To vaccinate or not to vaccinate. Between moral and criminal boundaries

Author:Phd. Laura Stanila
Position:Senior lecturer, Faculty of Law, West University, Timisoara, Romania
Pages:196-213
SUMMARY

In the current social context, the issue of children's vaccination is a hot topic that has divided both public opinion and medical professionals into two belligerent camps that are fighting an endless war. The issue of vaccination can be approached from a multiple perspective but, by virtue of our specialization, we have proposed an objective approach that starts with morality and ends with the identification of legal boundaries, both in terms of the state's right to impose the vaccination of children, as well as the right of parents to refuse to execute such an obligation. Can we talk about a right and a correlated legal obligation in terms of child vaccination? What would be the rationale for editing imperative rules imposing such a task that can have consequences in terms of physical development, health of children and even their life? The act of criminalizing human behaviour must respect the desiderata of specific social peril level, necessity and proportionality. Is the penal intervention of the State on the issue of sanctioning the parents' refusal to vaccinate their children in accordance with these desiderata? Here are just a few of the ideas that we propose to discuss in the present study, which aims not to provide terse solutions, but to invite to an open, impartial and balanced dialogue.

 
CONTENT
196 LAURA STANILA
TO VACCINATE OR NOT TO VACCINATE. BETWEEN MORAL
AND CRIMINAL BOUNDARIES
Phd. Laura Stanila
Senior lecturer, Faculty of Law, West University, Timişoara, Romania
Contact: laura.stnil@e-uvt.ro.
Abstract
In the current social context, the issue of children's vaccination is a hot topic that has divided
both public opinion and medical professionals into two belligerent camps that are fighting an endless
war. The issue of vaccination can be approached from a multiple perspective but, by virtue of our
specialization, we have proposed an objective approach that starts with morality and ends with the
identification of legal boundaries, both in terms of the state's right to impose the vaccination of
children, as well as the right of parents to refuse to execute such an obligation. Can we talk about a
right and a correlated legal obligation in terms of child vaccination? What would be the rationale for
editing imperative rules imposing such a task that can have consequences in terms of physical
development, health of children and even their life? The act of criminalizing human behaviour must
respect the desiderata of specific social peril level, necessity and proportionality. Is the penal
intervention of the State on the issue of sanctioning the parents' refusal to vaccinate their children in
accordance with these desiderata? Here are just a few of the ideas that we propose to discuss in the
present study, which aims not to provide terse solutions, but to invite to an open, impartial and
balanced dialogue.
Highlights
Public misconceptions contribute to the maintaining of the conflict between pros
and cons vaccine groups.
National legislators have developed different type of rules in the area of medical
law/vaccination: mandatory or permissive
The necessity of ruling through criminal means in case of vaccine refusal is
debatable.
Keywords: vaccine, criminal liability, ethics, legal boundaries, proportionality
Abbreviations
WHO – World Health Organization
SAGE - Strategic Advisory Group of Experts
IAC – Immunization Action Coalition, Minessotta USA.
Law Review vol. VIII, issue 2, Jul
y
-December 2018, pp. 196-213
To vaccinate or not to vaccinate. Between moral and criminal boundaries 197
MMR – vaccine for measles, mumps and rubella
BCG – vaccine for Bacillus Calmette-Guerin used to combat tuberculosis
TB – tuberculosis
DTP 1 – combined vaccine for diphtheria, pertussis and tetanus.
vs. – versus
art. – article
RCC – Romanian Criminal Code
HCC – Hungarian Criminal Code
a.n. - author's note
Contents
1.About the Ethics of Incrimination
2.About vaccination without prejudices. Definitions, numbers, facts, decisions
3.Draft law on vaccination voted by the Roman legislature and its
controversies
4.To vaccinate or not to vaccinate vs. to incriminate or not to incriminate.
Moral and criminal boundaries
4.1.Penal boundaries
4.2.Ethical boundaries
5.Conclusions
1. About the Ethics of Incrimination
The reaction of the society against dangerous harmful individual conducts is a
necessity dictated by the need to safeguard social order and the fundamental
values protected by the rules of law. The passivity of society facing human
behaviour that threatens the development of social relations could result in short,
medium and long-term damage, could generate chaos.
We argued, for several times now1, that the effective protection of the social
values identified in the field of bioethics by means of criminal law is not a matter
unanimously accepted in the literature. Some researchers think that certain areas of
social life, such as human reproduction and vaccination, should be excluded from
state protection by means of criminal law. It has been shown that the criminal law
has an excessively severe and inflexible character, and because of its rigor it cannot
keep up with the scientific progress whose results are so quick and surprising.
1 Laura Stnil, Provocrile bioeticii şi rspunderea penal (2015), Bucureşti, Editura Universul
Juridic, pp. 23-24; also see Laura Stnil, Principiul precauiei şi etica incriminrii. O abordare bioetic
(2015) in D. Popescu, S. Rduleiu (editors), Conference Proceedings, Vol. 4, Post-Doctoral Research within
Social and Humanistic Sciences, Editura Alma Craiova, pp. 288-302.
198 LAURA STANILA
Medical technologies, continuously developing, have generated and still
generate fierce controversy in society, and a regulation by non-penal rules is
preferable to excessive penal regulation that would require unanimous
agreement.2 The call for criminalization cannot be achieved as a solution to the lack
of other viable legislative options. Criminal laws are strict, inflexible and time-
consuming and are incapable of reflecting the diversity and complexity of ethical
theories present at a particular moment in society, non-penal regulation being
sufficiently flexible and effective in balancing the scientific development and
constantly changing social priorities.3
The second doctrinal orientation highlights the need to criminalize these
conducts occurred in the area of Bioethics, starting from the idea that avoidance or
lack of criminalization conveys a message of tolerance and encouragement of such
behaviours. The criminalization of a human conduct is the supreme indictment of
the maximum importance of that specific conduct to society. Also, and a penal rule
is able to be as flexible as a non-penal one, without hindering the progress of
science4.
