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 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 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 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 website

Pharmaceutical Expenditure And Policies

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 website

Information on human medicines

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 website

Endocrine disruptors

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 website

Access to affordable medicines

The European Public Health Alliance (EPHA) strongly supports the President of the EU’s critique of the current over-protection and misuse of intellectual property and related rights for pharmaceuticals, and its goal to better balance the reward for innovation against the assurance of affordability of medicines.

Additional market exclusivity, data exclusivity, and supplementary protection certificates (SPCs) that add to the internationally-agreed 20-year period of patent protection will delay price-lowering generic competition. Generic competition has proved central to cost containment everywhere, including Europe and the impact of these proposed additional protections must be properly analysed.

Without transparency of the R&D costs to originator companies and information on the actual prices paid for medicines across EU Member States, any discussion about fair medicine prices remains impossible. Ultimately, the current monopoly-based model of biomedical innovation steers research priorities away from the greatest health needs towards areas with the highest potential profitability.

To read the full article on access to affordable medicines on the website

Polio vaccine switch

Every country that was using trivalent oral polio vaccine (OPV) (containing all three serotypes of poliovirus) has permanently withdrawn this vaccine and either replaced it with bivalent OPV – containing only types 1 and 3 – or moved to an immunization schedule with only the inactivated form of polio vaccine (IPV).

Wild poliovirus type 2 has not been circulating since 1999 and was declared eradicated in September 2015. Removal of this eradicated serotype from the vaccine will further reduce the rare risk that a type 2 vaccine-derived poliovirus will emerge. The type 2 component of trivalent OPV also interferes with the immune response to poliovirus types 1 and 3.

For more information about the Polio Eradication Plan on the website


Health becomes a trade secret

The European Parliament has approved a new Directive on Trade Secrets which, according to the European Public Health Alliance (EPHA) means that trade secrets will outweigh the public interest. EPHA believes there will be a negative impact on health as information on the safety of medicines will be considered commercially confidential and kept secret from patients, regulators and the public.The Trade Secrets Law would gag journalists and whistle-blowers, undermining freedom of expression and preventing vital information reaching the media and public. With regard to public health, the new rules would erect a barrier to public access to data on the safety and efficacy of medicines.

The proposals for the Trade Secrets Directive are clearly intended to increase commercial confidentiality in the interest of drug makers who seek to keep clinical trials results secret, and would weaken patient safety protection and halt further research and independent analyses.

For more information about the Directive on Trade Secrets on the website