Assessment of the Current State of Pharmacovigilance System in Pakistan Using Indicator-Based Assessment Tool

Objectives: Pakistan felt the need for an effective and robust pharmacovigilance (PV) system after one of the deadliest drug-related tragedies causing more than 300 deaths in 2012. The country set up its national PV center in 2015 and joined WHO’s Program for International Drug Monitoring (PIDM) in 2018 as a full member. The current study was aimed to evaluate the PV system’s functionality, identify the gaps, areas of improvement, and a strategy to lead a functional PV system in Pakistan.Methods: The descriptive cross-sectional study was conducted by providing an interviewer-administered questionnaire of the PV system across Pakistan by utilizing the Indicator based Pharmacovigilance assessment tool (IPAT). By a convenience sampling method 36 study participants were selected from the Drug Regulatory Authority of Pakistan (DRAP), drug administration of provincial health departments of 4 provinces and federally affiliated areas, 5 national public health programs, and 23 public and private hospitals. The assessment includes document review, interviews of the key informants by structured open-ended questions, and a review of websites of relevant organizations.Results: Drug Regulatory Authority of Pakistan (DRAP) with a national PV center received a 75% overall performance score on IPAT. To be regarded as “minimally functioning,” a country’s PV and drug safety system must meet all core indicators. DRAP scored 80.76% on the core indicators so cannot be deemed functional at this time. The only province with a regional PV center, Punjab, had scored 72.13% on relevant parameters. Despite receiving funding from the Global Fund, none of the National Public Health Programs (PHPs) have PV centers or associated activities. All hospitals except two private hospitals could not qualify the minimum requirements for functional PV. The absence of a legal framework for mandatory ADR reporting, lack of drug information center, budgetary constraints, no active surveillance activities, the nonexistence of pharmacovigilance risk assessment expert committee, and insufficient coordination among stakeholders were identified as major gaps.Conclusion: The results of the study reveal that Pakistan’s PV system is not fully functional at all levels. A two-phased strategy encompassing the non-financial and financial interventions is proposed to improve the PV systems at the national, provincial, PHPs, and hospitals levels.

Media Generation and Pharmacy Regulatory Authority Awareness

Background: Professional regulatory authorities play a critical role in protecting public interest. Yet, there is a growing view that trust in regulatory authorities may be on the decline. Objective: Awareness has been identified as important for maintaining trust. However, research that examines public awareness and trust in pharmacy regulatory authorities (PRAs) is lacking. This research explores public awareness and trust of PRAs and presents recommendations to enhance PRA communication strategies. Methods: An online survey was conducted with the Nova Scotia (Canada) public in 2020. Adopting classifications from the Communications literature, 3 media generations were explored: newspaper, television, and the Internet. The χ2 test of independence and Kruskal-Wallis H test were adopted to explore differences between the generations. Results: Six hundred sixty-two usable surveys were obtained. Over 80% of those surveyed were aware of the existence of the PRA. Those who had heard of the PRA were most aware of its operational responsibilities and less aware of its governance. The Internet Generation was more aware that the PRA includes members of the public in its decision making than expected and showed increased trust toward the PRA versus the other media generations. Conclusion: The findings should help inform PRA communication plans and set baselines to assess whether such plans enhance awareness. Future studies should explore additional aspects of PRA awareness and trust, perform comparisons across pharmacy jurisdictions, and develop and test models of the relationship between PRA awareness and various dimensions of institutional trust.

In Silico Trial Approach For Biomedical Products: A Regulatory Perspective

The modern pharmaceutical industry is creating a transition from traditional methods to advanced technologies like artificial intelligence. In the current scenario, continuous efforts are being made to incorporate computational modelling and simulation in drug discovery, development, design, and optimization. With the advancement in technology and modernization, many pharmaceutical companies are approaching in silico trials to develop safe and efficacious medicinal products. To obtain marketing authorization for a medicinal product from the concerned National regulatory Authority, manufacturers must provide evidence for the safety, efficacy, and quality of medical products in the form of in vitro or in vivo methods. However, more recently this evidence was provided to regulatory agencies in the form of modelling and simulation, i.e., in silico evidence. Such evidence (computational or experimental) will only be accepted by the regulatory authorities if it considered as qualified by them and this will require the assessment of the overall credibility of the method. One must consider the scrutiny provided by the regulatory authority to develop or use the new in silico evidence. The United States Food and Drug Administration and European Medicines Agency are the two regulatory agencies in the world that accept and encourage the use of modelling and simulation within the regulatory process. More efforts must be made by other regulatory agencies worldwide to incorporate such new evidence, i.e., modelling and simulation (in silico) within the regulatory process. This review article focuses on the approaches of in silico trials, its verification, validation, and uncertainty quantification involved in the regulatory evaluation of biomedical products that utilize predictive models.

