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In the last few years, the interest of dentists in aesthetic treatments has grown considerably. For this reason, many European Union Country (E.U. Countries) have regulated the competences of dentists in the field of aesthetic medicine. One of the most common therapies in this field is represented by the injection of botulinum toxin type A (BTX-A). This study has analyzed the regulatory measures on the BTX-A administration adopted by all the E.U. member States. The search found the presence of a very varied regulatory framework and the need for convergence measures between legislations. In fact, the harmonization of dental competences is one of the pillars of the freedom to provide services under Directive 2005/36/EC. The prevision of common competences is functional not only to allow the professionals movement among the E.U. Member States, but also to guarantee the health of patients and avoid market distortions.
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The use of botulinum toxin for medical-aesthetic purposes in dentistry: a comparative medico-legal approach in the context of the European Union
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Full professor, Rector, Department of Oral and Maxillo- Facial Sciences, Sapienza University of Rome, Viale Regina Elena 287a, 00161 Rome, Italy.
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The use of botulinum toxin for medical-aesthetic purposes in dentistry: a comparative medico-legal approach in the context of the European Union
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                                                                                                     Original Article


The use of botulinum toxin for medical-aesthetic
purposes in dentistry: a comparative medico-legal
approach in the context of the European Union



G.L. Vaccaro1                                                 BTX-A is also able to reduce facial expression lines. In
G. Di Carlo2                                                  fact, medicines based on BTX-A have been authorized
A. Polimeni3                                                  by the EMA (European Medicines Agency) for canthal
                                                              and forehead wrinkles treatment [5]. BTX-A is also suc-
1
    Student, Department of Oral and Maxillo-Facial Sci-       cessfully administered to temporarily smooth perioral
    ences, Sapienza University of Rome, Viale Regina          wrinkles in off-label mode.
    Elena 287a, 00161 Rome, Italy.                            The efficacy of BTX-A in both dental and perioral area
2
    Assistant professor, Department of Oral and Maxillo-      aesthetic treatments has raised the question if this drug
    Facial Sciences, Sapienza University of Rome, Viale       can be legitimately administered by dentists. This issue
    Regina Elena 287a, 00161 Rome, Italy.                     is particularly important within the context of E.U. Coun-
3
    Full professor, Rector, Department of Oral and Maxillo-   tries because the dentistry field is subject to common
    Facial Sciences, Sapienza University of Rome, Viale       rules. In fact, Directive 2005/36/EC has defined a homo-
    Regina Elena 287a, 00161 Rome, Italy.                     geneous context of professional competences to allow
                                                              the free movement of dentists and the mutual recogni-
                                                              tion of qualifications [6].
Corresponding author:
                                                              The aim of this study is to highlight the existence of a
A. Polimeni
                                                              diversified framework of competences in the administra-
E-Mail: antonio.daddona@gmail.com
                                                              tion of BTX-A among E.U. member Countries. The study
                                                              also revealed that the anatomical fields of dentistry pres-
Abstract                                                      ent significant differences between States and the need
                                                              to provide for a unification of the rules.
In the last few years, the interest of dentists in aes-
thetic treatments has grown considerably. For this
reason, many European Union Country (E.U. Coun-               Method
tries) have regulated the competences of dentists
in the field of aesthetic medicine. One of the most           This study has taken into account the BTX-A regulation
common therapies in this field is represented by              for aesthetic purposes in the 27 E.U. member States.
the injection of botulinum toxin type A (BTX-A).              Only the regulations adopted by Institutional Bodies
This study has analyzed the regulatory measures               were considered significant results of the research. The
on the BTX-A administration adopted by all the E.U.           selection of regulatory sources has followed hierarchical
member States. The search found the presence of               criteria. The search has privileged the acts of primary
a very varied regulatory framework and the need               rank (State laws or equivalent acts, judgment of the Or-
for convergence measures between legislations.                dinary Judicial Authority). Failing that, steps were taken
In fact, the harmonization of dental competences is           first to seek measures adopted by the competent Min-
one of the pillars of the freedom to provide services         istries and Regulatory Agencies (secondary rank). Only
under Directive 2005/36/EC. The prevision of com-             if the search of primary and secondary rank acts failed
mon competences is functional not only to allow               were considered the acts of Dentists/Medical profes-
the professionals movement among the E.U. Mem-                sional Orders.
ber States, but also to guarantee the health of pa-           The conflicts between the normative sources of the
tients and avoid market distortions.                          same State have been solved with the application of the
                                                              following criteria: hierarchical (the higher-level source
                                                              prevails), chronological (if the sources have the same
Keywords: botulinum, toxin; dentistry; litigation             level, the more recent prevails), specialty (between
                                                              sources of the same level, the one prevails special over
                                                              the general one).
Introduction                                                  The issue of the anatomical boundaries of the dentists’
                                                              competence in BTX-A administration was also analyzed.
In recent years, numerous studies have demonstrated           In absence of indication in the regulatory sources, the
the efficacy of BTX-A in the treatment of dental patholo-     BTX-A administration was considered legitimate at least
gies such as bruxism, temporomandibular disorders             on the tissues covering the jaws (art. 5 of Council Di-
(TMD), hemifacial spasm and gummy smile [1] [2] [3] [4].      rective 78/687/EEC of 25 July 1978) [7]. The search for



