | GoogleScholarGoogle Scholar |

[6]  Frank RG, Salkever DS. Generic entry and the pricing of pharmaceuticals. J Econ Manage Strategy 1997; 6 75–90.
Generic entry and the pricing of pharmaceuticals.Crossref | GoogleScholarGoogle Scholar |

[7]  Frank RG Salkever DS 1992 Pricing, Patent Loss and the Market for Pharmaceuticals. Southern Economic Journal 59 2 165

[8]  Wiggins SN, Maness R. Price competition in pharmaceuticals: the case of anti-infectives. Econ Inq 2004; 42 247–63.
Price competition in pharmaceuticals: the case of anti-infectives.Crossref | GoogleScholarGoogle Scholar |

[9]  Aalto-Setälä V. The impact of generic substitution on price competition in Finland. Eur J Health Econ 2008; 9 185–91.
The impact of generic substitution on price competition in Finland.Crossref | GoogleScholarGoogle Scholar | 17508226PubMed |

[10]  Searles A, Jefferys S, Doran E, Henry DA. Reference pricing, generic drugs and proposed changes to the Pharmaceutical Benefits Scheme. Med J Aust 2007; 187 236–9.
| 17564580PubMed |

[11]  Bulfone L. High prices for generics in Australia – more competition might help. Aust Health Rev 2009; 33 200–14.
High prices for generics in Australia – more competition might help.Crossref | GoogleScholarGoogle Scholar | 19563309PubMed |

[12]  Clarke PM, Fitzgerald EM. Expiry of patent protection on statins: effects on pharmaceutical expenditure in Australia. Med J Aust 2010; 192 633–6.
| 20528715PubMed |

[13]  Spinks J, Richardson J. Paying the right price for pharmaceuticals: a case study of why the comparator matters. Aust Health Rev 2011; 35 267–72.
Paying the right price for pharmaceuticals: a case study of why the comparator matters.Crossref | GoogleScholarGoogle Scholar | 21871185PubMed |

[14]  McManus P, Birkett DJ, Dudley J, Stevens A. Impact of the Minimum Pricing Policy and introduction of brand (generic) substitution into the Pharmaceutcial Benefits Scheme in Australia. Pharmacoepidemiol Drug Saf 2001; 10 295–300.
Impact of the Minimum Pricing Policy and introduction of brand (generic) substitution into the Pharmaceutcial Benefits Scheme in Australia.Crossref | GoogleScholarGoogle Scholar | 1:STN:280:DC%2BD38%2FjsVeksg%3D%3D&md5=ef89c1636e92a8b780cd25b8cb99ee7eCAS | 11760489PubMed |

[15]  Löfgren H. Reshaping Australian drug policy: the dilemmas of generic medicines policy. Aust New Zealand Health Policy 2007; 4 11
Reshaping Australian drug policy: the dilemmas of generic medicines policy.Crossref | GoogleScholarGoogle Scholar | 17543116PubMed |

[16]  Department of Health and Ageing. PBS pricing. Canberra: Commonwealth Government of Australia; 2005. Available at: http://www.health.gov.au/internet/main/publishing.nsf/Content/health-pbs-pricing-adminguide [verified 20 July 2012].

[17]  Department of Health and Ageing. Pharmaceutical Benefits Scheme (PBS) reform. Commonwealth Government of Australia, Canberra; 2006. Available from: http://www.health.gov.au/internet/main/publishing.nsf/Content/pbs_reform_02feb07.htm [Verified 20 July 2012].

[18]  de Boer R. PBS Reform – a missed opportunity? Aust Health Rev 2009; 33 176–85.
PBS Reform – a missed opportunity?Crossref | GoogleScholarGoogle Scholar | 19563306PubMed |

[19]  Lexchin J. The effect of generic competition on the price of brand-name drugs. Health Policy 2004; 68 47–54.
The effect of generic competition on the price of brand-name drugs.Crossref | GoogleScholarGoogle Scholar | 15033552PubMed |

[20]  Australian Bureau of Statistics. Consumer price index, Australia. 2011. Available from: http://abs.gov.au/ausstats/abs@.nsf/mf/6401.0/ [Verified 9 October 2011]

[21]  Wang YR. Price competition in the Chinese pharmaceutical market. Int J Health Care Finance Econ 2006; 6 119–29.
Price competition in the Chinese pharmaceutical market.Crossref | GoogleScholarGoogle Scholar | 16783505PubMed |

[22]  Kong Y. The price premium of generic to brand-names and pharmaceutical price index. Appl Econ 2004; 36 731–7.
The price premium of generic to brand-names and pharmaceutical price index.Crossref | GoogleScholarGoogle Scholar |

[23]  Doran E, Alexander HD. Australian pharmaceutical policy: price control, equity and drug innovation in Australia. J Public Health Policy 2008; 29 106–20.
Australian pharmaceutical policy: price control, equity and drug innovation in Australia.Crossref | GoogleScholarGoogle Scholar | 18368023PubMed |

[24]  Lofgren H. Generic drugs: international trends and policy developments in Australia, Working Paper No.10, Pharmaceutical Industry Project, Equity, Sustainability and Industry development; 2002. Available from: http://www.cfses.com/documents/pharma/10-Role_of_generics.PDF [Verified 20 July 2012]

[25]  Department of Health and Ageing. Australian statistics on medicines, 2009. Canberra: Commonwealth Government of Australia; 2009. Available from: http://www.health.gov.au/internet/main/Publishing.nsf/Content/pbs-asm-2009 [Verified 5 January 2013]

[26]  Department of Health and Ageing. Policies, procedures and methods used in the recommendations for pricing of pharmaceutical products; 2009. Canberra: Commonwealth Government of Australia. Available from: http://www.health.gov.au/internet/publications/publishing.nsf/Content/health-pbs-pbpa-pricing-policiesdoc~attachF-further [Verified 2 August 2012]

[27]  Kalisch L, Roughead E, Gilbert A. Brand substitution or multiple switches per patient? An analysis of pharmaceutical brand substitution in Australia. Pharmacoepidemiol Drug Saf 2008; 17 620–5.
Brand substitution or multiple switches per patient? An analysis of pharmaceutical brand substitution in Australia.Crossref | GoogleScholarGoogle Scholar | 18324613PubMed |

[28]  Roughead E, Semple S. Medication safety in acute care in Australia: where are we now? Part 1: a review of the extent and causes of medication problems 2002–2008. Aust New Zealand Health Policy 2009; 6 18
Medication safety in acute care in Australia: where are we now? Part 1: a review of the extent and causes of medication problems 2002–2008.Crossref | GoogleScholarGoogle Scholar | 19671158PubMed |

[29]  Godman B, Hayxoc A, Schwabe U, Joppi R, Garattini S. Having your cake and eating it: office of fair trading proposal for funding new drugs to benefits patients and innovative companies. Pharmacoeconomics 2008; 26 91–8.
Having your cake and eating it: office of fair trading proposal for funding new drugs to benefits patients and innovative companies.Crossref | GoogleScholarGoogle Scholar | 18198930PubMed |

[30]  Wooldridge JM. Econometric analysis of cross section and panel data. Cambridge, MA: The MIT Press; 2002.

[31]  Staiger D, Stock JH. Instrumental variables regression with weak instruments. Econometrica 1997; 65 557–86.
Instrumental variables regression with weak instruments.Crossref | GoogleScholarGoogle Scholar |

[32]  Duckett SJ, Breadon P, Ginnivan L, Venkataraman P. Australia’s bad drug deal: high pharmaceutical prices. Melbourne: Grattan Institute; 2013.