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
Presentation of the report “The Value of Generic Medicines”
GENERIC MEDICINES HAVE ENABLED TWICE AS MANY PATIENTS TO GET TREATMENT FOR THE SAME BUDGET
Generic medicines save European countries 100 billion euros per year
Rome, October 12, 2016 – Through generic medicine competition , twice as many patients were able to get treatment without any impact on the treatment cost, according to the conclusions of the IMS Institute for Healthcare Informatics study on The Role of Generic Medicines in Sustaining Healthcare Systems: A European and Italian Perspective presented today in Rome during the Assogenerici Public Assembly.
The Assembly was attended by high level officials from the Italian authorities, Medicines for Europe Executive members, and more than 200 participants ranging from patient groups, physician organisations, scientific groups and the main bodies of the Italian pharma supply chain. Ahead of the presentation of the study, the President of Assogenerici Enrique Häusermann commented: “Generic medicines bring great benefits for patients and enable European states to increase patient access to treatment while simultaneously decreasing expenditure”. This is especially important for Italy where out of pocket expenses for medicines can be high.
Generic medicines also drive economic development. Pierluigi Antonelli, Medicines for Europe Vice-President highlighted that: “The generics industry is a fundamental part of the future of the Italian and European healthcare systems and we have to be a central stakeholder in the light of the future challenges for our healthcare systems around Europe. Our industry is a significant contributor to economic growth, with major production located in Italy”.
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. The generic medicines industry employs more than 160,000 people in Europe and generic medicines today represent 56% of the medicines prescribed in Europe.
About ASSOGENERICI
Assogenerici is the official representative body of the Italian generic and biosimilar pharmaceutical industry. Formed in 1993, Assogenerici represents over 50 pharmaceutical companies and their subsidiaries. Companies represented within Assogenerici provide over 10,000 direct and indirect jobs in Italy and are operating with a manufacturing base of 37 plants located in Italy. Cost-effective generic and biosimilar medicines save Italian patients and healthcare systems over €400 million each year, thus helping to ensure patient access to essential medicines and providing urgently needed headroom for new and innovative treatments. Assogenerici plays an important consultative role in Italian healthcare policy-making. Assogenerici and its members work with Italian authorities to develop affordable solutions for pharmaceutical care and to increase Italy’s competitive strength in the global pharmaceutical medicines market.
Assogenerici Communications: Paola Marzoto p.marzotto@assogenerici.it
About MEDICINES FOR EUROPE
Medicines for Europe represents the generic, biosimilar and value added medicines industries across Europe. Its vision is to provide sustainable access to high quality medicines, based on 5 important pillars: patients, quality, value, sustainability and partnership. Its members employ 160,000 people at over 350 manufacturing and R&D sites in Europe, and invest up to 17% of their turnover in medical innovation. Medicines for Europe member companies across Europe are both increasing access to medicines and driving improved health outcomes. They play a key role in creating sustainable European healthcare systems by continuing to provide high quality, effective generic medicines, whilst also innovating to create new biosimilar medicines and bringing to market value added medicines, which deliver better health outcomes, greater efficiency and/or improved safety in the hospital setting for patients. For more information please follow us at www.medicinesforeurope.com and on Twitter @medicinesforEU.
Medicines for Europe Communications: Doris Casares doris@medicinesforeurope.com
The Value Added Medicines Group a sector group of Medicines for Europe, participated in the CPhI Pre-connect Conference today to promote greater access to medicines for patients across Europe. During the conference, Pieter Dylst, Senior Manager Market Access & Value Added Medicines at Medicines for Europe presented the new study Value Added Medicines: Rethink, Reinvent & Optimise Medicines: Improving Patient Health and Access. The report by Mondher Toumi, Professor of Public Health at Aix-Marseille University, identified several areas of healthcare inefficiencies in Europe. It highlights new opportunities for innovation, health improvements and budget efficiency but also identifies several barriers to the uptake of value added medicines. To ensure that all stakeholders concerned can access and take advantage of this innovation, we need clear market access pathways that recognise the benefits these medicines provide.
Christoph Stoller, Chair of the Value Added Medicines Group called on companies investing in this important innovation to join Medicines for Europe in improving medicine options for patients “We need to move from responding to sickness towards improving well-being, keeping people healthy, looking ahead and thinking in the widest sense about care that is holistic, efficient and effective. “We need more companies to join us in strengthening the dialogue with policy makers, payers, patients, and healthcare professionals to address the barriers to access so that patients can benefit from value added medicines.”
The Value Added Medicines Group is open to existing members of Medicines for Europe and new Medicines for Europe members (i.e. not already member of any Medicines for Europe sector group) interested in developing this industrial sector. For more information please contact: info@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 and GPhA (Generic Pharmaceutical Association) are committed to supporting positive developments of the negotiations for a TTIP agreement and in particular the single development of biosimilar and complex generic medicines and the regulatory cooperation on pharmaceuticals therein. The conclusion of a Mutual Recognition Agreement on Good Manufacturing Practices (GMP) inspections between the EU and US would strongly stimulate efficiency and help ensure the quality of medicines while removing unnecessary duplications for both the industry and regulators. A joint Medicines for Europe and GPhA delegation led by their top management and composed of member companies’ senior managers has made a round of meetings in Washington DC during last week on the negotiations for a Transatlantic Trade and Investment Partnership (TTIP). USTR, FDA, and several offices of Congress were amongst the visited US institutions.
