scholarly journals The Impact of Reimbursement Practices on the Pharmaceutical Market for Off-Patent Medicines in Slovakia

2021 ◽  
Vol 12 ◽  
Author(s):  
Tomas Tesar ◽  
Peter Golias ◽  
Lucia Masarykova ◽  
Paweł Kawalec ◽  
András Inotai
Keyword(s):  
Comparative Analysis ◽  
Generic Drugs ◽  
European Medicines Agency ◽  
Medicinal Products ◽  
Generic Medicines ◽  
Patent Medicines ◽  
Reference Pricing ◽  
External Reference ◽  
The Impact ◽  
Visegrad Group

Background: The aim of this study was to investigate the impact of selected legislative initiatives and their implementation for off-patent medicinal products in Slovakia compared with the rest of the Visegrád Group (V4 countries).Methods: We analyzed the development of applications for the reimbursement of generic and biosimilar drugs. Particular emphasis was placed on a) the availability and penetration of biosimilars from 2006 to 2020 in Slovakia, b) a comparative analysis of biosimilars in V4 countries based on the national reimbursement lists of medicinal products for August 2021. Data relating to the sales of generic and biosimilar medicines in Czechia, Hungary, Poland, and Slovakia were based on the IQVIA MIDAS MAT July 2021.Results: The number of applications for the reimbursement of generic drugs decreased from 296 in 2016 to 165 in 2020. In financial terms, the sales of generic medicines in Slovakia increased from 21.7% in 2015 to 22.3% in 2020. Over the same period, the sales of generic drugs in Poland fell from 40.4% in 2015 to 35.0% in 2020, from 26.2 to 22.1% in Hungary, and from 29.6 to 20.4% in Czechia. When considering the 66 biosimilars registered by the European Medicines Agency 38 drugs (58%) were available on the Slovak market as of August 1, 2021; this compared to 32 drugs (48%) in Poland, 38 drugs (58%) in Hungary, and 40 drugs (61%) in Czechia. In financial terms, the sales of biosimilars in Slovakia increased from 0.94% in 2015 to 2.00% in 2020. Over the same period, the sales of biosimilars in Poland increased from 0.59% in 2015 to 1.29% in 2020, from 0.72 to 2.23% in Hungary, and from 0.76 to 2.15% in Czechia.Conclusion: To intensify the use of generic and biosimilar medicines, we suggest the comprehensive re-evaluation of combinations of the three-threshold entry, the amount of mandatory price reductions, and external reference pricing requirements (as the average of the three lowest prices among the official prices of a medicinal product in other Member States) for generic and biosimilar drugs. We also suggest cancellation of the exception from the fixed co-payment of the insured.

The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance: application to diabetes and vascular disease

2011 ◽  
Vol 11 (6) ◽  
pp. 304-307 ◽  
Author(s):  
Kevin V Blake ◽  
Camilla Smeraldi ◽  
Xavier Kurz ◽  
Peter Arlett ◽  
Stella Blackburn ◽  
...  
Keyword(s):  
Drug Utilisation ◽  
Real Life ◽  
European Medicines Agency ◽  
The European Union ◽  
Medicinal Products ◽  
European Network ◽  
Study Protocols ◽  
Real Life Setting ◽  
The Impact ◽  
Support Decision Making

The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) is an initiative led by the European Medicines Agency (EMA) aimed at further strengthening the post-authorisation monitoring of medicinal products in Europe by facilitating the undertaking of multi-centre, independent, studies focusing on safety and on benefit/risk. A key objective of ENCePP is to provide a unique point of access for all involved stakeholders, including industry or regulatory authorities, who are seeking collaboration for the commissioning or the performance of post-authorisation studies. The 2010 EMA regulatory action relating to rosiglitazone included a pharmacoepidemiological drug utilisation study to evaluate the benefit–risk profile in a real-life setting and has also led to the commissioning of an ENCePP study to evaluate the impact of risk-minimisation activities. ENCePP seeks to improve the European Union capacity to conduct such studies and thus support decision making. Application of the ENCePP study concept will result in an increase in trust in medicines and their use. In addition, the ENCePP register of studies will serve as a resource to allow for ready access to study protocols and results, thereby ensuring transparency.

