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1. Considering Returns on Federal Investment in the Negotiated “Maximum Fair Price” of Drugs Under the Inflation Reduction Act: an Analysis

Author:
Edward W. Zhou, Paula G. da Silva, Debbie Quijada, and Fred D. Ledley
Publication Date:
03-2024
Content Type:
Working Paper
Institution:
Institute for New Economic Thinking (INET)
Abstract:
The Inflation Reduction Act (IRA) of 2022 contained landmark provisions authorizing government to negotiate a “maximum fair price” for selected Medicare Part D drugs considering the manufacturer’s research and development costs, federal support for discovery and development, the extent to which the drugs address unmet medical needs, and other factors. This working paper describes federal investment in the discovery and development of the ten drugs selected for price negotiation in the first year of the IRA as well as the health value created through Medicare Part D spending on these drugs. We identified $11.7 billion in NIH funding for basic or applied research leading to approval of these drugs with median investment costs of $895.4 million/drug. This early public investment provided a median cost savings to industry of $1,485 million/drug, comparable to reported levels of investment by industry. From 2017-2021, Medicare Part D spent $126.4 billion (median $10.7 billion) for these products before rebates. Excluding two products for diabetes, Medicare Part D spending was $97.4 billion and the total health value created was 650,940 QALYs or $67.7 billion (WTP/QALY=$104K) representing a negative residual health value of -$29.7 billion (before rebates). We argue that a negotiated fair price should provide returns on both private and public investments in these products commensurate with the scale and risk of these investments, with the principal return on public sector investments being the residual health value (net price) accruing to those using the product. These empirical data provide a cost basis for negotiating a fair price that rewards early government investments in innovation and provides social value for the public.
Topic:
Economics, Health, Public Health, Pharmaceuticals, and Public Investment
Political Geography:
North America and United States of America

2. Setting Pharmaceutical Drug Prices: What the Medicare Negotiators Need to Know About Innovation and Financialization

Author:
Öner Tulum and William Lazonick
Publication Date:
09-2024
Content Type:
Working Paper
Institution:
Institute for New Economic Thinking (INET)
Abstract:
Mandated by the Inflation Reduction Act of 2022, the U.S. government through the Centers for Medicare and Medicaid Services (CMS) is negotiating with pharmaceutical companies over the “maximum fair price” of ten drugs in wide use by Medicare patients. Over the next few years, the number of drugs whose prices are subject to negotiations will increase. The pharmaceutical companies contend that a “fair” price would be a “value-based price” that enables the companies’ shareholders to capture the value that the drug creates for society. Invoking the dominant “maximizing shareholder value” ideology, the argument for value-based pricing assumes that it is only a pharmaceutical company’s shareholders who make the risky investments that fund drug innovation. Pharmaceutical executives and their lobbyists warn that a lowering of drug prices will reduce investments in new drugs. The purpose of this paper is to enable CMS negotiators to respond to these arguments by showing a) why drug-price regulation is required, given the relation between scale economies in supplying drugs and price inelasticity of drug demand; b) how the pharmaceutical companies with which they are negotiating prices are, in general, not using their profits from unregulated drug prices to fund drug innovation but rather to fund distributions to shareholders in the form of cash dividends and stock buybacks; c) that publicly listed pharmaceutical companies do not typically rely upon investment by shareholders to fund drug innovation; and d) that investment in drug innovation entails “collective and cumulative learning” in foundational and translational research that is both antecedent and external to the investments in clinical research that a pharmaceutical company may make to bring a safe and effective drug to market.
Topic:
Economics, Health, Finance, Innovation, Pharmaceuticals, and Medicare
Political Geography:
North America and United States of America

3. Tracking the Fortunes of Corporate Psychedelia

Author:
Sandy Hager
Publication Date:
01-2024
Content Type:
Working Paper
Institution:
City Political Economy Research Centre (CITYPERC), University of London
Abstract:
In recent years, new biotech companies have emerged hoping to cash in on a medical psychedelics market expected to be worth billions. This article examines the business models of two of the largest such companies. According to conventional wisdom, for-profit players are best positioned to deliver new cures for mental illness at scale because of their ability to tap capital markets. The analysis presented here challenges this story on two counts. First, it argues that profitability in the pharmaceutical business depends not on rapid scaling per se, but on controlling and restricting access to maintain pricing power. Second, it claims that the unruliness of psychedelics – manifested in the presence of cheap generics, murky intellectual property claims, and high costs of administration – raises serious questions about their commercial viability. The article then assesses the sector’s embrace of Johnson and Johnson’s patented form of esketamine, Spravato, as its prototype for commercialization. Spravato may provide a pathway for profitability, but patients must contend with high prices and a drug that provides only short-term relief and requires indefinite dosing. Rather than disrupt Big Pharma, corporate psychedelia replicates its main features, raising questions about its claims to tackle the mental health crisis.
Topic:
Business, Mental Health, Pharmaceuticals, Biotechnology, Psychedelics, and Medicalization
Political Geography:
Global Focus

