scholarly journals Strategic Patenting by Pharmaceutical Companies – Should Competition Law Intervene?

Author(s):  
Olga Gurgula

AbstractAs the COVID-19 pandemic is affecting the lives of thousands of people worldwide, the problem of timely access to affordable medicines has intensified today. Based on past experience of accessing medicines for life-threatening diseases there is a justifiable fear that access to any vaccines and treatments that are eventually developed may be hindered by patents, leading to unaffordable prices. In particular, one of the reasons that typically leads to high prices is strategic patenting employed by pharmaceutical companies. While this practice is currently considered lawful, this article argues that strategic patenting requires a long-overdue intervention by competition authorities and aims to attract their attention to its harmful effects. It maintains that, along with a more immediate negative effect in the form of high drug prices, strategic patenting affects dynamic competition by stifling innovation of both originators and generic companies. The article outlines the current approach to strategic patenting and provides arguments for the intervention of competition law. This, in turn, will open the possibility for competition authorities to investigate this practice and prevent its harmful effect on drug prices and pharmaceutical innovation, for the benefit of consumer welfare.

Author(s):  
Bjorn Lous ◽  
Johan Graafland

AbstractLiterature has established that, on a macroeconomic level, income inequality has a negative effect on average life satisfaction. An unresolved question is, however, which income groups are harmed by income inequality. In this paper we investigate this relationship at the microeconomic level combining national indicators of income inequality with individual data of life satisfaction from the World Values Survey for 39 countries over a period of 25 years. Tests on moderation by income category show that the Gini coefficient is most negatively related to life satisfaction of the lowest income groups, but the negative effects also extends to other income groups. For the income share of the top 1% we find a similar result. These findings show that income inequality is especially a concern for the lower income groups, but that the harmful effect of income inequality also spillovers to the life satisfaction of other income groups.


2021 ◽  
Vol 36 (Supplement_1) ◽  
Author(s):  
Nicholas Chesnaye ◽  
Yvette Meuleman ◽  
Esther De Rooij ◽  
Friedo W Dekker ◽  
Marie Evans ◽  
...  

Abstract Background and Aims Differences between the sexes are apparent in the epidemiology of CKD. Cross-sectional studies show that women consistently report a poorer health-related quality of life (QoL) than men, however, longitudinal studies are lacking. Here we investigate the sex-specific evolution of QoL over time in advanced CKD. As a secondary aim, we explore the sex-specific determinants of QoL. Method EQUAL is an observational prospective cohort study in stages 4 and 5 CKD patients ≥65 years not on dialysis with an incident estimated glomerular filtration rate (eGFR) < 20 ml/min/1.73m². Data on QoL (measured using the RAND-36), clinical and demographic patient characteristics were collected between April 2012 and September 2020. QoL trajectories were modelled by sex using linear mixed models, and joint models were applied to deal with informative censoring. We followed patients until death or dialysis initiation. Results We included 5151 QoL measurements in 1416 patients over a total of 1986 person years of follow-up. Overall, the physical component summary (PCS) declined with 2.0 (95% CI 1.4-2.6) points and the mental component summary (MCS) by 2.4 (95% CI 1.8-3.0) points per year. Although women had overall lower QoL scores, figure 1 demonstrates that PCS and MCS declined more than twice as fast in men (PCS: 2.4 per year, 95% CI 1.7 – 3.1, MCS: 2.9 per year, 95% CI 2.2 – 3.6) compared with women (PCS: 1.1 per year, 95% CI -0.2 – 2.0, MCS: 1.5 per year, 95% CI 0.5 – 2.4). We identified a non-linear interaction effect between sex and eGFR levels on QoL, demonstrating a stronger negative effect of decreased eGFR on both PCS (p=0.02) and MCS (p=0.04) in men compared with women. Subsequent adjustment for renal decline attenuated the difference in rate of QoL decline between men and women (difference after adjustment; PCS: 1.1, 95% CI -0.1 – 2.2, MCS: 1.2, 95% 0.0 – 2.3). In univariable analyses, higher serum haemoglobin was more beneficial to QoL in men compared to women (p-value for interaction; PCS: p=0.03, MCS: p=0.01). Higher serum phosphate had a strong harmful effect on both PCS and MCS in men, but not in women (PCS & MCS: p<0.001). The presence of pre-existing diabetes had a negative effect on PCS and MCS in men, but to a lesser extent in women (PCS: p=0.02, MCS: p=0.01). Conclusion Despite the higher overall QoL reported by men, both their physical and mental QoL declined approximately twice as fast compared with women. The faster decline in men was mediated in part by their lower levels of renal function, which had a stronger impact on their QoL as compared with women. Furthermore, in exploratory analyses we identified that high levels of phosphate, low levels of haemoglobin, and pre-existing diabetes were more detrimental to QoL in men than in women.


