Specialist reservation in the NiSV - why this will not come
Discussions are currently emerging as to whether the specialist doctor's reservation within the NiSV will return.
In the following article we would like to explain why everyone doctors - as before - you can buy or lease a laser for tattoo removal with a clear conscience.
Due to the recommendation to the German Medical Association by the dermatological and interdisciplinary professional associations DDL, DGDC, BVDD, DDG, DDA and DGLM, there is increasing uncertainty as to whether a Specialist reservation will come and how this could be designed. So much in advance: it will most likely not come and if it does, it would be unconstitutional - and could be attacked.
Starting point for the NiSV
On November 29.11.2018, 4, the ordinance on protection against the harmful effects of non-ionizing radiation when used in humans (NiSV) was published as Article XNUMX of the ordinance for the further modernization of radiation protection law (StrlSchNRV) in the Federal Law Gazette[1] announced.
When the ordinance came into force on December 31.12.2020, 31.12.2021, some cosmetic treatments with non-ionizing radiation were made subject to a doctor's reservation. Other applications of non-ionizing radiation require proof of specialist knowledge from December XNUMX, XNUMX.
The background to this is the increase in the level of protection for consumers from the harmful effects of non-ionizing radiation.
[1] Article 4 V. v. 29.11.2018 Federal Law Gazette I p. 2034, 2187 (No. 41).
Procedure
draft
The draft bill of May 30.05.2018, XNUMX still contained a specialist doctor's reservation, which restricted the treatments, which are now subject to medical reservation, to specialists with specialist training in skin and venereal diseases and plastic and aesthetic surgery as well as their directly supervised staff with specialist knowledge.[1] This was made with reference to a "serious loophole"[2]sometimes vehemently defended, but also often criticized.
Criticism about reservation by a specialist
As part of the hearing on the draft bill, the German Medical Association, among others, advocated with a statement of June 27.06.2018, XNUMX, to acquire the specialist knowledge in addition to the planned training courses also through medical license and to replace the specialist doctor's reservation with a doctor's reservation.[3]
In a plenary motion dated October 16.10.2018, XNUMX, with reference to an already existing shortage of specialists, Lower Saxony spoke out against making the removal of tattoos or permanent make-up subject to the reservation of specialists and instead demands that specialist knowledge be sufficient for this.[4] A doctor's reservation is also not necessary for consumer protection reasons.[5]
The recommendations of the committees of October 08.10.2018, XNUMX find even clearer words for this. According to the recommendation of the economic committee, the complete draft of the NiSV should be deleted, since similar health risks are not uncommon in other areas of cosmetics, such as piercing, and the high requirements for devices in the non-medical area compared to the medical area are too difficult lead to justified incongruence.[6]
Version in the NiSV
The wording on the existing doctor's reservation, which was probably adopted as a compromise between the positions in the regulation, comes word for word from the recommendation of the health committee.[7] According to the justification of the health committee, numerous other specialist groups have the necessary specialist knowledge, which is why it is appropriate to generally base the selection of authorized persons on licensed doctors with the appropriate knowledge and skills.[8]
[1] Draft bill of an ordinance for the further modernization of radiation protection law dated May 30.05.2018, 214, p. XNUMXf.
[2] Minutes of plenary 971 Declaration BUNDESRAT Stenographic report 971st meeting.
by State Secretary Rita Schwarzelühr-Sutter (BMU), p. 403f.
[3] Statement by the German Medical Association on the draft bill of an ordinance for the further modernization of radiation protection law dated June 27.06.2018, 42, serial no. No. XNUMXf.
[4] Federal Councilor printed matter 423/3/18, application by the State of Lower Saxony.
[5] Minutes of plenary 971 Declaration BUNDESRAT Stenographic report 971st meeting
by Minister Birgit Honé (Lower Saxony), p. 402f.
[6] Bundesrat Drucksache 423/1/18, p. 59, recommendation of the Economic Committee.
[7] Bundesrat Drucksache 423/1/18, p. 59, recommendation of the health committee.
[8] Bundesrat Drucksache 423/1/18, p. 59, recommendation of the health committee.
Expertise requirements
The current version of the NiSV has not conclusively clarified the respective specialist requirements for doctors.
For non-doctors, the NiSV makes specific requirements for the duration of the advanced training in Annex 3 of the ordinance, depending on the respective application, and specifies this in a specialist guideline[1] the detailed requirements for training courses, learning content and learning objectives through framework curricula.
Instead of these training courses, the necessary specialist knowledge for some applications can also be "acquired by licensed doctors through appropriate medical training or advanced training"[2] which, however, are not specified in the same way. Annex 3, Part A, item 1 describes the units required for “advanced training”, which is the same as one in accordance with Section 5 NiSV. Doctors therefore need the AGK and AOS modules with a total of 8 learning units (1 LE = 45 min).
