Brussels – The European Generic and Biosimilar Medicines Association (EGA) welcomes the publication in the official journal today of the Delegated Regulation supplementing Directive 2001/83/EC, which implements the Falsified Medicines Directive (2011/62/EU), on the safety features appearing on the packaging of medicines.
This Delegated Regulation will determine the technical specificities of the Unique Identifier and the repositories system that will enable the verification of the authenticity of individual packages of (mainly) prescription medicines.
Together with stakeholders (EFPIA, EAEPC, GIRP, PGEU), EGA will work to ensure the national implementation of an interoperable, pan-European repositories system, called the European Medicines Verification blueprint System.
Adrian van den Hoven, Director General of the European Generic and Biosimilar medicines Association (EGA) said “We are confident that the implementation of the European Medicines Verification Blueprint System will be a major step forward for the fight against counterfeit medicines. To ensure that our industries continue to deliver access to high quality medicines and to improve patient safety, we plan to work closely with Member States to allow the industries to apply voluntarily the safety features when needed to increase patient safety even more”.
About the EGA (European Generic and Biosimilar medicines Association)
The EGA represents the European generic, biosimilar and value-added medicines industries, which provide high-quality cost-competitive medicines to millions of European patients. Companies represented within the EGA provide over 160,000 skilled, high value direct jobs in Europe. Without generic medicines, payers in Europe would have had to pay €100 billion more in 2014. Generic medicines account for 56% of all dispensed medicines but for only 22% of the pharmaceutical expenditure in Europe. The European generic and biosimilar medicines industries’ vision is to provide sustainable access to high quality medicines for all European patients, based on 5 important pillars: patients, quality, value, sustainability and partnership. For more information please follow EGA at www.egagenerics.com and on twitter @egagenerics and @ebgbiosimilars.
London – 61 regulators from 25 countries made progress in improving the generic and biosimilar medicines regulatory landscape for patient needs at the 15th Regulatory and Scientific Affairs Conference organised by the European Generic and Biosimilar medicines Association (EGA).
The EMA/HMA Strategy 2020, complemented by the CMDh 2020 Strategy Paper, will pursue operational excellence in the EU Regulatory Network and engagement in international regulatory platforms which will ultimately deliver greater value to public health.
The generic and biosimilar medicines industries presented a number of regulatory improvements in the EGA Regulatory Efficiency report in support of the 2020 strategies.
Promoting high-standard global regulatory convergence, supporting a single development programme for generic and biosimilar medicines and optimising the scope of regulatory processes supported by telematics tools will contribute to better access for better health by 2020.
Adrian van den Hoven, Director General of the European Generic and Biosimilar medicines Association (EGA) said “this event provides an invaluable platform for manufacturers, regulators and stakeholders to improve regulatory efficiency so that our industries can deliver better access to high quality medicines in the future”.
About the EGA (European Generic and Biosimilar medicines Association)
The EGA represents the European generic, biosimilar and value-added medicines industries, which provide high-quality cost-competitive medicines to millions of European patients. Companies represented within the EGA provide over 160,000 skilled, high value direct jobs in Europe. Without generic medicines, payers in Europe would have had to pay €100 billion more in 2014. Generic medicines account for 56% of all dispensed medicines but for only 22% of the pharmaceutical expenditure in Europe. The European generic and biosimilar medicines industries’ vision is to provide sustainable access to high quality medicines for all European patients, based on 5 important pillars: patients, quality, value, sustainability and partnership. For more information please follow EGA at www.egagenerics.com and on twitter @egagenerics and@ebgbiosimilars.
London – In London this week, the European Generic and Biosimilar medicines Association (EGA) will gather some of the key national authorities, regulators and industry leaders to discuss how to improve safety for patients in the regulatory frame.
More than three years after the new pharmacovigilance legislation became operational, a continuous and open dialogue between regulators and industry proved to be the key for making significant progress towards better pharmacovigilance for better public protection. Further reduced duplication of effort, targeted administrative simplification and more clearly defined roles and responsibilities for all stakeholders involved are some of the main proposals from regulators and industry to improve safety for patients and therefore bring better access to high quality medicines in Europe.
Speaking ahead of the 9th EGA Pharmacovigilance Conference, Katarina Nedog, Safety and Regulatory Manager, European Generic and Biosimilar medicines Association and coordinator of the conference, commented that “this event provides an invaluable platform for manufacturers, regulators and stakeholders to promote patients’ safety and commit to continuing our work towards a more efficient pharmacovigilance system”.
