The claimant seeks to obligate the defendant to issue a consenting evaluation on the performance of preimplantation genetic diagnosis (hereinafter PGD) she applied for.

On 22 January 2016, she filed an application with the Bavarian Ethics Commission for Preimplantation Genetic Diagnosis (Bayerische Ethikkommission für Präimplantationsdiagnostik, hereinafter Ethics Commission) to consent to the performance of PGD. Attached to the application were several medical statements, including the summary of a genetic counselling on 18 December 2015. From these, it appears that the claimant's partner has been diagnosed by molecular genetic testing with myotonic dystrophy type 1. An analysis of the DMPK gene (dystrophia myotonica protein kinase) showed an expanded CTG repeat length in the 3' untranslated region of 500-1000 repeats. He showed significant muscle weakness and other symptoms of myotonic dystrophy, as do his older sister and his father. Should the claimant become pregnant, the probability for the birth of a child with myotonic dystrophy type 1 was 50 per cent.

By notice of 14 March 2016, the Ethics Commission rejected the claimant's application. Under section 3a (3) first sentence no. 2 in conjunction with (2) first sentence of the Embryo Protection Act (ESchG, Embryonenschutzgesetz), a consenting evaluation regarding the performance of PGD required that a high risk of a severe hereditary disease exists for the applicant's offspring. A hereditary disease was to be classified as severe if it differs significantly from other hereditary diseases in that it leads to reduced life expectancy or in the severity of the disease pattern and difficulty of treatment. These conditions were not met for the claimant. The characteristic symptoms of myotonic dystrophy type 1 were muscle stiffness and slowly progressing muscle weakness, in particular of the facial muscles, the cervical and nuchal muscles, as well as the muscles in the forearms and in the lower section of the legs. Other organs might also be affected. The age at the onset of the disease and the nature of the symptoms strongly depended on the length of the CTG repeat sequence. In a very substantial number of patients, the disease only became apparent at an advanced age. In the claimant's case in particular, as the disease would be inherited from the father, it was very unlikely that the offspring would suffer from a severe infantile form of the disease.

The claimant's action challenging this notice remained unsuccessful in the lower instances.

Upon the claimant's appeal on points of law, the Federal Administrative Court (BVerwG, Bundesverwaltungsgericht) amended the decisions of the lower instances, repealed the challenged notice and obligated the defendant to issue a consenting evaluation.

9 (...) The challenged judgment is based on a violation of federal law (section 137 (1) no 1) of the Code of Administrative Court Procedure (VwGO, Verwaltungsgerichtsordnung)). The Higher Administrative Court (VGH, Verwaltungsgerichtshof) incorrectly assumed that hereditary diseases are only to be classified as severe within the meaning of section 3a (2) first sentence ESchG if they reach the level of severity of the Duchenne type of muscular dystrophy. A severe hereditary disease within the meaning of this provision exists in particular if the relevant condition differs significantly from other hereditary diseases in a reduced life expectancy or in the severity of the disease pattern and difficulty of treatment. If it is unclear whether a hereditary disease is to be classified as severe based only on the expected manifestation of the disease in the offspring due to the genetic disposition of at least one parent, additional burdens on the affected woman or couple that are associated with the genetic disposition also have to be taken into account. Therefore, the claimant's action is successful (sections 113 (5) first sentence, 144 (3) first sentence no. 1 VwGO). The claimant has a right under section 3a (3) first sentence no. 2 in conjunction with (2) first sentence ESchG, section 6 (4) first sentence of the Ordinance on the Regulation of Preimplantation Genetic Diagnosis (PIDV, Präimplantationsdiagnostikverordnung) to be issued a consenting evaluation of the requested performance of preimplantation genetic diagnosis, as the conditions for a high risk of a severe hereditary disease are met.

10 1. The claimant admissibly pursues her request through an action for the issuance of an administrative act (Verpflichtungsklage) (section 42 (1) VwGO). The Higher Administrative Court assumed, in accordance with the law that is subject to an appeal on points of law (section 137 (1) no. 2 VwGO) that the decision under section 3a (3) first sentence no. 2 in conjunction with (2) ESchG, section 6 (4) first sentence PIDV by the Bavarian Ethics Commission for Preimplantation Genetic Diagnosis meets the requirements of an administrative act under article 35 first sentence of the Bavarian Administrative Procedure Act (BayVwVfG, Bayerisches Verwaltungsverfahrensgesetz) (see explanatory memorandum on the Ordinance on the Regulation of Preimplantation Genetic Diagnosis, Bundesrat printed paper (BR-Drs., Bundesratsdrucksache) 717/12 p. 30 <on section 6 (1) PIDV>; regarding the status of the Bavarian Ethics Commission for Preimplantation Genetic Diagnosis as a public authority: Bavarian State Parliament (Bayerischer Landtag), explanatory memorandum to the Act on the Implementation of the Ordinance on Preimplantation Genetic Diagnosis (Gesetz zur Ausführung der Präimplantationsdiagnostikverordnung), printed paper (Drs., Drucksache) 17/2382 p. 8 <on article 2 (1)>).

