The Proposed EU-regulation on Clinical Trials on Medicinal Products: An Unethical Proposal?

The Commission has proposed a regulation ‘on clinical trials on medicinal products for human use’ to introduce one regulatory framework for clinical trials in the European Union. This regulation should replace the current clinical trials directive (2001/20/EC). In this article we describe and critically review the main provisions of the proposed regulation. We assess the consequences for a sound authorisation procedure of clinical trials and the level of protection for human subjects. We note that the proposed regulation is inconsistent with applicable international legal documents, such as the Biomedicine Convention and the Declaration of Helsinki. We conclude that the proposed regulation does not ensure a “high level of human health protection” — required by its legal basis in the TFEU — because it may force Member States concerned to accept a reporting Member States’ approval of — in their estimation — an unethical clinical trial.

Analysis and Application of Deflection Curve Equation Expressed in Terms of Geometrical Parameters for Compressed Bars

A new solution to geometrically nonlinear problems is presented. It has been found that the deflection curve equation expressed in terms of geometrical parameters for a compressed bar is a result of superposition by an Euler’s curve for two-force member in buckling equilibrium and a deformation equation for two-force member in stable equilibrium. Corresponding with the superposition of deflection curves, the load case of the compressed bar is divided into an axial force with a moment and an axial force with a shear force applied to the two-force member respectively. The analytic principle and the deflection curve equation for compressed bars can be applicable to geometrical nonlinear analysis or buckling problems, which is called analytical methods. The decision rule for the equilibrium property of the deflection curve expressions is presented. Practical applications of analytical methods show that some brief formulas can be obtained in the load case without shear forces.

The ‘TBT Agreement’: A Perfect Tool to Monitor Regulatory Activities Worldwide

The Technical Barriers to Trade (hereinafter TBT) Agreement was negotiated at the Tokyo Round (1973–1979). However, at that time the GATT rules comprised no legally binding mechanism to force Member States to respect their obligations. Indeed, Member States remained free to defer the dispute settlement system. Consequently, for a very long time the TBT Agreement remained a dead letter.

The ‘TBT Agreement’: A Perfect Tool to Monitor Regulatory Activities Worldwide

The Technical Barriers to Trade (hereinafter TBT) Agreement was negotiated at the Tokyo Round (1973–1979). However, at that time the GATT rules comprised no legally binding mechanism to force Member States to respect their obligations. Indeed, Member States remained free to defer the dispute settlement system. Consequently, for a very long time the TBT Agreement remained a dead letter.