Na podlagi druge alinee prvega odstavka 107. člena in prvega odstavka 91. člena Ustave Republike Slovenije izdajam
o razglasitvi Zakona o ratifikaciji Konvencije Sveta Evrope o ponarejanju medicinskih izdelkov in podobnih kaznivih dejanjih, ki ogrožajo javno zdravje (MKSEPMI)
Razglašam Zakon o ratifikaciji Konvencije Sveta Evrope o ponarejanju medicinskih izdelkov in podobnih kaznivih dejanjih, ki ogrožajo javno zdravje (MKSEPMI), ki ga je sprejel Državni zbor Republike Slovenije na seji dne 16. marca 2022.
Št. 003-02-1/2022-82
Ljubljana, dne 24. marca 2022
O RATIFIKACIJI KONVENCIJE SVETA EVROPE O PONAREJANJU MEDICINSKIH IZDELKOV IN PODOBNIH KAZNIVIH DEJANJIH, KI OGROŽAJO JAVNO ZDRAVJE (MKSEPMI)
1. člen
Ratificira se Konvencija Sveta Evrope o ponarejanju medicinskih izdelkov in podobnih kaznivih dejanjih, ki ogrožajo javno zdravje, sprejeta v Moskvi 28. oktobra 2011.
Konvencija se v izvirniku v angleškem jeziku in prevodu v slovenskem jeziku glasi:
COUNCIL OF EUROPE CONVENTION
ON THE COUNTERFEITING OF MEDICAL PRODUCTS AND SIMILAR CRIMES INVOLVING THREATS TO PUBLIC HEALTH
Text corrected in accordance with the Committee of Ministers' decision (1151st meeting of the Ministers' Deputies, 18–19 September 2012
The member States of the Council of Europe and the other signatories to this Convention,
Considering that the aim of the Council of Europe is to achieve a greater unity between its members;
Noting that the counterfeiting of medical products and similar crimes by their very nature seriously endanger public health;
Recalling the Action Plan adopted at the Third Summit of Heads of State and Government of the Council of Europe (Warsaw, 16–17 May 2005), which recommends the development of measures to strengthen the security of European citizens;
Bearing in mind the Universal Declaration of Human Rights, proclaimed by the United Nations General Assembly on 10 December 1948, the Convention for the Protection of Human Rights and Fundamental Freedoms (1950, ETS No. 5), the European Social Charter (1961, ETS No. 35), the Convention on the Elaboration of a European Pharmacopoeia (1964, ETS No. 50) and its Protocol (1989, ETS No. 134), the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine (1997, ETS No. 164) and the Additional Protocols thereto (1998, ETS No. 168, 2002, ETS No.186, 2005, CETS No. 195, 2008, CETS No. 203) and the Convention on Cybercrime (2001, ETS No. 185);
Also bearing in mind the other relevant work of the Council of Europe, particularly the decisions of the Committee of Ministers and work of the Parliamentary Assembly, notably Resolution AP(2001)2 concerning the pharmacist's role in the framework of health security, the replies adopted by the Committee of Ministers on 6 April 2005 and on 26 September 2007, concerning respectively, Parliamentary Assembly Recommendations 1673 (2004) on "Counterfeiting: problems and solutions" and 1794 (2007) on the "Quality of medicines in Europe", as well as relevant programmes conducted by the Council of Europe;
Having due regard to other relevant international legal instruments and programmes, conducted notably by the World Health Organisation, in particular the work of the group IMPACT, and by the European Union, as well as in the forum of the G8;
Determined to contribute effectively to the attainment of the common goal of combating crime involving counterfeiting of medical products and similar crimes involving threats to public health, by introducing notably new offences and penal sanctions relative to these offences;
Considering that the purpose of this Convention is to prevent and combat threats to public health, giving effect to the provisions of the Convention concerning substantive criminal law should be carried out taking into account its purpose and the principle of proportionality;
Considering that this Convention does not seek to address issues concerning intellectual property rights;
Taking into account the need to prepare a comprehensive international instrument which is centred on the aspects linked to prevention, protection of victims and criminal law in combating all forms of counterfeiting of medical products and similar crimes involving threats to public health, and which sets up a specific follow-up mechanism;
Recognising that, to efficiently combat the global threat posed by the counterfeiting of medical products and similar crimes, close international co-operation between Council of Europe member States and non-member States alike should be encouraged,
Have agreed as follows:
Chapter I – Object and purpose, principle of non-discrimination, scope, definitions
Article 1 – Object and purpose
1 The purpose of this Convention is to prevent and combat threats to public health by:
a providing for the criminalisation of certain acts;
b protecting the rights of victims of the offences established under this Convention;
c promoting national and international co-operation.
2 In order to ensure effective implementation of its provisions by the Parties, this Convention sets up a specific follow-up mechanism.
Article 2 – Principle of non-discrimination
The implementation of the provisions of this Convention by the Parties, in particular the enjoyment of measures to protect the rights of victims, shall be secured without discrimination on any ground such as sex, race, colour, language, age, religion, political or any other opinion, national or social origin, association with a national minority, property, birth, sexual orientation, state of health, disability or other status.
This Convention concerns medical products whether they are protected under intellectual property rights or not, or whether they are generic or not, including accessories designated to be used together with medical devices, as well as the active substances, excipients, parts and materials designated to be used in the production of medical products.
For the purposes of this Convention:
a the term "medical product" shall mean medicinal products and medical devices;
b the term "medicinal product" shall mean medicines for human and veterinary use, which may be:
i any substance or combination of substances presented as having properties for treating or preventing disease in humans or animals;
ii any substance or combination of substances which may be used in or administered to human beings or animals either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis;
iii an investigational medicinal product;
c the term "active substance" shall mean any substance or mixture of substances that is designated to be used in the manufacture of a medicinal product, and that, when used in the production of a medicinal product, becomes an active ingredient of the medicinal product;
d the term "excipient" shall mean any substance that is not an active substance or a finished medicinal product, but is part of the composition of a medicinal product for human or veterinary use and essential for the integrity of the finished product;
e the term "medical device" shall mean any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software, designated by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, designated by the manufacturer to be used for human beings for the purpose of:
i diagnosis, prevention, monitoring, treatment or alleviation of disease;
ii diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap;
iii investigation, replacement or modification of the anatomy or of a physiological process;
iv control of conception;
and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means;
f the term "accessory" shall mean an article which whilst not being a medical device is designated specifically by its manufacturer to be used together with a medical device to enable it to be used in accordance with the use of the medical device intended by the manufacturer of the medical device;
g the terms "parts" and "materials" shall mean all parts and materials constructed and designated to be used for medical devices and that are essential for the integrity thereof;
h the term "document" shall mean any document related to a medical product, an active substance, an excipient, a part, a material or an accessory, including the packaging, labeling, instructions for use, certificate of origin or any other certificate accompanying it, or otherwise directly associated with the manufacturing and/or distribution thereof;
i the term "manufacturing" shall mean:
i as regards a medicinal product, any part of the process of producing the medicinal product, or an active substance or an excipient of such a product, or of bringing the medicinal product, active substance or excipient to its final state;
ii as regards a medical device, any part of the process of producing the medical device, as well as parts or materials of such a device, including designing the device, the parts or materials, or of bringing the medical device, the parts or materials to their final state;
iii as regards an accessory, any part of the process of producing the accessory, including designing the accessory, or of bringing the accessory to its final state;
j the term "counterfeit" shall mean a false representation as regards identity and/or source;
k the term "victim" shall mean any natural person suffering adverse physical or psychological effects as a result of having used a counterfeit medical product or a medical product manufactured, supplied or placed on the market without authorisation or without being in compliance with the conformity requirements as described in Article 8.
Chapter II – Substantive criminal law
Article 5 – Manufacturing of counterfeits
1 Each Party shall take the necessary legislative and other measures to establish as offences under its domestic law, the intentional manufacturing of counterfeit medical products, active substances, excipients, parts, materials and accessories.
2 As regards medicinal products and, as appropriate, medical devices, active substances and excipients, paragraph 1 shall also apply to any adulteration thereof.
3 Each State or the European Union may, at the time of signature or when depositing its instrument of ratification, acceptance or approval, by a declaration addressed to the Secretary General of the Council of Europe, declare that it reserves the right not to apply, or to apply only in specific cases or conditions, paragraph 1, as regards excipients, parts and materials, and paragraph 2, as regards excipients.
Article 6 – Supplying, offering to supply, and trafficking in counterfeits
1 Each Party shall take the necessary legislative and other measures to establish as offences under its domestic law, when committed intentionally, the supplying or the offering to supply, including brokering, the trafficking, including keeping in stock, importing and exporting of counterfeit medical products, active substances, excipients, parts, materials and accessories.
2 Each State or the European Union may, at the time of signature or when depositing its instrument of ratification, acceptance or approval, by a declaration addressed to the Secretary General of the Council of Europe, declare that it reserves the right not to apply, or to apply only in specific cases or conditions, paragraph 1, as regards excipients, parts and materials.
Article 7 – Falsification of documents
1 Each Party shall take the necessary legislative and other measures to establish as offences under its domestic law the making of false documents or the act of tampering with documents, when committed intentionally.