11 2. In the case of an action for the issuance of an administrative act, the relevant time for the assessment of the factual and legal situation usually is the time of the last oral hearing or decision. For the right asserted by the claimant for the issuance of a consenting evaluation on the performance of preimplantation genetic diagnosis pursuant to section 3a (3) first sentence no. 2 in conjunction with (2) first sentence ESchG, section 6 (4) first sentence PIDV, no deviating relevant time for the assessment proceeds from the substantive law. Accordingly, the Embryo Protection Act (ESchG, Embryonenschutzgesetz) of 13 December 1990 (Federal Law Gazette (BGBl., Bundesgesetzblatt) I p. 2746), last amended by article 1 of the Act of 21 November 2011 (BGBl. I p. 2228) and the Ordinance on the Regulation of Preimplantation Genetic Diagnosis (PIDV, Präimplantationsdiagnostikverordnung) of 21 February 2013 (BGBl. I p. 323), last amended by article 3 of the Ordinance of 2 July 2018 (BGBl. I p. 1078) are applicable.

12 3. Pursuant to section 3a (3) first sentence no. 2 ESchG, preimplantation genetic diagnosis pursuant to subsection 2 may only be performed after an interdisciplinary ethics commission at an approved centre for preimplantation genetic diagnosis has assessed whether the conditions of subsection 2 are met and has issued a consenting evaluation. Accordingly, the Ordinance on the Regulation of Preimplantation Genetic Diagnosis that was adopted on the basis of section 3a (3) third sentence ESchG, provides in its section 6 (4) first sentence PIDV that the ethics commissions are obligated to consentingly evaluate the application for the performance of preimplantation genetic diagnosis if they conclude, after assessing the information and documents specified in section 5 (2) PIDV, taking into account the relevant psychological, social and ethical aspects of the specific individual case, that the conditions provided for in section 3a (2) ESchG are met. The exception under section 3a (2) first sentence ESchG from the general prohibition of preimplantation genetic diagnosis under section 3a (1) ESchG presupposes that the offspring has a high risk of a severe hereditary disease due to the genetic disposition of the woman from whom the egg cell originates or of the man from whom the semen cell originates, or of both.

13 The Higher Administrative Court correctly assumed that the challenged decision by the Bavarian Ethics Commission for Preimplantation Genetic Diagnosis is subject to full review by the administrative courts. Ethics commissions for preimplantation genetic diagnosis do not have any margin of appreciation when assessing whether the conditions for a high risk of a severe hereditary disease pursuant to section 3a (3) first sentence no. 2 in conjunction with (2) first sentence ESchG are met.

14 a) article 19 (4) first sentence of the Basic Law (GG, Grundgesetz) guarantees the right to have recourse to the courts to anyone who asserts that his or her rights have been violated by public authority. This ensures access to the courts as well as the effectiveness of legal protection. Citizens have a right to the most effective judicial control possible, whereby it is irrelevant whether it concerns encroachments on protected legal interests or the refusal of rights provided for by law. The guarantee of effective legal protection as a matter of principle results in an obligation for the administrative courts to comprehensively examine the challenged administrative acts under legal and factual aspects. This in principle also means that they are not bound by the factual and legal findings and assessments made during the administrative procedure (Federal Constitutional Court (BVerfG, Bundesverfassungsgericht), decision of 31 May 2011 - 1 BvR 857/07 [ECLI:DE:BVerfG:2011:rs20110531.1bvr085707] - Rulings of the Federal Constitutional Court (BVerfGE, Entscheidungen des Bundesverfassungsgerichts 129, 1 <20> with further references). In the context of the application of an indefinite legal term, it can therefore only be justified in exceptional cases to grant the administrative authority its own margin of appreciation which is subject to judicial review only to a limited extent. The acknowledgement in exceptional cases of a margin of appreciation requires that the administrative body has the legal authority to conclusively decide whether the conditions defined by an indefinite legal provision or term are met. The nature and scope of this authority must follow at least by implication - through interpretation - from the relevant legal provisions. In addition, the exemption of the application of a law from judicial review always requires a sufficiently substantive objective reason, adjusted to the principle of effective legal protection (BVerfG, decision of 31 May 2011 - 1 BvR 857/07 - BVerfGE 129, 1 <22 et seq.>; BVerwG, judgments of 21 December 1995 - 3 C 24.94 - Rulings of the Federal Administrative Court (BVerwGE, Entscheidungen des Bundesverwaltungsgerichts) 100, 221 <225> and of 30 October 2019 - 6 C 18.18 [ECLI:DE:BVerwG:2019:301019U6C18.18.0] - BVerwGE 167, 33 para. 12 et seqq., each with further references).

15 b) Based on this, the assumption of a margin of appreciation is not justified here. An authorisation for the administrative authority to make use of a margin of appreciation does not follow with sufficient clarity from the legal provisions (aa) and a viable objective reason for the restriction of judicial review does not exist (bb).

