



Biologic medicines have revolutionised the management of many serious diseases over the last three decades. However, the potential of biologic medicines has not been fully realised, as many patients who could benefit from these state-of-the-art treatments do not have real access to them.
Biologic medicines have revolutionised the management of many serious diseases over the last three decades. Unfortunately, the potential of biologic medicines has not been fully realised, as many who would benefit from these state-of-the-art treatments cannot effectively access them. A key driver of this limited availability is the increasing struggle to finance new medicines within healthcare systems. I have talked with so many passionate people – patients, physicians, experts – who face this reality every day. We have to work together to overcome this hurdle, and ensure patients have access to the treatments they need.
The statistics are truly disturbing, with an annual death toll of around 100,000 from falsified and counterfeit medicines, according to the European Commission, and a criminal enterprise that the World Customs Organisation estimates could generate £1bn worth of illicit business in 2017.
But industry and regulatory authorities are fighting back with new measures to identify rogue shipments and coordinated action to disrupt the supply lines that criss-cross the globe.
The trend to seek medical aid online has made it easy for bogus medicines – containing anything from paint and antifreeze to brick dust and floor wax – to be mailed around the world. The Alliance for Safe Online Pharmacy in the EU (ASOP EU) warns that 130 million people in Europe are risking their health by ordering from the 30,000 illegal pharmacy websites that have flooded the Internet.
LONDON, Oct 18 (APM) – European countries should promote greater use of generics and biosimilars, as well as adopting drug price-control policies to meet long-term care costs, a report advises.
Unveiled late last week, the European Commission’s ‘Joint Report on Health Care and Long-Term Care Systems and Fiscal Sustainability’, prepared by the Commission Services (Directorate-General for Economic and Financial Affairs) and the Economic Policy
Committee (Ageing Working Group), sets out a series of recommendations to promote use of cheaper drugs and ensure there are sufficient numbers of carers in Europe’s ageing population.
In general terms, volume 1 says getting more value for money is key to ensuring long-term access, quality and financial sustainability of healthcare systems.
“By encouraging policies realising better value for money governments can achieve greater efficiency,” it added.
Health systems in Europe also need to do more to foster health promotion and disease prevention, it said.
European countries’ policies should focus on the “affordability of medicines”, the report said, while emphasising promotion of the use of “generics and biosimilars, appropriate pricing and price-control policies, promoting rational use of medicines”.
More incentives need to be put in place affecting the whole value chain from manufacturers to distributors, it said.
“Enhanced ways of cross-country cooperation should be explored further and enhanced,” the report added.
It said competition should be encouraged in pharmaceuticals, pharmacy distribution and diagnostic services.
In addition, data should be generated to compare performance across service providers “as well as health outcomes within and across countries and as an essential tool to support governance”.
Away from drugs, the report said long-term care systems should provide older people with adequate care that responds to their level of need and prevents them and their relatives from “falling into financial deprivation due to the high financial burden of paying for care”.
It added: “With rapidly growing long-term care needs, EU member states need to prioritise the use of public long-term care funds in order to ensure goals are met without endangering long-term fiscal sustainability.”
The second volume of the report describes the healthcare and long-term care systems of all EU countries on a country basis and presents the related policy challenges.
Medicines for Europe said it welcomed the report. In its statement, it said increased use of generic and biosimilar medicines in medical practice is a central policy option put forward to increase the health status of the European population without necessarily increasing expenditure.
The report highlights the need for policy action to safeguard and sustain the contribution of healthcare and long-term care systems to improve population health, it said.
Several recommendations are presented in order to get more value for money, ensure access to medicines and increase the cost-effectiveness of healthcare and long-term care services.
“Generic and biosimilar medicines in particular have a pivotal role to play in this process,” it added.
Adrian van den Hoven, Medicines for Europe Director General said: “This report once again underlines the important role of generic and biosimilar medicines for sustainable healthcare.
“Medicines for Europe and its national association members are ready to partner with the EU and member states to develop the most effective policies to increase access to generic and biosimilar medicines.”
Medicines for Europe began over 20 years ago as the European Generics Medicines Association (EGA) with the goal of representing the emerging generic industry, later growing to include biosimilar medicines to its portfolio.
by Guillaume Bietry
PARIS, July 20 (APM) – Generics and biosimilars body Medicines for Europe is campaigning for a smaller price difference between biosimilars and their originator drugs than that between generics and their branded equivalents, president Jacek Glinka has told APM.
About 20 biosimilars have been approved in Europe since 2006, but the optimal price difference – which would bring maximum savings while keeping the market attractive and competitive – is still under discussion.
Manufacturers’ viewpoints diverge, with some ready to accept a bigger discount than that for generics (60% in France) while others would prefer 20%-30%.
Novartis, one of the main players on the market via its subsidiary Sandoz, considers that biosimilars could be 75% cheaper than their reference drugs, saying that whatever might be lost in price terms would be compensated for by volume.
by Guillaume Bietry
PARIS, July 20 (APM) – European generics manufacturers want the French government to take more measures to encourage the development of a market that lags considerably behind those in other countries, the president of industry body Medicines for Europe Jacek Glinka has told APM.
While the generic penetration rate for Europe as a whole works out at between 50% and 60% of volumes consumed, in France it is around 30%, 20 years after this key way to reduce health insurance expenditure was written into the public health code.
According to the authorities, just over three boxes of reimbursed drugs in every 10 are generics, compared with three out of every four in Germany and the UK.
For the manufacturers, the French situation is due to successive price cuts, which reduce generics manufacturers’ means of promoting their products, and to doctors’ and patients’ lack of confidence in generics, whose efficacy and quality are regularly brought into question.
Glinka said that the authorities do not sufficiently encourage the development of the market.
European Pharmaceutical Review – VOLUME 21 ISSUE 3 2016
“Understanding the financial implications of the upcoming falsified medicines regulations” – Maarten Van Baelen and Johan Verhaeghe