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:
Over the past decade, biosimilar medicines have generated more than 400 million patient days of positive treatment experience mainly in areas such as endocrinology and supportive cancer care. With the European approvals of biosimilar infliximab and etanercept products, these treatment options are now available to treat more patients in rheumatology. A clear understanding of the underlying scientific principles of the biosimilarity concept is important for physicians to make informed choices for their patients and to increase access to highly innovative treatments.
Therefore, the Biosimilar Medicines Group, a Medicines for Europe sector group, organised today in London a satellite symposium on the science of extrapolation and interchangeability at the annual congress of the European League Against Rheumatism (EULAR). Several hundred rheumatologists had the opportunity to learn from renowned regulatory and clinical experts about the regulatory, scientific and the latest clinical knowledge regarding biosimilar medicines.
Ahead of the event, Adrian van den Hoven, Director General of Medicines for Europe highlighted that “the Biosimilar Medicines Group is engaging actively to reduce the information gap as an essential means to improving stakeholder trust, understanding and acceptance of biosimilar medicines, which are critical factors to increase patient access to medicines and to improve the efficiency and sustainability of healthcare systems.”
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
· Value Added Medicines bring innovation throughout a molecule’s lifecycle to address patients’ health, improve the safety and efficiency of the work of healthcare professionals and increase physicians’ treatment options, while preserving the sustainability of the healthcare system.
· The Value Added Medicines Group seeks to work together with policy makers, payers, patients and healthcare professionals to address the barriers to this innovation so that all concerned stakeholders can take advantage of these opportunities.
A new study Value Added Medicines: Rethink, Reinvent & Optimise Medicines: Improving Patient Health and Access was launched today in Brussels by the Value Added Medicines Group, a sector group of Medicines for Europe. The report, conducted by Mondher Toumi, Professor of Public Health at Aix-Marseille University, identified several areas of healthcare inefficiencies in Europe and highlights new opportunities for innovation, health improvements and budget efficiency. Professor Mondher Toumi emphasised that “on average, 50% of patients do not take their medication as prescribed[1], which can have considerable consequences for their health and the healthcare system[2]. Value added medicines represent an opportunity to address a number of healthcare inefficiencies such as the suboptimal use of drugs, but also an opportunity to enhance healthcare system efficiency and contribute to the sustainability of healthcare systems.”
This was acknowledged by Christoph Stoller, Chair of the Value Added Medicines Group: “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. The Value Added Medicines Group aims to rethink, reinvent and optimise medicines based on known molecules. It brings innovation throughout a molecule’s lifecycle to develop medicines which better understand patient needs and improve care delivery.”
While the majority of existing treatments deliver on their promises to a large number of patients, some may need to be adapted to match specific needs of the healthcare community. Since the discovery of these off-patent medicines more than 20 years ago, new scientific knowledge and new technologies have emerged, opening new research and development opportunities to address specific situations that could not be tackled 20 years ago.
The resulting value added medicines are medicines based on known molecules that address healthcare needs and deliver relevant improvement for patients, healthcare professionals and/or payers. Beyond improving patients’ quality of life and adherence, they can improve the safety and efficiency of the work of healthcare professionals, increase physicians’ treatment options and improve overall budget efficiency. Unfortunately, the current market environment in Europe does not allow the healthcare community to fully capture the benefits of value added medicines as the study has identified several obstacles for their uptake. While all stakeholders should recognise the benefits that value added medicines bring, HTA and pricing and reimbursement authorities should adapt their pathways so that their added value can be shown and rewarded appropriately. In return and with the right pathways, the industry needs to take a proactive approach and engage with authorities to assess how the evidence can be generated to support their claims.
Christoph Stoller added: “Delivering better outcomes will be lost if the healthcare community does not acknowledge and reward incremental innovation in the off-patent segment. Policy makers, payers, patients, healthcare professionals and our sector group need to work together to address the barriers highlighted in the study so that all concerned stakeholders can take advantage of this innovation”.
