The European Commission adopted two legal acts aimed at improving patient safety in the EU through good manufacturing practices (GMP) that ensure the highest quality of medicines for human use.
The first act is an implementing directive that sets out principles and guidelines of GMP in medicines where the manufacture or import is subject to a manufacturing authorisation: see Article 40 of the Community code Directive (2001/83/EC).
The second act is a delegated regulation that sets out GMP for investigational medicinal products, as required by the Clinical Trials Regulation (536/2014/EU), and detailed arrangements for inspections. This legal act ensures the highest quality of medicinal products used in clinical trials and prepares the smooth entry into force of this Regulation.
To read more about this on the europa.eu website: http://ec.europa.eu/newsroom/sante/newsletter-specific-archive-issue.cfm?newsletter_service_id=327&newsletter_issue_id=5153
Since 2015, hundreds of thousands of migrants and refugees have entered Europe, either escaping conflict in their country or in search of better economic prospects.Most migrants are healthy when they arrive in the EU, but they can be affected by conditions and factors prior to their travel or during their journey. They may be suffering from physical exhaustion, extreme distress, dehydration or cold. These challenges, combined with other issues, such as inadequate living conditions or unhealthy lifestyles, can seriously impact their physical and mental health. If they were already dealing with chronic diseases, their health may have further deteriorated.
No person entering the EU should be left without access to basic healthcare, and no EU country can or should be left alone to manage the public health dimension of such an unprecedented crisis.
To read more about improving health of refugees and migrants at europa.eu: http://ec.europa.eu/chafea/news/news523.html
Unhealthy diet is the biggest risk factor for disability adjusted life years lost (DALYs) in the EU, principally through diabetes, cancer, and cardiovascular diseases, with tobacco and alcohol also contributing significantly to the growing burden of chronic diseases on health services.
Of course, this is far from coincidental. The private sector has a number of strategies and approaches that it employs “to promote products and choices that are detrimental to health”. They include marketing, which enhances the desirability and acceptability of products. Marketing in all its forms is key to unhealthy commodities’ acceptability, and crucially, their appeal.
To read more about these links on the epha.org site: https://epha.org/explaining-the-links-between-commercial-determinants-of-health-and-chronic-diseases/
A study published today on antimicrobial resistance and the causes of non-prudent use of antibiotics carried out by Nivel (NL) as part of the EU-funded project ARNA, estimates that 7% of antibiotics taken in the EU are taken without a prescription. The highest rates of non-prescription use of antibiotics are in Romania (20%) and Greece (16%) with high rates also found in Cyprus, Hungary, Italy, Romania and Spain. Over the counter selling of antibiotics in pharmacies and the use of leftover antibiotics were found to be the main causes.
The study gives a number of policy recommendations, for example:
- A multi-faceted approach with interventions and policies that target both patients and healthcare professionals
- Education and awareness raising, e.g. media campaigns for citizens staring with school children, and education programmes for health professionals
- Better enforcement of laws in EU countries where antibiotics are available over the counter without prescription.
Read the study on antimicrobial resistance in full on the europe.eu website.
The European Commission has launched a public consultation on how Europe should promote digital innovation in health and care, for the benefits of citizens and health systems in Europe. The input will feed into a new policy Communication to be adopted by the end of 2017, as announced in the recent review of the Commission’s Digital Single Market strategy.
Mariya Gabriel and Carlos Moedas stated:
‘We are dedicated to improving European citizens’ quality of living by improving Europe’s health, care and research systems by using digital technologies to their full potential. This consultation will help us identify ways to offer citizens, medical professionals and researchers better access to health data, prevention, rapid response to pandemic threats, personalised treatments and care. We are considering new digital initiatives to deliver on the free movement of patients and data, to support the modernisation of national health systems, and to bring together scattered evidence and innovative knowledge from across Europe. At the heart of our policies, citizens and their wellbeing are our first priority.’
The consultation will collect information on three main pillars:
- Citizens’ secure access to their health data and the possibility to share it across borders, clarifying citizens’ rights and enhancing interoperability of electronic health records in Europe;
- Connecting and sharing data and expertise to advance research, personalise health and care, and better anticipate epidemics;
- Using digital services to promote citizen empowerment and integrated person-centred care.
Citizens, patient organisations, health and care professionals, public authorities, researchers, industries, investors, insurers and users of digital health tools are all invited to share their views via EU Survey until 12 October 2017.