4. Strategic Autonomy and the Competitiveness of Europe’s Innovative Pharmaceutical Sector: A Wake-up Call

Author:
Fredrik Erixon and Oscar Guinea
Publication Date:
04-2023
Content Type:
Working Paper
Institution:
European Centre for International Political Economy (ECIPE)
Abstract:
It is high time for Europe to break its relative decline in the pharmaceutical sector. Europe used to be the preeminent region in the world for Research and Development and innovation in the sector – being the location for a majority of R&D and the development of new medicines. However, its competitiveness has been going down for several decades – and, in more recent time, the pace of the decline is now accelerating. Europe is not just outpaced by the United States. Unless there is a new direction, China will soon be ahead of Europe too. Europe is behind the global frontier in innovation and new product development in medicines. It is not just Europe’s share of global R&D that is going down. Of all the new chemical and biological entities that are developed, Europe is contributing a falling share. There is a similar development in the drug pipeline – medicines that are in the regulatory approval process. The location of clinical trials for Advanced Therapy Medicinal Products – an area of new frontline drug development – is moving out of Europe. If Europe is to improve its strategic autonomy and restore competitiveness in the pharmaceutical sector, better policies are needed to incentivise innovation and attract R&D investment. A new strategy for the pharmaceutical industry should include – among other things – better protection of intellectual property, more and focused R&D expenditures, and streamlined regulatory and reimbursement processes.
Topic:
European Union, Pharmaceuticals, Strategic Autonomy, Research and Development, and Competition
Political Geography:
Europe

5. Friend-shoring in the Indo-Pacific

Author:
Akhil Ramesh and Rob York
Publication Date:
11-2023
Content Type:
Special Report
Institution:
Pacific Forum
Abstract:
The COVID-19 pandemic and Russia’s invasion of Ukraine highlight the challenges of increased economic interconnectedness with adversarial states. The shortages in critical sectors such as pharmaceuticals, semiconductors, and other industries significant for technological advancement in the fourth industrial revolution have revealed the importance of select supply chains to the American public and the broader global community. As the strategic competition between the US and China accelerates, understanding of their importance will only grow. The Biden administration, to its credit, realized early on the importance of four critical sectors for the future of US supply chain security: pharmaceuticals, critical minerals, large-scale batteries, and semiconductors. Alarmingly, through the research presented here by Akhil Ramesh and myself, we see that the People’s Republic of China has deeply embedded itself in three of these four sectors, and still seeks to strengthen its position in the fourth (semiconductors). Also, one of the recurring problems highlighted in this research is the tendency of the administration to consider the job done once it sources a critical technology from somewhere other than China—not realizing that the PRC serves as a source for that country elsewhere in the supply chain.
Topic:
Pharmaceuticals, Supply Chains, Semiconductors, Batteries, and Critical Minerals
Political Geography:
United States of America and Indo-Pacific

6. Unreliable Data Have Infected the Policy Debates Over Drug Patents

Author:
Adam Mossoff
Publication Date:
01-2022
Content Type:
Special Report
Institution:
Hudson Institute
Abstract:
The COVID-19 pandemic has vividly brought to the public’s attention the key role of medical innovation in saving lives and increasing the quality of daily life. The pandemic has also precipitated an international debate over the role of patents and other intellectual property rights in the discovery, manufacture, and distribution of drugs and vaccines to patients. Even before COVID-19, there has been an ongoing policy debate in Washington, D.C., over drug prices and patents with congressional hearings, proposed legislation, and antitrust enforcement actions. The pandemic has thus made apparent what reliable data have already shown: poorly crafted legislation or antitrust enforcement actions could have a tremendous negative impact on the innovation economy in general and on healthcare specifically by undermining the incentives that drive the billions invested annually in the research and development of life-saving drugs and other medical treatments. Congress and regulators should engage in evidence-based policymaking on these important issues, which have far-reaching implications for economic growth and quality of life. This policy memo identifies a serious concern about the data in these discussions.
Topic:
Science and Technology, Intellectual Property/Copyright, Innovation, Data, and Pharmaceuticals
Political Geography:
North America and United States of America