Adrian van den Hoven, Medicines for Europe Director General, highlighted during this visit that: “We appreciate the efforts employed by the EMA and the European Commission and the FDA to further align on approval processes of generic and biosimilar medicines. This will speed up access to these medicines for patients in EU and the US, and allow the EU and US to play a leading role in international regulatory cooperation initiatives on pharmaceuticals”.
David Gaugh, Senior Vice President, Sciences and Regulatory Affairs, GPhA, said: “Improving regulatory coordination can avoid unnecessary duplication of product development, regulatory review, and approval efforts; as well as help alleviate significant delays in getting safe, effective and more affordable medicines to patients. GPhA continues to support a joint regulatory strategy where generic drug guidances and guidelines are coordinated and adopted by both the EU and the US regulatory authorities. For example, if generic drug manufacturers could follow a single development pathway it would expedite patient access and grow health system savings.”
Medicines for Europe represents the generic, biosimilar and value added medicines industries across Europe. Its vision is to provide sustainable access to high quality medicines, based on 5 important pillars: patients, quality, value, sustainability and partnership. Its members employ 160,000 people at over 350 manufacturing and R&D sites in Europe, and invest up to 17% of their turnover in medical innovation. Medicines for Europe member companies across Europe are both increasing access to medicines and driving improved health outcomes. They play a key role in creating sustainable European healthcare systems by continuing to provide high quality, effective generic medicines, whilst also innovating to create new biosimilar medicines and bringing to market value added medicines, which deliver better health outcomes, greater efficiency and/or improved safety in the hospital setting for patients. For more information please follow us at www.medicinesforeurope.com and on Twitter @medicinesforEU.
Medicines for Europe Communications:
Doris Casares doris@medicinesforeurope.com
Andrea Bedorin abedorin@medicinesforeurope.com
GPhA represents the manufacturers and distributors of finished generic pharmaceuticals, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals fill 88 percent of the prescriptions dispensed in the U.S. but consume just 28 percent of the total drug spending. Additional information is available at gphaonline.org. Follow us on Twitter: @gpha.
GPhA Communications:
Steve Arnoff sarnoff@gphaonline.org
Medicines for Europe is engaged to tackle antimicrobial resistance by:
As a signatory of the Davos Declaration we welcome the continued high level political focus on Antimicrobial Resistance (AMR). The high-level meeting convened on 21 September 2016 by the President of the UN General Assembly gathered key stakeholders in this unique public health, economic and scientific challenging situation. Medicines for Europe welcomes the UN’s Political Declaration and the global high-level political support to curb antimicrobial resistance.
We recognize the magnitude of the problem and are engaged with our members and stakeholders to support efforts to reduce the spread of antimicrobial resistance whilst ensuring patient access to life-saving antibiotics. An across-the-board multi-sectoral approach is crucial in addressing this global threat. In this context, we underline the importance of conserving the full range of existing antibiotics to ensure that all current medicine options remain on the table for healthcare practitioners to deal with this challenge.
Medicines for Europe strongly believes that improved access to existing antibiotics is essential and must be balanced with health system measures to ensure appropriate use. The most appropriate procurement mechanisms to facilitate affordable access to high-quality antibiotics must be explored in a joint collaboration. Furthermore, the pharmaceutical industry is committed to delivering medicines at the highest possible standards. The industry is engaged in addressing the environmental impact that our products and manufacturing have. We are notably developing the Eco-Pharmaco-Stewardship project, a proactive industry-wide EU initiative to provide safe, efficient and high quality medicines to meet patient needs while minimising the effect on the environment.
Adrian van den Hoven, Medicines for Europe Director General, highlighted that ”We have to make sure that existing and useful antibiotics remain in stock and can be used when doctors need them. Having access to a wide diversity of antibiotics helps slow down resistance. Yet more and more essential antibiotics are being removed from the market because current procurement systems in Europe are unsustainable. We need a serious discussion about maintaining Europe’s industrial capacity to sustainably supply our health needs. This is a shared responsibility of industry and health authorities. Our industry remains committed to the fight against AMR.”
Biosimilar medicines provide a tremendous opportunity for governments throughout Europe to increase patient access to treatment with modern biologic therapies while at the same time supporting the sustainability of healthcare budgets. These benefits will however only continue provided the biosimilar medicines market is developed in a sustainable way. The cornerstone of a sustainable biosimilar medicines market is the alignment of payers’ and manufacturers’ understanding of the benefits in both the short and long terms, a new report revealed today.
