National Authorities Research Articles

Competition after mergers near review thresholds

Size thresholds determine whether a national authority reviews a merger and separate national and supranational responsibility. Firms could pursue competition-reducing mergers before they come under any regulatory oversight. Using data on German procurement auctions, I analyse competition effects near review thresholds. Four years after a merger, competition in procurement auctions decreases after mergers that are reviewed by the German national authority, relative to mergers below the threshold. However, when acquiror and target competed in procurement auctions before the merger, competition relatively increases after a German national merger review. Anti-competitive effects after nationally reviewed mergers without pre-merger activity in procurement may get unnoticed by the authority.

Some Aspects of Animal Husbandry in Africa

It is emphasized that animal husbandry, which has existed since ancient times in many regions of Africa and is one of the most important areas of human activity, is an integral part of the socio-cultural code of the African population. To date, pastoralism plays an important role not only in the economic, but also in the social sphere of the inhabitants of vast regions of the continent; the size of herds is the main criterion for assessing the property and social status of its owner. Being the subject of trade and direct exchange, cattle bring a significant and stable income to their sellers, while at the same time performing the function of a bride price at the conclusion of marriages. The challenges of our time require a certain degree of flexibility and adaptability from the population of livestock regions, which is associated with inevitable changes in the centuries-old way of life and the system of socio-cultural ties. Attention is drawn to the fact that the tradition of husbandry is influenced by numerous factors of modern development: climate change and epizootics of recent decades have a negative imprint on livestock activities. High losses of livestock, a reduction in their per capita population over time, combined with demographic growth, have had a negative impact on the well-being of pastoralists, significantly increasing their poverty level. The governments of many African countries, in which husbandry plays a leading role, have an interest not only in maintaining existing positions, but also in improving them. In situations of epizootic danger, national livestock health surveillance systems in African countries are approached by international partners, including FAO, WHO, as well as one of the world’s leading organization whose functions include the formation of links in the field of veterinary medicine, ensuring the interaction of national and regional veterinary authorities – the International Epizootic Office (OIE). Continuous field research in livestock regions in a number of African countries provides significant assistance in the fight against livestock diseases. The use of modern information technologies in epizootiological diagnostics is increasingly becoming the basis of anti-epizootic and preventive measures.

A One Health Platform for Future Epidemic Preparedness.

Here, we introduce the EpiConnect Intelligence Platform (ECIP), a platform facilitating rapid, transparent data sharing and analysis to support researchers and public health officials in Europe, with a focus on Italy. ECIP provides reliable, concise, machine-readable data to aid in epidemiological understanding, standardize case characteristics, and estimate key parameters. The platform adheres to FAIR (findable, accessible, interoperable, reusable) principles, offering easily accessible and downloadable datasets for researchers' endeavors. Future enhancements include involving national public health authorities, expanding data streams, and fostering collaboration between experts and users for improved epidemic risk monitoring. Shared standards among diverse surveillance systems are advocated to achieve common strategic goals, emphasizing the need for forward-looking policies to empower professionals to analyze disease dynamics in the context of evolving health crises. The recent emergencies underscore the importance of collective efforts towards shared strategic goals, highlighting the necessity for coordinated action to address mutual concerns affecting everyone's lives.

Leveraging social capital for the recovery and regeneration of the ecotourism sector in Cameroon

ABSTRACT This paper examines leveraging social capital to regenerate the ecotourism sector in Cameroon. Using a qualitative approach, in-depth interviews were held with local community leaders, governmental stakeholders, and NGOs. These informants possessed nuanced knowledge of the state of ecotourism in the region, thus constituted integral stakeholders in the ecotourism–community–social capital nexus. The findings of the study indicate that notions of social capital can be leveraged in the traditional hierarchy of communities to influence support for regenerating the sector. This can also address problems affecting the successful (re)development of the sector, stemming from the geopolitical crisis, where levels of trust (associated with social capital) in national authorities may be influenced by traditional authorities, like community leaders. The novelty and theoretical contribution of this paper lie in its unique conceptualisation of regeneration of ecotourism, through the lens of social capital and the nuanced geopolitical situation which contextualises the landscape.