About the EGA (European Generic and Biosimilar medicines Association)
The EGA represents the European generic, biosimilar and value-added medicines industries, which provide high-quality cost-competitive medicines to millions of European patients. Companies represented within the EGA provide over 160,000 skilled, high value direct jobs in Europe. Without generic medicines, payers in Europe would have had to pay €100 billion more in 2014. Generic medicines account for 56% of all dispensed medicines but for only 22% of the pharmaceutical expenditure in Europe. The European generic and biosimilar medicines industries’ vision is to provide sustainable access to high quality medicines for all European patients, based on 5 important pillars: patients, quality, value, sustainability and partnership. For more information please follow EGA at www.egagenerics.com and on twitter @egagenerics and@ebgbiosimilars.
More than 80 leading international pharmaceutical, generics, diagnostics and biotechnology companies, as well as key industry bodies, have come together to call on governments and industry to work in parallel in taking comprehensive action against drug-resistant infections – so- called ‘superbugs’ – with a joint declaration launched today at the World Economic Forum in Davos, Switzerland.
The statement sets out for the first time how governments and industry need to work together to support sustained investment in the new products needed to beat the challenges of rising drug resistance.
The Declaration on Combating Antimicrobial Resistance – drafted and signed by 85 companies and nine industry associations across 18 countries1 – represents a major milestone in the global response to these challenges, with commercial drug and diagnostic developers for the first time agreeing on a common set of principles for global action to support antibiotic conservation and the development of new drugs, diagnostics, and vaccines. The industry is calling on governments around the world to now go beyond existing statements of intent and take concrete action, in collaboration with companies, to support investment in the development of antibiotics, diagnostics, vaccines, and other products vital for the prevention and treatment of drug-resistant infections.
In particular, the Declaration supports a continuation of efforts towards improved conservation of antibiotics, including a call for improved uptake of rapid point-of-care diagnostics to improve how antibiotics are prescribed, and changes to incentive structures within health systems that directly reward doctors, pharmacists and veterinarians for prescribing antibiotics in greater volumes.
In what the Review on Antimicrobial Resistance recognises to be a notable step for the industry, the signatory companies call on governments to work with them to develop new and alternative market structures that provide more dependable and sustainable market models for antibiotics, and to commit the funds needed to implement them. These mechanisms are needed to provide appropriate incentives (coupled with safeguards to support antibiotic conservation) for companies to invest in R&D to overcome the formidable technical and scientific challenges of antibiotic discovery and development. These include mechanisms to ensure that, where appropriate, the pricing of antibiotics more adequately reflects the benefits they bring; and novel payment models that reduce the link between the profitability of an antibiotic and the volume sold. An integral part of these models is a reduced need for promotional activity by companies.
As well as calling for continued progress by governments on these fronts, the Declaration sets out a commitment to further action on drug resistance by its signatories, which the Review warmly welcomes. These span across three broad areas:
By bringing together such a wide range of companies in this unprecedented way, the Declaration provides a valuable roadmap to guide further collaborative efforts between industry, governments and NGOs in the global fightback against AMR. The Review will continue to work to drive progress towards a series of key international milestones in 2016 – including likely discussions on AMR at the UN General Assembly and as part of China’s G20 programme in the autumn – and in support of progress against the WHO Global Action Plan on AMR.
The Declaration will be updated every two years, to take account of the evolving global landscape of AMR and changing challenges and priorities. It remains open to accept new signatory companies and bodies at any time, with a complete list maintained on the Review on AMR’s website, www.amr- review.org/industry-declaration
For further detail and background relating to the Declaration and the work of the Review on Antimicrobial Resistance, please see Notes for Editors on page 8.
QUOTES ABOUT THE DECLARATION
Lord Jim O’Neill, Chairman of the Review on Antimicrobial Resistance, said:
“This Declaration from industry is a major step forward in establishing a properly global response to the challenges of drug resistance. I’m really impressed that such a wide range of companies have been able to agree on a common set of principles and commitments across these important issues: this is a level of consensus that we have not previously seen from the industry on this topic.
