European Union Definition Research Articles

When should we think about Fabry disease?

According to the European Union definition, a rare disease is a disease that occurs with a frequency of less than 5 per 10,000. Rare diseases pose a major diagnostic problem for physicians. Due to the often uncharacteristic symptoms and rarity of the disease, it can take a long time before a correct diagnosis and treatment is made. Fabry disease is classified as a rare disease. It is an X-linked hereditary syndrome caused by alpha-galactosidase A deficiency. This leads to accumulation of glycosphingolipids in tissues and dysfunction of many organs. The clinical picture is variable and dependent on residual alpha-galactosidase A activity. The classic form of the disease occurs most often in males due to the presence of only one X chromosome. When alpha-galactosidase A activity is partially preserved, a non-classical form develops, which is more commonly seen in the female sex. The most common clinical manifestations reported by patients are angiokeratoma, anhidrosis, diarrhoea or left ventricular hypertrophy. To diagnose Fabry disease, alpha-galactosidase A activity can be measured in whole blood - dry blood drop test (DBS), plasma or leukocytes. Fabry disease can be treated effectively, but treatment must last for life. The treatments reimbursed in Poland are agalsidase alfa and beta preparations and migalastat.

Changes in the European Union definition for endocrine disruptors: how many molecules remain a cause for concern? The example of crop protection products used in agriculture in France in the six last decades.

The endocrine-disrupting effects of phytopharmaceutical active substances (PAS) on human health are a public health concern. The CIPATOX-PE database, created in 2018, listed the PAS authorized in France between 1961 and 2014 presenting endocrine-disrupting effects for humans according to data from official international organizations. Since the creation of CIPATOX-PE, European regulations have changed, and new initiatives identifying substances with endocrine-disrupting effects have been implemented and new PAS have been licensed. The study aimed to update the CIPATOX-PE database by considering new 2018 European endocrine-disrupting effect identification criteria as well as the new PAS authorized on the market in France since 2015. The endocrine-disrupting effect assessment of PAS from five international governmental and non-governmental initiatives was reviewed, and levels of evidence were retained by these initiatives for eighteen endocrine target organs. The synthesis of the identified endocrine-disrupting effects allowed to assign an endocrine-disrupting effect level of concern for 241 PAS among 980 authorized in France between 1961 and 2021. Thus, according to the updated CIPATOX-PE data, 44 PAS (18.3%) had an endocrine-disrupting effect classified as "high concern," 133 PAS (55.2%) "concern," and 64 PAS (26.6%) "unknown effect" in the current state of knowledge. In the study, 42 PAS with an endocrine-disrupting effect of "high concern" are similarly classified in CIPATOX-PE-2018 and 2021, and 2 new PAS were identified as having an endocrine-disrupting effect of "high concern" in the update, and both were previously classified with an endocrine-disrupting effect of "concern" in CIPATOX-PE-2018. Finally, a PAS was identified as having an endocrine-disrupting effect of "high concern" in CIPATOX-PE-2018 but is now classified as a PAS not investigated for endocrine-disrupting effects in CIPATOX-PE-2021. The endocrine target organs associated with the largest number of PAS with an endocrine-disrupting effect of "high concern" is the reproductive system with 31 PAS. This is followed by the thyroid with 25 PAS and the hypothalamic-pituitary axis (excluding the gonadotropic axis) with 5 PAS. The proposed endocrine-disrupting effect indicator, which is not a regulatory classification, can be used as an epidemiological tool for occupational risks and surveillance.

Opportunity novelty, improvisation and network adaptation in the internationalization of Swedish SMEs

AbstractBy deviating from previous ways of working and improvising new solutions to problems in the internationalization process, small and medium‐sized enterprises (SMEs) will increase the likelihood of developing novel international opportunities. In this way, for instance, unforeseen customer demand, rather than following a specific plan, may govern market choice. Such novel opportunities, in turn, are likely to require network adaptation in order for the firm to reach an insidership position in the international business network. By integrating international opportunity theory with theories on improvisational behavior, three hypotheses are developed between the constructs of international opportunity novelty, improvisation, and network adaptation. The hypotheses were tested with Structural Equation Modelling on 258 realized international opportunities developed by Swedish SMEs (European Union definition: number of employees 10–250) and were observed through on‐site visits. It is revealed that improvisation increases the degree of international opportunity novelty as well as the need for network adaptation. The degree of novelty of realized international opportunities positively influences the need for adaptation to a foreign network. Novelty can be seen as a proxy for opportunity's wealth‐creating potential, and developing improvisation capabilities seems to be a way to increase the novelty of international opportunities developed. Managers that are risk averse and therefore refrain from improvisation risk missing valuable novel opportunities.