In every social context there are at least several controversial issues that tend to
divide society in pros and cons groups. As long as there is no unanimous view or
at least a significant majority of the expressed opinions, it is obvious that an
attempt to protect a specific social value by means of criminal law appears to be
excessive and unfair. The law, and in particular criminal law, is framed by religion
and grounded on its principles. The two major models of criminal policy currently
in existence - the repressive-authoritarian model and the liberal-preventive model -
obviously provide opposite solutions to the question we are addressing: is
criminalization an effective and useful to medical practice subject of bioethical
concerns?
a)The repressive-authoritarian model has reappeared as a result of the
proliferation of the criminal phenomenon in general. The number of crimes has
increased, the level of seriousness of sentences has increased, reaching what has
been called an "excess of incrimination" or overcriminalization. It has been shown
that this excess of incrimination is evidence that society is constantly evolving.5
Other scholars have also shown that in particular fields of bio-medicine the
excess of incrimination is not an exaggeration, but a path imposed by technical and
2 T. Caulfield, L. Knowles, E.M. Meslin, Law and Policy in the Era of Reproductive Genetics (2004), in
Journal of Medical Ethics, vol. 30: 2004, http://jme.bmj.com/content/30/4/414.full?sid=c32779f1-8a54-
4b71-b944-a5771774cd9e (accessed 30.04.2018). also see: Alexandra Huidu, Reproducerea uman medical
asistat. Etica incriminrii versus etica biologic. Studiu de drept comparat (2010), Editura Lumen, Iaşi, pp.
125-128.
3 T. Caulfield et al. (2004), p. 133.
4 Laura Stnil, Principiul…, p. 290.
5 Alexandrara Huidu (2010), p. 157.
To vaccinate or not to vaccinate. Between moral and criminal boundaries 199
scientific development that comes to counterbalance and reduce the impact of such
tendencies.6
We do not share this view, the excess of criminalization being an over-reaction
of society to a phenomenon that is hard to combat and control, but in the same
time very difficult to define - criminality. It is a natural reaction based on fear, fear
of escalation and chaos. This reaction is understandable, but undergoes beyond
area of normality, since fundamental principles, essential for society and the rule of
law are violated: the principle of proportionality, principle of minimum
intervention, the principle of individual autonomy. These principles being
breached, the desideratum of the common good that grounds any organized action
loses its brilliance.
b)The liberal-preventive model is based on the idea that criminal justice should
not only punish – ”eye for eye, tooth for tooth, evil for evil” - but must prevent and
educate, "to strike a balance between efforts to combat crime and the protection of
individual rights and freedoms"7.
Why open a discussion on the question of vaccination in relation with the issue
of criminalization? Because an increasing number of countries choose to regulate
vaccination as mandatory, opening paths for some voices which sustain a penal
intervention in case of vaccination refusal.
2. About vaccination without prejudices. Definitions, numbers, facts,
decisions
A vaccine is a biological preparation that improves immunity to a particular
disease. A vaccine typically contains an agent that resembles a disease-causing
microorganism, and is often made from weakened or killed forms of the microbe,
its toxins or one of its surface proteins. The agent stimulates the body's immune
system to recognize the agent as foreign, destroy it, and "remember" it, so that the
immune system can more easily recognize and destroy any of these
microorganisms that it later encounters.8 The increasing globalization in the
production and distribution of these biological medicines has opened new
possibilities to better manage public health concerns, but has also raised questions
about the equivalence and interchangeability of medicines procured across a
variety of sources. International standardization of starting materials, of
production and quality control testing, and the setting of high expectations for
6 Mark Brown, The Politics of Penal Excess an the Echo of Colonial Penalty (2002), in Punishment and
Society, no. 4/2002, p. 411.
7 Jean Pradel, Droit penal compare (2002), 2eme edition, Dalloz, Paris, p. 154.
8 World Health Organization (WHO), Definion of vaccine, http://www.who.int/topics/vaccines/
en/ (accesed 28.04.2018).
200 LAURA STANILA
regulatory oversight on the way these products are manufactured and used have
thus been the cornerstone for their continued success. But it remains a field in
constant change. The continuous technical advances in the field offer a promise of
developing potent new weapons against oldest public health threats, as well as
new ones - malaria, genetic deficiencies, pandemic influenza, etc. - but also put a
great pressure on manufacturers, regulatory authorities, and the wider medical
community to ensure that products continue to meet the highest standards of
quality attainable.9
Vaccine production systems in general use are well established and include
fermentation and the growth of viruses in cell culture. The use of recombinant
DNA-based expression systems, such as yeast, is well established, and the
regulatory issues associated with these systems have been considered in great
depth over the years, with a clear product development pathway. There are
numerous other possible production systems, however, including expression in
insect cells (or living insects), in transgenic animals and plants expressing foreign
proteins, or in other novel cell substrates, such as human tumor-derived cell lines.
The benefit-risk evaluation for vaccines requires especially careful consideration
giving the fact that they are medicines usually given to healthy individuals to
protect against diseases that they may never develop. The acceptable level of risk
and uncertainty is therefore very low, and the regulatory approach used is
extremely conservative. Therefore, while novel production systems may each
provide specific benefit over traditional ones, they must be evaluated carefully.10
In accordance with its mandate to provide guidance to Member States on
health policy matters, WHO issues a series of regularly updated position papers on
vaccines and combinations of vaccines against diseases that have an international
public health impact. These papers are concerned primarily with the use of
vaccines in large-scale national immunization programs. They summarize essential
background information on diseases and vaccines and conclude with the current
WHO position on the use of vaccines worldwide. 11
For example, Recommendation of WHO on the question if the BCG vaccine
should be given to infants at birth or at the time of the first dose of the diphtheria
tetanus and pertussis (DTP1) containing vaccine at 6 weeks of age to mitigate the
9 WHO, Immunization standards, http://www.who.int/immunization_standards/vaccine_
quality/en/ (accesed 28.04.2018).
10 Lindsay Elmgrena, Xuguang Lia, Carolyn Wilsonb, Robert Ballb, Junzhi Wangc, Klaus
Cichutekd, Michael Pfleidererd, Atsushi Katoe, Marco Cavalerif, James Southerng, Teeranart
Jivapaisarnpongh, Philip Minori, Elwyn Griffithsj, Yeowon Sohnk, David Wood, A global regulatory
science agenda for vaccines, in Vaccine, 2013, Volume 31, Supplement 2: B163-B175, p. B166,
https://ac.els-cdn.com/S0264410X12015939/1-s2.0-S0264410X12015939-main.pdf?_tid=c0f4909a-5e97-
4154-8917-53f9429a08c8&acdnat=1525087224_fff7f9ca967c6a06f6c73412bc15ffc8 (accesed 28.04.2018).
