Breakthrough Therapy, PRIME and Sakigake: A Comparison Between Neuroscience and Oncology in Obtaining Preferred Regulatory Status

2019 ◽  
pp. 216847901987406 ◽  
Author(s):  
Elena Tomaselli Muensterman ◽  
Yijia Luo ◽  
Jonathon M. Parker
Keyword(s):  
The United States ◽  
Accelerated Programs ◽  
The European Union ◽  
Regulatory Pathways ◽  
Drug Candidates ◽  
Regulatory Status ◽  
The Us ◽  
Life Threatening ◽  
Global Nature ◽  
Increasing Demand

Background: Because of the increasing demand for drugs addressing life-threatening and rare diseases, regulatory agencies have developed a variety of accelerated regulatory pathways. These programs are aimed at prioritizing the most promising drug candidates for diseases lacking satisfactory treatments. The most prominent accelerated programs introduced have been Breakthrough-Therapy Designation (BTD) in the United States, Priority Medicine (PRIME) in the European Union and Sakigake in Japan. This article reviews these designations and looks at differences in how they are granted across the 3 jurisdictions focusing on neuroscience and oncology. Methods: Our objective was to analyze BTD, PRIME, and Sakigake approvals between 2012 and 2019 with a focus on numerical disparities of designations granted between the 2 therapeutic areas. A search of public sources pertaining to topics of BTD, PRIME, and Sakigake was undertaken. Results: This analysis revealed that 48% of BTD were granted in oncology, while neuroscience received 8% of these designations, for PRIME designations were 27% received by oncology and 15% by neuroscience and in Japan, 50% of Sakigake were granted to oncology and 22% to neuroscience products. Conclusion: Given the global nature of drug development and relative similarity of these regulatory mechanisms, there is an apparent disparity between the US granting special status at 6:1 (oncology: neuroscience) and both the EU and Japan granting at 2:1. This disproportionate ratio is likely impacted by multifactorial issues; however, this difference is worth further investigation.

scholarly journals The Trend of Scientific Productivity of Chinese, EuropeanUnion, and United States Universities and Private Companies: Does the Future Belong to E-Technology Companies?

Publications ◽  
2021 ◽  
Vol 9 (2) ◽  
pp. 18
Author(s):  
Mauro G. Carta ◽  
Matthias C. Angermeyer ◽  
Silvano Tagliagambe
Keyword(s):  
United States ◽  
European Union ◽  
Scientific Productivity ◽  
The United States ◽  
The European Union ◽  
Private Companies ◽  
American Universities ◽  
The Us ◽  
Parametric Statistics ◽  
The Eu

The purpose is to verify trends of scientific production from 2010 to 2020, considering the best universities of the United States, China, the European Union (EU), and private companies. The top 30 universities in 2020 in China, the EU, and the US and private companies were selected from the SCImago institutions ranking (SIR). The positions in 2020, 2015, and 2010 in SIR and three sub-indicators were analyzed by means of non-parametric statistics, taking into consideration the effect of time and group on rankings. American and European Union universities have lost positions to Chinese universities and even more to private companies, which have improved. In 2020, private companies have surpassed all other groups considering Innovation as a sub-indicator. The loss of leadership of European and partly American universities mainly concerns research linked to the production of patents. This can lead to future risks of monopoly that may elude public control and cause a possible loss of importance of research not linked to innovation.

Germany's relations with the United States and China from a strategic triangle perspective

2021 ◽  
Author(s):  
Sebastian Biba
Keyword(s):  
United States ◽  
European Union ◽  
The United States ◽  
Great Power ◽  
The European Union ◽  
Bilateral Relations ◽  
Puzzle Piece ◽  
The Us ◽  
The World ◽  
Angela Merkel

