Medicines for Europe assessed the publication of the report ‘Health at a Glance 2016’ launched yesterday prepared by the OECD for the European Commission. The report acknowledges that the development of generic medicines markets increases efficiency in pharmaceutical spending, however it focusses on short term cost-containment rather than taking into account access to medicines and the long-term sustainability of healthcare. Generic cost-containment policies have had no significant impact on overall healthcare budgets as the expenditure for generic medicines is only 2-3%. On the other hand, as underlined by the German Pharma Dialogue, cost-containment measures such as tendering significantly increase the risk of medicines shortages that ultimately undermine patient health. The most extreme examples of medicines shortages in Europe are found in countries with unsustainable pharmaceutical pricing policies such as Romania, where the combination of external reference pricing, price linkage and clawback have led to the withdrawal of 2000 medicines and chronic shortages of inexpensive medicines.
Regrettably, the OECD report does not underline the importance of timely availability of generics and biosimilar medicines in order to facilitate patient access to pharmaceutical therapies and to improve the sustainability of national health systems , which would be in line with the Council conclusions and the ‘Joint Report on Health Care and Long-Term Care Systems & Fiscal Sustainability’. Aside from financially incentivising prescribers, pharmacists and patients, policies should be put in place to reduce time to market and to educate the population on the quality, safety and efficacy of generic medicines and their equivalence to originator medicines. Furthermore, it is important to emphasise the relevance of putting in place key policy measures to increase the use of biosimilar medicines which play a key role in increasing patient access and in the long-term sustainability of healthcare systems.
Adrian van den Hoven, Medicines for Europe Director General commented: “The State of Health in the EU cycle is an important platform to support health policies in EU countries. We encourage the Commission to focus on generic, biosimilar and value-added medicine policies that increase access to medicines for patients rather than short term and counterproductive cost containment measures. Our medicines are developed and manufactured to serve patient needs not austerity policies”.
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.
Summit to Provide Insight into Cost-Effective Compliance with Track & Trace Mandates for Pharma Contract Organizations in Europe & U.S.
Princeton, NJ – Supply Chain Wizard – a leading full-service global consulting firm specializing in serialization and traceability, as well as supply chain strategy and operational transformation programs – is co-hosting the Pharma CMO Summit on December 12, 2016 at the Ramada Hotel Alexanderplatz in Berlin. Titled Preparing Pharmaceutical CMOs & CPOs for Cost-Effective Serialization Compliance, the event will bring together manufacturers, CMOs, CPOs, 3PLs and solution providers for a full day of education and networking around the theme of making real progress toward serialization compliance.
The event is co-hosted with Medicines for Europe (formerly European Generics Association), an organization serving as the voice of Europe’s generic, biosimilar and value-added medicines industries. The December 12 gathering is the latest iteration in a series of such summits initiated by Supply Chain Wizard. Pharmaceutical industry professionals can register for the conference by visiting www.pharmacmosummit.com.
The goal of the event is to address the serious challenges presented by upcoming global serialization mandates, especially those in Europe and the United States. The day-long event will feature keynote addresses on major topics in serialization, along with panel discussions, breakout networking and roundtable sessions. Speakers and workshops will provide manufacturers and CMOs with strategies, processes and tools to prepare for serialization compliance and integration.
The event’s esteemed roster of sponsors speaks to the summit’s overall heft: The list includes Abbott, Teva and other leading pharmaceutical manufacturers. Solution providers will share best IT and packaging technologies, processes and tools for streamlining and enhancing serialization implementation. In addition, the conference will present opportunities for hands-on serialization learning activities, and will stress the sharing of content and experience among participants – a concept often seen as challenging in a largely close-to-the-vest pharmaceutical culture.
Another highlight of the event – one in which Supply Chain Wizard is particularly well-versed – is the opportunities for enhanced business practices through data analytics offered by optimized serialization systems. It is, according to the company, an instance where regulations once deemed onerous are opening doors to smarter manufacturing and supply chain operations.
“The exchange of knowledge this event will facilitate is the cornerstone of its success,” said Evren Ozkaya, founder and CEO of Supply Chain Wizard. “By bringing together multiple perspectives, and sharing both successes and struggles, we are confident attendees will leave this conference with a better understanding of what is needed to assure compliance with looming serialization mandates, and to effectively utilize the resulting data these new processes and systems will provide.”