A unified modelling framework for projecting sectoral greenhouse gas emissions

Effectively tackling climate change requires sound knowledge about greenhouse gas emissions and their sources. Currently, there is a lack of comprehensive, sectorally disaggregated, yet comparable projections for greenhouse gas emissions. Here, we project sectoral emissions until 2050 under a business-as-usual scenario for a global sample of countries and five main sectors, using a unified framework and Bayesian methods. We show that, without concerted policy efforts, global emissions increase strongly, and highlight a number of important differences across countries and sectors. Increases in emerging economies are driven by strong output and population growth, with emissions related to the energy sector accounting for most of the projected change. Advanced economies are expected to reduce emissions over the coming decades, although transport emissions often still show upward trends. We compare our results to emission projections published by selected national authorities as well as results from Integrated Assessment Models and highlight some important discrepancies.

Does tourism development, financial development and renewable energy drive high-quality economic development?

Tourism development is generally agreed upon to be a key tool in promoting economic growth, and green development has emerged as a significant idea and an efficient approach to accomplish this goal in a manner that is environmentally responsible. It is common knowledge that making the switch to renewable sources of energy may act as a catalyst for economic development in both developed and developing nations. Therefore, people all over the globe are beginning to realize the significance of advancing renewable energy's rising importance that suggests that it will be used extensively in the years to come. The purpose of this study is to examine the effect that increasing tourism and adopting renewable energy sources impact on green economic growth development in the region using the AMG test BRICS nations from 2001 to 2022. This research additionally makes use of a rigorous check by means of the CCEMG exam and the DCCEMG test. According to the findings, green economic growth is influenced favorably by the expansion of the tourist industry, renewable energy, and the digital economy, but urbanization and the rise financial industry are detrimental to green economic growth. D-H panel causality test results show that tourism development is causally related to green economic growth, green economic growth to urbanization, and green economic growth to the usage of renewable energy sources. According to these results, the management authorities of BRICS nations should embrace policies of green growth while also controlling environmental pollution in order to achieve sustainable economic development whereas in rural areas. The findings have major policy implications for the nations that make up the BRICS bloc. These implications pertain to the enhancement of tourist development, the digital economy (DIG), and financial institutions, all of which have the potential to improve environmental quality.

The WHO atlas for female-genital schistosomiasis: Co-design of a practicable diagnostic guide, digital support and training.

Up to 56 million young and adult women of African origin suffer from Female Genital Schistosomiasis (FGS). The transmission of schistosomiasis happens through contact with schistosomiasis infested fresh water in rivers and lakes. The transmission vector is the snail that releases immature worms capable of penetrating the human skin. The worm then matures and mates in the blood vessels and deposits its eggs in tissues, causing urogenital disease. There is currently no gold standard for FGS diagnosis. Reliable diagnostics are challenging due to the lack of appropriate instruments and clinical skills. The World Health Organisation (WHO) recommends "screen-and-treat" cervical cancer management, by means of visual inspection of characteristic lesions on the cervix and point-of-care treatment as per the findings. FGS may be mistaken for cervical cancer or sexually transmitted diseases. Misdiagnosis may lead to the wrong treatment, increased risk of exposure to other infectious diseases (human immunodeficiency virus and human papilloma virus), infertility and stigmatisation. The necessary clinical knowledge is only available to a few experts in the world. For an appropriate diagnosis, this knowledge needs to be transferred to health professionals who have minimal or non-existing laboratory support. Co-design workshops were held with stakeholders (WHO representative, national health authority, FGS experts and researchers, gynaecologists, nurses, medical doctors, public health experts, technical experts, and members of the public) to make prototypes for the WHO Pocket Atlas for FGS, a mobile diagnostic support tool and an e-learning tool for health professionals. The dissemination targeted health facilities, including remote areas across the 51 anglophone, francophone and lusophone African countries. Outcomes were endorsed by the WHO and comprise a practical diagnostic guide for FGS in low-resource environments.

The process of ratifying the treaty to establish the African Medicines Agency: perspectives of national regulatory agencies.

