Lietuviškai
Case No. 15/02
THE CONSTITUTIONAL COURT OF THE REPUBLIC OF
LITHUANIA
RULING
ON THE COMPLIANCE OF PARAGRAPH 4 (WORDING OF 4
JUNE 2002) OF ARTICLE 17 OF THE LAW ON
PHARMACEUTICAL ACTIVITIES WITH THE CONSTITUTION OF
THE REPUBLIC OF LITHUANIA
29 September 2005
Vilnius
The Constitutional Court of the Republic of Lithuania,
composed of the Justices of the Constitutional Court Armanas
Abramavičius, Egidijus Kūris, Kęstutis Lapinskas, Zenonas
Namavičius, Ramutė Ruškytė, Vytautas Sinkevičius, Stasys
Stačiokas, and Romualdas Kęstutis Urbaitis,
with the secretary of the hearing-Daiva Pitrėnaitė,
in the presence of:
the representative of a group of members of the Seimas of
the Republic of Lithuania, the petitioner, who was Raimondas
Šukys, a member of the Seimas,
the representative of the Seimas of the Republic of
Lithuania, the party concerned, who was Jurgita Meškienė, a
senior consultant to the Legal Department of the Office of the
Seimas,
pursuant to Articles 102 and 105 of the Constitution of
the Republic of Lithuania and Article 1 of the Law on the
Constitutional Court of the Republic of Lithuania, on 20
September 2005 in its public hearing heard Case No. 15/02 which
originated in a petition of a group of members of the Seimas of
the Republic of Lithuania, the petitioner, requesting to
investigate as to whether Article 8 of the Republic of
Lithuania Law on Amending Articles 1, 4, 5, 10, 11, 15, 17, 19,
20 of the Law on Pharmaceutical Activities and Supplementing It
With Articles 101 and 171 is not in conflict with Articles 25
and 46 of the Constitution of the Republic of Lithuania.
The Constitutional Court
has established:
I
A group of members of the Seimas, the petitioner, applied
to the Constitutional Court with a petition requesting to
investigate as to whether Article 8 of the Law on Amending
Articles 1, 4, 5, 10, 11, 15, 17, 19, 20 of the Law on
Pharmaceutical Activities and Supplementing It With Articles
101 and 171 (Official Gazette Valstybės žinios, 2002, No.
58-2348) is not in conflict with Articles 25 and 46 of the
Constitution.
II
The request of the petitioner is based on the following
arguments.
Upon amendment of Article 17 (wording of 4 July 2000) of
the Law on Pharmaceutical Activities, a prohibition was
established in Paragraph 4 of the said article to submit
information via radio and television about prescriptive
medicines and to advertise such medicines. It was also
prohibited to advertise prescriptive medicines by means of
electronic information media as well.
The petitioner asserts that under Paragraph 4 of Article
25 of the Constitution information about medicines can be
limited only when it is necessary to protect the health of the
human being, while a prohibition of absolute character to
submit information about prescriptive medicines is in conflict
with Paragraph 1 of Article 25 of the Constitution.
According to the petitioner, advertising can be limited
not only in the cases provided for by Article 25 of the
Constitution. In his opinion, in view of the fact that by means
of advertising one seeks to attain certain aims in economic
activity, in this case it is necessary to ground oneself upon
the provision "the law <...> shall protect freedom of fair
competition" of Paragraph 4 of Article 46 of the Constitution.
According to the petitioner, the prohibition to advertise
prescriptive medicines creates conditions to distort
competition in the market, since other medicines can be an
object of advertising and of other information. Therefore, in
the opinion of the petitioner, the prohibition of the aforesaid
advertising is in conflict with the Constitution.
III
In the course of the preparation of the case for the
hearing of the Constitutional Court, written explanations from
J. Meškienė, a senior consultant to the Legal Department of the
Office of the Seimas, were received.
It is maintained in the explanations of the representative
of the party concerned that the prohibition formulated in
Paragraph 4 of Article 17 of the Law on Pharmaceutical
Activities is applied to advertising of not any product, but of
prescriptive medicines. According to J. Meškienė, medicine is
not a merchandise whose acquisition and use should have to
depend upon the will of the acquirer (individual) only. The
choice of the medicine is an activity of specialists-doctors,
pharmacists-for which special knowledge is necessary. The most
varied data (health disorders for which the medicine in
question is to be used, dosage, counter indications for use of
the medicine, possible side effects etc.) which, as a rule, are
set down in the description of the medicine, constitute
information about the medicine. Taking account of the specific
character of the radio and television as public mass media,
there occur reasonable doubts whether it is possible to present
all the above-mentioned data by means of these media. The
representative of the party concerned thinks that the
prohibition to submit the information of such kind via radio or
television cannot be understood as an absolute one as
respective state institutions-the Medicine Information Centre,
the State Medicines Control Agency-doctors and other specials
of health care will continue submitting it and will publish it
in specialised periodicals etc.
According to J. Meškienė, Paragraph 3 of Article 25 of the
Constitution which provides that freedom to express
convictions, as well as to obtain and impart information, may
not be restricted other than by law, if it is necessary to
protect the health, honour and dignity, private life, and
morals of a human being, or to defend constitutional order,
virtually implies that freedom of information is not absolute,
nor that it is not subject to limitation. Freedom of
information can be subject to limitation but only by the law
and only in attempt to protect the values specified in
Paragraph 3 of Article 25 of the Constitution, which are the
right to health, dignity, private life and defence of
constitutional order.
According to J. Meškienė, in this situation freedom of
information, to be more precise, its specific
area-advertising-is related with the right of the person to
health. Having in mind the relation between these two rights,
the legislator, on the basis of Paragraph 3 of Article 25 of
the Constitution, may limit information about prescriptive
medicines. Such limitation is determined by the necessity to at
least minimally protect the consumers, their health, and
minors.
According to the representative of the party concerned,
prescriptive medicines and medicines sold without a
prescription are not identical goods from the point of view of
the Law on Pharmaceutical Activities, therefore, in this case,
application of different requirements cannot be regarded as
limitation on fair competition. Such interpretation would
distort the content and meaning of Paragraph 4 of Article 46 of
the Constitution and of respective provisions of the Law on
Competition and the Law on Pharmaceutical Activities.
In the opinion of J. Meškienė, the provisions of Article 8
of the Law on Amending Articles 1, 4, 5, 10, 11, 15, 17, 19, 20
of the Law on Pharmaceutical Activities and Supplementing It
With Articles 101 and 171 are not in conflict with the
Constitution.
IV
In the course of the preparation of the case for the
hearing of the Constitutional Court, written explanations were
received from D. Mikutienė, Chairwoman of the Seimas Committee
on Health Affairs, K. R. Dobrovolskis, Minister of Health Care
of the Republic of Lithuania, P. Koverovas, State Secretary of
the Ministry of Justice of the Republic of Lithuania, V.
Vadapalas, Director General of the European Law Department
under the Government of the Republic of Lithuania, J.
Rasimavičius, Acting Chairman of the Competition Council of the
Republic of Lithuania, S. J. Janonis, Director of the State
Patient Fund under the Ministry of Health Care of the Republic
of Lithuania, A. Mickys, Head of the Medicines Registration
Centre of the State Medicines Control Agency under the Ministry
of Health Care of the Republic of Lithuania, R. Pečiūra, Head
of the working group for drafting national medicines policy, L.
Akramas, President of the Institute of Pharmacy and Pharmacy
Market, E. Tarasevičius, President of the Lithuanian Pharmacy
Association, T. Birmontienė, Director of the Lithuanian Centre
for Human Rights, and E. Žiobienė, Director of the Lithuanian
Centre for Human Rights.
V
1. At the 20 September 2005 Constitutional Court hearing,
R. Šukys, the representative of the group of members of the
Seimas, reiterated the arguments set forth in the petition of
the petitioner and presented additional explanations concerning
the content and arguments of the petition of the petitioner.
2. At the 20 September 2005 Constitutional Court hearing,
J. Meškienė, the representative of the Seimas, the party
concerned, reiterated the arguments set forth in her written
explanations.
