Tracing donated tissue and cells

The EU has recently launched a Coding Platform to support healthcare professionals and national authorities in tracing donated tissues and cells from donor to recipient in the entire EU. The EU Directive on standards for quality and safety of human tissues and cells sets standards for tissues and cells such as bone marrow, reproductive cells, corneas, skin, etc., that are used within the EU and which will be identified by a Single European Code (SEC).

This SEC is an important tool for better patient safety as it enables the tracing of tissues and cells along the supply chain – from the donor to the patient receiving it. In case of a quality or safety issue, it allows appropriate action, including – where necessary, withdrawing or recalling all tissues and cells from the same donor, to be taken quickly. The EU Coding Platform contains information on all 2800 tissue establishments authorised in the EU as well as categories of tissue and cell product codes. It provides users with a free, simple and efficient tool, to build their SEC for a tissues and cells product, and takes into account the needs of small-sized and not-for-profit tissue establishments.

For more information about the Single European Code on the webgate.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

Digitising European public services

Delivering on its Strategy to create a Digital Single Market, the European Commission has developed plans to help European industry, SMEs, researchers and public authorities make the most of new technologies.

It has created a set of measures to support and link up national initiatives for the digitisation of industry and related services across all sectors and to boost investment through strategic partnerships and networks. It also proposes concrete measures to speed up the development of common standards in priority areas, such as 5G communication networks or cybersecurity, and to modernise public services.

The Commission will also set up a European cloud that will give Europe’s 1.7 million researchers and 70 million science and technology professionals a virtual environment to store, manage, analyse and re-use a massive amount of research data.

People and businesses are still not reaping the full benefit from digital public services that should be available seamlessly across the EU. The Commission has developed an e-government action plan that will modernise digital public services and make the EU a better place to live, work and invest. It has suggested 20 measures to be launched by the end of 2017, including a digital single gateway to help users operate across borders and a cross border e-health service.

Find more information about the Digitising of European Industry on the europa.eu website

UK-based researchers benefit from latest EU funding

Fifty-nine UK-based researchers are to receive up to €1.5 million (£1.3m) each to set up their own research teams and pursue ground-breaking ideas under the EU’s European Research Council (ERC) latest round of starting grants. These grants come from the ‘excellent science’ pillar of Horizon 2020, the EU’s research and innovation programme.

The UK is the second biggest beneficiary of this round after Germany who is hosting 61 beneficiaries.

The ERC offers three core grant schemes:

  • Starting grants encourage young talented research leaders to gain independence in Europe and to build their own careers.
  • Consolidator grants back up researchers who want to establish their research teams and continue developing a successful career in Europe.
  • Advanced grants allow outstanding research leaders to pursue ground-breaking, high-risk projects in Europe. The scheme targets researchers who have already established themselves as top independent research leaders.

More information about EU grants for research can be found on the ec.europa.eu 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

Breast cancer care

Breast cancer is the most common cancer in Europe.
It is the most deadly cancer in women: one out of every six women with cancer will die from breast cancer.
In addition, incidence and mortality rates for breast cancer vary widely between countries: although a higher mortality rate in some countries may be due to a higher incidence rate, in others it is due to a lower rate of survival. This reflects major inequalities, including diverse quality of care.
The European Commission Initiative on Breast Cancer is a person-centred, sustainable initiative aimed at improving and harmonising breast cancer care across Europe. It will include training templates and a platform of guidelines.
To download the leaflet on the Initiative on Breast Cancer from the ecibc.jrc.ec.europa.eu website

Ex smokers are unstoppable

The European Commission’s 3-year initiative ‘Ex-smokers are unstoppable’ has now finished but it proved enormously successful with one in three of the 480,000 registered users stopping smoking after three months.

The centre-piece of the programme was the iCoach, a digital health coach which was free and available both online and as a mobile app for Apple and Android devices in 23 languages.

It guided users through five progressive phases to quit smoking but also incorporated several personal, phase-specific challenges e.g.

  • Keep track of how many cigarettes you smoke a day as you may be underestimating your habit
  • Postpone the “nicest” cigarette of the day 10 times for 10 minutes and then for 20 minutes
  • Leave your cigarettes at home when you need to run a short errand

These challenges enabled users to set themselves small, attainable goals which once achieved, encouraged them to take on further challenges and gain control over their habit.

To read more about ‘Ex-smokers are unstoppable‘ on the ec.europa.eu website

Investing in innovative health solutions

The health sector represents 10% of the EU’s GDP and accounts for 8% of the total European workforce.
It is a vital economic sector strongly driven by innovation and is a growth-friendly area for investment.
The European Fund for Strategic Investments (EFSI) can support investment in innovative health solutions, new effective medicines and social infrastructures. Examples of investment include:
  • Spain: €100 million for research and development to improve medical treatment for conditions including Alzheimer’s, vascular and cardiovascular surgery.
  • UK: €148 million towards the construction of a new teaching hospital in a brown field site.
  • Ireland: €70 million towards the construction of new primary healthcare centres across Ireland.

For more information about funds for investment in innovative health solutions on the ec.europa.eu website

Need for greater EU action on antimicrobial resistance

Global consumption of antibiotics in human medicine rose by nearly 40% in the decade from 2000 and in 2007 25,000 people a year in the EU were dying from an infection due to antibiotic-resistant bacteria.

Infections due to these multi-drug resistant bacteria are estimated to cost the EU at least €1.5 billion a year in extra healthcare costs and lost productivity. If current trends continue, over the next 35 years 300 million people worldwide are expected to die prematurely because of drug resistance.

As part of its wider strategy to combat antimicrobial resistance (AMR), the European Commission has published a Special Eurobarometer survey, showing a decrease of 6% in the consumption of antibiotics but at the same time a persistent lack of awareness on their effects.

According to the report, over a third of Europeans took antibiotics in the twelve months preceding the survey, yet 57% of Europeans were unaware that antibiotics are ineffective against viruses. The survey clearly demonstrates that there exists a direct link between better information and lower consumption.

For more information on EU action on antimicrobial resistance on the ec.europa.eu website