European Agreements Research Articles

Linking Reimbursement to Patient Benefits for Advanced Therapy Medicinal Products and Other High-Cost Innovations: Policy Recommendations for Outcomes-Based Agreements in Europe

ObjectivesHealth technology assessment (HTA) of advanced therapy medicinal products (ATMPs), such as high-cost and one-time cell and gene therapies, is particularly challenging. Outcomes-based agreements (OBAs) are a potential solution to mitigate the risks while providing access to patients but are not widely used across Europe. This study aimed to develop policy recommendations to support the acceptability and implementation of OBAs in Europe. MethodsA policy sandbox approach was used to engage with stakeholders and explore how HTA organizations can support reimbursement decisions regarding OBAs for ATMPs. A panel of 38 experts from across the European region was convened in 2 workshops, representing payers, HTA organizations, patients, registries, and an industry trade body. ResultsPolicy recommendations were developed to support the appropriate consideration of OBAs for reimbursing highly uncertain technologies, such as ATMPs. If a positive HTA recommendation cannot be made at the proposed price, then a simple price discount reflecting the uncertainty is preferred over complex solutions such as OBAs. If an OBA is pursued, it should be designed collaboratively with all stakeholders to understand data collection feasibility and minimize burden to patients and providers. Payers are encouraged to approach OBAs as a tool for informed decision making, including a readiness to make negative reimbursement decisions based on unfavorable evidence. ConclusionsThe study presents a policy framework for using OBAs in reimbursement decisions. OBAs must be carefully designed, focusing on appropriateness and the burden of implementation. The relevant authorities should be committed to making decisions in light of the resulting evidence.

Defining directions for improving regulation of private law forms of technology transfer in the European Union

The object of this study is the existing regulatory approaches to the definition of private law forms of technology transfer in the law of the European Union, international treaties, and agreements. In the course of research and generalization of existing concepts, it was established that they are not unified and differ significantly. It has been proven that this does not meet the needs of technology transfer participants and destabilizes the technology transfer process. The expediency of improving the existing concept of defining private law forms of technology transfer by unifying them has been substantiated. Recommendations on the list of the main forms of technology transfer have been formed based on a systematic analysis of regulatory legal acts that determine the content of technology. A classification of the main private law forms of technology transfer has been proposed. Three main groups of private law forms of technology transfer were distinguished. The expediency of assigning each private law form of transfer to a certain group was substantiated. Directions for improving the current regulation of private law forms of technology transfer have been formed, by summarizing and supplementing them. The need to make changes to the provisions of such international treaties and agreements as the World Trade Organization Agreements, the Recommendations of the World Organization for the Protection of Intellectual Property, the Oslo Guidelines, the UNCTAD Recommendations, and the framework program "Horizon Europe" has been proven. The research was aimed at the formation of general theoretical foundations for the improvement of regulatory methods of identification of private law forms of technology transfer. The research results can be used in the formation of international normative acts, recommendations of international institutions, acts of national legislation and serve as a basis for further scientific research on these issues

Empirical Effects of Resale Price Maintenance: Evidence from Fixed Book Price Policies in Europe

Abstract This paper investigates the effects of Resale Price Maintenance (RPM) agreements in Europe by studying a legally permitted form of RPM in the book market. In particular, we study the effects of such agreements on prices and sales, finding that countries which have Fixed Book Prices policies witness higher book sales, relative to countries without such a policy, with no noticeable effect on the average price of books. We suggest that the mechanism for these findings is that FBP policies promote non-price competition and a diverse network of retailers, increasing quantity, whereas a change in bargaining power reduces double marginalisation, offsetting upward pricing pressure from RPM. While these results are limited to the book sector and are based on a limited number of countries changing policy, they nonetheless highlight that RPM agreements have the ability to confer positive competition effects and absolute prohibition of such agreements may not always be warranted.