“With discussions at this year’s UN General Assembly and as part of China’s G20 presidency looking likely, 2016 is set to be a pivotal year in the global fightback against AMR. This Declaration provides a strong basis for my Review, for governments and for NGOs to progress conversations with industry in the coming months about how we can turn these ideas and principles into concrete action.
“The pharmaceutical industry, as well as society at large, cannot afford to ignore the threat of antibiotic resistance, so I commend those companies who have signed the Declaration for recognising the long-term importance of revitalising R&D in antibiotics, and for their leadership in overcoming the difficult issues of collective action at play here.”
Pascal Soriot, Chief Executive of AstraZeneca plc, said:
“We welcome the leadership provided by Lord O’Neill’s Review on AMR, applaud the ongoing global efforts to ensure a sustained pipeline of new therapies is developed and are proud to support this endeavour.
“The Declaration’s call for collaborative action on new commercial models is timely. Industry is ready to engage with governments to develop alternative market structures to enable the sustainable investment that is necessary if we are to overcome the formidable technical and scientific challenges of antibiotic discovery and development.”
Sir Andrew Witty, Chief Executive of GlaxoSmithKline plc, said:
“Antibiotic resistance is the sort of global healthcare challenge that this industry should be using its expertise to tackle. That’s why I’m so pleased to see such a broad range of companies committing to this declaration. At GSK we have a long heritage and expertise in antibiotics, we’ve been researching and providing these medicines since the Second World War and we remain committed to continuing in this area. I’m proud that in spite of the scientific challenges of antibiotic research, we still have an active pipeline, which includes a potential new and first-in-class treatment entering late stage development.
“We are already taking a more open and collaborative approach to our antibiotic research, working in pre-competitive collaborations alongside other companies and academics, to overcome the scientific and technical barriers to developing these medicines. I’m hopeful that today’s declaration will encourage governments to work with us on new economic models that can help to secure a new supply of antibiotics for the future.”
Paul Stoffels, M.D., Chief Scientific Officer and Worldwide Chairman, Pharmaceuticals, Johnson & Johnson, said:
“We are pleased to be part of this important initiative to combat antimicrobial resistance. Antimicrobials are the backbone of modern medicine, and have played a key role in increasing life expectancy globally. At Johnson & Johnson, our long-standing commitment to innovation in antimicrobial R&D is evident through our legacy products and our new efforts to support ongoing research. For the world to continue to have new antibiotics, we need investments in basic science and novel incentive models for industry R&D, and to protect our existing treatments, we need new frameworks for appropriate use.”
Kenneth C. Frazier, Chairman and Chief Executive, Merck & Co., Inc., Kenilworth, New Jersey, USA, said:
“Antibiotic resistance is an urgent public health issue requiring a comprehensive, global approach. Assuring availability and proper use of effective antibiotics are shared responsibilities and we fully embrace the principles outlined in this declaration.”
Ian C. Read, Chairman and Chief Executive of Pfizer Inc., said:
“The growing problem of antimicrobial resistance requires new approaches and a heightened commitment to development of new treatments and vaccines. Pfizer applauds this declaration as a balanced and robust approach to stimulating R&D through market based incentives, and emphasising the importance of responsible stewardship.”
Dr Olivier Brandicourt, Chief Executive of Sanofi S.A., said:
“Finding solutions to meet this major challenge requires full participation of private and public sectors, non-governmental organisations, regulatory organisations and payers. It will be challenging as antibiotic stewardship must be improved and discovery of new treatments has been elusive.
Although sustainable business models remain to be found, we are up for the challenge. Together I believe we can overcome these hurdles and Sanofi is fully committed to this global effort.”
Dr Isao Teshirogi, President and Chief Executive, Shionogi & Co., Ltd., said:
“Shionogi has been seriously committing to combat AMR for years. Thus, I am pleased to support the declaration from industry, and our company will further contribute to this global challenge as much as we can.”
Dame Sally Davies, UK Chief Medical Officer, said:
“I welcome this Declaration as a clear sign of industry’s collective commitment to beating the threat of antimicrobial resistance, both by reducing unnecessary use of antibiotics and supporting the development of new ones.
“A secure supply of new antibiotics for the future is clearly of vital importance, and I look forward to seeing an advancement of discussions between companies and governments on how we build new and sustainable market models that properly incentivise the discovery and development of new antibiotics, whilst ensuring affordable access to these crucial drugs for all those who need them in all parts of the world.”