2 Each State or the European Union may, at the time of signature or when depositing its instrument of ratification, acceptance or approval, by a declaration addressed to the Secretary General of the Council of Europe, declare that it reserves the right not to apply, or to apply only in specific cases or conditions, paragraph 1, as regards documents related to excipients, parts and materials.
Article 8 – Similar crimes involving threats to public health
Each Party shall take the necessary legislative and other measures to establish as offences under its domestic law, when committed intentionally, in so far as such an activity is not covered by Articles 5, 6 and 7:
a the manufacturing, the keeping in stock for supply, importing, exporting, supplying, offering to supply or placing on the market of:
i medicinal products without authorisation where such authorisation is required under the domestic law of the Party; or
ii medical devices without being in compliance with the conformity requirements, where such conformity is required under the domestic law of the Party;
b the commercial use of original documents outside their intended use within the legal medical product supply chain, as specified by the domestic law of the Party.
Article 9 – Aiding or abetting and attempt
1 Each Party shall take the necessary legislative and other measures to establish as offences when committed intentionally, aiding or abetting the commission of any of the offences established in accordance with this Convention.
2 Each Party shall take the necessary legislative and other measures to establish as an offence the intentional attempt to commit any of the offences established in accordance with this Convention.
3 Each State or the European Union may, at the time of signature or when depositing its instrument of ratification, acceptance or approval, by a declaration addressed to the Secretary General of the Council of Europe, declare that it reserves the right not to apply, or to apply only in specific cases or conditions, paragraph 2 to offences established in accordance with Articles 7 and 8.
Article 10 – Jurisdiction
1 Each Party shall take the necessary legislative and other measures to establish jurisdiction over any offence established in accordance with this Convention, when the offence is committed:
a in its territory; or
b on board a ship flying the flag of that Party; or
c on board an aircraft registered under the laws of that Party; or
d by one of its nationals or by a person habitually residing in its territory.
2 Each Party shall take the necessary legislative and other measures to establish jurisdiction over any offence established in accordance with this Convention, when the victim of the offence is one of its nationals or a person habitually resident in its territory.
3 Each Party shall take the necessary legislative and other measures to establish jurisdiction over any offence established in accordance with this Convention, when the alleged offender is present in its territory and cannot be extradited to another Party because of his or her nationality.
4 Each State or the European Union may, at the time of signature or when depositing its instrument of ratification, acceptance or approval, by a declaration addressed to the Secretary General of the Council of Europe, declare that it reserves the right not to apply, or to apply only in specific cases or conditions, the jurisdiction rules laid down in paragraph 1, subparagraph d, and paragraph 2 of this article.
5 Where more than one Party claims jurisdiction over an alleged offence established in accordance with this Convention, the Parties concerned shall consult, where appropriate, with a view to determining the most appropriate jurisdiction for prosecution.
6 Without prejudice to the general rules of international law, this Convention shall not exclude any criminal jurisdiction exercised by a Party in accordance with its domestic law.
Article 11 – Corporate liability
1 Each Party shall take the necessary legislative and other measures to ensure that legal persons can be held liable for offences established in accordance with this Convention, when committed for their benefit by any natural person, acting either individually or as part of an organ of the legal person, who has a leading position within it based on:
a a power of representation of the legal person;
b an authority to take decisions on behalf of the legal person;
c an authority to exercise control within the legal person.
2 Apart from the cases provided for in paragraph 1, each Party shall take the necessary legislative and other measures to ensure that a legal person can be held liable where the lack of supervision or control by a natural person referred to in paragraph 1 has made possible the commission of an offence established in accordance with this Convention for the benefit of that legal person by a natural person acting under its authority.
3 Subject to the legal principles of the Party, the liability of a legal person may be criminal, civil or administrative.
4 Such liability shall be without prejudice to the criminal liability of the natural persons who have committed the offence.
Article 12 – Sanctions and measures
1 Each Party shall take the necessary legislative and other measures to ensure that the offences established in accordance with this Convention are punishable by effective, proportionate and dissuasive sanctions, including criminal or non-criminal monetary sanctions, taking account of their seriousness. These sanctions shall include, for offences established in accordance with Articles 5 and 6, when committed by natural persons, penalties involving deprivation of liberty that may give rise to extradition.
2 Each Party shall take the necessary legislative and other measures to ensure that legal persons held liable in accordance with Article 11 are subject to effective, proportionate and dissuasive sanctions, including criminal or non-criminal monetary sanctions, and may include other measures, such as:
a temporary or permanent disqualification from exercising commercial activity;
b placing under judicial supervision;
c a judicial winding-up order.
3 Each Party shall take the necessary legislative and other measures to:
a permit seizure and confiscation of:
i medical products, active substances, excipients, parts, materials and accessories, as well as goods, documents and other instrumentalities used to commit the offences established in accordance with this Convention or to facilitate their commission;
ii proceeds of these offences, or property whose value corresponds to such proceeds;
b permit the destruction of confiscated medical products, active substances, excipients, parts, materials and accessories that are the subject of an offence established under this Convention;
c take any other appropriate measures in response to an offence, in order to prevent future offences.
Article 13 – Aggravating circumstances
Each Party shall take the necessary legislative and other measures to ensure that the following circumstances, in so far as they do not already form part of the constituent elements of the offence, may, in conformity with the relevant provisions of domestic law, be taken into consideration as aggravating circumstances in determining the sanctions in relation to the offences established in accordance with this Convention:
a the offence caused the death of, or damage to the physical or mental health of, the victim;
b the offence was committed by persons abusing the confidence placed in them in their capacity as professionals;
c the offence was committed by persons abusing the confidence placed in them as manufacturers as well as suppliers;
d the offences of supplying and offering to supply were committed having resort to means of large scale distribution, such as information systems, including the Internet;
e the offence was committed in the framework of a criminal organisation;
f the perpetrator has previously been convicted of offences of the same nature.
Article 14 – Previous convictions
Each Party shall take the necessary legislative and other measures to provide for the possibility to take into account final sentences passed by another Party in relation to the offences of the same nature when determining the sanctions.
Chapter III – Investigation, prosecution and procedural law
Article 15 – Initiation and continuation of proceedings
Each Party shall take the necessary legislative and other measures to ensure that investigations or prosecution of offences established in accordance with this Convention should not be subordinate to a complaint and that the proceedings may continue even if the complaint is withdrawn.
Article 16 – Criminal investigations
1 Each Party shall take the necessary measures to ensure that persons, units or services in charge of criminal investigations are specialised in the field of combating counterfeiting of medical products and similar crimes involving threats to public health or that persons are trained for this purpose, including financial investigations. Such units or services shall have adequate resources.
2 Each Party shall take the necessary legislative and other measures, in conformity with the principles of its domestic law, to ensure effective criminal investigation and prosecution of offences established in accordance with this Convention, allowing, where appropriate, for the possibility for its competent authorities of carrying out financial investigations, of covert operations, controlled delivery and other special investigative techniques.
Chapter IV – Co-operation of authorities and information exchange
Article 17– National measures of co-operation and information exchange
1 Each Party shall take the necessary legislative and other measures to ensure that representatives of health authorities, customs, police and other competent authorities exchange information and co-operate in accordance with domestic law in order to prevent and combat effectively the counterfeiting of medical products and similar crimes involving threats to public health.
2 Each Party shall endeavour to ensure co-operation between its competent authorities and the commercial and industrial sectors as regards risk management of counterfeit medical products and similar crimes involving threats to public health.
3 With due respect for the requirements of the protection of personal data, each Party shall take the necessary legislative and other measures to set up or strengthen mechanisms for:
a receiving and collecting information and data, including through contact points, at national or local levels and in collaboration with private sector and civil society, for the purpose of preventing and combating the counterfeiting of medical products and similar crimes involving threats to public health;
b making available the information and data obtained by the health authorities, customs, police and other competent authorities for the co-operation between them.
4 Each Party shall take the necessary measures to ensure that persons, units or services in charge of co-operation and information exchange are trained for this purpose. Such units or services shall have adequate resources.
Chapter V – Measures for prevention
Article 18 – Preventive measures
1 Each Party shall take the necessary legislative and other measures to establish the quality and safety requirements of medical products.
2 Each Party shall take the necessary legislative and other measures to ensure the safe distribution of medical products.
3 With the aim of preventing counterfeiting of medical products, active substances, excipients, parts, materials and accessories, each Party shall take the necessary measures to provide, inter alia, for:
a training of healthcare professionals, providers, police and customs authorities, as well as relevant regulatory authorities;
b the promotion of awareness-raising campaigns addressed to the general public providing information about counterfeit medical products;
c the prevention of illegal supplying of counterfeit medical products, active substances, excipients, parts, materials and accessories.
Chapter VI – Measures for protection
Article 19 – Protection of victims
Each Party shall take the necessary legislative and other measures to protect the rights and interests of victims, in particular by:
a ensuring that victims have access to information relevant to their case and which is necessary for the protection of their health;
b assisting victims in their physical, psychological and social recovery;
c providing, in its domestic law, for the right of victims to compensation from the perpetrators.
