scholarly journals THE PROBLEMS OF CRIMINALIZATION OF THE SIMILAR CRIMES INVOLVING THREATS TO PUBLIC HEALTH (ARTICLE 8 OF THE COUNCIL OF EUROPE CONVENTION ON THE COUNTERFEITING OF MEDICAL PRODUCTS AND SIMILAR CRIMES INVOLVING THREATS TO PUBLIC HEALTH)

2020 ◽  
Vol 73 (12) ◽  
pp. 2733-2736
Author(s):  
Pavlo S. Berzin ◽  
Ivan S. Demchenko ◽  
Anzhela B. Berzina
Keyword(s):  
Public Health ◽  
Medical Devices ◽  
Structural Method ◽  
Medicinal Products ◽  
Council Of Europe ◽  
Medical Products ◽  
Commercial Use ◽  
Criminal Legislation ◽  
Intentional Acts ◽  
Active Substances

The aim: Medicrime Convention is a first international treaty against counterfeit medical products and similar crimes involving threats to public health. There are problems in criminalization of those acts that are listed in Art. 8 of the Medicrime Convention because the term of “similar crimes” is absent in the current criminal legislation of Ukraine. Materials and methods: The conducted study is based on the analysis of the provisions of the Medicrime Convention, the criminal legislation of Ukraine. The following methods: dialectical method; hermeneutic method; system-and-structural method; comparative-and-law method were used. Results: Comparison of the provisions of the Medicrime Convention allows to state that crimes in its Articles 5-8 that are different from those provided for in Art. 5-7 of this Convention and form independent types of actions, are at least “placing on the market” of medicinal products and medical devices provided in subparagraph “a” of paragraph 1 of Art. 8 and “commercial use of original documents” specified in subparagraph “b” of paragraph 1 of Art. 8. It's an assumption that Art. 5-8 of the Medicrime Convention provide for such independent types of crimes involving threats to public health as: 1) manufacturing of counterfeit medical products, active substances, excipients, parts, materials and accessories as well as medicinal products, medical devices, active substances and excipients; 2) the supplying, the offering to supply, the brokering, the trafficking, the keeping in stock, importing and exporting of counterfeit medical products, active substances, excipients, parts, materials and accessories; 3) the making of false documents or the act of tampering with documents; 4) placing on the market of medicinal products, medical devices; 5) the commercial use of false documents. Conclusions: The term of “similar crimes” in Art. 8 of the Medicrime Convention covers multi-ordinal intentional acts that constitute different types of independent crimes involving threats to public health, as well as special kinds of some of them. These types of crimes are not the same (identical).

scholarly journals THE PROBLEMS OF DEFINITION OF THE ABETTING IN THE COMISSION OF THE OFFENCES INVOLVING THREATS TO PUBLIC HEALTH (PART 1 OF ARTICLE 9 OF THE COUNCIL OF EUROPE CONVENTION ON THE COUNTERFEITING OF MEDICAL PRODUCTS AND SIMILAR CRIMES INVOLVING THREATS TO PUBLIC HEALTH)

2021 ◽  
Vol 74 (11) ◽  
pp. 2912-2915
Author(s):  
Pavlo S. Berzin ◽  
Ivan S. Demchenko ◽  
Anzhela B. Berzina
Keyword(s):  
Public Health ◽  
Criminal Code ◽  
Structural Method ◽  
Council Of Europe ◽  
Legal Method ◽  
Criminal Offenses ◽  
Adequate Understanding ◽  
The Subject ◽  
Definition Of ◽  
Criminal Legislation

The aim: based on the features of the notion of “abetting the commission of crimes established in accordance with the Convention” provided for in Part 1 of Art. 9 of the Medicrime Convention, it is necessary to offer an adequate understanding of the notion of “abetting” and define the types of criminal offenses (crimes) that are the “subject” of such abetting. Materials and methods: the research is based on an analysis of the provisions of the Medicrime Convention and the criminal law of Ukraine. The following methods were used: dialectical method; hermeneutic method; systemic-and-structural method; and comparative-legal method. Results: at the legislative level, there is a problem of designating the relevant socio-legal phenomena with adequate concepts and interpretations of these concepts. In the current criminal legislation of Ukraine, there is no definition of the concept of “abetting”, which is used in Part 1 of Art. 9 of the Medicrime Convention. Therefore, in the implementation of the requirements provided for in Part 1 of Art. 9 of the Medicrime Convention, each Party takes the necessary legislative and other measures to recognize abetting in committing any crimes, established under this Convention, as a crime, therefore we should take into account the existence of two alternative ways to explain the meaning of “abetting”: 1) to recognize at the legislative level that “abetting” and “incitement” are synonyms, and therefore the meaning of the term “abetting” can be explained by using the term “inclination”; 2) to recognize at the legislative level that the concept of “abetting” has a meaning different from the concept of “incitement”, and covers not only “inclination”, but also “coercion”, “motivation” and “encouragement”. Conclusions: the main disadvantage of using the concept of “abetting” in the text of the Ukrainian translation of the Medicrime Convention is that without an independent explanation of this concept at the legislative level, its content should be determined depending on the meaning of the term “inciter” under Part 4 of Art. 27 of the Criminal Code of Ukraine), and means inciting a person to commit any of the crimes specified in the Medicrime Convention.

