Search

Background: There is an inconsistency in the way pharmaceutical research is financed. While pull mechanisms are predominantly used to incentivize later-stage pharmaceutical research for products with demand in the Global North, so-called neglected diseases are chiefly financed by push funding. This discrepancy has so far been ignored in the academic debate, and any compelling explanation for why we draw the line between push and pull at poor people is lacking. Main body: Clinical development of new pharmaceuticals is chiefly financed by free market pull mechanisms. Even in cases where markets fail to deliver adequate incentives, demand enhancement mechanisms are used to replicate pull funding artificially, for example, with subscription models for antibiotics. Push funding in clinical research is almost always used when the poverty of patients means that markets fail to create sufficient demand. The general question of whether push or pull generally is the more efficient way to conduct pharmaceutical research arises. Conclusions: If the state is efficient in directing limited budgets for pharmaceutical research, push funding should be expanded to global diseases. If private industry is the more efficient actor, there would be enormous value in experimenting more aggressively with different approaches to enhance market demand artificially for neglected diseases. [ABSTRACT FROM AUTHOR]

Objectives: To describe the main features of a pharmaceutical market in which the duration of guaranteed monopoly periods would correspond to a new pharmaceutical product's value.Methods: After reviewing patent and regulatory exclusivity-based mechanisms for protecting prescription drug markets from competition to incentivize drug innovation in developed countries, we model market protection mechanisms within the current framework to give the longest-lasting market protections to drug developers that bring the most affordable products to market with highest public health and clinical value.Results: An approach tying pharmaceutical market exclusivity to value would have 3 main features. First, it would be based on regulatory exclusivity (ie, the drug regulator refrains from authorizing generic entry for a certain amount of time), rather than patents. Second, the duration of exclusivity period would be pegged to the magnitude of a product's anticipated health impact and its proposed price by using modified methods from the field of health technology assessment. Third, the duration of the value-based exclusivity period would be reassessed routinely 3 years after the product's launch to account for its real-world effectiveness.Conclusions: Linking a drug's proposed price to the duration of its regulatory-based exclusivities would both incentivize the development of high impact, low-cost products and motivate drug developers to introduce these products at lower prices. [ABSTRACT FROM AUTHOR]

• COVID-19 has prompted vastly more clinical trials than previous health emergencies. • Trials started faster, are collectively larger, and are more diverse geographically. • The initial trials so far are mostly not funded by industry. • Lack of coordination will lead to inefficiency and duplication. The clinical trial landscape for Coronavirus 2019 (COVID-19) is radically different from that of previous epidemics. Compared with H1N1, Ebola, and Zika, COVID-19 had an order of magnitude more clinical trials within the first 3 months following the declaration of a Public Health Emergency of International Concern (PHEIC). These trials have started much faster, are more geographically diverse, and are less likely to be funded by industry. However, the almost simultaneous design and initiation of hundreds of trials with 0.3 million participants across 78 countries creates the potential for congestion and inefficiencies and enhances risks for investors. Thus, an international coordination mechanism for clinical trials could be valuable in this and other situations. [ABSTRACT FROM AUTHOR]

• We surveyed 2,712 people in Canada following COVID-19 vaccine mandates in 2021. • Perceiving COVID-19 as less serious predicted reporting a mostly unvaccinated social circle. • Risk perception was a more powerful predictor than sociodemographic variables. • Risk perception may be a key indicator of social networks with lower intervention uptake. • Identifying high risk social circles has utility for outreach design and health system readiness. Social networks have an important impact on our health behaviours, including vaccination. People's vaccination beliefs tend to mirror those of their social network. As social networks are homogenous in many ways, we sought to determine in the context of COVID-19 which factors were most predictive of belonging to a mostly vaccinated or unvaccinated social group. We conducted a cross-sectional survey among Canadian residents in November and December 2021. Participants were asked about the vaccination status of their social networks their beliefs relating to COVID-19, and various sociodemographic factors. Respondents were split into three groups based on social network vaccination: low-, medium-, and high-risk. Chi-squared tests tested associations between factors and risk groups, and an ordinal logistic model was created to determine their direction and strength. Most respondents (81.1 %) were classified as low risk (i.e., a mostly vaccinated social network) and few respondents (3.7 %) were classified as high-risk (i.e., an unvaccinated social group). Both the chi-square test (29.2 % difference between the low- and high- risk groups [1.8 % vs. 31.0 %], p < 0.001) and the ordinal logistic model (odds ratio between the low- and high-risk groups: 14.45, p < 0.01) found that respondents' perceptions of COVID-19 as a "not at all serious" risk to Canadians was the most powerful predictor of belonging to a predominantly unvaccinated social circle. The model also found that those in mostly unvaccinated social circles also more often reported severe COVID-19 symptoms (odds ratio between the low- and high-risk groups: 2.26, p < 0.05). Perception of COVID-19 as a threat to others may signal communities with lower vaccination coverage and higher risk of severe outcomes. This may have implications for strategies to improve public outreach, messaging, and planning for downstream consequences of low intervention uptake. [ABSTRACT FROM AUTHOR]