Article 20 – The standing of victims in criminal investigations and proceedings
1 Each Party shall take the necessary legislative and other measures to protect the rights and interests of victims at all stages of criminal investigations and proceedings, in particular by:
a informing them of their rights and the services at their disposal and, unless they do not wish to receive such information, the follow-up given to their complaint, the possible charges, the general progress of the investigation or proceedings, and their role therein as well as the outcome of their cases;
b enabling them, in a manner consistent with the procedural rules of domestic law, to be heard, to supply evidence and to choose the means of having their views, needs and concerns presented, directly or through an intermediary, and considered;
c providing them with appropriate support services so that their rights and interests are duly presented and taken into account;
d providing effective measures for their safety, as well as that of their families and witnesses on their behalf, from intimidation and retaliation.
2 Each Party shall ensure that victims have access, as from their first contact with the competent authorities, to information on relevant judicial and administrative proceedings.
3 Each Party shall ensure that victims have access, provided free of charge where warranted, to legal aid when it is possible for them to have the status of parties to criminal proceedings.
4 Each Party shall take the necessary legislative and other measures to ensure that victims of an offence established in accordance with this Convention committed in the territory of a Party other than the one where they reside can make a complaint before the competent authorities of their State of residence.
5 Each Party shall provide, by means of legislative or other measures, in accordance with the conditions provided for by its domestic law, the possibility for groups, foundations, associations or governmental or non-governmental organisations, to assist and/or support the victims with their consent during criminal proceedings concerning the offences established in accordance with this Convention.
Chapter VII – International co-operation
Article 21 – International co-operation in criminal matters
1 The Parties shall co-operate with each other, in accordance with the provisions of this Convention and in pursuance of relevant applicable international and regional instruments and arrangements agreed on the basis of uniform or reciprocal legislation and their domestic law, to the widest extent possible, for the purpose of investigations or proceedings concerning the offences established in accordance with this Convention, including seizure and confiscation.
2 The Parties shall co-operate to the widest extent possible in pursuance of the relevant applicable international, regional and bilateral treaties on extradition and mutual legal assistance in criminal matters concerning the offences established in accordance with this Convention.
3 If a Party that makes extradition or mutual legal assistance in criminal matters conditional on the existence of a treaty receives a request for extradition or legal assistance in criminal matters from a Party with which it has no such a treaty, it may, acting in full compliance with its obligations under international law and subject to the conditions provided for by the domestic law of the requested Party, consider this Convention as the legal basis for extradition or mutual legal assistance in criminal matters in respect of the offences established in accordance with this Convention.
Article 22 – International co-operation on prevention and other administrative measures
1 The Parties shall co-operate on protecting and providing assistance to victims.
2 The Parties shall, without prejudice to their internal reporting systems, designate a national contact point which shall be responsible for transmitting and receiving requests for information and/or co-operation in connection with the fight against counterfeiting of medical products and similar crimes involving threats to public health.
3 Each Party shall endeavour to integrate, where appropriate, prevention and combating of the counterfeiting of medical products and similar crimes involving threats to public health into assistance or development programmes provided for the benefit of third States.
Chapter VIII – Follow-up mechanism
Article 23 – Committee of the Parties
1 The Committee of the Parties shall be composed of representatives of the Parties to the Convention.
2 The Committee of the Parties shall be convened by the Secretary General of the Council of Europe. Its first meeting shall be held within a period of one year following the entry into force of this Convention for the tenth signatory having ratified it. It shall subsequently meet whenever at least one third of the Parties or the Secretary General so requests.
3 The Committee of the Parties shall adopt its own rules of procedure.
4 The Committee of the Parties shall be assisted by the Secretariat of the Council of Europe in carrying out its functions.
5 A contracting Party which is not a member of the Council of Europe shall contribute to the financing of the Committee of the Parties in a manner to be decided by the Committee of Ministers upon consultation of that Party.
Article 24 – Other representatives
1 The Parliamentary Assembly of the Council of Europe, the European Committee on Crime Problems (CDPC), as well as other relevant Council of Europe intergovernmental or scientific committees, shall each appoint a representative to the Committee of the Parties in order to contribute to a multisectoral and multidisciplinary approach.
2 The Committee of Ministers may invite other Council of Europe bodies to appoint a representative to the Committee of the Parties after consulting them.
3 Representatives of relevant international bodies may be admitted as observers to the Committee of the Parties following the procedure established by the relevant rules of the Council of Europe.
4 Representatives of relevant official bodies of the Parties may be admitted as observers to the Committee of the Parties following the procedure established by the relevant rules of the Council of Europe.
5 Representatives of civil society, and in particular non-governmental organisations, may be admitted as observers to the Committee of the Parties following the procedure established by the relevant rules of the Council of Europe.
6 In the appointment of representatives under paragraphs 2 to 5, a balanced representation of the different sectors and disciplines shall be ensured.
7 Representatives appointed under paragraphs 1 to 5 above shall participate in meetings of the Committee of the Parties without the right to vote.
Article 25 – Functions of the Committee of the Parties
1 The Committee of the Parties shall monitor the implementation of this Convention. The rules of procedure of the Committee of the Parties shall determine the procedure for evaluating the implementation of this Convention, using a multisectoral and multidisciplinary approach.
2 The Committee of the Parties shall also facilitate the collection, analysis and exchange of information, experience and good practice between States to improve their capacity to prevent and combat the counterfeiting of medical products and similar crimes involving threats to public health. The Committee may avail itself of the expertise of other relevant Council of Europe committees and bodies.
3 Furthermore, the Committee of the Parties shall, where appropriate:
a facilitate the effective use and implementation of this Convention, including the identification of any problems and the effects of any declaration or reservation made under this Convention;
b express an opinion on any question concerning the application of this Convention and facilitate the exchange of information on significant legal, policy or technological developments;
c make specific recommendations to Parties concerning the implementation of this Convention.
4 The European Committee on Crime Problems (CDPC) shall be kept periodically informed regarding the activities mentioned in paragraphs 1, 2 and 3 of this article.
Chapter IX – Relationship with other international instruments
Article 26 – Relationship with other international instruments
1 This Convention shall not affect the rights and obligations arising from the provisions of other international instruments to which Parties to the present Convention are Parties or shall become Parties and which contain provisions on matters governed by this Convention.
2 The Parties to the Convention may conclude bilateral or multilateral agreements with one another on the matters dealt with in this Convention, for purposes of supplementing or strengthening its provisions or facilitating the application of the principles embodied in it.
Chapter X – Amendments to the Convention
1 Any proposal for an amendment to this Convention presented by a Party shall be communicated to the Secretary General of the Council of Europe and forwarded by him or her to the Parties, the member States of the Council of Europe, non-member States having participated in the elaboration of this Convention or enjoying observer status with the Council of Europe, the European Union, and any State having been invited to sign this Convention.
2 Any amendment proposed by a Party shall be communicated to the European Committee on Crime Problems (CDPC) and other relevant Council of Europe intergovernmental or scientific committees, which shall submit to the Committee of the Parties their opinions on that proposed amendment.
3 The Committee of Ministers, having considered the proposed amendment and the opinion submitted by the Committee of the Parties, may adopt the amendment.
4 The text of any amendment adopted by the Committee of Ministers in accordance with paragraph 3 of this article shall be forwarded to the Parties for acceptance.
5 Any amendment adopted in accordance with paragraph 3 of this article shall enter into force on the first day of the month following the expiration of a period of one month after the date on which all Parties have informed the Secretary General that they have accepted it.
Chapter XI – Final clauses
Article 28 – Signature and entry into force
1 This Convention shall be open for signature by the member States of the Council of Europe, the European Union and the non-member States which have participated in its elaboration or enjoy observer status with the Council of Europe. It shall also be open for signature by any other non-member State of the Council of Europe upon invitation by the Committee of Ministers. The decision to invite a non-member State to sign the Convention shall be taken by the majority provided for in Article 20.d of the Statute of the Council of Europe, and by unanimous vote of the representatives of the Contracting States entitled to sit on the Committee of Ministers. This decision shall be taken after having obtained the unanimous agreement of the other States/European Union having expressed their consent to be bound by this Convention.
2 This Convention is subject to ratification, acceptance or approval. Instruments of ratification, acceptance or approval shall be deposited with the Secretary General of the Council of Europe.
3 This Convention shall enter into force on the first day of the month following the expiration of a period of three months after the date on which five signatories, including at least three member States of the Council of Europe, have expressed their consent to be bound by the Convention in accordance with the provisions of the preceding paragraph.
4 In respect of any State or the European Union, which subsequently expresses its consent to be bound by the Convention, it shall enter into force on the first day of the month following the expiration of a period of three months after the date of the deposit of its instrument of ratification, acceptance or approval.
Article 29 – Territorial application
1 Any State or the European Union may, at the time of signature or when depositing its instrument of ratification, acceptance or approval, specify the territory or territories to which this Convention shall apply.
2 Any Party may, at any later date, by a declaration addressed to the Secretary General of the Council of Europe, extend the application of this Convention to any other territory specified in the declaration and for whose international relations it is responsible or on whose behalf it is authorised to give undertakings. In respect of such territory, the Convention shall enter into force on the first day of the month following the expiration of a period of three months after the date of receipt of such declaration by the Secretary General.
3 Any declaration made under the two preceding paragraphs may, in respect of any territory specified in such declaration, be withdrawn by a notification addressed to the Secretary General of the Council of Europe. The withdrawal shall become effective on the first day of the month following the expiration of a period of three months after the date of receipt of such notification by the Secretary General.
