Resolução da Assembleia da República n.º 305/2018
Resolução da Assembleia da República n.º 305/2018
Aprova a Convenção do Conselho da Europa Relativa à Contrafação de Medicamentos e Infrações Semelhantes que Envolvam Ameaças à Saúde Pública, aberta a assinatura em Moscovo, em 28 de outubro de 2011.
A Assembleia da República resolve, nos termos da alínea i) do artigo 161.º e do n.º 5 do artigo 166.º da Constituição, aprovar a Convenção do Conselho da Europa Relativa à Contrafação de Medicamentos e Infrações Semelhantes que Envolvam Ameaças à Saúde Pública, aberta a assinatura em Moscovo, em 28 de outubro de 2011, cujo texto, na versão autenticada em línguas inglesa e francesa, e respetiva tradução para língua portuguesa, se publica em anexo.
Aprovada em 2 de março de 2018.
O Presidente da Assembleia da República, Eduardo Ferro Rodrigues.
COUNCIL OF EUROPE CONVENTION ON THE COUNTERFEITING OF MEDICAL PRODUCTS AND SIMILAR CRIMES INVOLVING THREATS TO PUBLIC HEALTH (*)
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:
Object and purpose, principle of non-discrimination, scope, definitions
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.
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.
Substantive criminal law
Manufacturing of counterfeits
1 - Each Party shall take the necessary legislative and other measures to establish as offences under its domestic law, the...
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