scholarly journals Medicines Counterfeiting in Africa: A View from Zimbabwe

2017 ◽  
Vol 1 ◽  
pp. maapoc.0000017 ◽  
Author(s):  
Shingai D. Gwatidzo ◽  
Petronella K. Murambinda ◽  
Zivanai Makoni
Keyword(s):  
Public Health ◽  
Public Education ◽  
Medical Devices ◽  
Quantitative Data ◽  
Regulatory Authority ◽  
Medicinal Products ◽  
Street Vendors ◽  
Qualitative And Quantitative ◽  
Leading Role ◽  
Control Authority

With the sprouting of unregulated outlets on the streets of Zimbabwe, common questions that are raised include: (i) what is the Medicines Control Authority of Zimbabwe (MCAZ) doing about these street vendors? and (ii) is the law against unregulated markets and proliferation of substandard and falsified (SF) medicines being actively enforced? There is no doubt that this is a new challenge for MCAZ because of the risks involved with SF medicines. Notwithstanding the rather strong regulatory framework for the regulated market that the MCAZ has major control over, and its demonstrable regulatory prowess over the last 20 years as a National Medicines Regulatory Authority (NMRA), MCAZ is increasingly challenged to take a leading role in addressing this rising phenomenon. MCAZ has attempted to address the problem through collaboration with the Zimbabwe Republic Police (ZRP), public education and inspections by port officials at ports of entry. However, the problem still persists. A general lack of concrete qualitative and quantitative data on the commonly encountered SF medicinal products on the Zimbabwe market is another major issue. This is evidently a multi-layered problem and as the Shona adage goes “chara chimwe hachitswanye inda” (loosely translated “one thumb cannot crush all lice”), there is need for engaging local and regional partners in a bid to fulfil the MCAZ's mandate of protecting public health by ensuring medicines and medical devices intended for sale and distribution in Zimbabwe, are safe, effective and of good quality.

Company News

2001 ◽  
Vol 05 (14) ◽  
pp. 291-301
Keyword(s):  
Medical Devices ◽  
Strategic Alliance ◽  
State Of The Art ◽  
Life Sciences ◽  
Medical Products ◽  
First Order ◽  
Commercial Use ◽  
Sign Distribution ◽  
Wastewater Recycling ◽  
Set Up

Cell Robotics' Medical Devices Well Received in China. US National Nutritional Foods Association and China's Sanjiu Pharmaceutical Establish Historic Partnership. Novacor LVAS Approved for Commercial Use in Japan. NOMOS and Lynmed to Jointly Distribute Medical Products in China and HK. Eli Lilly to Buy Out Ranbaxy's Stake. US-based Dragon Expands Business in Hong Kong and China. Australia's Global Doctor and US MedAire Announce Strategic Alliance. Taiwan's Gene Born Biotech Corp Adopts Thermogenesis's BioArchive System. Cepheid and BioSynTech Sign Distribution Agreement To Enter Life Sciences Research Market in Southeast Asia. Harbin Pharmaceutical Completes China's Largest Antibiotic Wastewater Recycling Project. Eli Lilly to Set Up State-of-the-Art Systems Biology R&D Center in Singapore. Varian Receives First Order for World's Most Powerful NMR Spectrometer from Japan.

scholarly journals Council of Europe Convention on counterfeiting of medicinal products and similar crimes involving threats to public health

2020 ◽  
Vol 51 (1) ◽  
pp. 1-4
Author(s):  
Svjetlana Terzić ◽  
Miroslav Andrišić ◽  
Eleonora Perak Junaković ◽  
Dominika Fajdić ◽  
Mirta Pehnec ◽  
...  
Keyword(s):  
Public Health ◽  
Medicinal Products ◽  
Council Of Europe