Article 30 – Reservations
1 No reservation may be made in respect of any provision of this Convention, with the exception of the reservations expressly established.
2 Each Party which has made a reservation may, at any time, withdraw it entirely or partially by a notification addressed to the Secretary General of the Council of Europe. The withdrawal shall take effect from the date of the receipt of such notification by the Secretary General.
Article 31 – Friendly settlement
The Committee of the Parties will follow in close co-operation with the European Committee on Crime Problems (CDPC) and other relevant Council of Europe intergovernmental or scientific committees the application of this Convention and facilitate, when necessary, the friendly settlement of all difficulties related to its application.
Article 32 – Denunciation
1 Any Party may, at any time, denounce this Convention by means of a notification addressed to the Secretary General of the Council of Europe.
2 Such denunciation shall become effective on the first day of the month following the expiration of a period of three months after the date of receipt of the notification by the Secretary General.
Article 33 – Notification
The Secretary General of the Council of Europe shall notify the Parties, the member States of the Council of Europe, the non-member States having participated in the elaboration of this Convention or enjoying observer status with the Council of Europe, the European Union, and any State having been invited to sign this Convention in accordance with the provisions of Article 28, of:
a any signature;
b the deposit of any instrument of ratification, acceptance or approval;
c any date of entry into force of this Convention in accordance with Article 28;
d any amendment adopted in accordance with Article 27 and the date on which such an amendment enters into force;
e any reservation made under Articles 5, 6, 7, 9 and 10 and any withdrawal of a reservation made in accordance with Article 30;
f any denunciation made in pursuance of the provisions of Article 32;
g any other act, notification or communication relating to this Convention.
In witness whereof the undersigned, being duly authorised thereto, have signed this Convention.
Done in Moscow, this 28th day of October 2011, in English and in French, both texts being equally authentic, in a single copy which shall be deposited in the archives of the Council of Europe. The Secretary General of the Council of Europe shall transmit certified copies to each member State of the Council of Europe, to the non-member States which have participated in the elaboration of this Convention or enjoy observer status with the Council of Europe, to the European Union and to any State invited to sign this Convention.
O PONAREJANJU MEDICINSKIH IZDELKOV IN PODOBNIH KAZNIVIH DEJANJIH, KI OGROŽAJO JAVNO ZDRAVJE
Besedilo, popravljeno v skladu s sklepom Odbora ministrov, sprejetim na 1151. zasedanju namestnikov ministrov 18. in 19. septembra 2012.
Države članice Sveta Evrope in druge podpisnice te konvencije so se
ob upoštevanju, da je cilj Sveta Evrope doseči večjo enotnost med njegovimi članicami;
ob ugotovitvi, da ponarejanje medicinskih izdelkov in podobna kazniva dejanja že sama po sebi resno ogrožajo javno zdravje;
ob sklicevanju na akcijski načrt, ki je bil sprejet na tretjem vrhu voditeljev držav in vlad članic Sveta Evrope (Varšava, 16. in 17. maj 2005) ter priporoča razvoj ukrepov za krepitev varnosti evropskih državljanov;
ob upoštevanju Splošne deklaracije človekovih pravic, ki jo je Generalna skupščina Organizacije združenih narodov razglasila 10. decembra 1948, Konvencije o varstvu človekovih pravic in temeljnih svoboščin (1950, ETS št. 5), Evropske socialne listine (1961, ETS št. 35), Konvencije o izdelavi evropske farmakopeje (1964, ETS št. 50) in njenega protokola (1989, ETS št. 134), Konvencije o varstvu človekovih pravic in dostojanstva človeškega bitja v zvezi z uporabo biologije in medicine: Konvencije o človekovih pravicah v zvezi z biomedicino (1997, ETS št. 164) in dodatnih protokolov (1998, ETS št. 168, 2002, ETS št. 186, 2005, CETS št. 195, 2008, CETS št. 203) ter Konvencije o kibernetski kriminaliteti (2001, ETS št. 185);
ob upoštevanju drugega pomembnega dela Sveta Evrope, zlasti sklepov Odbora ministrov in dela Parlamentarne skupščine, zlasti Resolucije AP(2001)2 o vlogi farmacevta v okviru zdravstvene varnosti, odgovorov, ki jih je sprejel Odbor ministrov 6. aprila 2005 in 26. septembra 2007, glede – v navedenem zaporedju – priporočil Parlamentarne skupščine 1673 (2004) "Ponarejanje: problemi in rešitve" in 1794 (2007) "Kakovost zdravil v Evropi", ter ustreznih programov, ki jih izvaja Svet Evrope;
ob upoštevanju drugih ustreznih mednarodnopravnih aktov in programov, ki jih izvajajo predvsem Svetovna zdravstvena organizacija, še posebej skupina IMPACT, ter Evropska unija in forum G8;
odločene učinkovito prispevati k uresničitvi skupnega cilja boja proti kriminaliteti, ki vključuje ponarejanje medicinskih izdelkov in podobna kazniva dejanja, ki ogrožajo javno zdravje, zlasti z uvedbo novih kaznivih dejanj in kazenskih sankcij v zvezi s temi kaznivimi dejanji;
glede na to, da je namen te konvencije preprečevanje groženj za javno zdravje in boj proti njim, pri čemer je treba ob izvajanju določb konvencije, ki se nanašajo na materialno kazensko pravo, upoštevati njen namen in načelo sorazmernosti;
glede na to, da ta konvencija ne obravnava vprašanj v zvezi s pravicami intelektualne lastnine;
ob upoštevanju nujnosti priprave celovitega mednarodnega akta, ki bo osredotočen na vidike preprečevanja, zaščite žrtev in kazenskopravni vidik boja proti vsem oblikam ponarejanja medicinskih izdelkov in podobnih kaznivih dejanj, ki ogrožajo javno zdravje, in ki bo vzpostavil poseben mehanizem za spremljanje;
ob zavedanju, da je treba za učinkovit boj proti svetovni nevarnosti, ki jo pomenijo ponarejanje medicinskih izdelkov in podobna kazniva dejanja, spodbujati tesno mednarodno sodelovanje med članicami in nečlanicami Sveta Evrope,
dogovorile:
I. poglavje – Predmet in namen, načelo nediskriminacije, področje uporabe in opredelitev izrazov
1. člen – Predmet in namen
1 Namen te konvencije sta preprečevanje groženj za javno zdravje in boj proti njim z:
a zagotavljanjem določanja nekaterih dejanj za kazniva;
b zaščito pravic žrtev kaznivih dejanj, določenih v skladu s to konvencijo;
c zagotavljanjem sodelovanja na državni in mednarodni ravni.
2 Da bi pogodbenice učinkovito izvajale določbe te konvencije, se z njo vzpostavlja poseben mehanizem za spremljanje.
2. člen – Načelo nediskriminacije
Pogodbenice zagotavljajo izvajanje določb te konvencije, predvsem ukrepov za zaščito pravic žrtev, brez razlikovanja na kateri koli podlagi, kot je spol, rasa, barva kože, jezik, starost, vera, politično ali drugo prepričanje, narodnost ali družbeni izvor, pripadnost narodni manjšini, premoženje, rojstvo, spolna usmerjenost, zdravstveno stanje, invalidnost ali druge okoliščine.
3. člen – Področje uporabe
Ta konvencija se nanaša na medicinske izdelke ne glede na to, ali so zavarovani v skladu s pravicami intelektualne lastnine ali ne, ali so generični ali ne, vključno z opremo, namenjeno za uporabo skupaj z medicinskimi pripomočki, ter na zdravilne učinkovine, pomožne snovi, dele in materiale, namenjene za uporabo pri izdelavi medicinskih izdelkov.