Assessment of experimental pathogenicity of avian influenza virus H9N2 isolates by intravenous pathogenicity index (IVPI) test and histopathology

A total of 1,423 number of tissue samples received from various parts of India were processed for virus isolation in chicken embryos of 9-11 d old as a part of programme to monitor Avian Influenza Virus (AIV) infection in Indian poultry population and a total number of three samples were positive by HA test and the titre of the virus isolates ranged from 1:8 to 1:64. The virus isolates had been subjected to HI test with the reference positive serum imported from NVSL, USA for various subtypes. The virus isolates gave a HI titre of 1:32 with H9 subtype specific reference positive serum indicating that the virus isolates were influenza A H9 subtype. One of the isolates (accession no. 3722/04) was subjected to neuraminidase assay and the virus was found by N2 subtype and also virus sub typing was done by RT-PCR for further confirmation. The influenza H9N2 virus isolates (accession no. 2543/04, 2544/04, 2317/04, 2424/04, and 3722/04) were used in the intravenous pathogenicity index test. In the present study no, clinical signs and/or gross lesions in experimentally inoculated chickens were observed. All the five isolates studied were found to be non-pathogenic according to the European Union definition. The organs collected from the experimental chickens did not show significant lesions, on histopathological examination, except for some minor changes in some of the organs. Immunofluorescence test was used to study the tissue tropism of avian influenza viruses’ isolates experimentally infected in chickens. The antigen was detected only in the brain and trachea of the chickens experimentally infected with the isolates having accession no. 2543/04 and intestine of chickens experimentally infected with the isolate having accession number 2544/04. Avian influenza virus re-isolation from experimentally infected chickens was attempted in 9-11 d old embryonated chicken eggs. Virus could be re-isolated from some organs, three groups infected with the isolates with accession numbers 2543/04, 2544/04 and 2317/04. Thus, the present work was envisaged to fill in the gap formed by this lack of information on avian influenza in India.

РЕАЛІЗАЦІЯ КОНЦЕПЦІЇ НЕПЕРЕРВНОЇ ОСВІТИ В ЄВРОПЕЙСЬКОМУ ОСВІТНЬОМУ ПРОСТОРІ: НОРМАТИВНЕ ЗАБЕЗПЕЧЕННЯ

The article reveals the European context of the meaning of the «continuing education» concept, which is interpreted in the Memorandum on Lifelong Learning as a purposeful educational activity conducted on an ongoing basis to improve the knowledge, skills and abilities of citizens and is a basic principle of the education system. Continuing education has become a key element in the European Union definition of strategies to build the world’s most competitive and dynamic knowledge-based society. The analysis of international documents adopted by EU countries showed that the implementation of continuing education strategies in national systems is recognized as one of the priority areas and fundamental principles of educational system development in EU countries, which direct the national policy of their countries to implement the concept of lifelong learning and encourage higher education institutions increase access to education for different age groups. The system of continuing education is divided into three components. The first – additional professional education – contributes to the formation of the professional basis of human resources of the modern high-tech economy. The second component of the system of continuing education provides various groups with the opportunity to adapt to changing living conditions. The third component of the system of continuing education provides for the satisfaction of various individual educational needs of citizens. The implementation of the concept of continuing education is aimed at covering the educational programs of all people – from the youngest to the elderly. Attention is focused on finding ways to democratize access to education, increase the value of knowledge, increase investment in education and bring it closer to the consumer. The study and analysis of international documents on continuing education is necessary for the further development of the education system of Ukraine, which corresponds to the general trend of development of education systems in European and global space

From amyloidosis to Zellweger syndrome: how can the medical education system include thousands of rare diseases?

Over 7000 rare diseases have been described in accordance with the European Union definition of a condition that affects fewer than one in 2000 people. An initial browse of Orphanet’s Rare Disease Directory reveals a plethora of disparate conditions, which would prove an insurmountable challenge should they all be represented in the medical curriculum.

Influenza C virus in pre-school children with respiratory infections: retrospective analysis of data from the national influenza surveillance system in Germany, 2012 to 2014.