Dr Margaret Chan, Director General of the World Health Organization (WHO), said:
“Antimicrobial resistance is beyond the capacity of any organisation or country to manage or mitigate alone. WHO and its Member States have called for the development of new antimicrobial medicines and affordable access to them, in line with the global action plan on antimicrobial resistance. This Declaration affirms that the challenges of AMR can be addressed only through collaboration and global collective action.”
Professor Murat Akova, President of the European Society of Clinical Microbiology and Infectious Diseases (ESCMID), said:
“The European Society of Clinical Microbiology and Infectious Diseases (ESCMID) – an independent, non-profit society with a major focus on AMR – welcomes and applauds this broad initiative from industry to embrace all tough commitments necessary to successfully combat antimicrobial resistance. Fair, transparent agreements between industry, governments and the profession will be welcomed by all.”
Johan S. Bakken, MD, PhD, FIDSA, President of the Infectious Diseases Society of America (IDSA), said:
“The Infectious Diseases Society of America (IDSA) applauds the global industry leaders who issued the Declaration on Combating Antimicrobial Resistance. IDSA members are on the front lines treating increasing numbers of patients who suffer from infections caused by multi-drug resistant pathogens, and we have long called for a coordinated effort by all stakeholders to reduce resistance through ID physician led stewardship and to foster the development of urgently needed new antibiotics, diagnostics, and vaccines. We welcome industry’s commitment to work with us, government leaders, and others to address this growing public health crisis.”
Richard Bergström, Director General of the European Federation of Pharmaceutical Industries and Associations (EFPIA), said:
“With this statement, my member companies confirm their commitment to new business and valuation models for antibiotics, including those where you at least partially de-link revenues from sales. This will support the dual goal of incentivising research, while limiting consumption to when it is really needed.”
Dr Virginia Acha, Executive Director for Research and Medical Innovation, Association of the British Pharmaceutical Industry (ABPI), said:
“When David Cameron announced the AMR Review work in July 2014, he called for ‘a stronger, more coherent global response, with nations, business and the world of science working together to up our game in the field of antibiotics’. With this global Declaration of Support for Combating AMR, industry has given that response. It is up to us all to make sure that delivers new solutions to address AMR for patients everywhere.”
Kenneth Hillan, Chief Executive of Achaogen Inc., said:
“Achaogen is focused on the urgent need for new antibacterials to treat multi-drug resistant, Gram- negative infections and is committed to participating in the coordinated global action required to address the public health threat posed by AMR. We applaud the efforts of Lord O’Neill’s Review on AMR and are pleased to support this Declaration and the call for collective global measures to overcome the barriers to the development and commercialisation of life-saving antibiotics.”
Neil Murray, Chief Executive of Redx Pharma Plc, said:
“There is a doomsday clock ticking, with the effectiveness of antibiotics diminishing at an alarming rate. The potential consequences of the failure to tackle this crisis have already been highlighted by the UK Government’s O’Neill Review, which talks of 10 million extra deaths a year and a tragic reversal of over three decades of progress in treating TB, malaria and HIV. So Redx Pharma wholeheartedly supports today’s declaration and welcomes any efforts made in public and animal health to diminish the unnecessary use of antibiotics. We also share the widely-held view that new ways must be found to support innovation and drug discovery in this critical area.”
Florence Séjourné, Chief Executive of Da Volterra and co-founder of the BEAM Alliance, said:
“Antibiotic-resistant bacteria, left unchecked, would imperil long-term human stability and development. We welcome the opportunity to bring this life-and-death topic to the forefront at the World Economic Forum 2016. New antibiotics must be developed, and existing ones must be preserved. To this end, antibiotics should be used wisely, and novel strategies to overcome the emergence of resistance encouraged as well. Together with all the leaders and creative minds gathered in Davos, we should and will succeed in defining a future for combating bacterial resistance and better prevent and cure bacterial infections: let’s make it happen.”
Ankit Mahadevia, M.D., Chief Executive of Spero Therapeutics, said:
“We are proud to be part of this important declaration. Antibiotic resistant infections claim at least 50,000 lives each year across Europe and U.S. alone. We will continue to aggressively pursue new models for antibiotics that will curb this worldwide problem.”