Canadian drug plan pricing of generic drugs is in a state of flux, with different plans adopting different approaches. The manner in which public plans pay for generic drugs can affect five policy goals: low generic drug prices, security of the drug supply, a reliance on reimbursement rules (thereby avoiding the need for drug plan managers to exercise discretion over reimbursement levels), low administrative burden and finally, the provision of adequate incentives for generics to enter the market. We review five pricing mechanisms: maximum prices, tiered pricing, tendering, benchmarking and pharmacy competition. We examine international evidence on the success of the first three of these. We conclude with an assessment of promising reimbursement approaches. [ABSTRACT FROM AUTHOR]

The process of innovation is inherently complex, and it occurs within an even more complex institutional environment characterized by incomplete information, market power, and externalities. There are therefore different competing approaches to supporting and financing innovation in medical technologies, which bring their own advantages and disadvantages. This article reviews value- and cost-based pricing, as well direct government funding, and cross-cutting institutional structures. It argues that performance-based risk-sharing agreements are likely to have little effect on the sustainability of financing; that there is a role for cost-based pricing models in some situations; and that the push towards longer exclusivity periods is likely contrary to the interests of industry. [ABSTRACT FROM AUTHOR]

Antibiotics may be thought of as a common pool resource that can be depleted over time; the economics of this problem are relatively well known. The importance of antibiotics to human health means that limiting access through privatization is undesirable. Therefore, other solutions to prevent overuse are essential - stewardship programs, and for non-human use, taxation, all within the context of an international agreement. To solve problems of access while offering adequate rewards for innovation, a key tool is delinking prices from payment to innovators. [ABSTRACT FROM AUTHOR]

Background Manufacturers justify the high prices for orphan drugs on the basis that the associated R&D costs must be spread over few patients. The proliferation of these drugs in the last three decades, combined with high prices commonly in excess of $100,000 per patient per year are placing a substantial strain on the budgets of drug plans in many countries. Do insurers spend a growing portion of their budgets on small patient populations, or leave vulnerable patients without coverage for valuable treatments? We suggest that a third option is present in the form of a cost-based regulatory mechanism. Methods This article explores the use of a cost-based price control mechanism for orphan drugs, adapted from the standard models applied in utilities regulation. Results and conclusions A rate-of-return style model, employing yardsticked cost allocations and a modified twostage rate of return calculation could be effective in setting a new standard for orphan drugs pricing. This type of cost-based pricing would limit the costs faced by insurers while continuing to provide an efficient incentive for new drug development. [ABSTRACT FROM AUTHOR]

The article offers information on the new patent approaches for pharmaceutical drug innovation. It mentions the proposed mechanisms which includes push programs, which is the public funding of basic research and clinical trials, and pull programs which include royalty-based schemes and reward-based schemes to develop the pharmaceutical current systems. It also discusses the limitations of the drug patent system, alternatives and complements to patents, and implementation of the issues.

