1,720,988 research outputs found

    R&D and market size: who benefits from orphan drug regulation?

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    Since the early 80s, orphan drug regulations have been introduced to stimulate R&D for rare diseases. We develop a theoretical model to study the heterogeneous impact on optimal R&D decisions of the incentives for diseases with different levels of prevalence. We show the mechanisms through which the type of incentives deployed by orphan drug regulations may stimulate R&D more for orphan diseases with comparatively high prevalence, thus increasing inequality within the class of orphan diseases. Using data from the Food and Drug Administration on the number of orphan designations, our empirical analysis shows that, while R&D has increased over time for all orphan diseases, the increase has been much greater for the less rare. According to our baseline specification, the difference between the predicted number of orphan designations for a disease belonging to the highest and the lowest class of prevalence is 5.6 times larger after 2008 than it was in 1983. Our findings support the idea that the type of incentives in place may be responsible for this increase in inequality within orphan diseases

    Free-Riding in Pharmaceutical Price Regulation: Theory and Evidence

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    We present a model of the strategic interaction among authorities regulating pharmaceutical prices in different countries and the R&D investment decisions of pharmaceutical firms. Regulators’ decisions affect consumer surplus directly, via prices, and indirectly via firms’ profits and R&D investment policies, which in turn affect patient health. The positive externality of a price increase in one country provides an incentive for other countries to free-ride, and we show how country-level characteristics affect optimal pricing decisions and equilibria. Our theoretical predictions are tested using price data for a set of 70 cancer drugs in 25 OECD countries. We find evidence of behaviour that is consistent with the free-riding hypothesis and which, in line with the theoretical predictions, differs according to country-level characteristics. Countries with comparatively large market shares tend to react to increases in other countries’ prices by lowering their own prices; in countries with comparatively small market shares, regulators’ decisions are consistent with the objective of introducing the product at as low a price as possible. We discuss the policy implications of our results for incentivising global pharmaceutical R&D and the recent proposal to move towards a joint pharmaceutical procurement process at the European level

    Is Tax Compliance a Social Norm? A Field Experiment

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    We study the effect of social pressure on tax compliance, focusing on the compliance of shop sellers to the legal obligation of releasing tax receipts for each sale. We carry out a field experiment on bakeries in Italy, where a strong gap exists between the legal obligation and the actual behavior of sellers. Social pressure is manipulated by means of an explicit request for a receipt when not released. We find that a single request for a receipt causes a 17 per cent rise in the probability of a receipt being released for a sale occurring shortly thereafter. This provides evidence of a social multiplier: on average, a single request for a receipt causes 2.38 additional receipts being released overall

    DETERMINANTS AND EFFECTS OF INNOVATION: AN EMPIRICAL ANALYSIS

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    Questa tesi analizza le determinanti e gli effetti dell'innovazione attraverso un'analisi empirica. Nel primo capitolo viene analizzato l'impatto delle leggi di proprietà intellettuale sull'innovazione domestica in campo farmaceutico. Nel secondo capitolo, in cui vengono usati dati a livello di impresa, si studia la correlazione tra innovazione, export, produttività e vincoli finanziari. Infine nell'ultimo capitolo si studia l'effetto dell'innovazione domestica nell'attrarre investimenti diretti esteri. Mentre nel primo e nell'ultimo capitolo l'innovazione viene misurata come output, usando il numero di brevetti attribuiti ad un determinato paese, nel secondo capitolo vengono usati dati di R&D, e quindi di input di innovazione.This dissertation analyses the determinants and the effects of innovation using an empirical analysis. In the first chapter the impact of Intellectual Property Rights on domestic innovation in the pharmaceutical sector is estimated. In the second chapter the correlation between innovation, export, productivity and financial constraint is studied at the firm level. Finally, in the last chapter the role of domestic innovation in attracting Foreign Direct Investments is estimated. While in the first and in the last chapter innovation output is considered, and innovation is proxied by patent data, in the second chapter innovation input is taken into account, and R&D data are used

    The Effect of Intellectual Property Rights on Domestic Innovation in the Pharmaceutical Sector