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     The use of botulinum toxin for medical-aesthetic purposes in dentistry: a comparative medico-legal approach in the context of the European Union


  Table I. Summary table on BTX-A regulation for aesthetic reasons in the dentistry field within the E.U.

               E.U. Countries                            BTX-A Administration                                 Anatomical boundary
                                                         for Aesthetic purpose

     Austria                                 Not allowed

     Belgium                                 Not allowed

     Bulgaria                                Not allowed

                                                                                                     Mouth and jaw, including associated
     Croatia                                 Allowed
                                                                                                     tissue (Directive 78/687/CEE)
                                                                                                     Mouth and jaw, including associated
     Cyprus                                  No normative restrictions ---> Allowed
                                                                                                     tissue (Directive 78/687/CEE)

     Denmark                                 Allowed (only if delegated by a MD)                     No restriction

                                                                                                     Mouth and jaw, including associated
     Estonia                                 Allowed
                                                                                                     tissue (Directive 78/687/CEE)

     France                                  Not Allowed                                             Lips Red vermilion

     Germany                                 Allowed

                                                                                                     Mouth and jaw, including associated
     Greece                                  Allowed
                                                                                                     Tissue (Directive 78/687/CEE)

     Hungary                                 Not Allowed

                                                                                                     Mouth and jaw, including associated
     Ireland                                 Allowed
                                                                                                     tissue (Directive 78/687/CEE)

     Italy                                   Not Allowed

     Latvia                                  Not Allowed

     Lithuania                               Not Allowed

                                                                                                     Mouth and jaw, including associated
     Luxembourg                              Allowed
                                                                                                     tissue (Directive 78/687/CEE)
                                                                                                     Mouth and jaw, including associated
     Malta                                   Allowed
                                                                                                     tissue (Directive 78/687/CEE)

     Netherland                              Allowed                                                 Head and neck dermal cover tissue

     Poland                                  Allowed                                                 Craniofacial district

     Pourtugal                               Allowed                                                 Dermal tissues covering the face

     Republic of Czechoslovakia              Allowed                                                 Head and neck dermal cover tissue

                                                                                                     Mouth and jaw, including associated
     Romania                                 Allowed
                                                                                                     tissue

     Spain                                   Not Allowed

     Slovakia                                No normative restrictions (de facto allowed)

     Slovenia                                No normative restrictions (de facto allowed)

                                             Allowed (only with oral and maxillo-facial              Mouth and jaw, including associated
     Sweden
                                             specialization degree)                                  tissue




24                                                                                                                       10.59987/ads/2023.1.23-27
G.L. Vaccaro et al.

