scholarly journals EU POLICY AGAINST FALSIFIED MEDICINES: OPTIONS FOR FURTHER DEVELOPMENT

2020 ◽  
Vol 1 ◽  
pp. 147-153
Author(s):  
Krasimira Valcheva
Keyword(s):  
Supply Chains ◽  
Pharmaceutical Companies ◽  
The European Union ◽  
Effective Prevention ◽  
Patient Protection ◽  
Regulatory Frameworks ◽  
Falsified Medicines ◽  
Pharmaceutical Supply Chains ◽  
National Governments ◽  
Further Development

The globalization of trade and internet access significantly increased the health risks associated with falsified medicines. International organizations, pharmaceutical companies and national governments developed a wide variety of measures to combat their pervasive penetration into the legal supply chains. However, the lack of harmonization, broad acceptance and legally bound enforcement obstructed their endeavours. The unsatisfying outcomes resulted in enhanced supranational cooperation focused on strengthening the pharmaceutical regulatory frameworks and the improvement of patient protection.  In 2011 the European Union joined the global fight with the adoption of Directive 2011/62/EU that became known as the Falsified Medicine Directive. It is legally binding for Member States and amends the fundamental for the pharmaceutical sector Directive 2001/83/EC. The objective of the present paper is to verify if it represents a comprehensive tool for effective prevention of the access of falsified medicines in the European legal pharmaceutical supply chains. The results revealed that although it is rather detailed, there are areas that could be further developed and improved when compared to analogical policies and initiatives.

Organised crime will gain from world vaccine shortages

2021 ◽  
Keyword(s):  
Supply Chains ◽  
Organised Crime ◽  
Pharmaceutical Companies ◽  
Content Type ◽  
Illicit Trade ◽  
High Profile ◽  
Global Demand ◽  
Illegal Activities ◽  
Pharmaceutical Supply Chains ◽  
Vaccine Shortages

Significance However, it is vast global demand for the restricted supply of COVID-19 vaccines that offers the most alluring prize for criminal gangs. Black markets thrive in situations where demand outstrips supply, and there has long been an illicit trade in medicines. Impacts Countries with underdeveloped pharmaceutical supply chains will be vulnerable to theft and diversion of vaccine supplies. Government vaccine strategies could be undermined by high-profile black market vaccine scandals that damage public trust. Pharmaceutical companies are vulnerable to reputational damage if their supply chains are found to be tampered with. Criminal profits will fund other illegal activities such as trafficking of people, drugs and arms.

Performance Measurement of Medicines Delivery of Pharmaceutical Companies Under Chain of Sustainable Procurement

2019 ◽  
Vol 10 (3) ◽  
pp. 116-128
Author(s):  
Kaminee Sahu ◽  
Anoop Kumar Sahu
Keyword(s):  
Supply Chain ◽  
Supply Chains ◽  
Flexible Manufacturing ◽  
Service Level ◽  
Pharmaceutical Companies ◽  
Module Structure ◽  
Pharmaceutical Supply Chain ◽  
Manufacturing Firm ◽  
Sustainable Procurement ◽  
Pharmaceutical Supply Chains

Pharmaceuticals companies manufacture and maintain the stocks of several medicines. Presently, hospitals maintain stock to supply the appropriate medicine to patients under their care. The availability of medicines is dependent on the service level of suppliers. In last decade, the pharmaceutical supply chains have been an increasingly important topic. Pharmaceutical supply chains of the medicine manufacturing firm are based on traditional supply chain strategies. But, the concept became obsolete, replaced by modern supply chain strategy. The modern supply chain better analyzes pharmaceutical architectures such as green, service, agile, resilient, flexible manufacturing and is called the pharmaceutical G-F-A-L-R supply chain. To evolve a new model for the pharmaceutical supply chain, a 2nd second level pharmaceutical hierarchy G-F-A-L-R supply chain module structure has been constructed, where a Fuzzy Performance Index model has been applied on the module to compute the overall performance of individual pharmaceutical companies.

Glembotskaya G.T., Eremin S.Yu. Scientific and practical approach to optimizing costs on development and promotion of drugs

2019 ◽  
Vol 2019 (3) ◽  
pp. 47-53
Author(s):  
Галина Глембоцкая ◽  
Galina Glembockaya ◽  
Станислав Еремин ◽  
Stanislav Eremin
Keyword(s):  
Scientific Literature ◽  
Pharmacological Action ◽  
Pharmaceutical Market ◽  
Pharmaceutical Companies ◽  
Strategic Development ◽  
The World ◽  
The Russian Federation ◽  
The Cost ◽  
Further Development ◽  
Registration Phase