Abstract As the Sino-American Great Power competition continues to intensify, newly-elected US President Joe Biden's administration now seeks to enlist the support of its allies and partners around the world. As Europe's largest economy and a, if not the, leading voice within the European Union, Germany represents an important puzzle-piece for Biden. But Germany, at least under outgoing chancellor Angela Merkel, has been reluctant to take sides. It is against this backdrop that this article looks into Germany's past and present trilateral relationships with the US and China through the theoretical lens of the so-called strategic triangle approach. Applying this approach, the article seeks to trace and explain German behaviour, as well as to elucidate the opportunities and pitfalls that have come with it. The article demonstrates that Germany's recently gained position as a ‘pivot’ (two positive bilateral relationships) between the US and Chinese ‘wings’ (positive bilateral relations with Germany and negative bilateral relations with each other) is desirable from the perspective of the strategic triangle. At the same time, being pivot is also challenging and hard to maintain. Alternative options, such as entering a US–German ‘marriage’ directed against China, are also problematic. The article therefore concludes that Germany has tough decisions to take going forward.

scholarly journals Differentiation between the Regulatory paths placed on Mouthwashes in the US and EU

2018 ◽  
Vol 6 (2) ◽  
pp. 8-13
Author(s):  
Philip Saddik ◽  
John Pappan
Keyword(s):  
United States ◽  
The United States ◽  
The European Union ◽  
Oral Diseases ◽  
External Appearance ◽  
Regulatory Systems ◽  
The Us ◽  
United States Food ◽  
States Food ◽  
Therapeutic Properties

Regulating oral rinses has been and still is a topic of debate and confusion. Oral rinses are products that are mainly used for cleaning, perfuming and changing the appearance of the teeth, which in turn improves the individual’s external appearance. Adding medicinal ingredients to these rinses, it can then be used for the elimination and/or prevention of some oral diseases, an example being gingivitis. The United States Food and Drug Administration placed guidelines which state that mouthwashes with possible therapeutic properties should be registered as drugs rather than cosmetics. Meanwhile, on a different continent, Germany along with the other members of the European Union decided not to categorize mouthwashes as drugs, but rather as cosmetics, using its sole purpose of cleaning and beautifying the teeth as the excuse. The following research will thoroughly differentiate between the diverse regulatory systems forced upon mouthwashes across the two countries—the United States and Germany.

scholarly journals Controversial advertising of medicines. A comparison between Poland and the United States

2018 ◽  
Vol 21 (5) ◽  
pp. 67-79
Author(s):  
Marta Makowska
Keyword(s):  
United States ◽  
Prescription Drugs ◽  
The United States ◽  
The European Union ◽  
Negative Consequences ◽  
Direct To Consumer ◽  
Law And Ethics ◽  
The Us ◽  
The Law ◽  
Direct To Consumer Advertising

For many years, the subject of aggressive marketing campaigns conducted by pharmaceutical companies has been raised in Poland. Drug ads are everywhere, on television, the radio, magazines and on the Internet. Therefore, it is extremely important is to ensure both their legal and ethical dimension. This article will present the differences between direct-to-consumer advertising of medicines in Poland and in the US. The dissimilarities result mainly from differences in legislation. In Poland, the law is much stricter than in the US. For example, in the United States companies are allowed to advertise prescription drugs directly to patients. In the whole of the European Union, and thus in Poland, it is strictly prohibited. The article will also present other regulations existing in Poland and in the United States and it will compare them. It will offer examples of violations of the law and ethics in the advertising of medicine in both countries. Lastly, it will briefly outline the negative consequences of unacceptable pharmaceutical marketing.

scholarly journals Criminal Liability of Medical Profecionals Negligience: Comparative Analysis

2020 ◽  
Vol 38 (Especial II) ◽  
pp. 251-263
Author(s):  
Kateryna Danchenko ◽  
Olga Taran
Keyword(s):  
Comparative Method ◽  
Criminal Liability ◽  
The United States ◽  
Medical Professionals ◽  
The European Union ◽  
Judicial Decision ◽  
Criminal Proceedings ◽  
Medical Office ◽  
The Us ◽  
The Impact