4. člen – Opredelitev izrazov
V tej konvenciji:
a izraz "medicinski izdelek" pomeni zdravila in medicinske pripomočke;
b izraz "zdravilo" pomeni zdravila za uporabo v humani in veterinarski medicini, ki so lahko:
i vsaka snov ali kombinacija snovi, ki so predstavljene z lastnostmi za zdravljenje ali preprečevanje bolezni pri ljudeh ali živalih;
ii vsaka snov ali kombinacija snovi, ki se lahko uporablja pri ljudeh ali živalih ali se daje ljudem ali živalim, da bi se prek farmakološkega, imunološkega ali presnovnega delovanja ponovno vzpostavile, izboljšale ali spremenile fiziološke funkcije ali da bi se določila diagnoza;
iii zdravilo v preskušanju;
c izraz "zdravilna učinkovina" pomeni vsako snov ali mešanico snovi, ki je namenjena za uporabo pri proizvodnji zdravila in ki potem, ko se uporabi pri izdelavi zdravila, postane aktivna sestavina tega zdravila;
d izraz "pomožna snov" pomeni vsako snov, ki ni zdravilna učinkovina ali končno zdravilo, temveč je le del sestave zdravila za uporabo v humani ali veterinarski medicini in je ključnega pomena za celovitost končnega izdelka;
e izraz "medicinski pripomoček" pomeni vsak instrument, aparat, napravo, programsko opremo, material ali drug predmet, ki je uporabljen samostojno ali v kombinaciji, vključno s programsko opremo, ki jo je njegov proizvajalec predvidel izrecno za uporabo pri diagnostiki in/ali v terapevtske namene in je potrebna za njegovo pravilno uporabo, in ki ga je proizvajalec predvidel za uporabo pri ljudeh za:
i diagnosticiranje, preprečevanje, spremljanje, zdravljenje ali lajšanje bolezni;
ii diagnosticiranje, spremljanje, zdravljenje, lajšanje ali kompenzacijo poškodbe ali prizadetosti;
iii preiskovanje, nadomeščanje ali spreminjanje anatomije ali fiziološkega procesa;
iv nadzor nad spočetjem
in ki ne dosega svojega glavnega predvidenega učinka na človeško telo ali v njem s farmakološkimi, imunološkimi ali presnovnimi sredstvi, vendar pa so ta lahko v pomoč pri njegovem delovanju;
f izraz "dodatek" pomeni predmet, ki sicer ni medicinski pripomoček, vendar pa ga je njegov proizvajalec namenil izrecno za uporabo skupaj z medicinskim pripomočkom, da omogoči njegovo uporabo na način, kot ga je predvidel proizvajalec medicinskega pripomočka;
g izraza "deli" in "materiali" pomenita vse dele in materiale, ki so izdelani in se uporabljajo za medicinske pripomočke ter so ključni za njihovo celovitost;
h izraz "dokument" pomeni vsak dokument, ki se nanaša na medicinski izdelek, zdravilno učinkovino, pomožno snov, del, material ali dodatek, vključno z ovojnino, označevanjem, navodili za uporabo, potrdilom o poreklu ali katerim koli drugim potrdilom, ki je priloženo ali kako drugače neposredno povezano z njihovo proizvodnjo in/ali distribucijo;
i izraz "proizvodnja" pomeni:
i v zvezi z zdravilom kateri koli del postopka izdelave zdravila ali zdravilne učinkovine ali pomožne snovi takega izdelka ali postopka dokončanja izdelave zdravila, zdravilne učinkovine ali pomožne snovi;
ii v zvezi z medicinskim pripomočkom kateri koli del postopka izdelave medicinskega pripomočka in delov ali materialov za tak pripomoček, vključno z načrtovanjem pripomočka, delov ali materialov, ali postopka dokončanja izdelave medicinskega pripomočka, delov ali materialov;
iii v zvezi z dodatkom kateri koli del postopka izdelave dodatka, vključno z načrtovanjem dodatka, ali postopka dokončanja izdelave dodatka;
j izraz "ponarejanje" pomeni lažno predstavljanje glede identitete in/ali izvora;
k izraz "žrtev" pomeni vsako fizično osebo, ki utrpi neželene fizične ali duševne učinke zaradi uporabe ponarejenega medicinskega izdelka ali medicinskega izdelka, ki je bil proizveden, dobavljen ali dan na trg brez dovoljenja ali ne da bi izpolnjeval zahteve o skladnosti, kot je opisano v 8. členu.
II. poglavje – Materialno kazensko pravo
5. člen – Proizvodnja ponaredkov
1 Vsaka pogodbenica sprejme potrebne zakonodajne in druge ukrepe, s katerimi v svojem notranjem pravu kot kazniva dejanja določi naklepno proizvodnjo ponarejenih medicinskih izdelkov, zdravilnih učinkovin, pomožnih snovi, delov, materialov in dodatkov.
2 Prvi odstavek velja tudi za kakršno koli potvarjanje zdravil, in če je to primerno, medicinskih pripomočkov, zdravilnih učinkovin in pomožnih snovi.
3 Vsaka država ali Evropska unija lahko ob podpisu ali deponiranju svoje listine o ratifikaciji, sprejetju ali odobritvi z izjavo, naslovljeno na generalnega sekretarja Sveta Evrope, izjavi, da si pridržuje pravico, da ne uporablja prvega odstavka v zvezi s pomožnimi snovmi, deli in materiali ter drugega odstavka v zvezi s pomožnimi snovmi ali da ju uporablja samo v posebnih primerih ali pod posebnimi pogoji.
6. člen – Dobava, ponudba za dobavo in trgovanje s ponaredki
1 Vsaka pogodbenica sprejme potrebne zakonodajne in druge ukrepe, s katerimi v svojem notranjem pravu kot kazniva dejanja določi naklepno dobavo ali ponudbo za dobavo, vključno s posredništvom, trgovanjem, vključno s skladiščenjem, uvozom in izvozom ponarejenih medicinskih izdelkov, zdravilnih učinkovin, pomožnih snovi, delov, materialov in dodatkov.
2 Vsaka država ali Evropska unija lahko ob podpisu ali deponiranju svoje listine o ratifikaciji, sprejetju ali odobritvi z izjavo, naslovljeno na generalnega sekretarja Sveta Evrope, izjavi, da si pridržuje pravico, da ne uporablja prvega odstavka v zvezi s pomožnimi snovmi, deli in materiali ali da ga uporablja samo v posebnih primerih ali pod posebnimi pogoji.
7. člen – Ponarejanje dokumentov
1 Vsaka pogodbenica sprejme potrebne zakonodajne in druge ukrepe, s katerimi v svojem notranjem pravu kot kaznivo dejanje določi naklepno izdelavo ponarejenih dokumentov ali nedovoljeno spreminjanje dokumentov.
2 Vsaka država ali Evropska unija lahko ob podpisu ali deponiranju svoje listine o ratifikaciji, sprejetju ali odobritvi z izjavo, naslovljeno na generalnega sekretarja Sveta Evrope, izjavi, da si pridržuje pravico, da ne uporablja prvega odstavka v zvezi z dokumenti, ki se nanašajo na pomožne snovi, dele in materiale, ali da ga uporablja samo v posebnih primerih ali pod posebnimi pogoji.
8. člen – Podobna kazniva dejanja, ki ogrožajo javno zdravje
Vsaka pogodbenica sprejme potrebne zakonodajne in druge ukrepe, s katerimi v svojem notranjem pravu naslednja dejanja, kadar so storjena naklepno, določi kot kazniva, če tako ravnanje ni zajeto v 5., 6. in 7. členu:
a proizvodnjo, skladiščenje za dobavo, uvažanje, izvažanje, dobavo, ponudbo za dobavo ali dajanje v promet:
i zdravil brez dovoljenja, kadar se tako dovoljenje zahteva v skladu z notranjim pravom pogodbenice, ali
ii medicinskih pripomočkov, ki ne izpolnjujejo zahtev o skladnosti, kadar se taka skladnost zahteva po notranjem pravu pogodbenice;
b komercialno uporabo izvirnih dokumentov zunaj njihove predvidene uporabe v zakoniti dobavni verigi medicinskih izdelkov, kot jo določa notranje pravo pogodbenice.
9. člen – Pomoč ali napeljevanje in poskus
1 Vsaka pogodbenica sprejme potrebne zakonodajne in druge ukrepe, s katerimi kot kaznivo dejanje, kadar je storjeno naklepno, določi pomoč pri ali napeljevanje k storitvi katerega koli kaznivega dejanja, določenega v skladu s to konvencijo.
2 Vsaka pogodbenica sprejme potrebne zakonodajne in druge ukrepe, s katerimi kot kaznivo dejanje določi vsak naklepen poskus storitve kaznivega dejanja, določenega v skladu s to konvencijo.
3 Vsaka država ali Evropska unija lahko ob podpisu ali deponiranju svoje listine o ratifikaciji, sprejetju ali odobritvi z izjavo, naslovljeno na generalnega sekretarja Sveta Evrope, izjavi, da si pridržuje pravico, da ne uporablja drugega odstavka za kazniva dejanja, določena v skladu s 7. in 8. členom, ali da ga uporablja samo v posebnih primerih ali pod posebnimi pogoji.
10. člen – Sodna pristojnost
1 Vsaka pogodbenica sprejme potrebne zakonodajne in druge ukrepe, s katerimi določi svojo pristojnost za katero koli kaznivo dejanje, opredeljeno v skladu s to konvencijo, kadar:
a je storjeno na njenem ozemlju ali
b je storjeno na ladji, ki plove pod zastavo te pogodbenice, ali
c je storjeno na zrakoplovu, registriranem v skladu z zakonodajo te pogodbenice, ali
d ga stori njen državljan ali oseba z običajnim prebivališčem na njenem ozemlju.
2 Vsaka pogodbenica sprejme potrebne zakonodajne in druge ukrepe, s katerimi določi svojo pristojnost za katero koli kaznivo dejanje, opredeljeno v skladu s to konvencijo, kadar je žrtev kaznivega dejanja njen državljan ali oseba z običajnim prebivališčem na njenem ozemlju.
3 Vsaka pogodbenica sprejme potrebne zakonodajne ali druge ukrepe, s katerimi določi svojo pristojnost za katero koli kaznivo dejanje, opredeljeno v skladu s to konvencijo, kadar je domnevni storilec na njenem ozemlju in ga ni mogoče izročiti drugi pogodbenici na podlagi njegovega državljanstva.
4 Vsaka država ali Evropska unija lahko ob podpisu ali deponiranju svoje listine o ratifikaciji, sprejetju ali odobritvi z izjavo, naslovljeno na generalnega sekretarja Sveta Evrope, izjavi, da si pridržuje pravico, da ne uporablja pravil o sodni pristojnosti, določenih v pododstavku d prvega odstavka in v drugem odstavku tega člena, ali da jih uporablja samo v posebnih primerih ali pod posebnimi pogoji.
