Leniency programmes in competition law make it possible to grant immunity from fines, or a reduction of any fine that would otherwise have been imposed on an undertaking who was a party to an ...unlawful agreement restricting competition. This immunity or fine reduction is granted as a reward for the cooperation with the competition authority and the provision of evidence of an unlawful agreement restricting competition. Legal rules regarding the application of leniency programmes have been introduced at the EU level as well as in the national legislations of numerous countries, including Polish law. The author makes an attempt to establish the degree to which the Polish leniency programme is an effect of the impact of EU law or the application of law within the EU (for instance, by its institutions). The analysis has been made on three levels. Examined first was the degree to which the Polish leniency programme is a result of spontaneous harmonisation. Second, the impact of legislative harmonisation in the area of leniency programmes was taken into consideration. Finally, it was verified whether those Polish authorities that apply Polish competition law are inspired by judgements issued by EU courts in cases regarding leniency programmes
•Calls for harmonised ‘sustainability reporting’ standards are underpinned by myths.•It is a myth that a Global sustainability standard-setting body is urgently needed.•Financial materiality should ...not be paramount in determining sustainability disclosures.•Investor needs cannot be satisfied by consistent and comparable metrics alone.•Calls for harmonisation overlook needs of non-investor stakeholders.
We critically examine the call for ‘harmonisation’ of sustainability reporting frameworks and standards that occurred alongside an increase in environmental, social and governance (ESG) investing during the COVID-19 pandemic. We identify three myths that have been promulgated in calls for ‘harmonisation’ that seek to: simplify sustainability reporting and ESG analysis and shift the control for standard-setting to an investor-oriented private sector body. We argue that the myths are based on deception, misunderstandings, and disregard for both academic research and the views of sustainability practitioners. They demonstrate a lack of regard for different users of corporate sustainability information, a lack of analysis of the alternatives, an overestimation of the International Financial Reporting Standards (IFRS) Foundation’s expertise and mischaracterisation of sustainable/ESG financing.
Harmonisation sets the ground to a solid inter-comparison of integrated assessment models. A clear and transparent harmonisation process promotes a consistent interpretation of the modelling outcomes ...divergences and, reducing the model variance, is instrumental to the use of integrated assessment models to support policy decision-making. Despite its crucial role for climate economic policies, the definition of a comprehensive harmonisation methodology for integrated assessment modelling remains an open challenge for the scientific community.
This paper proposes a framework for a harmonisation methodology with the definition of indispensable steps and recommendations to overcome stumbling blocks in order to reduce the variance of the outcomes which depends on controllable modelling assumptions. The harmonisation approach of the PARIS REINFORCE project is presented here to layout such a framework. A decomposition analysis of the harmonisation process is shown through 6 integrated assessment models (GCAM, ICES-XPS, MUSE, E3ME, GEMINI-E3, and TIAM). Results prove the potentials of the proposed framework to reduce the model variance and present a powerful diagnostic tool to feedback on the quality of the harmonisation itself.
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•Step-by-step harmonisation on socio-economics, techno-economics, and policies•Up-to-date open source data are supplied for socio-economics and techno-economics.•The proposed harmonisation procedure reduces emissions gap to 2.3 Gt of CO2 in 2030.
Background, aim and scope
In 2005, a comprehensive comparison of life cycle impact assessment toxicity characterisation models was initiated by the United Nations Environment Program (UNEP)–Society ...for Environmental Toxicology and Chemistry (SETAC) Life Cycle Initiative, directly involving the model developers of CalTOX, IMPACT 2002, USES-LCA, BETR, EDIP, WATSON and EcoSense. In this paper, we describe this model comparison process and its results—in particular the scientific consensus model developed by the model developers. The main objectives of this effort were (1) to identify specific sources of differences between the models’ results and structure, (2) to detect the indispensable model components and (3) to build a scientific consensus model from them, representing recommended practice.