16 aa) It is not sufficient for the assumption of a margin of appreciation that the legislature assigned the decision to be taken under section 3a (3) first sentence no. 2 ESchG to an independent, interdisciplinary ethics commission (section 3a (3) first sentence no. 2, third sentence no. 2 ESchG in conjunction with section 4 (1) first and third sentence PIDV) whose members are independent and free from instructions when forming opinions and making decisions. The assignment of competence for administrative decisions to a pluralistic collegiate body with special expertise may indicate that the legislature's intention is to grant the administrative authority a margin of appreciation (see BVerwG, judgments of 25 November 1993 - 3 C 38.91 - BVerwGE 94, 307 <311>, of 16 May 2007 - 3 C 8.06 - BVerwGE 129, 27 para. 27 and of 14 October 2015 - 6 C 17.14 [ECLI:DE:BVerwG:2015:141015U6C17.14.0] - BVerwGE 153, 129 para. 35, each with further references). However, in the present case, this conclusion is neither prescribed by the wording of the provisions, nor do the legislative materials express that the ultimate interpretation of the conditions specified in section 3a (2) ESchG of a high risk of a severe hereditary disease is intended to be reserved for the ethics commissions and that review by the administrative courts is intended to be restricted (see explanatory memorandum to the draft of an act on the regulation of preimplantation genetic diagnosis, Bundestag printed paper (BT-Drs., Bundestagsdrucksache) 17/5451 p. 7 et seqq.; recommendation for a decision and report by the Committee on Health (Ausschuss für Gesundheit), BT-Drs. 17/6400 p. 11 et seqq.; explanatory memorandum to the Ordinance by the Federal Government on the Regulation of Preimplantation Genetic Diagnosis, BR-Drs. 712/12 p. 10 et seq., 25 et seqq.). The regulatory system of section 3a ESchG is an argument against the granting of a margin of discretion to the ethics commission. Pursuant to section 3a (1) ESchG, anyone who genetically examines the cells of an embryo in vitro prior to its intrauterine transfer is liable to punishment. Section 3a (2) ESchG regulates the conditions under which the performance of preimplantation genetic diagnosis pursuant to subsection 1 of the provision is not unlawful. The justification provision in section 3a (2) ESchG does not require the consenting evaluation of the ethics commission. Whoever performs preimplantation genetic diagnosis contrary to section 3a (3) first sentence no. 2 ESchG commits an administrative offence pursuant to section 3a (4) ESchG. It follows from this that the criminal courts must comprehensively review whether the conditions of section 3a (2) ESchG are met (...). It is not plausible that review of the same indefinite legal term by the administrative courts should be restricted.

17 bb) Also, there is no sufficiently substantive objective reason which would justify the restriction of legal protection by the administrative courts.

18 (1) The requirements regarding the substantiveness of the objective reason are particularly high if the affected regulatory area - as in the present case - requires the proportionate balancing of various conflicting legal and protected interests of constitutional rank (see BVerfG, decisions of 27 November 1990 - 1 BvR 402/87 - BVerfGE 83, 130 <142> and of 31 May 2011 - 1 BvR 857/07 - BVerfGE 129, 1 <22 et seq.>).

19 With the provision in section 3a ESchG, the legislature pursued the objective of achieving a proportionate balancing of the constitutional interests of the affected women and couples, and the protection of embryos in vitro (see explanatory memorandum to the draft of an act on the regulation of preimplantation genetic diagnosis, BT-Drs. 17/5451 p. 7). The explanatory memorandum makes reference to the state's special responsibility for the protection of born and unborn lives as well as the protection of embryos against abuse on the one hand, and the basic rights to a self-determined lifestyle and the freedom of reproduction on the other hand (BT-Drs. 17/5451 p. 2, 7). A couple's right to realise its desire to have children is protected by the basic right to the free development of one's personality under article 2 (1) in conjunction with article 1 (1) GG. Article 6 (1) GG might be affected as well. Other rights in focus are the woman's right to physical and mental integrity (article 2 (2) first sentence GG) and her right to the protection of, and respect for, her human dignity (article 1 (1) GG, see e.g. statement by the German Ethics Council (Deutscher Ethikrat) on preimplantation genetic diagnosis, BT-Drs. 17/5210 p. 12, 28; (...)). With regard to the embryos in vitro affected by preimplantation genetic diagnosis, the relevant basic rights are mainly the right to life (article 2 (2) first sentence GG) and the guarantee of dignity (article 1 (1) GG) (statement by the German Ethics Council on preimplantation genetic diagnosis, BT-Drs. 17/5210 p. 12 et seq., 28). The Federal Constitutional Court has not conclusively decided whether human life as protected by article 2 (2) first sentence GG already comes into existence at the moment when the egg and semen cells unite; however, it indicated that this stands to reason, making reference to knowledge available to medical anthropology (BVerfG, judgment of 28 May 1993 - 2 BvF 2/90 et al. - BVerfGE 88, 203 <251>). The legislature of the Embryo Protection Act of 13 December 1990 acted on the same assumption (see explanatory memorandum to the draft of an embryo protection act, BT-Drs. 11/5460 p. 6). A major part of the literature also assumes that the embryo's protection under basic rights already commences upon fertilization of the egg cell (...). Accordingly, the state's obligation to protect human life might also cover embryos in vitro. It is the legislature's task to determine the details of the nature and extent of this protection (see BVerfG, judgment of 28 May 1993 - 2 BvF 2/90 et al. - BVerfGE 88, 203 <254>).

20 The legislature of the Preimplantation Genetic Diagnosis Act carried out the balancing of the conflicting fundamental rights by permitting the performance of preimplantation genetic diagnosis within narrow limits (draft of an act on the regulation of preimplantation genetic diagnosis, BT-Drs. 17/5451 p. 7). It is prohibited as a matter of principle, under section 3a (1) ESchG. Section 3a (2) ESchG regulates the conditions under which it is not unlawful in exceptional cases. The permissibility of preimplantation genetic diagnosis furthermore requires compliance with the procedure provided for in section 3a (3) first sentence ESchG. Pursuant to section 3a (3) first sentence no. 2 ESchG, the ethics commissions are assigned with the authority to decide in an area which - as has been shown above - is particularly sensitive with regard to basic rights.