11 WHO, Weekly epidemiological record, 23 February 2018, 93th Year, no. 8, 2018, 93, 73–96,
http://www.who.int/wer, (accesed 28.04.2018).
To vaccinate or not to vaccinate. Between moral and criminal boundaries 201
risk of severe TB disease, with special focus on countries with a high burden of TB.
WHO recommends in countries or settings with a high incidence of TB and/or
leprosy, a single dose of BCG vaccine should be given to neonates at birth, or as
soon as possible thereafter, for prevention of TB and leprosy disease. If it cannot be
given at birth, it should be given at the earliest opportunity thereafter and should
not be delayed. Any delay in vaccination may lead to opportunities for known or
unknown exposure to TB or leprosy infected contacts. Co-administration of BCG
with the hepatitis B birth dose is safe and strongly recommended. In order to avoid
missed opportunities for neonatal vaccination, BCG multi-dose vials should be
opened and used despite any wastage of unused vaccine. If the birth dose was
missed, catch-up vaccination of unvaccinated older infants and children is
recommended since evidence shows it is beneficial. Catch-up vaccination should
be done at the earliest convenient encounter with the health-care system to
minimize known or unknown exposure to TB or leprosy infected contacts.12
Vaccines can generally be co-administered (i.e. more than one vaccine given at
different sites during the same visit). Recommendations that explicitly endorse co-
administration are indicated in the table, however, lack of an explicit co-
administration recommendation does not imply that the vaccine cannot be co-
administered; further, there are no recommendations against co-administration
(BCG, Hepatitis B, Polio, etc.). Other vaccines, such as varicella and pneumococcal
polysaccharide vaccines, may be of individual benefit but are not recommended
for routine immunization13.
Despite WHO recommendations and their obvious benefit for both public and
individual health, the number of doses a child gets from birth to the age of 10 and
some debatable side-effects are a question of maximum importance and a cause for
fierce controversy both in public opinion and among scholars.
For example, according to IAC Minessota USA, a child could get a minimum
of 25 up to 30 dozes of vaccine for several diseases14
In June 2012, a provincial court in Rimini, Italy granted compensation to the
family of a child named Valentino Bocca. The family alleged that the MMR vaccine
Valentino received as part of his childhood immunizations caused his autism, and
the court compensated them on that theory. The lower court’s decision was never
on very firm grounds: it depended in part on testimony of an expert witness who
relied on a debunked study written by Andy Wakefield. Unfortunately, this Italian
12 SAGE Evidence to recommendations framework, Table 3 BCG vaccination at birth vs. at 6 weeks,
p. 7, http://www.who.int/immunization/policy/position_papers/bcg_vaccination_birth_vs_6weeks.
pdf?ua=1, (accesed 30.04.2018).
13 WHO Recommendations for all immunization programmes, Table 1: Summary of WHO Position
Papers - Recommendations for Routine Immunization, p. 3, http://w ww.who.int/immunization/policy/
Immunization_routine_table1.pdf?ua=1 (accesed 30.04.2018).
14 IAC Saint Paul Minnesota USA, Vaccination for Infants and Children, Age 0-10 Years,
http://www.immunize.org/catg.d/p4019.pdf (accesed 30.04.2018).
202 LAURA STANILA
MMR autism decision has been used by anti-vaccine activists as part of their claims
that vaccines cause autism. On February 13, 2015, immunization rates in the
province of Romagna The Court of Appeal accepted the appeal filed by the
Ministry of Health. The expert appointed by the court of appeal highlighted that
there is no scientific evidence supporting an MMR autism link. The expert
highlighted that the lower court expert was wrong to rely on the study by Andrew
Wakefield, a study debunked and rejected by the scientific community.15 Despite
an impressive number of scientific studies16 demonstrating no connection between
vaccines and autism, the public debate is in flames and showing no signs of
abatement.
Another view on the problem is offered by some national courts which
interpret the medical rules in connection with vaccination as mandatory, forcing
parents to vaccinate their children against their will and believes: e.g. the case of a
vegan mother who wanted her sons to live a "toxin free" life was be forced to make
them receive routine vaccinations after the High Court in UK overruled her
objections.17 This is not the only available example. As a matter a fact there is an
important number of court decisions imposing the vaccines as mandatory.18
The European Court of Justice has been accused of undermining Britain’s
vaccination program after ruling that patients can sue for illnesses they believe
were caused by jabs, even when there is no scientific evidence.
15 Dorit Rubinstein Reiss, Italian MMR Autism Decision Overturned, article published on 20.12.2016
on skepticalraptor.com,
https://www.skepticalraptor.com/skepticalraptorblog.php/italian-mmr-autism-decision-
overturned/ (accesed 30.04.2018). See also http://www.repubblica.it/salute/medicina/2015/03/01/
news/autismo_i_giudici_assolvono_il_vaccino-108441541/?refresh_ce (accesed 30.04.2018).
16 E.g. V. Demicheli, A. Rivetti, M.G. Debalini MG, C. Di Pietrantonj, Vaccines for measles, mumps
and rubella in children, Cohrane Database Syst. Rev., 2012 Feb 15; (2):CD004407. doi:
10.1002/14651858.CD004407.pub3, https://www.ncbi.nlm.nih.gov/pubmed/22336803 (accessed
30.04.2018); F. Destefano, C.S. Price, E.S. Weintraub, Increasing exposure to antibody-stimulating proteins
and polysaccharides in vaccines is not associated with risk of autism, J Pediatr. 2013 Aug;163(2):561-7. doi:
10.1016/j.jpeds.2013.02.001. Epub 2013 Mar 30, https://www.ncbi.nlm.nih.gov/pubmed/23545349
(accessed 30.04.2018); K.M. Madsen, A. Hviid, M. Vestergaard, D. Schendel, J. Wohlfahrt, P. Thorsen,
J. Olsen, M. Melbye, A population-based study of measles, mumps, and rubella vaccination and autism, N
Engl J Med. 2002 Nov 7;347(19):1477-82. PubMed PMID: 12421889, https://www.nejm.org/
doi/full/10.1056/NEJMoa021134 (accessed 30.04.2018); D. Mrozek-Budzyn, A. Kiełtyka, R.