regulatory sources was conducted with the Google®              Lithuania, and Hungary the generic title of Medical Doc-
search engine. The laws were retrieved from the offi-          tor is not sufficient to administer BTX-A for aesthetic pur-
cial databases of the Governments of the E.U. Member           pose: in these States specialization in dermatology or
States. The administrative authorities measures were re-       plastic surgery is necessary (maxillofacial surgeons and
trieved from the institutional internet portals (Ministries,   ophthalmologists are also authorized in France). Differ-
Regulatory Authorities, Professional Associations). The        ences were also found among the States that license
translation of the documents from the official language        dentists to administer BTX-A. In fact, In Czech Republic
into Italian was carried out with the aid of the Google ®      and Sweden, only dentists specializing in oral and maxil-
“Translator” function.                                         lofacial surgery are authorized to administer BTX-A. In
                                                               Croatia, Ireland, Holland, Poland, the Czech Republic
                                                               and Romania, dentists can administer BTX-A only if they
Results                                                        demonstrate specific training (in the Czech Republic,
                                                               no further training is required only for dentists special-
Significant results were found in 24 E.U. Member States        izing in oral and maxillofacial surgery). In conclusion, in
out of the total of 27 (which corresponds to an average        7 States out of a total of 18, the title of dentist alone is
of 89%). Only in 3 cases (Cyprus, Slovenia and Slo-            not sufficient for the administration of BTX-A as further
vakia) it was not possible to find institutional norma-        training/specialization is required (corresponding to an
tive sources. In these States there are “de facto” no          average of 38%). In Denmark, dentists can administer
restrictions on BTX-A administration in dentistry. In 5        BTX-A only on the recommendation of a Medical Doctor
cases the BTX-A administration was regulated by law,           specialized in dermatology/plastic surgery or trained in
act equivalent to the law and judgment of the judicial         the use of the drug.
authority (Belgium, France, Germany, Poland and Swe-           From the analysis of the normative sources, differences
den). However, only in Belgium has been adopted a              also emerged in the dentistry anatomical areas of com-
proper law on aesthetic medicine and BTX-A adminis-            petence.
tration [8]. In Germany and Poland, the BTX-A admin-           In Croatia, Cyprus, Estonia, Finland, Greece, Ireland,
istration has been regulated by judicial authority with        Luxembourg, Malta, Romania, Slovenia, Slovakia and
a judgment [9] [10] [11]. In France and Sweden, the            Sweden, the administration of BTX-A is authorized at
legal framework on BTX-A administration has been re-           least within the anatomical boundaries established by
constructed on the basis of health care laws [12] [13].        Directive 78/687/EEC (Mouth and jaw, including asso-
In 14 cases the issue on the legitimacy of BTX-A ad-           ciated tissue). In fact, in these States the authorization
ministration has been addressed by the Health Authori-         for BTX-A administration do not indicate the anatomi-
ties (Austria [14], Bulgaria [15], Croatia [16], Denmark       cal limits. For this reason, at least the anatomical limits
[17], Estonia [18], Finland [19], Hungary [20], Italy [ 21]    recognized by Directive 78/687/EEC were considered
[22] [23], Latvia [24], Lithuania [25], Luxembourg [26],       included.
the Netherlands [27], the Czechoslovak Republic [28]           In Germany, on the other hand, the anatomical bound-
and Spain [29]). In all cases, except Italy and Spain,         aries have been defined in a very limited way (red ver-
the field of aesthetic medicine and BTX-A administra-          milion of the lips). In Czech Republic, The Netherlands,
tion was regulated by the Ministries of Health of each         Poland and Portugal the dentistry field of operation in
State. In 7 cases the legitimacy of BTX-A administration       BTX-A administration is much wider instead. In fact, in
in dentistry has been addressed by the Orders of Den-          Czech Republic and in The Netherlands Dentists can ad-
tists. In the Netherlands, Poland and Czech Republic,          minister BTX-A to the covering tissues of the head and
the Orders of Dentists intervened to supplement the            neck. In Poland, the authorization concerns the entire
ministerial legislation. In Greece [30], Ireland [31], Por-    craniofacial area while in Portugal the administration of
tugal [32] and Romania [33] the acts adopted by the            BTX-A is authorized on tissues of the whole face.
Orders of Dentists are the only source of legislation          In conclusion, this analysis shows notable differences in
(Table 2).                                                     the extent of the anatomical boundaries of dental com-
The study showed that the BTX-A administration for             petences in BTX-A administration. In fact, the dental
aesthetic purposes is legitimate in 18 E.U. Member             competence goes from the minimal borders of Germany
States out of a total of 27 (equal to an average of 67%).      (tissues associated with labial vermilion) to the very ex-
In 15 States has been provided an express authoriza-           tensive ones of Holland, Czech Republic, Poland and
tion for the aesthetic BTX-A administration in dentistry.      Portugal (the entire head and neck district). However, in
In the remaining 3 States (Cyprus, Slovenia and Slova-         the majority of cases (12 out of 18 States, equal to an
kia) the BTX-A administration is allowed due to lack of        average of 67%) it was found that the administration of
explicit prohibitions. In fact, explicit bans are provided     BTX-A is legally performed within the anatomical con-
only by 9 Countries (Austria, Belgium, Bulgaria, France,       texts of dental competence provided by Directive 78/687/
Hungary, Italy, Latvia, Lithuania and Spain) (Table 1).        EEC (Mouth and jaw, including associated tissue).


