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\"While the shockingly high prices of prescription drugs continue to dominate the news, the strategies used by pharmaceutical companies to prevent generic competition are poorly understood, even by the lawmakers responsible for regulating them. In this groundbreaking work, Robin Feldman and Evan Frondorf illuminate the inner workings of the pharmaceutical market and show how drug companies twist health policy to achieve goals contrary to the public interest. In highly engaging prose, they offer specific examples of how generic competition has been stifled for years, with costs climbing into the billions and everyday consumers paying the price. Drug Wars is a guide to the current landscape, a roadmap for reform, and a warning of what is to come. It should be read by policymakers, academics, patients, and anyone else concerned with the soaring costs of prescription drugs\"-- Provided by publisher.

Policy Points Much concern about generic drug markets has emerged in recent policy debates. Important changes in regulations, the structure of purchasing, and the length of the drug supply chain have affected generic drug markets. Effective price competition remains the rule in generic markets for large‐selling drugs. Smaller markets and those for injectable products often have less price competition and are more susceptible to supply disruptions. Context The image of generic drugs as a commodity sold in competitive markets is an oversimplification, as evidenced by increasing accounts of price spikes, sustained high price‐cost margins, and market disruptions. The mismatch between the canonical economic model of generic drug markets and reality motivated our empirical project. Methods To explore recent changes in those factors impacting the supply and demand for generic drugs, we studied, from a variety of sources, the data on price, competition, supply disruptions and recalls, changes to the supply chain, and buy‐side concentration. We examined quarterly data through 2018 for a cohort of 77 molecules that lost patent protection during the so‐called patent cliff between 2010 and 2013. Findings On the supply side, we found that for large‐market oral solids, generic entry and price declines were consistent with past studies showing a significant number of market entrants and substantial reductions in the average price of a molecule. In smaller markets for oral solids and injectable products, we observed fewer entrants, higher rates of exit, smaller price reductions, and, in some cases, considerable price instability. The number of reported shortages increased across all generic market types over time, with the rate of shortage increases especially pronounced in markets for injectable products. The number of product recalls also rose over our study period. Although we did not estimate causal effects, we did find several changes in the market environment for generic drugs that may contribute to these phenomena. The demand side for generics has become more concentrated. Supply chains rely more on producers outside the United States (particularly from China and India). Contracting practices have undergone changes that may inhibit competition in product supply. FDA regulatory scruitiny has increased. Conclusions Competition in generic drug markets varies widely by market size and product form. Recent changes in demand‐side market structure imply more downward pressure on prices stemming from buy‐side concentration. The FDA's greater regulatory oversight puts upward pressure on costs, and the lengthening of the supply chain increases production uncertainty for producers. Demand and supply‐side changes point to further market instabilities across all generic markets due to producers’ changing economic position.

China's national volume-based procurement (NVBP) policy uniquely requires the generic drug consistency evaluation (GCE) for generic drugs on the purchase list. It employs large-scale centralized procurement to lower the prices of qualified generic drugs and encourages manufacturers to get GCE certification for their generic drugs. Although it is a fundamental part of the NVBP system, research on the impact of NVBP on manufacturers has only recently emerged and is still not comprehensive enough. This study is the first to systematically evaluate the dynamic effects of the NVBP policy on the quantity of GCE-certified generic drugs and uncover their relationship in terms of both time and quantity. Interrupted time series analysis(ITSA). The NVBP lists were published by the National Healthcare Security Administration (NHSA). The information of GCE-certified generic drugs was obtained from the databases of the National Medical Products Administration (NMPA) and the Center for Drug Evaluation (CDE). Generic drugs were divided into four categories: all GCE-certified generics; GCE-certified generics of NVBP-listed drugs (NVBP-GCE generics); GCE-certified generics of non-NVBP drugs (non-NVBP GCE generics); and GCE-certified generics from each individual NVBP list. Overall, the 2018 NVBP intervention resulted in a monthly increase of 2.876 in generics certified by GCE (95% CI: 1.311-4.317). In contrast, the 2016 policy showed no statistical significance. Both NVBP-GCE and non-NVBP GCE generics experienced significant increases, with NVBP-GCE showing a more rapid initial rise. In the analysis of 8 NVBP batches, the 2016 intervention had no significant statistical impact on either the immediate or long - term effects. Conversely, the 2018 intervention significantly increased the quantity of GCE - certified generics in the short term and widened the gap between NVBP - GCE generics and non - NVBP GCE generics. Nevertheless, this effect gradually diminished over time. The quantity of NVBP - GCE generics reached its peak before or at the release of each NVBP list, while non - NVBP GCE generics continued to grow. The NVBP policy has resulted in a substantial increase in the quantity of GCE - certified generic drugs. From a comprehensive perspective, the growth rates of NVBP-GCE generics and non-NVBP GCE generics were comparable. The maximum number of GCE - certified generic drugs was witnessed either prior to or simultaneously with the release of each round of NVBP procurement documents. After the publication of each NVBP announcement, the number of GCE - certified generics on that particular procurement list started to decrease, whereas the number of non - NVBP GCE generics continued to increase steadily until April 2024.