CHALLENGES FACING INSURANCE BROKERS IN KENYA

Purpose: The insurance industry, like other industries, has faced obstacles that have threatened its productivity, profitability, and capacity to compete against its rivals. The objective of this study to identify and discuss the challenges facing insurance brokers in Kenya. The aim of this work is to enable the readers understand the various challenges facing insurance brokers and their impact on the insurance industry. Methodology: A desktop literature review was used for this purpose. Relevant seminal references and journal articles for the study were identified using Google Scholar. The inclusion criteria entailed papers that were not over five years old. Findings: The study concluded that customer experience & satisfaction, workflow inefficiency, uncertainties in the market, unfavorable government regulation, cybersecurity risk and lead generation are some of the challenges that affect insurance brokers in Kenya. These challenges have greatly been influenced by the ever-changing technology that has revolutionized the workforce labour and business activities generally in all organizations and government influence on the regulations set by the Insurance Regulatory Authority. Unique contribution to theory, practice and policy: The study therefore recommended that insurance brokers should embrace the use of well-developed digital services that will enable them service their customers efficiently and meet their needs while the Insurance Regulatory Authority should come up with strategies that will help mitigate the unfavorable government regulations that affect insurance brokers.

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.

Przesłanka interesu publicznego w działaniach Prezesa URE i Prezesa UOKiK na rynku energetycznym

Every action of the President of the Office of Competition and Consumer Protection [PL: Prezes Urzędu Ochrony Konkurencji i Konsumentów] must be taken in the public interest – the primary purpose of the antimonopoly regulation is to protect the business of entrepreneurs and consumers in the public interest. The President of the Energy Regulatory Office [PL: Urząd Regulacji Energetyki] is also governed by public interest activities. Under the applicable law, he is responsible for the development of competition, and one of his duties is to counteract the adverse effects of natural monopolies and balance the business of energy companies and fuel and energy consumers. In the Act on competition and consumer protection [PL: ustawa o ochronie konkurencji i konsumentów], the notion of public interest is defined very generally. However, the Act on Energy Law [PL: ustawa – Prawo energetyczne] precisely specifies which elements shall be taken into account by the President of the Energy Regulatory Office each time when making a decision. A number of his activities aim to balance the business of energy security with the protection of energy companies’ business and consumers’ business, including issuing decisions on approval of tariffs. The President of the Energy Regulatory Office ensures the implementation of the public interest in this respect, and such interest cannot be understood differently by another regulatory authority under another act. Otherwise, a violation of the axiological coherence of the legal system occurs. In this particular context (in terms of the implementation of the public interest), priority should be given to the utility regulatory authority (the President of ERO) and not to the antimonopoly authority. However, in this case, we are not dealing with a contradiction of the wording of the provisions but with a potential contradiction in terms of the understanding and application of the public interest premise. Therefore, the provisions of utility acts constitute a lex specialis in this respect to the Act on competition and consumer protection – taking into account this particular approach, such contradiction does not occur. Consequently, it should be concluded that if a given action of the President of ERO (an administrative decision issuance) implemented the public interest by the Act (and was maintained in legal transactions, was not repealed, etc.), it thus excludes the possibility of taking action by the President of the Office of Competition and Consumer Protection which was based on the need to protect this public interest.

Policing Gender Violence in Vanuatu

Gender violence is one of the greatest challenges to peace and security in Pacific Island Countries. The persistence of this problem is often linked to the limits of state-based policing authority. It is argued that this approach fails to grapple adequately with hybrid systems of regulatory authority in Pacific Island Countries that include customary and faith-based forms of authority. Feminist inquiry into the difficulties Pacific women face in securing justice when they are the victims of gendered crimes frequently highlights the gendered failings of state and customary systems of justice, finding that both systems reflect and further entrench the subordinated status of women. This paper addresses the tension between the apparent limits of state-centred models of policing and the shortfalls of hybridised structures of regulatory authority. It reports a theoretically informed empirical study that investigated how ni-Vanuatu women understand gender violence and the role that police can play in its prevention. Using participant research and photo elicitation surveys, we asked 1) how does the authority of policing agencies operate when addressing violence against women in relation to other sites of international and local sociocultural authority in the Vanuatu context, and 2) how do women understand and value policing authority relative to other sites of regulatory authority? We found that, while police in Vanuatu operate in the context of constructive complementarity with other forms of authority, women valued police, identifying them as the key source of regulatory authority that could provide help if their partner became violent or if they were threatened.

Investigating into the dual role of loan loss reserves in banking production process

This paper considers the use of loan loss reserves (LLRs) in the banking production process and treats it as one variable with a dual role. We establish a three-stage network Data Envelopment Analysis model to address this issue. Using a sample of 43 Chinese commercial banks over the period 2011–2019, the results show that the banks with the ratio between LLRs and total loans less than 1% have higher level of efficiency compared to the ones holding the ratio greater than 1%. The results show that when excluding LLRs in the production process, the efficiency scores are significantly inflated. We find that small and medium sized banks are more efficient than their big counterparts, however, the results show that big banks hold more than enough amounts of LLRs than the one required by the regulatory authority. When LLRs are excluded from the production process, it shows that big banks perform better than small and medium sized banks. Our findings show that less liquid banks perform better than the ones with higher levels of liquidity no matter in which way LLRs are treated. Finally, we find that lower capitalized banks, compared to the ones with high levels of capitalization, are less efficient. however, it shows that higher capitalized banks consistently keep more than 1% LLRs out of total loans.