The vision of the African Medicines Agency (AMA) is to ensure that all Africans have access to affordable medical products that meet internationally recognized standards of quality, safety and efficacy for priority diseases/conditions. The AMA is being established by a treaty which had to be ratified by a minimum of 15 African countries. Although there was no deadline, the ratification process has been slower than expected. This study therefore analysed the rationale, perceived benefits, enabling factors and challenges of the AMA's establishment. This study was a qualitative, cross-sectional, census survey of the national medicines regulatory authorities (NRAs) of 45 African countries. The Heads of NRAs and a senior NRA staff member were contacted to complete self-administered questionnaires. The existence of mature NRAs, the desire to have harmonized regulatory systems, the presence of strong political will and appropriate advocacy to expedite treaty signing are all enabling factors for AMA treaty signing. The challenges reported include the fact that the process is slow and there is limited understanding of the process. Competing national priorities, changes in office bearers in the public system and stagnation of the process at the ministerial level were also challenges reported. This study has improved the understanding of the treaty signing and ratification process and the perceived benefits and enabling factors of signing and ratification from African NRAs' perspective. NRAs also highlighted challenges encountered in the process. Addressing these challenges will result in effective medicines regulation by galvanizing technical support, regulatory expertise and resources at a continental level.

THE RIGHT TO ONE'S IMAGE, AS A RIGHT OF THE HUMAN PERSONALITY JURISPRUDENCE

Through a theoretical and practical approach, the study presents the main regulations of the right to image, as a personal non-patrimonial right: the Romanian Civil Code, the Romanian Constitution, and the new legislation in the field of personal data. The study presents practical issues such as jurisprudential solutions in Romania regarding the violation of the right to image in the online environment (Facebook, Instagram), television shows, and press articles. Also, the study deals with the much-disputed issues of using the person's image in the procedures for sanctioning the employees, analyzing how the National Authority for Supervision of Personal Data Processing (N.A.S.P.D.P.) from Romania sanctioned the abuses of the employers. The case studies and the analysis of European and Romanian legislation are also useful to students, theoreticians, and legal practitioners.

Regulatory requirement for Medical Devices

The safety and regulatory compliance of a widely used medical device have become a growing concern among a significant population. This has raised questions about the assessment of risks, monitoring of adverse drug reactions (ADR), and overall product safety. The efficacy and safety of such medical devices heavily rely on the regulations and guidelines set forth by regulatory agencies (RAs).
 In the pharmaceutical industry, regulatory affairs (RA) professionals play a crucial role in overseeing the lifecycle of healthcare products. They provide strategic, tactical, and operational guidance to ensure compliance with regulations, facilitating the efficient development and delivery of safe and effective healthcare products worldwide. Evaluating adherence to regulations requires a combination of expertise from the business, legal, and pharmaceutical domains.
 Regulatory authorities must thoroughly monitor medical device design, development, and manufacturing processes to guarantee that the products reaching the market are safe and effective. The certification process is intricate, involving multiple steps and the assessment of materials by competent authorities. In the United States, manufacturers must seek marketing authorization from the United States Food and Drug Administration (USFDA) through two primary application types: 510(k) and Pre-Market Application (PMA). In the European Union (EU), national authorities grant permission for the sale of medical devices, employing a third-party compliance system where notified bodies ensure quality assurance pre- and post-approval. In India, the Central Drug Standard Control Organization (CDSCO) licenses devices for sale and import under the CLAA framework.
 Conclusion
 Pharmaceutical regulatory affairs experts play a critical role in ensuring compliance with industry requirements for all pharmaceutical products. This review provides an overview of how medical devices are regulated and monitored in the EU, India, and the USA, emphasizing the importance of regulatory affairs in maintaining the safety and efficacy of healthcare products.

Assessment Of Radionuclides Concentration And Radiological Impact Of Abandoned Tin Mines Soils In Some Communities Of Barkin Ladi, Plateau State, Nigeria