In a widely cited 2003 article, DiMasi, Hansen, and Grabowski estimated the cost of pharmaceutical research and development to be $1.1 billion (year 2000 U.S. dollars) per new medicine coming onto the market in 2001. They also estimate that this cost is going up at a real (inflation-adjusted) rate of 7.4% annually. According to these estimates, the innovation cost per new medicine today is about $2.1 billion (year 2000 U.S. dollars) or $2.65 billion (year 2010 U.S. dollars). [ABSTRACT FROM PUBLISHER]

Is it really necessary to add something like the Health Impact Fund to the existing global patent system? We can divide this question into two parts. First, is there something seriously wrong with the status quo and, if so, what exactly is it? Second, how do we best go about solving the problem; that is, how does the design of the reform proposal address the flaws in the status quo? Jorn Sonderholm, in his critique of the Health Impact Fund, or HIF, raises both of these issues. These criticisms afford us the opportunity to reaffirm our commitment to ameliorating glaring problems with the current system for incentivizing R&D for essential medicines, and to clarify why we believe the HIF is exactly what the world needs. [ABSTRACT FROM PUBLISHER]

The authors propose the establishment of a Health Impact Fund (HIF) to provide pharmaceutical innovators with stable financial incentives to create and market new drugs. They emphasize the relevance of an incentive program to the creation of quality and affordable drugs and promote global health. They argue that a reform of the rewards programs for drug innovations is the most sustainable solution to improve drug access. The authors also describe the possible outcomes of HIF to the pharmaceutical industry and global health.

This paper offers an economic rationale for compulsory licensing of needed medicines in developing countries. The patent system is based on a trade-off between the “deadweight losses” caused by market power and the incentive to innovate created by increased profits from monopoly pricing during the period of the patent. However, markets for essential medicines under patent in developing countries with high income inequality are characterized by highly convex demand curves, producing large deadweight losses relative to potential profits when monopoly firms exercise profit-maximizing pricing strategies. As a result, these markets are systematically ill-suited to exclusive marketing rights, a problem which can be corrected through compulsory licensing. Open licenses that permit any qualified firm to supply the market on the same terms, such as may be available under licenses of right or essential facility legal standards, can be used to mitigate the negative effects of government-granted patents, thereby increasing overall social welfare. [ABSTRACT FROM AUTHOR]

The Health Impact Fund has been proposed as an optional, comprehensive advance market commitment system offering financial payments or ‘prizes’ to patentees of new drugs, which are sold globally at an administered low price. The Fund is designed to offer payments based on the therapeutic impact of the drugs or vaccines, so that innovators will have efficient incentives to develop drugs that maximize health gains. Consumers would have improved access to such drugs because of low prices. [ABSTRACT FROM PUBLISHER]

The article examines how parallel trade affects drug policies and prices in Canada and the U.S. U.S. consumers and Canadian pharmacies have taken advantage of the opportunity presented by price differences in patented pharmaceuticals. This brought the Canadian and U.S. systems for determining pharmaceutical pricing under increased scrutiny. It asserts that the price discrimination strategies of pharmaceutical manufacturers and exchange rate fluctuate have played an underappreciated role.

The article presents and explores some useful empirical facts about 'me-too' drugs. These drugs, which are sometimes called follow-on drugs, are products that largely duplicate the action of existing drugs. Pharmaceutical industry players are becoming concern regarding the increasing extent to which investment appears to be focused on developing me-too drugs.

This article analyzes the benefits and costs of replacing Canada's ten different provincial formularies with one single national formulary. The 2002 Romanow Commission on the Future of Health Care in Canada recommended that Canada should have a National Drug Agency which would maintain a national formulary, replacing the existing provincial formularies which balkanize drug markets across Canada. This recommendation has been in part incorporated into the Common Drug Review in which the provinces (excluding Quebec) have agreed to undertake a single evaluation of all new drugs; provinces, however, retain their own formularies and decide which products to list. This balkanized approach to listing and insurance coverage of drugs substantially weakens the bargaining position of the provinces and leads to higher costs. [ABSTRACT FROM AUTHOR]

What happens to microfinance organizations when faced with massive external shocks such as famines? Using a unique and extensive data set, we analyze the impact of the Great Irish Famine of the 1840s on the Irish loan funds. The funds were a large and important microfinance institution operating throughout Ireland. We find that the pre-famine capital ratio of each fund was a strong predictor of survival of the fund through the famine. Among available local demographic variables, the most significant is the rate of female literacy, which was strongly correlated with the probability of fund survival. [Copyright &y& Elsevier]

Brand-name pharmaceutical firms in Canada, upon the expiry of their patent, always license a "pseudogeneric" firm to compete directly against generic firms. This pseudo-generic is identical to the brand-name product, but is marketed as a generic, with the pseudo-generic firm receiving a distribution fee. This strategy deters entry into smaller drug markets, since the threat of pseudo-generic competition deters other generics from making the investment required to enter; and slows the process of entry by competing generic firms. [ABSTRACT FROM AUTHOR]

Examines the history of the loan fund system in Ireland. Operation of non-profit quasi-banks restricted to making small loans to the poor without collateral; Relevance of the loan fund system to microfinance; Applicability of the theories of institutional development.

