Comment to the Judgement of EU Court of Justice in Joined Cases C-807/18 and C-39/19 Telenor Magyarország Zrt. v Nemzeti Média- és Hírközlési Hatóság Elnöke

The case comment concerns the Judgement of the EU Court of Justice of 15 September 2020 of Telenor Magyarország Zrt. v Nemzeti Média – és Hírközlési Hatóság Elnöke (Joined Cases C-807/18 and C-39/19). This first judgment of the EU Court of Justice under the Regulation 2015/2120 provided clarity on the interpretation and application of Article 3(2) and Article 3(3) of said Regulation, generally in line with BEREC’s position known since 2016. In the opinion of the EU Court of Justice, commercial practices of providers of Internet access service, and agreements these providers conclude with end users are not prohibited per se if they involve ‘zero tariffs’. However, traffic management measures that slow down or block Internet traffic not subject to the ‘zero tariff’ once an end user’s data volume has been exhausted are incompatible with Article 3(3) of Regulation 2015/2120. To establish such incompatibility, no assessment of the influence of those traffic management measures on the exercise ofend users’ rights is required. However, such an assessment – involving an analysis of the markets for Internet access services, and for Internet content – would be necessary if a national regulatory authority wanted to establish incompatibility of the conduct of a provider of Internet access services with Article 3(2) of Regulation 2015/2120.

Independence of Regulatory Authorities in the Energy Market. Comment to the Judgement of EU Court of Justice in C-378/19 Prezident Slovenskej republiky

In its judgement C-378/19, the Court of Justice of the European Union responded to the question for a preliminary ruling referred by the Slovak Constitutional Court. The ECJ found in this judgement that Directive 2009/72/EC must be interpreted as not precluding withdrawal of the competence of the President of a Member State to appoint and dismiss the chairperson of the national regulatory authority, and conferral of the same power to the Member State’s government. Similarly, allowing the participation of the Ministers of the Environment and of the Economy in certain price-setting procedures does not violate the decision-making independence of the national regulatory authority. In his commentary, the author cites the line of argument in the judgement and presents the political context in Slovakia that led to the preliminary question. The author then comments approvingly on the judgement, noting that the Court rightly refrained from assessing the political situation in Slovakia, instead opting to focus on the law. At the end of the commentary, the author makes remarks of a general nature relating to the independence of national regulatory authorities.

Unprofessional conduct by nurses: A document analysis of disciplinary decisions

Background: A small minority of nurses are investigated when they fail to meet the required professional standards. Unprofessional conduct does not just affect the nurse but also patients, colleagues and managers. However, it has not been clearly defined. Objective: The objective was to identify unprofessional conduct by registered nurses by examining disciplinary decisions by a national regulator. Design: A retrospective document analysis. Data and research context: Disciplinary decisions delivered to 204 registered nurses by the Finnish national regulatory authority from 2007 to 2016. The data were analysed with quantitative statistics. Ethical consideration: The study received permission from the Finnish National Supervisory Authority for Welfare and Health and used confidential documents that were supplied on the basis of complete anonymity and confidentiality. Findings: The mean age of the registered nurses who were disciplined was 44 years and 81% were female. Two-thirds had worked for their employer for 5 years or less, 53% had two or more employers and 18% had a criminal history. All the decisions included a primary reason for why the nurses were investigated, but there were also 479 coexisting reasons. In most cases, unprofessional conduct was connected to substance abuse (96%). In addition, stealing of medicine, a decreased ability to work and neglect of nursing guidelines were reported. Discussion: We found that the nurses were investigated for unprofessional conduct for complex combinations of primary and coexisting reasons. Our study highlighted that more attention needs to be paid to the key markers for unprofessional conduct. Conclusion: Unprofessional conduct is a complex phenomenon that is connected to nurses’ individual and working backgrounds and has an impact on their work performance. More research is needed to identify how nursing communities can detect, manage and limit the serious effects and consequences of unprofessional conduct.

