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
This email address is being protected from spambots. You need JavaScript enabled to view it.”>
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.