Materials and methods
A chemical test set of 45 organics covering a wide range of property combinations was selected for this purpose. All models used this set. In three workshops, the model comparison participants identified key fate, exposure and effect issues via comparison of the final characterisation factors and selected intermediate outputs for fate, human exposure and toxic effects for the test set applied to all models.
Results
Through this process, we were able to reduce inter-model variation from an initial range of up to 13 orders of magnitude down to no more than two orders of magnitude for any substance. This led to the development of USEtox, a scientific consensus model that contains only the most influential model elements. These were, for example, process formulations accounting for intermittent rain, defining a closed or open system environment or nesting an urban box in a continental box.
Discussion
The precision of the new characterisation factors (CFs) is within a factor of 100–1,000 for human health and 10–100 for freshwater ecotoxicity of all other models compared to 12 orders of magnitude variation between the CFs of each model, respectively. The achieved reduction of inter-model variability by up to 11 orders of magnitude is a significant improvement.
Conclusions
USEtox provides a parsimonious and transparent tool for human health and ecosystem CF estimates. Based on a referenced database, it has now been used to calculate CFs for several thousand substances and forms the basis of the recommendations from UNEP-SETAC’s Life Cycle Initiative regarding characterisation of toxic impacts in life cycle assessment.
Recommendations and perspectives
We provide both recommended and interim (not recommended and to be used with caution) characterisation factors for human health and freshwater ecotoxicity impacts. After a process of consensus building among stakeholders on a broad scale as well as several improvements regarding a wider and easier applicability of the model, USEtox will become available to practitioners for the calculation of further CFs.
•Identified measurement variability in CRP and NT-proBNP.•Highlighted gaps in standardization protocols.•Urged for robust international guidelines.•Advocated for standardized collection protocols.
...The harmonization of laboratory biomarkers is pivotal in ensuring consistent and reliable diagnostic outcomes across different clinical settings. This systematic review examines the harmonization of C-Reactive Protein (CRP) and N-Terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP) measurements, both of which are jointly utilized in the diagnosis and management of cardiovascular diseases. To identify relevant studies, we searched the PubMed electronic database using specific medical subject headings and keywords such as C-Reactive Protein, CRP, high sensitivity C-Reactive Protein (hs-CRP), N-terminal pro B-type natriuretic peptide, and NT-proBNP, focusing on publications from June 1 to September 26, 2021. The query filtered studies to include only those in English involving human subjects. From our search, 97 articles met the inclusion criteria and were included for in-depth analysis. Despite their widespread use, significant variability remains in the measurements of CRP and NT-proBNP due to a lack of standardized pre-analytical, analytical, and post-analytical practices. This review highlights the consequences of this variability on clinical decision-making and patient outcomes and emphasizes the need for international standards and guidelines to achieve better harmonization. Our findings advocate for the establishment of universal protocols to enhance the reliability of these biomarker measurements across different clinical environments, ensuring improved healthcare delivery.
Recombinant antibodies (Abs) are an integral modality for the treatment of multiple tumour malignancies. Since the Food and Drug Administration (FDA) approval of rituximab as the first monoclonal ...antibody (mAb) for cancer treatment, several mAbs and antibody (Ab)‐based therapies have been approved for the treatment of solid tumour malignancies and other cancers. These Abs function by either blocking oncogenic pathways or angiogenesis, modulating immune response, or by delivering a conjugated drug. The use of Ab‐based therapy in cancer patients who could benefit from the treatment, however, is still limited by associated toxicity profiles which may stem from biological features and processes related to target binding, alongside biochemical and/or biophysical characteristics of the therapeutic Ab. A significant immune‐related adverse event (irAE) associated with Ab‐based therapies is cytokine release syndrome (CRS), characterized by the development of fever, rash and even marked, life‐threatening hypotension, and acute inflammation with secondary to systemic uncontrolled increase in a range of pro‐inflammatory cytokines. Here, we review irAEs associated with specific classes of approved, Ab‐based novel cancer immunotherapeutics, namely immune checkpoint (IC)‐targeting Abs, bispecific Abs (BsAbs) and Ab‐drug‐conjugates (ADCs), highlighting the significance of harmonization in preclinical assay development for safety assessment of Ab‐based biotherapeutics as an approach to support and refine clinical translation.