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    This paper analyses the causal impact of Intellectual Property Rights (IPR) on pharmaceutical innovation in a panel of 74 countries. The identification strategy exploits the different timing across countries of two sets of IPR reforms. Domestic innovation is measured as citation-weighted domestic patents filed at the European Patent Office (EPO): to account for their distribution, count data models are used. A Zero Inated Negative Binomial model is adopted to consider the choice not to patent at the EPO. Results show that, in the short-run, IPR stimulate innovation. The effect for developing countries is roughly half of that for developed countries

    The 2023 European Commission proposal and the 2024 European Parliament proposal for the EU pharmaceutical legislation: policy content analysis

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    A revision of the pharmaceutical legislation is ongoing at the European Level. The European Commission proposed a first draft in April 2023, and the European Parliament has adopted a position on the proposal in April 2024. The proposal consists of a new Directive and a new Regulation, with the aim of integrating different provisions that have been introduced over time. The proposal aims at encouraging the industry in conducting research and developing technologies that reach patients, while addressing market failures. We discuss both general and targeted incentives that are proposed, as well as the provisions to foster access to medicines for all patients in the European Union. Although the legislative process has not been completed yet, an analysis of the texts that have been debated in the early stages, vis-à-vis the legislation in force, can inform on the most relevant and debated issues and on the aspects the reform is most likely to affect

    The impact of Managed Entry Agreements on pharmaceutical prices

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    Managed entry agreements (MEA) have been used for several years, with the aim of curbing the growth of pharmaceutical expenditure and enhancing patient access to innovation. Yet, much remains to be understood about their economic implications. This paper studies the impact of MEAs on list prices, that is prices before the deduction of any discount. Using a theoretical model, we show that, under most price setting regimes, the introduction of a MEA leads to a higher list price. This is confirmed by our empirical analysis of a sample of 156 medicines in six countries, providing a conservative estimate of the increase in price due to the MEA of 5.9%. A relevant policy implication is that payers may overestimate the financial gains that can be achieved through this tool

    When the two ends meet: an experiment on cooperation across the Italian North-South divide

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    We study the behaviour of individuals with different geographic origins interacting in a same public good game. We exploit the peculiar composition of the experimental sample to compare the performance of groups where individuals have mixed origins to homogeneous groups. We find that, despite the absence of any geographic framing, mixed groups exhibit significantly lower contributions. We also find that cooperation levels differ significantly across geographic origins, in line with the existing literature. This is explained by a different impact of coordination opportunities, such as communication, as we show by manipulating them. Our results point towards integration as a crucial aspect for the economic development of intercultural societies. They also confirm that, rather than being explained just by the differences in institutions and economic opportunities, the Italian North-South divide embeds elements of distrust, prejudice and a consequent path dependence in the level of social capital

    When the two ends meet: an experiment on cooperation across the Italian North-South divide

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    We study the behavior of individuals coming from different geographic regions of Italy, in a same public good game. We confirm previous findings according to which, faced with the same incentives and experimental conditions, Southern citizens exhibit a lower propensity to cooperate than Northern ones. This difference is mainly explained by a gap in the impact of coordination devices available to participants, as we show by manipulating them. Most importantly, when subjects with different geographic origins are teamed up together, their contributions decrease with respect to homogeneous groups, again because of a reduced effect of coordination devices. These findings reinforce the interpretation of the Italian South-North divide as related to trust, prejudice and a consequent path-dependence in levels of social capital, rather than due to the mere effect of differences in institutions and economic opportunities

    COVID-19: R0 is lower where outbreak is larger

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    We use daily data from Lombardy, the Italian region most affected by the COVID-19 outbreak, to calibrate a SIR model individually on each municipality. These are all covered by the same health system and, in the post-lockdown phase we focus on, all subject to the same social distancing regulations. We find that municipalities with a higher number of cases at the beginning of the period analyzed have a lower rate of diffusion, which cannot be imputed to herd immunity. In particular, there is a robust and strongly significant negative correlation between the estimated basic reproduction number (R0R_0) and the initial outbreak size, in contrast with the role of R0R_0 as a emph{predictor} of outbreak size. We explore different possible explanations for this phenomenon and conclude that a higher number of cases causes changes of behavior, such as a more strict adoption of social distancing measures among the population, that reduce the spread. This result calls for a transparent, real-time distribution of detailed epidemiological data, as such data affects the behavior of populations in areas affected by the outbreak
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