WHO and Health Action International (HAI) have developed a standardised method for surveying medicine prices, availability, affordability, and price components in low-income and middle-income countries. Here, we present a secondary analysis of medicine availability in 45 national and subnational surveys done using the WHO/HAI methodology. Data from 45 WHO/HAI surveys in 36 countries were adjusted for inflation or deflation and purchasing power parity. International reference prices from open international procurements for generic products were used as comparators. Results are presented for 15 medicines included in at least 80% of surveys and four individual medicines. Average public sector availability of generic medicines ranged from 29·4% to 54·4% across WHO regions. Median government procurement prices for 15 generic medicines were 1·11 times corresponding international reference prices, although purchasing efficiency ranged from 0·09 to 5·37 times international reference prices. Low procurement prices did not always translate into low patient prices. Private sector patients paid 9–25 times international reference prices for lowest-priced generic products and over 20 times international reference prices for originator products across WHO regions. Treatments for acute and chronic illness were largely unaffordable in many countries. In the private sector, wholesale mark-ups ranged from 2% to 380%, whereas retail mark-ups ranged from 10% to 552%. In countries where value added tax was applied to medicines, the amount charged varied from 4% to 15%. Overall, public and private sector prices for originator and generic medicines were substantially higher than would be expected if purchasing and distribution were efficient and mark-ups were reasonable. Policy options such as promoting generic medicines and alternative financing mechanisms are needed to increase availability, reduce prices, and improve affordability. None.

The shortage of oseltamivir may soon be a thing of the past. But whether the drug will become cheap enough for developing countries and how well it will work against a pandemic remain to be seen.

Millions of people, particularly in low- and middle-income countries, lack access to effective pharmaceuticals, often because they are unaffordable. The 2001 Ministerial Conference of the World Trade Organization (WTO) adopted the Doha Declaration on the TRIPS (Trade-Related Aspects of Intellectual Property Rights) Agreement and Public Health. The declaration recognized the implications of intellectual property rights for both new medicine development and the price of medicines. The declaration outlined measures, known as TRIPS flexibilities, that WTO Members can take to ensure access to medicines for all. These measures include compulsory licensing of medicines patents and the least-developed countries pharmaceutical transition measure. The aim of this study was to document the use of TRIPS flexibilities to access lower-priced generic medicines between 2001 and 2016. Overall, 176 instances of the possible use of TRIPS flexibilities by 89 countries were identified: 100 (56.8%) involved compulsory licences or public noncommercial use licences and 40 (22.7%) involved the least-developed countries pharmaceutical transition measure. The remainder were: 1 case of parallel importation; 3 research exceptions; and 32 non-patent-related measures. Of the 176 instances, 152 (86.4%) were implemented. They covered products for treating 14 different diseases. However, 137 (77.8%) concerned medicines for human immunodeficiency virus infection and acquired immune deficiency syndrome or related diseases. The use of TRIPS flexibilities was found to be more frequent than is commonly assumed. Given the problems faced by countries today in procuring high-priced, patented medicines, the practical, legal pathway provided by TRIPS flexibilities for accessing lower-cost generic equivalents is increasingly important.