Christopher Micetich, President and Chief Executive of Fedora Pharmaceuticals Inc., said:
“Fedora Pharmaceuticals shares the signatories’ commitment to combatting antimicrobial resistance through innovation, stewardship and improved access. We applaud the collaborative spirit expressed by these companies in coming together to address this incredibly important global health issue.”
Avi Pelossof, Global President of Infectious Diseases, Alere Inc., said:
“Alere is proud to support this declaration and is committed to improving the uptake of rapid point- of-care diagnostics, helping healthcare professionals make the right antibiotic prescribing decision, and addressing the global threat of antimicrobial resistance.”
Manos Perros, President and Chief Executive of Entasis Therapeutics Inc., said:
“At Entasis Therapeutics, we discover and develop antibacterials for the treatment of multi-drug resistant infections. Through our pathogen-targeted approach, we are building a pipeline of innovative molecules to treat patients responsibly, optimizing our experimental drugs to target some of the most urgent medical needs. We acknowledge the efforts of Lord O’Neill’s Review to build a framework of global measures which will rekindle and sustain scientific innovation, incentivise development and commercialization, and ensure access and responsible use of current and future antibacterials.”
Alexandre Mérieux, Chief Executive of bioMérieux SA, said:
“Strongly involved in the fight against antimicrobial resistance, the diagnostic industry strives to develop rapid and high medical value tests in close collaboration with healthcare professionals. Building on more than 50 years of expertise in the diagnosis of infectious diseases and its leadership position in microbiology, bioMérieux is an strong advocate for the development of innovative, rapid and beneficial diagnostics in order to facilitate the rational use of antibiotics and curb global resistance. True to our pioneering spirit, we are proud to sign this joint Declaration and place great hope in the outcomes of such an unprecedented collective call to action to protect public health worldwide for the years to come.”
Dr Habil Khorakiwala, Founder Chairman of Wockhardt Ltd., said:
“Wockhardt has over the years made focussed investments in antibiotic discovery and development, culminating in a pipeline of novel antibacterial drug candidates to effectively manage the AMR issue. Wockhardt expects governments’ help in creating a sustainable economic model for antibiotic R&D.”
Dr Yusuf K Hamied, Chairman of Cipla Ltd., said:
“The work being done by this committee is of particular relevance to India, where the overuse of antibiotics needs to be curbed.”
Radha Rangarajan, Chief Executive of Vitas Pharma, said:
“There is a dire need for novel therapies that overcome drug resistance. To support R&D today, is to save lives tomorrow.”
Daikichiro Kobayashi, President of Meiji Seika Pharma Co., Ltd., said:
“We welcome global efforts to combat antimicrobial resistant such as the activities under this declaration and will continue to struggle with the problem for public health.”
Steve Bates, Chief Executive of the UK Bio Industry Association (BIA), said:
“The ever-growing threat to world health from antimicrobial resistance cannot be tackled unless industry and governments around the world work together in new ways. It’s fantastic to see so many key organisations already signed up to the declaration and the UK innovation ecosystem has a lot to contribute to this global challenge.”
Doris-Ann Williams MBE, Chief Executive of the British In Vitro Diagnostics Association (BIVDA), said:
“The in vitro diagnostics (IVD) sector is ready to stand shoulder to shoulder with colleagues from across industry to tackle the threat of AMR to human health. IVDs have a critical role to play in preventing unnecessary prescriptions of antibiotics or accurately targeting their use. BIVDA is pleased to be supporting the Declaration and we look forward to continued collaborative work to support the AMR challenge”
Adrian van den Hoven, Director General of the European Generic and Biosimilar Medicines Association (EGA), said:
“The rational use of medicines through good prescription practice and better health literacy to ensure patient compliance with antibiotic medicines is crucial to maintain the effectiveness and availability of these life-saving treatments”
1 This reflects the final confirmed number of signatories at the time of publication, and updates the figure used in earlier versions of this press notice.
About antimicrobial resistance
Notes for Editors
This Press Release will also be available on Thursday, January 21st 2016 on www.amr-review.org/industry-declaration.
Media enquiries should be addressed to the Review on AMR team on: info@amr-review.org; and
+44 20 7611 5710 or +44 7715 426 895.
Additionally, all signatory companies may be contacted directly for comment via their own media offices or via the Review on AMR.
Antimicrobials, and specifically antibiotics, play a crucial role in modern medicine. These precious medicines are often taken for granted and are not only necessary to treat life-threatening infections, but are also vital to underpin most common surgical procedures and many chronic treatments such as chemotherapy and HIV and transplant medicines. They also play a crucial role in the health of animals.