21 (2) A viable objective reason which may justify the granting of a margin of appreciation to the ethics commissions for this area with particular sensitivity with regard to basic rights is not apparent (...).

22 (2.1) This objective reason cannot be assumed to exist merely because, with the interdisciplinary ethics commissions for preimplantation genetic diagnosis under section 3a (3) first sentence no. 2 ESchG, a body with special expertise is called upon to decide (see BVerwG, judgment of 30 October 2019 - 6 C 18.18 - BVerwGE 167, 33 para. 19).

23 (2.2) A margin of appreciation for an administrative authority may in particular be justified if the decision-making programme provided for by law is vague and if its application to specific cases proves to be particularly difficult and complex because a large number of evaluation factors need to be identified, weighted and put into relation to each other, for which, in addition, difficultly calculable prognoses must be made, or if the decision to a large extent defies control via an abstract-general regulatory framework because it is characterised by individual assessments and experience (BVerwG, judgments of 24 November 2010 - 6 C 16.09 - BVerwGE 138, 186 para. 42, of 14 October 2015 - 6 C 17.14 - BVerwGE 153, 129 para. 35 and of 30 October 2019 - 6 C 18.18 - BVerwGE 167, 33 para. 15). These conditions have not been met in the present case. The fact that the constituent elements mentioned in section 3a (2) first sentence ESchG, i.e. a severe hereditary disease and a high risk, require interpretation does not justify the assumption of a margin of appreciation. The terms can be interpreted with sufficient certainty using the traditional legal methodology (see 5. below). The assessment of the conditions of section 3a (2) first sentence ESchG furthermore does not have a level of difficulty or complexity that would surpass the administrative courts' ability to obtain findings. It is not apparent that the courts would be unable to deal with the tasks of identifying the facts that are relevant for the decision, and of legally assessing these facts. They can take recourse to the documents submitted during the administrative procedure (see section 5 (2) second sentence no. 1 PIDV) and the expertise of the ethics commissions for preimplantation genetic diagnosis that first deal with the matter (see section 4 (1) third sentence, section 6 (2) first sentence PIDV). If necessary, they can use the assistance of additional experts (see BVerwG, judgments of 28 May 2009 - 2 C 33.08 - BVerwGE 134, 108 para. 11 and of 25 July 2013 - 2 C 12.11 - BVerwGE 147, 244 para. 25).

24 4. The Higher Administrative Court assumed that hereditary diseases are only to be classified as severe within the meaning of section 3a (2) first sentence ESchG if they reach the level of severity of the Duchenne type of muscular dystrophy. This is incompatible with federal law.

25 a) The term hereditary diseases within the meaning of section 3a (2) first sentence ESchG, which is oriented towards the generally accepted current state of genetic diagnostics, comprises in particular monogenic disorders (see explanatory memorandum to the draft of an act on the regulation of preimplantation genetic diagnosis, BT-Drs. 17/5451 p. 8). The Higher Administrative Court also acted on this assumption.

26 b) Contrary to the assumption of the Higher Administrative Court, the provision in section 3 ESchG on the prohibition of sex selection and its classification of the Duchenne type of muscular dystrophy as a severe hereditary disease linked to the sex does not allow the conclusion that the level of severity of the Duchenne type of muscular dystrophy is also the standard for the evaluation of a hereditary disease as severe within the meaning of section 3a (2) first sentence ESchG.

27 aa) The different wording of the two provisions already mitigates against this conclusion.

28 Pursuant to section 3 ESchG, anyone who undertakes to artificially fertilize a human egg cell with a semen cell that has been selected according to the sex chromosome contained in it incurs a sentence of up to one year imprisonment or a fine (first sentence). This does not apply if the selection of the semen cell by a physician serves to protect the child from suffering from the Duchenne type of muscular dystrophy or similarly severe hereditary diseases that are linked to the sex, provided that the disease that the child may be suffering from has been recognised by the competent body under the law of the relevant federal state as correspondingly severe (second sentence). In section 3 ESchG, the term "severe" therefore merely refers to hereditary diseases that are linked to the sex. In section 3a (2) first sentence ESchG, however, it refers to hereditary diseases, without any restrictions.

29 The term "similarly severe hereditary diseases linked to the sex" in section 3 second sentence ESchG refers to the Duchenne type of muscular dystrophy. This is a clear determination that the level of severity of this disease is to be the standard for the classification of a hereditary disease that is linked to the sex as "severe" within the meaning of section 3 ESchG. In contrast, section 3a (2) first sentence ESchG does not specify a standardising reference point for the term "severe hereditary disease". If the level of severity of the sex-linked disease Duchenne type muscular dystrophy were intended to also be used as a standard for the hereditary diseases within the meaning of section 3a (2) first sentence ESchG, it would have stood to reason to clearly state this in the wording of the provision.

30 bb) The legislative materials do not support the interpretation of the Higher Administrative Court either.