7. Past Economic Decline Predicts Opioid Prescription Rates

Author:
Herb Susmann, Elias Nosrati, Michael Ash, Michael Marmot, and Lawrence King
Publication Date:
12-2022
Content Type:
Working Paper
Institution:
Political Economy Research Institute (PERI), University of Massachusetts Amherst
Abstract:
America is in undergoing an epidemic of opioid related deaths. Analysts have emphasized two different (but not mutually exclusive) arguments. Supply based explanations emphasize the immoral activity of pharmaceutical companies from 1996 to aggressively market opioids. They typically use prescription rates as a measure of this variable. Demand based explanations emphasize the demand for opioids caused by economic hardship. This paper demonstrates that prescription rates are not entirely exogenous. We show that the decline of average household income from 1979 to 1989 at the county level is a significant predictor of opioid prescription rates in 2010. This is consistent with research that shows that childhood trauma predicts adult drug abuse. The policy implications of this finding are that an adequate response to the opioid epidemic must address economic dislocation and insecurity.
Topic:
Political Economy, Health Crisis, Pharmaceuticals, Opioid Crisis, and Income
Political Geography:
North America and United States of America

8. Will the Biden Administration Support Global US Leadership in the Innovative Medicines Industry?

Author:
Thomas J. Duesterberg
Publication Date:
01-2021
Content Type:
Policy Brief
Institution:
Hudson Institute
Abstract:
Given the historically unprecedented speed with which the US pharmaceutical industry has developed COVID-19 vaccines—3 of the 4 first products likely to be approved for marketing are almost certainly from US firms—it would seem appropriate for a renewed sense of confidence, support and even acclaim for the economic model that lies behind this success. Instead, the sector remains under pressure to lower prices and protections for its patented products, both in the United States and globally. It is worth noting that the entire world benefits from the new medical advances in treating the worst pandemic in at least 50 years. Instead, President Trump has continued to criticize the industry for its pricing model for newly developed drugs, while countries such as India, Pakistan, and Brazil call for breaching of the patent shield for the new vaccines (and recent treatments such as those for HIV and Hepatitis C), and developed countries in Europe, East Asia, as well as Canada, persist in questioning the medical value of the new medicines to their citizens.1 To add to the current uncertainty about US leadership, there is ever-increasing competition from China in terms of basic science and pharmaceutical products. The Chinese national goal of self-sufficiency in these two fields has resulted in a huge increase in research and development funding and purchases of leading biotechnology firms in the United States and Europe. At the same time, China’s global market share in generic drugs and active pharmaceutical ingredients (APIs) is steadily growing. Chinese government funding for research in these fields has grown by 20 percent annually since 2008. The incoming Biden administration is calling for new pricing models and the use of compulsory licensing for some new products, especially those related to the new virus pandemics. Compulsory licensing allows a government to license entities other than the patent holder to produce and sell patented products without the patent holder’s permission. If the economic and scientific model which promotes constant advances in medicines and new treatments is to survive, the current domestic ecosystem for research and development ought to be strengthened, instead of being undermined by reducing private sector incentives and weakening the protection of intellectual property (IP). Additionally, ways to address the problem with other countries enjoying a “free ride” at the expense of US consumers and public health systems, need to be considered.
Topic:
Health Care Policy, Manufacturing, Innovation, Vaccine, COVID-19, Medicine, and Pharmaceuticals
Political Geography:
North America and United States of America

9. Dividing up Covid-19 vaccine: distribution based on countries’ weight

Author:
Al Jazeera Center for Studies
Publication Date:
02-2021
Content Type:
Policy Brief
Institution:
Al Jazeera Center for Studies
Abstract:
Ending the coronavirus pandemic is not only about the technical issue of vaccine development. The challenge is multidimensional, involving a global proprietary pharmaceutical system and an exclusive, nationalist tendency in wealthy, prosperous states.
Topic:
Nationalism, Vaccine, COVID-19, Health Crisis, and Pharmaceuticals
Political Geography:
Global Focus

10. Facilitating Trade in Pharmaceuticals: A Response to the COVID-19 Pandemic

Author:
Ben Shepherd
Publication Date:
04-2021
Content Type:
Research Paper
Institution:
Economic Research Institute for ASEAN and East Asia (ERIA)
Abstract:
This paper reviews trade in pharmaceutical products, focusing on ASEAN countries. Trade in this sector is of singular policy importance as a result of the COVID-19 pandemic. First, the paper shows that pharmaceuticals are traded within Global Value Chains, which in turn means that international linkages are complex. Second, the paper shows that policy reforms can help boost trade in the sector, which has important human development implications during the pandemic period.
Topic:
Globalization, International Trade and Finance, Pandemic, Global Value Chains, COVID-19, and Pharmaceuticals
Political Geography:
Asia and Southeast Asia