Majewska, Lack of association between measles-mumps-rubella vaccination and autism in children: a case-
control study, Pediatr Infect Dis J. 2010 May; 29(5):397-400. doi: 10.1097/INF.0b013e3181c40a8a.
PubMed PMID: 19952979, https://www.ncbi.nlm.nih.gov/pubmed/19952979 (accessed 30.04.2018);
and so on.
17 Rachel Roberts, Vegan mother forced by High Court to vaccinate her children, article
published in Independent UK on 6.04.2017, https://www.independent.co.uk/news/uk/home-
news/vegan-mother-vaccinate-children-high-court-toxin-free-kids-mmr-anti-vaxxer-a7670881.html,
(accessed 28.04.2018).
18 BBC News, High Court orders two sisters must receive MMR vaccine, article published on
11.10.2013, http://www.bbc.com/news/health-24493422, (accessed 30.04.2018).
To vaccinate or not to vaccinate. Between moral and criminal boundaries 203
The EU's highest court said on 21st of June 2017 that if a number of healthy
people developed a disease shortly after receiving a vaccine then that would serve
as enough proof to bring a claim.19
The ruling, which health experts in Britain said was of serious concern, opens
the door for class actions from patients who believe their health was affected by
vaccines, even when there is no medical proof.20
The European court vaccine decision is – despite all the comments it led to – a
decision that allows, even encourages, under specific presumptions, member
states, in situations of scientific uncertainty in product liability – not just vaccines –
to consider other factors, such as temporal proximity of harm to vaccine, and
compensate a plaintiff even without clear scientific evidence supporting
causation.21
3. Draft law on vaccination voted by the Roman legislature and its
controversies
Arguing with provisions from its basic law - art. 34 al. 2 of the Romanian
Constitution stipulating that "the state is obliged to take the necessary measures to
ensure public hygiene and health" - and with the provisions of the UN Convention
on the Rights of the Child adopted by the United Nations General Assembly on 20
November 1989 and ratified by the Romania Law no. 18/199022, the Romanian
19 Case N. W and Others v Sanofi Pasteur MSD SNC and Others, Judgement of the Court on 21st of
June 2017 in Case C-621/15, http://curia.europa.eu/juris/celex.jsf?celex=62015CJ0621&lang1=ro&
lang2=EN&type=TXT&ancre= (accessed 30.04.2018).
20 Sarah Knapton, European Court of Justice ruling could open floodgates for spurious vaccination
claims, article published in Telegraph UK on 22.06.2017, https://www.telegraph.co.uk/science/2017/
06/22/european-court-justice-ruling-could-open-floodgates-spurious/ (accessed 28.04.2018).
21 Facts: Mr. J.W. received a series of hepatitis B vaccine starting in December 1998, and ending in
July 1999. Starting in August 1999 his health deteriorated, and in November 2000 he was diagnosed
with multiple sclerosis (MS), which is an unpredictable, often disabling disease of the central nervous
system that disrupts the flow of information within the brain, and between the brain and body. The
cause of MS is still unknown – scientists believe the disease is triggered by as-yet-unidentified
environmental factor in a person who is genetically predisposed to respond. Mr. W.’s health
continued to deteriorate, leaving him disabled. On October 30, 2011, Mr. W. died. His family
sued Sanofi Pasteur, the manufacturer of the hepatitis B vaccine he received, claiming that the vaccine
caused his MS. The law in France, mirroring the EU directive, required the plaintiffs to prove a defect
in the product that caused his harm. French law required that plaintiff prove both the existence of a
defect and that the defect caused the harm with “serious, specific and consistent presumptions.” It
also, apparently, made use of a number of legal presumptions. For a proper analysis see Dorit
Rubinstein Reiss, European court vaccine decision – a legal analysis, article published on 25.06.2017 on
Skeptical Raptor, https://www.skepticalraptor.com/skepticalraptorblog.php/european-court-
vaccine-decision-analysis/ (accessed 28.04.2018).
22 Published in the "Official Monitor of Romania", Part I, no. 109 of 28th September 1990 and
republished in the "Official Monitor of Romania", part I, no. 314 of 13th June 2001.
204 LAURA STANILA
legislator tried a courageous move through the legislative initiative on compulsory
vaccination. Thus, by the explanation of the PL-x no. 399/201723 deposited with the
Chamber of Deputies of Romania it is stated that this draft-law is inspired by the
legislation of other European countries where the immunization rate exceeds 95%.
Thus, in 11 European countries the immunization of children is compulsory, and
the children are not accepted in the community if they do not have the complete
vaccination scheme, Romania being far below the European average. For example,
in Belgium, since 1967, the polio vaccine is mandatory. But when children are
enrolled in the community, serums for pertussis, measles and mumps are also
mandatory. In Slovenia, 9 vaccines are mandatory and 6 in Latvia. According to
the draft-law, parents and legal representatives have the following responsibilities
and obligations:
a) to ensure that the child is presented to the family doctor / health care
provider to complete the age-appropriate vaccination scheme for mandatory
vaccinations to ensure his/her right to health.
b) to present at the request of the County Vaccination Commission or of the
Bucharest Municipality.
c) In the case of parents who are leaving the country and who leave children
eligible for vaccination in the care of family members or other persons under the
conditions stipulated by law, they are obliged to designate a person responsible for
accompanying the child to the vaccination. In this regard, parents are advised to
notify the family doctor in writing of the person's name within 15 days of receiving
the information from the family doctor.
The draft-law was initiated due to the measles epidemic in 2016 - 2017 and to
sharp rise in the number of children not vaccinated with the MMR (ROR in
Romania) vaccine. MMR vaccine coverage (for measles, mumps and rubella, no) -
the first dose for children aged 2 years was of 94.7 percent in 2011 and 95.1 percent
in 2012. The number of measles cases in the 2016-2017 epidemic reached 4,070 in a
very short time. Legislative intervention was necessary in the opinion of the
Romanian Minister of Health due to the fact that, since the onset of the 2016
epidemic in Romania, 21 deaths were recorded in a first period in patients with
unvaccinated measles, while in 2010-2015 there were only 4 deaths24.