31 The explanatory memorandum to section 3a ESchG states as follows as an introduction to part "B. Detailed reasons": "An incorporation of the provision after section 3 is recommended due to the similarity of the regulatory content: section 3 second sentence allows for severe genetic reasons an exception from the general prohibition provided for in the first sentence to select a semen cell for artificial fertilization according to the sex; section 3a aims to regulate for corresponding reasons a limited exception from the general protection of embryos - however, for the event that already fertilized egg cells are not implanted." (explanatory memorandum to the draft of an act on the regulation of preimplantation genetic diagnosis, BT-Drs. 17/5451 p. 8 <on no. 1>). This means that the legislature considers the provisions to be comparable, as both are worded as prohibitions with exception rules, and as, in both cases, an exception from the relevant prohibition is only permissible if severe genetic reasons apply. It does not follow from this that the level of severity of the Duchenne type of muscular dystrophy is also intended to be the standard for section 3a (2) first sentence ESchG.

32 The explanatory memorandum to section 3a (2) ESchG does not allow a different conclusion either. This reads: "The term 'severe hereditary disease' of the child makes reference to a wording already used in the ESchG in section 3 second sentence." (BT-Drs. 17/5451 p. 8 <on subsection 2>). Even though an isolated assessment of this statement may also be understood to mean that, by referring to the term in section 3 second sentence ESchG, the legislature intended to express an equalisation of content. However, the subsequent explanation in the memorandum clarifies that the legislature links an autonomous understanding of the term to the wording "severe hereditary disease" used in section 3a (2) first sentence ESchG. According to this, hereditary diseases are severe in particular if they differ significantly from other hereditary diseases in that they lead to reduced life expectancy or in the severity of the disease pattern and difficulty of treatment. The Duchenne type of muscular dystrophy is not mentioned in the context of this definition - nor in the remainder of the explanatory text. Furthermore, in the explanatory memorandum, the two conditions "reduced life expectancy" and "severity of the disease pattern and difficulty of treatment" are included as alternatives ("or"). However, the Duchenne type of muscular dystrophy will usually meet both these conditions. This means that applying the Duchenne type as a standard - as the Higher Administrative Court believes to be required - would narrow the scope of application of section 3a (2) first sentence ESchG intended by the legislature. All of these arguments mitigate against the assumption that only diseases that reach at least the level of severity of the Duchenne type of muscular dystrophy are to be classified as severe diseases within the meaning of the provision.

33 cc) Another argument against the application of the disease named specifically in section 3 sentence 2 ESchG as a standard for the required level of severity of the hereditary disease under section 3a (2) first sentence ESchG is the different regulatory purpose of the two provisions. Section 3 ESchG provides for the prohibition of selecting a semen cell for artificial fertilization according to the sex. This means that an intentional determination of the sex of the future child is impermissible as a matter of principle, and is permitted only in very narrowly limited exceptional cases. The draft of an embryo protection act had originally provided for permitting the selection of the semen cell if it serves to prevent a severe hereditary disease of the child that is linked to the sex (BT-Drs. 11/5460 p. 10). During the legislative procedure, the exception rule was further clarified by adding the disease Duchenne type of muscular dystrophy as a standard for the required level of severity. The reason provided for the change was that it significantly limits the exceptions from the otherwise applicable prohibition of a selection by sex ( recommendation for a decision and report by the Committee on Legal Affairs (Rechtsausschuss) on <inter alia> the draft of an embryo protection act proposed by the Federal Government, BT-Drs. 11/8057 p. 15).

34 The protective and regulatory purpose of the provision in section 3a ESchG has a different focus. It serves the objective of creating a legal basis for a limited application of the medical procedure of preimplantation genetic diagnosis. In exceptional cases, the genetic examination of the cells of an embryo in vitro is to be permitted in order to identify particularly severe hereditary diseases and chromosome anomalies and, possibly, to be able to prevent transmission of the disease to the child by not implanting the affected embryo (see explanatory memorandum to the draft of an act on the regulation of preimplantation genetic diagnosis, BT-Drs. 17/5451 p. 2 et seq.). The general prohibition of preimplantation genetic diagnosis has the purpose of protecting the embryos in vitro against abuse, and intends to take account of medical and ethical concerns regarding the performance of such diagnostics. With the limited permission of preimplantation genetic diagnosis in accordance with section 3a (2) first sentence ESchG, women and couples with the desire to have a child are intended to be protected from severe physical and mental burdens which may arise because one or both parents have a genetic disposition for a severe disease, and because there is a high risk that they will transmit this disease to their child (BT-Drs. 17/5451 p. 2, 7). The legislature intentionally refrained from listing diseases that are an indication that preimplantation genetic diagnosis is permissible. A decision is to be made in each individual case (BT-Drs. 17/5451 p. 7). This regulatory purpose could not be achieved if the reference disease specified in section 3 second sentence ESchG were used as a standard for the required level of severity of the hereditary diseases within the meaning of section 3a (2) first sentence ESchG.

35 dd) Furthermore, the two provisions deviate with regard to their procedural design. Section 3 ESchG does not provide for a separate administrative procedure during which an assessment is carried out prior to performance of the relevant artificial fertilization as to whether the conditions of section 3 second sentence ESchG are met. The provision merely requires that the disease the child may suffer from must have been acknowledged by the competent body under the law of the relevant federal state as being correspondingly severe (section 3 second sentence second half-sentence ESchG). It therefore stood to reason to name a reference disease in order to more precisely define the exception rule (recommendation for a decision and report by the Committee on Legal Affairs on <inter alia> the draft of an embryo protection act proposed by the Federal Government, BT-Drs. 11/8057 p. 15). Section 3a (3) first sentence no. 2 ESchG, in contrast, provides that, prior to the performance of preimplantation genetic diagnosis, compliance with the conditions of section 3a (2) first sentence ESchG must be assessed as part of an administrative procedure, and assigns the administrative decision to a body with special expert legitimation. This difference is another argument that mitigates against equating the contents of the term "severe" in section 3a (2) first sentence ESchG with the level of severity of the Duchenne type of muscular dystrophy named in section 3 second sentence ESchG.

