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On the advertising of medicines

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 REPUBLIC OF LITHUANIA’S 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

The court reporter—Daiva Pitrėnaitė

Seimas member Raimondas Šukys, acting as the representative of a group of members of the Seimas of the Republic of Lithuania, the petitioner

Jurgita Meškienė, a senior consultant to the Legal Department of the Office of the Seimas, acting as the representative of the Seimas of the Republic of Lithuania, the party concerned

The Constitutional Court of the Republic of Lithuania, 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, considered case No. 15/02 subsequent to the petition of a group of members of the Seimas of the Republic of Lithuania, the petitioner, requesting an investigation into whether Article 8 of the Republic of Lithuania’s 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, have applied to the Constitutional Court with the petition requesting an investigation into 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 petition of the petitioner is based on the following arguments.

Upon the 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 against submitting information via radio and television about prescriptive medicines and against advertising 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 an absolute character against submitting 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 on advertising prescriptive medicines creates the conditions for distorting 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 against 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 not any product, but 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 should 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, reasonable doubts occur 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 on submitting 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 specialists 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 law and only in an 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 legislature, 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, Chairperson 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 Chairperson 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 Constitutional Court’s hearing of 20 September 2005, 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 Constitutional Court’s hearing of 20 September 2005, 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 an investigation into 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 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 both prescriptive and non-prescriptive medicines is allowed. Advertising 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 non-prescriptive medicines together with the 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 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 medicines, its rendition and the distribution of medicines not for sale, among the representatives of trading in medicine preparations and their qualifications and activities shall be established by the Minister of Health Care.

The supervision over advertising medicines and the control over the requirements for advertising 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, it should be held that the petitioner requests an investigation into 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 an investigation into 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 the amendment of Article 17 (wording of 4 July 2000) of the Law on Pharmaceutical Activities, upon establishing a prohibition in Paragraph 4 of the said article against submitting information via radio and television about prescriptive medicines and against advertising such medicines and upon prohibiting advertising 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 before, 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 (the Constitutional Court’s 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 (the Constitutional Court’s 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 for exerting influence upon the behaviour and choice of people, inter alia, for inducing them to choose, acquire and/or use certain goods or to use certain services or not to choose them. The dissemination of such information is commonly referred to as advertising.

In the context of the constitutional justice case at issue, it should be noted 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 (the Constitutional Court’s rulings of 13 February 1997 and 26 January 2004).

It needs to be noted that by means of advertising 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) should 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, the 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 (the Constitutional Court’s 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 (the Constitutional Court’s ruling of 19 September 2005).

In the context of the constitutional justice case at issue, it should especially be noted that a duty to the legislature stems from the Constitution to legislatively establish the legal regulation which would permit preventing the 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, it should especially be noted that the Constitution provides for a possibility of limiting 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 on 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 limiting 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 legislature 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 legislature 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; the subjects that enjoy the powers to supervise the observance of the prohibitions and/or limitations, which are established by law, to disseminate certain information; the subjects that apply liability for disregard of the prohibitions and/or limitations, which are established by law, to disseminate certain information; efficient measures of judicial protection of freedom of information (the Constitutional Court’s 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 over the prohibitions, established by means of laws, against disseminating information and/or limitations on dissemination of information also by substatutory legal act, 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, or any such legal regulation which competes with that established by law (the Constitutional Court’s 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’s 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 should 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 implies, inter alia, 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 (the Constitutional Court’s ruling of 13 December 2004). Otherwise, opportunities to subjects of law to learn what law demands would be worsened.

Heed should also be paid to the said requirements which stem from the Constitution where 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 (the Constitutional Court’s 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 should be treated as a state function (the Constitutional Court’s 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 before, inter alia, encompasses freedom of advertising) may also be limited to a certain extent by means of a law. However, such limitation on 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 legislature, when it 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 legislature, it is not useful to the people, although it is not harmful to them. It must also be noted that selective limitation on advertising, i.e. limitation on 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. It should especially be noted that limitations upon freedom of advertising established by law 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 by advertising medicines (irrespective of whether or not this activity is charged) it is always sought to induce the usage of respective medicines, while this can create preconditions for inflicting harm on 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 before, is not covered by the constitutional concept of freedom of advertising.

