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The characterisation of new psychoactive drugs which were identified in the last years in continuously increasing numbers is a challenge for different academic institutions. This paper gives an overview on new psychoactive drugs in regard of their chemistry, pharmacology, metabolism, analytics and legal aspects in Germany.

On 10th of July 2014 the European Court of Justice made in his decisions in relation to the cases D. (C-358/13) and G. (C-181/14) an interpretation, that the concept of 'medicinal product' according to the law of the European Union does not include the materials, which are - as not covering substances, such as those at issue in the main proceedings, which produce effects that merely modify physiological functions but which are not such as to have any beneficial effects, either immediately or in the long term, on human health, are consumed solely to induce a state of intoxication and are, as such, harmful to human health. The Court made his interpretation after the request for preliminary ruling from the Bundesgerichtshof (the High Court of Justice in Germany). The Court had to decide in two criminal procedures, whether for the retail of mixtures including syntetic canabinoids, such as complements of marihuana, due the fact that they are "unsafe medicinal products", a criminal proceeding can be initiated or not. The Ordinary Courts had two persons (D. and G.) for selling the unsafe medicinal products sentenced to one year and nine months imprisonment, and suspension (D.), and sentenced (G.) to four years and six months imprisonment and fined with a charge of two hundred thousand Euro. The retail of herb mixtures containing, inter alia, synthetic cannabinoids, did not fall under the German law on narcotic drugs at the material time, resulting that the German Authorities could not initiate a criminal procedure.

Substituting generic formulations of the same chemical agent is a common practice in German health care on the basis of so called rebate contracts. The substitution of a medication may affect the patients' adherence or result in adverse events. While adverse events which may be caused by the pharmacological activity of the agent itself can be explained, some non-specific side effects cannot be substantiated referring to pharmacological factors. These adverse reactions are summarized under the term nocebo effect. Since patients experiencing a nocebo effect can subsequently become non-adherent or even discontinue an appropiate therapy, the aim of this article is to study patients' adherence to generic substitution and the extent of the nocebo effect. In MEDLINE and EMBASE, a search was carried out for articles which were published between March 25th, 1989 and March 25th, 2009 by using the following search terms: generic substitution, adherence, non-adherence, non-persistence, rebate contracts, patients' attitude, nocebo, negative placebo effects, placebo adverse reactions, placebo induced side effects and negative placebo responses. In addition a manual search was performed in the reference lists of the articles retrieved. 14 studies met the inclusion and exclusion criteria and were included in this article. The generic substitution was generally accepted by over two thirds of the study populations. But up to 34% of patients being treated for psychological diseases confronted with a change of their medication had additional adverse events. On the basis of the studies analysed, the conclusion can be drawn that the nocebo effect can play a crucial role in the treatment of psychological diseases. Therefore, physicians and pharmacists should be responsible to prevent the nocebo effect through adequately educating the patients.

If globally active pharmaceutical companies are to remain competitive, it is essential for them to be able to conduct research and development on an appropriate scale. Generally, their respective domestic market forms their base. For that reason, conditions there should be research-and innovation-friendly. In addition, pharmaceutical research calls for very long-term investment decisions. Companies that become involved in this interaction of profit and loss differ fundamentally from state or public organizations. The ensuing conflict of interest has become increasingly evident in Germany since the end of the 70s. The regulatory environment surrounding the market has changed in all fields, be they fiscal, sociopolitical or in pharmaceutical legislation, into a confusing and incoherent body of regulations. Moreover, part of society is undecided about its attitude towards pharmaceutical progress and the introduction of new technologies. In view of these developments it is high time to change course and help ensure that one of the few remaining competitive sectors in Germany-and one with a promising future-stays in the country.