The Constitutional Court
holds that:
I
1. A group of members of the Seimas, the petitioner,
requests to investigate as to whether Article 8 of the Law on
Amending Articles 1, 4, 5, 10, 11, 15, 17, 19, 20 of the Law on
Pharmaceutical Activities and Supplementing It With Articles
101 and 171 is not in conflict with Articles 25 and 46 of the
Constitution.
2. On 4 June 2002, the Seimas adopted the Law on Amending
Articles 1, 4, 5, 10, 11, 15, 17, 19, 20 of the Law on
Pharmaceutical Activities and Supplementing It With Articles
101 and 171 by Article 8 whereof it amended Article 17 (wording
of 4 July 2000) of the Law on Pharmaceutical Activities and set
it forth in a new wording. The Law on Amending Articles 1, 4,
5, 10, 11, 15, 17, 19, 20 of the Law on Pharmaceutical
Activities and Supplementing It With Articles 101 and 171 went
into effect on 14 June 2002.
The Law on Pharmaceutical Activities was subsequently
amended and supplemented, however Paragraph 4 of Article 17
(wording of 4 July 2000) whereof was not amended and/or
supplemented.
3. Article 8 titled "Amendment of Article 17" of the Law
on Amending Articles 1, 4, 5, 10, 11, 15, 17, 19, 20 of the Law
on Pharmaceutical Activities and Supplementing It With Articles
101 and 171 provides:
"To amend Article 17 and to set it forth as follows:
'In the Republic of Lithuania only the medicines entered
into the state medicines register may be advertised.
The advertising of medicines must not be deceptive, it
must be objective; the information and terms employed must be
in line with the abstract of characteristics of the medicine
confirmed by the institutions which execute state registration
of medicines, while the information must objectively explain
the features of the medicine and induce its rational use.
Institutions of state governance and control as well as
municipal institutions are prohibited from advertising
medicines.
It shall be prohibited to advertise prescriptive medicines
and present information about them via radio and television.
Advertising of these medicines by means of electronic
information media shall also be prohibited.
In the advertisement directed to specialists of health
care, pharmacy and veterinary, advertising of both prescriptive
and non-prescriptive medicines is allowed. Advertising of
prescriptive medicines is allowed in the publications
designated to specialists only. The lists of such publications
shall be confirmed by the Government or an institution
authorised by it.
In the course of advertising samples of medicines which
are not for sale may be submitted only to the doctors who have
the right to prescribe medicines. The package of such medicine
must contain the note "Sample not for sale". Only one smallest
registered package of the medicine baring the same trade name,
form and strength of the medicine may be submitted to the
doctor. It shall be prohibited to distribute the samples of
medicines not for sale which contain substances entered into
the lists of narcotic and psychotropic substances confirmed by
the Minister of Health Care. It shall be prohibited to sell
samples of medicines which are not for sale.
In the advertising directed to residents only advertising
of non-prescriptive medicines together with indication of
necessary references is allowed. The content of the references
is established by the Ministry of Health Care.
In the advertising directed to residents it shall be
prohibited to advertise:
1) prescriptive medicines save the cases where the
manufacturers of the medicine, upon receiving a permit from the
Ministry of Health Care, carry out a programme of vaccination
of residents;
2) medicines which contain substances entered into the
list of narcotic and psychotropic substances confirmed by the
Minister of Health Care;
3) medicines (regardless of their strength or quantity in
the package) whose trade names are entered into the Priced
Catalogue of Basic Prices of Medicines Subject to Compensation
confirmed by the Ministry of Health Care.
In the course of advertising of medicines to residents it
shall be prohibited:
1) to name these therapeutical indications: tuberculosis,
sexually transmitted diseases, serious cancer and other tumour
diseases, chronic insomnia, diabetes and metabolism diseases;
2) to assert that scientists, specialists and other famous
people advise to use the medicine in question;
3) to present a concrete medical history, thus inducing
the residents to diagnose the disease themselves;
4) to assert in a deceptive way that the patient, if he
uses the medicine, will recover;
5) to employ deceptive terms and graphical material,
depicting changes in the body of the human being or an animal,
which are caused by the disease, injury or the medicine
advertised;
6) to present material directed to children;
7) to specify that the medicine is registered in the
Republic of Lithuania;
8) to distribute to residents samples of medicines which
are not for sale;
9) to indicate that doctor's advice, treatment or
operation prescribed by him are not necessary, especially in
cases where a concrete diagnosis is indicated or acquisition of
medicines by mail is proposed;
10) to indicate that using the medicine its therapeutic
effect is ensured and that there are no side effects;
11) to indicate that the medicine advertised is more
effective or as effective as other medicine or way of
treatment;
12) to indicate that if the medicine advertised is used,
one's health becomes better;
13) to indicate that if the medicine advertised is not
used, it may have negative effects upon one's health; this
provision is not applied when vaccination programmes are
carried out;
14) to indicate that the medicine is foodstuff, cosmetics
or other remedy which is widely used;
15) to indicate that the medicine is safe or effective
only because it is natural.
Other requirements to advertising of medicines, its
rendition and distribution of medicines not for sale, to
representatives of trade in medicine preparations and their
qualifications and activities shall be established by the
Minister of Health Care.
The supervision of advertising of medicines and control of
the requirements to advertising of medicines established in
this article shall be executed by the Ministry of Health Care
or an institution authorised by it.'"
4. Taking account of the fact that by Article 8 of the Law
on Amending Articles 1, 4, 5, 10, 11, 15, 17, 19, 20 of the Law
on Pharmaceutical Activities and Supplementing It With Articles
101 and 171, Article 17 (wording of 4 July 2000) of the Law on
Pharmaceutical Activities was amended and set forth in a new
wording, one is to hold that the petitioner requests to
investigate as to whether Article 17 (wording of 4 July 2000)
of the Law on Pharmaceutical Activities is not in conflict with
the Constitution.
5. Although the petitioner requests to investigate as to
whether entire Article 17 (wording of 4 July 2000) of the Law
on Pharmaceutical Activities is not in conflict with the
Constitution, it is clear from the arguments of the petition
(inter alia from the statement of the petitioner that upon
amendment of Article 17 (wording of 4 July 2000) of the Law on
Pharmaceutical Activities and upon establishing a prohibition
in Paragraph 4 of the said article to submit information via
radio and television about prescriptive medicines and to
advertise such medicines and upon prohibition to advertise
prescriptive medicines by means of electronic information
media) that the petitioner had doubts as to the compliance of
not entire Article 17 (wording of 4 July 2000) of the Law on
Pharmaceutical Activities, but only the compliance of Paragraph
4 of the same article with the Constitution.
6. The petitioner had doubts as to the compliance of
Paragraph 4 of Article 17 (wording of 4 July 2000) of the Law
on Pharmaceutical Activities with Article 25 of the
Constitution. Regardless of the fact that in the references to
Article 25 of the Constitution the petitioner mentions
expressis verbis Paragraphs 1 and 4 of this article (which are
not even cited), it is clear from the arguments of the
petitioner (inter alia from the statement of the petitioner
that information about medicines can be limited only when it is
necessary to protect the health of the human being) that the
petitioner had doubts whether Paragraph 4 of Article 17
(wording of 4 July 2000) of the Law on Pharmaceutical
Activities is not in conflict with not entire Article 25 of the
Constitution, but only with Paragraph 3 of the said article of
the Constitution, which provides that "freedom <...> to obtain
and impart information, may not be restricted other than by
law, if it is necessary to protect the health <...> of a human
being".
7. The petitioner had doubts as to the compliance of
Paragraph 4 of Article 17 (wording of 4 July 2000) of the Law
on Pharmaceutical Activities with Article 46 of the
Constitution. It is clear from the arguments of the petitioner
(inter alia from the indicated provision "the law <...> shall
protect freedom of fair competition" of Paragraph 4 of Article
46 of the Constitution) that the petitioner had doubts whether
Paragraph 4 of Article 17 (wording of 4 July 2000) of the Law
on Pharmaceutical Activities is not in conflict with not entire
Article 46 of the Constitution but only with the provision "the
law <...> shall protect freedom of fair competition" of
Paragraph 4 of the said article of the Constitution.