Military Balancing for Future Conventional Arms Control Agreements in Europe

Abstract A qualitative assessment of the conventional military balance between NATO and Russia may form a basis of any potential conventional arms control (CAC) agreement in Europe. Article discusses methods to assess force capability and military balances, and then suggests updates to the methods based on insights from recent conflicts, military capability trends and developments. The article offers a weighted static force analysis model to assess military balances, that can be used for CAC agreements, called the Quantitative Approach to Conventional Arms Control (QuACAC). This approach may help narrow areas of disagreement between negotiating parties, and provide a basis for CAC agreement adaptation.

Mezzanine momentum: A cross continental examination of corporate financing trends

Aim/purpose – Aside from conventional debt financing, mezzanine debt funding is an essential, nontraditional, and innovative instrument for financing a corporation. Nonethe- less, the use and discussions on this particular type of financing are still limited. This study aims to investigate the nature and patterns of mezzanine debt financing and agreements at the global and regional levels, seeking to understand the trends and differ- ences in its funding flows and deal movements across various continents so that busi- nesses looking to grow abroad might use this analysis to identify places where mezza- nine finance is more accessible or advantageous. Moreover, investors can select the most appealing markets and conditions for mezzanine investments, thus improving their port- folios. Design/methodology/approach – Using seven global regions (e.g., Asia, Africa, Eu- rope, Middle East, North America, Oceania, and rest of the world (RoW)) annual data from 2006 to 2023, this study employs descriptive analysis and applies the one-way between groups ANOVA. Findings – The findings show notable differences in the flows of mezzanine debt fund- ings and deals across different geographical locations globally. Besides, it also explores that mezzanine debt financing and agreements in North America and Europe make up most of the contributions, while other regions are still at the early stage of development. Research implications – Policymakers and governments in regions like Asia, Africa, the Middle East, Oceania, and the RoW should look into ways to increase the flow and growth of their agreements because the patterns and trends of funding and deals in those regions are considerably lower than North America and Europe. Originality/value/contribution – The literature on mezzanine debt mainly addresses its definition, features, facilities, disadvantages, and possible borrowers. This study investi- gates the recent pattern and trend of mezzanine debt funding and its deals globally based on different geographical locations. Keywords: mezzanine, mezzanine financing, mezzanine debt, mezzanine deals. JEL Classification: D24, G11, H63.

Collective bargaining and power: Wage premium of collective agreements in Europe 2002–2018

AbstractThis article uses the European Structure of Earnings Survey to describe the evolution of collective bargaining coverage in European countries during 2002–2018 and how this affected the pay premium associated with being covered. Pay premia are an outcome of negotiations, reflecting the bargaining power on behalf of employees as well as the system of coverage, separately for the public and private sector. Descriptively, we show a decline in collective bargaining coverage linked to a general reduction in the pay differences. This hides much variation though. In a multivariate analysis of changes over time, we show that centrally bargained agreements are associated with larger pay premia if more people are covered and in countries and sectors with stronger trade unions. As this power declines over time, so do wage premia. At higher rates of coverage, there can be a spillover effect where wages for all workers increase, thereby reducing the premia.

Region oriented and integrated approach to reduce emissions of nutrients and greenhouse gases from agriculture in the Netherlands

Agricultural practices are causing a variety of environmental impacts such as emissions of ammonia (NH3) and greenhouse gases (GHG), and leaching and runoff of nutrients to groundwater and surface water. Measures need to be taken to achieve environmental targets set in European agreements and directives, such as the Birds and Habitats Directives, Nitrates Directive, Water Framework Directive and Fit for 55 package. To explore solutions for these issues an integral approach is needed, in which synergies between measures are included and pollution swapping is avoided. In addition, spatial interaction needs to be included because the environmental impacts are related to the spatial distribution of nature sites, farming systems, soil type and hydrology. We performed a regionalised approach for the Netherlands using a suite of models to simulate the effect of agricultural measures on manure and fertilizer distribution, emissions of NH3 and GHG, nitrogen (N) deposition on nature, nitrate (NO3−) leaching to groundwater, N and phosphorus (P) losses to surface waters, and soil carbon (C) sequestration. A mix of structural, technical and management measures was evaluated to achieve targets on both regional and national level for a regionalised approach and a more generic (national) approach. Results show that the regionalised approach is more beneficial, especially for water quality improvement and N deposition reduction and to a lesser extend for the mitigation of GHG emissions and NO3− leaching. When all measures are fully implemented, the 2030 targets for NO3− and N deposition can be attained, but the targets for surface water and climate mitigation cannot be met.