This work uses harmonised life-cycle indicators of hydrogen to explore its role in the environmental performance of proton exchange membrane fuel cell (PEMFC) passenger vehicles. To that end, three ...hydrogen fuel options were considered: (i) conventional, fossil-based hydrogen from steam methane reforming; (ii) renewable hydrogen from biomass gasification; and (iii) renewable hydrogen from wind power electrolysis. In order to increase the robustness of the life-cycle study, the environmental profile of each hydrogen option was characterised by three harmonised indicators: carbon footprint, non-renewable energy footprint, and acidification footprint. When enlarging the scope of the assessment according to a well-to-wheels perspective, the results show that the choice of hydrogen fuel significantly affects the life-cycle performance of PEMFC vehicles. In this regard, the use of renewable hydrogen –instead of conventional hydrogen from steam methane reforming– is essential when pursuing low carbon and energy footprints. Nevertheless, the identification of the most favourable renewable hydrogen option was found to be conditioned by the prioritised life-cycle indicators.
•Well-to-wheels assessment of PEMFC passenger vehicles with three hydrogen options.•Use of harmonised carbon, energy and acidification footprints of hydrogen.•High influence of the hydrogen fuel on the life-cycle performance of PEMFC vehicles.•Need for renewable hydrogen when pursuing low carbon and energy footprints.•Preferred renewable hydrogen option conditioned by the prioritised indicators.
This publication contains the proceedings of the 9th European Criminal Law Academic Network (ECLAN) PhD Seminar on European Criminal Justice "The significance of EU criminal law in the 21st century: ...the need for further harmonisation or new criminal policy", hosted by the Vilnius University Faculty of Law. Participants of the event presented their research in various criminal law fields related to the EU substantive criminal law and its national implementation, combating organised crime and the EPPO, criminal policy and human rights and cooperation in criminal matters and other legal instruments. Thus, the publication provides short papers of the main ideas and conclusions of several speakers’ presentations.
Insufficient access to quality, safe, efficacious and affordable medical products in Africa has posed a significant challenge to public health for decades. In part, this is attributed to weak or ...absent policies and regulatory systems, a lack of competent regulatory professionals in National Medicines Regulatory Authorities (NMRAs) and ineffective regional collaborations among NMRAs. In response to national regulatory challenges in Africa, a number of regional harmonisation efforts were introduced through the African Medicines Regulatory Harmonisation (AMRH) initiative to, among others, expedite market authorisation of medical products and to facilitate the alignment of national legislative frameworks with the AU Model Law on Medical Products Regulation. The goals of the model law include to increase collaboration across countries and to facilitate the overall regional harmonisation process. The AMRH initiative is proposed to serve as the foundation for the establishment of the African Medicines Agency (AMA). The AMA will, as one of its mandates, coordinate the regional harmonisation systems that are enabled by AU Model Law domestication and implementation. In this paper, we review the key entities involved in regional and continental harmonisation of medicines regulation, the milestones achieved in establishing the AMA as well as the implementation targets and anticipated challenges related to the AU Model Law domestication and the AMA's establishment. This review shows that implementation targets for the AU Model Law have not been fully met, and the AMA treaty has not been ratified by the minimum required number of countries for its establishment. In spite of the challenges, the AU Model Law and the AMA hold promise to address gaps and inconsistencies in national regulatory legislation as well as to ensure effective medicines regulation by galvanising technical support, regulatory expertise and resources at a continental level. Furthermore, this review provides recommendations for future research.
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