Review | Jotup

EU medicines agencies reflect on lessons learned from COVID-19

Retrieved on:

Monday, December 18, 2023

Safety, COVID-19 vaccine, HMA, EMA, Agency, European, Collaboration, Vaccine, COVID-19, Mass vaccination, Therapy, Communication, Review, Workload, Network, Public, Pharmaceutical industry, Medical device

Additionally, the European Union (EU) safety monitoring and risk management system was strengthened to collect and monitor the high volume of data from the mass vaccination campaigns.

Key Points:

Additionally, the European Union (EU) safety monitoring and risk management system was strengthened to collect and monitor the high volume of data from the mass vaccination campaigns.
Throughout the COVID-19 crisis, the EMRN also ensured that medicines for other diseases affecting Europeans continued to be evaluated and supervised without delays.
In addition, the ongoing review of the EU pharmaceutical legislation will also provide a vehicle to bring about other changes to the EU regulatory toolbox.
The recommendations will also be considered in future updates of the European Medicines Agencies Network strategy.

Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 5-7 December 2023

Retrieved on:

Monday, December 18, 2023

The Committee adopted by consensus a positive opinion for a variation requiring assessment for Solensia (frunevetmab) to implement the outcome of the MAH’s signal management…

Key Points:

The Committee adopted by consensus a positive opinion for a variation requiring assessment for Solensia (frunevetmab) to implement the outcome of the MAH’s signal management…

First version of the Union list of critical medicines agreed to help avoid potential shortages in the EU

Retrieved on:

Monday, December 18, 2023

Medicine, Industry, Review, EMA, Good, Urinary tract infection, Patient, Union, Vaccine, Union List, Nursing, Pharmaceutical industry, Risk management

The list is an important tool to support the EU’s efforts in ensuring supply security and preventing shortages of critical medicines.

Key Points:

The list is an important tool to support the EU’s efforts in ensuring supply security and preventing shortages of critical medicines.
It is included in the Union list of critical medicines if it meets certain criteria, including being critical in more than one third of EU/EEA countries.
The list contains active substances covering a wide range of therapeutic areas, and includes vaccines and medicines for rare diseases.
The publication of the Union list will not impact existing or to-be-established national lists of critical medicines.

EMA Management Board: highlights of December 2023 meeting

Retrieved on:

Monday, December 18, 2023

Work programme and budget for 2024The Board adopted EMA’s work programme for 2024, acknowledging that the Agency will continue to deliver on all its strategic priorities.EMA and…

Key Points:

Work programme and budget for 2024The Board adopted EMA’s work programme for 2024, acknowledging that the Agency will continue to deliver on all its strategic priorities.EMA and…

If NZ's new government wants a simple fix to improve child poverty, here’s what it should do

Retrieved on:

Thursday, November 9, 2023

For those without children, its proposed payment of the full Independent Earner Tax Credit for incomes between NZ$24,000 and $66,000 would kick in from April 1 next year.

Key Points:

For those without children, its proposed payment of the full Independent Earner Tax Credit for incomes between NZ$24,000 and $66,000 would kick in from April 1 next year.
This would help some 380,000 people in low and modestly paid work with an extra $10 a week.
At the same time, the work effort of low-income parents can be better rewarded.

How the poverty trap works

When a family’s joint gross income exceeds the (very low) fixed $42,700 threshold, every extra dollar earned denies them 27 cents of WFF assistance.
To help explain this, it’s useful to imagine a typical family in those circumstances.
Let’s say this family has two children at school, with one parent in full-time employment and the other half-time, both on the minimum wage.
Read more:
Forcing people to repay welfare ‘loans’ traps them in a poverty cycle – where is the policy debate about that?

Letting people work and earn more

Delaying the change only decreases the incentive to work, with flow-on effects for productivity.
This would also address child poverty, as about half of the country’s poor children are in families in low-paid work.
Many slip further into debt every week, waste precious time arguing for means-tested top-ups from Work and Income, or need food parcels from stretched and underfunded foodbanks.

A simple solution

This would best be achieved by an immediate increase to the Family Tax Credit, over and above the required inflation adjustment.
Here is a counter-intuitive but serious suggestion: reduce the In Work Tax Credit by $25 a week and increase the Family Tax Credit by the same amount.
But this basic suggestion could still be a win-win for National’s key objectives at roughly the same eventual annual cost.