IntroductionRecent data on influenza C virus indicate a possible higher clinical impact in specified patient populations than previously thought.AimWe aimed to investigate influenza C virus circulation in Germany.MethodsA total of 1,588 samples from 0 to 4 year-old children presenting as outpatients with influenza-like illness (ILI) or acute respiratory infection were analysed retrospectively. The samples represented a subset of all samples from the German national surveillance system for influenza in this age group in 2012–14. The presence of influenza C virus was investigated by real-time PCR. For positive samples, information on symptoms as well as other respiratory virus co-infections was considered. Retrieved influenza C viral sequences were phylogenetically characterised.ResultsInfluenza C viral RNA was detected in 20 (1.3% of) samples, including 16 during the 2012/13 season. The majority (18/20) of influenza C-positive patients had ILI according to the European Union definition, one patient had pneumonia. Viruses belonged to the C/Sao Paulo and C/Kanagawa lineages. Most (11/20) samples were co-infected with other respiratory viruses.ConclusionOur data are the first on influenza C virus circulation in Germany and notably from a European national surveillance system. The low detection frequency and the identified virus variants confirm earlier observations outside a surveillance system. More virus detections during the 2012/13 season indicate a variable circulation intensity in the different years studied. Influenza C virus can be considered for ILI patients. Future studies addressing its clinical impact, especially in patients with severe disease are needed.

Gene-edited plants on the plate: the 'CRISPR cabbage story'.

The European Union (EU) has very strict regulations for genetically modified plants, but gene editing challenges the basis of the legislation. Genome editied plants with no foreign DNA added were according to the Swedish competent authority Jordbruksverket falling outside of the EU definition of genetically modified plants, and should hence not be regulated. This article describes the background to this interpretation and also how plants gene edited using CRISPR-Cas9 (a Brassica deletion mutant) for the first (?) time were grown in a garden, cooked and eaten, and the subsequent media attention. Furthermore, it also adresses the troubles authorities in other European countries have to handle these plants.

UNDERSTANTING THE NOTION OF STATE AID AND ITS CORRECT APPLICATION

AbstractThe present paper emphasizes the need to deepen the understanding of the notion of State Aid according to article 107, paragraph 1 from the Treaty on the Functioning of the European Union definition, to correctly harmonize the Romanian legislation with the European one and directly apply it through the Guide Regarding State Aid[1]. The national implementation of the European recommendations presented here is meant to be achieve through the Emergency Ordinance no. 77/201, and State Aid Schemes Decision no. 807/2014 and 332/2014.[1] Developed by the Competition Council, available only in Romanian.

How to Deliver the Necessary Data about Serious Injuries to the European Union

In the EU (European Union) in 2011, the number of the serious road injuries was more than 250,000 and the death tolls were 28,000. In the last period (between 2001 and 2011), the number of those who lost their lives as a result of road accident decreased ordinarily by 43% in the EU countries on average, whereas that of the seriously injured by 36%--in the light of these countries' own definitions differing from one another. The MAIS3+ is the adopted common EU definition, that is all Grade-3 or above values according to the MAIS (maximum abbreviated injury scale). Although the definition seems professionally justified, further clarification is necessary in our view. For the years 2014 and 2015, the EU has already drawn up specific tasks for the member states. Since the Baltic States were particularly successful in the field of road safety in the last 10 years, it is certain that in the future they can do a lot in order to have the number of serious road accident victims significantly reduced and also internationally compared and assessed. Language: en

The burden of rare cancer in Japan: Application of the RARECARE definition

BackgroundDespite the fact that rare cancer is a new target of cancer control in Japan, the incidence of rare cancers is unknown and there is no generally accepted definition of rare cancers in this country. With the aim of calculating incidences of rare cancers in Japan, we therefore adopted a definition and classification of rare cancers that had been published in the European Union (EU) in 2011. MethodsUsing incidence data between 1998 and 2007 submitted by 12 of population based cancer registries in Japan that met our quality criteria and drawing on the EU definition (incidence <6 per 100,000 per year), we estimated the incidences of 845 combinations of tumor sites and histological groups and thus identified the cancers that are rare in Japan. ResultsAfter identifying 193 combinations of tumor sites and histological groups that fit our criteria for rare cancers, we estimated their incidence to be about 75 per 100,000, which corresponds to about 94,800 new diagnoses in 2012 or approximately 15% of all cancer diagnoses. The categorization of rare and common cancers was almost the same in Japan as in EU. ConclusionsThe present study provides an indication of the size of the rare cancer burden in Japan and epidemiological information to explore this. We are expecting further discussion based on our results with stakeholders in order to construct a Japanese definition of rare cancers.

