scholarly journals Problems in the regulatory policy of the drug market

2015 ◽  
Vol 49 (0) ◽  
Author(s):  
Nathália Molleis Miziara ◽  
Diogo Rosenthal Coutinho

OBJECTIVE Analyze the implementation of drug price regulation policy by the Drug Market Regulation Chamber.METHODS This is an interview-based study, which was undertaken in 2012, using semi-structured questionnaires with social actors from the pharmaceutical market, the pharmaceuticals industry, consumers and the regulatory agency. In addition, drug prices were compiled based on surveys conducted in the state of Sao Paulo, at the point of sale, between February 2009 and May 2012.RESULTS The mean drug prices charged at the point of sale (pharmacies) were well below the maximum price to the consumer, compared with many drugs sold in Brazil. Between 2009 and 2012, 44 of the 129 prices, corresponding to 99 drugs listed in the database of compiled prices, showed a variation of more than 20.0% in the mean prices at the point of sale and the maximum price to the consumer. In addition, many laboratories have refused to apply the price adequacy coefficient in their sales to government agencies.CONCLUSIONS The regulation implemented by the pharmaceutical market regulator was unable to significantly control prices of marketed drugs, without succeeding to push them to levels lower than those determined by the pharmaceutical industry and failing, therefore, in its objective to promote pharmaceutical support for the public. It is necessary reconstruct the regulatory law to allow market prices to be reduced by the regulator as well as institutional strengthen this government body.

2021 ◽  
Vol 6 (9) ◽  
pp. e005519
Author(s):  
Jing Yuan ◽  
Z Kevin Lu ◽  
Xiaomo Xiong ◽  
Bin Jiang

To cope with the increasing healthcare costs brought about by the universal health insurance programme, national volume-based procurement (NVBP) was implemented in China to reduce drug prices. However, the impact of NVBP remains unknown. We reported the effects of the NVBP pilot programme on medication affordability and discussed the challenges and recommendations for further reforms. A total of 25 molecules won the bidding in the NVBP pilot programme, and price cuts ranged from 25% to 96%. Medication affordability was measured as the number of days’ wages needed to pay for a course of treatment, and the medication was identified as affordable if the cost of a treatment course was less than the average daily wage. After the NVBP, the proportion of affordable drugs increased from 33% to 67%, and the mean affordability improved from 8.2 days’ wages to 2.8 days’ wages. Specifically, for rural residents, the proportion of affordable drugs increased from 13% to 58%, and the mean affordability improved from 15.7 days’ wages to 5.3 days’ wages. For urban residents, the proportion of affordable drugs increased from 54% to 71%, and the mean affordability improved from 5.9 days’ wages to 2.0 days’ wages. Implementing the NVBP substantially improved medication affordability. In future reforms, a multifaceted approach addressing all issues in the health system is needed to enhance medicine access.


Author(s):  
Yesha Yadav

This chapter examines the interaction between automated, algorithmic markets and fundamental legal concepts in securities regulation, an area to which policy-makers have devoted little attention. Recent advances in communication technology have facilitated the rapid rise of algorithmic trading and automated market mechanics. This chapter surveys eight framework notions critical to regulation and discusses how these might apply in an automated marketplace. Specifically, it examines reasonableness; strict liability; foreseeability; contribution; scienter; damage and harm; evidence and proof; and disclosure and information dissemination. This analysis reveals how deeply-held assumptions guiding regulatory law sit uneasily in today’s complicated and fast-paced markets.


