[Newborn blood spot screening (NBS) in Germany : Status quo and presentation of a concept for further development]. / Neugeborenen-Screening aus Trockenblut (NBS) in Deutschland : Status quo und Vorstellung eines Konzeptes zur Weiterentwicklung.

Newborn screening from dried blood spots (NBS) is a highly effective secondary prevention measure that has been established for many years. Against the background of the inclusion of "new diseases" that meet the screening criteria, a concept for the further advancement of NBS was developed on behalf of the GKV-Spitzenverband. This was based on a systematic literature review and a survey of the status quo of NBS in Germany using quantitative and qualitative methods.It is essential for the success of NBS that all newborns affected by a target disease are diagnosed and treated at an early stage and that the harm to be expected with each screening (e.g., due to false positive findings) is kept as low as possible. This requires the organisation of screening in the sense of an integrated programme through central coordination with standardised structures, continuous quality management and digitalisation in line with data protection requirements.Although in general NBS is being implemented successfully in Germany, the research project presented here also reveals weaknesses and a need for action. Proposals and recommendations were compiled in a concept paper, which shows approaches for further development of NBS in line with the current state of research in consideration of changing demands on the infrastructure and processes in the health system. This review article summarises the challenges, current status and possible solutions for the central topics of the concept paper.

[Medical occupational law--limits of medical duties from a legal viewpoint]. / Grenzen der Pflichten eines Arztes aus juristischer Sicht.

The medical profession is not a trading business. The privileged position that society concedes to the medical professionals has a price: responsibility. The responsible professional can demand freedom as long as he does not abuse this freedom. Professional rules mark the border. These, however, are not only a tie, but also a protection against interference with medical independence.

[Is preimplantation diagnosis legal?--on the need for harmonizing legislation]. / Zulässigkeit der Präimplantationsdiagnostik? Harmonisierungsbedarf der Gesetzgebung.

Whether PGD is already legally permitted in Germany today is a moot point. A guidelines draft of the Germany's Federal General Medical Council, the Bundesärztekammer, on pre-implantation genetic diagnostics that--like the earlier findings of the ethics commission of the German federal state of the Rhineland-Palatinate--assumed that the method is admissible, if certain clearly-defined indications are present and a rigorous testing procedure has been established, has given the discussion a new impetus. The discussion is in full swing, with calls by politicians for the legislator to pass a regulation mounting. Of late, though, constitutional objections have been raised against a positive-law regulation. Such a simple legal move to regulate PGD, it is claimed, would violate the constitutionally-guaranteed right to inviolable human dignity. Critics, however, point out that such an absolute inviolability does not exist. According to them, not only the verdicts by the German Federal Constitutional Court, the Bundesverfassungsgericht, on the reform of section 218 of the German Federal Penal Code (StGB)--the paragraph that specifies the conditions under which an abortion is not punished--that relativize (in terms of the indication model) one claim to existence with respect to another, but also the approval in terms of pharmaceutical and medicine-products law of nidation-blocking agents, serve to show this. If the condition of being a human being were made to coincide with the completion of the genetic code upon the completion of the process of fertilisation, then one tended to forget, the critics noted, that this attendant dignity was not properly "infused with life" unless nidation had been successful. Without nidation everything were fragmentary, the total protection of human dignity according to Article 1 Section 1 of the Federal Republic's Basic Law, Germany's constitution, notwithstanding. During every in vitro fertilisation embryo transfer is conditional upon a variety of factors the presence of which is not noted until after fertilisation has taken place. On the part of the embryos, too, certain conditions have to be met whose presence at the moment of fertilisation is not assured. Thus an embryo with, for instance, defects that can be visually detected will not be transferred. With regard to these facts too the opponents of pre-implantation genetic diagnostics must be challenged to answer the question of why an embryo with visually-detectable defects should undoubtedly be allowed to be discarded, but the act of searching for "internal" defects be banned. Thus the fact remains that the mere acceptance of the loss of created embryos does not make artificial insemination a punishable offense, as long as the motive for the act is to bring about pregnancy. To achieve legal security for the couples and the physicians involved the law on the protection of embryos should be changed. The new regulations should determine under which conditions PGD is permissible. As is already the case for other norms that apply to reproductive medicine, but also for the practice of abortion, these regulations should contain an analogous right of refusal for the professionals involved. The laws relating to the healing professions, to the professional chambers, as well as the regulations of the various German federal states (which together constitute the Federal Republic of Germany) that apply to the professions should be amended accordingly.