State of children’s medicines in the EU

The European Commission had presented a report to the European Parliament and the Council, on progress made in children’s medicines since the Paediatric Regulation came into force 10 years ago. It concludes that positive advances in the development of medicines for children could not have been achieved without specific EU legislation – e.g. the authorisation of 260 new medicines. The Paediatric Regulation also gives a good return on investment. However, the report acknowledges that more effort is needed to combine the effects of the Paediatric with those of the Orphan medicines Regulation to address shortcomings in treating rare diseases in children.

Commenting on the report, VytenisAndriukaitis, Commissioner for Health and Food Safety, said: “Whereas I am pleased with the overall progress made in improving children’s access to safe, tailored medicines, I am committed to extending these positive gains to children with rare diseases. When we consider the advances in adult oncology, it upsets me deeply that we have not made the same progress in treating the cancers that affect children. In the next 10 years we must focus on making similar breakthroughs for children, by combining the incentives under the Orphans and the Paediatric Regulations, and by ensuring that the European Reference Networks – in particular ‘ERN PaedCan’ on paediatric cancer, reach full capacity”.

To read more about this on the European Commission website go to: http://europa.eu/rapid/press-release_IP-17-4121_en.htm

The eHealth journey in Latvia

In a journey that started over a decade ago, the Ministry of Health of Latvia demonstrated its commitment to achieving universal health coverage by creating a national programme of electronic health (eHealth). This has been a key element of ensuring that Latvian people receive the right care in the right place and at the right time.

In the past, concerns such as data privacy and confidentiality were a barrier to converting Latvia’s fragmented, paper-based system into a modern, efficient and accessible eHealth system. Now, several comprehensive improvements, aided by technical support from the WHO Country Office in Latvia, have helped the eHealth system reach a high level of reliability and acceptance.

To read more about Latvia’s eHealth journey on the WHO website go to: WHO/Europe | The eHealth journey in Latvia

European Antibiotic Awareness Day 2017

The European Antibiotic Awareness Day is an annual European public health initiative that took place on 18 November to raise awareness about the threat to public health of antibiotic resistance and the importance of prudent antibiotic use. The latest data confirms that across the European Union the number of patients infected by resistant bacteria is increasing and that antibiotic resistance is a major threat to public health.

Prudent use of antibiotics can help stop resistant bacteria from developing and help keep antibiotics effective for the use of future generations.

To read more about the European Antibiotic Awareness Day on the European Centre for Disease Prevention and Control website go to: https://ecdc.europa.eu/en/news-events/european-antibiotic-awareness-day-2017

 

EU food donation guidelines

The primary focus of food waste prevention should be to act directly at source by limiting the generation of surplus food at each stage in the food supply chain (i.e. production, processing, distribution and consumption). If this cannot be achieved, the best destination for food surplus, which ensures the highest value use of edible food resources, is to redistribute this food for human consumption where safe to do so.

As part of the Circular Economy Action Plan, the Commission has adopted EU food donation guidelines in order to facilitate the recovery and redistribution of safe, edible food to those in need. Developed in consultation with the EU Platform on Food Losses and Food Waste, the EU food donation guidelines seek to:

  • facilitate compliance of providers and recipients of surplus food with relevant requirements laid down in the EU regulatory framework (e.g. food safety, food hygiene, traceability, liability, VAT, etc.);
  • promote common interpretation by regulatory authorities in the EU Member States of EU rules applying to the redistribution of surplus food.

To read more about food donation on the European Commission website, click here: Food Donation – European Commission

Scientific Advice on breast implants and health

The European Commission and its Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) have published two Scientific Advices related to breast implants and health, requested by the European Commission. These are on:

1) new scientific information on the safety of PIP breast implants

The first piece of advice concerns whether there is sufficient new scientific information on the safety of PIP breast implants to warrant an update of the 2014 SCENIHR Opinion. Based on the scientific information it has gathered and evaluated, the SCHEER concludes that this is not the case at present

2) the possible association between breast implants and anaplastic large cell lymphoma (ALCL).

The second piece of advice is on the state of scientific knowledge on a possible association between breast implants and anaplastic large cell lymphoma. The SCHEER concluded that, at present, there is insufficient scientific information available to establish a methodologically robust risk assessment on the potential association of breast implants with the development of ALCL.