Background: The Patented Medicine Prices Review Board (PMPRB), the agency that regulates the prices of patented medicines in Canada, published proposed amendments to the regulatory framework in December 2017. Because of a series of changes and delays, the revised policy has not yet been finalized. We sought to evaluate the potential early impact of the uncertainty about the PMPRB policy on patented-medicine launches. Methods: We developed a retrospective cohort of patented medicines (molecules) sold in Canada and the 13 countries that the PMPRB currently uses or has proposed to use as price comparators, from sales data from the IQVIA MIDAS database for 2012–2021. The outcome was whether a molecule was launched (i.e., sold) in a specific country within 2 years of its global first launch (2-yr launch). We compared the change of 2-year launch before (2012–2017) and after the proposed amendments were published ("uncertain period," 2018–2021) in Canada with the change in the United States and the other 12 countries as a group ("other-countries group"), using interrupted time series and logistic regressions, respectively. We further conducted analyses for each individual country and subgroups by molecule characteristics, such as therapeutic benefit, separately. Results: We included 242 and 107 new molecules launched before publication of the proposed amendments and during the uncertain period, respectively. The corresponding 2-year launch proportions were 45.0% and 30.8% in Canada, 81.4% and 82.2% in the US, and 83.9% and 70.1% in the other-countries group. All analyses showed changes in 2-year launch during the uncertain period in the US and in the other-countries group that were similar to the changes in Canada. Greater decreases were observed in Norway and Sweden than in Canada. The 2-year launch proportion for molecules with major therapeutic benefit decreased from 45.8% to 31.3% in Canada during the uncertain period and from 87.5% to 62.5% in the other-countries group, but increased from 91.7% to 100% in the US. Interpretation: No negative impact of the PMPRB-policy uncertainty on molecule launches was observed when comparing Canada with price-comparator countries, except for molecules with major therapeutic benefit. The reduction in launches of medicines with major therapeutic benefit in Canada requires continuing investigation. [ABSTRACT FROM AUTHOR]

Examines six microcredit organizations of 19th-century Europe to identify what financial institutional designs were conducive to success and sustainability. Method used; Brief histories of the six organizations; Conclusions.

Focuses on a study on mid-19th century loan funds societies in Ireland. Feature of financial market in Ireland; Explanations for the absence of the banks from a large segment of their potential market; Background on loan funds; Results of the study; Conclusions.

The article discusses the rational preservation of antibiotics, a types of medications that destroy or slow down the growth of bacteria. It reflects on the stocks of antibiotics in the U.S. wherein 51 tons of it are consumed daily in agriculture and aquaculture. It focuses on the nonhuman utilization of antibiotics which contributed antimicrobial resistance to humans. It notes the prohibition of the Food and Drug Administration in the U.S. on the use of fluoroquinolones in poultry in 2005.

One reason expressed in surveys of people reporting coronavirus disease 2019 (COVID-19) vaccine hesitancy is how rapidly these vaccines have reached the market. To estimate the length of time the COVID-19 vaccine spent in research and development as compared to other novel vaccines, we apply previously established methods for estimating medical product development times, using the key associated patent filings cited by the manufacturer as the marker of when commercial development activity began. Applying these methods to a cohort of recently approved innovative vaccines and comparing them to the first-approved COVID-19 vaccine (BioNTech/Pfizer), we found key patent filings for the technology in this COVID-19 vaccine occurred 10.0 years prior to regulatory authorization. By this metric, the development timelines for innovative vaccines have been shortening since the 1980s, and the COVID-19 vaccine comfortably fits within this pattern. Vaccine development timelines have now even drawn to parity with many of the most commonly used drugs. [ABSTRACT FROM AUTHOR]