2017 ◽  
Vol 52 (12) ◽  
pp. 1140-1148 ◽  
Author(s):  
Patrícia Elias Haddad ◽  
Luis Garrigós Leite ◽  
Cleusa Maria Mantovanello Lucon ◽  
Ricardo Harakava

Abstract: The objective of this work was to evaluate, in vitro and in vivo, the potential of Trichoderma spp. strains to control Sclerotinia sclerotiorum in soybeans (Glycine max) and to perform the molecular identification of the best perfoming strains. The effect of 120 strains of Trichoderma spp. on the viability of S. sclerotiorum sclerotia was evaluated in vitro through immersion in suspension of conidia from the antagonists and plating in culture medium. The best performing strains were evaluated in vivo, in a greenhouse, for control of the pathogen inoculated on 'Pintado' soybean seeds and plants. Of the 120 strains tested in vitro, 22 strains of Trichoderma spp. caused 100% inhibition of sclerotia germination. In the greenhouse, five strains inhibited the negative effect of the pathogen on seed germination and two strains increased in up to 67% plant dry matter. The best performing strains were identified as T. koningiopsis (3 strains), T. asperelloides (3), T. atroviride (2), and T. virens (1). Trichoderma strains are able to protect soybean plants from the harmful effect of S. sclerotiorum and, at the same time, they can promote the growth of the aerial part in greenhouse conditions.


Author(s):  
Muchlinski Peter T

This chapter studies competition law (antitrust law in US terminology), which protects competition to maximize consumer welfare. Multinational enterprises (MNEs) may use their market power to distort competitive conditions. Unlike purely domestic firms, MNEs can do this in a transnational context. Therefore, regulating MNE competition involves not only substantive rules but also jurisdictional questions which have led to extraterritoriality conflicts. The chapter then examines the competition issues arising from the market power of MNEs operating global networks of production and distribution in often concentrated markets. It also assesses whether competition law should control MNE entry and establishment to preserve the national economy from harmful foreign competition, involving issues of industrial policy and national security. Moreover, MNE operations challenge the hitherto predominantly national approach to competition regulation. To date, there has been little progress towards global competition rules, but it remains a worthwhile question, especially in the context of sustainable development, which has been introduced into competition policy debates in recent years.


Author(s):  
Alison Jones ◽  
Brenda Sufrin ◽  
Niamh Dunne

This chapter provides an introduction to, and basis for, the material discussed in the subsequent chapters. It introduces some relevant concepts of microeconomics including demand curves, consumer and producer surplus, elasticity of demand, and economies of scale and scope. It discusses the model of perfect competition and the concepts of allocative, productive and dynamic efficiency; the problems in competition terms of monopoly and oligopoly; and the concept of welfare, particularly consumer welfare and total welfare. It considers various schools of competition analysis and theories and concepts relevant to competition law. It discusses the possible objectives of competition law, and particularly considers what objectives are pursued by EU competition law. The chapter also looks at US antitrust law; competition law and the digital economy; competition law and regulation; and at some basic issues in the application of EU competition law.


2019 ◽  
Vol 26 (3) ◽  
pp. 747-753 ◽  
Author(s):  
Dimitra Ioanna Lampropoulou ◽  
Konstantinos Laschos ◽  
Anna-Lea Amylidi ◽  
Ariadni Angelaki ◽  
Nikolaos Soupos ◽  
...  

Fluoropyrimidine-based regimens are among the most commonly used chemotherapy combinations for the treatment of solid tumors. Several genetic polymorphisms that are implicated with fluoropyrimidine anabolism and catabolism have been associated with the development of life-threatening toxicities. Uridine triacetate is an FDA-approved antidote for 5-fluorouracil or capecitabine overdose and early-onset, life-threatening toxicity within 96 h of last chemotherapy dose. To date, it is not accessible for Greek patients as per the current summary of product characteristic's time restrictions. We report and discuss the course and outcome of capecitabine toxicity in a 66-year-old female colorectal cancer patient with heterozygous dihydropyrimidine dehydrogenase deficiency. This paper highlights the difficulty in timely access of this lifesaving medication for Greek and possibly other European patients.


