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 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 Defining the Threshold of Permissible Risk for Non-therapeutic Clinical Trials with Children in Europe

2017 ◽  
Vol 24 (4) ◽  
pp. 414-431
Author(s):  
Katherine Wade*
Keyword(s):  
Clinical Trials ◽  
Medical Care ◽  
Medicinal Products ◽  
Council Of Europe ◽  
Therapeutic Trials ◽  
Research With Children ◽  
Individual Trial ◽  
The One ◽  
Definition Of ◽  
Trial Participants

Abstract It is important that clinical research with children is encouraged so that they are not exposed to the dangers of extrapolation from adult treatments. Clinical trials with investigational medicinal products (imps) are an important part of improving medical care for children. Both the 2001 Clinical Trials Directive and the 2014 Regulation recognise the need for such research, including the need for non-therapeutic trials with imps. However, it is also recognised that a balance must be struck between permitting tailored medical care for children as a group on the one hand, and protecting individual trial participants from harm on the other. A central issue in striking this balance relates to defining the threshold of risk which should be permitted in such research. This article provides a critical analysis of the current European law in relation to the definition of acceptable risk for non-therapeutic clinical trials with imps and makes recommendations for reform, drawing on law from the Council of Europe, as well as law from the us.

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.

THE METHOD OF FORECASTING AS AN IMPORTANT STAGE IN SOLVING THE PROBLEMS FACING HEALTH IN THE FIELD OF MEDICAL CARE OF THE POPULATION

2020 ◽  
Vol 73 (11) ◽  
pp. 2507-2511
Author(s):  
Ivanna V. Sakhanda ◽  
Rimma L. Skrypnyk ◽  
Kostyantyn L. Kosyachenko ◽  
Lena L. Davtian ◽  
Olena V. Welchinska ◽  
...  
Keyword(s):  
Public Health ◽  
Economic Factors ◽  
Plant Origin ◽  
Medicinal Products ◽  
Government Programs ◽  
Important Stage ◽  
Forecasting Methods ◽  
Statistical Studies ◽  
Socio Demographic Factors ◽  
Drug Provision

The aim: Of the work is to investigate and prove the effectiveness of medicinal products of plant origin for the treatment of cardiovascular diseases. Materials and methods: Pharmacoeconomic, social, medical demographic and statistical studies were studied. The study involved cardiologists, pharmacists, consumers of pharmacies and patients of cardiology departments. Results: Forecasting the need for cardiac medicines in general, and in medicinal products of plant origin (MP PO), in particular, is increasing as the population, life expectancy, under the influence of socio-demographic factors, and, most importantly, the increase in the number of elderly people. When solving problems facing public health in the field of drug provision of the population, a regular analysis of the pharmaceutical market and a forecast of the need for medicines in the context of the pharmacotherapeutic group that is being studied are necessary. An important stage in the choice of forecasting methods is the possibility of attracting the required number of indicators, which is a characteristic of the normative method, whose accessibility and simplicity make it possible to use it by specialists who do not have special mathematical training at the level of medical and pharmaceutical organizations. Conclusions: Prevention of diseases should be based on the implementation of government programs for prevention and promotion of health. This will improve and actively use methods of early detection of social and economic factors, which is a threat of development of diseases of the cardiovascular system.

scholarly journals P39 Establishment of the swiss database for dosing medicinal products in pediatrics

2019 ◽  
Vol 104 (6) ◽  
pp. e33.1-e33
Author(s):  
E Giger ◽  
A Glauser ◽  
D Panis ◽  
R Tilen ◽  
C Berger
Keyword(s):  
Public Health ◽  
Interprofessional Collaboration ◽  
National Database ◽  
Health Administration ◽  
Medicinal Products ◽  
Public Database ◽  
Dosage Recommendation ◽  
Public Health Administration ◽  
Hospital Pharmacists ◽  
Frequency Of Use

BackgroundDrug therapy in children is challenging. Due to the lack of licensed drugs for paediatric use, off-label or unlicensed prescription is frequent. To improve quality and safety of prescription of medicinal products for children in Switzerland, the requirement to create and continuously run a national database was added in the revision of the therapeutic products act (TPA Art. 67a). The task of operating the database was given to SwissPedDose, an association representing eight Swiss children’s hospitals, the Swiss Society of Paediatrics (SGP) and the Swiss Association of Public Health Administration and Hospital Pharmacists (GSASA).MethodsSubstances used in three therapeutic areas ‘general paediatrics’, ‘infectious diseases’ and ‘neonatology’ are selected according to their frequency of use in the eight participating hospitals. Dosage data of substance-indication pairs are requested from the hospital pharmacists. Based on these data and literature review a dosage suggestion consisting of substance, indication, route of administration, dose, daily repetitions and, if applicable, additional remarks is then elaborated by a specialised pharmacist of SwissPedDose. This suggestion is then discussed by experienced physicians delegated from the eight clinics. The elaboration, discussion and agreement on a national dosage recommendation takes place and is documented in an online platform specially programmed for this structured harmonisation process. Once an agreement has been achieved, the national dosage recommendation is sent to the eight participating clinics and published in a free accessible public database.ResultsAs of December 31st 2018, 195 dosage recommendations for children including 87 indications and 54 substances have been harmonised and published and are available for medical professionals on https://swisspeddose.ch/database.ConclusionThe goal of published recommendations for 100 substances by March 2021 is feasible to reach due to interprofessional collaboration. SwissPedDose may thus contribute to a more efficient and safe use of drugs prescribed to children in Switzerland.Disclosure(s)Source of Funding: Project funded by the Federal Office of Public Health. Conflict of interest: None, for all listed authors.

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 Legislation on the preparation of medicinal products in European pharmacies and the Council of Europe Resolution

2016 ◽  
Vol 24 (4) ◽  
pp. 224-229 ◽  
Author(s):  
H PA Scheepers ◽  
J Langedijk ◽  
V Neerup Handlos ◽  
S Walser ◽  
M H Schutjens ◽  
...  
Keyword(s):  
Medicinal Products ◽  
Council Of Europe

Medical Research on Patients with Dementia – the Role of Advance Directives in European Legal Instruments

2006 ◽  
Vol 13 (3) ◽  
pp. 235-261 ◽  
Author(s):  
Salla Lötjönen
Keyword(s):  
Medical Research ◽  
Advance Directives ◽  
Legal Status ◽  
Research Participant ◽  
Medicinal Products ◽  
Council Of Europe ◽  
The United Kingdom ◽  
The Will ◽  
Conflicting Messages

AbstractCurrent international legal instruments recognise the use of advance directives to carry on the will of the dementing research participant beyond the boundaries of her present legal capacity. Advance directives are gaining greater recognition in patient care than in medical research, where their legal status is still somewhat unclear. In particular, the three major international documents on medical research – the Council of Europe Convention on Biomedicine and Human Rights (ETS 164), its Additional Protocol on Biomedical Research (ETS 195), and Directive 2001/20/EC on Clinical Trials on Medicinal Products – give conflicting messages on the legal status of advance directives in medical research. This article examines the provisions in these documents and their national applications in Finland and the United Kingdom.

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