Background: The private versus public contribution to developing new health knowledge and interventions is deeply contentious. Proponents of commercial innovation highlight its role in late-stage clinical trials, regulatory approval, and widespread distribution. Proponents of public innovation point out the role of public institutions in forming the foundational knowledge undergirding downstream innovation. The rapidly evolving COVID-19 situation has brought with it uniquely proactive public involvement to characterize, treat, and prevent this novel health treat. How has this affected the share of research by industry and public institutions, particularly compared to the experience of previous pandemics, Ebola, H1N1 and Zika? Methods: Using Embase, we categorized all publications for COVID-19, Ebola, H1N1 and Zika as having any author identified as affiliated with industry or not. We placed all disease areas on a common timeline of the number of days since the WHO had declared a Public Health Emergency of International Concern with a six-month lookback window. We plotted the number and proportion of publications over time using a smoothing function and plotted a rolling 30-day cumulative sum to illustrate the variability in publication outputs over time. Results: Industry-affiliated articles represented 2% (1,773 articles) of publications over the 14 months observed for COVID-19, 7% (278 articles) over 7.1 years observed for Ebola, 5% (350 articles) over 12.4 years observed for H1N1, and 3% (160 articles) over the 5.7 years observed for Zika. The proportion of industry-affiliated publications built steadily over the time observed, eventually plateauing around 7.5% for Ebola, 5.5% for H1H1, and 3.5% for Zika. In contrast, COVID-19's proportion oscillated from 1.4% to above 2.7% and then declined again to 1.7%. At this point in the pandemic (i.e., 14 months since the PHEIC), the proportion of industry-affiliated articles had been higher for the other three disease areas; for example, the proportion for H1N1 was twice as high. Conclusions: While the industry-affiliated contribution to the biomedical literature for COVID is extraordinary in its absolute number, its proportional share is unprecedentedly low currently. Nevertheless, the world has witnessed one of the most remarkable mobilizations of the biomedical innovation ecosystem in history. [ABSTRACT FROM AUTHOR]

Background: High orphan drug prices have gained the attention of payers and policy makers. These prices may reflect the need to recoup the cost of drug development from a small patient pool. However, estimates of the cost of orphan drug development are sparse.Methods: Using publicly available data, we estimated the differences in trial characteristics and clinical development costs with 100 orphan and 100 non-orphan drugs.Results: We found that the out-of-pocket clinical costs per approved orphan drug to be $166 million and $291 million (2013 USD) per non-orphan drug. The capitalized clinical costs per approved orphan drug and non-orphan drug were estimated to be $291 million and $412 million respectively. When focusing on new molecular entities only, we found that the capitalized clinical cost per approved orphan drug was half that of a non-orphan drug.Conclusions: More discussion is needed to better align on which cost components should be included in research and development costs for pharmaceuticals. [ABSTRACT FROM AUTHOR]

The author comments on the deal finalized by the Council of the Federation with generic drug manufacturers to reform the reimbursement scheme for generic drugs. Topics covered include the concept of the tiered pricing scheme, the consequences of the ad hoc price reductions pursued by provincial drug plans in the generic drug market and the possible effect of tendering on incentives to challenge patents on existing brand name drugs.

Questions whether there is justification for compulsory licensing of pharmaceuticals and other medical services in the developed world. Idea that compulsory licensing involves breaking a patent right in order to change the terms of bargaining between a buyer and a seller; Standard analysis of patents which focuses on the trade-off between economic efficiency and incentives for innovation; Public health care system in Canada.

Background Management of suspected Clostridioides difficile infection (CDI) in the hospital setting typically results in patient isolation, laboratory testing, infection control, and presumptive treatment. We investigated whether implementation of rapid near-patient testing (NPT) reduced patient isolation time, hospital length of stay (LOS), antibiotic usage, and cost. Methods A 2-period pragmatic cluster randomized crossover trial was conducted. Thirty-nine wards were randomized into 2 study arms. The primary outcome measure was effect of NPT on patient isolation time using a mixed-effects generalized linear regression model. Secondary outcomes examined were hospital LOS and antibiotic therapy based on a negative binomial regression model. Natural experiment (NE), intention-to-treat (ITT), and per-protocol (PP) analyses were conducted. Results During the entire study period, a total of 656 patients received NPT for CDI and 1667 received standard-of-care testing. For the primary outcome, a significant decrease of patient isolation time with NPT was observed (NE, 9.4 hours [ P <.01]; ITT, 2.3 hours [ P <.05]; PP, 6.7 hours [ P <.1]). A significant reduction in hospital LOS was observed with NPT for short stay (NE, 47.4% [ P <.01]; ITT, 18.4% [ P <.01]; PP, 34.2% [ P <.01]). Each additional hour delay for a negative result increased metronidazole use (24 defined daily doses per 1000 patients; P <.05) and non-CDI-treating antibiotics by 70.13 mg (P <.01). NPT was found to save 25.48 US dollars per patient when including test cost to the laboratory and patient isolation in the hospital. Conclusions This pragmatic cluster randomized crossover trial demonstrated that implementation of CDI NPT can contribute to significant reductions in isolation time, hospital LOS, antibiotic usage, and healthcare cost. Clinical Trials Registration. NCT03857464. [ABSTRACT FROM AUTHOR]