scholarly journals Corporate Strategies for Generic Medicines in Brazil: A Study with the Sector’s Ten Largest CompaniesHttp://Dx.Doi.Org/10.5585/Riae.V10i1.1710

2011 ◽  
Vol 10 (1) ◽  
pp. 77-101
Author(s):  
Silvia Antonio Sfair ◽  
Dirceu Da Silva ◽  
Mauro Neves Garcia ◽  
Sérgio Luiz do Amaral Moretti
Keyword(s):  
Generic Drugs ◽  
Government Performance ◽  
Medicinal Products ◽  
Generic Medicines ◽  
Point Of Sale ◽  
Direct Sales ◽  
Corporate Strategies ◽  
The Subject ◽  
Growth Barriers ◽  
Depth Interviews

In Brazil, generic drugs are considered safe and effective and substantially cheaper than the so-called reference medicinal products. Due to this, generic drugs have become an important sector within the pharmaceutical market. However, topical studies are scarce and researchers focus on health professionals and direct sales. This article looks to expand on the understanding concerning the subject investigating the vision of those responsible for production, its relationship with physicians, government policies and delivery chain management in serving the consumer. To present this objective, in-depth interviews were conducted with ten executives occupying strategic positions in the pharmaceutical industry in general. The sample represents approximately 84% of generic drug sales in Brazil. The results have demonstrated that government performance plays an important role in the marketing of generic drugs to the population, while the drugstore and distributors were identified in this market as growth barriers, due to the practices used at point of sale. Doctors are considered the prime agent in popularizing the use of generic drugs in Brazil.

scholarly journals STATISTICAL ANALYSIS OF CURRENT TRENDS IN THE TOURISM DEVELOPMENT OF THE VISEGRAD GROUP

2021 ◽  
Author(s):  
Tatyana Derkach ◽  
Olha Mylashko
Keyword(s):  
Comparative Analysis ◽  
Regression Model ◽  
Impact Analysis ◽  
Tourism Development ◽  
International Tourism ◽  
The European Union ◽  
International Tourist ◽  
The World ◽  
The Impact ◽  
Visegrad Group

The paper presents the research results of tourism state and patterns development in the Visegrad Group. The regional grouping of Central and Eastern Europe, the Visegrad Group, has become a separate subsystem of the European Union, which has received economic, logistical, cultural and political content. These processes are important for Ukraine. The experience of the Visegrad Group, the ability to quickly solve current issues and face the challenges, understanding the real hierarchy of priorities while preserving the national identity of the Visegrad Group (VG) are significant for Ukraine. Tourism is an area that can positively influence both the development of the integrated structure as a whole and the socio-economic development of its member countries. The article carries out a comparative analysis of tourism development trends in the Visegrad Group countries, Europe and the world, as well as develops recommendations for assessing the cooperation prospects between Ukraine and the VG using econometric methods. To achieve the goal of the study, a comparative analysis of global, European and Visegrad trends in tourism was developed, arrivals of international tourists on the amount of income from international tourism by conducting a correlation-regression analysis, substantiated and developed applied aspects for forecasting the potential mutual benefit from cooperation between Ukraine and the VG. According to the World Trade Organization, the forecast of the number of international tourists in the world for 2020-2021 was made. Based on the impact assessment of the number of international tourist arrivals on the amount of income from international tourism, a linear regression model was built, the adequacy and reliability of the regression coefficient was confirmed by Fisher's and Student's estimates. During the analysis (from a priori analysis, proving the quantitative and qualitative homogeneity of the two sets, to the construction, evaluation and analysis of the obtained model) a regression model was built, which can be recommended to be used in the impact analysis of tourist arrivals on international tourism. A comparative analysis of the dynamics of international tourist arrivals and revenues from international tourism in Poland and Ukraine was done. As a result of Poland's experience research, a model of revenues from international tourism is recommended, the factors of which are gross investment (% of GDP) and the number of tourist arrivals.