The concentration of natural radionuclides in the soil around the world has become an environmental concern for international and national authorities because of the harmful effect of radiation exposure on human health. The samples of soil used for this study were collected from Foron and Heipang districts of Barkin Ladi Local Government Area of Plateau State. The samples were analyzed using Canberra Model 727/727R Lead Shield Gamma-ray Spectrometer with NaI(Ti) detector. The result shows that 40K ranges from 301.91 ± 0.24 Bq/kg to 124.97 ± 0.31 Bq/kg from the mining spot to 400 m away from the mining spots. 226Ra ranges from 105.43 ± 1.76 Bq/Kg to 43.10 ± 0.62 Bq/Kg from mining spots to 400 m away from the mining spots, and 232Th also ranges from 92.79 ± 0.26 Bq/kg to 26.97 ± 0.39 Bq/kg respectively. The absorbed dose rate in the air (Dr) has a mean value of 82.88 nGh-1. The annual effective dose rate (AEDR) mean value was 0.1mSvy-1, and the radium equivalent (Ra eq) mean value was 180.23 Bq/kg, Hex and Hin have mean values of 0.49 and 0.69 respectively. The calculated excess lifetime cancer risk (ELCR) ranges from 0.0003 to 0.00039 with a mean value of 0.00035 in the soil samples. Therefore, this result suggested that the area under study could be termed radiologically unsafe for people living around or close to the area.
 

Human rights globalization: How local and global actions institutionalize human rights

We introduce this special issue with an elaboration of the concept of human rights globalization as a dynamic process that involves local and global action by civil society and other actors to strengthen governments’ accountability to global human rights norms and standards. This process challenges economic globalization that prioritizes international trade and financialization over human rights. Recent decades have seen growing movements of activists appealing to global human rights norms as they mobilize popular pressure on local and national authorities. We provide a brief overview of contributions to this special issue, which describe these movements and their impacts on the long-term strengthening of global human rights governance.

The Problems with Online Health Product Sales: How can Regulations be Improved?

With the rapid proliferation of online businesses, national authorities are facing challenges managing the online supply of illegal health products due to the anonymity of the internet, increasing number of global syndicates, new technologies, and inability to enforce against overseas sellers. This paper describes these challenges and the Health Sciences Authority's regulatory approaches to tackle the online sales of illegal health products. These include partnering with platform administrators to remove illegal online postings, leveraging technological tools and relevant legislation, empowering consumers to make informed decisions, and fostering closer collaborations across different jurisdictions to combat online pharmaceutical crimes.

Paving the Path for Sustainable and Responsible Off-Label Use of Pharmaceutical Products in Europe.

Off-label use of pharmaceuticals involves a wide array of aspects ranging from legal and regulatory ones to clinical to safety considerations. Access to off-label therapies is particularly relevant question for patients in areas of unmet medical need. Simultaneously, off-label use also triggers wider considerations relating to social and economic sustainability of health care systems and access to health. National authorities have adapted different regulatory approaches to off-label use of pharmaceuticals, ranging from (1) "regulatory silence"; to (2) allowing off-label use at the discretion of the treating physician; and to (3) a more stringent approach in which off-label use is subject to third party approval. This article provides a brief overview of these different regulatory approaches from a helicopter perspective, and it discusses benefits and shortcomings these approaches. Finally, it presents ideas for preconditions for sustainable and responsible off-label use of pharmaceutical products to ensure patient safety whilst ensuring their timely access to health.

Shielding Africa, Protecting the World: Unleashing the Power of Preventative Use of Ebola Vaccines

Africa CDC recently conducted a comprehensive risk ranking assessment of epidemic-prone diseases across the continent, identifying Ebola as one of the top 19 infectious diseases with the highest scores in disease severity risk and epidemic potential. The Ebolaviruses first described in the Democratic Republic of the Congo (DRC) in 1976 have left a harrowing trail across sub-Saharan Africa, triggering no less than 34 Ebola outbreaks in 11 sub-Saharan Africa countries, a statistic further compounded by the recent outbreak in Uganda in 2022. At present, the World Health Organization (WHO) has approved two Ebola vaccines, including Ervebo and two-component Zabdeno and Mvabea boost vaccines, for use by individuals above the age of 1 year, including pregnant women as per the Strategic Advisory Group of Experts on Immunization (SAGE) recommendations. The use of these vaccines has demonstrated noteworthy efficacy in safeguarding against Ebola in most African communities and frontline health workers in Ebola-endemic countries such as Sierra Leone, Guinea, and Liberia, among others. Unfortunately, the uptake of these vaccines in Ebola-endemic countries remains dishearteningly constrained despite their availability due to, among other things, the unpredictable timing of outbreaks, sub-optimal surveillance, vaccine demand volatility, palpable vaccine hesitancy, and fragile health infrastructure. Addressing these challenges requires a multifaceted approach that includes a synergy of partnerships between governments, communities, development partners, and private sector partners, such as pharmaceuticals. Recognizing that outbreaks originate and seize at the community level, the imperative of confronting hesitancy through sustained proactive community engagement and utilizing promising vaccination strategies such as ring vaccination must be encouraged. Governments must increase investments to strengthen the regulatory environment for timely access to vaccine stockpiles, robust and cost-effective Ebola vaccination programs for at-risk populations, and preventative use for the health workforce. The International Coordinating Group (ICG) on Vaccine Provision also recommends that national and international health authorities initiate vaccine access by submitting a request to the ICG. This opportunity is at no cost for GAVI-eligible countries and on a reimbursement basis for non-eligible countries. In parallel, Africa CDC is also working closely with Member States on the continent to increase availability and access to medical countermeasures, which include therapeutics, vaccines, and diagnostics, making it critical that Africa CDC is included in the ICG. This will promote timely issue profiling and resolution for increased demand for vaccine stockpiles across the continent where they are needed most as the continent moves towards enhanced health security.

