scholarly journals High prices for generics in Australia — more competition might help

2009 ◽  
Vol 33 (2) ◽  
pp. 200 ◽  
Author(s):  
Liliana Bulfone
Keyword(s):  
Price Competition ◽  
Generic Drugs ◽  
Developed Countries ◽  
Dominant Strategy ◽  
Generic Product ◽  
The Us ◽  
Generic Products ◽  
The Government ◽  
The Individual ◽  
Pharmaceutical Benefits Scheme

It is commonly believed that dispensed prices of medicines in Australia are substantially lower than those in other developed countries, particularly the US. This article reports the results of an analysis comparing dispensed prices for the most commonly prescribed and the highest cost items in Australia with dispensed prices in the US. Although a large majority of items are less expensive in Australia than in the US, Australian prices are higher for a substantial number of products, particularly generic drugs. This article examines various policies affecting the pricing of generics in Australia. It is postulated that the main cause for higher prices for a substantial number of generic products is the lack of price competition. This results from government policy which ensures that a price reduction by one company is communicated immediately to all competitors in that market along with an invitation to match the reduced price. The dominant strategy for all suppliers is to only reduce their price in response to a reduction in price by a competitor. The result is a lack of differentiation in pricing across brands of a medicine on the Schedule of Pharmaceutical Benefits. The government could improve the structure of the generics market and encourage greater competition by ceasing to disclose competitor firms? offers to other competitors. The government could conduct pricing reviews of each generic product relatively infrequently (eg, only once annually or every 18 months). At the time of the pricing review, the government would request confidential offers on price for a generic from all players in the market. Brands should then all be listed under the Pharmaceutical Benefits Scheme (PBS) at the offered price. Prices offered by the individual supplier would apply until the next pricing review. The PBS would continue to subsidise up to the price of the lowest priced brand, with brand premiums applying to all brands priced higher than the benchmark price. Such an approach would provide opportunity for players in the market to capture market share by being the lowest priced brand.

Recent developments in US law: Remedies and damages for improper patent listings in the FDA's Orange Book

10.5912/jcb29 ◽  
1969 ◽  
Vol 9 (3) ◽  
Author(s):  
Daniel G Brown
Keyword(s):  
Price Competition ◽  
Generic Drugs ◽  
Pharmaceutical Product ◽  
Pharmaceutical Companies ◽  
White House ◽  
Drug Products ◽  
The Us ◽  
Recent Developments ◽  
The Usa ◽  
Orange Book

The Drug Price Competition and Patent Term Restoration Act (Publ. No. 98-417, 98 Stat. 1585 (1984)), commonly known as the Hatch–Waxman Act (the Act) provides the statutory framework by which most generic drugs are approved for marketing in the USA. Most provisions in the Act concern the standards and procedures the US Food and Drug Administration (FDA) must follow to approve generic drugs. A relatively small number of the provisions, however, create a framework for resolving patent disputes between the brand and generic pharmaceutical companies. These provisions have been the subject of much recent activity, in the US Courts, in Congress, in the FDA itself and in the White House. Much of the activity revolves around a publication by FDA entitled Approved Drug Products with Therapeutic Equivalence Evaluations, known colloquially as the Orange Book.Under present FDA practice, the mere listing of a patent in the Orange Book corresponding to a brand pharmaceutical product invokes a number of statutory provisions that confer valuable exclusivity rights on the brand company, and also possibly on one or more generic companies. This situation creates a strong incentive for patentees and brand pharmaceutical companies to list patents in the Orange Book. A number of recent court cases have addressed the remedies and damages available when the listing is found to be improper. Thus far, the most successful means to challenge or prevent improper listings has been through private and governmental enforcement of the antitrust laws.