Under the Constitution, the legislature 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 for inflicting harm on people’s health. Under the Constitution, the legislature 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 for inflicting harm on people’s health. By establishing, by means of a law, the said constitutionally necessary legal regulation, the legislature must also establish efficient ways of control over advertising medicines as well as that over other information about medicines, which might create preconditions for inflicting harm on people’s health. In this context, attention should be paid to that fact that, in foreign democratic states, various ways of efficient control over information about medicines (inter alia, advertising medicines) whose dissemination might create preconditions for inflicting harm on people’s health are established, as, for example: preliminary check-up of information disseminated by mass media, limitations upon dissemination of such information, the powers of state institutions to resort to actions so that the 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 over the prohibitions, established by means of laws, against disseminating information and/or limitations on dissemination of information also by substatutory legal act, however, the substatutory legal acts cannot establish any such legal regulation which is not based on the Constitution and laws, or any such legal regulation which competes with that established by law.

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 medicines as well as upon other information about medicines, whose dissemination can create preconditions for inflicting harm on people’s health, as, for instance: what information about medicines (inter alia, advertising medicines) is subject to limitation or subject to prohibition altogether; the ways of limitation on the said information (advertising) and/or conditions of its dissemination; the extent (amount) of prohibitions; the criteria according to which medicines are categorised as such whose advertising can create preconditions for inflicting harm on people’s health and, due to this, is subject to limitation or subject to prohibition altogether; the subjects, who enjoy the 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 law; the subjects that enjoy the 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 should 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 (the Constitutional Court’s rulings of 13 February 1997 and 13 May 2005); the content of the notion “the general welfare of the Nation” is disclosed in every particular case when one takes account of economic, social and other important factors (the Constitutional Court’s 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 on economic activity whereby one seeks to protect people’s health should 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 law 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 medicines as well as other information about medicines whose dissemination can create preconditions for inflicting harm on people’s health.

In this context, it should also be mentioned that, as it was held by the Constitutional Court in its ruling of 13 February 1997, restrictions on advertising are 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 legislature must legislatively establish such legal regulation so that there should not occur any preconditions for inducing uncontrolled use of medicines, which might inflict damage on people’s health.

12. In the context of the constitutional justice case at issue, it needs to be noted that the legislature 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 medicines). One of the grounds of differentiation made by the legal regulation (which is widespread all over the world) is grouping 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 for inflicting harm on 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 categorisation of certain medicines (their groups) as prescriptive or non-prescriptive ones and the prescription of medicines to patients is a matter of the professional competence of a 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 law the legal regulation of relations related to dissemination of information about medicines (inter alia, advertising 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 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 impugned by the petitioner and which provides that advertising 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 should 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’s 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’s 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’s 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’s 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’s 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 the 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 impugned by the petitioner, should 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 both prescriptive and non-prescriptive medicines is allowed. Advertising 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 medicines and of information about medicines, which are established in the Law on Pharmaceutical Activities, in a systemic manner, it should be held 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 categorised as 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 categorised as 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 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 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 impugned by the petitioner, should also be construed in the context of legal regulation established in other laws, as well.

4.1. Under Article 6 of the Republic of Lithuania’s 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 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, advertising 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 law and other legal act, 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 laws of the Republic of Lithuania 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 laws of the Republic of Lithuania establish additional or other requirements in the use of advertising, or establish other procedure for the control over the use of advertising or liability of subjects 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, it should be held 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 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 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 impugned by the petitioner and which provides that advertising 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 prescriptive medicines by means of electronic information media (advertising prescriptive medicines by means of electronic information media shall incur a fine from one thousand to ten thousand litas for subjects of advertising activity), while Paragraph 7 thereof provides for liability for advertising narcotic and psychotropic medicines carried out in violation of the requirements of the Law on Pharmaceutical Activities (advertising narcotic and psychotropic medicines in violation of the said requirements shall incur a fine from five thousand to twenty thousand litas for subjects of advertising activity). However, it must be emphasised that although fines are established for subjects of advertising activity for disregard of the established prohibition on advertising prescriptive medicines by means of electronic information media, also for advertising 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 the imposition of fines specified in the Law on Pharmaceutical Activities. No legal acts establish a procedure for the imposition of the said fines, either. Thus, it should be held that, inter alia, the prohibitions regarding advertising 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 impugned by the petitioner, is not a matter of investigation in this constitutional justice case.