Almost 5% of parents refuse vaccination, and this led, according to Health
Ministry officials, to the emergence of the measles epidemic. Most of the parents
who refuse vaccination are not well informed, doctors say. On July 21st, 2017, the
23 Explanation of the draft law on vaccination submitted to the Chamber of Deputies,
http://www.cdep.ro/proiecte/2017/300/90/9/em497.pdf (accessed 28.04.2018).
24 https://stirileprotv.ro/stiri/actualitate/un-copil-de-un-an-si-jumatate-si-o-tanara-de-17-ani-
au-murit-din-cauza-rujeolei-numarul-total-de-decese-a-ajuns-la-21.html (accessed 28.04.2018).
To vaccinate or not to vaccinate. Between moral and criminal boundaries 205
number of measles diseases rose to 8,246 cases, of which 32 deaths, so it doubled in
two months while the number of deaths increased dramatically25.
The Romanian Health Ministry wants a mandatory vaccination law to force
parents to immunize their children. The project says that "at birth, the parent has
the right to refuse in writing the child's vaccination. Then, at the age of 3, when to
be included in the community, the kindergarden cannot refuse the child because
the child's right to education is guaranteed by the Constitution. But the parent is
asked to submit the recovery schedule for the vaccination within two months.
Those who do not submit will be charged with maltreatment of the minor and risk
up to six years in prison. And the baby may be entrusted to the state and be
vaccinated eventually".
The Draft Law on Vaccination stated, in the original version of art. 11,
paragraph (4), let. n), among other attributions, the obligation of the County
Vaccination Commissions and the Municipality of Bucharest to "refer to the
competent institutions for the detection of the offense of maltreatment by the
parents or legal representatives of the juvenile who reaches the age of 3 years and
has not received the compulsory vaccines age-appropriate."
This particular provision, which has now been removed following a strong
opposition from public opinion, has raised the question of the need to introduce
into the draft law some clear criminalizing provisions to penalize parents or legal
representatives who refuse to initiate or continue the compulsory vaccination
scheme. As a matter of fact, by corroborating the provisions of the draft law (which
does not provide criminalizing rules, but only an administrative sanction (fine),
with those of the criminal law, it could be proved the committing of the offense of
ill-treatment applied to the minor stipulated in art. 197 RCC. Thus, according to
this text of incrimination the offense of ill treatments applied to underage persons
consists in causing of serious jeopardy, through measures or treatments of any
kind, of the physical, intellectual or moral development of an underage person, by
parents or by any person under whose care the underage person and is punishable
by no less than 3 and no more than 7 years of imprisonment and a ban on the
exercise of certain rights. Obviously, in case of vaccination refusal in the context of
an epidemic situation, with serious peril for the child’s life, one can argue that the
child’s future physical development is in danger, so, an intervention through penal
means is imperative. But is that so?
25 Explanation of the draft law on vaccination submitted to the Chamber of Deputies,
http://www.cdep.ro/proiecte/2017/300/90/9/em497.pdf (accessed 28.04.2018).
206 LAURA STANILA
4. To vaccinate or not to vaccinate vs. to incriminate or not to incriminate.
Moral and criminal boundaries
Everybody agrees on the complex features of the issue of vaccination while
arguers should keep in mind its importance for the society and for public health.
But in the same time regulating in the field of vaccination must be taken seriously
for the fact that, if too low legal standards are set, dangers could result for the
community. If legal standards imposed are too harsh, this could cause the violation
of fundamental rights.
We cannot say for sure that compulsory vaccination results in improved
vaccination rates because this result is highly dependant on country context,
historical circumstance, cultural and social norms, as well as the practicalities of
implementing and enforcing such a law. As Vanderslott and Roser stated,
”certainly in Eastern Bloc countries when the vaccination law was compulsory,
vaccination rates have been high but it is unclear whether to attribute this to the
law or the behaviours and mechanisms of compliance under communist rule.
Certain vaccinations have historically been compulsory such as smallpox, polio,
and yellow fever. Here vaccination rates have also been high but it also
encouraged organised opposition to vaccination and public discontent. This is a
major concern for public health authorities that a relationship of trust, between
governments and citizens is threatened (particularly for health where a rhetoric of
self-responsibility, personalisation, and choice is encouraged).”26 The authors
underline the fact that there are countries with high vaccination rates without
compulsory vaccination and governments do not want to disrupt public trust and
self-responsibility by making vaccination compulsory, particularly if it is not seen
as needed.27 Alternative ways (such as education of the population, financial
rewards etc.) are preferred. In recent years governments have acted in response to
epidemics to modify their legislation in order to make vaccination compulsory
(France, Italy, Germany, and Romania). But talking about modifying the legislation
for this purpose is not the same with talking about criminalizing the refusal of
vaccination, even if in limited circumstances.
4.1.Ethical boundaries
Bioethics is a new arena for jurists, a domain with so many incentive and novel
features. Regulating in this area may be is as difficult as it appears at a first glance,
meaning that a set of principles is needed to ground the specific legislation. ”These
principles stressed the autonomy of the individual, not surprising given the
26 Samantha Vanderslott, Max Roser, Vaccination (2018), published online at OurWorldInData.
org, https://ourworldindata.org/vaccination (accessed 30.04.2018).
27 Idem.
To vaccinate or not to vaccinate. Between moral and criminal boundaries 207
paternalistic and authoritarian manner that sometimes characterized modern
medicine in the last century”28.
Scholars were preoccupied to identify the basic and general directions of legal
thinking proposing the following set: 1) producing benefits; 2) avoiding,
preventing, and removing harms; 3) producing the maximal balance of benefits
over harms and other costs (i.e., utility); 4) distributing benefits and burdens fairly
(distributive justice) and ensuring public participation, including the participation
of affected parties (procedural justice); 5) respecting autonomous choices and
actions, including liberty of action; 6) protecting privacy and confidentiality; 7)
keeping promises and commitments; 8) disclosing information as well as speaking
honestly and truthfully (i.e., transparency); and 9) building and maintaining trust.