The increase in bacterial resistance to antibiotics has been dramatic, and combating this growth is a top priority for global policy and public health. There is a particular concern that antibiotics are losing effectiveness faster than they are being replaced by new, innovative drugs, including both antibiotics and alternative non-antibiotic approaches to treating and preventing infections.
This innovation gap has been examined extensively and is widely acknowledged to be the result of a combination of scientific as well as commercial barriers that have impeded antibiotic development over a number of years. The scientific difficulties are formidable and traditional R&D approaches have largely failed: companies, private and public funders have invested billions of dollars over the last 20 years to discover new antibacterials, yet no new class of antibiotic for Gram-negative infections has reached approval in over 40 years.
This situation poses a unique set of challenges. We will always need a supply of innovative new antibiotics; all antibiotics need to be used cautiously to conserve their effects; and, in many countries, we still need to improve access to existing antibiotics.
We welcome the economic analysis of Jim O’Neill’s Review on Antimicrobial Resistance (AMR), which quantifies both the costs and investments needed. The challenges are clearly substantial and call for transformational changes from many stakeholders. The pharmaceutical, biotechnology, and diagnostics industries have an important role to play, and we are committed to doing our part.
Leadership from other sectors is also required, and we welcome the initiative of the Review on AMR, as well as the attention of governments and politicians world-wide (including the recent G7 Berlin declaration), and the leadership of key international organisations (WHO, OIE, FAO, ECDC, US CDC), public funding bodies (NIH, BARDA, the European Commission, and IMI), and charitable foundations (Wellcome Trust, BMGF, and Pew Charitable Trusts)*, amongst others.
We similarly welcome those steps already taken by key regulatory authorities around the world, such as the US Food and Drug Administration (FDA) and European Medicines Agency (EMA), to enable antibiotic development in advance of widespread resistance, and we support a continuation of these efforts to ensure greater harmonisation of regulatory processes internationally.
Taking collective action
We support the increasing recognition that the value assigned to antibiotics and diagnostics often does not reflect the benefits they bring to society, nor the investment required for their creation. Therefore, we call on governments to commit to allocating the funds needed to create a sustainable and predictable market for these technologies while also implementing the measures needed to safeguard the effectiveness of antibiotics. Specifically:
Commitments by signatory companies
The under-signed companies are already actively engaged in combating AMR as appropriate to their business. We stand ready to work in partnership with leading countries to deliver sustainable solutions to meet this global challenge. We invite other companies to join this Declaration and comments from all other stakeholders are welcome. We will review and update the Declaration every 2 years, to reflect progress and changing priorities.
We commit to:
Work to reduce the development of antimicrobial resistance
Invest in R&D to meet public health needs with new innovative diagnostics & treatments
Improve access to high-quality antibiotics and ensuring that new ones are available to all
Signatories
CONFIRMED LIST AT TIME OF PUBLICATION (JANUARY 21, 2016)
Pharmaceutical and biotechnology companies
Diagnostic companies
Industry Associations
We support the aims of the Declaration signed by our Member companies and look to work with all stakeholders to help deliver its objectives.
*WHO – World Health Organization; OIE – World Organisation for Animal Health; FAO – Food and Agriculture Organisation of the United Nations; ECDC – European Centre for Disease Control; US CDC – United States Centers for Disease Control; NIH – US National Institutes of Health; BARDA – US Biomedical Advanced Research and Development Authority; IMI – European Innovative Medicines Initiative; BMGF – Bill & Melinda Gates Foundation.
Barcelona – At their joint Executive meeting in Barcelona today, the Spanish Generic Medicines Association (AESEG) and the European Generic and Biosimilar Medicines Association (EGA) confirmed their commitment to join forces and bring access to generic medicines to the Spanish market, reinforcing the industry’s commitment to increase patient access to high quality medicines. A recent IGES study has shown that better access to generic medicines can have significant health outcome benefits for patients.
The AESEG and EGA Executives debated the importance of re-introducing price differentiation between originator and generic medicines to stimulate competition, the negative consequences of the procurement system in Andalusia and the SPC (Supplementary Protection Certificate) manufacturing waiver proposal which would create thousands of jobs for the Spanish pharmaceutical industry.
