The Applicability of Process-Orientation to Software Development Projects

The progress in the digital single market (DSM) has been acknowledged as one of the 10 political priorities by the European Commission since 2015. It could contribute € 415 billion per year (GDP) to the economy of the 28 EU Member States and create hundreds of thousands of new jobs. Nowadays, the ICT sector and the European Digital Agenda have declared it as one of the seven pillars of the Europe 2020 strategy. In order to speed up the development of new information technology and its commercialisation, it is necessary to increase software quality aimed at accelerating and improving technology transfer, taking into account process quality management. The aim of this article is to give an overview of a new approach to producing an additional value of the software development projects to improve the technology transfer process.

Competitiveness of EU Member States Regarding the Implementation of the Europe 2020 Strategy Assumptions

The Europe 2020 Strategy occupies a prominent place in the European Union's (EU) cohesion policy as a long-term programme for social and economic advancement. The main objective of the strategy is to implement the idea of smart, sustainable and inclusive development. An important priority implemented by EU countries in the context of implementing the assumptions of the Europe 2020 strategy is smart growth, i.e., the development of an economy based on knowledge and innovation. This requires significant spending on research and development and the use of mechanisms that enable the rapid transfer of theoretical knowledge into economic practice. The Europe 2020 strategy has set new targets for increasing competitiveness and accelerating the development of EU regions and countries. For all regions, including the economically weakest ones, the implementation of the Europe 2020 Strategy goals has been an important stimulus for the development and increase in competitiveness of EU regions. The decade just ending justifies carrying out assessments that must be intricately linked to the analysis of indicators set by the European Commission within the framework of the strategy's three priorities, i.e., smart, sustainable and inclusive development. The aim of the article is to assess the degree of implementation of the assumptions of the Europe 2020 Strategy in EU Member States. With the use of a synthetic indicator calculated using a multidimensional comparative analysis based on the Hellwig method, a ranking of EU countries, in terms of implementing the Europe 2020 Strategy assumptions, was established. The main indicators proposed by Eurostat for monitoring the Europe 2020 Strategy were applied for the assessment. As a result of the conducted research, conclusions were formulated regarding the importance of the Europe 2020 Strategy in the implementation of the cohesion policy principles in EU Member States. The research results show that the countries that have achieved the best results in the implementation of the assumptions of the Europe 2020 Strategy are also leaders in the ranking of competitiveness taking GDP per capita into account published by the European Commission.

The European framework for intellectual property rights for biological medicines

Introduction: The Pharmaceutical Strategy for Europe (2020) proposes actions related to intellectual property (IP) rights as a means of ensuring patients’ access to medicines. This review aims to describe and discuss the European IP framework and its impact on accessibility of biological medicines and makes some recommendations. Methods: A non-systematic literature review on IP for biological medicines was conducted. Data on authorizations and patent and exclusivity expiry dates of biological medicines obtained from the European Medicines Agency’s (EMA) website and literature was analysed quantitatively and qualitatively. Results: The analysis showed that as at end July 2021, 1,238 medicines were authorized in Europe, of which 332 (26.8%) were biological medicines. There were only 55 biosimilars for 17 unique biologicals. There is an increasing trend in biological authorizations but signifi cant delays in submission of applications for marketing authorization of biosimilars, with no signifi cant diff erences in the time for assessment for marketing authorization between originator biologicals and biosimilars. For some of the more recent biosimilars, applications for authorization were submitted prior to patent and exclusivity expiry. COVID vaccines confi rmed the impact of knowledge transfer on accessibility, especially when linked to joint procurement. Discussion: IP protects originator products and impacts the development of biosimilars. Strategies to improve competition in the EU biological market are discussed. Pricing policies alone do not increase biosimilar uptake since patients are switched to second generation products. Evergreening strategies might be abusing the IP framework, and together with trade secrets and disproportionate prices compared to R & D and manufacturing costs lead to an imbalance between market access and innovation. Conclusion: The European Pharmaceutical Strategy should focus on IP initiatives that support earlier authorization of biosimilars of new biologicals. Recommendations include knowledge sharing, simplifi cation of the regulatory framework and transparency of prices and R & D costs.

Efficiency of Implementing Climate/Energy Targets of the Europe 2020 Strategy and the Structural Diversity between Old and New Member States

The most important goals included in the Europe 2020 Strategy are climate/energy targets, which determine not only the achievement of its other goals but also climate neutrality by 2050. This article aims to assess the efficiency of implementing the climate/energy targets of the Europe 2020 Strategy and to analyse changes over time, taking into consideration the structural diversity between the old (EU 15) and new EU members (EU 13) in the period of 2014–2018. The assessment of changes in the efficiency of climate/energy targets over time adds value to the evaluation methods used to date in this area. This was done using data envelopment analysis (DEA) and the Malmquist index. Earlier works usually specified only the level of target achievement, mostly jointly in relation to all of the goals of the Europe 2020 Strategy. The efficiency of their implementation at the macroeconomic level has not been studied. Furthermore, the added value of this paper consists in obtaining additional information concerning the internal structure and character of the studied efficiency of old and new member states. Changes in the efficiency level have been analysed with regard to the key climate/energy indicators used to monitor the Europe 2020 Strategy. Based on the results, the EU countries were divided into six groups with similar levels of efficiency in achieving energy and climate objectives and ranked using the DEA–Malmquist index according to changes in their level over time. This makes it possible not only to assess the performance of countries but also to formulate recommendations for decision-makers.

Vaccination programs for children aged up to 18 years in Europe, 2020

Although all European countries have vaccination policies for children, there are no comprehensive studies of pediatric vaccination programs in Europe. We studied vaccination programs for children in Europe. Vaccinations against diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b, hepatitis B, measles, mumps, rubella, and influenza existed in 42 countries, against human papilloma virus in 41 countries, and against pneumococcus in 40 countries. In addition, the following vaccinations existed: against tuberculosis (35 countries), hepatitis A (33), meningococcus A, C, W, Y (30), rotavirus and varicella (28 countries each), meningococcus B (24), tick-born encephalitis (22), and meningococcus C (16). Mandatory vaccinations are implemented in 21 countries, mainly against diphtheria, tetanus, pertussis, poliomyelitis, H. influenzae type b, hepatitis B, measles, mumps, rubella, tuberculosis, and pneumococcus. There are significant differences among pediatric vaccination programs in Europe regarding number, schedules, indications, and regulatory frame (recommended or mandatory vaccinations). A consensus-based vaccination program for all children is needed.

WHAT IS NEW IN THE EU COHESION POLICY?

Based on the review of regulations and press releases of EU institutions, the content of changes in the cohesion policy in 2021–2027 was revealed in comparison with the period 2014– 2020. The conclusion is made about the preservation of a significant role of the cohesion policy in the EU’s activities and high volume of its allocations from the EU Budget. The author sees an element of novelty in the synthesis of well-known methods and principles of supranational regulation of the socio-economic development of the EU territories – the budget method, the principle of financial conditionality and the open method of coordination. Particular attention is paid to the decision to reorient a third of the allocations of European regional policy funds for programs of transition to a circular and climate-neutral economy in 2021–2027. The explanation of such strong link between the goals of regional policy and the ecological and climatic goals of the EU is proposed. Namely, the success of the «Europe 2020» Strategy only in terms of climate benchmarks, according to the author, gives to the official Brussels a reason to see the potential to increase the effectiveness of regional policy.