The cost of drug development: A systematic review

Morgan, Steve; Grootendorst, Paul; Lexchin, Joel; Cunningham, Colleen; Greyson, Devon

doi:10.1016/j.healthpol.2010.12.002

Cited by 415 publications

(259 citation statements)

References 14 publications

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“…One plausible alternative is to set the user fee so that it supports the development of replacement antibiotics. Credible estimates of the development cost of new drugs range from $500m to over $1.5bn per new approved drug [47]. Antibiotics may differ systematically in their cost of development.…”

Section: Results: Setting a User Feementioning

confidence: 99%

The path of least resistance: Paying for antibiotics in non-human uses

Hollis

Ahmed

2014

Health Policy

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Antibiotic resistance is a critical threat to human and animal health. Despite the importance of antibiotics, regulators continue to allow antibiotics to be used in low-value applications --subtherapeutic dosing in animals, and spraying tobacco plants for blue mold, for example --where the benefits are unlikely to outweigh the costs in terms of increased resistance. We explore the application of a user fee in non-human uses of antibiotics. Such a fee would efficiently deter low value uses while also providing funding to support the development of the urgently needed new antibiotics.

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Section: Results: Setting a User Feementioning

confidence: 99%

The path of least resistance: Paying for antibiotics in non-human uses

Hollis

Ahmed

2014

Health Policy

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“…According to our findings, despite of thirty years of research in this area, no published estimate of the cost of developing a drug can be considered a gold standard (Morgan et al, 2011). But, estimated new drug development takes about 12 years with an estimated cost of US$500-600 million to be developed (Henry and Lexchin, 2002).…”

Section: Research and Development (Randd)mentioning

confidence: 97%

Efficacy of international approaches to medicine price regulation and control: A scoping review

et al. 2017

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Background:The access to affordable medicines is counted as a challenge, despite international measures taken towards cost containment and price regulation. Objective: To identify and review the literature on international approaches related to medicine price regulation, control, and its effectiveness. Methods: In this scoping review, peer-reviewed research and review articles, discussion papers, public documents relating to medicine pricing policies were reviewed. The search strategy was structured according to STARLITE principles. The key search terms and phrases were "medicine prices", "causes of high medicine prices", " approaches towards medicine prices control", "national medicine policies", "international approaches towards medicine price control", "containment policies", and "effects of pricing policy on medicine". Results: Medicine pricing and price regulation policies were drafted and implemented with no optimal results and things don't seem to have improved much and remain as the distant goal. These policies were either less comprehensive, outdated and fell short in implementation especially in low and middle-income countries (LMICs) due to lack of funding, infrastructure or trained professional task force. Overall, none of the policy options was preferred. Multi-pronged policy options crafted in local context are required to tackle the issue. Conclusion: The authors identify gaps in the literature and propose advanced research in the area to strengthen the healthcare system by improving medicine pricing system in each country.

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“…Estimates vary significantly, but most figures cannot be independently verified because the industry systematically refuses to disclose the underlying data for independent review. 46 Industry associations usually refer to the Tufts Center for the Study of Drug Development (CSDD) -an institute established as a result of a conference held at the Chicago School of Economics with funding from the pharmaceutical industry. 47 The CSDD's most recent estimates report drug development costs of up to 2.6 billion USD.…”

Section: The Innovation Argumentmentioning

confidence: 99%

Raising the Barriers to Access to Medicines in the Developing World – The Relentless Push for Data Exclusivity

Diependaele¹,

Cockbain²,

Sterckx³

2016

Developing World Bioethics

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Since the adoption of the WTO-TRIPS Agreement in 1994, there has been significant controversy over the impact of pharmaceutical patent protection on the access to medicines in the developing world. In addition to the market exclusivity provided by patents, the pharmaceutical industry has also sought to further extend their monopolies by advocating the need for additional 'regulatory' protection for new medicines, known as data exclusivity.Data exclusivity limits the use of clinical trial data that need to be submitted to the regulatory authorities before a new drug can enter the market. For a specified period, generic competitors cannot apply for regulatory approval for equivalent drugs relying on the originator's data. As a consequence, data exclusivity lengthens the monopoly for the original drug, impairing the availability of generic drugs. This article illustrates how the pharmaceutical industry has convinced the US and the EU to impose data exclusivity on their trade partners, many of them developing countries. The key arguments formulated by the pharmaceutical industry in favor of adopting data exclusivity and their underlying ethical assumptions are described in this article, analyzed, and found to be unconvincing. Contrary to industry's arguments, it is unlikely that data exclusivity will promote innovation, especially in developing countries. Moreover, the industry's appeal to a property rights claim over clinical test data and the idea that data exclusivity can prevent the generic competitors from 'free-riding' encounters some important problems: Neither legitimize excluding all others.

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The cost of drug development: A systematic review

Cited by 415 publications

References 14 publications

The path of least resistance: Paying for antibiotics in non-human uses

The path of least resistance: Paying for antibiotics in non-human uses

Efficacy of international approaches to medicine price regulation and control: A scoping review

Raising the Barriers to Access to Medicines in the Developing World – The Relentless Push for Data Exclusivity

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