Policy recommendations for a sustainable biosimilars market: lessons from Europe

2020 ◽  
Vol 9 (2) ◽  
pp. 76-83
Author(s):  
Philip J Schneider ◽  
Michael S Reilly

Approximately 25% of all new medicines approved in recent years and in development today are biologicals. The complexity of biologicals, the investment needed to meet ever more stringent regulatory and payer requirements, combined with the needs of an ageing population, mean the cost of these medicines and the burden on governments and insurance companies is growing. However, the introduction of biosimilars has broadened treatment choices for physicians and their patients and, by increasing competition, reduced healthcare expenditures. The biosimilar market in Europe is the largest in the world, representing approximately 60% of the global biosimilar market and growing consistently year on year. As of October 2019, 54 biosimilars of 15 originator biological medicines have marketing authorization in Europe. European countries, with their large biosimilar markets and diverse healthcare systems, serve as valuable examples of different approaches to biosimilar policy. Several studies, research papers and position statements have been published on such policies. These findings, along with real-world policy and procurement examples from European countries, provide an opportunity for other countries to learn from. This paper will review the different approaches to biosimilar policy across the European continent, highlighting principles which can be applied to develop an efficient and sustainable biosimilar market.

2011 ◽  
Vol 21 (2) ◽  
pp. 180-192 ◽  
Author(s):  
Inder Singh ◽  
Ruth E Hubbard

SummaryPopulations throughout the world are ageing, with the oldest old the most rapidly growing segment of society. Caring for this ageing population, some of whom have multiple chronic and disabling diseases, will be challenging to healthcare systems. Current training programmes are generating relatively low numbers of geriatricians, largely because students and residents lack interest in a career in geriatric medicine. Therefore, specialists in geriatric medicine cannot directly provide care for all older people. There is a responsibility to ensure that successful practices and essential skills are shared.Here we explore negative attitudes towards geriatric medicine and contrast these with factors motivating change. Educational theories are discussed to investigate how processes of learning and the personal development of students can be optimized. An understanding of geriatric medicine is important for undergraduates, postgraduate trainees in geriatric medicine, general practitioners and allied health professionals. The different challenges presented by each group are reviewed, accompanied by recommendations to enhance learning and examples of effective teaching practices.


Author(s):  
Olivier Maquaire

Western European countries are subject to natural phenomena that can cause disasters. Their origins are various: geophysical (earthquakes), hydrometeorological (sea storms, floods, and avalanches), or geomorphologic (landslides). They are fairly widespread but less frequent and of relatively low intensity compared with other regions of the world; for example, an earthquake in France or Belgium is not likely to be as violent as in Greece or Japan. Some of the countries concerned, such as France and Germany, are subject to all the hazards mentioned above, while Denmark and The Netherlands are seldom exposed to earthquakes and never to avalanches because they have no mountains. Man is not responsible for phenomena such as earthquakes, but contributes significantly to the onset and aggravation of other hazards, and is sometimes largely responsible for the direct and indirect consequences, having built and maintained installations in ‘risk’ sectors. The number of victims and the cost of the damage may be high, depending on the circumstances, the intensity, and the duration of the phenomenon. Western European countries have experienced real natural disasters in the distant or recent past. Floods following a storm wave in The Netherlands in 1953 were responsible for some 2,000 deaths and damage amounting to over 3 billion Euros. Two hundred people died in the most destructive flood ever known in France in 1930 in the Tarn (Ledoux 1995). Natural phenomena such as these can recur with at least the same intensity but may entail much greater damage because of increased human occupation in the sectors concerned: the flooding submerges zones which are much more urbanized than they were in the nineteenth century. Whether prevention measures are taken depends on the level of risk which the populations concerned are prepared to accept. These measures should be associated with spatial and temporal forecasts and preceded by an analysis of the processes for these phenomena to be fully understood. In order to remove the ambiguities and the inaccuracies of terminology that are observed all too often, it is necessary in the first instance to define ‘geomorphic hazards and natural risks’, particularly in terms of the notions of risk, hazards, and vulnerability.


2011 ◽  
Vol 8 (2) ◽  
pp. 35-38 ◽  
Author(s):  
Vicky Banks ◽  
Geoff Searle ◽  
Rachel Jenkins

The National Health Service (NHS) serves the UK through four devolved organisations for England, Scotland, Wales and Northern Ireland. It is one of the largest public healthcare systems in the world, universal and free at the point of delivery. Its key challenge is to maintain this approach within tight financial constraints, while embracing new technologies, treatments and styles of service delivery, as well as meeting the health needs of an ageing population.