scholarly journals Where is Industry Getting it Wrong? A Review of Quality Concerns Raised at Day 120 by the Committee for Medicinal Products for Human Use during European Centralised Marketing Authorisation Submissions for Chemical Entity Medicinal Products

2009 ◽  
Vol 12 (2) ◽  
pp. 181 ◽  
Author(s):  
John Joseph Borg ◽  
Jean-Louis Robert ◽  
George Wade ◽  
George Aislaitner ◽  
Michal Pirozynski ◽  
...  
Keyword(s):  
Marketing Authorisation ◽  
Drug Product ◽  
Point Of View ◽  
Chemical Entity ◽  
European Medicines Agency ◽  
Medicinal Products ◽  
Drug Products ◽  
Human Use ◽  
Consistent Information ◽  
The Impact

ABSTRACT – Purpose. The aim of this study was to identify common trends in the deficiencies identified in the quality part of the dossier during the evaluation of marketing authorisation applications for medicinal products for human use submitted through the EU’s centralised procedure. Methods. We analysed all the adopted Day 120 list of questions on the quality module of 52 marketing authorisation applications for chemical entity medicinal products submitted to the European Medicines Agency and evaluated by the Committee for Medicinal Products for Human Use (CHMP), during 12 consecutive plenary meetings held in 2007 and 2008. Subsequently we calculated the frequency of common deficiencies identified across these applications. Results. Frequencies and trends on quality deficiencies have been recorded and presented for 52 marketing authorisation applications. 32 “Major Objections” originated from 13 marketing authorisation applications. 13 concerned were raised regarding drug substances and 19 for drug products. Furthermore, 905 concerns on drug substance and 1,054 on drug product were also adopted. Conclusions. The impact of the frequencies and trends in quality deficiencies that were identified are discussed from a regulatory point of view. It is expected that the results of this study will not only be of interest to pharmaceutical companies but will also aid regulators’ in obtaining consistent information on drug products based on transparent rules safeguarding the necessary pharmaceutical quality of medicinal products.

scholarly journals The impact of generic medicines on the European pharmaceutical market: The example of Poland

Ekonomia ◽  
2018 ◽  
Vol 23 (4) ◽  
pp. 251-260
Author(s):  
Julia Matsuieva
Keyword(s):  
European Union ◽  
Social Role ◽  
Generic Drugs ◽  
Pharmaceutical Market ◽  
The European Union ◽  
Generic Medicines ◽  
Rational Use ◽  
The Social ◽  
The Impact

The impact of generic medicines on the European pharmaceutical market: The example of PolandIn this paper has been done a review of the existing situation on European pharmaceutical market. It was found that the Polish pharmaceutical market is quite different from other countries of the European Union. The share of generic medicines in Poland is the highest in the European Union. Quantitatively about 85% of the pharmaceutical market is composed of generic drugs. The social role of generics is expressed in their accessibility, affordable price, diversity and security for the most vulnerable part of the population — people with various health problems. It is impossible to overestimate the importance of generic medicines in both saving of the state’s budgets and the rational use of public fi nances.

scholarly journals A RIPPLE EFFECT OF COVID-19 PANDEMIC ON SHORTAGE OF MEDICINAL PRODUCTS AND ITS IMPACT ON PATIENT CARE

2021 ◽  
pp. 364-370
Author(s):  
BIPLAB KUMAR DEY ◽  
EFFICIENCY MYRSING ◽  
RUHUL AMIN ◽  
FARUK ALAM ◽  
MIZANUR RAHMAN ◽  
...  
Keyword(s):  
Health Care ◽  
Medicinal Product ◽  
Antimicrobial Agents ◽  
The United States ◽  
Public Health Issue ◽  
European Medicines Agency ◽  
Ripple Effect ◽  
Medicinal Products ◽  
Short Supply ◽  
The Impact