EGA Director General Adrian van den Hoven highlighted that “Our industry is ready to work with the Spanish authorities to remove barriers to competition and increase the cost-effectiveness of therapies to ensure better access to high quality medicines for patients”.
AESEG Director General Angel Luis Rodriguez de la Cuerda, pointed out that “7 out of 10 generic medicines in Spain are manufactured in Spain. Healthy generic competition in the Spanish market will provide additional value and jobs for the country. Therefore, the European Commission proposal for an SPC manufacturing waiver is essential to create new manufacturing and job opportunities in Spain. We call on the Spanish Government to strongly support this job creating measure in the EU”.
PICTURE (from left to right side): Adrian van den Hoven (EGA Director General), Christoph Stoller (EGA Vicepresident), Raúl Díaz-Varela (AESEG President), Ángel Luis Rodríguez de la Cuerda (AESEG Director General).
About the EGA (European Generic and Biosimilar medicines Association)
The EGA represents the European generic, biosimilar and value-added medicines industries, which provide high-quality cost-competitive medicines to millions of European patients. Companies represented within the EGA provide over 160,000 skilled, high value direct jobs in Europe. Without generic medicines, payers in Europe would have had to pay €100 billion more in 2014. Generic medicines account for 56% of all dispensed medicines but for only 22% of the pharmaceutical expenditure in Europe. The European generic and biosimilar medicines industries’ vision is to provide sustainable access to high quality medicines for all European patients, based on 5 important pillars: patients, quality, value, sustainability and partnership. For more information please follow EGA at www.egagenerics.com and on Twitter @egagenerics and @ebgbiosimilars.
EGA Communications: Doris Casares dcasares@egagenerics.com
About AESEG (Spanish Generic Medicines Association)
AESEG is the official representative body of the generic pharmaceutical industry in Spain. Any pharmaceutical company manufacturing raw materials and pharmaceutical active substances as well as technological development companies that focus activities on generic medicines in Spain can be a member of AESEG.
AESEG was constituted in Barcelona in March 1998 as a nationwide non-profit organisation, aimed to foster awareness and use of generic medicines and to create a real generic medicines culture in the heart of the Spanish society. For more information : www.aeseg.es and www.engenerico.com
AESEG Communications: Marisol Atencio matencio@aeseg.es
Brussels – Today, EGA members unanimously adopted disclosure rules for the generic, biosimilar and value added medicines industry. This will form an integral part of the EGA’s Code of Conduct that was adopted one year ago, available here.
The new chapter provides a framework to disclose support for patient organisations, healthcare professionals (HCPs) such as meetings and hospitality or educational support, as well as contributions to healthcare organisations (HCOs). EGA members will have one year to implement the disclosure requirements as they will start recording the data in January 2017 to publicly disclose in 2018.
“We are proud that the European generic, biosimilar and value added medicines industry has taken another bold step to build on its existing Code of Conduct. Disclosure enables the industry, healthcare professionals and patient organisations to jointly promote shared values of transparency, integrity, accountability and collaboration”, stated EGA President Jacek Glinka.
About the EGA (European Generic and Biosimilar medicines Association)
The EGA represents the European generic, biosimilar and value-added medicines industries, which provide high-quality cost-competitive medicines to millions of European patients. Companies represented within the EGA provide over 160,000 skilled, high value direct jobs in Europe. Without generic medicines, payers in Europe would have had to pay €100 billion more in 2014. Generic medicines account for 56% of all dispensed medicines but for only 22% of the pharmaceutical expenditure in Europe. The European generic and biosimilar medicines industries’ vision is to provide sustainable access to high quality medicines for all European patients, based on 5 important pillars: patients, quality, value, sustainability and partnership. For more information please follow EGA at www.egagenerics.com and on twitter @egagenerics and @ebgbiosimilars.
Brussels – Generic and biosimilar medicines represent an essential opportunity to optimize the efficiency of healthcare systems in Italy, according to an article published this week in the Journal of Generic Medicines, Generic and Biosimilar Medicines Use and Expenditure: A Report from the National Observatory on the Use of Medicines (OsMed) of the Italian Medicines Agency (AIFA).
The article signed by Alessandro Monaco from AIFA highlights the opportunity for generic and biosimilar medicines to enable access and meet the growing demand of healthcare systems in terms of the effectiveness of therapies and to address the sustainability of healthcare budgets. AIFA also underlines the importance of generic and biosimilar competition for the overall sustainability of healthcare systems.