2018 ◽  
Vol 36 (4) ◽  
pp. 319-325 ◽  
Author(s):  
Noa Gordon ◽  
Salomon M. Stemmer ◽  
Dan Greenberg ◽  
Daniel A. Goldstein

Purpose Cancer drug prices at launch have increased in recent years. It is unclear how individual drug prices change over time after launch and what market determinants influence these changes. We measured the price trajectories of a cohort of cancer drugs after their launch into the US market and assessed the influence of market structure on price changes. Methods We studied the changes in mean monthly costs for a cohort of 24 patented, injectable anticancer drugs that were approved by the US Food and Drug Administration between 1996 and 2012. To account for discounts and rebates, we used the average sales prices published by the Centers for Medicare and Medicaid Services. Costs were adjusted to US general and health-related inflation rates. For each drug, we calculated the cumulative and annual drug cost changes. We then used a multivariable regression model to evaluate the association between market and cost changes over time. Results With a mean follow-up period of 8 years, the mean percent change in cost for all drugs was +25% (range, −14% to +96%). After adjusting for inflation, the mean cost change was +18% (range, −16% to +59%). Rituximab and trastuzumab followed a similar pattern in cost increases over time, and the inflation-adjusted monthly costs rose since approval by 49% and 44%, respectively. New supplemental US Food and Drug Administration approvals, new off-label indications, and new competitors did not influence the annual cost change rates. Conclusion Anticancer drug costs may change substantially after launch. Regardless of competition or supplemental indications, there is a steady increase in costs of patented anticancer agents over time. New regulations may be needed to prevent additional increases in drug costs after launch.


Author(s):  
Reena Shaik ◽  
Pradeep M Muragundi

Objective: Even though the generic medicines are considered to be a cheaper option compared to the branded medicines in India, there is a need to study the price disparity among the generic medicines. Hence, the present study aims to evaluate the price disparity in generic medicines under Government Scheme in India.Methods: It was found that there were 101 generic medicines approved at a fixed price for procurement under the Central Government Health Services scheme. The prices of these medicines were searched for their availability as well as for current price in Bureau of Pharma PSUs of India (under Jan Aushadhi scheme) website.Results: The major category of the generic medicine were antibiotics (53.45%) followed by nonsteroidal anti-inflammatory drugs (10.89%) and cardiovascular (6.93%) drugs. It was evident from the result obtained by comparing the prices across categories that there were both positive and negative deviations.Conclusion: It was very much evident from the results of the mean of differences that even though fixed price contracts being in place, there is a price disparity in the generic drug prices seen under Government Scheme.


2021 ◽  
Vol 30 (2) ◽  
pp. 277-315
Author(s):  
Jihee CHOI

Since ancient times, fake drugs have been on the market in Chinese society. However, during the Ming-Qing Dynasty, this problem intensified as the size of the pharmaceutical market grew, the collection and distribution structure of pharmaceutical products became increasingly complex, and the phenomenon of separation between the prescription and distribution of drugs advanced. Additionally, the government did not manage the manufacturing or quality of drugs and there was no law or institution designed to solve the problem of fake drugs. Furthermore, social opinion also criticized the widespread problem of fake drugs, and patients and doctors had to rely on various pharmacognostic books and medical knowledge to find reliable drugs in the drug market.<br>Meanwhile, as merchants participated and invested commercial capital in the pharmaceutical industry, large reputable pharmacies began to emerge in large cities and produced drugs. With the commercialization of the pharmaceutical market, the public gained interest in drugs and consumed drugs produced by these pharmacies. Moreover, there were frequent problems in the market as fake drugs imitating popular drugs were distributed and the names of famous pharmacies were stolen. Although fake drugs were a universal social problem, the Qing government was reluctant to strictly control them tried to solve this issue by enforcing banning and punishment through local governments. Prominent pharmacies filed several lawsuits against the government over the theft of fake drugs and drug names. They also advertised the legitimacy and authenticity of drugstore to the public and customers. Doctors and merchants responded to the problem of fake drugs by following occupational morality, developing drug discrimination, cracking down on organizational discipline, filing complaints with government offices, and advertising their authenticity. However, the fake medicines did not easily disappear despite such a response, as there was no state control or legislation. Evidently, the pharmaceutical market was already highly commercialized and its structure were complex. Moreover, the financial benefits of fake drugs, competition in the pharmaceutical market, and public demand for drugs with similar effects at low prices also affected the popularity of fake drugs. Hence, the distribution of fake medicine in the Qing society can be seen as a phenomenon of separation between the prescription and distribution of drugs, commercialization and consumption of drugs, and competition on the medical market.