About Supply Chain Wizard
Supply Chain Wizard, LLC, is a leading full-service global consulting firm specializing in serialization and traceability, as well as supply chain strategy and operational transformation programs. Dedicated to optimizing operations for growth, service and efficiency, Supply Chain Wizard offers strategic innovations in products and services targeting serialization and supply chain transformation initiatives, along with a team of expert consultants providing comprehensive support toward cost-effective compliance with serialization mandates and post-go-live operational support.
Supply Chain Wizard organizes serialization roundtables, summits and training programs throughout Europe, Asia Pacific and the United States, and runs frequent webinars to support clients with their regulatory and compliance challenges. Committed to helping clients maintain significant and sustainable performance improvements, Supply Chain Wizard guides customers to a more secure supply chain via the implementation of high return-on-investment initiatives.
Supply Chain Wizard is headquartered in Princeton, NJ, with additional offices in Germany, Turkey and India. For more information, please visit www.supplychainwizard.com.
Medicines for Europe welcomes the publication of the ‘Joint Report on Health Care and Long-Term Care Systems & Fiscal Sustainability’ prepared by DG ECFIN[1] and the Economic Policy Committee (Ageing Working Group). The report presents policy challenges for healthcare and long-term care, and options on how to contain spending pressures through efficiency gains, in order to ensure fiscally sustainable access to good quality services for all. 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. 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.
Adrian van den Hoven, Medicines for Europe Director General commented: “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”.
[1] The European Commission’s Directorate-General for Economic and Financial Affairs
Medicines for Europe Communications:
Doris Casares doris@medicinesforeurope.com
Andrea Bedorin abedorin@medicinesforeurope.com
Medicines for Europe strongly supports the French government campaign to boost generic medicines. Thanks to generic medicines, in Europe twice as many patients in 7 key therapeutic areas[1] (diabetes, depression, epilepsy, cardiovascular disease, hypertension, asthma/COPD, gastro-intestinal disease) have been able to be treated over the last ten years with no impact on overall treatment costs. Nowadays, generic medicines account for 35% of all dispensed medicines in France but account for only 18% of the pharmaceutical expenditure. Generic medicines contribute significantly to healthcare in France by ensuring greater access to medicines for patients and offering more options to healthcare professionals to treat their patients.
The French campaign is displayed through a website and will use communications platforms as social media, television, radio, posters in pharmacies and newspapers with a special section open to questions on generic medicines coming from citizens. The campaign is part of a wider generic strategy which should also stimulate generic prescribing by physicians in both general practice and the hospital setting.
Adrian van den Hoven, Director General at Medicines for Europe commented on the campaign: “France has one of the lowest generic market shares in Europe. We therefore strongly support this first step in the implementation of the French « Plan Générique ». All measures in the «Plan Générique » should now be rapidly implemented – especially the incentives for physicians to prescribe within the substitution list (« Répertoire ») to ensure access to medicines for French patients and to contribute to a more sustainable healthcare budget ”.
[1] IMS Institute for Healthcare Informatics Report The role of generic medicines in sustaining healthcare systems: a European perspective: https://www.medicinesforeurope.com/2015/06/01/ims-health-2015-the-role-of-generic-medicines-in-sustaining-healthcare-systems-a-european-perspective-june-2015/
Lisbon, September 28, 2016 – Without the use of generic medicines, European countries would spend a hundred billion euros more per year to treat patients. This is one of the conclusions of the IMS Institute for Healthcare Informatics study on The Role of Generic Medicines in Sustaining Healthcare Systems: A European Perspective presented today in Portugal during the seminar “The Value of Generic Medicines”, organised by APOGEN.
The study concluded that by 2050 the European population aged over 65 will increase from 129 to 191 million, with a consequent increase in the incidence of chronic diseases and the corresponding impact on the health expense of states. Between 2005 and 2014, generic medicines made it possible for European countries to double the number of patients treated, whilst maintaining the same pharmaceutical budget.
The study Value of Generic Medicines – Health Economics Study conducted by IGES Institute for Medicines for Europe also presented, concludes also that with the use of generic medicines, it is possible to treat a considerably a greater number of patients suffering from hypertension maintaining the same levels of expenditure; treat as many patients with breast cancer with lower levels of expenditure and treat more patients suffering from depression, with a slight increase in expense.
