Orphan Drugs under EU Competition Law: The Price is not Right

In principle, pharmaceutical producers lack the incentives to develop orphan drugs, i.e. medicines intended to treat rare diseases. Regulation (EC) n. 141/2000 addresses the issue, providing orphan drug producers with accelerated approval, tax benefits, and a ten-year market exclusivity period. Today, orphan drug prices are extremely high and are set independently of ordinary pharmaceutical pricing criteria. Consequently, some scholars suggest that a competition law action for unfair prices under Art. 102, let. a, TFEU may be warranted. This paper claims that the prohibition of abuse of dominant position could play a role in reducing orphan drugs’ prices. First, it is shown that market exclusivity provides orphan drug manufacturers with a dominant position in their reference markets. Then, the paper applies and adapts the excessive price test developed by the ECJ to orphan drugs. Civil liability could also play a role, by compensating the damages suffered by NHSs. Finally, recent enforcement developments in the EU concerning excessive prices of medicines confirm the potential role of competition law in curbing orphan drug prices

Healthcare Provider Awareness of Food Insecurity Resources in Berlin, VT

https://scholarworks.uvm.edu/fmclerk/1687/thumbnail.jp

The global fight against trans fat: the potential role of international trade and law

Non-communicable diseases in general and cardiovascular diseases in particular are a leading cause of death globally. Trans-fat consumption is a significant risk factor for cardiovascular diseases. The World Health Organization’s ‘REPLACE’ action package of 2018 aims to eliminate it completely in the global food supply by 2023. Legislative and other regulatory actions (i.e., banning trans-fat) are considered as effective means to achieve such a goal. Both wealthier and poorer countries are taking or considering action, as shown by the United States food regulations and Cambodian draft food legislation discussed in this paper. This paper reviews these actions and examines public and private stakeholders’ incentives to increase health-protecting or health-promoting standards and regulations at home and abroad, setting the ground for further research on the topic. It focuses on the potential of trade incentives as a potential driver of a ‘race to the top’. While it has been documented that powerful countries use international trade instruments to weaken other countries’ national regulations, at times these powerful countries may also be interested in more stringent regulations abroad to protect their exports from competition from third countries with less stringent regulations. This article explores practical and principled considerations on how such a dynamic may spread trans-fat restrictions globally. It argues that trade dynamics and public health considerations within powerful countries may help to promote anti-trans-fat regulation globally but will not be sufficient and is ethically questionable. True international regulatory cooperation is needed and could be facilitated by the World Health Organization. Nevertheless, the paper highlights that international trade and investment law offers opportunities for anti-trans-fat policy diffusion globally

education as a resource of social innovation

1. Fiorenzo Parziale[1][1] 2. Ivano Scotti[2][2][⇑][3] 1. 1Sapienza University of Rome, Italy 2. 2University of Naples Federico II, Italy 1. Ivano Scotti, Department of Social Sciences, University of Naples Federico II, Vico Monte di Pieta 1, Naples 80138, Italy. Email: ivano.scotti{at}unina.it Focusing on the Italian context, this research aims to analyze the relationship between investment in education and economic development through a critical exam of the human capital theory. This paradigm is compared with the social investment paradigm, particularly the Esping-Andersen's thesis, which seems more useful to unfold the link between social stratification and education level as a resource of social innovation. From this standpoint, our hypothesis is that educational policies have positive effects on the economic system if they are oriented to reduce socio-economic inequalities increasing the rate of social inclusion, which can promote a wider social innovation. [1]: #aff-1 [2]: #aff-2 [3]: #corresp-

Appropriate safeguards and Article 89 of the GDPR: considerations for biobank, databank and genetic research

The collection and use of biological samples and data for genetic research, or for storage in a biobank or databank for future research, impacts upon many fundamental rights, including the right to dignity, the right to private and family life, the right to protection of personal data, the right to freedom of arts and sciences, and the right to non-discrimination. The use of genetic data and other health-related data in this context must be used in a manner that is rooted in human rights. Owing in part to the General Data Protection Regulation (GDPR) coming into force, the right to the protection of personal data in the context of scientific research has been afforded increasing attention. The GDPR gives effect to the right to data protection, but states that this right must be balanced against other rights and interests. The GDPR applies to all personal data, with specific attention to special categories of data, that includes health and genetic data. The collection, access to, and sharing of such data must comply with the GDPR, and therefore directly impacts the use of such data in research. The GDPR does provide for several derogations and exemptions for research from many of the strict processing requirements. Such derogations are permitted only if there are appropriate safeguards in place. Article 89 states that to be appropriate, safeguards must be “in accordance” with the GDPR “for the rights and freedoms of the data subject”. In particular, those safeguards must ensure “respect for the principle of data minimisation”. Despite the importance of safeguards, the GDPR is silent as to the specific measures that may be adopted to meet these requirements. This paper considers Article 89 and explores safeguards that may be deemed appropriate in the context of biobanks, databanks, and genetic research

