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, 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
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 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
Across OECD countries, pharmaceutical spending was around US$800 billion in 2013, accounting for about 20% of total health spending on average (hospital consumption and retail).
This paper ‘Pharmaceutical expenditure and policies: past trends and future challenges‘ examines the drivers of recent spending trends, highlighting differences across therapeutic classes. While the consumption of medicines continues to increase and to push pharmaceutical spending up, cost-containment policies and patent expiries of a number of top-selling products have exerted downward pressure on pharmaceutical expenditures in recent years.
The paper also looks at emerging challenges for policy makers in the management of pharmaceutical spending. The proliferation of high-cost specialty medicines will be a major driver of health spending growth in the coming years. While some of these medicines bring great benefits to patients, others provide only marginal improvements. This challenges the efficiency of pharmaceutical spending.
To download the paper on pharmaceutical expenditure from the oecd-ilibrary.org website
The European Medicines Agency (EMA) has produced a guide on the information the Agency publishes on centrally and non-centrally authorised medicines for human use.
Providing an overview of the range of documents produced by EMA during the life span of a medicine, the guide covers early development, through initial evaluation, adoption of positive or negative opinions, post-authorisation changes and safety reviews.
Details of types of EMA documents, their publication times and where to find them on the EMA’s website are listed in an easy-reference annex.
Stakeholders will also find best-practice advice enabling coordinated, consistent and timely communication activities to ensure that information on medicines is accurate and reaches interested parties on time.
To download the Guide on medicines for human use from the ema.europa.eu website
Endocrine disruptors are chemicals which impact on the hormone system of animals and humans. They have three cumulative characteristics: a hormonal function, an adverse effect, and a causality between the two.
There has been increasing interest in endocrine disruptors and the European Commission has produced a factsheet that answers some of the most common questions about these chemicals and their possible impact on human health and wellbeing.
For more information about endocrine disruptors on the europa.eu website