The seminar was attended by national and international experts as Adrian van den Hoven, Medicines for Europe Director General, António Vaz Carneiro, Professor, Faculty of Medicine of Lisbon and Director of CEMBE, Carlos Gouveia Pinto, Associate Professor of ISEG, Hélder Mota Filipe, member of the Board of INFARMED, IP or Paul Lilaia, President of APOGEN.
“APOGEN’s mission is to disseminate the concepts of generic and biosimilar medicines, actively contributing to the development of this market segment in Portugal, making medicines more affordable, in a sustainable health system” says Paul Lilaia, President of APOGEN. “The presentation of these two studies concludes that generic medicines bring great benefits for patients and for European states to increase patient access to treatment and simultaneously decrease the expense of the states with medicines.”
Adrian van den Hoven, Medicines for Europe Director General highlighted that “IMS report confirms the efforts by generic manufacturers to invest to bring better access for patients and more sustainability to pharmaceutical markets in Portugal and across Europe. Over the last ten years, generic medicines have increased access to medicines by over 100% in 7 key therapeutic areas without increasing the overall treatment cost. Millions of European patients have benefited from better access to gold standard therapies, treating most acute and chronic ailments ranging from cardiovascular, to diabetes and even to cancer”.
Also worth noting that the generic medicines industry employs more than 160,000 people in Europe and generic medicines already represent today 56 percent of the medicines prescribed in Europe.
Medicines for Europe will engage rapidly with Health Ministers across Europe to implement the Health Council Conclusions on “strengthening the balance in the pharmaceutical system in the EU and its Member States”. The Conclusions underline the importance of the timely availability of generics and biosimilar medicines to improve patient access to therapy and to ensure the sustainability of national health systems. Value added medicines should also be included in this process as they can also contribute significantly to the efficiency of health systems while stimulating more competition between pharmaceutical innovation models.
Adrian van den Hoven, Medicines for Europe Director General, commented on the conclusions: “Member States have now understood the importance of stimulating competition in pharmaceuticals after patent expiry to help rebalance a market heavily impacted by the introduction of new highly priced patent protected medicines. Our members are ready to drive this agenda forward to ensure better access for better health”.
Medicines for Europe strategy to deliver better access for better health can contribute significantly to efficient and sustainable pharmaceutical policies. To strengthen the balance of the pharmaceutical market in Europe, Medicines for Europe calls for:
During the next two days, the key pharmaceutical industry leaders from the generic, biosimilar and value added medicines industries will meet in Dubrovnik to foster international partnership, cooperation and dialogue and discuss the most recent challenges of these industries for the future. With this year’s conference in Croatia, Medicines for Europe and the International Generic and Biosimilar Medicines Association (IGBA) celebrate their first joint event.
Amongst the key topics that will be tackled during the conference are the most important global challenges that the generic, biosimilar and value added medicines industries are facing today, such as the need to stimulate more competition in pharmaceutical markets, the trade and regulatory cooperation for better access, sustainable business models, improving the efficiency of healthcare systems and the stronger representation of the generic, biosimilar and value added industries in global fora regulating the pharmaceutical industry.
Jacek Glinka, Medicines for Europe President commented: “The impact of high cost new medicines on healthcare system sustainability is a concern for many healthcare policy-makers and advocacy groups. However, our industry is committed to delivering solutions that improve patient access to high quality medicines. We see this as an opportunity for our industry to provide leadership in the pharmaceutical market through an accessible innovation policy”.
Vivian Frittelli, IGBA Chair highlighted that “The majority of the world’s medicines in use today are generic medicines, while biosimilar medicines offer opportunities to treat millions more patients with biologic medicines and value added medicines are bringing sustainable innovation to all patients across the world”.
About IGBA
The International Generic and Biosimilar Medicines Association (IGBA) was founded as IGPA (International Generic Pharmaceutical Alliance) in March 1997 to strengthen cooperation between associations representing manufacturers of generic medicines. Its membership includes Medicines for Europe (Europe), the CGPA (Canada), the GPhA (USA), the JAPM (Jordan), the NAPM (South Africa), the TGPA (Taiwan) and the JGA (Japan) while the associations from Australia (GBMA), Brazil (ProGenericos) and Mexico (AMEGI) are Associate Members. The IGBA is at the forefront of stimulating competitiveness and innovation in the pharmaceutical sector by providing high quality pro-competitive medicines to millions of patients around the world. Through its constituent member associations, the IGBA maintains constant dialogue with government authorities (including the European Commission for Europe) as well as with international institutions such as WTO, WIPO and WHO. More information: www.igbamedicines.org