scholarly journals European Patients' Rights to Be Protected Against Counterfeit Medicines

2016 ◽  
Vol 2 (1) ◽  
pp. 34
Author(s):  
Cristina Luiza Erimia ◽  
Rodica Sîrbu ◽  
Radu George Cazacincu ◽  
Emin Cadar ◽  
Aneta Tomescu ◽  
...  

Because the falsification of medicines is a global problem, requires increased and effective international coordination and cooperation to ensure the effectiveness of the strategies to combat counterfeiting, especially in relation to the sale of such products on the Internet. In the context of people’s health and life rank foremost among the values and interests protected by the TFEU, this article examines the evolution of the legislative process regulating the internal market for medicinal products in order to ensure a high level of protection of public health against falsified medicines and to present the legislative initiatives that have been taken at EU level taking account of new risk profiles, measures meant to ensure, at the same time, the functioning of the internal market of medicinal products. However, this article aims to address consumers’ right to have access to safe, effective, quality and innovative medicinal products as a right of the European patient. Ensuring the free movement of medicinal products on the EU market must not violate or restrict this fundamental right of thepatient.The threat that falsified medicines pose to public health is also recognized by the World Health Organization (WHO), which has established the International Medical Products Anti-Counterfeiting Taskforce ("IMPACT").IMPACT has developed the Principles and Elements for National Legislation against Counterfeit Medical Products, which were endorsed by the IMPACT General Meeting in Lisbon on 12 December 2007.

2019 ◽  
Vol 2 (1) ◽  
pp. 8
Author(s):  
Cristina Luiza Erimia ◽  
Rodica Sîrbu ◽  
Radu George Cazacincu ◽  
Emin Cadar ◽  
Aneta Tomescu ◽  
...  

Because the falsification of medicines is a global problem, requires increased and effective international coordination and cooperation to ensure the effectiveness of the strategies to combat counterfeiting, especially in relation to the sale of such products on the Internet. In the context of people’s health and life rank foremost among the values and interests protected by the TFEU, this article examines the evolution of the legislative process regulating the internal market for medicinal products in order to ensure a high level of protection of public health against falsified medicines and to present the legislative initiatives that have been taken at EU level taking account of new risk profiles, measures meant to ensure, at the same time, the functioning of the internal market of medicinal products. However, this article aims to address consumers’ right to have access to safe, effective, quality and innovative medicinal products as a right of the European patient. Ensuring the free movement of medicinal products on the EU market must not violate or restrict this fundamental right of thepatient.The threat that falsified medicines pose to public health is also recognized by the World Health Organization (WHO), which has established the International Medical Products Anti-Counterfeiting Taskforce ("IMPACT").IMPACT has developed the Principles and Elements for National Legislation against Counterfeit Medical Products, which were endorsed by the IMPACT General Meeting in Lisbon on 12 December 2007.


2016 ◽  
Vol 4 (1) ◽  
pp. 34 ◽  
Author(s):  
Cristina Luiza Erimia ◽  
Rodica Sîrbu ◽  
Radu George Cazacincu ◽  
Emin Cadar ◽  
Aneta Tomescu ◽  
...  

Because the falsification of medicines is a global problem, requires increased and effective international coordination and cooperation to ensure the effectiveness of the strategies to combat counterfeiting, especially in relation to the sale of such products on the Internet. In the context of people’s health and life rank foremost among the values and interests protected by the TFEU, this article examines the evolution of the legislative process regulating the internal market for medicinal products in order to ensure a high level of protection of public health against falsified medicines and to present the legislative initiatives that have been taken at EU level taking account of new risk profiles, measures meant to ensure, at the same time, the functioning of the internal market of medicinal products. However, this article aims to address consumers’ right to have access to safe, effective, quality and innovative medicinal products as a right of the European patient. Ensuring the free movement of medicinal products on the EU market must not violate or restrict this fundamental right of thepatient.The threat that falsified medicines pose to public health is also recognized by the World Health Organization (WHO), which has established the International Medical Products Anti-Counterfeiting Taskforce ("IMPACT").IMPACT has developed the Principles and Elements for National Legislation against Counterfeit Medical Products, which were endorsed by the IMPACT General Meeting in Lisbon on 12 December 2007.