Discussion                                                     Conclusions

The results of the analysis on BTX-A regulation have           This study has highlighted the presence of an inhomo-
highlighted numerous differences between the E.U.              geneous framework of competences with respect to
States. In about 2/3 thirds of the E.U. States, dentists       the BTX-A administration for medical-aesthetic reasons
are authorized to BTX-A administration for aesthetic           within the E.U. On the other hand, the correct function-
treatments. Only in 9 States have been provided an ex-         ing of the principle of free movement of professionals
plicit prohibition. Moreover, in Belgium, Bulgaria, France,    requires common competences. An intervention by the


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     The use of botulinum toxin for medical-aesthetic purposes in dentistry: a comparative medico-legal approach in the context of the European Union

     Table2. Summary table on normative source on BTX-A administration in dentistry for aesthetic purpose within the E.U.

                                        Normative source on BTX-A administration in dentistry for aesthetic purpose
      E.U. Countries               Law on           Systematic          Judgments           Measures of         Measures of             No
                                  Aesthetic        interpretation      of the judicial      the National        the Order of         regulation
                                  medicine         of health laws         authority            Health             dentists
                                                                                             Authorities
      Austria                                                                                      X
      Belgium                          X

      Bulgaria                                                                                     X

      Croatia                                                                                      X

      Cyprus                                                                                                                              X

      Denmark                                                                                      X

      Estonia                                                                                      X

      Finland                                                                                      X

      France                                               X                                       X
                                                                                            (National
                                                                                           Medicaments
                                                                                             Agency)
      Germany                                                                  X

      Greece                                                                                                           X

      Hungary                                                                                      X

      Ireland                                                                                                          X

      Italy                                                                                        X
                                                                                            (National
                                                                                           Medicaments
                                                                                             Agency)
      Latvia

      Lithuania

      Luxembourg                                                                                                                          X

      Malta

      Netherland                                                                                                       X

      Poland                                                                                                           X

      Pourtugal                                                                                                        X

      Republic of                                                                                  X                   X
      Czechoslovakia
      Romania                                                                                                          X

      Spain                                                                                        X
                                                                                            (National
                                                                                           Medicaments
                                                                                             Agency)
      Slovakia                                                                                                                            X

      Slovenia                                                                                                                            X

      Sweden                                               X




26                                                                                                                         10.59987/ads/2023.1.23-27
G.L. Vaccaro et al.

proper Institutions would therefore be appropriate not                                           dienste/vernetzung/rechtsprechung?Gericht=OVG%20Nor-
only to avoid market distortions, but also to prevent dan-                                       drhein-Westfalen&Datum=18.04.2013&Aktenzeichen=13%20
gers to the health and safety of patients/consumers. The                                         A%201210/11”& HYPERLINK “https://dejure.org/dienste/
                                                                                                 vernetzung/rechtsprechung?Gericht=OVG%20Nordrhein-
use of the BTX-A in the dental field is in fact becoming                                         Westfalen&Datum=18.04.2013&Aktenzeichen=13%20A%20
more and more common and accepted by the scientific                                              1210/11”Aktenzeichen=13%20A%201210/11
community. However, BTX-A is a drug that is not without                                    11.   https://www.iww.de/zp/quellenmaterial/id/195656
risks and side effects. If the competent Institution wanted                                12.   h t t p s : / / w w w. l e g i f r a n c e . g o u v. f r / c o d e s / i d / L E G I -
to include BTX-A in the field of dentistry, it will be also                                      TEXT000006072665
necessary to provide adequate training for the operators.                                  13.   https://www.lakemedelsverket.se/sv/lagar-och-regler/
                                                                                                 foreskrifter/2016-34-konsoliderad
An acceptable solution might be to expand university                                       14.   h t t p s : / / w w w . r i s . b k a . g v. a t / G e l t e n d e F a s s u n g .
dentistry curricula or provide mandatory post-graduate                                           wxe?Abfrage=Bundesnormen HYPERLINK “https://www.ris.
training. This kind of solution would also comply with ar-                                       bka.gv.at/GeltendeFassung.wxe?Abfrage=Bundesnormen&G
ticles 21, paragraph 6 and 36, paragraph 2 of Directive                                          esetzesnummer=20007939”& HYPERLINK “https://www.ris.
2005/36/EC which provide that the dentist’s competenc-                                           bka.gv.at/GeltendeFassung.wxe?Abfrage=Bundesnormen&G
es and his university training can be expanded and mod-                                          esetzesnummer=20007939”Gesetzesnummer=20007939
                                                                                           15.   h t t p s : / / w w w. m h . g o v e r n m e n t . b g / m e d i a / f i l e r _ p u b -
ified to adapt them to scientific and technical progress.                                        lic/2021/03/18/naredba4-24-02-2021-standart-plastichna-
                                                                                                 hirurgiq.pdf
                                                                                           16.   https://www.zakon.hr/z/499/Zakon-o-reguliranim-profesijama-
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