II
1. As mentioned, the petitioner had doubts as to whether
Paragraph 4 of Article 17 (wording of 4 July 2000) of the Law
on Pharmaceutical Activities is not in conflict with Paragraph
3 of Article 25 of the Constitution.
2. Article 25 of the Constitution provides:
"The human being shall have the right to have his own
convictions and freely express them.
The human being must not be hindered from seeking,
obtaining, and imparting information as well as ideas.
Freedom to express convictions, as well as to obtain and
impart information, may not be restricted other than by law, if
it is necessary to protect the health, honour and dignity,
private life, and morals of a human being, or to defend
constitutional order.
Freedom to express convictions and impart information
shall be incompatible with criminal actions-the instigation of
national, racial, religious, or social hatred, violence and
discrimination, slander and disinformation.
The citizen shall have the right to obtain any available
information which concerns him from State institutions in the
manner established by law."
3. The provisions of Article 25 of the Constitution
constitute the constitutional basis of freedom of information;
the constitutional freedom of information is inseparable from
the constitutional freedom of convictions and their expression
and is their pre-condition (Constitutional Court ruling of 19
September 2005). The constitutional freedom to seek, obtain,
and impart information as well as ideas unhindered is one of
the bases of an open, just and harmonious civil society and
state under the rule of law; the Constitution guarantees and
protects the interest of the society to be informed
(Constitutional Court rulings of 23 October 2002, 26 January
2004, 8 July 2005, and 19 September 2005). The implementation
of human rights and freedoms largely depends upon the
opportunities to obtain information from various sources of
information and to make use of it.
4. The constitutional concept of freedom of information is
especially broad, it encompasses freedom to seek, obtain and
impart most varied information. Information can also encompass
such knowledge by imparting which one strives to exert
influence upon the behaviour and choice of people, inter alia
to induce them to choose, acquire and/or use certain goods or
to use certain services or not to choose them. Dissemination of
such information is commonly referred to as advertising.
In the context of the constitutional justice case at
issue, one is to note that freedom of information entrenched in
the Constitution includes also freedom of advertising, inter
alia freedom to advertise goods and services.
All advertising is information; this is a peculiar type if
information. Advertising is an important means of competition
(Constitutional Court rulings of 13 February 1997 and 26
January 2004).
It needs to be noted that by means of advertising of goods
and services, irrespective of whether or not this activity is
charged, it is always sought to induce usage of certain goods
or services. In this context, it needs to be mentioned that
indirect inducement to use certain goods or certain services
(when it is done in a way so that the recipients of the
advertising cannot understand that they are receiving the
advertising information of such kind in particular) is to be
treated as covert advertising.
In the context of the constitutional justice case at
issue, it needs to be emphasised that also the information can
induce to use certain goods or services, in the course of
dissemination of which one does not seek to induce to do so
(e.g., statistical data, technical and other information, which
announce something, draw one's attention to something, etc.).
Under certain circumstances, dissemination of such information
can exert the same influence upon receivers of such information
as advertising, thus, in this respect, it can amount to
advertising.
It also must be emphasised that disseminated information
is not necessarily of only advertising or only of
non-advertising content: it can contain both elements of
advertising content and information whose dissemination is not
advertising.
5. Freedom of information is not absolute (Constitutional
Court rulings of 20 April 1995, 19 December 1996, 10 March
1998, 23 October 2002 and 26 January 2004).
5.1. The constitution concept of freedom of information
does not encompass war propaganda, nor does it encompass the
alleged freedom, which denies the constitutional values in
essence, to perpetrate the criminal actions specified in
Paragraph 4 of Article 25 of the Constitution, i.e. to
disseminate such thoughts, convictions, etc. by which one
instigates national, racial, religious, or social hatred,
violence and discrimination, by which persons are slandered or
where society or its individual members are disinformed
otherwise (Constitutional Court ruling of 19 September 2005).
In the context of the constitutional justice case at issue
one has especially to note that a duty to the legislator stems
from the Constitution to legislatively establish the legal
regulation which would permit to prevent dissemination of
disinformation. The constitutional concept of freedom of
advertising does not encompass disinformation, nor
dissemination of advertising which deliberately deceives the
consumers.
5.2. The Constitution defines the limits of implementation
of freedom of information.
5.2.1. For instance, under Article 28 of the Constitution,
in exercising rights and freedoms, thus, also the freedom of
information, the human being must observe the Constitution and
the laws of the Republic of Lithuania and must not impair the
rights and freedoms of other people. Under Article 145 of the
Constitution, freedom of information may be temporarily
restricted after martial law or a state of emergency is
imposed.
5.2.2. In the context of the constitutional justice case
at issue one has especially to note that the Constitution
provides for a possibility to limit freedom of information, if
it is necessary to protect the health, honour and dignity,
private life, and morals of a human being, or to defend
constitutional order, i.e. if by means of restriction of
freedom of information one seeks to protect and defend the
values specified in Paragraph 3 of Article 25 of the
Constitution. In its ruling of 19 September 2005, the
Constitutional Court emphasised that the list of the
constitutional values enumerated in Paragraph 3 of Article 25
of the Constitution cannot be construed as a thorough and final
one, i.e., as not permitting to limit freedom to obtain and
impart information in cases where it is necessary to protect
other constitutional values, which are not mentioned expressis
verbis in Paragraph 3 of Article 25 of the Constitution.
It needs to be emphasised that the legal regulation
defining the limits on the implementation of freedom of
information must be established only by means of a law. Under
Paragraph 3 of Article 25 of the Constitution, the legislator
must, by means of a law, define the content of the information
the dissemination of which is either prohibited or limited, as
well as the ways by means of which dissemination of certain
information is prohibited, as well as other conditions of
dissemination of corresponding information if this in any
manner limits freedom of information. The legislator also must,
by means of a law, establish: liability for disregard of the
said prohibitions and limitations, including that for
dissemination of information the dissemination of which is
prohibited; entities which enjoy powers to supervise the
observance of the prohibitions and/or limitations, which are
established by laws, to disseminate certain information;
entities which apply liability for disregard of the
prohibitions and/or limitations, which are established by laws,
to disseminate certain information; efficient measures of
judicial protection of freedom of information (Constitutional
Court ruling of 19 September 2005).
The Constitution does not prevent regulation of certain
relations linked with obtaining and dissemination of
information, including the relations linked with supervision
and control of the prohibitions, established by means of laws,
to disseminate information and/or limitations on dissemination
of information also by substatutory legal acts, however, the
substatutory legal acts by which the aforesaid relations are
regulated cannot establish any such legal regulation which is
not based on the Constitution and laws, nor any such legal
regulation which competes with that established by laws
(Constitutional Court ruling of 19 September 2005).
Along with the requirement to establish limitations upon
freedom of information only by means of a law, also other
requirements stem from the Constitution, which must be paid
heed to in the course of limiting the constitutional freedom of
information. In this context, it needs to be emphasised that,
as it has been held by the Constitutional Court in its rulings
many a time, under the Constitution it is permitted to limit,
by means of a law, human rights and freedoms, thus also
including freedom of information, if the following conditions
are followed: the limitations are necessary in a democratic
society in order to protect the rights and freedoms of other
persons and values entrenched in the Constitution as well as
constitutionally important objectives; the limitations do not
deny the nature of the rights and freedoms, nor their essence;
one follows the constitutional principle of proportionality.
In this context it needs to be noted that, as it was held
in the Constitutional Court ruling of 13 December 2004, when
setting legal restrictions and liability for violations of law,
one must pay heed to the requirement of reasonableness and the
principle of proportionality, according to which the
established legal measures are to be necessary in a democratic
society and suitable for achieving legitimate and universally
important objectives (there must be a balance between the
objectives and measures), they may not restrict the rights of
the person more than it is necessary in order to achieve the
said objectives, and if these legal measures are related to the
sanctions for the violation of law, in such case the
aforementioned sanctions must be proportionate to the committed
violation of law.