The system of law and the legal system of Ukraine in the era of globalism (integration)

In the changing conditions of the modern world, marked by the rapid development of technologies, economic globalization, and growing international cooperation, legal systems and legal systems of national states are becoming the object of significant transformations. The dynamic nature of these processes creates complex challenges and opportunities that require serious scientific understanding and analysis. One of the key aspects of this transformation is the interaction of the legal systems of nation-states with global challenges and integration processes.
 Ukraine, as a sovereign state, does not remain aloof from these processes. In the context of active participation in the European and world community, the country is forced to adapt its legal system to international standards, as well as effectively interact with other legal systems. At the same time, the preservation of national identity and unique legal traditions requires a careful balance between external influences and internal needs of society.
 The current stage of Ukraine‘s development is characterized by intensive processes of European integration, which cover various aspects of society, including the legal sphere. Accession to various European agreements, creation of joint economic spaces, and mutual adaptation of normative acts create new challenges for the legal system of Ukraine. At the same time, these integration efforts have the potential to contribute to the modernization and improvement of the efficiency of the national legal system.
 Therefore, in the context of globalism and integration processes, the legal system and the legal system of Ukraine become the subject of deep research. Understanding the impact of global trends on the national legal system, as well as the possibility of harmonization and adaptation to international standards, requires a systematic approach and scientific expertise. In this context, the study of the interaction between the legal system of Ukraine and global integration processes becomes particularly relevant, contributing to the disclosure of opportunities and challenges of this complex institutional relationship.

The concept and structure of the rule-making activity of the state as one of the types of human activity

The article examines the theoretical and legal problems of the concept and structure of the rule-making activity of the state from the standpoint of the general scientific concept of activity and its structure. Activity is considered as work, actions of people, a specifically human form of attitude to the surrounding world, as a form of activity that characterizes the ability of a person or related systems to be the cause of changes in being. In the structure of activity, the concept and content of the goal (goals), subjects, object, means, as well as control over its implementation, are distinguished and disclosed. The purpose of rule-making activities includes the implementation of legal regulation, the protection of social relations, the achievement of its constitutional goals determined by the purpose of the state, the protection of human rights and freedoms, the provision of decent conditions for its life, the needs of the development of a democratic, social, legal state, the implementation of state tasks in the economic, social and cultural spheres, as well as the need to ensure the development of law, its systematization, maintenance of the entire array of legal acts in proper condition.The range of subjects of the state’s rule-making activity is outlined, which include state authorities authorized to adopt normative acts, local self-government bodies, their officials, and other subjects empowered by law to adopt (issue) normative acts. Disclosed means (substantive or substantial), means of implementation into the national legal system of international and European agreements, normative acts of the European Union, means and techniques of legal technique) and results of rule-making activity (there is a formal and legal form of expression of this activity in the form of a corresponding normative act and meaningful the result is regulated social relations).Forms of control over rule-making activities are outlined (the implementation of the entire range of professional and public examinations of normative acts, public discussions of draft normative acts, control checks within the powers of the relevant state authorities, monitoring the effectiveness of their implementation, judicial control in the process of challenging the relevant legal acts), as well as the assessment of the role of the procedural form of rule-making activity as one of the most important elements of rule-making activity, in which all other elements of rule-making activity are concentrated, is given.

Labor mobility agreements and exit of migrants: Evidence from Europe

AbstractIn this paper, we study how free labor mobility agreements in Europe, usually thought to favor inward migration, might actually create good incentives for already settled migrants to exit their host country. Using outmigration data between 1990 and 2011, a period of observation where some countries entered the EU and especially a period during which Schengen agreements have been progressively implemented by a large number of European countries, we could test this conjecture. While the evidence for EU is mixed, we find very strong evidence that Schengen did increase migrations outflows by 40 to 53%. The effect appears to be even higher for outmigrants originating from Eastern Europe after their countries' accession to Schengen. Also, and consistent with the hypothesis of preferences for living at home or in a country with a close culture to home, the effect of Schengen on outmigration happens to be smaller when the countries of origin and of residence of the outmigrants are close in terms of their cultural traits. Also, we document that the Schengen effect is significantly higher for outmigration flows than for immigration flows by almost 20 percentage points.