2020 ◽  
pp. 49-59
Author(s):  
O. M. Zaliska ◽  
К.-О. Ya. Stasiv ◽  
N. M. Maksymovych

In Ukraine, in order to achieve the Sustainable Development Goals, the State Strategy for the Implementation of the State Policy for the Provision of the Population with Medicines for the Period until 2025 has been approved, which includes improving the availability of drugs to improve the quality of life. Assisted Reproductive Technologies (ART) are gaining widespread implementation and funding from the budget in the world. Goal – the aim of the work was to analyze the state and dynamics of ART cycles in Ukraine for 1999–2019 and to estimate the cost of ART in Ukraine and to develop a methodology for estimating the availability of ART and comparison with European countries. Materials – international and domestic publications on the assessment of the availability of drugs, the cost of ART. Research methods: system analysis, data synthesis and generalization of information, webometric analysis, statistical analysis of data on the number of ART cycles for 1999-2018, analysis of ART costs. It is determined that the indicator of the number of ART cycles per 1 million population increased 29.9 times for 1999–2018, which is due to the increase in the number of ART centers conducted ART cycles in relation to the decrease in the population of Ukraine. It was found that 85% of ART centers are concentrated in only 4 cities (Kyiv, Lviv, Odessa, Kharkiv), which reduces the accessibility of the population to ART cycles, especially in the conditions of quarantine and pandemic COVID-19. It was found that in 1999–2018 the number of ART centers increased 7.7 times, but only 10.8% of ART centers have state funding, which indicates the low availability of ART for budget funds. It was found that the structure of ART cycles changed significantly. The average costs for the most common ART cycles IVF and ICSI in Ukraine as of the end of 2019 have been determined. It has been shown that only 26% of ART centers provide information on the cost of ART cycles, and web pages need to be filled with information on the cost of ART cycles to ensure that patients are properly informed. It is shown that in Ukraine as of 2020 the costs of ART cycles are 24 425–30 516 UAH (917,25–1 010,57 Euro) depending on the type of cycle from the perspective of the payer. It is estimated that the availability of ART is 1.5–9.98 depending on the type of ART cycle, the cost of ART cycles is 6–10 times higher than the average family income, when in European countries the availability of ART is much lower 1,5–4.2, which showed higher availability of ART in European countries from payer prospect.


2019 ◽  
Vol 48 (1) ◽  
pp. 58-64
Author(s):  
Achim Regenauer

Due to an increasingly better understanding of the human genome, the number of potential molecular targets, and therefore, potential applications by gene therapies is also increasing. After almost two decades of basic research, the first gene therapeutics are now entering the market. They are among the most expensive types of treatment in medicine. Over the next 10 years, the number and volume of their applications will increase significantly. So, our healthcare systems and inherently health insurance companies will face considerable challenges that will require new approaches to financial solutions. This article first describes the mode of action of the first gene therapies of cancer and their by now known side effects. Subsequently, the cost problems are dealt with and possible financing options are pointed out.


2019 ◽  
Vol 29 ◽  
pp. 49-57
Author(s):  
Sergey V.  Lebedev ◽  
Galina N.  Lebedeva

In the article the authors note that since the 1970s, with the rise of the Islamic movement and the Islamic revolution in Iran, philosophers and political scientists started to talk about religious renaissance in many regions of the world. In addition, the point at issue is the growing role of religion in society, including European countries that have long ago gone through the process of secularization. The reasons for this phenomenon, regardless of its name, are diverse, but understandable: secular ideologies of the last century failed to explain the existing social problems and give them a rational alternative.


2015 ◽  
Vol 6 (01-02) ◽  
Author(s):  
Anis Ur Rehman ◽  
Yasir Arafat Elahi ◽  
Sushma .

India has recently emerged as a major political and economic power in the world. The financial crisis that engulfed the world in 2008 needed developing countries like India to lead the rescue and recovery, instead of G7 westerns countries who dealt with such crisis in the past. Recently, discussions and negotiations are going amongst G20 countries regarding a new global financial architecture (G-20 Summit, 2008). The outcome will affect the relevant industries in India and hence it is a public interest issue for the actuarial profession in the country. Increased and more intrusive and costly regulations and red tapes are likely to be a part of the new deal (Economic Survey 2009-10). The objective of this paper is to study the perception of higher level authorities in Insurance sector regarding the role of regulator in minimizing the impact of global financial crisis. The primary data has been collected from 200 authorities in insurance industry. The data has been analyzed with statistical tools like MS-Excel. On the basis of the findings, various measures and policy recommendations for insurers have been suggested to minimize the impact of crisis.


2019 ◽  
Vol 2019 (3) ◽  
pp. 47-53
Author(s):  
Галина Глембоцкая ◽  
Galina Glembockaya ◽  
Станислав Еремин ◽  
Stanislav Eremin

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.


This volume documents the intellectual influence of the United Nations through its flagship publication, the World Economic and Social Survey (WESS) on its seventieth anniversary. Prepared at the Department of Economic and Social Affairs (DESA) and first published in 1948 as the World Economic Report (subsequently renamed the WESS), it is the oldest continuous post-World War II publication of this kind, recording and analysing the performance of the global economy and social development trends, and offering relevant policy recommendations. This volume highlights how well WESS has tracked global economic and social conditions, and how its analyses have influenced and have been influenced by the prevailing discourse over the past seven decades. The volume critically reflects on its policy recommendations and their influence on actual policymaking and the shaping of the world economy. Although world economic and social conditions have changed significantly over the past seven decades and so have the policy recommendations of the Survey, some of its earlier recommendations remain relevant today; recommendations in WESS provided seven decades ago seem remarkably pertinent as the world currently struggles to regain high levels of employment and economic activity. Thus, in many ways, WESS was ahead of the curve on many substantive issues. Publication of this volume will enhance the interest of the wider community of policymakers, academics, development practitioners, and members of civil society in the analytical work of the UN in general and UN-DESA in particular.


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