5 Kadar več pogodbenic uveljavlja sodno pristojnost glede domnevnega kaznivega dejanja, določenega v skladu s to konvencijo, se te pogodbenice, kadar je to primerno, posvetujejo o določitvi najprimernejše sodne pristojnosti za pregon.
6 Ne glede na splošna pravila mednarodnega prava ta konvencija ne izključuje kazenske pristojnosti, ki jo izvaja pogodbenica v skladu s svojim notranjim pravom.
11. člen – Odgovornost pravnih oseb
1 Vsaka pogodbenica sprejme potrebne zakonodajne in druge ukrepe, s katerimi zagotovi, da pravne osebe lahko odgovarjajo za kazniva dejanja, ki so opredeljena v skladu s to konvencijo, kadar jih v njihovo korist samostojno ali kot del organa pravne osebe stori fizična oseba, ki ima v njej vodilni položaj na podlagi:
a pravice zastopanja pravne osebe;
b pooblastila za odločanje v imenu pravne osebe;
c pooblastila za opravljanje nadzora v pravni osebi.
2 Poleg primerov iz prvega odstavka vsaka pogodbenica sprejme potrebne zakonodajne in druge ukrepe, s katerimi zagotovi, da lahko odgovarja pravna oseba, kadar je pomanjkljiv nadzor ali kontrola, ki jo opravlja fizična oseba iz prvega odstavka, omogočila, da je njej podrejena fizična oseba storila kaznivo dejanje, opredeljeno v skladu s to konvencijo, v korist te pravne osebe.
3 V skladu s pravnimi načeli pogodbenic je odgovornost pravne osebe lahko kazenska, civilna ali upravna.
4 Taka odgovornost ne vpliva na kazensko odgovornost fizičnih oseb, ki so storile kaznivo dejanje.
12. člen – Sankcije in ukrepi
1 Vsaka pogodbenica sprejme potrebne zakonodajne in druge ukrepe, s katerimi zagotovi, da se kazniva dejanja, opredeljena v skladu s to konvencijo in ob upoštevanju njihove teže, kaznujejo z učinkovitimi, sorazmernimi in odvračilnimi sankcijami, vključno s kazenskimi ali nekazenskimi denarnimi sankcijami. Za kazniva dejanja, ki so določena v skladu s 5. in 6. členom konvencije in jih storijo fizične osebe, te sankcije vključujejo kazni odvzema prostosti, kar je lahko povod za izročitev.
2 Vsaka pogodbenica sprejme potrebne zakonodajne in druge ukrepe, s katerimi zagotovi, da se pravne osebe, ki so odgovorne v skladu z 11. členom, kaznujejo z učinkovitimi, sorazmernimi in odvračilnimi sankcijami, ki vključujejo kazenske ali nekazenske denarne sankcije, lahko pa tudi druge ukrepe, kot so:
a začasna ali stalna prepoved opravljanja gospodarske dejavnosti;
b uvedba sodnega nadzora;
c sodno odrejeno prenehanje.
3 Vsaka pogodbenica sprejme potrebne zakonodajne in druge ukrepe, da:
a omogoči zaseg in odvzem:
i medicinskih izdelkov, zdravilnih učinkovin, pomožnih snovi, delov, materialov in dodatkov ter blaga, dokumentov in drugih pripomočkov, ki so bili uporabljeni za storitev kaznivih dejanj, opredeljenih v skladu s to konvencijo, ali so pripomogli k njihovi storitvi;
ii premoženjske koristi, pridobljene s temi kaznivimi dejanji, ali premoženja, katerega vrednost ustreza tej premoženjski koristi;
b dovoli uničenje zaseženih medicinskih izdelkov, zdravilnih učinkovin, pomožnih snovi, delov, materialov in dodatkov, ki so predmet kaznivega dejanja, opredeljenega v skladu s to konvencijo;
c sprejme druge ustrezne ukrepe kot odgovor na kaznivo dejanje, da se preprečijo kazniva dejanja v prihodnje.
13. člen – Obteževalne okoliščine
Vsaka pogodbenica sprejme potrebne zakonodajne in druge ukrepe, s katerimi zagotovi, da se lahko naslednje okoliščine, če niso že eden od znakov kaznivega dejanja, v skladu z ustreznimi določbami notranjega prava obravnavajo kot obteževalne okoliščine pri določanju sankcij v zvezi s kaznivimi dejanji, opredeljenimi v skladu s to konvencijo:
a kaznivo dejanje je povzročilo smrt ali resno prizadelo telesno ali duševno zdravje žrtve;
b kaznivo dejanje je storila oseba, ki je zlorabila zaupanje, ki ga je bila deležna kot strokovnjak;
c kaznivo dejanje je storila oseba, ki je zlorabila zaupanje, ki ga je bila deležna kot proizvajalec oziroma dobavitelj;
d kazniva dejanja dobave in ponudbe za dobavo so bila storjena z dostopom do sredstev široke distribucije, kot so informacijski sistemi, vključno z internetom;
e kaznivo dejanje je storila hudodelska združba;
f storilec je bil predhodno že obsojen za istovrstna kazniva dejanja.
14. člen – Predkaznovanost
Vsaka pogodbenica sprejme potrebne zakonodajne in druge ukrepe, s katerimi predvidi možnost, da se pri določanju sankcij upoštevajo pravnomočne sodbe, ki jih je v zvezi z istovrstnimi kaznivimi dejanji izrekla druga pogodbenica.
III. poglavje – Preiskovanje, pregon in procesno pravo
15. člen – Začetek in nadaljevanje postopka
Vsaka pogodbenica sprejme potrebne zakonodajne in druge ukrepe, s katerimi zagotovi, da preiskovanje ali pregon kaznivih dejanj, opredeljenih v skladu s to konvencijo, ni odvisen od prijave in da se postopek lahko nadaljuje tudi, če se prijava umakne.
16. člen – Kazenske preiskave
1 Vsaka pogodbenica sprejme potrebne ukrepe, s katerimi zagotovi, da so osebe, enote ali službe, ki vodijo kazenske preiskave, specializirane za boj proti ponarejanju medicinskih izdelkov in podobnim kaznivim dejanjem, ki ogrožajo javno zdravje, oziroma da so osebe usposobljene za ta namen, vključno s finančnimi preiskavami. Take enote ali službe morajo imeti ustrezne vire.
2 Vsaka pogodbenica sprejme potrebne zakonodajne in druge ukrepe, da v skladu z načeli svojega notranjega prava zagotovi učinkovito kazensko preiskavo in pregon kaznivih dejanj, opredeljenih v skladu s to konvencijo, in kadar je to primerno, dopusti možnost, da njeni pristojni organi izvajajo finančne preiskave, prikrite operacije, spremljajo nadzorovane pošiljke in uporabljajo druge posebne preiskovalne tehnike.
IV. poglavje – Sodelovanje organov in izmenjava podatkov
17. člen – Notranji ukrepi za sodelovanje in izmenjavo podatkov
1 Vsaka pogodbenica sprejme potrebne zakonodajne in druge ukrepe, s katerimi zagotovi izmenjavo podatkov in sodelovanje med predstavniki zdravstvenih organov, carino, policijo in drugimi pristojnimi organi v skladu s svojim notranjim pravom za preprečevanje in učinkovit boj proti ponarejanju medicinskih izdelkov in podobnim kaznivim dejanjem, ki ogrožajo javno zdravje.
2 Vsaka pogodbenica si prizadeva zagotoviti sodelovanje med svojimi pristojnimi organi ter trgovinskim in industrijskim sektorjem glede obvladovanja tveganj v zvezi s ponarejenimi medicinskimi izdelki in podobnimi kaznivimi dejanji, ki ogrožajo javno zdravje.
3 Ob spoštovanju zahtev glede varstva osebnih podatkov vsaka pogodbenica sprejme potrebne zakonodajne in druge ukrepe, s katerimi vzpostavi ali okrepi mehanizme za:
a sprejemanje in zbiranje informacij in podatkov, tudi prek kontaktnih točk, na državni ali lokalni ravni ter v sodelovanju z zasebnim sektorjem in civilno družbo z namenom preprečevanja ponarejanja medicinskih izdelkov in podobnih kaznivih dejanj, ki ogrožajo javno zdravje, in boja proti njim;
b dajanje na voljo informacij in podatkov, ki jih pridobijo zdravstveni organi, carina, policija in drugi pristojni organi za svoje medsebojno sodelovanje.
4 Vsaka pogodbenica sprejme potrebne ukrepe, s katerimi zagotovi, da so osebe, enote ali službe, pristojne za sodelovanje in izmenjavo podatkov, usposobljene za ta namen. Te enote ali službe morajo imeti ustrezne vire.
V. poglavje – Ukrepi za preprečevanje
18. člen – Preprečevalni ukrepi
1 Vsaka pogodbenica sprejme potrebne zakonodajne in druge ukrepe, s katerimi določi zahteve glede kakovosti in varnosti medicinskih izdelkov.