Dana 1. siječnja 2020. godine u Republici Hrvatskoj na snagu je stupila Konvencija Vijeća Europe o krivotvorenju farmaceutskih proizvoda i sličnim kažnjivim djelima koja uključuju prijetnje javnom zdravlju (engl. Council of Europe Convention on counterfeiting of medicinal products and similar crimes involving threats to public health). Konvencija je potpisana 3. rujna 2015. godine, a Vlada Republike Hrvatske ju je ratificirala 20. rujna 2019. godine. Konvencija se odnosi i na medicinske proizvode koji se koriste u veterinarskoj medicini. Važnost borbe protiv krivotvorenih lijekova prepoznata je u Hrvatskoj godinama, a Hrvatska je i jedna od brojnih sudionica Interpolovih akcija protiv krivotvorenih lijekova. Prihvaćanjem ove Konvencije otvara se mogućnost učinkovitijeg nadzora nad krivotvorenim lijekovima za primjenu u humanoj i veterinarskoj medicini te bolja međunarodna suradnja.

scholarly journals European Patients' Rights to Be Protected Against Counterfeit Medicines

2019 ◽  
Vol 2 (1) ◽  
pp. 8
Author(s):  
Cristina Luiza Erimia ◽  
Rodica Sîrbu ◽  
Radu George Cazacincu ◽  
Emin Cadar ◽  
Aneta Tomescu ◽  
...  
Keyword(s):  
Public Health ◽  
General Meeting ◽  
Internal Market ◽  
World Health ◽  
Legislative Process ◽  
Medicinal Products ◽  
Medical Products ◽  
Falsified Medicines ◽  
Health Organization ◽  
The Impact

Because the falsification of medicines is a global problem, requires increased and effective international coordination and cooperation to ensure the effectiveness of the strategies to combat counterfeiting, especially in relation to the sale of such products on the Internet. In the context of people’s health and life rank foremost among the values and interests protected by the TFEU, this article examines the evolution of the legislative process regulating the internal market for medicinal products in order to ensure a high level of protection of public health against falsified medicines and to present the legislative initiatives that have been taken at EU level taking account of new risk profiles, measures meant to ensure, at the same time, the functioning of the internal market of medicinal products. However, this article aims to address consumers’ right to have access to safe, effective, quality and innovative medicinal products as a right of the European patient. Ensuring the free movement of medicinal products on the EU market must not violate or restrict this fundamental right of thepatient.The threat that falsified medicines pose to public health is also recognized by the World Health Organization (WHO), which has established the International Medical Products Anti-Counterfeiting Taskforce ("IMPACT").IMPACT has developed the Principles and Elements for National Legislation against Counterfeit Medical Products, which were endorsed by the IMPACT General Meeting in Lisbon on 12 December 2007.

scholarly journals European Patients' Rights to Be Protected Against Counterfeit Medicines

2016 ◽  
Vol 4 (1) ◽  
pp. 34 ◽  
Author(s):  
Cristina Luiza Erimia ◽  
Rodica Sîrbu ◽  
Radu George Cazacincu ◽  
Emin Cadar ◽  
Aneta Tomescu ◽  
...  
Keyword(s):  
Public Health ◽  
General Meeting ◽  
Internal Market ◽  
World Health ◽  
Legislative Process ◽  
Medicinal Products ◽  
Medical Products ◽  
Falsified Medicines ◽  
Health Organization ◽  
The Impact

Because the falsification of medicines is a global problem, requires increased and effective international coordination and cooperation to ensure the effectiveness of the strategies to combat counterfeiting, especially in relation to the sale of such products on the Internet. In the context of people’s health and life rank foremost among the values and interests protected by the TFEU, this article examines the evolution of the legislative process regulating the internal market for medicinal products in order to ensure a high level of protection of public health against falsified medicines and to present the legislative initiatives that have been taken at EU level taking account of new risk profiles, measures meant to ensure, at the same time, the functioning of the internal market of medicinal products. However, this article aims to address consumers’ right to have access to safe, effective, quality and innovative medicinal products as a right of the European patient. Ensuring the free movement of medicinal products on the EU market must not violate or restrict this fundamental right of thepatient.The threat that falsified medicines pose to public health is also recognized by the World Health Organization (WHO), which has established the International Medical Products Anti-Counterfeiting Taskforce ("IMPACT").IMPACT has developed the Principles and Elements for National Legislation against Counterfeit Medical Products, which were endorsed by the IMPACT General Meeting in Lisbon on 12 December 2007.

scholarly journals European Patients' Rights to Be Protected Against Counterfeit Medicines

2016 ◽  
Vol 2 (1) ◽  
pp. 34
Author(s):  
Cristina Luiza Erimia ◽  
Rodica Sîrbu ◽  
Radu George Cazacincu ◽  
Emin Cadar ◽  
Aneta Tomescu ◽  
...  
Keyword(s):  
Public Health ◽  
General Meeting ◽  
Internal Market ◽  
World Health ◽  
Legislative Process ◽  
Medicinal Products ◽  
Medical Products ◽  
Falsified Medicines ◽  
Health Organization ◽  
The Impact