The research, undertaken by Simon Kucher & Partners on behalf of the Biosimilar Medicines Group, a Medicines for Europe sector group, takes a deep dive into biosimilar medicines pricing and market access policies across 7 European countries (DE, ES, FR, IT, NO, PL and the UK) and their impact on parameters such as biosimilar medicines use and price. Through a detailed analysis of today’s biosimilar medicines landscape, combined with interviews with payers, policy makers and industry representatives, Simon Kucher & Partners were able to develop principles supporting a sustainable biosimilar medicines market, taking into account the perspective of both payers and manufacturers.
Michael Dilger, Partner at Simon-Kucher & Partners, explained that “the challenge for a sustainable biosimilar medicines market is to align the perspectives of both payers and manufacturers. This report tried to develop principles for a sustainable biosimilar medicines market that were acceptable for both stakeholder groups.”
The research puts forward 13 principles, among which: the importance of healthy competition (multiple business operators), commercial attractiveness and a balanced relationship between price erosion and biosimilar medicines use in medical practice. Carol Lynch, Chair of the Biosimilar Medicines Group and Global Head of Biopharmaceuticals at Sandoz highlighted that, “a sustainable biosimilar medicines market is one that provides continued benefits to all stakeholders: increased access for patients, more treatment options for physicians, sustainability healthcare budgets for payers and business opportunities for manufacturers. Beyond the payer-industry relationship, a multi-stakeholder approach is crucial to develop a sustainable biosimilar medicines market and gainsharing in particular has proven to be a successful driver for increased utilisation of biosimilar medicines in medical practice throughout Europe providing benefits to all stakeholders”.
For full insight, please find the report here.
The report will also be presented through a dedicated webinar on Friday 23 September. For more information, please contact Andrea Bedorin at Medicines for Europe: abedorin@medicinesforeurope.com.
The European pharmaceutical industry welcomes the workshop organised today by the European Commission Directorate General for the Internal Market, Industry, Entrepreneurship and SMEs (DG Grow) on access to biosimilar medicines in Europe, in relation to the Corporate Responsibility Programme. Patients, doctors, pharmacists, academics, authorities, press and industry will gather at this workshop to share experiences with biosimilar medicines across Europe.
For the pharmaceutical industry to contribute effectively to the health and wellbeing of EU citizens, industry strategies must be in line with societal needs. The European Commission set up the ‘Process on Corporate Responsibility in the Field of Pharmaceuticals’ to facilitate discussions on ethics and transparency, and on non-regulatory conditions for better access to medicines after they have been granted a marketing authorisation.
The expanding numbers and use of biosimilars can support better value for healthcare and the potential for greater access for patients. The three associations thank the European Commission for organising this workshop and standing behind the development of this annual update from IMS on the impact of biosimilar competition.
The new IMS report, entitled “The Impact of Biosimilar Competition” highlights key aspects such as price competition and the significant increase in access resulting from the introduction of biosimilar medicines, especially in countries where there has been an unmet medical need, such as in Romania, Bulgaria, Slovakia and Poland.
In addition, while at last year’s event, the patient organisations voiced the need for more information on biological medicines – including biosimilars – at the event taking place today, the initial results of a patient-friendly Q&A on biosimilar medicines was presented.
About the issuers of this press release
The industry is represented by the European Federation of Pharmaceutical Industries and Associations (EFPIA) and Medicines for Europe-Biosimilar Medicines Group.
For further information, please contact:
EFPIA: Communications Team, +32 2626 2555, communications@efpia.eu
Medicines for Europe: Doris Casares, +32 2 533 98 18, doris@medicinesforeurope.com
EuropaBio: Cosmin Popa, +32 2 739 11 73, c.popa@europabio.org
About EFPIA
The European Federation of Pharmaceutical Industries and Associations (EFPIA) represents the pharmaceutical industry operating in Europe. Through its direct membership of 33 national associations and 39 leading pharmaceutical companies, EFPIA is the voice on the EU scene of 1,900 companies committed to researching, developing and bringing to patients new medicines that will improve health and the quality of life around the world.
About Medicines for Europe – Biosimilar Medicines Group
Medicines for Europe (formerly EGA) represents the generic, biosimilar and value added medicines industries across Europe. Its vision is to provide sustainable access to high quality medicines, based on 5 important pillars: patients, quality, value, sustainability and partnership. Its members employ 160,000 people at over 350 manufacturing and R&D sites in Europe, and invest up to 17% of their turnover in medical innovation.
The Biosimilar Medicines Group is a sector group of Medicines for Europe and represents the leading companies developing, manufacturing and marketing biosimilar medicines across Europe. Our members bring competition to the biologic medicines market, thereby increasing access to highly innovative medical treatments to patients in Europe and around the world, and supporting the sustainability of the European healthcare systems.
About EuropaBio
EuropaBio, the European Association for Bioindustries, promotes an innovative and dynamic European biotechnology industry. EuropaBio and its members are committed to the socially responsible use of biotechnology to improve quality of life, to prevent, diagnose, treat and cure diseases, to improve the quality and quantity of food and feedstuffs and to move towards a biobased and zero-waste economy. EuropaBio represents 77 corporate and associate members and bio regions, and 16 national biotechnology associations in turn representing over 1800 biotech SMEs.
Read more about our work at www.europabio.org.
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: