New prescription drugs are developed and tested for quality, safety, and efficacy by the pharmaceutical industry, and little or no drug testing is conducted by governments in modern industrialised countries. Governments have regulatory authorities which have a legal duty to protect public health by ensuring that new drugs are not licensed unless they are of adequate quality, safety, and efficac...

After 4 years of early benefit assessment (EBA) in Germany, it is becoming evident that the Federal Joint Committee (FJC) frequently considers well-established clinical endpoints as not being relevant to patients. Focusing on assessments of oncology medicines, we analysed the FJC's view on primary endpoints and compared it with the approach used by regulatory authorities. Mortality data were ac...

Embedded in a dissertation project that is dedicated to a comparative analysis of data protection authorities (DPAs; EU Directive 1995),1 this chapter aims to shed light on the conception of DPAs as a new regulatory approach by the European Union (EU). Since there is little research on DPAs from a political science perspective, the theoretical foundations of and empirical findings about indepen...

BACKGROUND In October 2013, the Declaration of Helsinki was revised a seventh time in its 50 year history. While it is the most widely accepted set of ethical principles for the protection of patients participating in medical research, the Declaration of Helsinki has also been subject of constant controversy. In particular, its paragraph on the use of placebo controls in clinical trials divides...

In every country, a manufacturer of medicinal products for either human or veterinary use is required to operate in compliance with local legislation. In all EU Member States, legislation is approximated to the effect that they are committed to abide by the same standards. The candidate countries transpose the acquis into their national legislation, including the good manufacturing practice (GM...

Based on favorable hemodynamic data, flosequinan, an oral vasodilator, received marketing approval in Europe in September 1992 and in the United States in March 1993 for use in chronic heart failure (HF). Later, a phase III trial signaled increased mortality, prompting its withdrawal from the market. Oral milrinone was initially used for refractory HF but was later shown to increase adverse eve...

Information campaigns to increase tax compliance could be framed in different ways. They can either highlight the potential gains when tax compliance is high, or the potential losses when compliance is low. According to regulatory focus theory, such framing should be most effective when it is congruent with the promotion or prevention focus of its recipients. Two studies confirmed the hypothesi...