A COMPENDIOUS REVIEW ARTICLE ON COVID-19 VACCINATION

A COVID-19 vaccine is a vaccine intended to provide acquired immunity aim to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes coronavirus disease 2019 (COVID-19). In Phase III trials, several COVID-19 vaccines have demonstrated effectiveness as high as 95% in preventing symptomatic COVID-19 infections. Almost twenty vaccines have been approved by at least one national regulatory authority for public use: nine conventional inactivated vaccines, two RNA vaccines, ve viral vector vaccines, and four protein subunit vaccines. At least nine different technology platforms are doing continuous research and development to create an effective as well as active vaccine against the deadlier infective disease COVID-19. Our immune system uses numerous tools to defend any kind of infection. Blood contains red blood cells, carries oxygen to tissues and organs, and white blood cells or immune cells helps to ght to defend infection. Different varieties of white blood cells defend infections in various ways. COVID-19 vaccines give assistance to our bodies to develop immunity against the coronavirus which causes COVID-19 without getting illness. It naturally takes few weeks to months after vaccination for the body to produce T-lymphocytes as well as Blymphocytes. Sometimes after vaccination also the process of building immunity can cause symptoms like fever, runny nose etc. These symptoms are usual indicating that the body is building immunity. After COVID vaccination the chances of getting a Corona infection will be only 10%. Through all available information, it is known that taking COVID vaccine is very essential.

A comprehensive review on registration requirements for Drug Approval in India, South Africa and US

The drug approval process is country-specific. The regulatory framework of all the national regulatory agencies differ from one another in terms of administration and product specific guidelines for registration of drug and drug products in a particular country. Every national regulatory authority provides regulatory guidelines for drug or drug product registration and the pharmaceutical industries which rely upon these guidelines prepare drug applications along with all the required administrative, non-clinical and clinical data in the form of a technical dossier which is known as Common Technical Document. This Dossier is prepared either in an electronic format or in the paper submission format. This review focuses on the comparative study of the registration requirements for getting a drug approval in India, South Africa and United States of America. The significant differences between the technical requirements of these three markets have been discussed in detail.

Pharmacovigilance in Covid-19 vaccines

The ongoing pandemic coronavirus disease of 2019 (COVID-19), originated from Wuhan, China, has caused universal challenging and threatening with considerable health impact and economic losses. Therefore, vaccination, as preventive and protective medical countermeasure, remains an excellent issue for reducing morbidity and mortality of this emerging infectious disease. As of April 2021 and by Emergency Use Authorization (EUA) process, 16 vaccines were authorized by at least one national regulatory authority for public use: two Ribonucleic Acid (RNA) vaccines (Pfizer–BioNTech and Moderna), seven conventional inactivated vaccines (BBIBP-CorV manufactured by Siinopharm, CoronaVac, Covaxin, WIBP-CorV, CoviVac, Minhai-Kangtai and QazVac), five viral vector vaccines (Sputnik Light, Sputnik V, Oxford–AstraZeneca, Convidecia, and Johnson & Johnson) and two protein subunit vaccines (EpiVacCorona and RBD-Dimer). As other countries, Morocco has established an anti-COVID-19 vaccine strategy in order to effectively contribute to the monitoring of vaccine safety supported by the national platform health vigilance and regulated by the National Anti-Poison and Pharmacovigilance Center (CAPM). In this review, we recorded the main current developed COVID-19 vaccines and discussed pharmacovigilance strategies and tools related safety and tolerability of those therapies. In parallel, a review of the Moroccan experience in this field is also conducted.

FINES AND DAILY FINES UNDER THE ACT ON THE AMENDMENTS TO COMPETITION ACT WITH SPECIAL EMPHASIS ON MITIGATING AND AGGRAVATING CIRCUMSTANCES

The paper analyzes the amendments to Title VIII of the Croatian Competition Act regulating penalty clause or the fines, daily fines, and the methods for their imposition, adopted in April 2021. Daily fines are a new institute that further extends the Croatian Competition Agency's (CCA) power as a general, national regulatory authority responsible for the protection of competition in all markets. Therefore, each amended article of that Title is analysed to accurately reflect what has changed and with which provision of the Directive (EU) 2019/1 it has been harmonized. The paper also provides a detailed tabular overview and comparison of the amount of the fine and mitigating and aggravating circumstances that the Agency considered into account when imposing them in cases in the period from 2013 to the end of 2020, so that, finally, it can be concluded if there is a consistent relationship between the number of mitigating and aggravating circumstances and the amount of the fine that CCA imposes when there are infringements of the national and EU competition law.