Global evaluation of model agreement and uncertainty in terrestrial water storage simulations from ISIMIP 2b framework

Terrestrial water storage (TWS) is a vital component in global hydrologic cycle with direct linkage to water resources availability and hydrologic extremes. Assessing the uncertainty in TWS projections are fundamentally important for developing counter-measures against impacts of climate change on water resources and disasters. This study presents a global-scale evaluation of model agreement and uncertainty in TWS anomaly (TWSA) simulations within the ISIMIP 2b framework by comparison with the 2006–2016 Gravity Recovery and Climate Experiment (GRACE) data. The total 24 members of ISIMIP2b ensembles considered here include the permutations of 6 global water models (GWMs: CLM4.5, H08, LPLmL, MATSIRO, PCR-GLOBWB, WaterGAP2) simulations forced by 4 global climate models (GCMs: GFDL-ESM2M, HadGEM2-ES, IPSL-CM5A-LR, MIROC5) under RCP2.6 and RCP6.0 scenarios. Results show that the fraction of global land area with the same sign between the ISIMIP2b ensemble mean and GRACE TWSA is 47.5 % and 47.3 % under RCP2.6 and RCP6.0, respectively. The ensemble mean reproduces the negative (positive) TWSA in southern North America, southwestern Asia, northern and central Africa (central South America and northern Europe) under both scenarios. More than 50 % of ensemble members agree with GRACE TWS better in the sign of drying trend than wetting trend over the global land. The interannual TWS variations among ensemble members show better agreement in North America and Europe than other continents. More than 80 % of ensemble members simulate larger (smaller) TWS seasonal amplitude than GRACE in North America, Europe, and Asia (South America, Africa, and Australia). GWM is found to be the main source of uncertainty in TWS simulations in North America, Europe, and Asia (>55 %), while GCM uncertainty is the dominant uncertainty source in South America, Africa, and Australia (>45 %).

Demonstrating proof of concept for value-based agreements in Europe: two real-world cases.

Value-based agreements (VBAs) link access, reimbursement, or price to the real-world usage and impact of a medicine, thereby enabling patient access while reducing clinical or financial uncertainty for the payer. VBAs have the potential to support improved patient outcomes, given the value-oriented approach to care, and lead to overall savings, while enabling payers to share risk and reduce uncertainty. This commentary outlines the key challenges, enablers, and a framework for successful implementation by comparing the experience of two VBAs for AstraZeneca medicines, aiming to increase confidence in their future use. Engagement by payers, manufacturers, physicians, and provider institutions, and robust data collection systems that are accessible, simple to use, and add little burden to physicians were key to successfully negotiating a VBA that worked for all stakeholders. In both country systems, a legal/policy framework enabled innovative contracting. These examples demonstrate proof of concept for VBA implementation in different settings, and may inform future VBAs.

The No Drawback Rule in EU Preferential Agreements

Drawback is a tool available to countries to promote their exports but also a measure that harms trade liberalization. This article argues that the no drawback rule in European Union preferential agreements does not apply when the exemption or reduction of duties derives from an EUR.1 or an origin declaration in application of that agreement. On the other hand, this reasoning cannot always be extended when the exemption of duties derives from the application of an inward processing regime. Therefore, an operator in the European Union will find more convenient and smoother to establish trade relations with operators located in countries with which the European Union has concluded preferential trade agreements. no drawback, origin, inward processing regime, preferential treatment, Approved Exporter, EUR.1