Because the falsification of medicines is a global problem, requires increased and effective international coordination and cooperation to ensure the effectiveness of the strategies to combat counterfeiting, especially in relation to the sale of such products on the Internet. In the context of people’s health and life rank foremost among the values and interests protected by the TFEU, this article examines the evolution of the legislative process regulating the internal market for medicinal products in order to ensure a high level of protection of public health against falsified medicines and to present the legislative initiatives that have been taken at EU level taking account of new risk profiles, measures meant to ensure, at the same time, the functioning of the internal market of medicinal products. However, this article aims to address consumers’ right to have access to safe, effective, quality and innovative medicinal products as a right of the European patient. Ensuring the free movement of medicinal products on the EU market must not violate or restrict this fundamental right of thepatient.The threat that falsified medicines pose to public health is also recognized by the World Health Organization (WHO), which has established the International Medical Products Anti-Counterfeiting Taskforce ("IMPACT").IMPACT has developed the Principles and Elements for National Legislation against Counterfeit Medical Products, which were endorsed by the IMPACT General Meeting in Lisbon on 12 December 2007.

scholarly journals Study of the Effectiveness against Test Strain Mycobacterium terrae DSM 43227 of Some Substances Containing Fragment of Phenolic

2016 ◽  
Vol 15 (4) ◽  
pp. 37-41
Author(s):  
T. A. Grenkova ◽  
A. I. Chizhov ◽  
M. P. Gusarova ◽  
N. V. Gudova
Keyword(s):  
Public Health ◽  
Mycobacterium Tuberculosis ◽  
Phenolic Compounds ◽  
Medical Devices ◽  
Test Strain ◽  
Drug Resistant ◽  
Phenol Compounds ◽  
Low Concentrations ◽  
The World ◽  
Active Substances

Relevance. Multi-drug-resistant Mycobacterium tuberculosis has been an important problem in public health around the world. However, development of effective methods and means of disinfection is now extremely urgent. Phenol is probably the oldest known disinfectant. Disinfectants based on substances containing phenolic practically used in almost every countries of the worldwide for the disinfection of medical devices, surfaces and hand hygiene. Goal. Comparative study of the activity of certain disinfectants containing phenol fragment against the test strain. Materials and methods. Multi-drug-resistant M. terrae, M. avium-intracellulara and M. tuberculosis have similar characteristics of resistance to chemical disinfectants, herefore M. terrae DSM 43227 used as the test strain. We studied five used in Russia for the production of disinfectants and antiseptics. substances containing a phenolic. Results. The disinfectant effect of substances with phenol compounds was detected in lower concentrations (from 0.02% for 2-benzil-4-chlorphenol to 1.0% for ortophenylphenol) than with substances containing glutaraldehyde or chloramine B compounds. Conclusions. Saving disinfecting effectiveness at low concentrations of the active substances in the working solutions can be recommended disinfectants based on phenolic compounds for disinfection measures in the complex of measures for prevention of occurrence and spread of tuberculosis.

scholarly journals FALSIFICATION OF MEDICAL PRODUCTS: CRIMINAL LAW MECHANISM COMBATING THREATS TO PUBLIC HEALTH

2019 ◽  
Vol 72 (5) ◽  
pp. 856-861
Author(s):  
Nataliya Gutorova ◽  
Oleksandr Zhytnyi ◽  
Oleksii Soloviov
Keyword(s):  
Public Health ◽  
United Nations ◽  
Criminal Law ◽  
Organized Crime ◽  
Criminal Liability ◽  
Transnational Organized Crime ◽  
Medical Products ◽  
United Nations Convention ◽  
The United Nations ◽  
Criminal Legislation