Among these, three of them may be ranked as general principles of bioethics with
an important moral core: benefitting others, preventing and removing harms,
utility—while other three could lead to a conflict with them - justice, autonomy
privacy – possibly limiting public health activities. 29
If we reduce our analysis to the most simple and obvious moral dezideratum -
do no harm to others - when applied to vaccination its implications are multiple:
the vaccination should be of benefit to the subject being vaccinated; care should be
taken to prevent any harm caused by vaccination; vaccination should be the best
opportunity for successfully preventing disease as compared to the risk for harm;
and if harm does result from the vaccination, the benefit of vaccination to the
subject should at least compensate for the harm incurred.
In the same time the precautionary principle has been defined as being
relevant to activities that concern public health with the aim to protect populations
against reasonably foreseeable threats, even under conditions of uncertainty. 30
4.2.Penal boundaries
It is quite facil to use Criminal law to punish non-vaccinating individuals in
the context of a death from preventable disease – the unvaccinated child, or
someone infected as a result of his/her non-vaccinaton. The manslaughter
28 Alvin Nelson El Amin, Michelle T. Parra, Robert Kim-Farley, Jonathan E. Fielding, Ethical
Issues Concerning Vaccination Requirements, Public Health Reviews, Vol. 34: 14, No 1, p. 2,
https://doi.org/10.1007/BF03391666.
https://publichealthreviews.biomedcentral.com/track/pdf/10.1007/BF03391666.
29 James F. Childress, Ruth R. Faden, Ruth D. Gaare, Lawrence O. Gostin, Jeffrey Kahn, Nancy E.
Kass, Anna C. Mastroianni, Jonathan D. Moreno, Phillip Nieburg, Public Health Ethics: Mapping the
Terrain, Journal of Law, Medicine, and Ethics 2002; 30(2):170–178. https://jhu.pure.elsevier.com/en/
publications/public-health-ethics-mapping-the-terrain-3 (accessed 30.04.2018).
30 L.O. Gostin, R.Bayer, A.L. Fairchild, Ethical and legal challenges posed by severe acute respiratory
syndrome: implications for the control of severe infectious disease threats, Journal of the American Medical
Association 2003, 290(24): 3229-3237, https://www.ncbi.nlm.nih.gov/pubmed/14693876 (accessed
30.04.2018).
208 LAURA STANILA
provisions are the proper tool. Different national legislations could request
recklessness or just negligence to meet the required mental state for the
manslaughter statute. Other legislations ban under criminal sanction the breach of
parental duties and child abuse or neglect. But not vaccinating a child, particularly
when there is no ongoing outburst, may not be perceived by a court as neglect,
since it is very difficult to demonstrate the specific state of mind.31
Scholars showed that no parent has been prosecuted for the death of a non-
vaccinated child from a vaccine preventable disease, but there were several cases
where parents were prosecuted for failure to provide medical aid to a sick child.
The question is if these cases could be extended to apply to a situation in which the
child dies as a result of being unvaccinated . The arguments for admitting the
extension are:
parents have a legal duty to provide medical aid to their children that can
include providing the child with appropriate medication or taking the child to a
doctor in appropriate circumstances. If a parent violates that duty and a child dies,
a parent may be prosecuted under a manslaughter or homicide statute, depending
on the circumstances.32
But, against extension one can bring the issue of the mens rea: parents choosing
not to vaccinate are acting like this for the child’s benefit. If recklessness is
required, it cannot be proved in this case that the parents were very negligent.
Not vaccinating is probably negligent: the risks of not vaccinating are
substantially higher than the risks of vaccinating, and vaccinating is supported by
an extensive medical consensus, but still negligence in this case seems wrong. Lot
of parents who choose to vaccinate their children are educated and well informed
on de issue of vaccination, so the mens rea required is missing.
Other sensitive issue is the religious argument. In some legislations religious
exemptions exonerate a parent of child neglect for using faith healing; but as a
counter-argument, one can emphasize that child does not get to choose the
religion, and the parent should bear responsibility in this case.33
In order to explain the social context in which a non-vaccinated person/child
is involved, an author introduced the concept of ”liminality”. ”The comparison of
unvaccinated children to liminality is no doubt unintentional to their parents but
exists nonetheless.”34 Liminality traditionally exists as a sociological theory of
31 Voices for vaccines, Vaccines and the law. An Advocate s Toolkit, 2014, https://www.voicesfor
vaccines.org/content/uploads/2014/10/Vaccines-and-the-Law-Toolkit.pdf (accessed 30.04.2018).
32 Dorit Rubinstein Reiss, Rights of the Unvaccinated Child: Criminal Law, 2014, https://s hotof
prevention.com/2014/02/25/rights-of-the-unvaccinated-child-criminal-law/ (accessed 29.04.2018).
33 Dorit Rubinstein Reiss, Rights of the Unvaccinated Child: Criminal Law, 2014, https://shotof
prevention.com/2014/02/25/rights-of-the-unvaccinated-child-criminal-law/ (accessed 29.04.2018).
34 Cody Bondarchuk, Redefining Mandatory Vaccination as Necessary to Life and the Refusal of
Vaccination as Criminal Negligence Causing Death, Sociology Undergraduate Journal Vol. 2 (2017),
https://journals.library.ualberta.ca/invoke/index.php/invoke/issue/view/1941 (accessed 29.04.2018).
To vaccinate or not to vaccinate. Between moral and criminal boundaries 209
being in-between life and death, and the same logic could be applied to an
unvaccinated child., they simultaneously do and do not have the ability to be
infected with the preventable disease, and the results cannot be determined until
they either contract the disease or get the vaccine.
Finally, it is worth it to analyse the case-law of Romanian's neighbour,
Hungary and the struggles of Hungarian doctrine to detangle the issue of
criminalizing refusal of vaccination.
According to Section 208 (1) HCC35 (a.n. ex-section 195 (1))abuse of a minor is
committed if the special subject of the crime, through the serious neglect of his
obligation, endangers – in the present case – the physical development of the
minor. Based on judicial sentencing, the commission of the crime may be
established if the breach of duty endangers the physical development of the minor
directly, therefore, general, abstract danger is not sufficient for factuality. The
person who refuses to vaccinate the minor commits the abuse of a minor offense.