Strategies for Business Firms in Declining Markets

2009 ◽  
Vol 5 (2) ◽  
pp. 173-181
Author(s):  
Sarira Aurangabadkar
Keyword(s):  
Interest Rates ◽  
Developed Countries ◽  
Fiscal Year ◽  
Government Growth ◽  
Global Recession ◽  
Reserve Bank ◽  
The Us ◽  
Manufacturing Activity ◽  
The Government ◽  
The Uk

The economic crisis that has engulfed the world since 2007 has become serious by the first quarter of 2009.Many developed countries too are affected severely, namely the US, Germany, the UK and others. Fortunately, India as of now seems to be less affected, yet the winds of global recession are now felt. The Indian economy grew at an annual rate of 7.6% in the quarter ending in September, 2008. As per the projections of the government growth in the fiscal year, 2008-09 could be in the range of 7 to 8 %, which is, lower than 9% in the last year. The government has unveiled a multibillion dollar stimulus on 7th December, 2008 and 2nd January, 2009 respectively. The Reserve Bank of India has cut interest rates aggressively. India Inc has felt the heat of the global meltdown in the third quarter ending in December, 2008 where the income has dropped by a massive 23% points compared to the previous year. Indian manufacturing activity has contracted for the second consecutive month in December, 2008 to its lowest in more than three and half years. India’s exports too have declined by 12.1 % in October, 2008 showing a negative trend for the first time in the last five years.

scholarly journals The Role of Medicine Pricing Policy for Improving the Affordability of Medicines

2018 ◽  
Vol 16 (2) ◽  
pp. 172
Author(s):  
Yusi Anggriani
Keyword(s):  
Developing Countries ◽  
Price Competition ◽  
Developed Countries ◽  
Pharmaceutical Product ◽  
Small Country ◽  
Pricing Policy ◽  
Middle Income ◽  
Bargaining Position ◽  
Medicine Prices ◽  
The Government

Medicine is a pharmaceutical product that has imperfect market characteristics. This affects affordability to the community, and therefore it is necessary for the government to regulate medicine prices. Medicine prices can be regulated in the medicine supply chain by the industry, importers, distributors and health facilities such as pharmacies, hospitals and medicine sellers. Developed and high income countries generally regulate the prices of medicines and are part of a health insurance system. In contrast with the situation in developed countries, medicine pricing regulation in developing countries and Lower Middle Income Countries is not well established. The regulation of mark-ups in distribution channels is the most common strategy used by LMIC. Small country with only a few pharmaceutical facilities has a weak bargaining position, generally the government cannot set prices. The application of cost-plus pricing is quite effective if it is implemented in a small country. In developing countries with a large market segment and adequate pharmaceutical industry facilities the price competition method is an effective strategy option to get lower prices. In practice, the application of  medicine pricing policy is dynamic. The medicine pricing system in a country can be changed or combined with other methods if the evaluation does not provide optimal results or generates unintended impacts.

Forecast on China's New Energy Vehicle Market Demand

2014 ◽  
Vol 496-500 ◽  
pp. 2822-2826 ◽  
Author(s):  
Jian Shi ◽  
Bin Liu ◽  
Yong He Huang ◽  
Hua Liang Hou
Keyword(s):  
Market Share ◽  
Rapid Development ◽  
Developed Countries ◽  
Market Demand ◽  
Financial Policies ◽  
The Us ◽  
New Energy ◽  
The Government ◽  
New Energy Vehicle ◽  
New Energy Vehicles

With the rapid development of new energy vehicle in China, the volume has been the hot topic in the fields of automotive industry. A series of subsidy and financial policies has been released by the government. Peoples in this industry care about the effective of the policies especially the new energy vehicles volume and market share in China. In this paper, we analysis the development experience of developed countries such as the US and Japan, and calculate the new energy vehicles volume and market share in China from 2015 to 2020 by model. Its more effective to the government department to draw a plan of new energy vehicle development blue print.

scholarly journals Why Scientific Research is Imperative for Entrepreneurship and Sustainable Development in Pakistan

2016 ◽  
Vol 21 (Special Edition) ◽  
pp. 1-14
Author(s):  
Bilal U. Haq
Keyword(s):  
Scientific Research ◽  
Developed Countries ◽  
Expert Advice ◽  
Technological Breakthrough ◽  
The Us ◽  
Research Leadership ◽  
The Government ◽  
Acquisition Of Expertise ◽  
Innovation And Entrepreneurship