Limits on access to injectable generic drugs force providers to use potentially less effective alternatives, current patients to discontinue therapy, and some new patients to receive more invasive interventions. Yet shortages of important generic drugs remain frequent. In November 2016, one of the two manufacturers of bacille Calmette–Guérin (BCG) informed health care providers that it planned to exit the market in mid-2017. 1 Intravesical immunotherapy with BCG is the standard of treatment for preventing recurrence and disease progression in high-risk patients with non–muscle-invasive bladder cancer, who account for a substantial minority of patients with newly diagnosed bladder cancer. 2 Yet the past few years have seen intermittent disruptions of the BCG supply. The most recent disruption occurred in 2014, after a plant was temporarily closed because of manufacturing quality issues. The November announcement raises the prospect of a sustained . . .

Over the past three decades, the U.S. health care system has experienced numerous shortages of commonly-used older medicines that are both off-patent and inexpensive. Commentators seeking to explain shortages have often pointed to manufacturing quality and low profit margins as principal causes. These proximate causes, however, do not explain why there was a sudden and dramatic increase in shortages between 2007 and 2012, when shortages almost tripled from 154 to 456, or why they have persisted at similar levels into the 2020s despite repeated efforts to address them. This Article posits that low prices and quality problems derive from underlying shifts in the market environment, and that these shifts in turn are largely the result of Congressional legislation. The role of such well-intentioned legislation over the past fifty years is evaluated, including the 1984 Hatch-Waxman Act, the 2003 Medicare Modernization Act, the 2012 Generic Drug User Fee Act, and the 2015 Bipartisan Budget Act. The analysis reveals these laws have inadvertently squeezed profitability out of the generic drug market and thereby served as a true root cause of many drug shortages. Also considered are the potential effects on drug shortages of more recent legislation, including the 2021 American Rescue Act Plan and the 2022 Inflation Reduction Act.

In the USA, a hypertension registry was created to support systems-level improvements for 600 000 patients, which raised hypertension control rates from 44% to 80% over 8 years.16 This approach has also been applied to hypertension treatment in Palestinian refugee camps in Jordan.17 Simplification of treatment protocols, including specification of drugs and dosages to use at each step, is another key element to improve treatment of hypertension.9,18 When patients receive standardised care, delivery systems can be planned and streamlined and decision making by providers can be simplified. In May, 2013, the World Health Assembly endorsed a set of global voluntary targets for non-communicable diseases, including a 25% reduction in the prevalence of raised blood pressure by 2025.20 We estimate that treating half of people with uncontrolled hypertension, including those untreated and those inadequately treated, would avert 10 million cardiovascular events worldwide over 10 years.21 Global innovations in HIV/AIDS and tuberculosis show that treatment of people with a chronic or long-term disorder can have a broad reach and population effect.

Access to medicines and vaccines to prevent and treat non-communicable diseases (NCDs) is unacceptably low worldwide. In the 2011 UN political declaration on the prevention and control of NCDs, heads of government made several commitments related to access to essential medicines, technologies, and vaccines for such diseases. 30 years of experience with policies for essential medicines and 10 years of scaling up of HIV treatment have provided the knowledge needed to address barriers to long-term effective treatment and prevention of NCDs. More medicines can be acquired within existing budgets with efficient selection, procurement, and use of generic medicines. Furthermore, low-income and middle-income countries need to increase mobilisation of domestic resources to cater for the many patients with NCDs who do not have access to treatment. Existing initiatives for HIV treatment offer useful lessons that can enhance access to pharmaceutical management of NCDs and improve adherence to long-term treatment of chronic illness; policy makers should also address unacceptable inequities in access to controlled opioid analgesics. In addition to off-patent medicines, governments can promote access to new and future on-patent medicinal products through coherent and equitable health and trade policies, particularly those for intellectual property. Frequent conflicts of interest need to be identified and managed, and indicators and targets for access to NCD medicines should be used to monitor progress. Only with these approaches can a difference be made to the lives of hundreds of millions of current and future patients with NCDs.