Doctrine has presented several cases – such as Kaposvar and Szekesfehervar –
which have shown different views of the public prosecutors. In the first case the
prosecutor stated that vaccination was to be enforced within the framework of
administrative proceedings and not by the instruments of criminal law, the
physical development of the minor must be in danger de facto and causal relations
must be established between this danger and the perpetrator’s intentional conduct
to this purpose. Therefore, considering these facts, the act does not constitute a
crime. In the second case the prosecutor argued that the parents endanger the
health of their children, and through it, indirectly, their physical development as
well if they consciously hinder the administration of the compulsory vaccinations
dependant on age at the most appropriate time. Namely, if the children do not
receive the vaccination at the indicated time, they are exposed to the danger of
such preventable diseases which may lead to serious complications or may even
end by death. A third controversed case was that of a mother who had failed to
provide her children with one of the compulsory vaccinations was given a
suspended sentence of six months’ imprisonment by the County Court of
Csongrad. Because one of her children has suffered side effects after vaccine
inoculation, she decided not to vaccinate the others. Despite her reasons to reject
vaccination, the court convicted her as shown.36
35 HCC available at http://www.parliament.am/library/Qreakan/Hungary.pdf (accessed
29.04.2018).
36 Cases presented by Lilla David, The evaluation of the refusal to submit to compulsory vaccination in
Hungarian criminal law, Revista de Ştiine Juridice (2013) nr. 2:117-123, pp.119-120, drept.ucv.ro/RSJ/
images/articole/2007/RSJ2/013Lilla.pdf (accessed 29.04.2018).
210 LAURA STANILA
5. Conclusions
The issue of compulsory vaccination is, as shown in the present article, very
difficult to approach and even more difficult to regulate under a single branch of
law. We tried to demonstrate that criminal law may not be the most effective
solution to force parents to vaccinate their children. It should be ultima ratio on the
national Governments agenda on public health policy.
Maybe some national legislators have managed to impose vaccination even if
they did not use penal instruments, and maybe in the Communist Era Europe was
immunized, but, in the same time, cases presented and ruled by courts in different
countries have shown how easy it is to cross the barrier of public utility and
commit an authority abuse, violating fundamental rights, both of the parent and of
the child or of the person forced to accept inoculation.
The solution is in the hands of the State which can think-out an efficient public
health policy based on education of the parents and of the public opinion about
benefits of vaccines and on alternative measures, such as specific benefits, light
non-criminal sanctions, suspending the allowance for children etc.
It is difficult for the states to find through the legislative solutions adopted, a
middle path between respecting individual autonomy and the public interest, as it
is equally difficult to implement a common global strategy on vaccination, cultural,
historical, social and economic features of each country having an overwhelming
importance in establishing a State internal attitude towards the issue of
vaccination.
References
1. BBC News (2013), High Court orders two sisters must receive MMR
vaccine, article published on 11.10.2013, http://www.bbc.com/news/health-
24493422, (accessed 30.04.2018).
2. Bondarchuk, C. (2017). Redefining Mandatory Vaccination as Necessary to
Life and the Refusal of Vaccination as Criminal Negligence Causing Death.
Sociology Undergraduate Journal Vol. 2, https://journals.library.ualberta.ca/invoke/
index.php/invoke/issue/view/1941 (accessed 29.04.2018).
3. Brown, M. (2002). The Politics of Penal Excess an the Echo of Colonial
Penalty. Punishment and Society, no. 4/2002.
4. European Court of Justice. Case N. W and Others v Sanofi Pasteur MSD SNC
and Others. Judgement of the Court on 21st of June 2017 in Case C-621/15,
http://curia.europa.eu/juris/celex.jsf?celex=62015CJ0621&lang1=ro&lang2=EN&t
ype=TXT&ancre= (accessed 30.04.2018).
5. Caulfield, T., Knowles, L., Meslin, E.M. (2004). Law and Policy in the Era of
Reproductive Genetics. Journal of Medical Ethics, vol. 30. http://jme.bmj.com/
To vaccinate or not to vaccinate. Between moral and criminal boundaries 211
content/30/4/414.full?sid=c32779f1-8a54-4b71-b944-a5771774cd9e (accesed
28.04.2018);
6. Childress, J.F., Faden, R.R., Gaare, R.D., Gostin, L.O., Kahn, J., Kass, Nancy
E., Mastroianni, A.C., Moreno, J.D., Nieburg, P. (2002). Public Health Ethics:
Mapping the Terrain, Journal of Law, Medicine, and Ethics; 30(2):170–178.
https://jhu.pure.elsevier.com/en/publications/public-health-ethics-mapping-the-
terrain-3 (accessed 30.04.2018).
7. David, L. (2013). The evaluation of the refusal to submit to compulsory
vaccination in Hungarian criminal law. Revista de Ştiine Juridice nr. 2:117-123,
drept.ucv.ro/RSJ/images/articole/2007/RSJ2/013Lilla.pdf (accessed 29.04.2018).
8. Demicheli, V., Rivetti, A., Debalini M.G., Di Pietrantonj, C. (2012). Vaccines
for measles, mumps and rubella in children. Cohrane Database Syst. Rev., Feb 15; (2):
CD004407. doi: 10.1002/14651858.CD004407.pub3, https://www.ncbi.nlm.nih.
gov/pubmed/22336803 (accessed 30.04.2018);
9. Destefano, F., Price, C.S., Weintraub, E.S. (2013). Increasing exposure to
antibody-stimulating proteins and polysaccharides in vaccines is not associated
with risk of autism. J Pediatr. Aug; 163(2):561-7. doi: 10.1016/j.jpeds.2013.02.001.
Epub 2013 Mar 30, https://www.ncbi.nlm.nih.gov/pubmed/23545349 (accessed
30.04.2018);
10. El Amin, A.N., Parra, M.T., Kim-Farley, R., Fielding, J.E. (2012). Ethical
Issues Concerning Vaccination Requirements. Public Health Reviews, Vol. 34: 14,
No 1, https://doi.org/10.1007/BF03391666. https://publichealthreviews.biomed
central.com/track/pdf/10.1007/BF03391666 (accessed 30.04.2018);
11. Elmgrena, L., Lia, X., Wilsonb, C., Ballb, R., Wangc, J., Cichutekd,
K., Pfleidererd, M., Katoe, A., Cavalerif, M., Southerng, J., Jivapaisarnpongh,
T., Minori, P., Griffithsj, E., Sohnk, Y., Wood, D. (2013). A global regulatory science
agenda for vaccines. Vaccine, Volume 31, Supplement 2: B163-B175, https://ac.els-
cdn.com/S0264410X12015939/1-s2.0-S0264410X12015939-main.pdf?_tid=c0f4909a-
5e97-4154-8917-
53f9429a08c8&acdnat=1525087224_fff7f9ca967c6a06f6c73412bc15ffc8 (accesed
28.04.2018).