Susan St John is affiliated with the Child Poverty Action Group.

How to never get a speeding fine again — and maybe save a child's life

Retrieved on:

Thursday, November 9, 2023

We could help motorists avoid speeding — and therefore reduce emissions and fuel use, improve traffic flow, reduce crashes, lower insurance costs, make streets feel safer to walk and cycle – and totally avoid speeding fines.

Key Points:

We could help motorists avoid speeding — and therefore reduce emissions and fuel use, improve traffic flow, reduce crashes, lower insurance costs, make streets feel safer to walk and cycle – and totally avoid speeding fines.
It’s no wonder Australians want this technology – 81% believe “intelligent speed assist” technology is important for making roads safer.

Technology to stop speeding

“Intelligent speed assist” is the name of the low-cost technology that could save lives every year by reducing speeding.

The idea of helping drivers to avoid speeding is more than 100 years old.
Currently, we must constantly monitor speed limits and adjust our speed accordingly to avoid speeding.
Given how often speed limits can change on a route, and that we all make mistakes, it’s no wonder speeding is so common.

Will it work?

Installing intelligent speed assist in all cars could prevent at least 8% and up to 19% of all crashes Australia-wide. This represents up to 200 lives saved per year. A NSW Centre for Road Safety trial found advisory intelligent speed systems reduced speeding in 89% of vehicles, across more than 1.9 million kilometres of testing. Intelligent speed assist is not yet a perfect system. Hurdles to overcome include:
But shouldn’t we be doing everything we can to overcome these hurdles, to make such a life-saving, child-saving technology work as well as it can?

What’s already been done?

Legislation in 2022 has made intelligent speed assist technology mandatory for all new cars sold in the European Union.
In Australia, if you drive a relatively new car, you may already have the option of intelligent speed assist.

What about older vehicles?

So retrofitting older cars with intelligent speed assist technology has been trialled.
It is common, though, to retrofit fleet cars such as government and company vehicles with intelligent speed assist.

‘But I only speed a little bit’

More than one in four Australians think it’s ok to speed if driving “safely”.
For every 1km/h increase in speed, there is a 4% increase in fatal crashes.
If everyone was to increase their speed by just 1km/h, we could expect an extra 48 deaths a year.
Road deaths remain the number one killer of children in Australia and speed is the most common factor in a crash.

3 actions to get started

Intelligent speed assist is not a silver bullet. But it is one of five crucial actions that can make zero road deaths possible. More than 200 cities around the world have already achieved this goal at least five times for a calendar year since 2009. Here are three actions to get started:
install intelligent speed assist in all all public buses and government fleet cars – the NSW government fleet, for example, has 25,000 cars
require intelligent speed assist for a 5-star ANCAP safety rating
adopt the EU legislation in Australia to require intelligent speed assist in all new cars.
We have an urgent problem, we have the technology, we have the evidence it works, so what’s stopping us using it to save lives on our roads? The authors have provided footage online of intelligent speed assist in action, for free reuse.

Matthew 'Tepi' Mclaughlin receives research funding from the Australian government's Medical Research Future Fund and the government of Western Australia's Healthway.
He also receives salary support through the Australian Research Council's Centre of Excellence for Children and Families over the Life Course.
Paul Roberts receives funding from: 1. the government of Western Australia via the Road Safety Commission of Western Australia funding of the Western Australian Centre for Road Safety; 2. the Australian Office of Road Safety.

Grattan on Friday: When Labor states don't dance to the Albanese government's tune

Retrieved on:

Thursday, November 9, 2023

It’s helpful for the Albanese government to have all mainland states in Labor hands – but only up to a point.

Key Points:

It’s helpful for the Albanese government to have all mainland states in Labor hands – but only up to a point.
In May, the government announced a 90-day review of the $120 billion infrastructure pipeline it inherited from the Coalition.
The government’s aim was to reduce the number of projects (many of them small) and rearrange priorities.
The political difficulties of abolishing or changing projects, often involving negotiation with states and territories, are obvious enough.
The government has received its stocktake, and Treasurer Jim Chalmers says the overall cost of the program has blown out by some $33 billion.
Being pushed into minority is something Albanese – a senior figure in the minority Gillard government – would want to avoid at all costs.
The challenge of keeping out of minority increases the importance of the “ground game” in Labor’s marginal electorates.

