Improving understanding of biosimilars 

The European Medicines Agency (EMA) has published additional information on biosimilar medicines, as part of their ongoing work to improve understanding of biosimilars across the EU. A biosimilar is a biological medicine that is highly similar in all essential aspects to a ‘reference’ biological medicine already authorised.

The new material includes an animated video for patients that explains key facts on biosimilar medicines and how EMA works to ensure that they are as safe and effective as their reference biological medicines.

For more information on biosimilars 

 

Pharmaceutical spending

Pharmaceutical spending accounts for approximately 20% of total health spending in OECD countries when taking into account medicines dispensed in both outpatient and inpatient settings of care. Recent developments in the pharmaceutical market and spending raise concerns for the future:

  • Spending has become increasingly skewed toward high-cost “specialty medicines” which now account for between 30% and 50% of spend and this percentage will increase in future
  • Launch prices of new medicines have been soaring in some therapeutic categories – in the US the prices of new cancer medicines now typically exceed USD 10,000 per month and one was launched at USD 64,000 per month. The prices of orphan medicines are also very high
  • New hepatitis C treatments, which represent a real breakthrough for patients, have been launched at a list price of up to USD 84,000. They were assessed as cost-effective at this price although the company recouped 25 times the initial outlay in R&D in less than two years

The OECD is preparing a study that will focus on therapeutic areas where new medicines are very costly and/or have a high budget impact for health systems, such as oncology, rare diseases, HIV, Hepatitis C, diabetes and Alzheimer’s disease. The overall objective is to improve patient access to innovative treatments and ensure the sustainability of health spending as well as continued innovation that meets patient needs.

To read more about the study on the OECD website, go to: Pharmaceuticals 

How Pharmaceutical Systems are organized in Asia and the Pacific 

There are important differences in the markets for medicines in countries in Asia and the Pacific in this study. These are mainly due to the political, financial and regulatory environments as well as characteristics of the pharmaceutical manufacturing industry. However, all countries face the test of transition brought about by demographic changes, shifting epidemiological trends and increasing inequities, among others. As with other regions of the world, a characteristic of lower- and upper-middle-income countries is that pharmaceuticals account for a high proportion of health expenditures. Medicines account for a larger share of the health budgets in resource-constrained countries.

To read more about pharmaceutical systems in Asia and the Pacific go to: How Pharmaceutical Systems are organized in Asia and the Pacific – en – OECD

EU/US collaboration on medicines and tobacco

Senior officials from the European Commission (EC), together with the European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA) held their 2018 bilateral meeting in Brussels, Belgium, on 18 and 19 June. The two-day bilateral regulatory dialogue allowed the strategic partners to review their ongoing cooperative initiatives, discuss strategic priorities for the coming years and further strengthen the continuous close collaboration with specific action in the field of pharmaceuticals.

To read more about the outcomes of this meeting go to:

http://ec.europa.eu/newsroom/sante/newsletter-specific-archive-issue.cfm?archtype=specific&newsletter_service_id=327&newsletter_issue_id=9457&page=1&fullDate=Fri%2022%20Jun%202018&lang=default

Falsified medicines

Falsified medicines are often disguised as authentic medicines but may contain ingredients of bad or toxic quality, or in the wrong dosage. As they have not been properly checked for quality, safety and efficacy, as required by strict EU authorisation, they can pose a real risk to your health. As falsified medicines become more sophisticated, the risk of them reaching patients in the EU increases. They represent a serious threat to global health and call for a comprehensive strategy both at European and International level.

To read more about Falsified medicines on the European Commission website go to: Falsified medicines – European Commission

Pharmaceutical companies and Brexit

Regulatory guidance for pharmaceutical companies to prepare for UK’s withdrawal from EU:

The European Medicines Agency and the European Commission have published additional guidance to help pharmaceutical companies prepare for the United Kingdom’s withdrawal from the European Union.

Companies are reminded to plan in advance for the situation that the United Kingdom  will leave the EU on 29 March 2019 in order to avoid any impact on the continuous supply of medicines for human and veterinary use within the EU.

To access this guidance go to: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2017/12/news_detail_002864.jsp&mid=WC0b01ac058004d5c1

Medicine packaging

Since 2001, EU rules have required the medicines we buy in the EU to contain a package leaflet which should provide us – the user, with clear information on the medicines we are taking – including the name of the product and the manufacturer, therapeutic indications, dosage, shelf life and adverse reactions.

The Commission has recently put forward recommendations on how they could be improved to better meet the needs of patients and healthcare professionals.

To read the recommendations on improved medicine packaging on the ec.europa.eu website

Health care without harm

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.
To download the summary report on health care without harm from the ec.europa.eu website

Pharmacovigilance

All medicinal products in the EU are subject to a strict testing and assessment of their quality, efficacy and safety before being authorised. Once placed on the market they continue to be monitored to ensure that any aspect which could impact the safety profile of a medicine is detected and assessed and that necessary measures are taken. This monitoring is called pharmacovigilance.

Pharmacovigilance activities include:

  • Collecting and managing data on the safety of medicines.
  • Looking at the data to detect “signals” (any new or changing safety issue).
  • Evaluating the data and making decisions with regard to safety issues.
  • Pro-active risk management to minimise any potential risk associated with the use of the medicine.
  • Acting to protect public health (including regulatory action).
  • Communicating with and informing stakeholders and the public.
  • Audit, both of the outcomes of action taken and of the key processes involved.

For more information about pharmacovigilance on the ec.europa.eu website

New approach needed to tackle rising drug prices

The proliferation of high-cost medicines and rising drug prices are increasing pressures on public health spending and calling into question the pharmaceutical industry’s pricing strategies.

According to a new report from the OECD, ‘ New Health Technologies: Managing Access, Value and Sustainability’, pharmaceutical spending is increasingly skewed towards high-cost products. The launch prices of drugs for cancer and rare diseases are rising, sometimes without a commensurate increase in health benefits for patients. For instance in the United States the launch price of oncology drugs per life-year gained has been multiplied by four in less than 20 years and now exceeds $200,000.

For more information on Pharmaceutical Price Rises on the oecd.org website