The European Commission has asked SCHEER to assess the potential health risks associated with LED emissions in the general population. The review of the published research conducted by the Committee has resulted in valuable conclusions and identified certain gaps in the knowledge on potential risks to human health from LEDs.
The Committee concluded that there is no evidence of direct adverse health effects from LEDs in normal use (lightening and displays) by the healthy general population.
Vulnerable and susceptible population (young children, adolescent and elderly people) were studied separately. Children have a higher sensitivity to blue light. Although emissions may not be harmful, blue LEDs may be very dazzling and may induce photochemical retinopathy, which is a concern especially for children below three years of age. Moreover, elderly people may experience discomfort from exposure to LED systems, including blue LED displays.
Despite the existence of cellular and animal studies showing adverse effects of LED exposure, their conclusions derive from results obtained using exposure conditions that are difficult to relate to human exposures or using exposure levels greater than those likely to be achieved with LED lighting systems in practice.
Since the use of LED technology is still evolving, the Committee considers that it is important to closely monitor the risk of adverse health effects from long term LED use to the general population.
For more information on the public consultation of Light Emitting Diodes (LEDs).
The European Parliament funds a number of pilot projects designed to test the feasibility and usefulness of action, develop evidence-based strategies to address a problem, identify good practices, and provide policy guidance in the area of health inequalities.
One such pilot is VulnerABLE: Improving the health of those in isolated and vulnerable situations
It targets specific vulnerable and isolated populations such as children and families from disadvantaged backgrounds; those living in rural/isolated areas; those with physical, mental and learning disabilities or poor mental health; the long-term unemployed; the inactive; the ‘in-work poor’; older people; victims of domestic violence and intimate partner violence; people with unstable housing situations (the homeless); and prisoners.
Due to their circumstances, these groups may be more at risk of poor health and/or face barriers in accessing healthcare services. The project will assess their particular health needs and challenges, as well as identify best practices to support them and ultimately improve their health.
Initial research has found that unmet health needs are a significant factor for those living in vulnerable and isolated situations. For example:
- Data from the Survey of Health, Ageing and Retirement in Europe (SHARE) show that in older people socioeconomic factors such as a lower level of education and lower income increase the likelihood of older people experiencing limitations to their mobility, and the prevalence of eyesight, hearing and chewing problems
- Those living in rural areas are less likely than urban residents to seek the healthcare they need because of cost, distance, and/or a lack of health facilities and professionals
- Most prisoners have pre-existing vulnerabilities, such as substance abuse and mental health needs, which overcrowding and poor hygiene in prison may make worse
- Those with lower levels of education are more likely to have a lower life expectancy
- Long-term unemployment and inactivity is associated with a range of poor health outcomes
Over its two-year lifetime, the ‘VulnerABLE’ project will create training materials and capacity-building workshops for national and regional authorities who deliver healthcare services and have a vital role to play in tackling health inequalities
For more information about Pilot projects to tackle Health Inequalities on the ec.europa.eu website
The EU has published its Action Plan to tackle Antimicrobial Resistance (AMR) – a growing threat that is responsible for 25,000 deaths and a loss of €1.5 billion in the EU every year.
The plan includes guidelines for doctors, nurses, pharmacists, hospital administrators and others who play a role in antimicrobial use to promote their prudent use in people. These guidelines complement infection prevention and control guidelines which may exist at national level. In addition, the plan foresees more than 75 actions built on three main pillars:
- making the EU a best-practice region
- boosting research, development and innovation
- shaping the global agenda
For more information on the Action Plan to tackle Antimicrobial Resistance on the ec.europa.eu website
The EU has produced new rules on medical devices to enhance patient safety and modernise public health.
There are over 500,000 types of medical devices and in-vitro diagnostic medical devices on the EU market. Examples of medical devices are contact lenses, x-ray machines, pacemakers, breast implants and hip replacements and sticking plasters. In vitro diagnostic medical devices, which are used to perform tests on samples, include HIV blood tests, pregnancy tests and blood sugar monitoring systems for diabetics.
The new Regulations will help to ensure that all medical devices – from heart valves to sticking plasters to artificial hips – are safe and perform well. The new rules will improve market surveillance and traceability as well as make sure that all medical and in vitro diagnostic devices are designed to reflect the latest scientific and technological state-of-the art. The rules will also provide more transparency and legal certainty for producers, manufacturers and importers and help to strengthen international competitiveness and innovation in this strategic sector.
For more information on the new rules about medical devices on the europa.eu website