Indigenous scientific research is vital for a country’s long-term economic growth. The simple transference of technology or acquisition of expertise ultimately has developmental limitations. Examples from the hydrocarbon industry clearly illustrate this paradox: oil-rich developing countries can afford to procure expert advice with ease, but rarely develop the new skills essential to make the next technological breakthrough or scientific paradigm shift. Underlying this failing is often the absence of a culture of open scientific enquiry. For resource-deficient countries, this is compounded by the dearth of infrastructure. Such countries argue that they cannot afford to finance scientific research, although this does not always require large investments up front. Software research and development is a good example, requiring primarily technical knowhow, skilled labor and a desire for innovative success. The deficit of scientific research in Pakistan stems from many of these factors, even though the requisite human resources are available in abundance. Innovation and entrepreneurship requires a special mix of encouragement and incentives from the government and industry. This paper outlines some of these issues based on the author’s experience of several decades of research leadership and funding in the US and Europe, and his involvement in transferring advanced scientific knowledge to developing as well as developed countries.

scholarly journals Regulatory Prototype for Biological Products in the United States

2021 ◽  
pp. 60-72
Author(s):  
G. M. Pavithra ◽  
N. Venugopal
Keyword(s):  
Price Competition ◽  
Generic Drugs ◽  
The United States ◽  
Biological Application ◽  
Biological Products ◽  
License Application ◽  
The Us ◽  
High Degree ◽  
Degree Of Similarity ◽  
Improve Access

Biological products are used for the treatment of many disease, so the biological application submitted for the approval of products are also increasing. The progress of a biosimilarproduct is more difficult and expensive than a small molecule generic product. Biosimilars are not true generic drugs, but demonstrate a high degree of similarity to the reference biological product. In order to improve access to costly biological treatments, a biosimilar pathway in the US was established under the Biologics Price Competition and Innovation Act of 2009. The study highlighted the “Regulatory prospective for the registration of Biological products in US” and a brief description about the development, Manufacturing and approval process of biosimilar products. This article is also focused on the regulatory framework, Biological License Application, Purple book, and Pharmacovigilance of biological products.

A participant observation study of the resolution of audit engagement challenges in government tax compliance audits

2014 ◽  
Vol 11 (4) ◽  
pp. 416-439 ◽  
Author(s):  
Rick Stephan Hayes ◽  
Richard Baker
Keyword(s):  
Participant Observation ◽  
Tax Compliance ◽  
Observation Study ◽  
Content Type ◽  
Tobacco Tax ◽  
The Us ◽  
The Difference ◽  
The Government ◽  
Us Federal Government ◽  
The Individual

Purpose – The aim of this paper is to extend the prior auditing literature by examining audit engagement challenges arising during government tax compliance audits. The prior auditing literature has examined how audit engagement challenges have been resolved through auditor/auditee negotiations. Design/methodology/approach – The empirical evidence for the paper was gathered during a participant observation study conducted by the primary researcher over a period of six years while working as an auditor for the Alcohol and Tobacco Tax and Trade Bureau (TTB) of the US Department of Treasury. Findings – This paper discusses various challenges faced by government auditors and how these challenges were resolved. The path to resolution was not always clearly marked. Resolution depended a great deal on the individual auditor’s judgment, interpretation of the Code of Federal Regulations (CFRs), and the willingness of the auditee to change the methods and techniques they use in operating and reporting wine operations. Materiality was determined by compliance with the regulation criteria [CFRs and the US Code (USC)] – any non-compliance was considered to be material. Resolution of many of the challenges resulted in an increased payments of excise taxes or penalties by the auditee entities. In other cases, the audit agency allowed the auditees to agree to change or amend their practices to correct a violation or a lack of compliance with US federal government regulations. As such, while the difference in the role and status of the government tax compliance auditor as compared with the independent external auditor did not necessarily lead to a different set of audit procedures, the pattern of communications between the auditor and the auditee in a government tax compliance audit were quite different from an external audit of financial statements. The government tax compliance environment is often complex, but the auditor may draw on a number of sources of knowledge and communication: CFRs, USC, Generally Accepted Government Auditing Standards, national audit planning, national experts, winery management, local peers, local government supervision, legal counsel and other auditors. Originality/value – The primary contribution of the paper lies in the fact that little or no prior research in auditing has been conducted using participant observation as a research methodology. The use of participant observation provides new perspectives on the resolution of audit engagement challenges and auditor/auditee communication and negotiation.

scholarly journals LITIGATION WITH HUAWEI 5G CORP AND ICT SECURITY

2021 ◽  
Vol 7 (2) ◽  
pp. 21-27
Author(s):  
Norbert Malec ◽  
Marcin Jurgilewicz ◽  
Adrianna Czarnecka
Keyword(s):  
New Technologies ◽  
Modern Technology ◽  
Domestic Markets ◽  
The Social ◽  
The Us ◽  
Us Government ◽  
The Government ◽  
The Individual ◽  
Ict Security ◽  
The Impact

