UN European coalition on health

The UN European coalition on health is a coordination mechanism focusing on the achievement of Sustainable Development Goal (SDG) 3 – to ensure healthy lives and promote well-being for all at all ages – in the pan-European Region, and of the health-related targets present in other SDGs.

At its initial meeting in 2016 the coalition identified four key workstreams to focus on:

  1. health throughout the life-course, with a focus on maternal and child health (contributing to SDG 3, 4, 5, 16);
  2. communicable diseases, with a focus on HIV and tuberculosis (contributing to SDG 3, 1, 6);
  3. universal health coverage, with a focus on medicines (contributing to SDG 3, 1, 5);
  4. migration, including aspects of emergencies (contributing to SDG 3, 1, 10, 11, 13).

For more information about the UN European coalition on health on the euro.who.int website

Guidance on endocrine disruptors

The European Food Safety Authority (EFSA) and the European Chemicals Agency (ECHA) are developing scientific guidance to enable identification of endocrine disruptors.

In 2016 the European Commission proposed science-based criteria for identifying endocrine disruptors in the context of EU legislation on pesticides and biocides. Discussions with Member States and experts are on-going and the criteria are expected to enter into force in 2017.

EFSA and ECHA, supported by the Commission’s Joint Research Centre, will produce an outline of the guidance that will be published and will provide information on the drafting and endorsement processes.

For more information on endocrine disruptors on the efsa.europa.eu website

Improving access to medicines

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

Healthcare workers as “Antibiotic Guardians”

Antibiotic resistance presents one of the biggest threats to global health and development today – and the threat is growing. On any given day, about 80,000 patients – or 1 in 18 patients in hospitals – in the EU have at least one health care associated infection according to estimates from the European Centre for Disease Prevention and Control (ECDC) and these are often difficult to treat because the microorganisms that cause them are resistant to antibiotics. These infections are estimated to result in 16 million extra days spent in hospital and 37,000 attributable deaths, as well as contributing to an additional 110,000 deaths a year. Annual financial losses are estimated at approximately €7 billion (direct costs only).

Health professionals – including general practitioners, nurses, hospital prescribers, dentists and pharmacists – can help prevent and control the spread of antibiotic resistance by following five key recommendations from WHO:

  • if you think a patient might need antibiotics, where possible test to confirm and find out which one;
  • only prescribe antibiotics when they are truly needed, according to current guidelines;
  • prescribe and dispense the right antibiotic at the right dose for the right duration;
  • prevent infections by using safe hygiene practices to ensure that your hands, instruments and environment are clean; and
  • keep your patients’ vaccinations up to date.

For more information about Antibiotic resistance on the euro.who.int website

Children’s medicines

Do you have an interest in safe medicines for children – as a parent, researcher or prescriber? If so, you are invited to participate in a stakeholder consultation launched by the European Commission. The aim is to gather real-life experiences and opinions on the Paediatric Regulation which came into force a decade ago and has three main objectives:

  • to ensure high-quality research into the development of medicines for children
  • to ensure that the majority of medicines used by children are specifically authorised for such use and so reduce the level of off-label use
  • to ensure the availability of high-quality information about medicines used by children.

The consultation is open until 20 February 2017.

More information about medicines for children and to contribute to the consultation on the ec.europa.eu website.

Monitoring medicine safety in the EU

Monitoring the safety of medicines throughout their life cycle (pharmacovigilance) is the responsibility of the European Medicines Agency (EMA) on behalf of Member States. The European Commission has published a report, accompanied by a detailed Staff Working document, describing the activities of the collaborative EU system for monitoring and controlling the safety of human medicines.

The aim of EU rules on pharmacovigilance is to monitor the safety of medicines so that regulators can take action to reduce the risks and increase the benefits of medicines for human use. The role of individual EU countries is to monitor medicine safety data, assess signals of possible emerging side effects, and analyse the data when a safety issue is identified at European level. EMA has a central role in the EU system of pharmacovigilance as it coordinates the activities of an EU regulatory network of over 30 national competent authorities, and provides technical, regulatory and scientific support.

The report concludes that the European pharmacovigilance network is an example of successful cooperation at EU level which directly benefits patients. The networked system engages stakeholders (including healthcare professionals and patients) who can report suspected side effects directly. It operates with a high degree of transparency and ensures that EU medicines remain safe and effective and that accurate information on the safety of medicines reaches the public in a timely fashion.

Download the staff working document and report on pharmacovigilance from the ec.europa.eu website

Training in medicine pricing policies

A summer school on pharmaceutical pricing – the first of its kind – helped train high-level civil servants in the WHO European Region responsible for shaping and implementing policies on pricing medicines.

The Austrian Health Institute organized the five-day course, which ran from the 29th August to 2nd September, and 36 participants from 20 countries learnt about medicine pricing across Europe, funding and reimbursement models, methods for comparing and analysing prices, and the benefits and limitations of various policies.

For more information on the course and pharmaceutical pricing on the euro.who.int website

China tackles antimicrobial resistance

China, the world’s largest consumer of human and animal antibiotics, has pledged to step up research and development into new antimicrobials and to rein in overuse of existing medicines to counter growing global antimicrobial resistance.

As part of a national action plan unveiled on 26 August, the Chinese central government said that it would mobilize the efforts of 14 ministries and departments including health, food and drugs, and agriculture. By 2020, the government aims to develop new antimicrobials, make sales of the drugs by prescription only, ramp up surveillance of human and veterinary usage, and increase training and education for both medical professionals and consumers on their proper use.

For more information about China and AMR on the sciencemag.org website

 

Antibiotic drug discovery

Antimicrobial resistance is a global crisis that threatens public health and modern medicine. The discovery and development of novel antibiotic products are critical components in combating it. Many international, EU and national initiatives address the scientific, regulatory and economic barriers to antibiotic innovation. This study identifies, reviews and critically assesses these initiatives, and provides policy recommendations for improving the global and European agendas for research and development of antibiotics.

To download the report on antibiotic drug discovery and development from the euro.who.int website

The EU pharmacovigilance system

The European Commission has published a report on activities by Member States and the European Medicines Agency (EMA), to monitor the safety of medicines throughout their life cycle (a process called ‘pharmacovigilance’).

The aim of EU rules on pharmacovigilance is to monitor the safety of medicines so that regulators can take action to reduce the risks and increase the benefits of medicines for human use. The role of individual EU countries is to monitor medicine safety data, assess signals of possible emerging side effects, and analyse the data when a safety issue is identified at European level. EMA has a central role in this pharmacovigilance as it coordinates the activities of an EU regulatory network of over 30 national competent authorities, and provides technical, regulatory and scientific support.

The report concludes that the European pharmacovigilance network is an example of successful cooperation at EU level which directly benefits patients. The networked system engages stakeholders, including healthcare professionals and patients – who can report suspected side effects directly. It operates with a high degree of transparency and ensures that EU medicines remain safe and effective and that accurate information on the safety of medicines reaches the public in a timely fashion.

Work is underway on improving the system’s infrastructure, and on simplifying and streamlining existing processes where possible, to minimise the administrative burden for all stakeholders.

To download the full report on pharmacovigilance on the ec.europa.eu website