Legal and regulatory update: Voluntary withdrawal of marketing authorisations and consequences for parallel importers

10.5912/jcb46 ◽  
1969 ◽  
Vol 9 (4) ◽  
Author(s):  
John Wilkinson
Keyword(s):  
Public Health ◽  
Marketing Authorisation ◽  
Parallel Import ◽  
Voluntary Withdrawal ◽  
Actual Risk ◽  
Regulatory Update

When a reference marketing authorisation is withdrawn for reasons unconnected with the protection of health, as in cases C-15/01 and C-113/01, it is not acceptable that a parallel import licence granted there under should automatically terminate unless an actual risk to public health can be demonstrated.

scholarly journals PND72 Measuring the IMPACT of Almitrine Marketing Authorisation Withdrawal on Public Health in France

2020 ◽  
Vol 23 ◽  
pp. S636
Author(s):  
S. Lane ◽  
E. Lynn ◽  
J. Slattery ◽  
S. Shakir
Keyword(s):  
Public Health ◽  
Marketing Authorisation ◽  
The Impact

scholarly journals Antimicrobial Drug-Resistant Salmonella in Urban Cats: Is There an Actual Risk to Public Health?

Antibiotics ◽  
2021 ◽  
Vol 10 (11) ◽  
pp. 1404
Author(s):  
János Dégi ◽  
Kálmán Imre ◽  
Viorel Herman ◽  
Iulia Bucur ◽  
Isidora Radulov ◽  
...  
Keyword(s):  
Public Health ◽  
Urban Areas ◽  
The Elderly ◽  
Automated System ◽  
Public Health Issue ◽  
Molecular Testing ◽  
Salmonella Spp ◽  
Actual Risk ◽  
Antimicrobial Susceptibility Profile ◽  
Faecal Samples

The present study was undertaken to investigate the presence of Salmonella spp. in the faeces of client-owned cats in urban areas and to evaluate the risk that is posed to public health. Fresh faecal samples were collected directly from the rectums from 53 diarrhoeic and 32 non-diarrhoeic cats. The samples were individually screened for the presence of Salmonella spp. using standard methods and, in the case of positive findings, the resulting typical colonies were then biochemically confirmed using the VITEK®2 automated system. Subsequently, all of the Salmonella spp. isolates were molecularly tested for the presence of the invA gene. All of the isolates were serotyped using the slide agglutination technique according to the White–Kauffmann–Le Minor scheme. The phenotypic antimicrobial susceptibility profile of the isolated strains was obtained from the VITEK®2 system using specific cards from the Gram-negative bacteria. A total of 16 of the samples (18.82%) tested positive for Salmonella spp. according to conventional and molecular testing methods. Serotyping of the Salmonella isolates showed the presence of three serotypes, namely S. enteritidis (n = 9; 56.3%), S. typhimurium (n = 4; 25%), and S. kentucky (n = 3; 18.8%). All of the tested strains showed strong resistance towards cefazolin, cefepime, ceftazidime, and ceftriaxone. Additionally, resistance (listed in descending order of strength) was observed to trimethoprim/sulfamethoxazole (11/16; 68.8%), ampicillin (10/16; 62.5%), ampicillin/sulbactam (9/16; 56.3%), gentamicin (9/16; 56.3%), nitrofurantoin (8/16; 50.0%), and amikacin (5/16; 31.3%). No resistance was expressed against ciprofloxacin, ertapenem, imipenem, levofloxacin, piperacillin/tazobactam, and tobramycin. The results of this study highlight a substantial public health issue and medical concern, especially in vulnerable people, such as children, the elderly, and immunocompromised individuals.

scholarly journals Who is afraid of ticks and tick-borne diseases? Results from a cross-sectional survey in Scandinavia

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Daniel Slunge ◽  
Solveig Jore ◽  
Karen Angeliki Krogfelt ◽  
Martin Tugwell Jepsen ◽  
Anders Boman
Keyword(s):  
Public Health ◽  
Perceived Risk ◽  
Risk Perceptions ◽  
Tick Bite ◽  
Tick Bites ◽  
Cross Sectional Survey ◽  
Online Questionnaire ◽  
Cross Sectional ◽  
Actual Risk ◽  
Perceived Seriousness

Abstract Background In Scandinavia, the distribution of ticks is expanding and tick-borne diseases constitute growing health risks. While the probability of getting a tick-borne disease after a tick bite is low, the health impacts can be large. This, as well as other characteristics of these diseases make tick-related risks difficult for laypeople to assess and perceived risk may differ substantially from actual risk. Understanding risk perceptions is important since it is the perceived risk, rather than actual risk, that determine behaviour and even more so for new and emerging risks. The aim of this study is to investigate knowledge and risk perceptions related to tick bites and the tick-borne diseases Lyme borreliosis (LB) and tick-borne encephalitis (TBE). By analysing risk perceptions and knowledge, the study helps inform the development of public health strategies in response to the increasing incidence of these diseases in Scandinavia. Methods Two thousand, six hundred sixty-eight respondents in Denmark, Norway and Sweden answered an online questionnaire with 48 questions, including 7 questions on risk perceptions and 9 knowledge questions. Chi-squared tests were used to analyse statistical differences between country sub-samples, gender and age groups. A multivariate regression model was used to analyse factors associated with risk perceptions. Results Risk perceptions were on average high in comparison with scientific estimates, with respondents grossly overrating the probability of contracting LB or TBE if bitten by a tick. Also, the average perceived seriousness of a single tick bite and of getting LB or TBE was high. Knowledge on the other hand was low, especially among men and the youngest age group (18–29 years). Higher levels of knowledge about tick-borne diseases were associated with lower perceived seriousness of tick bites and LB and higher perceived seriousness of TBE. Also, having been diagnosed with LB was negatively associated with the perceived seriousness of LB. Conclusions Our results indicate that informing about ticks and tick-borne diseases would be a relevant public health strategy as it could make risk perceptions better aligned with actual risk. Should the TBE virus spread further in Denmark and Norway, increasing knowledge about TBE vaccination would be especially important.