36 ee) The argument that the link to the term "severe" in section 3 second sentence ESchG eliminated concerns under constitutional law regarding the precision of the provision cannot be used to justify the interpretation result reached by the Higher Administrative Court. Even without this link, the provision in section 3a (3) first sentence no. 2 in conjunction with (2) first sentence ESchG meets the requirements of the principle of precision resulting from article 20 (3), article 103 (2) GG.

37 According to the principle of precision that follows from the rule of law principle laid down by article 20 (3) GG, legal provisions must be worded as precisely as possible in view of the characteristic features of the real-world fact situation they are intended to regulate, taking into account the purpose of the provisions. In this context, the legislature may to a certain extent use indefinite legal terms, provided they can be filled with tangible content by applying the traditional interpretation methodology (established jurisprudence, see e.g. BVerwG, judgments of 7 October 1988 - 7 C 65.87 - BVerwGE 80, 270 <275 et seq.>, of 12 May 1999 - 6 C 14.98 - BVerwGE 109, 97 <102>, of 21 June 2017 - 6 C 4.16 [ECLI:DE:BVerwG:2017:210617U6C4.16.0] - BVerwGE 159, 171 para. 10 and of 24 January 2019 - 3 C 7.17 [ECLI:DE:BVerwG:2019:240119U3C7.17.0] - BVerwGE 164, 253 para. 23, each with further references). Under article 103 (2) GG, the legislature is obligated to describe the requirements for criminal liability or liability for an administrative fine as precise as necessary to ensure that the scope of application and the implications of the criminal or administrative offences are recognisable and can be determined by means of interpretation. This does not rule out the use of terms which need to be interpreted by a judge. Concerns regarding the use of indefinite terms do not exist in criminal law and the law of administrative offences provided that a reliable basis for the interpretation and application of the provision can be obtained with the help of the traditional interpretation methodology (see BVerwG, judgments of 15 April 2010 - 7 C 9.09 - (...) para. 34 and of 29 February 2012 - 9 C 8.11 - BVerwGE 142, 84 para. 16, each with further references). Based on this, the provision in section 3a (3) first sentence no. 2 in conjunction with (2) first sentence ESchG provides sufficient precision, as the legal terms "high risk" and "severe hereditary disease" are capable of detailed specification by means of interpretation (see 5. below).

38 5.a) It is necessary to decide separately in each individual case whether the conditions for a high risk of a severe hereditary disease under section 3a (3) first sentence no. 2 in conjunction with (2) first sentence ESchG are met. As has been shown above, this corresponds to the legislature's intent and is reflected in the provisions of the Ordinance on the Regulation of Preimplantation Genetic Diagnosis on the procedure for the application for the performance of preimplantation genetic diagnosis (section 3a (3) third sentence no. 2 ESchG in conjunction with section 5 et seq. PIDV). According to these provisions, the ethics commission for preimplantation genetic diagnosis acts to assess and evaluate according to section 3a (3) first sentence no. 2 ESchG only upon a written application filed by the women from whom the egg cell originates (section 5 (1) PIDV). The application must include all information and documents which the ethics commission needs to be able to assess whether the conditions stipulated in section 3a (2) ESchG are met (section 5 (2) first sentence PIDV). In the cases under section 3a (2) first sentence ESchG, these documents comprise in particular a medical human genetic report regarding the genetic disposition of the woman from whom the egg cell originates, or the man from whom the semen cell originates, or from both, including the name of the resulting hereditary disease, as well as information on the probability that the offspring will suffer from the disease and the expected manifestation of the disease (section 5 (2) second sentence no. 1 PIDV). When assessing the application and the documents submitted, the ethics commission can additionally use the information tools specified in section 6 (2) first sentence PIDV. This puts the ethics commission in a position to obtain the necessary expertise to assess the specific individual case and to reach a well-founded evaluation (see explanatory memorandum to the Ordinance on the Regulation of Preimplantation Genetic Diagnosis, BR-Drs. 717/12 p. 30). Pursuant to section 6 (4) first sentence PIDV, the ethics commission shall make its decision on whether or not the conditions of section 3a (2) ESchG are met taking into account the relevant psychological, social and ethical aspects of the specific individual case.

39 b) The wording of section 3a (2) first sentence ESchG does not provide more detailed information on the conditions that justify the classification of a hereditary disease as severe within the meaning of this provision. The required level of severity is not specified in detail. When viewed together with the second exception from the general prohibition of preimplantation genetic diagnosis provided for in section 3a (2) second sentence ESchG, it becomes clear that the exception in section 3a (2) first sentence ESchG is not limited to diseases that may result in stillbirth or miscarriage. Pursuant to section 3a (2) second sentence ESchG, anyone who performs preimplantation genetic diagnosis with the written consent of the woman from whom the egg cell originates in order to identify potential severe damage of the embryo which is highly likely to result in stillbirth or miscarriage, does not act unlawfully. Section 3a (2) first sentence ESchG does not contain a similar restriction of the constituent elements of the provision.