Assogenerici Director General, Michele Uda, welcomed the AIFA publication: “Today when we measure the practical impact of innovation on pharmaceutical expenditure, with antivirals for the treatment of chronic hepatitis C, it seems evident that biosimilars can not only contain public pharmaceutical spending, but directly impact on the access to gold standard therapies and allow, at the same time, the use of the latest generation therapies, thanks to the release of the necessary resources. But it is clear, as stated by the AIFA, this requires first of all a work of general acculturation, now urgently needed, given the imminent arrival of other expensive treatments. We hope that the important messages that the AIFA addressed to the scientific community and healthcare decision makers are taken into due consideration”.
EGA Director General, Adrian van den Hoven, commented that “AIFA’s article confirms the efforts by generic and biosimilar manufacturers to invest heavily to bring better access for patients and more sustainability to pharmaceutical markets in Italy. For example, thanks to biosimilar filgrastim, 44% more cancer patients gained access to this life saving treatment in the EU5 countries ”.
About the EGA (European Generic and Biosimilar medicines Association)
The EGA represents the European generic, biosimilar and value-added medicines industries, which provide high-quality cost-competitive medicines to millions of European patients. Companies represented within the EGA provide over 160,000 skilled, high value direct jobs in Europe. Without generic medicines, payers in Europe would have had to pay €100 billion more in 2014. Generic medicines account for 56% of all dispensed medicines but for only 22% of the pharmaceutical expenditure in Europe. The European generic and biosimilar medicines industries’ vision is to provide sustainable access to high quality medicines for all European patients, based on 5 important pillars: patients, quality, value, sustainability and partnership. For more information please follow EGA at www.egagenerics.com and on Twitter @egagenerics and @ebgbiosimilars.
EGA Communications: Doris Casares dcasares@egagenerics.com
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About Assogenerici (Italian Generic and Biosimilar medicines Association)
Assogenerici is the official representative body of the Italian generic and biosimilar pharmaceutical industry. Formed in 1993, Assogenerici represents over 60 pharmaceutical companies and their subsidiaries. Companies represented within Assogenerici provide over 5,000 direct jobs in Italy. Cost-effective generic 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 budget headroom for new and innovative treatments. Assogenerici plays an important consultative role in Italian healthcare policy-making. Assogenerici and its members work with the Italian government and the EU institutions to develop affordable solutions for pharmaceutical care and to increase Italy’s competitive strength in the global pharmaceutical medicines market.
ASSOGENERICI Communications: Massimo Cherubini m.cherubini@vrelations.it
Brussels – The European Generic and Biosimilar medicines Association (EGA) announced today the launch of the European Value Added medicines (EVA) group, a new sector group of the EGA.
“EVA will be the leading voice of a broad-multi-stakeholder coalition supporting value-added medicines in Europe, engaging with patients and healthcare professionals in response to their needs and with payers to increase access to high quality and sustainable innovation for patients across Europe and worldwide,” said Adrian van den Hoven, EGA Director General.
Value-added medicines are medicines based on known molecules which deliver significant improvements for patients, payers and/or health care professionals. For example, the added value may be created thanks to better health outcomes, better quality of life, improved tolerability, better adherence, less dosing frequency, reduction of medical errors or any other innovative solution addressing unmet needs for key stakeholders.
The new European Added Value medicines group will be a partner for healthcare systems to improve the efficiency of healthcare and access to sustainable pharmaceutical innovation in Europe. This group will be open to EGA and to non-EGA members active in this field.
About the EGA (European Generic and Biosimilar medicines Association)
The EGA represents the European generic, biosimilar and value-added medicines industries, which provide high-quality cost-competitive medicines to millions of European patients. Companies represented within the EGA provide over 160,000 skilled, high value direct jobs in Europe. Generic medicines save EU patients and healthcare systems over €40 billion each year and account for 55% of all dispensed medicines but for only 21% of the pharmaceutical expenditure in Europe. The European generic, biosimilar and value-added medicines industries’ vision is to provide sustainable access to high quality medicines for all European patients, based on 5 important pillars: patients, quality, value, sustainability and partnership. For more information please follow EGA at www.egagenerics.com and on Twitter @egagenerics and @ebgbiosimilars.