The principle of a state under the rule of law
consolidated in the Constitution inter alia implies that the
legal regulation established in laws and other legal acts must
be clear, easy to understand, consistent, formulas in the legal
acts must be explicit, consistency and internal harmony of the
legal system must be ensured, the legal acts may not contain
any provisions, which at the same time regulate the same public
relations in a different manner (Constitutional Court ruling of
13 December 2004). Otherwise, opportunities to subjects of law
to learn what law demands would be worsened.
One must pay heed to the said requirements which stem from
the Constitution also when one limits freedom of advertising by
means of laws.
6. It has been mentioned that, under Paragraph 3 of
Article 25 of the Constitution, freedom of information can be
limited by law if it is necessary to protect the health of a
human being. Thus, on the said grounds freedom of advertising
may be limited as well.
6.1. Paragraph 1 of Article 53 of the Constitution
provides that the state shall look after the health of the
people and shall guarantee medical aid and services for the
human being in the event of sickness, also that the procedure
for providing medical aid to citizens free of charge at state
medical establishments shall be established by law. While
construing these provisions of the Constitution, the
Constitutional Court has held that the health of a human being
and of society is one of the most important values of society
(Constitutional Court ruling of 11 July 2002), also that
protection of people's health is a constitutionally important
objective, a public interest, while looking after people's
health is to be treated as a state function (Constitutional
Court rulings of 14 January 2002 and 26 January 2004).
6.2. When one is seeking to protect people's health, a
constitutional value, freedom of information (which, as
mentioned, inter alia encompasses freedom of advertising) may
also be limited to a certain extent by means of a law. However,
such limitation of this constitutional freedom must be
necessary in a democratic society, while the chosen measures
must be proportionate to the objective sought.
It needs to be noted that the legislator, when he limits,
by means of a law, freedom of advertising (alongside, that of
information) so that people's health might be protected, must
establish the legal regulation so that a reasonable balance
could be maintained between the obligation to the state,
established in the Constitution, to look after people's health
and the constitutional right of a human being to seek, obtain
and impart information. Information, also that of advertising
content, cannot be limited only due to the fact that, in the
opinion of the legislator, it is not useful to the people,
although it is not harmful to them. It must also be noted that
selective limitation of advertising, i.e. limitation upon its
dissemination and/or obtaining by means of certain sources and
non-limitation upon its dissemination and/or obtaining by means
of other sources is permissible only when such differentiation
is objectively justifiable. Especially, one is to note that
limitations upon freedom of advertising established by laws
cannot, under the Constitution, be bigger than it is necessary
inter alia to protect the health of a human being.
7. In the context of the constitutional justice case at
issue, it also needs to be noted that advertising of medicines
(irrespective of whether or not this activity is charged) it is
always sought to induce usage of respective medicines, while
this can create preconditions to make harm to people's health-a
value that is consolidated in, and protected and defended by
the Constitution. Such effects can be caused also by deceptive
information (of both advertising and non-advertising content)
about medicines, which, in some cases can amount to
disinformation whose dissemination, as mentioned, is not
covered by the constitutional concept of freedom of
advertising.
Under the Constitution, the legislator has a duty to
establish, by means of a law, the legal regulation which could
prevent dissemination of information (of both advertising and
non-advertising content) about medicines as well as other
information about medicines, which might create preconditions
to make harm to people's health. Under the Constitution, the
legislator has also a duty to establish, by means of a law, the
legal regulation which could prevent dissemination of deceptive
information (of both advertising and non-advertising content)
about medicines as well as other information about medicines,
which might create preconditions to make harm to people's
health. By establishing, by means of a law, the said
constitutionally necessary legal regulation, the legislator
must also establish efficient ways of control of advertising of
medicines as well as that of other information about medicines,
which might create preconditions to make harm to people's
health. In this context one must pay attention to that fact
that in foreign democratic states various ways of efficient
control of information about medicines (inter alia advertising
of medicines) whose dissemination might create preconditions to
make harm to people's health are established, as, for example:
preliminary check up of information disseminated by mass media,
limitations upon dissemination of such information, powers of
state institutions to resort to actions so that dissemination
of such information (inter alia of deceptive advertising) could
be discontinued, etc.
It has been mentioned that the Constitution does not
prevent regulation of certain relations linked with obtaining
and dissemination of information, including the relations
linked with supervision and control of the prohibitions,
established by means of laws, to disseminate information and/or
limitations on dissemination of information also by
substatutory legal acts, however, the substatutory legal acts
cannot establish any such legal regulation which is not based
on the Constitution and laws, nor any such legal regulation
which competes with that established by laws.
In the context of the constitutional justice case at issue
it needs to be emphasised that by means of a law one must
establish the main elements of limitations upon advertising of
medicines as well as upon other information about medicines,
whose dissemination can create preconditions to make harm to
people's health, as, for instance: what information about
medicines (inter alia advertising of medicines) is subject to
limitation or subject to prohibition altogether; the ways of
limitation of the said information (advertising) and/or
conditions of its dissemination; the extent (amount) of
prohibitions; the criteria according to which medicines are
attributed to such whose advertising can create preconditions
to make harm to people's health and, due to this, is subject to
limitation or subject to prohibition altogether; the subjects,
who enjoy powers to supervise how one observes the prohibitions
and/or limitations to disseminate corresponding information,
which are established in laws; the liability for disregard of
the aforesaid requirements which are established by laws; the
subjects who enjoy powers to hold someone liable for respective
violations of laws; effective measures of judicial defence of
freedom of advertising, etc.
8. It has been mentioned that the petitioner had doubts
whether Paragraph 4 of Article 17 (wording of 4 July 2000) of
the Law on Pharmaceutical Activities is not in conflict with
the provision "the law <...> shall protect freedom of fair
competition" of Paragraph 4 of Article 46 of the Constitution.
9. In the context of the constitutional justice case at
issue, the provision "the law <...> shall protect freedom of
fair competition" of Paragraph 4 of Article 46 of the
Constitution is to be construed while relating it to the
provision "the state shall regulate economic activity so that
it serves the general welfare of the Nation" of Paragraph 3 of
Article 46 of the Constitution.
In its ruling of 13 May 2005, the Constitutional Court
held that not only the right but also the obligation of the
state to regulate economic activity by legal acts so that it
serves the general welfare of the Nation is consolidated in the
provision "the State shall regulate economic activity so that
it serves the general welfare of the Nation" of Paragraph 3 of
Article 46 of the Constitution; the obligation of the state to
seek the general welfare of the Nation and the obligation of
the state to regulate, while seeking the general welfare of the
Nation, to regulate the economic activity in this country are
entrenched in the Constitution. The Constitutional Court has
also held that the welfare of the Nation may not be understood
only in material (financial) sense and that hardly would it be
fair and moral to seek material welfare in such a way which is
harmful to people's health (Constitutional Court rulings of 13
February 1997 and 13 May 2005); the content of the notion "the
general welfare of the Nation" is revealed in every particular
case when one takes account of economic, social and other
important factors (Constitutional Court rulings of 6 October
1999, 18 October 2000, 26 January 2004, and 13 May 2005).
10. It has been mentioned that the health of a human being
and of society is one of the most important values of society,
that protection of people's health is a constitutionally
important objective, a public interest, while looking after
people's health is a state function. Therefore, the limitation
of economic activity whereby one seeks to protect people's
health is to be treated as one designated to ensure the general
wealth of the Nation and, in itself, if requirements arising
from the Constitution are paid heed to, is not to be held as
violating the Constitution.
11. Under the Constitution, the state must regulate
economic activity so that the implementation of the state
function to look after people's health might be ensured.
Therefore, the state, while regulating economic activity by
laws and while paying heed to the Constitution, may establish
specific limitations upon the economic activity, which is inter
alia related with protection of people's health, including
advertising of medicines as well as other information about
medicines whose dissemination can create preconditions to make
harm to people's health.
In this context one is also to mention the fact that, as
it was held by the Constitutional Court in its ruling of 13
February 1997, restriction of advertising is one of the ways
applied to reduce the unrestricted promotion and consumption of
materials which are harmful to people's health.