Laboratory preparedness for detection and monitoring of Shiga toxin 2-producing Escherichia coli O104:H4 in Europe and response to the 2011 outbreak

A hybrid strain of enteroaggregative and Shiga toxin 2-producing Escherichia coli (EAEC-STEC) serotype O104:H4 strain caused a large outbreak of haemolytic uraemic syndrome and bloody diarrhoea in 2011 in Europe. Two surveys were performed in the European Union (EU) and European Economic Area (EEA) countries to assess their laboratory capabilities to detect and characterise this previously uncommon STEC strain. Prior to the outbreak, 11 of the 32 countries in this survey had capacity at national reference laboratory (NRL) level for epidemic case confirmation according to the EU definition. During the outbreak, at primary diagnostic level, nine countries reported that clinical microbiology laboratories routinely used Shiga toxin detection assays suitable for diagnosis of infections with EAEC-STEC O104:H4, while 14 countries had NRL capacity to confirm epidemic cases. Six months after the outbreak, 22 countries reported NRL capacity to confirm such cases following initiatives taken by NRLs and the European Centre for Disease Prevention and Control (ECDC) Food- and Waterborne Disease and Zoonoses laboratory network. These data highlight the challenge of detection and confirmation of epidemic infections caused by atypical STEC strains and the benefits of coordinated EU laboratory networks to strengthen capabilities in response to a major outbreak.

The Relevance of Security Sector Reform in Humanitarian Intervention: The Case of the European Union in the Mediterranean

Security sector reform (SSR) is a new concept that was adopted by international institutions at the end of the 1990s as a relevant and critical part of development and stabilization processes. It consists of reforming the security sector in those states in which security structures are not able to protect citizens from security challenges facing developing and transitional societies. It includes a large spectrum of services and is strongly based on the abandoning of the classical conception of security as strictly connected with the territorial integrity of a state and the adoption of the broader concept of security and a security agenda that considers the well-being of populations and the respect of human rights. This article aims at analyzing the relevance of SSR in the security relations between European Union (EU) and Mediterranean countries. In the first part, a definition of SSR will be developed. In the second part, the EU's definition of SSR will be stressed, and its links with the security concept as it has been developed in EU external action. In the third part, the EU missions in Mediterranean countries will be analyzed in order to verify if SSR is included in the aims of the missions.

Editorial Commentary: Rules and regulations in reproductive medicine: sensible requirements that should start with evidence

Over the last decade, reproductive medicine in Western countries has seen a vast increase in rules and regulations, promoting or mandating the responsible application of available medical technologies. These regulations are meant to improve the quality and safety of the provided services and, in the case of the European Union (EU), to bring about harmonization over national borders (Pennings, 2004; Tatarenko, 2006; Johnson and Petersen, 2008). The issues considered relate to ethical, organizational and legal issues and set technical standards. In Europe, one of the most influential recent documents concerned with artificial reproductive technology (ART) is the EU Tissues and Cells Directive from 2004 (EUTCD; 2004/23/EC), with its supplementary Technical Directives (2006/17/EC, 2006/86/EC). The EUTCD and Technical Directives cover all transplanted tissues and cells, with the exception of blood and blood products. As a result, this also encompasses gametes, zygotes and embryos when processed outside the human body, irrespective of the relations between the people involved in the treatment. The EUTCD and Technical Directives provide minimum standards that ought to be taken up in the legislation of EU member states within 2 years after the adoption of 2004/23/EC. In this issue, Wingfield and Cottell present a critical appraisal of the regulatory aspects in the context of tissue and cell donation that they have been working with in Ireland since the recent introduction of mandatory testing regimes. They evaluate and question the regulations mandated by the European Directives and the national rules that these Directives have translated into in their homeland, focusing on the requirements relating to viral screening in ‘partner donation’ (the donation of cells between a man and woman who have an intimate physical relationship, according to the EU definition) (Wingfield and Cottell, 2010). The authors have scrutinized the medical and scientific evidence for the mandated procedures, complementing their literature search with a survey of the experiences in seven Irish ART clinics over the last few years. They come to the conclusion that there is no medical or scientific evidence for requiring virology screening in each treatment cycle of partner donation, and assert that it is both discriminatory and distressing. This is in line with ESHRE’s statement (2009) on the very same topic; both the statement and the overview make an appeal for reconsideration of the requirements concerned and, in general, call on professionals, politicians and others involved in making ART regulations to think about the fundamental reasons for various requirements in directives, laws, protocols etc. Are these requirements sensible and do they derive from evidence, or is ART approached as an exceptional branch of medicine for which the approach to rules may differ (Johnson and Petersen, 2008)? Wingfield and Cottell’s contribution presents a good illustration of cases that may deviate from reasonableness. It may be useful to distinguish the two basic types of reasons for questioning the regulations applied in the context of partner donation of gametes. Both are touched upon, directly and indirectly, by Wingfield and Cottell (2010) and have been dealt with in other contributions (Mortimer, 2005; ESHRE position paper, 2007; ESHRE statement, 2009):