[1] Requirements for acquiring specialist knowledge for non-ionizing applications
Radiation sources in humans - joint guideline of the federal and state governments
with the exception of the state of Saxony-Anhalt from March 16, 2020.
[2] Sections 5 I, 6 I NiSV.
text
The medical training includes learning special medical skills, for example to obtain the qualification as a specialist, a specialization based on this in areas of focus or additional training. With regard to the course of the procedure, appropriate further training is to be understood in particular as the numerous specialist training courses. According to the wording, this includes not only specialist training in skin and venereal diseases and plastic, reconstructive and aesthetic surgery, but also other corresponding medical training such as specialist training in ophthalmology. This is reinforced by the prescriber's assumption that, in the case of further training, the updating of the specialist knowledge is already sufficient with the medical training obligation.[1]
Advanced training, on the other hand, describes a more specific update and expansion of medical knowledge and is legally defined as an update of specialist knowledge within the framework of the NiSV in Appendix 3. The advanced training within the NiSV undoubtedly relates to the advanced training according to § 4 III 2 NiSV and, according to the wording, also corresponds to the advanced training of doctors, for example in § 5 II NiSV.
Systematics
The NiSV is pervaded with detailed regulations of the technical knowledge for non-doctors and shows the sensitivity of the legislator for the need to specify the requirements for training. Unless more detailed information on further education and training for doctors is articulated, further requirements cannot generally be assumed.
Telos and history
The change in the draft bill, taking into account the status of the discussion and the criticism expressed about the reservation of specialists, also indicates that consciously moved away from the strict requirement for specialist training should be.
Intermediate result
The corresponding continuing medical education or training includes, on the one hand, numerous specialists who are awarded the necessary specialist knowledge through broad knowledge in the respective area and, on the other hand, doctors who can acquire the necessary specialist knowledge through further training in the sense of updating the specialist knowledge according to Annex 3 of the NiSV.
[1] Federal Council printed matter 423/18 of 05.09.2018, p. 524, on paragraph 3.
Recommendation of the dermatological and interdisciplinary professional associations
The recommendation of the dermatological and interdisciplinary professional associations DDL, DGDC, BVDD, DDG, DDA and the DGLM to the BAK on the requirements for the training of doctors without specialist certification for "skin and venereal diseases" comes from dubious premises hardly acceptable results.
General and special expertise
The recommendation differentiates between general specialist knowledge with (96 LE) and special specialist knowledge with (146 LE). Within the NiSV, however, there are no indications for a significant distinction within the pair of terms of continuing medical education or training.
Extent of continuing medical education or training
The recommendation is based on a predominantly uniform, suitable advanced training and refers to the Federal Law Gazette Part I No. 41. Within the NiSV, however, only medical training is provided or Advanced training spoken.
The scope of this proposed "further and advanced training" for licensed doctors is also similar to that for medical laypeople and exceeds this in terms of self-defined special expertise even in the area of the "optical radiation" module (Annex 3 Part C: 120 LE for medical laypersons; recommendation: 130 LE for licensed doctors).
Uniform further and advanced training
The NiSV regulates in Annex 3 Part A the necessary modules related to systems for the use of laser devices according to § 5 NiSV, high-frequency devices according to § 6 NiSV, electrical nerve and muscle stimulation and magnetic field stimulation according to § 7 NiSV, the stimulation of the central nervous system according to § 8 NiSV or the use of ultrasound according to § 9 NiSV. The content of the specialist knowledge in §§ 5 to 9 and the associated annex are specific to the application.
The recommendation does not make this differentiation. As a result, the acquisition of specialist knowledge for non-doctors regarding the use of high-frequency devices with the modules GK (80 LE) and EK (40 LE) comprises significantly fewer learning units than the use of laser equipment with the modules GK (80 LE) and OS (120 LE). The proposed further and advanced training for doctors does not differentiate here and requires uniform advanced and advanced training regardless of the individual application. A differentiation, however, appears to be imperative, since the devices falling under the scope of the regulation differ greatly in their mode of operation and the type of application.[1]
[1] Federal Council printed matter 423/18 of 05.09.2018, p. 524, on § 4, on paragraph 1.
Legal appreciation of a NiSV change
For the (purely) hypothetical casethat the legislator should follow the recommendations, we will now examine the chances of success of a constitutional complaint.
Should the recommendation on the requirements for the training of doctors lead to another amendment to the NiSV with the reservation of specialists for doctors with specialist training for skin and venereal diseases, one would have Constitutional complaint by a doctor against the amended NiSV with specialist doctor's reservation, high prospect of success.
A constitutional complaint would be justified. In particular, the NiSV's reservation of a specialist doctor would violate the complainant's basic right to freedom of occupation in accordance with Art. 12 I GG.