In order to identify promising strategic development possibilities for the pharmaceutical industry in the Russian Federation, a pilot study was conducted, which has analyzed the main trends in the development of innovative medicines. As a result of the content analysis of available sources of scientific literature, the characteristics of options used in the world practice for increasing the innovative activity of individual subjects and the pharmaceutical market as a whole are presented. Possible reserves for the further development of the innovative component of the pharmaceutical market within the framework of the concept of personalized medicine according to the P4 principle (predictive - personalized - preventive - participatory) are identified and structured. The results of use by individual pharmaceutical companies of scientifically and practically justified approaches to optimizing the costs of development and promoting drugs are presented. The advantages and real prospects of a generally accepted method to reduce the cost of development by «expanding the pharmacological effect» (label expansion) of already existing drugs with a known safety profile in the world practice are shown. A scientific generalization and structuring of the goals and results of the post-registration phase of clinical trials to expand the pharmacological action of a number of drugs already existed at the market have been carried out.

Epilogue

2018 ◽  
Author(s):  
José van
Keyword(s):  
Paradigm Shift ◽  
Information Age ◽  
The Other ◽  
The European Union ◽  
Checks And Balances ◽  
The Us ◽  
Autocratic Regime ◽  
Digital Strategy ◽  
National Governments ◽  
State Interference

The epilogue sketches a few scenarios on potential geopolitical consequences of the global paradigm shift toward multiple online platform “spheres.” Currently, the neoliberal US-based platform ecosystem dominates. This ecosystem revolves around the promotion of individualism and minimal state interference, leaving checks and balances to the market. On the other end of the ideological spectrum is the Chinese ecosystem, in which the autocratic regime controls the platform ecosystem via regulated censorship of tech corporations. Squeezed between the US and the Chinese models is the European Union, whose member states neither own nor operate any major platforms in either ecosystem. For European democracies to survive in the information age, its cities, national governments, and supranational legislature need to collaborate on a blueprint for a common digital strategy toward markets and public sectors.

scholarly journals Differences between the European Union and United States of America in Drug Regulatory Affairs Affect Global Patient Safety Standards and Public Health Awareness: The Case of Deferasirox and Other Iron Chelating Drugs

Medicines ◽  
2021 ◽  
Vol 8 (7) ◽  
pp. 36
Author(s):  
George J. Kontoghiorghes
Keyword(s):  
Patient Safety ◽  
Generic Drugs ◽  
Benefit Assessment ◽  
Regulatory Control ◽  
Pharmaceutical Companies ◽  
The European Union ◽  
Regulatory Policies ◽  
Regulatory Affairs ◽  
Risk Benefit Assessment ◽  
The Eu

Regulatory policies on drugs have a major impact on patient safety and survival. Some pharmaceutical companies employ all possible methods to achieve maximum sales in relation to the monopoly of their patented drugs, leading sometimes to irregularities and illegal activities. Misinformation on the orphan drug deferasirox has reached the stage of criminal investigations and fines exceeding USD 100 million. Additional lawsuits of USD 3.5 billion for damages and civil fines were also filed by the FBI of the USA involving deferasirox and mycophenolic acid, which were later settled with an additional fine of USD 390 million. Furthermore, a USD 345 million fine was also settled for bribes and other illegal overseas operations including an EU country. However, no similar fines for illegal practises or regulatory control violations have been issued in the EU. Misconceptions and a lack of clear guidelines for the use of deferasirox in comparison to deferiprone and deferoxamine appear to reduce the effective treatment prospects and to increase the toxicity risks for thalassaemia and other iron loaded patients. Similar issues have been raised for the activities of other pharmaceutical companies promoting the use of new patented versus generic drugs. Treatments for different categories of patients using new patented drugs are mostly market driven with no clear safeguards or guidelines for risk/benefit assessment indications or for individualised effective and safe optimum therapies. There is a need for the establishment of an international organisation, which can monitor and assess the risk/benefit assessment and marketing of drugs in the EU and globally for the benefit of patients. The pivotal role of the regulatory drug authorities and the prescribing physicians for identifying individualised optimum therapies is essential for improving the survival and safety of millions of patients worldwide.

scholarly journals Financing Responsible Small- and Medium-Sized Enterprises: An International Overview of Policies and Support Programmes

2020 ◽  
Vol 14 (1) ◽  
pp. 10
Author(s):  
Susanne Durst ◽  
Wolfgang Gerstlberger
Keyword(s):  
Regional Differences ◽  
Social Dimension ◽  
The European Union ◽  
International Organisations ◽  
The Social ◽  
Support Policy ◽  
Primary Focus ◽  
Support Programmes ◽  
National Governments ◽  
Desk Research

In the last few years, the financing of responsibly operating small and medium-sized enterprises (SMEs) has become the focus of attention of several national and international bodies. Consequently, a number of policies and support programmes have been established aimed at supporting SMEs that take a responsible approach concerning the company and its operations. Against this background, this article presents a comprehensive international overview of support programmes for financing responsible SMEs. Based on systematic desk research, documents of national governments as well as supranational and international organisations have been investigated. The findings reveal that there are strong regional differences in terms of support policy approaches, intensity, and criteria. The largest part of the identified programmes has been launched by the European Union and/or its member states. Additionally, the findings clarify that the primary focus of extant programmes is on the environmental dimension of sustainability, mainly energy-related questions. The social dimension has been neglected so far in the programmes.