Is it Time for an EU Definition of the Precautionary Principle?

The potential of the precautionary principle (PP) as a democratizing tool and the articulation of a European Union (EU) definition for assisting in resolving some of the misunderstandings surrounding the EU's conception of precaution is discussed. The PP can provide a structured framework to assist in dealing with the difficult questions that risk regulation poses, and, of utilized properly, it may highlight and address environmental/public health concerns without dictating courses of action.

Investigating the role of CMMI with expanding company size for small- to medium-sized enterprises

In this article we show how the results from software process appraisals of ten small- to medium-sized software development enterprises demonstrate that as companies become larger they naturally use an increasing number of practices within the Capability Maturity Model Integration (CMMI®). The companies involved in this study had no CMMI® experience prior to this work. We identify those practices that tend to be best followed by both small- and medium-sized enterprises and those that tend to be introduced as the company size increases from small to medium. We conclude that the CMMI® appears to have an inherent roadmap for process improvement, buried within its explicit structure of capability levels that is driven by company expansion. The results of this study can be used by organisations to plan process improvement as they expand in size and staff complement. We further show how our results are consistent with the European Union's definition of a ‘Small’ and a ‘Medium’ sized enterprise. Copyright © 2009 John Wiley & Sons, Ltd.

Investigating the role of CMMI with expanding company size for small‐ to medium‐sized enterprises

AbstractIn this article we show how the results from software process appraisals of ten small‐ to medium‐sized software development enterprises demonstrate that as companies become larger they naturally use an increasing number of practices within the Capability Maturity Model Integration (CMMI®). The companies involved in this study had no CMMI® experience prior to this work. We identify those practices that tend to be best followed by both small‐ and medium‐sized enterprises and those that tend to be introduced as the company size increases from small to medium. We conclude that the CMMI® appears to have an inherent roadmap for process improvement, buried within its explicit structure of capability levels that is driven by company expansion. The results of this study can be used by organisations to plan process improvement as they expand in size and staff complement. We further show how our results are consistent with the European Union's definition of a ‘Small’ and a ‘Medium’ sized enterprise. Copyright © 2009 John Wiley &amp; Sons, Ltd.

An integrated framework for understanding the driving forces behind non‐sequential process of internationalisation among firms

PurposeIs non‐sequential internationalization process solely technology enabled or a product of mutually interdependent forces? This paper aims to show that even though the sequential approach in the process model is intuitively appealing, not all firms follow such a path. Hence, integrated framework to explain how the international market entry process has changed with respect to the sequential approach is presented.Design/methodology/approachThe data banks of the Swedish Trade Council and the Chambers of Commerce are used to identify small and medium‐sized enterprises (SMEs) with between 50 and 250 employees (in compliance with European Union's definition of SMEs). Data are collected through the use of questionnaires and in‐depth interviews from 60 Swedish SMEs operating in other countries and foreign SMEs operating in Sweden that tends not to develop in incremental stages with respect to their international.FindingsSome of the findings are: that the sequential model is by no means reflective of, or appropriate for all firms' approaches to international business; the usefulness gained by using an international network approach to study the international activity of a firm; and the interplay between the identified driving forces behind a non‐sequential internationalization process.Research limitations/implicationsEven though market entry patterns of firms investigated demonstrate a non‐sequential internationalization process, they are still within the general theoretical framework where the basic assumption of the sequential internationalization model can maintain its validity. Firms are indeed exposed to irrecoverable transaction costs that hamper their behaviours and complicate export supply responses in international markets. However, the magnitude of the costs and speed of internationalization is dependent on the ability of the firms to take advantage of the enablers of non‐sequential internationalization pattern. This is particularly important for firms to and from developing countries and emerging markets and their propensities to succeed in their internationalization endeavours.Originality/valueKnowledge acquired from the empirical study of firms that tend not to develop in incremental stages with respect to their international activities, and therefore start international activities by entering very distant markets and multiple countries right from birth without prior experience, is used to develop an integrated framework which aptly depicts that non‐sequential internationalization process is not solely enabled by technology, as commonly envisaged in literature, but a product of mutually interdependent forces. Consequently, this study provides a holistic view on the driving forces behind the rapid internationalization process encountered by many SMEs today.