In the context of the constitutional justice case at
issue, it needs to be noted that the legislator must
legislatively establish such legal regulation so that there
should not occur any preconditions to induce uncontrolled use
of medicines, which might make damage to people's health.
12. In the context of the constitutional justice case at
issue, it needs to be noted that the legislator enjoys broad
discretion to choose how, while taking account of the fact that
certain medicines can make harm to people's health and
dissemination of information about them can create
preconditions for making harm to people's health, to
differentiate the legal regulation of acquisition of medicines,
their circulation and use, as well as of dissemination of
information about medicines (including advertising of
medicines). One of the grounds of differentiation made by the
legal regulation (which is widespread all over the world) is
grouping of medicines into prescriptive and non-prescriptive,
where certain medicines, i.e. prescriptive ones, due to the
fact that their unrestricted acquisition, circulation and use
can create preconditions to make harm to people's health may be
acquired, be in circulation and be used only by doctors'
prescriptions, while acquisition, circulation and use of other,
non-prescriptive medicines are not restricted. The attribution
of certain medicines (their groups) to prescriptive or
non-prescriptive ones and prescription of medicines to patients
is a matter of professional competence of the specialist from a
corresponding area.
In the context of the constitutional justice case at
issue, it needs to be noted that the said grouping of medicines
into prescriptive and non-prescriptive ones may be (and
actually is) one of the main grounds to differentiate by the
law the legal regulation of relations related to dissemination
of information about medicines (inter alia advertising of
medicines).
III
1. There are two prohibitions consolidated in Paragraph 4
(wording of 4 July 2002) of Article 17 of the Law on
Pharmaceutical Activities: (1) regarding advertising of
prescriptive medicines via radio and television and by means of
electronic information media; (2) regarding presentation of
information about prescriptive medicines via radio and
television.
2. While deciding whether Paragraph 4 (wording of 4 July
2002) of Article 17 of the Law on Pharmaceutical Activities,
which is disputed by the petitioner and which provides that
advertising of prescriptive medicines by means of electronic
information media shall be prohibited and information about
prescriptive medicines via radio and television shall be
prohibited, is not in conflict with the Constitution, one must
elucidate the content of the notion of advertising as used in
this paragraph.
It needs to be noted that in the Law on Pharmaceutical
Activities the notion of advertising is not defined; it is to
be construed on the basis of how it is defined in other laws.
2.1. On 9 May 1989, the Council of Europe adopted the
European Convention on Transfrontier Television (hereinafter
also referred to as the Convention). By Article 1 of the
Republic of Lithuania Law "On Ratifying the European Convention
on Transfrontier Television and the Amendments Protocol to this
Convention" adopted on 17 February 2000, the Seimas ratified
the Convention; for Lithuania it became effective on 1 January
2001. Article 4 of the amendments protocol of the Convention
defines advertising as "any public announcement in return for
payment or similar consideration or for self-promotional
purposes, which is intended to promote the sale, purchase or
rental of a product or service, to advance a cause or idea, or
to bring about some other effect desired by the advertiser or
the broadcaster itself".
2.2. Paragraph 7 of Article 2 of the Republic of Lithuania
Law on Advertising, which was adopted by the Seimas on 18 July
2000 and which went into effect (with established exceptions)
on 1 January 2001, defines advertising as "information
disseminated in any form and by any means which is related with
the commercial-economic, financial or professional activity of
the person, in order to induce to acquire goods or make use of
services, including acquisition of real property and takeover
of property rights and obligations".
2.3. By Article 1 of the Republic of Lithuania Law on
Amending the Law on the Provision of Information to the Public,
which was adopted by the Seimas on 29 August 2000 and which
went into effect on 1 October 2000, the Republic of Lithuania
Law on the Provision of Information to the Public was set forth
in a new wording. Paragraph 24 (wording of 29 August 2000) of
Article 2 of the Law on the Provision of Information to the
Public defined advertising as "information disseminated by
producers of public information and/or disseminators for a
certain fee or other similar payment, which is ordered by a
person who is related to a commercial, economic or professional
activity, for the purpose of self-advertising or in order to
induce to buy goods or make use of services, including
acquisition of real property and takeover of property rights
and obligations."
By Article 2 of the Republic of Lithuania Law on Amending
and Supplementing Articles 1, 2, 23, 24, 29, 31, 32, 33, 35,
38, 39, 47, 48, 49, 51, 53 of Law on the Provision of
Information to the Public and Recognition of Articles 25 and 41
Thereof as No Longer Valid and Supplementing Article 56 and an
Annex Thereto, which was adopted on 27 April 2004 and went into
effect on 1 May 2004, Article 2 (wording of 29 August 2000) of
the Law on the Provision of Information to the Public was
amended and set forth in a new wording. Article 2 (wording of
27 April 2004) defines advertising as "information disseminated
in any form and by any means which is related with the
commercial-economic, financial or professional activity of the
person, in order to induce to acquire goods or make use of
services, including acquisition of real property and takeover
of property rights and obligations".
2.4. Thus the Convention, the Law on Advertising and the
Law on the Provision of Information to the Public present
different definitions of advertising. However, all the
aforementioned legal acts point out the main feature of
advertising-advertising is information which seeks to promote
sales or to induce one to acquire goods or make use of
services.
3. Paragraph 4 (wording of 4 July 2002) of Article 17 of
the Law on Pharmaceutical Activities, which is disputed by the
petitioner, is to be construed in the context of Paragraphs 5
and 8 of this article.
Under Paragraph 8 (wording of 4 July 2002) of Article 17
of the Law on Pharmaceutical Activities, in the advertising
directed to residents it shall be prohibited to advertise
prescriptive medicines save the cases where the manufacturers
of the medicine, upon receiving a permit from the Ministry of
Health Care, carry out a programme of vaccination of residents
(Item 1). The fact must also be mentioned that, under the same
paragraph, in the advertising directed to residents it shall be
prohibited to advertise medicines which contain substances
entered into the list of narcotic and psychotropic substances
confirmed by the Minister of Health Care (Item 2), as well as
medicines (regardless of their strength or quantity in the
package) whose trade names are entered into the Priced
Catalogue of Basic Prices of Medicines Subject to Compensation
confirmed by the Ministry of Health Care (Item 3).
Paragraph 5 (wording of 4 July 2002) of Article 17 of the
Law on Pharmaceutical Activities provides: "In the
advertisement directed to specialists of health care, pharmacy
and veterinary, advertising of both prescriptive and
non-prescriptive medicines is allowed. Advertising of
prescriptive medicines is allowed in the publications
designated to specialists only. The lists of such publications
shall be confirmed by the Government or an institution
authorised by it."
While construing the legal regulation of the relations of
advertising of medicines and of information about medicines,
which are established in the Law on Pharmaceutical Activities,
in a systemic manner, one is to hold that, under this law, it
is prohibited to advertise, by all means of information (inter
alia in publications, by radio and television and electronic
information media), prescriptive medicines as well as medicines
(regardless of whether or not they are attributed to
prescriptive ones) which contain substances entered into the
list of narcotic and psychotropic substances confirmed by the
Minister of Health Care as well as medicines (regardless of
whether or not they are attributed to prescriptive ones and
irrespective of their strength or quantity in the package)
whose trade names are entered into the Priced Catalogue of
Basic Prices of Medicines Subject to Compensation confirmed by
the Ministry of Health Care, save the exceptions specified in
the Law on Pharmaceutical Activities itself: (1) advertising of
prescriptive medicines to residents is permitted in all
information media cases where the manufacturers of the
medicines, upon receiving a permit from the Ministry of Health
Care, carry out a programme of vaccination of residents; (2)
advertising of prescriptive medicines, save the medicines which
contain substances entered into the list of narcotic and
psychotropic substances confirmed by the Minister of Health
Care as well as medicines, is permitted in the publications
designated to specialists only. Besides, any information about
prescriptive medicines on radio and television, thus, also the
information which is not advertising, are prohibited.