A European comparison of continuing education in pathology

In the coming years, the shortage of pathologists will become internationally evident. In addition, the increase in knowledge, technical transformation processes, and the attractiveness of working conditions pose clear challenges for the field of pathology. Abi-directional opening for international mobility of pathologists could be apotential solution.In this analysis, the European training concept of the European Union of Medical Specialists (UEMS) was compared with its implementation in the 27countries of the EU plus its 4associated countries with regard to nationally differentiated concepts, type and implementation of the specialist examination, and additional qualifications. Subsequently, questions regarding the recognition of exams, titles, and specialist exams were elicited.The duration of training ranges between 4 and 6years. The number of cases also varies considerably. Obtaining the specialist title can be done by simply completing the specifications up to astructured examination. In the EU, exams are mutually recognized, but this does not necessarily apply to academic titles and additional qualifications. Increasingly, on-site training centers are also subject to auditing procedures.The European agreements allow ahigh degree of permeability. However, national regulations pose hurdles for international mobility. The UEMS is therefore focusing on harmonization, including the certification of training centers. The so-called European Pathology Progress Test of the European Society of Pathology (ESP) is afurther step towards the development of afuture European specialist title. It remains the joint responsibility of residents and institutes to shape the future of the next generation of pathologists from the variety of different concepts.

Outcome-based reimbursement in Central-Eastern Europe and Middle-East.

Outcome-based reimbursement models can effectively reduce the financial risk to health care payers in cases when there is important uncertainty or heterogeneity regarding the clinical value of health technologies. Still, health care payers in lower income countries rely mainly on financial based agreements to manage uncertainties associated with new therapies. We performed a survey, an exploratory literature review and an iterative brainstorming in parallel about potential barriers and solutions to outcome-based agreements in Central and Eastern Europe (CEE) and in the Middle East (ME). A draft list of recommendations deriving from these steps was validated in a follow-up workshop with payer experts from these regions. 20 different barriers were identified in five groups, including transaction costs and administrative burden, measurement issues, information technology and data infrastructure, governance, and perverse policy outcomes. Though implementing outcome-based reimbursement models is challenging, especially in lower income countries, those challenges can be mitigated by conducting pilot agreements and preparing for predictable barriers. Our guidance paper provides an initial step in this process. The generalizability of our recommendations can be improved by monitoring experiences from pilot reimbursement models in CEE and ME countries and continuing the multistakeholder dialogue at national levels.

Implementation of environmental policy of Ukraine in the context of circular economy

European practice has proven that all EU member states are responsible for the implementation of adopted European environmental agreements. Since 1992, the countries of the European Union have identified environmental protection as a priority for their own development. The study of the process of implementing Ukraine’s environmental policy in the context of the circular economy is gaining relevance. The purpose of the article is to study the processes of implementation of the environmental policy of Ukraine in the context of the circular economy. In the process of writing a scientific article, general scientific research methods were used: the method of theoretical generalization; categorical analysis; method of comparison; method of abstraction; grouping method; forecasting method. In the process of research, the key directions of implementation of environmental policy at the state level are given. The main aspects of the implementation of the circular economy at the regional level have been established. Three levels of formation and implementation of environmental policy in Ukraine are defined. Various tools for implementing environmental policy in the context of the circular economy are presented. It was established that in Ukraine today there is practically no development and implementation of effective mechanisms for the implementation of the state environmental policy, there are no tools for eliminating the causes of environmental problems and reducing the negative impact on the ecological sphere during the implementation of economic activities. It has been established that in the process of implementation of environmental policy, the state may have an appropriate role, either promoter, facilitator, or catalyst. Conclusions have been made regarding the importance of implementing the circular economy. The study of the implementation of the environmental policy of Ukraine in the context of the circular economy gained further development in terms of taking into account the components of the environmental policy, aspects of the circular economy and the comprehensive implementation of the environmental policy at the international, state, regional and local levels. The practical value of scientific research lies in the theoretical justification of the process of implementing environmental policy in the context of the circular economy, taking into account international experience and tools for implementing environmental policy at all levels

The European Agri-Food Legislation and Trade Agreements in the Context of the covid-19 Crisis