'Children and obesity: a pan-European project examining the role of food marketing'

Rising levels of obesity in school-age children across Europe are causing increasing concern. The 'Children, Obesity and associated avoidable Chronic Diseases' project sought to examine the effects of promotion within food marketing, given the influential role it plays in children's diets. A questionnaire and data-collection protocol was designed for the national co-ordinators, facilitating standardized responses. Co-ordinators collected data from within 20 European Union countries relating to food promotion to children. Results showed that unhealthy foods such as savoury snacks and confectionary were the most commonly marketed and consumed by children across all countries. Television was found to be the prime promotional medium, with in-school and internet marketing seen as growth areas. Media literacy programmes designed specifically to counterbalance the effects of food marketing to children were reported by only a few of the 20 countries. An ineffective and incoherent pattern of regulation was observed across the countries as few governments imposed tough restrictions with most preferring to persuade industry to voluntarily act with responsibly. Most health, consumer and public interest groups supported food marketing restrictions whilst industry and media groups advocated self-regulation. Recommendations include the amendment of the European Union's Television Without Frontiers Directive to ban all TV advertising of unhealthy food to children, the adoption of a commonly agreed European Union definition of an 'unhealthy' food, and the establishment of a mechanism for pan-European monitoring of the nature and extent of food marketing to children and its regulation.

Key issues in fighting organised crime in the Balkans

Traditional definitions of organised crime tend to focus on its links with the market. They depict organised crime as an alternative industry based on the stable supply of a criminal market, characterised by the use of force or threat by it, and motivated by illicit profit or a quest of political power. These definitions arise from the historically most common depictions of specific activities of organised crime, which in most parts of Europe and North America have traditionally been associated with the illegal collection of debts, extortion rackets, contract murders or systemic corruption leading to, and associated with, a transnational trade in drugs. Through the evolution of the definitions, these stereotypes have gradually waned away, and the use of violence, as well as the primary motivation by material profit, has been omitted from the lists of obligatory characteristics that a crime must fulfill in order to be classified as ?organised crime?. More recently, in the European Union definition, the use of violence and motivation by profit alone have been made only conditional criteria, and the quest of institutional power has been recognised as a motivating factor for organised crime equal to that of generating illicit profit. These new definitional approaches have opened the way to revolutionary ways of understanding the development of organised crime, specifically to including white-collar crime and massive fraud in the future definitions of organised crime, as well as further elaborating the aspect of political violence that is present in many organised crime activities across the world. In the Balkans, these new moments in defining organised crime appear to have been tested particularly directly in Serbia, where, first, there has been a long public debate over a systematic ?siphoning away? of public funds to the accounts of private companies through the mass corruption of a former, post-communist government until 2001. Subsequently, organised criminal rings have been accused of having masterminded and executed the assassination of the late Serbian Prime Minister, Dr Zoran Djindjic. The Balkans, and particularly Serbia, have been exposed to some of the most destructive consequences of organised crime. Correspondingly, the region can serve as a polygon or testing grounds for the exploration of the conceptual issues associated with organised crime. Finally, the experiences in crime control gained in this process could be valuable tools to address organised crime elsewhere. This especially concerns the emergence of what has recently become known in criminological discourse as the ?New War-Making Criminal Entity?. This paper explores the key features of organised crime against the background of the Serbian, and, by extension, Balkan circumstances, and draws conclusions as to how these experiences can be useful more globally.