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
In the WHO European Region, 42 of 53 countries have interrupted endemic transmission of measles, and 37 Member States have interrupted endemic transmission of rubella as of the end of 2016. This was determined by the European Regional Verification Commission for Measles and Rubella Elimination (RVC) at its 6th meeting in June 2017.
“I congratulate each country for fulfilling the commitment to protect its people from measles and rubella and collectively moving the European Region closer to its elimination goal,” said Dr Zsuzsanna Jakab, WHO Regional Director for Europe. “However, we cannot become complacent now. Outbreaks continue to cause unnecessary suffering and loss of life.”
To read more about this on the WHO/Europe website: http://www.euro.who.int/en/media-centre/sections/press-releases/2017/measles-no-longer-endemic-in-79-of-the-who-european-region
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
Pharmaceuticals in the environment represent a global pollution problem – over 631 different pharmaceutical agents (or their metabolites) have been detected in at least 71 countries covering all continents. Pharmaceutical residues have been detected in surface water, sewage effluents, groundwater, drinking water, manure, soil, and other environmental matrices. Antibiotics in the environment can promote the development of antibiotic-resistant pathogens – a major global health threat. Also, little is known about the effects on humans from continuous, long-term exposure to low concentrations of pharmaceuticals. Pharmaceutical substances are often engineered so
that they remain unchanged during their passage through the human body; unfortunately this stability means they also persist outside the human body and, as a consequence, can build up in the environment. Several studies have confirmed that medicines pose environmental risks, and that concentrations found in the environment can have detrimental effects on aquatic systems and wildlife.
The Dutch organisation – health care without harm Europe – has produced a report outlining what steps are being taken in Europe to reduce anti-microbial resistance (AMR) and offers opportunities for countries to work together on this shared problem.
This report ‘How can voluntary cross-border collaboration in public procurement improve access to health technologies in Europe?’ examines the legal framework put in place by the EU to foster voluntary cross-border collaboration in the field of public procurement of health technologies. It looks at recent experiences and developments in cross-border collaboration across Europe and explores the challenges and opportunities that such cross-border collaboration present.
To download the report on cross-border collaboration in public procurement from the euro.who.int website
European Reference Networks (ERNs) are unique and innovative cross-border cooperation platforms between specialists for the diagnosis and treatment of rare or low prevalence complex diseases.
In 2017 24 thematic ERNs, gathering over 900 highly specialised healthcare units from 26 countries, will begin working together on a wide range of issues, from bone disorders to haematological diseases, from paediatric cancer to immunodeficiency. Joining up of EU’s best expertise on this scale should benefit thousands of patients with diseases requiring a particular concentration of highly specialised healthcare in medical domains where the expertise is rare.
For more information on European Reference Networks on the europa.eu website
Antibiotic resistance is widespread across the whole of Europe. High resistance, often seen in the southern and eastern countries of the European Union, is also found in the eastern part of the European Region. In particular, resistant bacteria are spreading in hospitals and health care settings, putting patients at risk of contracting incurable diseases. This is the concerning picture painted by the second Central Asian and Eastern European Surveillance of Antimicrobial Resistance (CAESAR) report, published by WHO.
The aim of the report is to provide guidance and inspiration to countries that are building or strengthening their national AMR surveillance and to stimulate the sharing of data internationally. 19 non-EU countries are engaged in CAESAR (Albania, Armenia, Azerbaijan, Belarus, Bosnia and Herzegovina, Georgia, Kazakhstan, Kyrgyzstan, Montenegro, the Republic of Moldova, the Russian Federation, Serbia, Switzerland, Tajikistan, the former Yugoslav Republic of Macedonia, Turkey, Turkmenistan, Ukraine, Uzbekistan.)
More information about Anti-Microbial Resistance in Europe on the euro.who.int website
A new WHO report provides insight into how countries in the WHO European Region can improve access and reduce medicine prices through strategic and well-planned procurement processes. It also addresses collaboration within and across countries to improve availability of affordable medicines for patients in the Region.
Countries in the Region have varying capacity and negotiating power when it comes to procuring new medicines and health technologies. As a result, the prices that a given country is asked to pay for its medicines may be disproportionally high and incompatible with its purchasing power.
A study cited in the report illustrates this problem. It compares ex-factory prices of 2 new medicines used to treat hepatitis C – sofosbuvir and ledipasvir-sofosbuvir – and reveals that the cost of treating the entire hepatitis C-infected population in each of the 30 countries examined would range from 10.5% of the total pharmaceutical expenditure in the Netherlands to 190.5% in Poland. The price of a single course of sofosbuvir was equivalent to 5.28 years of the average annual wage in Turkey. The high price of ledipasvir-sofosbuvir in England led the National Health Service to restrict treatment to the most severely ill patients.
Download the report on Strategic Purchasing of Medicines from the euro.who.int website
Although the number of refugee and migrant arrivals has seen an overall reduction in recent months, migration to Europe continues at a steady rate. In 2016 more than 330,000 refugees and migrants reached Italy and Greece with over 4,200 being found dead or reported missing at sea, compared to 3,771 in 2015.
The health systems in countries receiving refugees and migrants should be able to deal with the immediate health needs of new arrivals, as well as diagnose and treat common infectious diseases and noncommunicable illnesses. They should have effective disease surveillance and reporting systems in place to investigate and respond to outbreaks.
WHO has launched the first ever European Knowledge Hub on Health and Migration to support the work of those who deal directly with the health aspects of migration, serving as a repository for scientific evidence on the subject. It will act as a learning platform for all stakeholders working in the field of migration and health, including policy-makers, health professionals, social workers, managers of migration centres and first-line responders.
More information about Migrants and Health on the euro.who.int website
Across Europe, 16 patients die every day waiting for the organs they need. However, there were over 800 more organ transplants in the EU in 2015, compared to 2014. This confirms an encouraging trend, with over 4000 additional transplants over 5 years, a 14% increase compared with 2010.
The ‘EU Action Plan on Organ Donation and Transplantation‘ has promoted training, cross-border exchange and sharing of best practices between Member States. Through the Public Health Programme, the Commission has co-funded several European projects to give practical support to Member States to help them improve their donation programmes.
In addition, a recently developed IT tool has been used to offer organs not allocated in their home country, enabling 23 transplants to take place during the pilot phase, mainly in children; that otherwise would not have been possible.
Read more about Organ Donation and Transplant from the ec.europa.eu website