Objective: Shortages of medicinal products are complex global problems. Drug shortages remain a significant public health issue. Global shortages of medical products have a potential effect on patient health and total healthcare costs. Countries worldwide, especially those affected by Coronavirus disease 2019 (COVID-19), is experiencing a rapid increase in drug shortage, which causes several complications for physicians, health care provider, patients, health institutes and health regulatory bodies. Methods: To carry out the study of shortages, several efforts have been taken by the regulators and industries. Prominent amongst these include FDA's research the needs and the reforms made in the regulations about shortages. We also searched for electronic databases (PubMed, Science direct, Web of Science) using the terms (COVID-19 and shortage) or (medicine and COVID-19) for articles in periods of 2019 to 2021. Results: On assessment based on the report, the number of shortage drugs in 2020 is 835; Anesthesia drugs are highest during the COVID-19 outbreak data indicate the number of shortages is 143 in USA. It was found that generic products were mostly in short supply, with antimicrobial agents (63%) topping the list of therapeutic categories of medicines with interrupted supply, followed by oncology medicines (47%) and then anesthetic agents (38%) during COVID-19 pandemic. Conclusion: Many steps have been taken to reduce the impact of a shortage of health care. Agencies like the United States Food and Drug Administration (US FDA) and European Medicines Agency (EMA) has established guidelines and works with manufacturers and other partners to help prevent shortages. This article aims to the analysis the root cause of medicinal product shortages, their effects on the patient outcome, medication error, which occurs due to the substitution safe and effective therapies with alternative treatments, identify possible solutions and policies established to manage medicinal product shortages.

Corruption as “one‑stop‑shop”: theory and empirical analysis

2018 ◽  
pp. 32-51
Author(s):  
R. Yu. Kochnev ◽  
L. I. Polishchuk ◽  
A. Yu. Rubin
Keyword(s):  
Comparative Analysis ◽  
Business Environment ◽  
Enterprise Performance ◽  
Double Jeopardy ◽  
One Stop ◽  
The Commons ◽  
Public Production ◽  
Performance Project ◽  
The Impact ◽  
Sector Theory

We present the comparative analysis of the impact of centralized and decentralized corruption for private sector. Theory and empirical evidence point out to a “double jeopardy” of decentralized corruption which increases the burden of corruption upon private firms and weakens the incentives of bureaucracy to provide public production inputs, such as infrastructure. These outcomes are produced by simultaneous free-riding and the tragedy of the commons effects. The empirical part of the paper utilizes data of the Business Environment and Enterprise Performance project.

Assessment of small businesses activities in Ukraine

2019 ◽  
pp. 40-47
Author(s):  
Igor Ponomarenko ◽  
Kateryna Volovnenko
Keyword(s):  
Comparative Analysis ◽  
Statistical Analysis ◽  
Small Business ◽  
Small Businesses ◽  
Government Agencies ◽  
Small Enterprises ◽  
The Subject ◽  
Business Entities ◽  
The Impact ◽  
Micro Enterprises

The subject of the research is a set of approaches to the statistical analysis ofthe activities of small business entities in Ukraine, including micro-enterprises. The purpose of writing this article is to study of the features of functioningof small business entities in Ukraine. Methodology. The research methodology isto use a system-structural and comparative analysis (to study the change in thenumber of small enterprises by major components); monographic (when studyingmethods of statistical analysis of small businesses); economic analysis (when assessing the impact of small business entities on socio-economic phenomena andprocesses in Ukraine). The scientific novelty consists to determine the features ofthe functioning of small businesses in Ukraine in modern conditions. The influenceof the activities of the main socio-economic and political indicators on the activities of small enterprises in recent periods of time has been identified. It has beenestablished that there is flexibility in the development of strategies by small businesses in conditions of significant competition, which makes it possible to quicklyrespond to changing situations in specific markets. Conclusions. The use of acomprehensive statistical analysis of small businesses functioning in Ukraine willallow government agencies to develop a set of measures to optimize the activitiesof these enterprises, which ultimately will positively affect the strengthening oftheir competitiveness and will contribute to the growth of the national economicsystem.

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