Author(s):  
Darryl Biggar ◽  
Alberto Heimler

Abstract In recent years, the economic foundation of antitrust law is increasingly being called into question. The hypothesis that antitrust law seeks to promote consumer welfare has historically been extremely popular but in recent years has come under attack. In part, this is due to the fact that neither the law, nor the decisions of competition law enforcers, can be fully explained as consistent with a strict consumer welfare standard. Neither do competition laws promote a textbook concept of total economic welfare, neither in their wording, nor in the way they are enforced. Some commentators argue that competition law should protect the competitive process, but this approach lacks a foundation in welfare economics and therefore lacks the ability to make basic trade-offs between desirable goals. This article puts forward an alternative hypothesis, which focuses on the sunk, relationship-specific investments made by market participants. We propose that an important, and overlooked, role of competition law is to protect trading partners from the threat of hold-up, where it is unreasonable for the parties to use conventional mechanisms to protect those sunk investments themselves. This approach can help to explain features of competition law and law enforcement that cannot be explained by the traditional consumer welfare or total welfare frameworks. We suggest that this approach offers promise as providing a consistent, comprehensive, economic foundation for competition law.


2019 ◽  
Vol 2019 ◽  
pp. 1-15 ◽  
Author(s):  
Piotr Rychter ◽  
Diana Rogacz ◽  
Kamila Lewicka ◽  
Jozef Kollár ◽  
Michał Kawalec ◽  
...  

The Phytotoxicological Aspects of a Novel Superabsorbent/Hydrogels: poly(acrylamide-co-sodium 4-hydroxy-2-methylenebutanoate), prepared from renewable monomer Tulipalin A, on the growth and development of monocotyledonous Avena sativa and dicotyledonous Raphanus sativus, was investigated and compared with the effect of borate-crosslinked poly(vinyl alcohol), poly(acrylamide), and poly(acrylamide-co-sodium acrylate) conventional hydrogels. Tulipalin A-based superabsorbent hydrogels revealed superior properties in terms of the combination of the tested properties. The results confirmed excellent suitability of Tulipalin A-based hydrogels for application as reservoirs of water during plant stress condition. Values of fresh matter (yield) and shoot height of the examined plants growing in soil amended with these hydrogels were ca 10% higher than those of plants growing in soil without hydrogels. Reference borate-crosslinked PVA hydrogels (containing increasing amount of borax cross-linker) revealed harmful effect on plants. The negative effect was observed on most of the investigated properties, increasing with content of the hydrogel in soil and concentration of the borax in it.


2020 ◽  
Vol 16 (1) ◽  
Author(s):  
Kyung-Bok Son

Abstract Background Health systems are struggling with unprecedented drug spending and governments have devised various policy options to manage high-priced medicines. Meanwhile, some pricing and reimbursement processes are currently moving under the jurisdiction of international agreements. This study aims to understand trends in international agreements from the perspectives of pricing and reimbursement policies for newly marketed medicines. Methods We proposed the framework to interpret the international agreements as code and applied computational text analysis to understand international agreements as data. In particular, we selected the AUSFTA, KORUS, and TPP to assess the progress and evolution in international agreements and investigate the existing relevant content on the pricing and reimbursement of newly marketed medicines. Results Similar to the provisions for intellectual property, the scope of international agreements regarding pricing and reimbursement decisions are broadened and strengthened. Over time, the domain of transparency, re-naming procedural fairness, has changed significantly more than the remaining domains. Pharmaceutical companies will have more opportunities to advocate for their positions, to protect their interests in decision processes, to investigate the decisions on listings and setting the amounts of reimbursement, and to challenge these decisions. Conclusions Recently signed international agreements favor companies over governments with underscoring procedural fairness and timely access. However, access to affordable medicines is the goal towards which international agreements should aim. In a similar vein, substantial fairness and the accountability of companies should be discussed when negotiating agreements or adopting international agreements through domestic legislation.


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