40 The legislative materials show that section 3a ESchG is intended to create the foundation for a narrowly limited application of preimplantation genetic diagnosis. This diagnostics method is intended to be permissible only in "exceptional cases" or "in narrowly defined cases" (explanatory memorandum to the draft of an act on the regulation of preimplantation genetic diagnosis, BT-Drs. 17/5451 p. 3, 7). Regarding the cases provided for in section 3a (2) first sentence ESchG, the legislative material states that a "particularly severe" hereditary disease is required (BT-Drs. 17/5451 p. 7; see also p. 2 <"transmission of particularly severe diseases">). As has been shown above, the explanatory memorandum specifies the term "severe" by stating that the criterion is met in particular if the hereditary disease differs significantly from other hereditary diseases in that it leads to reduced life expectancy or in the severity of the disease pattern and difficulty of treatment (BT-Drs. 17/5451 p. 8). With this, the legislature takes into consideration in particular hereditary diseases that already manifest themselves in (early) childhood, may lead to severe disorders regarding the child's physical and/or cognitive development or even early death of the affected children, and that are incurable or difficult to treat (see BT-Drs. 17/5451 p. 2: "These are in particular couples who already have a seriously ill child, or may already have lost a child ..."). However, the scope of application of section 3a (2) first sentence ESchG is not limited to this. The criteria "reduced life expectancy" and "severity of the disease pattern" are alternatives and do not apply cumulatively. Also, the legislative materials do not otherwise rule out that severe hereditary diseases that manifest themselves after childhood age may also meet the conditions of section 3a (2) first sentence ESchG (BT-Drs. 17/5451 and 17/6400; see also statement by the German Ethics Council on preimplantation genetic diagnosis, BT-Drs. 17/5210 p. 27, 31 et seq.: The recommendation to prohibit PGD for late-manifesting diseases is not reflected in the provision in section 3a ESchG nor in the explanatory memorandum).

41 c) The decisive aspect for the assessment of the severity of a hereditary disease is the manifestation of the disease in the offspring to be expected in the specific case due to the genetic disposition of one of the parents. If it is then unclear whether a hereditary disease is to be classified as severe based only on the expected manifestation of the disease in the offspring due to the genetic disposition of at least one parent, additional burdens on the affected woman or couple that are associated with the genetic disposition also have to be taken into account.

42 aa) According to the wording of section 3a (2) first sentence ESchG, the child's potential hereditary disease is the point of reference for the level of severity to be assessed. This requires a medical indication that shows that the disease may lead to a severe impairment of health in the offspring. The assessment of the severity of the expected manifestation of the disease is to be based on all disease-related factors, such as, in particular, the nature and severity of the disease pattern, the time of manifestation of symptoms of the disease (childhood/adolescence/adult age), the progression of the disease, the treatability of the disease and the life expectancy.

43 bb) If, based on this, it is unclear whether the hereditary disease is severe enough to justify the performance of the requested preimplantation genetic diagnosis, other aspects associated with the relevant genetic disposition also have to be taken into account.

44 (1) As has been shown above, one of the regulatory purposes of the limited permissibility of preimplantation genetic diagnosis is to prevent severe burdens, in particular on the affected women, but also the couples or entire families. What the legislature of the Act on Preimplantation Genetic Diagnosis had in mind in particular was the conflict situation of couples with a genetic disposition for a severe hereditary disease who already have a seriously ill child, or may already have lost a child, or where the women, after undergoing prenatal diagnostics and medical counselling, had an abortion under the rules of section 218a (2) of the German Criminal Code (StGB, Strafgesetzbuch) (see explanatory memorandum to the draft of an act on the regulation of preimplantation genetic Diagnosis, BT-Drs. 17/5451 p. 2, 7). This indicates that these aspects should be taken into consideration when assessing whether the criterion "severe" in section 3a (2) first sentence ESchG is met. The same applies to similarly severe burdens on the couple that are associated with their genetic disposition, such as the fact that one parent himself/herself suffers from the disease.

45 (2) The wording of section 3a (2) first sentence ESchG does not preclude this interpretation. It does not allow the derivation of a prohibition to include burdening circumstances of the nature described above into the evaluation of the severity of the hereditary disease. As they originate from the genetic disposition of one or both parents, the wording of the law provides sufficient basis for taking them into consideration. They also have the required relation to the disease. The reason for this is that they concern severe physical or mental burdens which the hereditary disease has either already entailed for the affected individuals or which are to be expected in the future.

46 (3) The fact that, when evaluating the severity of the hereditary disease, additional aspects associated with the genetic disposition are eligible for consideration in addition to the medical impact of the disease for the offspring does not allow the conclusion that if such aspects are not present the classification of the relevant hereditary disease as "severe" is precluded. Rather, in such cases, it must be assessed solely on the basis of the expected manifestation of the disease in the offspring whether the hereditary disease is severe within the meaning of section 3a (2) first sentence ESchG.