Adapting prescribing criteria for amyloid-targeted antibodies for adults with Down syndrome.

Prior authorization criteria for Federal Drug Administration (FDA) approved immunotherapeutics, among the class of anti-amyloid monoclonal antibodies (mAbs), established by state drug formulary committees, are tailored for adults with late-onset Alzheimer's disease. This overlooks adults with Down syndrome (DS), who often experience dementia at a younger age and with different diagnostic assessment outcomes. This exclusion may deny DS adults access to potential disease-modifying treatments. To address this issue, an international expert panel convened to establish adaptations of prescribing criteria suitable for DS patients and parameters for access to Centers for Medicare & Medicaid Services (CMS) registries. The panel proposed mitigating disparities by modifying CMS and payer criteria to account for younger onset age, using alternative language and assessment instruments validated for cognitive decline in the DS population. The panel also recommended enhancing prescribing clinicians' diagnostic capabilities for DS and initiated awareness-raising activities within healthcare organizations. These efforts facilitated discussions with federal officials, aimed at achieving equity in access to anti-amyloid immunotherapeutics, with implications for national authorities worldwide evaluating these and other new disease-modifying therapeutics for Alzheimer's disease.

A harmonized Danube basin-wide multi-compartment concentration database to support inventories of micropollutant emissions to surface waters

BackgroundThe European Water Framework Directive foresees the establishment of emission inventories for micropollutants (MP) to facilitate an evidence-based development of mitigation measures. Regionalized pathway analysis constitutes a moderately data-intensive approach to quantify the contribution of different pathways to the total pollution of surface waters. So far, only few European member states have created an inventory that includes diffuse pathways. The fundamental basis to enable it is an accessible, well-structured and harmonized database with data on the concentration of MPs in multiple compartments, such as soils, groundwater, atmospheric deposition and urban systems. Combined with the water and suspended substance balance in river basins, such data enables the estimation of emission loads via specific pathways. In the Danube River Basin, but in general in Europe, a public data management platform with such scope and criteria is still lacking.ResultsWe collected and harmonized MP measurements across multiple compartments and countries together with key metadata, harmonized and combined them into a new database. The resulting tool, available for download, facilitates the assessment of current data availability, in terms of quantity and quality. For example, while the majority of available data stems from groundwater and surface water, other highly relevant compartments are scarcely represented. By examining differences in MP concentration level across compartments, the database can lead to understand the relevance of specific emission pathways and thus to prioritize data-retrieval and calculation efforts in modelling applications. Selected examples show how to exploit the metadata associated to the measurements to extrapolate the results to regions not covered by specific monitoring programmes. For example, PFAS concentrations in treated wastewater show significant dependence on the design capacity of the treatment plant.ConclusionsThis study showcases how such database can support the setup of emission inventories, guide data providers and national authorities in prioritizing the allocation of resources for new surveys and in optimizing their national data collection and management systems. The process tested showed a great need for enhanced data literacy across countries and institutions to increase data availability and quality to secure the exploitation of the full information potential generated via monitoring programmes.

