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

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

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

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

Effects of Shock-Tube Cleanliness on Hypersonic Boundary Layer Transition at High Enthalpy

The prediction of a high-speed boundary-layer transition (BLT) location is critical to hypersonic vehicle design; this is because the increased skin friction and surface heating rate after transition result in increased weight of the thermal protection system. Experimental studies using hypervelocity wind tunnels are one component of BLT research

Differential Interferometric Measurement of Instability at Two Points in a Hypervelocity Boundary Layer

The focused laser differential interferometer (FLDI) was used to investigate disturbances in a hypervelocity boundary layer on a sharp five degree half-angle cone. The T5 hypervelocity free-piston driven reflected-shock tunnel was used as the test facility; in such a facility the study of thermo-chemical/fluid-dynamic energy exchange is emphasized. Two sensitive FLDI probe volumes were aligned along a generator of the cone that recorded time-traces of density fluctuation at sufficient time resolution, spatial resolution, and signal to noise ratio, so that the boundary layer instability could be resolved. This arrangement of the FLDI allows for the interpretation of disturbances at two points and the correlation between them. The acoustic instability is detected with narrow-band peaks in the spectral response at a number of frequencies (500 kHz to 1.29 MHz). The data indicate that the instability driving the boundary layer to turbulence is acoustic in nature. Preliminary analysis indicates that there is not a significant difference between N2 and air acoustic boundary layer disturbance amplification factors for the representative cases presented. Computation of acoustic damping by thermo-chemical relaxation processes is presented for the same representative cases, and indicates that there is a negligible amount of absorption for both air and N_2 at the observed disturbance frequencies

A probabilistic security risk assessment methodology for quantification of risk to the public

We describe a methodology for obtaining probabilistic risk estimates of deliberate unauthorized acts, integrating estimates of frequencies of serious plots, probabilities of avoiding detection and interdiction, probabilities of successful action, and consequences of the act. This methodology allows us to compare the risks of deliberate acts with those of accidents and to identify the most cost- effective risk reduction measures through cost-benefit analysis

Turbulent Spot Observations within a Hypervelocity Boundary Layer on a 5-degree Half-Angle Cone

Laminar to turbulent transition is a critically important process in hypersonic vehicle design. Higher thermal loads, by half an order of magnitude or more, result from the increased heat transfer due to turbulent flow. Drag, skin friction, and other flow properties are also significantly impacted. Transition to turbulence in initially laminar boundary layers can occur along many paths. In low-speed flow under ideal conditions (quiet freestream, nominally smooth surfaces with favorable or zero pressure gradient and minimal crossflow) transition occurs over a finite distance and is associated with the creation and growth of propagating patches of turbulent flow, known as turbulent spots. Spots may be due to the breakdown of linear instabilities or induced by “bypass mechanisms” associated with nonideal effects in the flow or model. H.W. Emmons (1951) was the first to propose that laminar boundary layers break down through the convergence of spots, after observations of a water-table analogy to air flow. Spot formation has been studied extensively in subsonic flows, a recent review of past and current work on spots in incompressible flows is given by Strand and Goldstein (2011)

Effects of Shock-Tube Cleanliness on Hypersonic Boundary Layer Transition at High Enthalpy

The prediction of a high-speed boundary-layer transition (BLT) location is critical to hypersonic vehicle design; this is because the increased skin friction and surface heating rate after transition result in increased weight of the thermal protection system. Experimental studies using hypervelocity wind tunnels are one component of BLT research

The Dynamics of Internet Traffic: Self-Similarity, Self-Organization, and Complex Phenomena

The Internet is the most complex system ever created in human history. Therefore, its dynamics and traffic unsurprisingly take on a rich variety of complex dynamics, self-organization, and other phenomena that have been researched for years. This paper is a review of the complex dynamics of Internet traffic. Departing from normal treatises, we will take a view from both the network engineering and physics perspectives showing the strengths and weaknesses as well as insights of both. In addition, many less covered phenomena such as traffic oscillations, large-scale effects of worm traffic, and comparisons of the Internet and biological models will be covered.Comment: 63 pages, 7 figures, 7 tables, submitted to Advances in Complex System