Michelle Grattan does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.

How autistic parents feel about breastfeeding and the support they receive – new research

Retrieved on:

Thursday, November 9, 2023

Taste, Thirst, Spectrum, Sound, Education, Time, System, Housing, Heart rate, Digestion, Interoception, Skin, Research, Milk, Infant, Learning, Joint, Review, Smell, Pain, Breast, Communication, Clothing, Parent, Birth control, Mobile phone

We also found that communication by health professionals didn’t always meet the needs of autistic parents.

Key Points:

We also found that communication by health professionals didn’t always meet the needs of autistic parents.
So, for our newly released study, we asked 152 autistic parents from across the UK about their breast- and formula-feeding experiences.
That said, many of these autistic parents described experiencing sensory difficulties, with touch-related issues being their most frequently reported challenge.

Interoception

But we also have three other senses that are just as important.
The vestibular system helps us keep our balance and move around safely; proprioception lets us know how our muscles and joints are moving; and interoception tells us about what is happening inside our bodies, such as our heart rate, breathing and digestion.

Adaptation strategies

Whether our parents breast- or formula-fed, the intensity of babies’ frequent feeding could be overwhelming – a well-known issue among the general population of parents too. However, for autistic parents, carefully developed strategies to stay regulated and de-stress, such as going for a walk or watching an episode of a favourite TV show, could be disrupted by the busy routine of new parenthood.

This included adapting their clothing and distracting themselves during feeding by looking at a mobile phone, for example.
There is evidence that bonding is not negatively impacted by the use of smartphones when breastfeeding in a general population.
So, these types of distraction should be encouraged for all parents who are finding breastfeeding hard but want to continue doing so.

Room for improvement

The national autism training programme, which is developed and delivered by autistic adults, aims to improve this situation across England.
A second area for improvement is for autistic parents, their partners and other people supporting them to be aware of potential feeding issues in advance, so they can be better prepared.

Kathryn Williams receives funding for her PhD studentship from the Economic and Social Research Council.
She is affiliated with Autistic UK CIC, where she is a voluntary non-executive director.

European Supervisory Authorities publish joint criteria on the independence of supervisory authorities

Retrieved on:

Thursday, November 9, 2023

Review, European Insurance and Occupational Pensions Authority, European Securities and Markets Authority, European Banking Authority, ESMA, EBA, EIOPA, Pension, Pension fund, Property management, European, EU

25 October 2023

Key Points:

25 October 2023
The three European Supervisory Authorities– the European Banking Authority (EBA), European Insurance and Occupational Pensions Authority (EIOPA) and European Securities and Markets Authority (ESMA) (EBA, EIOPA and ESMA – the ESAs) – today published their joint criteria on the independence of supervisory authorities.
Supervisory independence is key to ensure that fair, effective and transparent decisions are taken by appropriately resourced supervisory authorities.
Building on these reports and based on the 2021 EIOPA’s criteria and international standards, the ESAs further worked together to issue joint criteria on the independence of supervisory authorities.
The criteria can be used by supervisory authorities as a tool to enhance their independence and, at a later stage, by the ESAs to assess supervisory independence in the EU.

The EBA issues Opinion on a measure to address macroprudential risk following a notification by the Swedish Financial Supervisory Authority

Retrieved on:

Thursday, November 9, 2023

Review, Civil service commission, SME, European Commission, Council, Opinion, European, EBA, Housing, IRB, Intention, Swedish financial transaction tax, European Banking Authority, Bank

The measure entails a credit institution-specific minimum level of 25% for the average risk weight of Swedish housing loans applicable to credit institutions that have adopted the internal ratings-based (IRB) approach to calculate their capital requirements..

Key Points:

The measure entails a credit institution-specific minimum level of 25% for the average risk weight of Swedish housing loans applicable to credit institutions that have adopted the internal ratings-based (IRB) approach to calculate their capital requirements..
The measure targets retail exposures secured by real estate, both small and medium-sized (SME) and non-SME exposures.
In its Opinion, addressed to the Council, the European Commission, and the Swedish Financial Supervisory Authority, the EBA do not object to the extension of the current measure.
The EBAtakes note of ongoing concerns regarding systemic risk relating to the housing market and the persistence of macroprudential vulnerabilities in the Swedish financial system.