2 Vsaka pogodbenica sprejme potrebne zakonodajne in druge ukrepe, s katerimi zagotovi varno distribucijo medicinskih izdelkov.
3 Za preprečevanje ponarejanja medicinskih izdelkov, zdravilnih učinkovin, pomožnih snovi, delov, materialov in dodatkov vsaka pogodbenica sprejme potrebne ukrepe, s katerimi med drugim zagotovi:
a usposabljanje zdravstvenih strokovnjakov, izvajalcev, policijskih in carinskih organov ter ustreznih regulativnih organov;
b spodbujanje kampanj za ozaveščanje splošne javnosti z obveščanjem o ponarejenih medicinskih izdelkih;
c preprečevanje nezakonitega razpečevanja ponarejenih medicinskih izdelkov, zdravilnih učinkovin, pomožnih snovi, delov, materialov in dodatkov.
VI. poglavje – Ukrepi za zaščito
Vsaka pogodbenica sprejme potrebne zakonodajne in druge ukrepe, s katerimi zaščiti pravice in koristi žrtev, zlasti z:
a zagotavljanjem, da imajo žrtve dostop do informacij, ki se nanašajo na njihov primer in so potrebne za zaščito njihovega zdravja;
b pomočjo žrtvam pri njihovem telesnem, duševnem in socialnem okrevanju;
c zagotavljanjem, v svojem notranjem pravu, pravice žrtvam, da od storilcev dobijo odškodnino.
20. člen – Položaj žrtev v kazenskih preiskavah in postopkih
1 Vsaka pogodbenica sprejme potrebne zakonodajne in druge ukrepe, s katerimi zaščiti pravice in koristi žrtev v vseh fazah kazenskih preiskav in postopkov, zlasti z:
a obveščanjem žrtev o njihovih pravicah in storitvah, ki so jim na voljo, in, razen če tega ne želijo, o ukrepanju v zvezi z njihovo prijavo, mogočih obtožbah, splošnem poteku preiskave ali postopkov in njihovi vlogi pri tem ter rešitvi njihovega primera;
b omogočanjem žrtvam, da so v skladu s postopkovnimi pravili notranjega prava zaslišane, predložijo dokaze ter izberejo načine, kako bodo njihovi pogledi, potrebe in skrbi neposredno ali po tretji osebi predstavljeni ter obravnavani;
c zagotavljanjem žrtvam dostop do ustreznih podpornih služb, da so njihove pravice in koristi ustrezno predstavljene in upoštevane;
d zagotavljanjem učinkovitih ukrepov za varnost žrtev ter varnost njihovih družin in prič pred ustrahovanjem in maščevanjem.
2 Vsaka pogodbenica zagotovi, da imajo žrtve že od svojega prvega stika s pristojnimi organi dostop do informacij o ustreznih sodnih in upravnih postopkih.
3 Vsaka pogodbenica zagotovi, da imajo žrtve dostop do pravne pomoči, če je upravičeno, brezplačne, kadar so lahko stranke v kazenskih postopkih.
4 Vsaka pogodbenica sprejme potrebne zakonodajne in druge ukrepe, s katerimi zagotovi, da žrtve kaznivega dejanja, ki je opredeljeno v skladu s to konvencijo in ni bilo storjeno na ozemlju pogodbenice, v kateri imajo stalno prebivališče, lahko vložijo prijavo pri pristojnih organih države stalnega prebivališča.
5 Vsaka pogodbenica z zakonodajnimi ali drugimi ukrepi pod pogoji, ki jih določa njeno notranje pravo, skupinam, ustanovam, združenjem ali vladnim ali nevladnim organizacijam zagotovi možnost, da v kazenskih postopkih, ki se nanašajo na kazniva dejanja, opredeljena v skladu s to konvencijo, žrtvam z njihovo privolitvijo pomagajo in/ali jim zagotavljajo podporo.
VII. poglavje – Mednarodno sodelovanje
21. člen – Mednarodno sodelovanje v kazenskih zadevah
1 Pogodbenice v skladu s to konvencijo in na podlagi ustreznih veljavnih mednarodnih in regionalnih aktov in dogovorov, ki temeljijo na poenoteni ali vzajemni zakonodaji, ter notranjega prava čim bolj sodelujejo med seboj pri preiskavah ali postopkih v zvezi s kaznivimi dejanji, opredeljenimi v skladu s to konvencijo, vključno z zasegom in odvzemom.
2 Pogodbenice čim bolj sodelujejo med seboj pri izvajanju ustreznih veljavnih mednarodnih, regionalnih in dvostranskih sporazumov o izročitvi in medsebojni pravni pomoči v kazenskih zadevah v zvezi s kaznivimi dejanji, opredeljenimi v skladu s to konvencijo.
3 Če pogodbenica, ki za izročitev ali medsebojno pravno pomoč v kazenskih zadevah kot pogoj postavlja obstoj mednarodne pogodbe, od druge pogodbenice, s katero nima sklenjene take mednarodne pogodbe, prejme zaprosilo za izročitev ali pravno pomoč v kazenskih zadevah, lahko, ob popolni skladnosti s svojimi obveznostmi po mednarodnem pravu in pod pogoji, ki jih določa notranje pravo zaprošene pogodbenice, to konvencijo šteje za pravno podlago za izročitev ali medsebojno pravno pomoč v kazenskih zadevah v zvezi s kaznivimi dejanji, opredeljenimi v skladu s to konvencijo.
22. člen – Mednarodno sodelovanje pri preprečevanju in drugi upravni ukrepi
1 Pogodbenice sodelujejo pri zaščiti žrtev in pomoči žrtvam.
2 Pogodbenice, ne da bi posegale v svoje notranje sisteme poročanja, imenujejo nacionalno kontaktno točko, ki je pristojna za pošiljanje in sprejemanje zahtev za informacije in/ali sodelovanje v zvezi z bojem proti ponarejanju medicinskih izdelkov in podobnim kaznivim dejanjem, ki ogrožajo javno zdravje.
3 Vsaka pogodbenica si prizadeva, da v programe pomoči ali razvojne programe, ki so namenjeni tretjim državam, po potrebi vključi preprečevanje ponarejanja medicinskih izdelkov in podobnih kaznivih dejanj, ki ogrožajo javno zdravje, in boj proti njim.
VIII. poglavje – Mehanizem za spremljanje
23. člen – Odbor pogodbenic
1 Odbor pogodbenic sestavljajo predstavniki pogodbenic konvencije.
2 Odbor pogodbenic skliče generalni sekretar Sveta Evrope. Prvi sestanek je v enem letu po začetku veljavnosti te konvencije za deseto podpisnico, ki jo je ratificirala. Zatem se sestaja na zahtevo najmanj ene tretjine pogodbenic ali generalnega sekretarja.
3 Odbor pogodbenic sprejme svoj poslovnik.
4 Odboru pogodbenic pri opravljanju njegovih nalog pomaga Sekretariat Sveta Evrope.
5 Država pogodbenica, ki ni članica Sveta Evrope, prispeva k financiranju Odbora pogodbenic tako, kot po posvetu z njo odloči Odbor ministrov.
24. člen – Drugi predstavniki
1 Parlamentarna skupščina Sveta Evrope, Evropski odbor za vprašanja kriminalitete (CDPC) in drugi ustrezni medvladni ali znanstveni odbori Sveta Evrope imenujejo po enega predstavnika v Odbor pogodbenic, da se zagotovi večsektorski in večdisciplinarni pristop.
2 Odbor ministrov lahko po posvetovanju z Odborom pogodbenic povabi druge organe Sveta Evrope, da v Odbor pogodbenic imenujejo svojega predstavnika.
3 Predstavniki ustreznih mednarodnih organov so v Odbor pogodbenic lahko sprejeti kot opazovalci v skladu s postopkom, določenim na podlagi ustreznih pravil Sveta Evrope.
4 Predstavniki ustreznih uradnih organov pogodbenic so v Odbor pogodbenic lahko sprejeti kot opazovalci v skladu s postopkom, določenim na podlagi ustreznih pravil Sveta Evrope.
5 Predstavniki civilne družbe, zlasti nevladnih organizacij, so v Odbor pogodbenic lahko sprejeti kot opazovalci v skladu s postopkom, določenim na podlagi ustreznih pravil Sveta Evrope.
6 Pri imenovanju predstavnikov v skladu z drugim do petim odstavkom je treba zagotoviti uravnoteženo zastopanost različnih sektorjev in strok.
7 Predstavniki, imenovani v skladu s prvim do petim odstavkom zgoraj, na sestankih Odbora pogodbenic sodelujejo brez pravice glasovanja.
25. člen – Naloge Odbora pogodbenic
1 Odbor pogodbenic nadzira izvajanje te konvencije. Postopek za ocenjevanje izvajanja te konvencije je določen v poslovniku Odbora pogodbenic na podlagi večsektorskega in večdisciplinarnega pristopa.
2 Odbor pogodbenic omogoča lažje zbiranje, analizo in izmenjavo informacij, izkušenj in dobrih praks med državami, da se poveča njihova zmogljivost za preprečevanje ponarejanja medicinskih izdelkov in podobnih kaznivih dejanj, ki ogrožajo javno zdravje, in boj proti njim. Odbor lahko uporabi strokovno znanje drugih ustreznih odborov in organov Sveta Evrope.