2020 ◽  
Vol 28 (1) ◽  
Author(s):  
Iben Axén ◽  
Cecilia Bergström ◽  
Marc Bronson ◽  
Pierre Côté ◽  
Casper Glissmann Nim ◽  
...  

Abstract Background In March 2020, the World Health Organization elevated the coronavirus disease (COVID-19) epidemic to a pandemic and called for urgent and aggressive action worldwide. Public health experts have communicated clear and emphatic strategies to prevent the spread of COVID-19. Hygiene rules and social distancing practices have been implemented by entire populations, including ‘stay-at-home’ orders in many countries. The long-term health and economic consequences of the COVID-19 pandemic are not yet known. Main text During this time of crisis, some chiropractors made claims on social media that chiropractic treatment can prevent or impact COVID-19. The rationale for these claims is that spinal manipulation can impact the nervous system and thus improve immunity. These beliefs often stem from nineteenth-century chiropractic concepts. We are aware of no clinically relevant scientific evidence to support such statements. We explored the internet and social media to collect examples of misinformation from Europe, North America, Australia and New Zealand regarding the impact of chiropractic treatment on immune function. We discuss the potential harm resulting from these claims and explore the role of chiropractors, teaching institutions, accrediting agencies, and legislative bodies. Conclusions Members of the chiropractic profession share a collective responsibility to act in the best interests of patients and public health. We hope that all chiropractic stakeholders will view the COVID-19 pandemic as a call to action to eliminate the unethical and potentially dangerous claims made by chiropractors who practise outside the boundaries of scientific evidence.


2021 ◽  
Vol 16 (1) ◽  
pp. 083-088
Author(s):  
Umema Ahmed ◽  
S.S. Daga ◽  
R.K. Kumawat

In December, 2019, novel corona virus 2019-nCoV or SARS- CoV-2 or COVID 19 was reported in Wuhan city of China. Expeditious transmissibility, extremely virulent nature and acute pathogenicity, World Health Organization declared as a public health emergency of international concern on 30th January 2020. During the pandemic era crime and illicit economies such as organized criminal activities, domestic violence, terrorism, street crime, online crime, illegal markets and smuggling, human and wildlife trafficking, slavery, robberies and burglaries increased in the exponential manner. It was established that the viral particles remain on various surfaces 3 to 5 days, this long lasting persistence of viral particles are serious concern to public health. Since, forensic investigators as well as police personnel directly deal with the crime exhibits, which impose serious concern to their lives.In this report, we explore the impact of COVID 19 pandemic on forensic and new normal practice.


2019 ◽  
Vol 3 ◽  
pp. 1651
Author(s):  

Visceral leishmaniasis (VL) is a neglected tropical disease (NTD) caused by Leishmania protozoa that are transmitted by female sand flies. On the Indian subcontinent (ISC), VL is targeted by the World Health Organization (WHO) for elimination as a public health problem by 2020, which is defined as <1 VL case (new and relapse) per 10,000 population at district level in Nepal and sub-district level in Bangladesh and India. WHO is currently in the process of formulating 2030 targets, asking whether to maintain the 2020 target or to modify it, while adding a target of zero mortality among detected cases. The NTD Modelling Consortium has developed various mathematical VL transmission models to gain insight into the transmission dynamics of VL, identify the main knowledge gaps, and predict the feasibility of achieving and sustaining the targets by simulating the impact of varying intervention strategies. According to the models, the current target is feasible at the appropriate district/sub-district level in settings with medium VL endemicities (up to 5 reported VL cases per 10,000 population per year) prior to the start of the interventions. However, in settings with higher pre-control endemicities, additional efforts may be required. We also highlight the risk that those with post-kala-azar dermal leishmaniasis (PKDL) may pose to reaching and sustaining the VL targets, and therefore advocate adding control of PKDL cases to the new 2030 targets. Spatial analyses revealed that local hotspots with high VL incidence remain. We warn that the current target provides a perverse incentive to not detect/report cases as the target is approached, posing a risk for truly achieving elimination as a public health problem although this is taken into consideration by the WHO procedures for validation. Ongoing modelling work focuses on the risk of recrudescence when interventions are relaxed after the elimination target has been achieved.