Information about non-prescriptive medicines nor their
advertising is not prohibited.
It must be emphasised that the prohibitions which are
consolidated in Paragraph 4 of Article 17 (wording of 4 June
2002) of the Law on Pharmaceutical Activities to advertise
prescriptive medicines on radio and television and by means of
electronic information media and present information about
prescriptive medicines on radio and television cannot be
construed as ones denying the exceptions specified in this law.
4. Paragraph 4 of Article 17 (wording of 4 June 2002) of
the Law on Pharmaceutical Activities, which is disputed by the
petitioner, is also to be construed in the context of legal
regulation established in other laws, as well.
4.1. Under Article 6 of the Republic of Lithuania Law on
the Control of Narcotic and Psychotropic Substances, which was
adopted by the Seimas on 8 January 1998 and which went into
effect on 23 January 1998, advertisement of narcotic and
psychotropic substances shall be prohibited. Information
regarding drugs that are narcotic and psychotropic substances
shall be provided to health care, pharmaceutical and veterinary
specialists and consumers, according to the procedure
established by the Ministry of Health. Paragraph 1 of Article 2
of the same law defines narcotic and psychotropic substances as
"the biological and synthetic substances included in the lists
of controlled substances, approved by the Ministry of Health,
the harmful effects or misuse whereof give rise to serious
deterioration of human health, marked by mental and physical
dependence on them, or pose danger to human health".
Thus, the Law on the Control of Narcotic and Psychotropic
Substances treats narcotic and psychotropic substances as those
which cause harmful effects and which give rise to negative
consequences-dependence on narcotic and psychotropic substances
and/or danger to human health; advertising of these substances
(regardless of whether or not they are contained in certain
medicines) is prohibited to all subjects: consumers,
specialists and persons who produce, supply these substances
and/or medicines (which contain such substances), trade in
them, etc. alike. Dissemination of information about the
medicines which are narcotic and psychotropic substances is
also restricted: such information may be submitted only to
specialists of health care, pharmacy and veterinary and
consumers under the procedure established by the Ministry of
Health Care. Such procedure has not been established yet.
4.2. Paragraph 1 of Article 57 of the Law on the Health
System provides that in the Republic of Lithuania the
advertising of goods, products and services which may have a
detrimental effect on health shall be prohibited and the
procedure for restricting or prohibiting the advertising of the
above goods, products and services shall be established by laws
and other legal acts, while Paragraph 3 of the same article
provides that the peculiarities of restricting the advertising
of medicines shall be specified by the Law on Pharmaceutical
Activities.
4.3. Paragraph 3 of Article 1 (wording of 18 July 2000) of
the Law on Advertising used to provide that given other
Republic of Lithuania laws establish additional or other
requirements or prohibitions in the use of advertising, the
provisions of those laws shall apply, and given the
international treaties of the Republic of Lithuania establish
other requirements in the use of advertising, the provisions of
those treaties shall prevail. Similar provisions are
established in Paragraph 3 (wording of 3 December 2002) of
Article 1 of the Law on Advertising: "Given other Republic of
Lithuania laws establish additional or other requirements in
the use of advertising, or establish other procedure for the
control of the use of advertising or liability of entities of
advertising activity, the provisions of those laws shall apply.
Given the international treaties of the Republic of Lithuania
establish other requirements in the use of advertising, the
provisions of those treaties shall prevail."
Under Article 10 (wording of 18 July 2000) of the Law on
Advertising, this law and the Law on Provision of Information
to the Public shall set forth the requirements of advertising
in television programmes.
Thus, when construing the aforementioned provisions of the
Law on Advertising, in a systemic manner, one is to hold that
it established the stipulation to follow the requirements which
are established not only by the Law on Advertising and the Law
on Provision of Information to the Public, but also other laws,
inter alia the Law on Pharmaceutical Activities.
4.4. It was established in Paragraph 9 of Article 39
(wording of 29 August 2000) of the Law on Provision of
Information to the Public that it shall be prohibited to
advertise in the mass media, except special publications or
broadcasts, medicines and treatment with medicines available
only on prescription; advertising of other medicines or
treatment with medicines must be readily recognisable and must
warn the public about possible harmful effects through
incorrect use. Virtually, the same provision (by replacing the
word "readily" with the word "clearly" and by replacing the
word "incorrect" with the word "improper") is established in
Paragraph 9 of Article 39 (wording of 27 April 2004) of the Law
on Provision of Information to the Public.
4.5. Under Paragraph 3 of Article 15 of the European
Convention on Transfrontier Television, advertising for
medicines and medical treatment which are only available on
medical prescription shall not be allowed.
Thus, the Convention prohibits advertising of not only
medicines which are only available on medical prescription, but
also medical treatment which is only available on medical
prescription.
5. It needs to be mentioned that Paragraph 4 (wording of 4
July 2002) of Article 17 of the Law on Pharmaceutical
Activities, which is disputed by the petitioner and which
provides that advertising of prescriptive medicines by means of
electronic information media shall be prohibited and
information about prescriptive medicines via radio and
television shall be prohibited, is related to Paragraphs 6 and
7 of Article 171 (wording of 4 June 2002). Paragraph 6 of
Article 171 (wording of 4 June 2002) of the Law on
Pharmaceutical Activities provides for liability for inter alia
advertising of prescriptive medicines by means of electronic
information media (advertising of prescriptive medicines by
means of electronic information media shall incur a fine from
one thousand to ten thousand litas to entities of advertising
activity), while Paragraph 7 thereof provides for liability for
advertising of narcotic and psychotropic medicines carried out
in violation of the requirements of the Law on Pharmaceutical
Activities (advertising of narcotic and psychotropic medicines
in violation of the said requirements shall incur a fine from
five thousand to twenty thousand litas to entities of
advertising activity). However, it must be emphasised that
although fines are established to entities of advertising
activity for disregard of the established prohibition to
advertise prescriptive medicines by means of electronic
information media, also for advertising of narcotic and
psychotropic medicines in violation of the requirements of the
Law on Pharmaceutical Activities, neither the Law on
Pharmaceutical Activities nor any other laws establish the
subjects empowered to adopt decisions concerning imposition of
fines specified in the Law on Pharmaceutical Activities. No
legal acts establish a procedure for imposition of the said
fines, either. Thus, one is to hold that inter alia the
prohibitions regarding advertising of narcotic and psychotropic
medicines and information about prescriptive and narcotic and
psychotropic medicines established in Paragraph 4 (wording of 4
July 2002) of Article 17 of the Law on Pharmaceutical
Activities and other laws are somewhat declarative.
6. The discussed legal regulation established in the
articles (parts thereof) of the Law on Pharmaceutical
Activities and other laws, which are not disputed by the
petitioner, is not a matter of investigation in this
constitutional justice case.
7. As mentioned, grouping of medicines into prescriptive
and non-prescriptive means that, prescriptive medicines (due to
the fact that their unrestricted acquisition, circulation and
use can create preconditions to make harm to people's health)
may be acquired, be in circulation and be used only by doctors'
prescriptions, while acquisition, circulation and use of
non-prescriptive medicines are not restricted, also that
grouping of medicines into prescriptive and non-prescriptive is
one of the main grounds to differentiate by the law the legal
regulation of relations related to dissemination of information
about medicines (inter alia advertising of medicines). In
addition, it was mentioned that the attribution of certain
medicines (their groups) to prescriptive or non-prescriptive
ones and prescription of medicines to patients is a matter of
professional competence of the specialist from a corresponding
area. On the other hand, it was held in this Ruling of the
Constitutional Court that the criteria according to which
medicines are attributed to such whose advertising can create
preconditions to make harm to people's health and, due to this,
is subject to limitation or subject to prohibition altogether
must be established by means of a law; substatutory legal acts
cannot establish any such legal regulation which is not based
on the Constitution and laws, nor any such legal regulation
which competes with that established by laws.
7.1. It needs to be noted that the Law on Pharmaceutical
activities does not establish any clear criteria according to
which medicines either are or are not attributed to
prescriptive medicines; nor does it establish any clear
criteria according to which medicines are attributed to such
whose advertising can create preconditions to make harm to
people's health and due to this their advertising is either
restricted or prohibited altogether.