3 Poleg tega Odbor pogodbenic, kadar je to primerno:
a spodbuja učinkovito uporabo in izvajanje te konvencije, vključno z ugotavljanjem vsakršnih težav in vplivov katere koli izjave ali pridržka, danega po tej konvenciji;
b izrazi mnenje o kakršnem koli vprašanju v zvezi z uporabo te konvencije in spodbuja izmenjavo informacij o pomembnih dogajanjih na področju prava, politik ali tehnologije;
c daje pogodbenicam posebna priporočila v zvezi z izvajanjem te konvencije.
4 Evropski odbor za vprašanja kriminalitete (CDPC) se redno obvešča o dejavnostih iz prvega, drugega in tretjega odstavka tega člena.
IX. poglavje – Razmerje do drugih mednarodnih aktov
26. člen – Razmerje do drugih mednarodnih aktov
1 Ta konvencija ne vpliva na pravice in obveznosti, ki izhajajo iz določb drugih mednarodnih aktov, katerih pogodbenice so ali bodo postale pogodbenice te konvencije in ki vsebujejo določbe o zadevah, ki jih ureja ta konvencija.
2 Pogodbenice konvencije lahko med seboj sklepajo dvostranske ali večstranske sporazume o zadevah, ki jih obravnava ta konvencija, da dopolnijo ali krepijo njene določbe ali omogočijo lažjo uporabo v njej vsebovanih načel.
X. poglavje – Spremembe konvencije
1 Vsak predlog za spremembo te konvencije, ki ga pripravi pogodbenica, se sporoči generalnemu sekretarju Sveta Evrope, ki ga pošlje pogodbenicam, državam članicam Sveta Evrope, državam nečlanicam, ki so sodelovale pri pripravi te konvencije ali imajo status opazovalke pri Svetu Evrope, Evropski uniji in vsaki državi, ki je bila povabljena k podpisu te konvencije.
2 Vsaka sprememba, ki jo predlaga pogodbenica, se sporoči Evropskemu odboru za vprašanja kriminalitete (CDPC) in drugim ustreznim medvladnim ali znanstvenim odborom Sveta Evrope, ki svoje mnenje o predlagani spremembi sporočijo Odboru pogodbenic.
3 Odbor ministrov lahko, potem ko je proučil predlagano spremembo in mnenje Odbora pogodbenic, spremembo sprejme.
4 Besedilo vsake spremembe, ki jo sprejme Odbor ministrov v skladu s tretjim odstavkom tega člena, se pošlje pogodbenicam v sprejetje.
5 Vsaka sprememba, sprejeta v skladu s tretjim odstavkom tega člena, začne veljati prvi dan meseca po poteku enega meseca po dnevu, ko so vse pogodbenice obvestile generalnega sekretarja, da so jo sprejele.
XI. poglavje – Končne določbe
28. člen – Podpis in začetek veljavnosti
1 Ta konvencija je na voljo za podpis državam članicam Sveta Evrope, Evropski uniji in državam nečlanicam, ki so sodelovale pri njeni pripravi ali imajo status opazovalke pri Svetu Evrope. Na povabilo Odbora ministrov je na voljo za podpis tudi vsaki drugi državi, ki ni članica Sveta Evrope. Odločitev, da se država nečlanica povabi k podpisu konvencije, se sprejme z večino, določeno v odstavku d 20. člena Statuta Sveta Evrope, in s soglasjem vseh predstavnikov držav pogodbenic, ki imajo pravico sodelovati v Odboru ministrov. Ta odločitev se sprejme po pridobitvi soglasja drugih držav/Evropske unije, ki so že izrazile soglasje, da jih ta konvencija zavezuje.
2 To konvencijo je treba ratificirati, sprejeti ali odobriti. Listine o ratifikaciji, sprejetju ali odobritvi se deponirajo pri generalnem sekretarju Sveta Evrope.
3 Ta konvencija začne veljati prvi dan meseca po poteku treh mesecev po dnevu, ko je pet podpisnic, vključno z najmanj tremi državami članicami Sveta Evrope, v skladu z določbami prejšnjega odstavka izrazilo svojo privolitev, da jih konvencija zavezuje.
4 Za vsako državo ali Evropsko unijo, ki pozneje izrazi svojo privolitev, da jo konvencija zavezuje, ta začne veljati prvi dan meseca po poteku treh mesecev po dnevu deponiranja njene listine o ratifikaciji, sprejetju ali odobritvi.
29. člen – Ozemeljska uporaba
1 Vsaka država ali Evropska unija lahko ob podpisu ali deponiranju listine o ratifikaciji, sprejetju ali odobritvi določi ozemlje ali ozemlja, na katerih se ta konvencija uporablja.
2 Vsaka pogodbenica lahko kadar koli pozneje z izjavo, naslovljeno na generalnega sekretarja Sveta Evrope, razširi uporabo konvencije na katero koli drugo ozemlje, ki je navedeno v izjavi in za katerega mednarodne odnose je odgovorna ali v imenu katerega je pooblaščena prevzemati obveznosti. Za tako ozemlje začne konvencija veljati prvi dan meseca po poteku treh mesecev po dnevu, ko generalni sekretar prejme tako izjavo.
3 Vsaka izjava, dana na podlagi prejšnjih dveh odstavkov, se lahko za vsako ozemlje, ki je v njej navedeno, umakne z uradnim obvestilom, naslovljenim na generalnega sekretarja Sveta Evrope. Umik začne veljati prvi dan meseca po poteku treh mesecev po dnevu, ko generalni sekretar prejme tako uradno obvestilo.
1 Glede določb te konvencije ni mogoč noben pridržek, razen tistih, ki so izrecno predvideni.
2 Vsaka pogodbenica, ki je dala pridržek, ga lahko kadar koli v celoti ali deloma umakne z uradnim obvestilom, naslovljenim na generalnega sekretarja Sveta Evrope. Umik začne veljati z dnem, ko generalni sekretar prejme tako uradno obvestilo.
31. člen – Prijateljsko reševanje
Odbor pogodbenic bo v tesnem sodelovanju z Evropskim odborom za vprašanja kriminalitete (CDPC) in drugimi ustreznimi medvladnimi ali znanstvenimi odbori Sveta Evrope spremljal uporabo te konvencije in po potrebi omogočil prijateljsko reševanje vseh težav, povezanih z njeno uporabo.
1 Vsaka pogodbenica lahko kadar koli odpove to konvencijo z uradnim obvestilom, naslovljenim na generalnega sekretarja Sveta Evrope.
2 Taka odpoved začne veljati prvi dan meseca po poteku treh mesecev po dnevu, ko generalni sekretar prejme uradno obvestilo.
33. člen – Uradno obvestilo
Generalni sekretar Sveta Evrope pogodbenice, države članice Sveta Evrope, države nečlanice, ki so sodelovale pri pripravi te konvencije ali imajo status opazovalke pri Svetu Evrope, Evropsko unijo in vsako državo, ki je bila povabljena k podpisu te konvencije v skladu z določbami 28. člena, uradno obvesti o:
a vsakem podpisu;
b deponiranju vsake listine o ratifikaciji, sprejetju ali odobritvi;
c vsakem dnevu začetka veljavnosti te konvencije v skladu z 28. členom;
d vsaki spremembi, sprejeti v skladu s 27. členom, in datumu začetka veljavnosti take spremembe;
e vsakem pridržku, danem po 5., 6., 7., 9. in 10. členu, ter vsakem umiku pridržka v skladu s 30. členom;
f vsaki odpovedi na podlagi določb 32. člena;
g vsakem drugem dejanju, uradnem obvestilu ali sporočilu v zvezi s to konvencijo.
V potrditev tega so podpisani, ki so bili za to pravilno pooblaščeni, podpisali to konvencijo.
Sklenjeno v Moskvi, dne 28. oktobra 2011, v angleškem in francoskem jeziku, pri čemer sta besedili enako verodostojni, v enem izvodu, ki se hrani v arhivu Sveta Evrope. Generalni sekretar Sveta Evrope pošlje overjene kopije vsaki državi članici Sveta Evrope, državam nečlanicam, ki so sodelovale pri pripravi te konvencije ali imajo status opazovalke pri Svetu Evrope, Evropski uniji in vsaki državi, ki je bila povabljena k podpisu te konvencije.
Republika Slovenija daje naslednji pridržek:
»V skladu s četrtim odstavkom 10. člena konvencije Republika Slovenija izjavlja, da si pridržuje pravico, da ne uporablja pravil o sodni pristojnosti, določenih v pododstavku d prvega odstavka in v drugem odstavku 10. člena te konvencije.«.
Za izvajanje konvencije skrbi ministrstvo, pristojno za zdravje, v sodelovanju z ministrstvom, pristojnim za pravosodje, ministrstvom, pristojnim za notranje zadeve, ministrstvom, pristojnim za carinski sistem, ministrstvom, pristojnim za veterinarstvo, ministrstvom, pristojnim za zunanje zadeve, in Vrhovnim državnim tožilstvom Republike Slovenije.
Ta zakon začne veljati petnajsti dan po objavi v Uradnem listu Republike Slovenije – Mednarodne pogodbe.
Št. 500-01/18-30/11
Ljubljana, dne 16. marca 2022
EPA 346-VIII