The purpose of this article is to study the criminal liability of medical professionals in cases of suspension, in accordance with jurisprudence in Ukraine, the European Union and the United States of America (USA). He made the comparative method. According to the investigation, the number of criminal proceedings in Ukraine by the authority and misconduct of medical doctors is about 2% per population, my figure that rises to 30% in Europe and is the stable yes in the US and is 28%. 32%. The main objective of the article is often area identify specializations in the medical office occurs with the mayor based on Ukrainian jurisprudence (data from Ukraine’s only state judicial decision register from 2016 to 2019). In addition, the study analyses the impact of the main influences on the ability of medical professionals for their professional functions. From counting the results show that surgeons, gynecologists, paramedics, and anesthesiologists are the most prone to deviation and medical error. Key proposed criteria have been proposed as medical errors differ from medical writing.

Antitrust Regulation of IT Giants` Activities: Main Trends of Foreign and Russian Legislation

2021 ◽  
Author(s):  
D.V. Shram ◽  
Keyword(s):  
House Of Representatives ◽  
Network Effects ◽  
The United States ◽  
The European Union ◽  
The United Kingdom ◽  
The Us ◽  
The Usa ◽  
Economic Concentration ◽  
The Uk ◽  
Antitrust Regulation

The article is devoted to the antimonopoly regulation of IT giants` activities. The author presents an overview of the main trends in foreign and Russian legislation in this area. The problems the antimonopoly regulation of digital markets faces are the following: the complexity of determining the criteria for the dominant position of economic entities in the digital economy and the criteria for assessing the economic concentration in the commodity digital markets; the identification and suppression of cartels; the relationship between competition law and intellectual property rights in the digital age. Some aspects of these problems are considered through the prism of the main trends in the antimonopoly policy in the United States, the European Union, the United Kingdom and Russia. The investigation findings of the USA House of Representatives Antitrust Subcommittee against Apple, Google, Amazon and Facebook are presented. The author justifies the need to separate them, which requires the adoption of appropriate amendments to the antimonopoly legislation. The article analyzes the draft law of the European Commission on the regulation of digital markets – Digital Markets Act, reveals the criteria for classifying IT companies as «gatekeepers», and notes the specific approaches to antimonopoly regulation in the UK and the US. The article describes the concepts «digital platform» and «network effects», presented in the «fifth antimonopoly package of amendments», developed in 2018 by the Federal Antimonopoly Service of the Russian Federation, and gives an overview of the comments of the Ministry of Economic Development regarding these concepts wording in the text of the draft law, which formed the basis for the negative conclusion of the regulator. It is concluded that in the context of the digital markets’ globalization, there is a need for the international legal nature antitrust norms formation, since regional legislation obviously cannot cope with the monopolistic activities of IT giants.

Analysis of the US Privacy Model

2021 ◽  
pp. 1818-1825
Author(s):  
Francisco García Martínez
Keyword(s):  
Data Privacy ◽  
Personal Information ◽  
National Level ◽  
The United States ◽  
The European Union ◽  
General Data Protection Regulation ◽  
Privacy Laws ◽  
The Us ◽  
General Data ◽  
State Of Art

The creation of the General Data Protection Regulation (GDPR) constituted an enormous advance in data privacy, empowering the online consumers, who were doomed to the complete loss of control of their personal information. Although it may first seem that it only affects companies within the European Union, the regulation clearly states that every company who has businesses in the EU must be compliant with the GDPR. Other non-EU countries, like the United States, have seen the benefits of the GDPR and are already developing their own privacy laws. In this article, the most important updates introduced by the GDPR concerning US corporations will be discussed, as well as how American companies can become compliant with the regulation. Besides, a comparison between the GDPR and the state of art of privacy in the US will be presented, highlighting similarities and disparities at the national level and in states of particular interest.