Introduction: Every civilized state has the duty to its citizens to create an effective health care system, a necessary component of which is the use of safe and high-quality medical products. This duty is based both on the standards of international law and national constitutional norms and principles. The spread of falsified medical products poses a global threat to public health, can lead to death or cause significant harm to human health. Given the extreme risk of such acts, there is a need to create and operate an effective criminal law mechanism to combat such acts. The aim: The purpose of the article is to study the existing criminal law mechanism to combat the falsification of medical products at the international, regional and national levels (Poland and Ukraine as an example), as well as to develop proposals for improving of such a mechanism. Materials and methods: This study is based on the empirical and analytical data of the WHO, the United Nations Convention against Transnational Organized Crime, the Council of Europe Convention on the counterfeiting of medical products and similar crimes involving threats to public health (The Medicrime Convention), criminal legislation of Ukraine and Poland, General Prosecutor’s Office data on the criminal liability of those who committed falsification of medicines. Totally 28 laws and papers, 25 court judgments were analyzed. Dialectical, comparative, analytic, synthetic and system analyses research methods were used, also for interpretation purposes. Results: Falsification of medical products worldwide is characterized by high prevalence and is one of the highly profitable activities of transnational organized crime. Therefore, an effective counteraction to these crimes is impossible through isolated actions by one separate State and requires the establishment of a multi-level integrated mechanism to combat this phenomenon. The criminal law mechanism, as a necessary component of abovementioned mechanism, should be established at the international, regional and national levels. An analysis of the situation in Poland and Ukraine showed that the falsification of medical products is quite common in these countries, but national criminal legislation and practice of its implementation needs improvement. Conclusions: There is a need to create and implement an effective criminal law mechanism (at international, regional and national levels) to combat the spread of falsified medical products. At the international level, in order to increase the effectiveness of this mechanism, we fully support the EU initiative to amend the United Nations Convention against Transnational Organized Crime, which would establish additional liability for the falsification of medicines. Improving the criminal law mechanism to combat the falsification of medical products at the European regional level requires intensifying of The Medicrime Convention ratification process and full implementation of rules on criminal liability for falsifying medical products into national criminal legislation. At the national level, it is necessary to improve both the criminal legislation and the practice of its implementation, to intensify the activity of law enforcement agencies to combat these crimes, to ensure a fair trial and effective criminal penalties for those who have committed a crime of falsifying medical products.

scholarly journals Detection of Possible Medical Product-Related Infection or Pathogen Transmission—United States, 2015–2019

2020 ◽  
Vol 41 (S1) ◽  
pp. s30-s31
Author(s):  
Isaac Benowitz ◽  
Joseph Perz ◽  
Julia Marders
Keyword(s):  
Public Health ◽  
Infection Control ◽  
Medical Devices ◽  
Medical Product ◽  
Pathogen Transmission ◽  
Healthcare Associated Infections ◽  
Healthcare Facilities ◽  
Biological Products ◽  
Medical Products ◽  
Healthcare Associated

Background: Medications, medical devices, biological products, and other medical products can cause healthcare-associated infections related to contamination in production or transportation (intrinsic contamination) or contamination at the point of use (extrinsic contamination). Rapid identification of contaminated medical products can lead to actions to decrease further patient harm. We sought to describe events that prompted public health investigations of contaminated medical products in healthcare facilities. Methods: We reviewed records of CDC consultations with health departments and healthcare facilities from January 2015 through August 2019 to identify public health investigations in which medical products were identified as a likely source of patient infection or pathogen transmission to at least 1 patient. We collected data on products, contamination type, pathogens, route of patient exposure, healthcare setting where exposure occurred, and resulting actions. Results: There were 34 investigations involving medications (n = 15, 44%), medical devices (n = 12, 35%), biological products (n = 3, 9%), and other medical products (n = 4, 12%). Intrinsic contamination was suspected in 15 investigations (44%), with 13 (87%) based on isolation of a pathogen from unopened products and 2 (13%) based on isolation of similar pathogens from patients in contact with a medical product at multiple facilities. Extrinsic contamination was suspected in 19 investigations (56%) based on evidence of pathogen transmission at a single healthcare facility and concurrent infection control gaps at that facility supporting a mechanism of contamination. The most common pathogens prompting investigation were nontuberculous mycobacteria (n = 9, 26%), Burkholderia spp (n = 7, 21%), Klebsiella spp (n = 3, 9%), Serratia spp (n = 2, 6%), and other environmental and commensal organisms. Patients were most commonly exposed in hospitals (n = 19, 56%) and outpatient settings (n = 9, 26%). The most common patient exposures that resulted in transmission of the pathogen were infusions and injections (n = 15, 44%), diagnostic and therapeutic procedures (n = 9, 26%), and surgery (n = 5, 15%). Patient were notified and offered testing in at least 6 investigations (18%) . Interventions included product removal, healthcare provider alerts, patient notification and testing, modification of injection safety practices and other general infection control practices, correction of improper storage and handling, and changes in product design, manufacturing processes, or instructions for use. Conclusions: Public health investigations identified intrinsic and extrinsic contamination of medications, devices, and other products as a cause of healthcare-associated infections. Healthcare facilities should consider contaminated products in investigations of healthcare-associated infections, take steps to identify local infection control concerns, and alert public health authorities to events that could suggest widespread contamination.Funding: NoneDisclosures: None

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