To read the full report and advice on the European Commission website go to: http://ec.europa.eu/newsroom/sante/newsletter-specific-archive-issue.cfm?newsletter_service_id=327&newsletter_issue_id=3209

Turkey and e-cigarettes

In a public statement made at the Turkish Grand National Assembly Commission on Planning and Budget, Minister of Finance Naci Ağbal stated that plans to allow the importation and production of heat-not-burn tobacco products and electronic nicotine delivery systems  in Turkey were withdrawn. He confirmed that these products would not be sold or produced in the country.

The announcement followed a press conference and strong public reaction to the threats posed by the tobacco industry’s proposals to begin importing and producing heat-not-burn and ENDS products in the country. The press conference, held in Ankara, Turkey, saw WHO and prominent academics and health specialists jointly voicing their condemnation of the tobacco industry’s proposed new strategy.

To read more about this announcement and the reasons behind it on the WHO Europe website to go:  http://www.euro.who.int/en/health-topics/disease-prevention/tobacco/news/news/2017/10/turkey-withdraws-plans-to-loosen-tobacco-control-laws

EU-US mutual recognition of inspections of medicines manufacturers

The start of the month the coming into operation of further aspects of the mutual recognition agreement between the European Union and the United States to recognise inspections of manufacturing sites for human medicines conducted in their respective territories. This agreement, which updates the agreement from 1998, allows for recognition of each other’s inspection outcomes and hence for better use of inspection expertise and resources.

In June, the European Commission confirmed that the US Food and Drug Administration has the capability, capacity and procedures in place to carry out good manufacturing practice inspections at a level equivalent to the EU. Today, the FDA confirmed the capability of eight EU Member States (Austria, Croatia, France, Italy, Malta, Spain, Sweden, and United Kingdom). The remaining inspectorates will continue to be assessed until 15 July 2019.

To read more about this mutual recognition go to the EMA website: European Medicines Agency – News and Events – EU-US mutual recognition of inspections of medicines manufacturers enters operational phase

Assessing progress on reduction of antimicrobial resistance and antimicrobial consumption

A set of indicators will assist European Union  Member States to assess their progress in reducing the use of antimicrobials and combatting antimicrobial resistance. These indicators have been established by the European Food Safety Authority, the European Medicines Agency and the European Centre for Disease Prevention and Control, following a request from the European Commission.

The indicators address both the human and animal sectors and they reflect antimicrobial consumption and antimicrobial resistance in the community, in hospitals and in food-producing animals. The indicators are based on data already gathered through existing EU monitoring networks.

To read more about this go to the European Medicines Agency website: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2017/10/news_detail_002833.jsp&mid=WC0b01ac058004d5c1

 

Sales of antibiotics for animal use decrease by 13% in Europe

The European Medicines Agency has published a report on the sales of veterinary antibiotics in 2015 in Europe, which confirms the decreasing trend in most countries. This positive trend demonstrates that European Union guidance and national campaigns promoting prudent use of antibiotics in animals to fight antimicrobial resistance start to have an effect.

Between 2011 and 2015 the sales of antibiotics to treat animals decreased by 13.4%. This result covers those 25 out of the 30 participating countries that have provided data since 2011.

To read more about the decreasing sales of antibiotics for animal use on the EMA website go to: European Medicines Agency – News and Events – Sales of antibiotics for animal use decrease by 13% in Europe between 2011 and 2015

Responding to children and adolescents who have been sexually abused

Sexual abuse of children and adolescents is a gross violation of their rights and a global public health problem. It adversely affects the health of children and adolescents. Health care providers are in a unique position to provide an empathetic response to children and adolescents who have been sexually abused. Such a response can go a long way in helping survivors recover from the trauma of sexual abuse.

WHO has published new clinical guidelines Responding to children and adolescents who have been sexually abused aimed at helping front-line health workers, primarily from low resource settings, in providing evidence-based, quality, trauma-informed care to survivors. The guidelines emphasize the importance of promoting safety, offering choices and respecting the wishes and autonomy of children and adolescents. They cover recommendations for post-rape care and mental health; and approaches to minimizing distress in the process of taking medical history, conducting examination and documenting findings.

To read more about this on the WHO website go to: WHO | Responding to children and adolescents who have been sexually abused