7.2. At present the criteria according to which medicines
are grouped into prescriptive and non-prescriptive ones are
established in the General Rules for Registration of Medical
Preparations (wording of 24 May 2004) confirmed by Order of the
Minister of Health Care No. 669 "On Confirming the General
Rules for Registration of Medical Preparations" of 22 December
2001, although such criteria must be established by a law.
Item 31 (wording of 24 May 2004) of the said rules
provides that at the time of registering, medicines are
classified as prescriptive (and their sub-groups) and
non-prescriptive according to the Criteria of Classification of
Medical Preparations confirmed in Annex 7. Under Item 2 of
Annex 7 to the General Rules for Registration of Medical
Preparations, medicines that correspond to at least one of the
following criteria are attributed to prescriptive medical
preparations: (1) if used without a doctor's supervision (even
though if the instructions are followed), they can pose direct
or indirect danger to one's health; (2) if used often or
improperly to large extent, and thus can pose direct or
indirect danger to one's health; (3) they contain substances or
compositions thereof whose effect and/or undesirable reactions
want further investigation; (4) they are used by parenteral
way.
IV
1. In the context of the constitutional justice case at
issue, it needs to be mentioned that in documents of the World
Health Organisation (23 May 1998 resolution WHA21.41
(Pharmaceutical Advertising), 13 May 1988 resolution WHA41.17
(Ethical Criteria for Medicinal Drug Promotion) etc.)
prescriptive medicines are treated as special products which
can pose danger to human health, while in some cases-even to
one's life.
2. It also needs to be noted that limitations on
advertising of prescriptive medicines and of narcotic and
psychotropic medicines are established in acts of European
Union law as well.
On 6 November 2001, the European Parliament and the
Council adopted Directive 2001/83/EC on the Community code
relating to medicinal products for human use which regulates
inter alia classification of medicines and advertising of
prescriptive medicines. The said directive of the European
Parliament and of the Council went into effect on 18 December
2001.
On 31 March 2004, the European Parliament and the Council
adopted Directive 2004/27/EC Amending Directive 2001/83/EC on
the Community code relating to medicinal products for human
use. The said directive of the European Parliament and of the
Council went into effect on 30 April 2004.
Title VIII of the 6 November 2001 European Parliament and
the Council Directive 2001/83/EC on the Community code relating
to medicinal products for human use, which was in part amended
by the 31 March 2004 European Parliament and the Council
Directive 2004/27/EC Amending Directive 2001/83/EC on the
Community code relating to medicinal products for human use, is
designed for legal regulation of advertising of medicines. It
shall be prohibited to advertise to the general public
medicinal products which are available on medical prescription
only, and which contain psychotropic or narcotic substances,
such as the United Nations Conventions of 1961 and 1971
(Article 88). Medicinal products shall be subject to medical
prescription where they: are likely to present a danger either
directly or indirectly, even when used correctly, if utilized
without medical supervision, or are frequently and to a very
wide extent used incorrectly, and as a result are likely to
present a direct or indirect danger to human health, or contain
substances or preparations thereof, the activity and/or adverse
reactions of which require further investigation, or are
normally prescribed by a doctor to be administered parenterally
(Paragraph 1 of Article 71). Where Member States provide for
the sub-category of medicinal products subject to special
medical prescription, they shall take account of the following
factors: the medicinal product contains, in a non-exempt
quantity, a substance classified as a narcotic or a
psychotropic substance within the meaning of the international
conventions in force, such as the United Nations Conventions of
1961 and 1971, or the medicinal product is likely, if
incorrectly used, to present a substantial risk of medicinal
abuse, to lead to addiction or be misused for illegal purposes,
or the medicinal product contains a substance which, by reason
of its novelty or properties, could be considered as belonging
to the group envisaged in the second indent as a precautionary
measure (Paragraph 2 of Article 71). The competent authorities
may fix sub-categories for medicinal products which are
available on medical prescription only. In that case, they
shall refer to the following classification: (a) medicinal
products on renewable or non-renewable medical prescription;
(b) medicinal products subject to special medical prescription;
(c) medicinal products on restricted medical prescription,
reserved for use in certain specialized areas (Paragraph 2 of
Article 70). Where Member States provide for the sub-category
of medicinal products subject to restricted prescription, they
shall take account of the following factors: the medicinal
product, because of its pharmaceutical characteristics or
novelty or in the interests of public health, is reserved for
treatments which can only be followed in a hospital
environment, the medicinal product is used in the treatment of
conditions which must be diagnosed in a hospital environment or
in institutions with adequate diagnostic facilities, although
administration and follow-up may be carried out elsewhere, or
the medicinal product is intended for outpatients but its use
may produce very serious adverse reactions requiring a
prescription drawn up as required by a specialist and special
supervision throughout the treatment (Paragraph 3 of Article
71). If a competent authority does not designate medicinal
products into sub-categories referred to in Article 70(2), it
shall nevertheless take into account the criteria referred to
in paragraphs 2 and 3 of this Article in determining whether
any medicinal product shall be classified as a
prescription-only medicine (Paragraph 5 of Article 71).
The 6 November 2001 European Parliament and the Council
Directive 2001/83/EC on the Community code relating to
medicinal products for human use, which was in part amended by
the 31 March 2004European Parliament and the Council Directive
2004/27/EC Amending Directive 2001/83/EC on the Community code
relating to medicinal products for human use also obligates
Member States to establish penalties for inter alia disregard
of the prohibition to advertise prescriptive medicines: for
instance, Article 99 provides that Member States shall take the
appropriate measures to ensure that the provisions of Title
VIII are applied and shall determine in particular what
penalties shall be imposed should provisions adopted in the
execution of this Title be infringed.
3. In the context of the constitutional justice case at
issue one is also to mention the jurisprudence of the European
Court of Human Rights which (as it was held in Constitutional
Court rulings many a time) as a source of construction of law
is also important to construction and application of Lithuanian
law. For example, in the case Sunday Times v. United Kingdom
(Judgment in the case of Sunday Times v. United Kingdom of 26
April 1979, series A No. 30) in which it was decided whether
due to the fact that United Kingdom courts, upon a request of a
pharmaceutical company, issued an injunction restraining
publication of articles about a drug which had inflicted harm
on the health of the people that had used it, Article 10 of the
Convention for the Protection of Human Rights and Fundamental
Freedoms had not been violated, Paragraph 1 whereof provides
that everyone has the right to freedom of expression, that this
right shall include freedom to hold opinions and to receive and
impart information and ideas without interference by public
authority and regardless of frontiers, and that this article
shall not prevent states from requiring the licensing of
broadcasting, television or cinema enterprises, while Paragraph
2 provides that the exercise of these freedoms, since it
carries with it duties and responsibilities, may be subject to
such formalities, conditions, restrictions or penalties as are
prescribed by law and are necessary in a democratic society, in
the interests of national security, territorial integrity or
public safety, for the prevention of disorder or crime, for the
protection of health or morals, for the protection of the
reputation or rights of others, for preventing the disclosure
of information received in confidence, or for maintaining the
authority and impartiality of the judiciary, the European Court
of Human Rights recognised that the disputed injunction was not
necessary in a democratic society, since the respective medical
drug had caused negative effects and the society enjoyed the
right to know about the effect of the drug.
V
On the compliance of Paragraph 4 (wording of 4 July 2002)
of Article 17 of the Law on Pharmaceutical Activities with
Paragraph 3 of Article 25 of the Constitution.
1. As mentioned, there are two prohibitions consolidated
in Paragraph 4 (wording of 4 July 2002) of Article 17 of the
Law on Pharmaceutical Activities: (1) regarding advertising of
prescriptive medicines via radio and television and by means of
electronic information media; (2) regarding presentation of
information about prescriptive medicines via radio and
television. It was also mentioned that these prohibitions
cannot be construed as denying the exceptions specified in the
law itself, which are: (1) advertising of prescriptive
medicines to residents is permitted in all information media
cases where the manufacturers of the medicines, upon receiving
a permit from the Ministry of Health Care, carry out a
programme of vaccination of residents; (2) advertising of
prescriptive medicines, save the medicines which contain
substances entered into the list of narcotic and psychotropic
substances confirmed by the Minister of Health Care as well as
medicines, is permitted in the publications designated to
specialists only.