Biodefense Spending and Waste: Impact on Public Health Initiatives

2016 ◽  
Vol 13 (3) ◽  
pp. 295-300
Author(s):  
Erin Lynne Kelly ◽  
Adam Zola ◽  
Monica Strzalkowski ◽  
Benjamin Macmillan ◽  
Gavin Macgreggor-Skinner
Keyword(s):  
Public Health ◽  
Infectious Disease ◽  
Pandemic Influenza ◽  
Emerging Diseases ◽  
Fatality Rate ◽  
Government Oversight ◽  
Actual Risk ◽  
Health Initiatives ◽  
Public Health Initiatives

Abstract While the threat of bioterrorism carries with it strong emotions of fear and panic, the likelihood-adjusted fatality rates for a horrific bioterror event pale in comparison to that of an infectious disease like influenza. Based on this assumed risk of occurrence, the likelihood-adjusted fatality rate of a bioweapon attack is 900 deaths per year as compared to 36,000 deaths per year for influenza. The FY2016 budget for biodefense was $1.4 million in comparison to $1.2 million for pandemic influenza and emerging diseases. In addition to poor allocation of funds based on actual risk, the biodefense budget lacks government oversight, has poorly defined objectives and unnecessary redundancy. Streamlining the budget and appropriating funds with more emphasis on actual risk would allow an increase in essential areas of public health.

scholarly journals Analysis of FDA’s IQOS marketing authorisation and its policy impacts

2020 ◽  
pp. tobaccocontrol-2019-055585 ◽  
Author(s):  
Lauren Kass Lempert ◽  
Stanton Glantz
Keyword(s):  
Public Health ◽  
Marketing Authorisation ◽  
Scientific Evidence ◽  
Health Impacts ◽  
Public Confidence ◽  
Independent Research ◽  
The Public ◽  
Philip Morris ◽  
Important Health ◽  
The Usa

BackgroundPhilip Morris Products SA (PMPSA) submitted a premarket tobacco application (PMTA) to US Food and Drug Administration (FDA) seeking an order permitting it to market IQOS in the USA. US law requires FDA to deny marketing authorisation if applicants fail to demonstrate that their product is ‘appropriate for the protection of the public health’. FDA issued a marketing order for IQOS in April 2019, which Philip Morris is using to promote IQOS outside the USA.MethodsWe analysed FDA’s Technical Project Lead Review and marketing order for IQOS, relevant law and guidance on PMTAs and independent research on the health impacts of IQOS.ResultsFDA found that the evidence PMPSA submitted did not demonstrate reduction in long-term disease risks and that IQOS aerosol emits toxins with carcinogenic and genotoxic potential, some at higher levels than conventional cigarettes. PMPSA did not appropriately consider the health impacts of dual use, the product’s attractiveness to youth or data showing that consumers do not accurately perceive the addiction risks of IQOS. Despite FDA’s own scientists’ recommendations and independent research showing that IQOS presents serious risks to users including cytotoxic, genotoxic, hepatotoxic, cardiovascular and pulmonary risks, FDA concluded that IQOS is ‘appropriate for the protection of the public health’.ConclusionFDA’s decision allowing IQOS to be marketed in the USA disregarded valid scientific evidence and misapplied the public health standard mandated by law. This decision may have important health impacts, influence marketing IQOS outside the USA and erode public confidence in FDA’s future PMTA decisions.

Promoting the Off–label Use of Medicines: Where to Draw the Line?

2016 ◽  
Vol 7 (2) ◽  
pp. 426-433
Author(s):  
Genevra Forwood ◽  
James Killick
Keyword(s):  
Public Health ◽  
Clinical Trials ◽  
Patient Safety ◽  
Marketing Authorisation ◽  
Regulatory System ◽  
Eu Law ◽  
Off Label Use ◽  
Compassionate Use ◽  
Off Label ◽  
Label Use

In Europe, medicines can only be marketed once they have passed through a strict regulatory process, designed primarily to protect patient safety. It is only after in–depth testing on the targeted disease population, including three phases of clinical assessment and clinical trials, that a medicine will obtain a ‘marketing authorisation’. Given its primary goal of ensuring patient safety, EU law only allows a few narrow exceptions to the requirement of amarketing authorisation. Adrug can only be used “off–label”, meaning outside the limits of its marketing authorization, in authorised clinical trials or under one of the strictly defined exceptions, such as severe public health risk, compassionate use for groups of patients or for individual patients on a named patient basis.However, in recent years, a trend has emerged Among Member States to push the boundaries of the existing regulatory system, and actively promote the off–label use of medicines on the ground that they are cheaper than the alternative, authorised medicine. It is questionable whether this trend is in line with EU law.

Public Health and Newborn Hearing Screening

1997 ◽  
Vol 6 (1) ◽  
pp. 11-16
Author(s):  
Terrey Oliver Penn ◽  
Susan E. Abbott
Keyword(s):  
Public Health ◽  
Hearing Screening ◽  
Newborn Hearing Screening ◽  
Newborn Hearing
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