Drug plans take different approaches to determining reimbursement prices for generic drugs. One common approach is to set the maximum reimbursement price as a percentage of the price of the interchangeable branded drug. In many countries this percentage depends on the number of generic entrants, a model we call "tiered pricing." This paper seeks to enhance understanding of how to set the tiers. We construct a simple model of tiered pricing and set parameters to match evidence on generic drug costs and the distribution of revenues. Using simulation methods, we then assess different tier structures in terms of total surplus and average drug cost. We find when tiers are bunched tightly together welfare outcomes are poor. Moreover, there are large welfare gains from increasing the number of tiers from one to two, and only small welfare gains from increasing the number of tiers beyond four. The choice of tiers has substantial welfare and cost implications. While it is possible to refine the simulation analysis based on specific market characteristics, an optimal tier structure, such as the one we propose in the paper, should have at least two tiers. [ABSTRACT FROM AUTHOR]

Background: Manufacturers justify the high prices for orphan drugs on the basis that the associated R&D costs must be spread over few patients. The proliferation of these drugs in the last three decades, combined with high prices commonly in excess of $100,000 per patient per year are placing a substantial strain on the budgets of drug plans in many countries. Do insurers spend a growing portion of their budgets on small patient populations, or leave vulnerable patients without coverage for valuable treatments? We suggest that a third option is present in the form of a cost-based regulatory mechanism.Methods: This article explores the use of a cost-based price control mechanism for orphan drugs, adapted from the standard models applied in utilities regulation.Results and Conclusions: A rate-of-return style model, employing yardsticked cost allocations and a modified two-stage rate of return calculation could be effective in setting a new standard for orphan drugs pricing. This type of cost-based pricing would limit the costs faced by insurers while continuing to provide an efficient incentive for new drug development. [ABSTRACT FROM AUTHOR]

The article explores the problem in the pricing and procurement of orphan drugs using an old orphan drug, trientine, for the treatment of Wilson disease, as an example. Topics covered include the aim of the traditional laws for orphan drugs in Canada, the regulatory status of D-penicillamine and trientine as oral treatments for Wilson disease, in Canada, and the reason pharmaceutical firm Valeant Canada announced that the price of Syprine would match the U.S. price.

The article focuses on the laws on pharmaceutical intellectual property of Canada. It states that the federal government has changed the pharmaceutical intellectual property policy for several years including in 1969, 1987, and 1993. It says that the Patent Act in 1969 was amended to allow generic drug firms to import active ingredients while in 1987, a set of reforms was passed in which did not eliminate compulsory licensing for drug firms and in 1993, the compulsory licensing was eliminated. INSET: Summary of Canadian laws protecting pharmaceutical intellectual...