Lessons Learned from the Canada–China FIPA for the US–China BIT and beyond

2019 ◽  
pp. 116-141 ◽  
Author(s):  
Kyle Dylan Dickson-Smith
Keyword(s):  
United States ◽  
Legal Protection ◽  
The United States ◽  
International Investment ◽  
Economic Benefits ◽  
Lessons Learned ◽  
The European Union ◽  
Investment Protection ◽  
The Us ◽  
Investment Agreements

Key lessons can be made from analysing a unique and recent BIT, the Canada–China Foreign Investment Protection Agreement (FIPA), in order better to predict and identify the opportunities and challenges for potential BIT counterparties of China (such as the United States, the European Union (EU), India, the Gulf Cooperation Council, and Columbia). The Canada–China FIPA and the anticipated US–China BIT (and EU–China BIT) collectively fall into a unique class of investment agreements, in that they represent a convergence of diverse ideologies of international investment norms/protections with two distinct (East/West) underlying domestic legal and economic systems. The purpose of this chapter is to appreciate and utilize the legal content of the Canada–China FIPA in order to isolate the opportunities and challenges for investment agreements currently under negotiation (focusing on the US–China BIT). This analysis is conducted from the perspective of China’s traditional BIT practice and political–economic goals, relative to that of its counterparty. This chapter briefly addresses the economic and broader diplomatic relationship between China and Canada, comparing that with the United States. It then analyses a broad selection of key substantive and procedural obligations of the Canada–China FIPA, addressing their impact, individually and cumulatively, to extract what lessons can be learned for the United States (US) and other negotiating parties. This analysis identifies the degree of investment liberalization and legal protection that Canada and China have achieved, and whether these standards are reciprocally applied. The analysis is not divorced from the relevant political economy and negotiating position between China and the counterparty and the perceived economic benefits of each party, as well as any diplomatic sensitive obstacles between the parties. While this chapter does not exhaustively analyse each substantive and procedural right, it provides enough of a comprehensive basis to reveal those challenges that remain for future bilateral negotiations with China.

Pharmaceutical Regulation in the European Union

2018 ◽  
Author(s):  
Stuart O. Schweitzer ◽  
Z. John Lu
Keyword(s):  
European Union ◽  
Drug Approval ◽  
Good Clinical Practice ◽  
The United States ◽  
Good Manufacturing Practice ◽  
Pharmaceutical Products ◽  
European Medicines Agency ◽  
Regulatory Regime ◽  
The European Union ◽  
Regulatory Pathways

The main scientific and technical aspects of new drug registration, including pathways to marketing authorization approval, clinical study design and method, and requirement of and specifications for Good Clinical Practice, Good Laboratory Practice, and Good Manufacturing Practice, are all quite similar between Europe and the United States. Differences do exist, however. This chapter provides a closer examination of the drug regulatory regime in the European Union. After providing a brief history of the European Medicines Agency, the chapter examines the agency’s organizational structure and role in ensuring the safety and efficacy of pharmaceutical products for Europe, and discusses the regulatory pathways for generics and biosimilars in the EU. The chapter also looks at recent trends in international drug approval lags.

Analysis of the US Privacy Model

2019 ◽  
Vol 3 (1) ◽  
pp. 43-52
Author(s):  
Francisco García Martínez
Keyword(s):  
Data Privacy ◽  
Personal Information ◽  
National Level ◽  
The United States ◽  
The European Union ◽  
General Data Protection Regulation ◽  
Privacy Laws ◽  
The Us ◽  
General Data ◽  
The Eu

The creation of the General Data Protection Regulation (GDPR) constituted an enormous advance in data privacy, empowering the online consumers, who were doomed to the complete loss of control of their personal information. Although it may first seem that it only affects companies within the European Union, the regulation clearly states that every company who has businesses in the EU must be compliant with the GDPR. Other non-EU countries, like the United States, have seen the benefits of the GDPR and are already developing their own privacy laws. In this article, the most important updates introduced by the GDPR concerning US corporations will be discussed, as well as how American companies can become compliant with the regulation. Besides, a comparison between the GDPR and the state of art of privacy in the US will be presented, highlighting similarities and disparities at the national level and in states of particular interest.

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