Currently, there is an open discussion in the world on the introduction of new technologies to the lives of citizens and the economic sector. Doubts concern the impact of these technologies on the security of the individual and the state. Companies with modern technologies try to cooperate with the government and enter markets with their services. Not all countries undertake such cooperation. The presented text deals with the deliberations on the introduction of the new 5G technology. Its implementation meets the social discussion on social and state security. The implication of modern technology requires changes to the laws of states. The text focuses on studies on a study case concerning Huawei and a dispute with the US government. The discussed example presents the challenges of the authorities and rules enshrined in legal regulations with the functioning of companies introducing 5G to domestic markets. The presented text shows the legal conflict between the Trump government and a company that had to go to legal action. Paper presents analyzes the jurisprudence of the US courts in the dispute between the two above-mentioned entities.

scholarly journals Comparison in vitro felodipine release rate from the original versus generic product with controlled release of the drug

Medicina ◽  
2007 ◽  
Vol 43 (4) ◽  
pp. 326 ◽  
Author(s):  
David Vetchy ◽  
Martina Vetcha ◽  
Miloslava Rabiškova ◽  
Eva Gryczova ◽  
Lenka Bartošikova
Keyword(s):  
Controlled Release ◽  
Patent Protection ◽  
Generic Drugs ◽  
Pressure Control ◽  
Generic Product ◽  
In Vitro Dissolution ◽  
Information Leaflet ◽  
Original Product ◽  
Generic Products

After patent protection of original brand is over, there are a lot of generic products occurring on the pharmaceutical market. It may be the way to reduce the price, but on the other hand, one should expect the same quality and almost identity with original brand, because the development of generic drugs is based on pharmacological properties of the original brand. The aim of this study was to compare the similarity of two products with controlled release of felodipine – generic product Presid® and original brand Plendil® – which are commercially available in Czech Republic, based on in vitro dissolution testing. The dissolution test in three dissolution media of increasing pH (1.2, 4.5, and 6.5) for the simulation of physiological pH within the gastrointestinal tract confirmed controlled release of felodipine from the original product Plendil ER 5 mg and Plendil ER 10 mg during the period of 24 hours. The release of felodipine from generic products Presid 5 mg and Presid 10 mg was not controlled for 24 hours as it is indicated in the information leaflet. In the generic products, felodipine release was controlled just for 12 or 18 hours and in this respect did not show similarity with the original brand. Since patients take the drug just once a day in the morning, the controlled release of felodipine, which lasts only 12 to 18 hours, can cause insufficient blood pressure control especially in the most critical morning hours and higher cardiovascular risk.

Political Nationalism and Attitudes towards Immigration: The Interaction of Knowledge and Policy

2012 ◽  
Vol 19 (2) ◽  
pp. 115-127 ◽  
Author(s):  
Maria Elena Sandovici ◽  
Tor Georg Jakobsen ◽  
Zan Strabac
Keyword(s):  
Multilevel Models ◽  
Developed Countries ◽  
European Social Survey ◽  
Right Wing ◽  
Political Issue ◽  
Policy Positions ◽  
Individual Level ◽  
Human Rights Regime ◽  
The Government ◽  
The Individual

The issue of immigration is highly salient to citizens of industrialised democracies. Globalisation and the emergence of an international human rights regime, among other reasons, led to high levels of immigration to industrialised countries in recent decades. Immigrant-receiving states have shown only limited ability to control the size and composition of their immigrant population. Immigration has therefore emerged as a prominent political issue in practically all economically developed countries, and there are raising concerns over anti-immigration sentiments and nationalist tendencies that seem to be taking hold among modern publics. We argue that anti-immigration attitudes are not merely a response to increased immigration, but rather that these attitudes mirror governments’ nationalistic and anti-immigration stance. In addition, people who are interested in politics are expected to be more influenced by their governments’ policies than those who show less interest. We use data from the European Social Survey and the Comparative Manifesto Project to test these claims. Results from our multilevel models show that people living in countries where the government is right wing are more opposed to immigration than people living in countries where the government exhibits less right-wing tendencies. The effect of government policy positions is also found to be conditioned by political interest at the individual level.

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