Background: Public support of public health measures including physical distancing, masking, staying home while sick, avoiding crowded indoor spaces and contact tracing/exposure notification applications remains critical for reducing spread of COVID-19. The aim of our work was to understand current behaviours and attitudes towards public health measures as well as barriers individuals face in following public health measures. We also sought to identify attitudes persons have regarding a COVID-19 vaccine and reasons why they may not accept a vaccine.Methods: A cross-sectional online survey was conducted in August 2020, in Alberta, Canada in persons 18 years and older. This survey evaluated current behaviours, barriers and attitudes towards public health measures and a COVID-19 vaccine. Cluster analysis was used to identify key patterns that summarize data variations among observations.Results: Of the 60 total respondents, the majority of persons were always or often physically distancing (73%), masking (65%) and staying home while sick (67%). Bars/pubs/lounges or nightclubs were visited rarely or never by 63% of respondents. Persons identified staying home while sick to provide the highest benefit (83%) in reducing spread of COVID-19. There were a large proportion of persons who had not downloaded or used a contact tracing/exposure notification app (77%) and who would not receive a COVID-19 vaccine when available (20%) or were unsure (12%). Reporting health authorities as most trusted sources of health information was associated with greater percentage of potential uptake of vaccine but not related to contact tracing app download and use. Individuals with lower concern of getting and spreading COVID-19 showed the least uptake of public health measures except for avoiding public places such as bars. Lower concern regarding COVID-19 was also associated with more negative responses to taking a potential COVID-19 vaccine.Conclusion: These results suggest informational frames and themes focusing on individual risks, highlighting concern for COVID-19 and targeting improving trust for health authorities may be most effective in increasing public health measures. With the ultimate goal of preventing spread of COVID-19, understanding persons' attitudes towards both public health measures and a COVID-19 vaccine remains critical to addressing barriers and implementing targeted interventions and messaging to improve uptake. [ABSTRACT FROM AUTHOR]

Background: Drug repurposing (i.e., finding novel uses for existing drugs) is essential for maximizing medicines' therapeutic utility, but obtaining regulatory approval for new indications is costly. Policymakers have therefore created temporary indication-specific market exclusivities to incentivize drug innovators to run new clinical investigations. The effectiveness of these exclusivities is poorly understood. Objective: To determine whether generic entry impacts the probability of new indication additions. Methods: For a cohort of all new small-molecule drugs approved by the FDA between July 1997 and May 2020, we tracked new indications added for the subset of drugs that experienced generic entry during the observation period and then analyzed how the probability of a new indication changed with the number of years since/to generic entry. Results: Of the 197 new drugs that subsequently experienced generic entry, only 64 (32%) had at least one new indication added. The probability of a new indication addition peaked above 4% between 7 and 8 years prior to generic entry and then to dropped to near zero 15 years after FDA approval. We show that the limited duration of exclusivity reduces the number of secondary indications significantly. Conclusion: Status quo for most drug innovators is creating novel one-indication products. Despite indication-specific exclusivities, the imminence of generic entry still has a detectable impact on reducing the chances of new indication additions. There is much room for improvement when it comes to incentivizing clinical investigations for new uses and unlocking existing medicines' full therapeutic potential. [ABSTRACT FROM AUTHOR]

Background: To monitor the magnitude of the drug shortage problem in Canada, since 2017, Health Canada has required manufacturers to report drug shortages. This study aimed to identify the factors associated with drug shortages in Canada. Methods: We conducted a retrospective cohort study of all prescription drugs available on the market between Mar. 14, 2017, and Sept. 12, 2018, in Canada. All drugs of the same active ingredient, dosage form, route of administration and strength were grouped into a "market." Our main outcome was shortages at the market level, determined using the Drug Shortages Canada database. We used logistic regression to identify associated factors such as market structure, route or dosage form, and Anatomic Therapeutic Chemical (ATC) classification. Results: Among the 3470 markets included in our analysis, 13.3% were reported to be in shortage. Markets with a single generic manufacturer were more likely to be in shortage than other markets. Markets with oral nonsolid route or dosage form were more likely to be in shortage than those that were oral solid with regular release (odds ratio [OR] 1.66, 95% confidence interval [CI] 1.11 to 2.49). Markets for sensory organs were more likely to be in shortage than most other ATC classes. Markets with a higher proportion of drugs covered by public insurance programs were more likely to be in shortage (OR 1.03, 95% CI 1.00 to 1.05 per 10% increase). Interpretation: Markets with a single generic manufacturer were most likely to be in shortage. To ensure the security of drug supply, governments should be vigilant in monitoring markets with a single generic manufacturer, with complex manufacturing processes, with higher demand from public programs or those that are in certain ATC classes. [ABSTRACT FROM AUTHOR]

The article discusses the impact of price negotiation through rebates to the drug expenditure of the patients. It highlights the development of publicly funded prescription insurance plans with a co-insurance payment structure for the patients. It also cites the confidentiality of pricing agreements between the government and pharmaceutical manufacturers.

Several letters to the editor are presented in response to the article "Where will new drugs come from?," in the January 8, 2010 issue of "Lancet."

A letter to the editor is presented in response to the article "The Health Impact Fund," by Jeremiah Norris, published in the March 13, 2010 issue.