2. While deciding whether the prohibition to advertise
prescriptive medicines via radio and television and by means of
electronic information media, which is established in Paragraph
4 (wording of 4 July 2002) of Article 17 of the Law on
Pharmaceutical Activities, is not in conflict with Paragraph 3
of Article 25 of the Constitution, it needs to be noted that,
as held in this Ruling of the Constitutional Court:
- under Paragraph 3 of Article 25 of the Constitution,
freedom of information can be limited by law if it is necessary
to protect the health of a human being;
- advertising of medicines (irrespective of whether or not
this activity is charged) it is always sought to induce usage
of respective medicines, while this can create preconditions to
make harm to people's health-a value that is consolidated in,
and protected and defended by the Constitution;
- under the Constitution, the legislator has a duty to
establish, by means of a law, the legal regulation which could
prevent dissemination of information (inter alia of advertising
character) about medicines as well as of deceptive information
about medicines, which might create preconditions to make harm
to people's health;
- under Paragraph 3 of Article 25 of the Constitution, the
legislator must, by means of a law, define the content of the
information the dissemination of which is prohibited, as well
as the ways by means of which dissemination of certain
information is prohibited.
3. The prohibition to advertise prescriptive medicines via
radio and television and by means of electronic information
media, which is consolidated in Paragraph 4 (wording of 4 July
2002) of Article 17 of the Law on Pharmaceutical Activities, is
to be assessed as one seeking to protect the health of a human
being-a value established in and defended and protected by the
Constitution-and thus as necessary in a democratic society.
This limitation of freedom of advertising, which is established
in the Law on Pharmaceutical Activities, is not bigger than
necessary in order to protect the health of a human being, thus
it is not disproportionate to the constitutionally important
objective sought.
4. Thus, it is to be held that by means of the prohibition
to advertise prescriptive medicines via radio and television
and by means of electronic information media, which is
consolidated in Paragraph 4 (wording of 4 July 2002) of Article
17 of the Law on Pharmaceutical Activities, Paragraph 3 of
Article 25 of the Constitution is not violated.
5. The compliance of the prohibition to present
information about prescriptive medicines via radio and
television, which is consolidated in Paragraph 4 (wording of 4
July 2002) of Article 17 of the Law on Pharmaceutical
Activities, with the Constitution is to be assessed
differently.
6. It has been held in this Ruling of the Constitutional
Court that, under the Constitution, the legislator has a duty
to establish, by means of a law, the legal regulation which
could prevent dissemination of information (both of advertising
and non-advertising character; which is deceptive and which is
not deceptive) about medicines, which might create
preconditions to make harm to people's health. It was held,
too, that also such information can induce to use certain goods
or services, in the course of dissemination of which one does
not seek to induce to do so (e.g., statistical data, technical
and other information, which announce something, draws one's
attention to something, etc.); under certain circumstances,
dissemination of such information can exert the same influence
upon receivers of such information as advertising, thus, in
this respect, it can amount to advertising.
7. The prohibition to present information about
prescriptive medicines via radio and television, which is
consolidated in Paragraph 4 (wording of 4 July 2002) of Article
17 of the Law on Pharmaceutical Activities, seeks to achieve a
constitutionally important objective, which is protection of
the health of a human being, however, it ignores the fact that
not nearly all information about prescriptive medicines, which
can be disseminated by means of radio and television (inter
alia statistical data, technical and other information)
- is deceptive;
- is of advertising character or can amount to
advertising;
- is such whose dissemination via radio and television can
create preconditions to make harm to people's health.
The prohibition of dissemination of such information via
radio and television about medicines, which is not deceptive,
is not of advertising character nor can amount to advertising,
also whose dissemination via radio and television does not
create preconditions to make harm to people's health is to be
assessed as disproportionate to the constitutionally important
objective sought, i.e. protection of the health of a human
being.
8. Thus, it is to be held that the prohibition to present
information about prescriptive medicines via radio and
television, which is consolidated in Paragraph 4 (wording of 4
July 2002) of Article 17 of the Law on Pharmaceutical
Activities violates Paragraph 3 of Article 25 of the
Constitution and the constitutional principle of
proportionality as one of the elements of the constitutional
principle of a state under the rule of law.
9. Taking account of the arguments set forth, one is to
conclude that Paragraph 4 (wording of 4 July 2002) of Article
17 of the Law on Pharmaceutical Activities to the extent that
it prohibits to present via radio and television the
information about medicines which is of not advertising
character and which does not amount to advertising, the
dissemination of which via radio and television would not
create preconditions to make harm to people's health, is in
conflict with Paragraph 3 of Article 25 of the Constitution and
the constitutional principle of a state under the rule of law.
VI
On the compliance of Paragraph 4 (wording of 4 July 2002)
of Article 17 of the Law on Pharmaceutical Activities with
Paragraph 4 of Article 46 of the Constitution.
1. It was held in this Ruling of the Constitutional Court
that Paragraph 4 (wording of 4 July 2002) of Article 17 of the
Law on Pharmaceutical Activities to the extent that it
prohibits to present via radio and television the information
about medicines which is of not advertising character and which
does not amount to advertising, the dissemination of which via
radio and television would not create preconditions to make
harm to people's health, is in conflict with Paragraph 3 of
Article 25 of the Constitution and the constitutional principle
of a state under the rule of law.
2. The mere fact that Paragraph 4 (wording of 4 July 2002)
of Article 17 of the Law on Pharmaceutical Activities to the
aforesaid extent is in conflict with Paragraph 3 of Article 25
of the Constitution and the constitutional principle of a state
under the rule of law is not a sufficient basis for recognition
that it is also in conflict with the provision "the law <...>
shall protect freedom of fair competition" of Paragraph 4 of
Article 46 of the Constitution, since, on the one hand, the law
prohibits to advertise prescriptive medicines, thus, there
cannot exist any competition as regards their advertising (in
any aspect), on the other hand, the established limitations on
information about prescriptive medicines via radio and
television, even to the extent that they are in conflict with
Paragraph 3 of Article 25 of the Constitution and the
constitutional principle of a state under the rule of law,
neither discriminate nor grant privileges to any economic
entities operating in the radio and television market, thus,
they do not impede competition nor distort it in this market.
3. Taking account of the arguments set forth, one is to
draw a conclusion that Paragraph 4 (wording of 4 July 2002) of
Article 17 of the Law on Pharmaceutical Activities is not in
conflict with the provision "the law <...> shall protect
freedom of fair competition" of Paragraph 4 of Article 46 of
the Constitution.
Conforming to Articles 102 and 105 of the Constitution of
the Republic of Lithuania and Articles 1, 53, 54, 55, and 56 of
the Law on the Constitutional Court of the Republic of
Lithuania, the Constitutional Court of the Republic of
Lithuania has passed the following
ruling:
To recognise that Paragraph 4 (wording of 4 July 2002) of
Article 17 of the Republic of Lithuania Law on Pharmaceutical
Activities to the extent that it prohibits to present via radio
and television the information about medicines which is of not
advertising character and which does not amount to advertising,
the dissemination of which via radio and television would not
create preconditions to make harm to people's health, is in
conflict with Paragraph 3 of Article 25 of the Constitution of
the Republic of Lithuania and the constitutional principle of a
state under the rule of law.
This ruling of the Constitutional Court of the Republic of
Lithuania is final and not subject to appeal.
The ruling is promulgated in the name of the Republic of
Lithuania.
Justices of the Constitutional Court: Armanas Abramavičius
Egidijus Kūris
Kęstutis Lapinskas
Zenonas Namavičius
Ramutė Ruškytė
Vytautas Sinkevičius
Stasys Stačiokas
Romualdas Kęstutis Urbaitis