47 (4) Section 6 (4) first sentence PIDV does not lead to a different conclusion. According to this provision, the ethics commissions for preimplantation genetic diagnosis shall make their decision on whether or not the conditions specified in section 3a (2) ESchG are met "taking into account the relevant psychological, social and ethical aspects of the specific individual case". The wording must be interpreted in line with section 3a (2) first sentence ESchG. The materials to the Ordinance state that the family background of the affected couple usually also has to be considered, because the classification of a hereditary disease as severe rarely follows from the diagnosis alone (see BR-Drs. 717/1/12 p. 8). This means that content-wise the incorporation of psychological, social and ethical aspects provided for in section 6 (4) first sentence PIDV does not go beyond the legal provision in section 3a (2) first sentence ESchG. As has been shown above, the eligibility for consideration of the couple's family situation already follows from section 3a (2) first sentence ESchG, so that the wording in the Ordinance that merely repeats this rule does not meet with any concerns in the light of section 3a (3) third sentence no. 2 ESchG, article 80 (1) GG (...).

48 d) The Higher Administrative Court correctly assumed that the "high risk" required under section 3a (2) first sentence ESchG exists for monogenic hereditary diseases if the probability of developing the disease is between 25 to 50 per cent (or more). This interpretation is supported by the legislative materials. The explanatory memorandum to the draft of an act on the regulation of preimplantation genetic diagnosis states that the couple must have a high genetic risk with regard to the relevant disease. It states that this is the case if there is a high probability that significantly deviates from the normal risk to the population in Germany. The probability of developing the disease has to be assessed genetically according to the rules of transmissibility and combination of genetic predispositions. A probability of 25 to 50 per cent is classified as a high risk (BT-Drs. 17/5451 p. 8; see on monogenic hereditary predispositions: statement of the German Ethics Council on preimplantation genetic diagnosis, BT-Drs. 17/5210 p. 5 et seq.). Pursuant to section 3a (2) first sentence ESchG, the "high risk" does not have to be based on a genetic disposition of both parents, but may also result from the genetic disposition of one parent (see also BT-Drs. 17/5451 p. 8).

49 The requirement of a probability of developing the disease of 25 per cent might not be understood to be a rigid minimum threshold. The wording originally used in the draft act, "high probability of a severe hereditary disease", was replaced in the further course of the legislative process by the wording "high risk of a severe hereditary disease". The reason provided for this change was that, in certain genetic constellations such as balanced translocations, the probability for the child of developing the disease is difficult to quantify as a percentage. The affected parent had not developed the disease. However, there is an increased risk to sire offspring with unbalanced translocation and thus with a very severe disease (recommendation for a decision and report by the Committee on Health, BT-Drs. 17/6400 p. 14). It can be derived from this that the conditions of section 3a (2) first sentence ESchG might be met even if the risk of a severe hereditary disease cannot be quantified to be at least 25 per cent. In such cases, the risk is to be classified as "high" if it significantly deviates from the normal risk to the population (see above).

50 6. Based on this, the claimant has the right under section 3a (3) first sentence no. 2 ESchG, section 6 (4) first sentence PIDV to be issued a consenting evaluation by the Bavarian Ethics Commission for Preimplantation Genetic Diagnosis on her application for the performance of preimplantation genetic diagnosis. The conditions for a high risk of a severe hereditary disease within the meaning of section 3a (2) first sentence ESchG are met in her case. This can be conclusively assessed on the basis of the factual finding by the Higher Administrative Court and further circumstances of the case that result from the files. Therefore, the Senate may decide on the matter itself (section 144 (3) first sentence no. 1 VwGO).

51 a) Based on the findings by the Court of Appeal, the probability that, due to the genetic disposition of the claimant's partner, their offspring will develop the classical form of myotonic dystrophy type 1 is 50 per cent, which constitutes a high risk. Myotonic dystrophy type 1 is a monogenic disease, and therefore a hereditary disease within the meaning of section 3a (2) first sentence ESchG.

52 b) Under the circumstances of the present case, the disease justifies a classification as severe.

53 aa) According to the Higher Administrative Court's findings, the condition is a multi-systemic disease which, apart from the skeletal muscles, may also affect the smooth muscles, the eyes, the heart, the hormonal balance and the central nervous system. In the area of the skeletal muscles, it leads to muscle weakness and abnormal muscle relaxation. The disease mainly affects the facial muscles, the neck flexor, and the distal muscles of the limbs (forearms and hands, lower legs and feet). Regarding the heart, the disease may manifest itself as cardiac arrhythmias and, less common, in myocardial insufficiency (cardiomyopathy). The eyes often develop a clouding of the lens (cataract). Hormonal disorders may manifest themselves, for instance, in diabetes mellitus. A typical symptom of the disease is that the patients suffer from increasing daytime tiredness as the disease progresses (...). For the classical form of myotonic dystrophy type 1 (200 to 1,000 repeats), the first symptoms of the disease manifest themselves during adolescence or early adult age. The disease is progressive and leads to significant health-related restrictions and impairments of lifestyle for the affected individuals. They also have a reduced life expectancy. They have to anticipate that they will (only) reach advanced adult age (...). These findings, which were not challenged by a procedural or counter-complaint, are binding for the appeal proceedings on points of law (section 137 (2) VwGO).

54 bb) It is not necessary to finally decide whether this expected manifestation of the disease in the claimant's and her partner's offspring already results in the assumption of a severe hereditary disease. The criterion is met in any event, as an aggravating factor in the claimant's case is that her partner himself shows obvious symptoms of the disease. This follows from the documents submitted to the Ethics Commission and is not in dispute between the parties.