Supporting documents
[1] Sabaté E. Adherence to long-term therapies. Evidence for action. World Health Organisation (WHO). 2003. [Internet]. Available from: http://apps.who.int/iris/bitstream/10665/42682/1/9241545992.pdf (Cited 2016 May 09)
[2] Kelly M, McCarthy S, Sahm LJ. Knowledge, attitudes and beliefs of patients and carers regarding medication adherence: a review of qualitative literature. IJPP 2015, Supplement 1: 28–49. (Original reference: European Council Policy Makers Debate. An EU response to medication non-adherence. Brussels, 2010)
Medicines for Europe stands ready to contribute to the work of Fight the Fakes in educating and informing people about the public health risk posed by fake medicines.
Medicines for Europe, the voice of the generic, biosimilar and value added medicines in Europe, is proud to announce its partnership in the Fight the Fakes campaign. By joining this initiative, Medicines for Europe acknowledges the magnitude of the problem related to the existence of fake medicines. Fake medicines can be branded or generic, prescription or over-the-counter medicines. They are a threat to patient safety as they will not treat illness and can worsen a patient’s condition, potentially leading to further illness, disability and even death.
Public awareness of the issues related to medicine counterfeiting is fundamental and Medicines for Europe is ready to contribute to Fight the Fakes in educating and informing the public about these risks. Fake medicines represent a serious public health threat, since their quality and safety cannot be proved. Medicines for Europe joins over 30 partner organisations from across the world who will collaborate in raising awareness of fake medicines as part of the Fight the Fakes campaign. This new partnership is being launched today, at the 69th World Health Assembly in Geneva, where Fight the Fakes is participating in an event on the importance of empowering people in the fight against fake medicines.
Adrian van den Hoven, Medicines for Europe Director General highlighted that “Fake medicines are illegal and dangerous. Fight the Fakes represents a great opportunity for a multi-stakeholder and multi-disciplinary collaboration”.
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.
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.
Fight the Fakes is a campaign that aims to raise awareness about the dangers of fake medicines. The campaign gives a voice to those who have been personally impacted and shares the stories of those working to put a stop to this threat to public health. It seeks to build a global movement of organisations and individuals who will shine a light on the negative impact that fake medicines have on people around the globe and aim to reduce the negative consequences on individuals worldwide. Fight the Fakes partners endorse the campaign and share the belief that coordination among all actors involved in the manufacturing and distribution of medicines is vital to tackle this public health threat. A Joint Statement signed by all partners is available at www.fightthefakes.org. Follow the campaign @FightTheFakes.
Fight the Fakes campaign communications: Cyntia Genolet c.genolet@fightthefakes.org
Medicines for Europe, the voice of the generic, biosimilar and added value medicine industries, applauds the adoption of the European Parliament’s report on the Single Market Strategy in Plenary. In their report, Members of the Parliament urged the European Commission to introduce and implement before 2019 an SPC (Supplementary Protection Certificate) manufacturing waiver to boost the competitiveness of the European generic and biosimilar medicines industries in a highly competitive global environment which will create additional jobs and growth in the EU.
The export of generic and biosimilar medicines to unprotected markets during the SPC period will stimulate investment in Europe, support the creation of highly skilled jobs and increase access to high quality medicines in third countries, without changing the equilibrium between the originator and the generic & biosimilar medicines industries in the EU.
“The European Parliament’s strong support for the creation of pharmaceutical manufacturing jobs in Europe through an SPC manufacturing waiver is clear” said Adrian van den Hoven, Medicines for Europe Director General. “This is the third time that the Parliament calls for the manufacturing waiver, now we expect the Commission to quickly introduce this strong trade stimulus to spur high-tech job creation and economic growth in Europe”.
For more information please follow us at www.medicinesforeurope.com and on Twitter @medicinesforEU.