7. As mentioned before, grouping medicines into prescriptive and non-prescriptive means that, prescriptive medicines (due to the fact that their unrestricted acquisition, circulation and use can create preconditions for inflicting harm on 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 medicines into prescriptive and non-prescriptive is one of the main grounds to differentiate by law the legal regulation of the relations connected with the dissemination of information about medicines (inter alia, advertising medicines). In addition, it was mentioned that the categorisation of certain medicines (their groups) as prescriptive or non-prescriptive ones and the prescription of medicines to patients is a matter of the professional competence of a 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 categorised as such whose advertising can create preconditions for inflicting harm on 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 law.

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 categorised as prescriptive medicines; nor does it establish any clear criteria according to which medicines are categorised as such whose advertising can create preconditions for inflicting harm on 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) as confirmed by the 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 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 subgroups) 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 categorised as 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 can thus pose a 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 prescriptive medicines and 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, the classification of medicines and advertising 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 the legal regulation of advertising 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 utilised 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 subcategory 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 subcategories 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 specialised areas (Paragraph 2 of Article 70). Where Member States provide for the subcategory 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 subcategories 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 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 also obligates Member States to establish penalties for, inter alia, disregard of the prohibition on advertising 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 should also mention the jurisprudence of the European Court of Human Rights which (as it was held in the Constitutional Court’s 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 power 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 impugned 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 before, 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 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 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 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 on advertising 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;

by advertising medicines (irrespective of whether or not this activity is charged) it is always sought to induce the usage of respective medicines, while this can create preconditions for inflicting harm on people’s health—a value that is consolidated in, and protected and defended by the Constitution;

under the Constitution, the legislature has a duty to establish, by means of a law, the legal regulation which could prevent dissemination of information (inter alia, of an advertising character) about medicines as well as of deceptive information about medicines, which might create preconditions for inflicting harm on people’s health;

under Paragraph 3 of Article 25 of the Constitution, the legislature 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 on advertising 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, should be regarded 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 on 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 should be held that by means of the prohibition on advertising 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 on presenting 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 should be assessed differently.

6. It has been held in this ruling of the Constitutional Court that, under the Constitution, the legislature has a duty to establish, by means of a law, the legal regulation which could prevent dissemination of information (both of an advertising and non-advertising character; which is deceptive and which is not deceptive) about medicines, which might create preconditions for inflicting harm on 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, the 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 on presenting 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 an advertising character or can amount to advertising;

is such whose dissemination via radio and television can create preconditions for inflicting harm on people’s health.

The prohibition against the dissemination of such information via radio and television about medicines, which is not deceptive, is not of an advertising character nor can amount to advertising, also whose dissemination via radio and television does not create preconditions for inflicting harm on people’s health should be assessed as disproportionate to the constitutionally important objective sought, i.e. protection of the health of a human being.

8. Thus, it should be held that the prohibition on presenting 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, it should be concluded that Paragraph 4 (wording of 4 July 2002) of Article 17 of the Law on Pharmaceutical Activities to the extent that it prohibits presenting via radio and television the information about medicines which is not of an advertising character and which does not amount to advertising, the dissemination of which via radio and television would not create preconditions for inflicting harm on 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 presenting via radio and television the information about medicines which is not of an advertising character and which does not amount to advertising, the dissemination of which via radio and television would not create preconditions for inflicting harm on 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 recognising 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 advertising 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 subjects 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, the conclusion should be drawn 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 gives the following

ruling:

To recognise that Paragraph 4 (wording of 4 July 2002) of Article 17 of the Republic of Lithuania’s Law on Pharmaceutical Activities to the extent that it prohibits presenting via radio and television the information about medicines which is not of an advertising character and which does not amount to advertising, the dissemination of which via radio and television would not create preconditions for inflicting harm on 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 is final and not subject to appeal.

The ruling is pronounced 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