2020 ◽  
Vol 221 (Supplement_5) ◽  
pp. S519-S524
Author(s):  
William Godwin ◽  
Joaquin M Prada ◽  
Paul Emerson ◽  
P J Hooper ◽  
Ana Bakhtiari ◽  
...  

Abstract Background As the World Health Organization seeks to eliminate trachoma by 2020, countries are beginning to control the transmission of trachomatous inflammation–follicular (TF) and discontinue mass drug administration (MDA) with oral azithromycin. We evaluated the effect of MDA discontinuation on TF1–9 prevalence at the district level. Methods We extracted from the available data districts with an impact survey at the end of their program cycle that initiated discontinuation of MDA (TF1–9 prevalence &lt;5%), followed by a surveillance survey conducted to determine whether TF1–9 prevalence remained below the 5% threshold, warranting discontinuation of MDA. Two independent analyses were performed, 1 regression based and 1 simulation based, that assessed the change in TF1–9 from the impact survey to the surveillance survey. Results Of the 220 districts included, TF1–9 prevalence increased to &gt;5% from impact to surveillance survey in 9% of districts. Regression analysis indicated that impact survey TF1–9 prevalence was a significant predictor of surveillance survey TF1–9 prevalence. The proportion of simulations with &gt;5% TF1–9 prevalence in the surveillance survey was 2%, assuming the survey was conducted 4 years after MDA. Conclusion An increase in TF1–9 prevalence may represent disease resurgence but could also be due to measurement error. Improved diagnostic tests are crucial to elimination of TF1–9 as a public health problem.


Author(s):  
Vaijanath Babshetti ◽  
Jyothi E. Singh ◽  
Prakash B. Yaragol

The COVID-19 pandemic originated in Wuhan, China, in December 2019. The virus has spread across the globe over the last 20 months. In the interest of public health, the World Health Organization (WHO) has declared a public health emergency to harmonise international responses to the virus. In a strongly interconnected world, the effect of the pandemic goes beyond mortality and morbidity. The unprecedented outbreak of COVID-19 has also resulted in a global economic crisis. Almost every sector of the economy has been gravely affected by the pandemic to various degrees. In an attempt to curb the spread of the virus many countries have initiated measures such as lockdowns, travel restrictions, ban on public and private transportation, closure of schools and colleges and restrictions on public and social gatherings. These initiatives have led to the decline in GDP, foreign trade and foreign exchange reserves, the rise of unemployment, the crash of stock markets and the depreciation of national currencies among other things. This study assesses the impact of COVID-19 on selected macroeconomic parameters of various Asian countries to present insights on the economic and health crisis caused due to COVID-19. The study analyses the effect of the pandemic on the macroeconomic factors listed above as well as the human cost of the pandemic during the last 20 months. The research finds that the outbreak adversely affected the economy and lives of people in India when compared to selected Asian nations.


2020 ◽  
Vol 30 (Supplement_5) ◽  
Author(s):  
R Singh ◽  
K Sharma

Abstract Background World Health Organization (WHO) declared that the outbreak of novel coronavirus (2019-nCoV) constituted a Public Health Emergency of International Concern (PHEIC) on 30 January 2020 and characterized the novel coronavirus disease (COVID-19) as a pandemic on 11 March 2020. India enacted such measures early on for effective mitigation and suppression to reduce community transmission, including an onerous national lockdown. The impact of the health system governance is quite apparent among all stakeholders including the public in such emergency contexts. Methods We compiled the daily data on the number of COVID-19 cases, recoveries and deaths from January 30th until June 16th, 2020. Different stages were categorized from post PHEIC declaration (pre-lockdown) phase to lockdown phases and unlocking phase as implemented. The several measures adopted by the national government were structured in four broad categories as Governance and socioeconomic, travel restrictions, lockdown and public health measures. These measures were compared during each phase. Results It was revealed that while the cases are rising the phased restrictions has helped in delaying the peak and remarkably interrupted the rate of transmission. The national average doubling rate was 3 days at the beginning which improved to 22 days. The basic reproduction number remained close to 1 during the last week of lockdown. However, the initial interruption of needed aid and technical support had negative social and economic impacts on the affected population. Conclusions As the situation abates following the measures adopted by the government, an articulate strategy of unlocking through increased testing and prompt isolation needs to be developed for more effective reduction and protecting the livelihoods allowing to further relax the lockdown measures. Key messages There is need for the local government to consider a strategic easing of the lockdown for protecting the rights of the most affected population. As the transmission rates are low, the easing of lockdown can be benefited from improved testing and prompt isolation.