Party-Political and Socio-Economic Сonsequences of Elections to the German Bundestag

2021 ◽  
pp. 24
Author(s):  
V.B. Belov
Keyword(s):  
Point Of View ◽  
The European Union ◽  
Social Democrats ◽  
The Social ◽  
Angela Merkel ◽  
The Face ◽  
German Bundestag ◽  
The Impact ◽  
Further Development

The article examines the results of the last Bundestag elections. They marked the end of the Angela Merkel era and reflected the continuation of difficult party-political and socio-economic processes in the informal leader of the European Union. The main attention of the research focuses on the peculiarities of the election campaign of the leading parties and of the search for ways of further development of Germany in the face of urgent economic and political challenges. These challenges include the impact of the coronavirus crisis, the impact of the energy and digital transition to a climate-neutral economy, and the complex international situation. Based on original sources, the author analyzes the causes of the SPD victory and the CDU/CSU bloc defeat, the results of the negotiations of the Social Democrats with the Greens and Liberals, the content of the coalition agreement from the point of view of the prospects for the development of domestic and foreign policy and the economy of Russia's main partner in the west of the Eurasian continent. The conclusion is made about the absence of breakthrough ideas, the consistent continuation of the course started by the previous government for a carbon-free economy and the strengthening of the role of Germany in Europe and the world. For this course, conflicts and problems in achieving the set goals will be immanent due to the compromising nature of the coalition agreements.

Blockchain for Governance of Sustainability Transparency in the Global Energy Value Chain: Part 2, Reconciling the Technology/Regulation Mismatch

2021 ◽  
Vol 2 (1) ◽  
pp. 22-50
Author(s):  
Lauren Downes ◽  
Chris Reed
Keyword(s):  
Value Chain ◽  
Regulatory Change ◽  
The European Union ◽  
Regulatory Requirements ◽  
Global Energy ◽  
Energy Value ◽  
Related Information ◽  
Governance Model ◽  
Regulatory Frameworks

In this second part of a two-part article we continue our consideration of how global energy value chains could be managed more sustainably through blockchain by greatly increasing transparency. The aim is to use this transparency to incentivise more sustainable behaviour on the part both of energy producers and suppliers and of consumers. Incentives of this kind are market based, and so we have concentrated on market-based instruments in the energy sector, emphasising those that decrease the CO2 footprint of energy consumption, such as emissions trading schemes and renewable energy certificates. Blockchain can enhance transparency by improving the quality of, and access to, sustainability-related information. However, existing laws and regulatory frameworks that govern market-based instruments may prevent these benefits from becoming fully realised. We review the governance frameworks of market-based instruments in several international jurisdictions (Brazil, India, Kazakhstan, Mexico, South Africa and Ukraine, as well as the European Union with particular reference to the Netherlands and United Kingdom (which was a member of the EU at the time of this writing), to ascertain how laws, rules and regulations may limit transparency of sustainability information. We also consider jurisdictional differences to identify difficulties in the creation of a global framework for managing sustainability information from market-based instruments. Jurisdictional differences mean that a one-size fits all solution may not be possible. To overcome this, we propose a blockchain governance model, using aggregated blockchains and peering agreements. It allows flexibility when disclosing information, through layering of permissions, and this means that it should be possible to construct a transparency system which complies with existing domestic legal and regulatory requirements, rather than requiring major legal and regulatory change.

The ‘Pillared-Privatisation’ of Pension Provision in the European Union: The Case of the United Kingdom

2002 ◽  
Vol 4 (1) ◽  
pp. 5-24 ◽  
Author(s):  
Patrick Ring ◽  
Roddy McKinnon
Keyword(s):  
European Union ◽  
World Bank ◽  
The European Union ◽  
Means Testing ◽  
The Road ◽  
The United Kingdom ◽  
The World Bank ◽  
The Government ◽  
The Uk ◽  
National Governments

Across the European Union, national governments are re-assessing the institutional mechanisms through which pension provision is delivered. This articles sets the debate within the wider context of the ‘pillared’ structural analysis often adopted by international institutions when discussing pensions reform. It then sets out a detailed discussion of developments in the UK, arguing that the UK is moving towards a model of reform akin to that promoted by the World Bank – referred to here as ‘pillared-privatisation’. The themes of this model indicate more means-testing, greater private provision, and a shift of the burden of risk from the government to individuals. An assessment is then made of the implications of UK developments for other EU countries. It is suggested that while there are strong reasons to think that other countries will not travel as far down the road of ‘pillared-privatisation’ as the UK, this should not be taken as a ‘given’.

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