Analysis of non-compliances identified in GMP inspections between 2013 and 2022

Ensuring the quality and safety of medicinal products is of paramount importance to the pharmaceutical industry. Good manufacturing practice (GMP) regulations are part of a pharmaceutical manufacturer’s quality management system and ensure that medicinal products are manufactured, imported and controlled consistently to quality standards appropriate to their intended use. The aim of the present study is to analyze the non-compliant operations identified during GMP inspections carried out by national competent authorities (NCA) in the EU/EEC between 2013 and 2022. A retrospective analysis of non-compliance reports published in the EudraGMDP database between 2013 and 2022 was performed. Overall, 99 reports by 21 national competent authorities were analyzed presenting the results of inspections in 19 countries. A total of 1458 deficiencies were identified, of which 544 (37%) were classified as major and 127 (9%) as critical. The most common non-compliant operations were the manufacturing of active substances (49 deficiencies) and the preparation of non-sterile products (47 deficiencies). In 41 cases, the NCA recommended suspension or voiding of the certificate of suitability (CEP) and in 36 cases revocation of the GMP certificates. The observed deficiencies highlight the importance and need for continuous monitoring and improvement of manufacturers’ production processes and quality management systems.

"Arming half-baked people with weapons!" Information enclaving among professionals and the need for a care-centred model for antibiotic use information in Uganda, Tanzania and Malawi.

The overuse of antimicrobial medicines is a global health concern, including as a major driver of antimicrobial resistance. In many low- and middle-income countries, a substantial proportion of antibiotics are purchased over-the-counter without a prescription. But while antibiotics are widely available, information on when and how to use them is not. We aimed to understand the acceptability among experts and professionals of sharing information on antibiotic use with end users - patients, carers and farmers - in Uganda, Tanzania and Malawi. Building on extended periods of fieldwork amongst end-users and antibiotic providers in the three countries, we conducted two workshops in each, with a total of 44 medical and veterinary professionals, policy makers and drug regulators, in December 2021. We carried out extensive documentary and literature reviews to characterise antibiotic information systems in each setting. Participants reported that the general public had been provided information on medicine use in all three countries by national drug authorities, health care providers and in package inserts. Participants expressed concern over the danger of sharing detailed information on antibiotic use, particularly that end-users are not equipped to determine appropriate use of medicines. Sharing of general instructions to encourage professionally-prescribed practices was preferred. Without good access to prescribers, the tension between enclaving and sharing of knowledge presents an equity issue. Transitioning to a client care-centred model that begins with the needs of the patient, carer or farmer will require sharing unbiased antibiotic information at the point of care.

The SBAR tool for communication and patient safety in gynaecology and obstetrics: a Tunisian pilot study

BackgroundIn healthcare, inadequate communication among providers and insufficient information transmission represent primary contributors to adverse events, particularly in medical specialties such as obstetrics and gynecology. The implementation of SBAR (Situation-Background-Assessment-Recommendation) has been proposed as a standardized communication tool to enhance patient safety. This study aims to evaluate the knowledge, attitudes, and practices related to SBAR communication through a pilot study conducted in a middle-income country.MethodsThis prospective longitudinal study took place in the gynecology-obstetrics department of a Tunisian university hospital from May to June 2019. All medical and paramedical staff underwent comprehensive theoretical and practical training through a 4-hour SBAR simulation. To gauge participants’ knowledge, anonymous multiple-choice questionnaires were administered before the training initiation, with a second assessment conducted at the end of the training to measure satisfaction levels. Two months later, the evaluation utilized questionnaires validated by the French National Authority for Health (HAS).ResultsAmong the 62 care staff participants in this study, a majority (89%) demonstrated a low level of knowledge regarding the SBAR tool. The majority (75.8%) expressed enjoyment with the training and indicated their intention to implement changes in their practice by incorporating the SBAR tool in the future (80.7%). Notably, over half of the participants (79%) expressed satisfaction with the training objectives, and 74% reported acquiring new information. Evaluation of the practice revealed positive feedback, particularly in terms of clarity, the relevance of communication, and the time spent on the call.ConclusionOur pilot study showed that the majority of professionals on the ward had little knowledge of the SBAR tool, a good attitude and a willingness to put it into practice. It is essential that healthcare managers and professionals from all disciplines work together to ensure that good communication practice is developed and maintained. Organisations, including universities and hospitals, need to invest in the education and training of students and health professionals to ensure good quality standardised communication.