Usi off-label di farmaci nell'UE: il ruolo della responsabilità civile tra mercato e regolazione

La regolazione europea e nazionale degli usi fuori registrazione dei farmaci attribuisce ai soggetti che operano in questo complesso mercato una serie di poteri discrezionali e facoltà suscettibili di essere strumentalizzate a danno dei portatori di interessi rilevanti. La nostra ipotesi è che la responsabilità civile può svolgere un ruolo cruciale nel far sì che i titolari esercitino le rispettive facoltà nel rispetto dei diritti e interessi degli altri operatori, offrendo maggiore certezza del diritto e livelli più elevati di tutela. La prima parte del lavoro è dedicata alla ricostruzione della regolazione comunitaria e nazionale del mercato farmaceutico, con particolare riguardo al fenomeno degli usi fuori registrazione. Gli ordinamenti presi in considerazione sono Italia, Germania (caratterizzati da regimi speciali di responsabilità applicabili ai danni prodotti da farmaci) e Regno Unito (che rappresenta in modello storico di riferimento per la regolazione comunitaria del mercato sotto l'egida dell'EMA). Su questa base si individuano, anche con riferimento alla casistica emersa negli ultimi anni, i poteri discrezionali suscettibili di strumentalizzazione, da un lato, nelle relazioni delle imprese farmaceutiche con le autorità competenti, con la comunità scientifica e con i pazienti; dall'altro lato, nei rapporti tra medici prescriventi e pazienti. Quindi per ciascuna di queste relazioni si adotta il punto di vista dei tre ordinamenti civili selezionati, verificando come il ricorso alle regole generali di responsabilità, ai regimi speciali e a categorie giurisprudenziali (come l'abuso del diritto) possa agire virtuosamente sulle zone grigie della regolazione, secondo un approccio coordinato in cui possono interagire, completandosi a vicenda, diversi settori dell'ordinamento, come appunto la regolazione x ante, la responsabilità civile e, nel caso, anche la tutela antitrust

Art at The Bar: Competition Law and Civil Liability In The Art Market Regulation

The art market is rapidly developing along the ways of globalisation, digitalisation, and democratisation. Yet, it has several characteristics that favour market manipulation, such as lack of transparency and conflicts of interest. Despite substantial advancements, it is acknowledged that sector regulation does not address such limitations properly. In the light of US, EU, and national case-law, this article assesses the role that competition law could play in the art sector, also in conjunction with civil liability. It is found that competition law enforcement in the art market has been scarce so far. It provided for effective reaction tools against few, significant market manipulation strategies carried out by key auction houses. On those occasions, competition authorities and undertakings set shared, basic rules of conduct through commitments. Such cases also seem to have inspired recent self- and heteroregulatory initiatives. All in all, competition law seems to play the residual role of a sentinel in the secondary art market. In contrast, whether or not competition law will be enforced in the authentication service sector mainly depends on how private enforcement will develop in the EU and the US

Dynamical separation of spherical bodies in supersonic flow

An experimental and computational investigation of the unsteady separation behaviour of two spheres in Mach-4 flow is carried out. The spherical bodies, initially contiguous, are released with negligible relative velocity and thereafter fly freely according to the aerodynamic forces experienced. In experiments performed in a supersonic Ludwieg tube, nylon spheres are initially suspended in the test section by weak threads which are detached by the arrival of the flow. The subsequent sphere motions and unsteady flow structures are recorded using high-speed (13 kHz) focused shadowgraphy. The qualitative separation behaviour and the final lateral velocity of the smaller sphere are found to vary strongly with both the radius ratio and the initial alignment angle of the two spheres. More disparate radii and initial configurations in which the smaller sphere centre lies downstream of the larger sphere centre each increases the tendency for the smaller sphere to be entrained within the flow region bounded by the bow shock of the larger body, rather than expelled from this region. At a critical angle for a given radius ratio (or a critical radius ratio for a given angle), transition from entrainment to expulsion occurs; at this critical value, the final lateral velocity is close to maximum due to the same ‘surfing’ effect noted by Laurence & Deiterding (J. Fluid Mech., vol. 676, 2011, pp. 396–431) at hypersonic Mach numbers. A visualization-based tracking algorithm is used to provide quantitative comparisons between the experiments and high-resolution inviscid numerical simulations, with generally favourable agreement