2019 ◽  
Vol 22 (9) ◽  
pp. 1476-1483 ◽  
Author(s):  
Emma Beard ◽  
Sarah E Jackson ◽  
Robert West ◽  
Mirte A G Kuipers ◽  
Jamie Brown

Abstract Aim To quantify population-level associations between quit attempts and factors that have varied across 2007–2017 in England. Methods Data from 51 867 past-year smokers participating in the Smoking Toolkit Study (a monthly cross-sectional survey of individuals aged 16+) were aggregated over an 11-year period. Time series analysis was undertaken using ARIMAX modeling. The input series were: (1) prevalence of smoking reduction using (a) e-cigarettes and (b) nicotine replacement therapy; (2) prevalence of roll-your-own tobacco use; (3) prevalence of (a) smoking and (b) non-daily smoking; (4) mass media expenditure; (5) average expenditure on smoking; (6) characteristics in the form of (a) prevalence of high motivation to quit, (b) average age, (c) proportion from lower social grades, and (d) average number of cigarettes smoked; and (7) implementation of tobacco control policies. Results There was a decline in the prevalence of quit attempts from 44.6% to 33.8% over the study period. The partial point-of-sale ban was associated with a temporary increase in quit attempt prevalence (Badjusted = 0.224%; 95% confidence interval [CI] 0.061 to 0.388). Quit attempts were positively associated with the prevalence of high motivation to quit (Badjusted = 0.165%;95% CI 0.048 to 0.282) and negatively associated with the mean age of smokers (Badjusted = −1.351%; 95% CI −2.168 to −0.534). All other associations were nonsignificant. Conclusion Increases in the prevalence of high motivation to quit was associated with higher prevalence of attempts to quit smoking, while an increase in the mean age of smokers was associated with lower prevalence. The introduction of the partial point-of-sale ban appeared to have a temporary positive impact. Implications This study provides insight into how monthly changes in a wide range of population-level factors are associated with changes in quit attempts over an extended time period in a country with a strong tobacco control climate. The findings suggest a need for intervention or policy to stimulate quit attempts in older smokers. Otherwise, increases in the mean age of a smokers appears likely to undermine wider efforts to promote quit attempts in a population.


Author(s):  
Peter J. Neumann ◽  
Joshua T. Cohen ◽  
Daniel A. Ollendorf

New medications can provide substantial benefits, but high prescription drug prices have led to calls to contain costs. Even after accounting for discounts and rebates, average prices of leading brand-name drugs in the United States are two to four times higher than in other wealthy countries, raising questions about what these higher prices are buying us. With the advent of ever more targeted and powerful treatments, including cell- and gene-based therapies with multimillion dollar price tags, the need for sensible drug pricing policies will intensify. Price controls, common in other countries, seem appealing, but these measures can discourage innovation. Moreover, on what basis should policymakers develop such controls? This book argues that pricing prescription drugs to reflect the value they bring to patients, families, and society achieves the right balance. The book reviews the distinguishing features of the prescription drug market and explains why simple solutions like price controls and importing drugs from countries with lower drug prices are problematic without explicit assessments of value. It then describes how economists measure value, how value assessment for drugs is now being used in the United States, and what must happen going forward to overcome challenges.


2015 ◽  
Vol 42 (1) ◽  
pp. 5-38 ◽  
Author(s):  
Ilja Viktorov

The article examines how informal networks inside the Russian state influenced the formation and further development of the country’s financial markets during the 1990s and 2000s. The main argument is that the activities of these networks made it difficult to implement any coherent state regulation policy in the field. At the same time, rivalry between competing informal networks and different organizations contributed to institutional development and some improvements. The result was a dualist institutional structure of the Russian speculative financial markets that reproduced itself throughout the period in question. The study is based on in-depth interviews conducted at Moscow-based financial institutions.


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