Protection area
The area of protection of Art. 12 I GG would be open to physicians with German or European citizenship. Doctors with other nationalities received an equal level of protection under Art. 2 I GG.
The material scope of protection of Art. 12 I GG is opened because the complainant is impaired in his professional practice by the regulation. Art. 12 I GG protects both the choice of profession and the exercise of a profession as a uniform basic right of freedom of occupation.
Intervention
An intervention would exist as a self-executing norm due to a specialist doctor's reservation of the NiSV. In the sense of the three-step theory of the Federal Constitutional Court, a specialist doctor's reservation is in individual cases an intervention in the form of a professional practice regulation or even a subjective admission requirement.
justification
The encroachment on the protection of the freedom of occupation would not be constitutionally justified.
There is a uniform, simple legal reservation for the exercise and choice of occupation in accordance with Art. 12 I 2 GG.
The NiSV, for its part, would have to be constitutional in order to restrict the basic right of occupational freedom according to Art. 12 I GG. An encroachment by a regulation can only be justified if the basis of authorization itself is constitutional and the special requirements of Art. 80 GG are met.
In the present case, the law on protection against non-ionizing radiation when used on humans (NiSG) is determined, as well as formally and materially lawful. In particular, the Federal Government, with the consent of the Federal Council, is the correct addressee for authorization.
Formal constitutionality of the regulation
Section 5 II No. 6 of the law on protection against non-ionizing radiation when used on humans (NiSG) empowers the federal government to determine by ordinance with the consent of the Federal Council the protection of people from the harmful effects of non-ionizing radiation when operating systems in accordance with Section 3 NiSG what requirements must be placed on the necessary technical knowledge of persons working in the company and what evidence must be provided to the competent authority.
Substantive constitutionality of the regulation
However, the regulation is / would be materially unconstitutional.
A legitimate purpose is pursued with health protection, for which a specialist doctor's reservation is suitable. A specialist doctor's reservation within the NiSV would, however, not be necessary. The protection provided so far by licensed doctors with appropriate medical training or further training offers identical, if not more comprehensive, health protection. This ensures in individual cases that treatment may only be carried out with sufficient and, if necessary, updated specific knowledge about the dangers of the respective application. This topicality would not necessarily be guaranteed by a reservation for specialists with specialist training in skin and venereal diseases. Alternatively, the professional training of the users would also be a sensible way of establishing health protection without the massive restrictions.
In addition, a specialist doctor's reservation would also not be appropriate. It is true that the applications of NiSV are potentially dangerous treatments. A narrowing of the group of treating persons to specialists with specialist training for skin and venereal diseases would be disproportionate due to the existing shortage of specialists. There are 8.228 specialists in skin and venereal diseases in Germany. 6.205 of them are employed. 4.724 of them work on an outpatient basis, 1.080 as an inpatient in a clinic.[1] In contrast, according to a survey by the Ipsos Institute (edition 9/2019 B), the enormous number of 21,0% of women and men in Germany who have one or more tattoos and of whom 6,8% regret this tattoo. That equates to just over a million people who regret having their tattoo. In particular, the effects on the health and psyche of people with an unwanted tattoo should not be underestimated.
In addition, health protection by licensed doctors with appropriate medical training or advanced training is already very high in the current version of the NiSV. It is also assumed by the ordinance that doctors are imparted sound knowledge of the anatomy of the skin, subcutaneous tissue and their vessels, the skin appendages and the mucous membranes close to the skin as well as knowledge and experience with ultrasound therapeutic procedures as part of medical training.[2] The skills they have acquired professionally enable physicians licensed for cosmetic and non-medical treatments to be regularly aware of health risks and to act accordingly.
[1] https://aerztestellen.aerzteblatt.de/de/redaktion/facharzt-weiterbildung/facharzt-weiterbildung-haut-und‑geschlechtskrankheiten#:~:text=Anzahl%20der%20Fachärzte%3A%20In%20Deutschland,1.080%20stationär%20in%20einer%20Klinik.
[2] Federal Council printed matter 423/18 of 05.09.2018, p. 531.
Conclusion
In view of the opinion of the German Medical Association dated June 27.06.2018, XNUMX, in which a doctor's reservation was proposed instead of the previously planned specialist doctor's reservation, it is very doubtful whether the recommendation of the dermatological and interdisciplinary professional associations can adequately represent the opinion of the German Medical Association. In any case, the excessive requirements of the dermatological specialist standard in conjunction with the methodological deficiencies in the content of the recommendation make it unlikely that the recommendation will be adopted.
In addition, a change to the NiSV would be a reservation for specialists with specialist training in skin and venereal diseases unconstitutional and could be successfully attacked by other doctors before the Federal Constitutional Court .
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