12. Explanation of the draft law on vaccination submitted to the Chamber of
Deputies, http://www.cdep.ro/proiecte/2017/300/90/9/em497.pdf (accessed
28.04.2018).
13. Gostin, L.O., Bayer, R., Fairchild, A.L. (2003). Ethical and legal challenges
posed by severe acute respiratory syndrome: implications for the control of severe
infectious disease threats. Journal of the American Medical Association, 290(24): 3229-
3237, https://www.ncbi.nlm.nih.gov/pubmed/14693876 (accessed 30.04.2018).
14. http://www.parliament.am/library/Qreakan/Hungary.pdf (accessed
29.04.2018).
15.
http://www.repubblica.it/salute/medicina/2015/03/01/news/autismo_i
_giudici_assolvono_il_vaccino-108441541/?refresh_ce (accesed 30.04.2018).
212 LAURA STANILA
16. https://stirileprotv.ro/stiri/actualitate/un-copil-de-un-an-si-jumatate-si-o-
tanara-de-17-ani-au-murit-din-cauza-rujeolei-numarul-total-de-decese-a-ajuns-la-
21.html (accessed 28.04.2018).
17. https://www.skepticalraptor.com/skepticalraptorblog.php/italian-mmr-
autism-decision-overturned/ (accesed 30.04.2018),
18. Huidu, A. (2010). Reproducerea uman medical asistat. Etica incriminrii
versus etica biologic. Studiu de drept comparat, Editura Lumen, Iaşi;
19. IAC Saint Paul Minnesota USA, Vaccination for Infants and Children, Age
0-10 Years, http://www.immunize.org/catg.d/p4019.pdf (accesed 30.04.2018).
20. Knapton, S. (2017). European Court of Justice ruling could open floodgates
for spurious vaccination claims, article published in Telegraph UK on 22.06.2017,
https://www.telegraph.co.uk/science/2017/06/22/european-court-justice-
ruling-could-open-floodgates-spurious/ (accessed 28.04.2018).
21. Madsen, K.M., Hviid, A., Vestergaard, M., Schendel, D., Wohlfahrt, J.,
Thorsen, P., Olsen, J., Melbye, M. (2002). A population-based study of measles,
mumps, and rubella vaccination and autism. N Engl J Med. Nov 7; 347(19):1477-82.
PubMed PMID: 12421889, https://www.nejm.org/doi/full/10.1056/NEJMoa
021134 (accessed 30.04.2018);
22. Mrozek-Budzyn, D., Kiełtyka, A., Majewska, R. (2010). Lack of association
between measles-mumps-rubella vaccination and autism in children: a case-control
study. Pediatr Infect Dis J. May; 29(5):397-400. doi: 10.1097/INF.0b013e3181c40a8a.
PubMed PMID: 19952979, https://www.ncbi.nlm.nih.gov/pubmed/19952979
(accessed 30.04.2018);
23. Pradel, J.(2002). Droit penal compare, 2eme edition, Dalloz, Paris;
24. Roberts, R. (2017), Vegan mother forced by High Court to vaccinate her
children, article published in Independent UK on 6.04.2017, https://www.
independent.co.uk/news/uk/home-news/vegan-mother-vaccinate-children-high-
court-toxin-free-kids-mmr-anti-vaxxer-a7670881.html, (accessed 28.04.2018).
25. Rubinstein Reiss, D. (2017). European court vaccine decision – a legal
analysis, article published on 25.06.2017 on Skeptical Raptor, https://www.
skepticalraptor.com/skepticalraptorblog.php/european-court-vaccine-decision-
analysis/ (accessed 28.04.2018).
26. Rubinstein Reiss, D. (2016). Italian MMR Autism Decision Overturned,
article published on 20.12.2016 on skepticalraptor.com,
27. Rubinstein Reiss, D. (2014). Rights of the Unvaccinated Child:
Criminal Law, 2014, published online https://shotofprevention.com/2014/02/25/
rights-of-the-unvaccinated-child-criminal-law/ (accessed 29.04.2018).
28. SAGE Evidence to recommendations framework, Table 3 BCG vaccination
at birth vs. at 6 weeks, http://www.who.int/immunization/policy/position_
papers/bcg_vaccination_birth_vs_6weeks.pdf?ua=1, (accesed 30.04.2018).
To vaccinate or not to vaccinate. Between moral and criminal boundaries 213
29. Stnil, L. (2015). Principiul precauiei şi etica incriminrii. O abordare
bioetic in D. Popescu, S. Rduleiu (eds.), Conference Proceedings, Vol. 4, Post-
Doctoral Research within Social and Humanistic Sciences, Editura Alma Craiova,
288-302.
30. Stnil, L. (2015). Provocrile bioeticii şi rspunderea penal, Bucureşti,
Editura Universul Juridic;
31. Vanderslott, S., Roser M. (2018). Vaccination. Published online at
OurWorldInData.org, https://ourworldindata.org/vaccination (accessed 30.04.2018).
32. Voices for vaccines (2014). Vaccines and the law. An Advocate s Toolkit.
https://www.voicesforvaccines.org/content/uploads/2014/10/Vaccines-and-
the-Law-Toolkit.pdf (accessed 30.04.2018).
33. World Health Organization. Definion of vaccine. http://www.who.int/
topics/vaccines/en/ (accesed 28.04.2018);
34. World Health Organization. Immunization standards. http://www.who.
int/immunization_standards/vaccine_quality/en/ (accesed 28.04.2018);
35. World Health Organization. Recommendations for all immunization
programs, Table 1: Summary of WHO Position Papers - Recommendations for
Routine Immunization. http://www.who.int/immunization/policy/Immunization_
routine_table1.pdf?ua=1 (accesed 30.04.2018).
36. World Health Organization. Weekly epidemiological record, 23 February
2018. 93th Year, no. 8, 2018, 93, 73–96, http://www.who.int/wer, (accesed
28.04.2018).