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Embryo Protection Law [Germany]

The artificial alteration of the human germline is criminalized by the Embryo Protection Law (art. 5, par. 1). Likewise, the law punishes anyone who uses or attempts to use a human germ cell with artificially altered genetic information for fertilization (art. 5). Exceptions to this prohibition are possible if the germ line alteration is not the aim, but only a side effect of medical treatment. The pertinent article of the law reads as follows:

“Paragraph 1 (art. 5) does not apply to:
1. an artificial alteration of the genetic information of a germ cell situated outside the body, if any use of it for fertilization has been ruled out,
2. an artificial alteration of the genetic information of a different body’s germ line cell, that has been removed from a dead embryo, from a human being or from a deceased person, if it has ruled out that
a) they will be transferred to an embryo, fetus or human being or
b) a germ cell will originate from them, and likewise
3. inoculation, radiation, chemotherapeutic or other treatment by which an alteration of the genetic information of germ line cells is not intended.”

For the purposes of the Embryo Protection Law, germ line cells “are all cells that lead from the egg and sperm cells to the resultant human being and, further, the egg cell from capture or penetration of the sperm cell until the ending of fertilization by fusion of the nuclei.” In addition, the term “embryo” has been defined as a “human egg cell, fertilized and capable of development, from the time of fusion of the nuclei, as well as each totipotent cell removed from an embryo that is capable, in the presence of other necessary conditions, of dividing and developing into an individual.”

Gene therapy and somatic cell therapy products used in or on humans (in vivo) are termed gene transfer medicinal products (GT-MPs). They are medicinal products (drugs) according to Section 2 (1) of the German Drug Law (AMG) and include DNA, viral or non-viral vectors and genetically modified autologous, allogeneic or xenogeneic cells (used in vivo). No official definition of GT-MPs is given in the AMG. GT-MPs are either vaccines, blood products, or other drugs, according to Section 4 (4) and Section 4 (2) of the AMG. According to Section 77 of the AMG, the Paul-Ehrlich-Institute, Langen, is the competent higher authority for those GT-MPs which are vaccines and blood products, whereas the Federal Institute for Drugs and Medical Devices (BfArM, Bonn) is the competent higher authority for other GT-MPs.

As for other medicinal products, regulations relevant to the manufacture and clinical trial of GT-MPs are provided by the AMG and the professional law of physicians. In contrast to other medicinal products, an appraisal of the central Commission Somatic Gene Therapy of the Scientific Board of the German Medical Association is required for clinical trials involving the use of GT-MPs (http://www.bundesaerztekammer.de/30/Ethik/80Themen/85KomSomGen/).

Prior to licensing, gene transfer medicinal products are to be used in or on humans during clinical trials only (according to the appraisal of the Kommission Somatische Gentherapie’der Bundesärztekammer; (KSG-BÄK)). Very few exceptions require special consideration by the KSG-BÄK. The Guidelines for Gene Transfer into Human Body Cells published by the German Medical Association specify the necessary ethical considerations and are guidelines for clinical trial applications. Clinical trials can only be conducted if certain requirements are met (see Sections 40 & 41 of the AMG).

The Federal Institute for Drugs and Medical Devices (BfArM) is an independent higher federal authority within the portfolio of the Federal Ministry of Health. The main tasks of the BfArM are licensing and registration of medicinal products, authorization of clinical trials, and recording and assessment of risks associated with medicinal products and medical devices, as well as control of the (legal) trade with narcotic drugs. The BfArM is involved in the development of regulatory and scientific standards and guidelines. It also provides scientific advice for government authorities and information for expert groups and the general public.

The Research Council is the most important research-related BfArM body. It is involved in continuing development of research concepts and their transfer into practice. The council evaluates the applications for research projects and devises the basic procedures for research organizations. The final decision regarding the recommendations given by the council is made by the head of BfArM. The council was appointed by the Federal Ministry of Health in late 2003 and formally constituted in 2004.

(Please refer to: Paul-Ehrlich-Institut. Regulation of Gene Transfer Medicinal Products in Germany)

Other normative measures

Due to the promise for discovering cures for diseases and decreasing human suffering, the German Society of Human Genetics recommends that somatic gene therapy be promoted. In its Position Paper, the society adds that, “before such a gene therapy is used, the usual requirements for medical treatments must be met and the patient must be counseled beforehand.” However, the society does not support the development and use of gene therapy procedures for non-therapeutic purposes. The society considers germline therapy to be a “genetic manipulation of embryonal cells after an in vitro fertilization with the goal of producing a human individual without a certain genetically determined disorder,” a prohibited act. Germline therapy is therefore not a medical treatment for patients but an experiment, “a basic hypothesis of which is to be verified or refuted by a human existence.” The society further adds that, “currently and in the near future, reasonable and responsible application of these techniques is not foreseeable because of technical and ethical problems.”

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