Author(s):  
Tarcísio M. Rocha Filho ◽  
Fabiana Sherine Ganem dos Santos ◽  
Victor Bertollo Gomes ◽  
Thiago Augusto Hernandes Rocha ◽  
Julio Henrique Rosa Croda ◽  
...  

AbstractIn January 2020 China reported to the World Health Organization an outbreak of pneumonia of undetermined origin in the city of Wuhan, Hubei. In January 30, 2020, the World Health Organization declared the outbreak of COVID-19 as a Public Health Emergency of International Interest (PHEI).ObjectivesThe aim of this study is to assess the impact of a COVID-19 epidemic in the metropolitan region of São Paulo, Brazil.MethodsWe used a generalized SEIR (Susceptibles, Exposed, Infectious, Recovered) model, with additional Hospitalized variables (SEIHR model) and age-stratified structure to analyze the expected time evolution during the onset of the epidemic in the metropolitan area of São Paulo. The model allows to determine the evolution of the number of cases, the number of patients admitted to hospitals and deaths caused by COVID-19. In order to investigate the sensibility of our results with respect to parameter estimation errors we performed Monte Carlo analysis with 100 000 simulations by sampling parameter values from an uniform distribution in the confidence interval.ResultsWe estimate 1 368 (IQR: 880, 2 407) cases, 301 (22%) in older people (≥60 years), 81 (50, 143) hospitalizations, and 14 (9, 26) deaths in the first 30 days, and 38 583 (IQR: 16 698, 113, 163) cases, 8 427 (21.8%) in older people (≥60 years), 2181 (914, 6392) hospitalizations, and 397(166, 1205) deaths in the first 60 days.LimitationsWe supposed a constant transmission probability Pc among different age-groups, and that every severe and critic case will be hospitalized, as well as that the detection capacity in all the primary healthcare services does not change during the outbreak.ConclusionSupposing the reported parameters in the literature apply in the city of São Paulo, our study shows that it is expected that the impact of a COVID-19 outbreak will be important, requiring special planning from the authorities. This is the first study for a major metropolitan center in the south hemisphere, and we believe it can provide policy makers with a prognosis of the burden of the pandemic not only in Brazil, but also in other tropical zones, allowing to estimate total cases, hospitalization and deaths, in support to the management of the public health emergence caused by COVID-19.


2020 ◽  

The Pan American Health Organization (PAHO) Strategic Plan sets out the Organization’s strategic direction, based on the collective priorities of its Member States, and specifies the public health results to be achieved during the period 2020-2025. The Plan establishes the joint commitment of PAHO Member States and the Pan American Sanitary Bureau for the next six years. PAHO Member States have clearly stated that the Strategic Plan is a principal instrument for implementation of the Sustainable Health Agenda for the Americas 2018-2030 (SHAA2030) and thus for realizing the health-related Sustainable Development Goals (SDGs) in the Region of the Americas. The 11 SHAA2030 goals form the impact-level objectives of this Plan. Under the theme Equity at the Heart of Health, this Plan seeks to catalyze efforts in Member States to reduce inequities in health within and between countries and territories in order to improve health outcomes. The Plan identifies specific actions to tackle health inequality, including those recommended by the Commission on Equity and Health Inequalities in the Americas, with guidance from the High-level Commission for Universal Health. Four cross-cutting themes are central to this Plan’s approach to addressing the determinants of health: equity, gender, ethnicity, and human rights. In addition to highlighting an integrated multisectoral approach, this Plan applies evidence-based public health strategies, such as health promotion, the primary health care approach, and social protection in health, to address the social determinants. In addition to directly addressing the regional priorities established in the SHAA2030, this Plan aligns with the World Health Organization (WHO) 13th General Programme of Work (GPW13) and with other regional and global mandates in force during the planning period.


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