Abstract This article performs an assessment of the EU Agri-food legislation in the context of the covid-19 crisis: new priorities into a new scenario. Taking the General Food Law as a focal point, this article analyses and explains the institutional, substantive, and procedural elements of EU food law and his intersection with International Trade Law. Principles are discussed as well as specific rules addressing food as a product, the processes related to food and communication about food to consumers. In fact, it is interesting to retrace the points of contact that food legislation shares with other legal disciplines since it is well known that the matter has a cross-cutting scope, i.e., from Agricultural Law to ip Law, from Criminal Law to International Trade Law. Although, the importance of food and related trade issues have always been regulated in times of emergency, as the bse crisis (Bovine Spongiform Encephalopathy, commonly known as “mad cow disease”) or during a worldwide pandemic (covid-19). However, until the publication of the Reg. 178/2002, it would have been impossible any given attempt to attribute the requisites of a coherent legal framework to the disordered, episodic, and often dictated by hot reactions of Food Law, understood as a system of rules ordered based on its own principles. Progress made by regulatory interventions that allows today to observe the matter under a different angle. In fact, attention is given to the international context (wto, Codex Alimentarius) as well as to the relationship with food trade policies and the current legal framework and regulatory provisions (such as those contained in Chapter i and ii) of Reg. 178/2002, the latter titled General Food Law.

Predicaments during a period of health emergency: Waiving patent protections or innovative public procurement? The example of advance purchase agreements (APA) for COVID-19 vaccines.

The health emergency provoked by the worldwide pandemic requires immediate action to achieve the immunization of the population and to stop further contagion. The systems of public procurement needed to adapt in a very short time to reach agreements with the pharmaceutical industry. Proposing options between the waiving of patent protections and innovative public procurement, principally the European Advance Purchase Agreements (APA). A description of the actual situation and the necessary regulatory reforms. The sources are scientific articles, legislative compendiums and opinion pieces and the current press. The debate over the waiving of patent protections at this time is both misleading and ineffective due to the economic and legal problems involved. The path of the APA has proven to be very effective, although some deficits should be corrected, principally regarding questions of transparency and confidentiality. Among the possible options for the acquisition of the COVID-19 vaccine and its universal access, agreements and cooperation between States and innovative industry are desirable. One successful path is that of the advance purchase agreements utilized by the European Union, another could be that of voluntary licensing. We propose following these routes as opposed to the waiving of patent protections.

An Uncertain Future for EU-Level Collective Bargaining: The New Rules of the Game After EPSU

Abstract The General Court of the European Union (GCEU) in EPSU and Goudriaan vs. Commission and the Court of Justice of the European Union (CJEU) in the subsequent appeal judgment reached an identical conclusion on a key aspect of the system of EU level collective bargaining. The Courts held that Article 155(2) of the Treaty on the Functioning of the European Union (TFEU) does not impose any obligation on the European Commission to send a social partner agreement to the Council. This is in line with the Commission’s recent interpretation of Article 155(2) TFEU that subordinates the implementation of the European agreements to a positive assessment of their appropriateness. This article critically assesses the GCEU and CJEU rulings in EPSU and argues that they confirm a major break with the praxis of European collective bargaining that will have negative consequences for the social partners’ autonomy and role in the EU. In order to better understand this break, the article examines how and when the Commission changed its approach to European social dialogue, resulting in the new interpretation of Article 155(2) TFEU, and proposes a hypothesis to understand why. The article concludes by describing the consequences of the new reading of Article 155(2) TFEU for the idea of collective autonomy in EU law as well as for the practice of EU level social dialogue and collective bargaining.

Home Field Advantage? EU–ACP Economic Partnership Agreement Meeting Locations and Textual Tone

AbstractThe European Union's Economic Partnership Agreements (EPAs) with countries in the African, Caribbean and Pacific (ACP) group are touted as a new form of equitable engagement. However, many argue that the EPAs simply substitute a different form of political and economic domination. In this paper, we consider if the siting of meetings has a substantive impact on EPA outcomes or media reporting thereof. Using a difference‐in‐difference like approach we evaluate if the tone and polarity of media reports about the EPAs during periods of ‘home’ meetings in the ACP countries differs from media reports during ‘away’ meetings in the EU. Using two different datasets we arrive at differing results, leading to inconclusive overall findings. While we suspect that the alternating meeting site norm has implications for EPA process and outcomes, further research will be needed to uncover the precise nature of these effects.