ABPI, EFPIA and IFPMA issue joint statement following
publication of the final report by the Review on AMR
The Association of the British Pharmaceutical Industry (ABPI), the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) have today issued a joint statement following the publication of the final report by the Review on Antimicrobial Resistance (AMR), led by Lord O’Neill.
“Lord O’Neill and the Review on Antimicrobial Resistance team have succeeded in bringing the world’s attention that resistance to antibiotics is one of the greatest global health threats of our time. We welcome the ambition for global action mapped out in the Final Report, and the call for political leadership, global coordination and diversity in local action, as well as pragmatism in highlighting a range of potential new systems to deliver a lasting sustainable solution.
The publication of the Final Report does not mark the end of the work, but rather the start of the collaboration that must now begin to address drug resistance and the rise of the superbug. Detecting, preventing and controlling resistance requires a strategic, coordinated, and sustained global and local response dependant on action from government, academia, the pharmaceutical industry, healthcare providers, patients, and the agricultural community. Keeping antibiotics effective is everybody’s responsibility.
The global pharmaceutical industry is already at the forefront of leading action to address antimicrobial resistance. In January this year, over 100 companies and 13 associations signed the Declaration by the Pharmaceutical, Biotechnology and Diagnostics industries on Combating Antimicrobial Resistance [1].
The Davos Declaration set out three key commitments. First, to reduce the development of drug resistance; second, to increase investment in R&D to meet global public health needs; and third, to improve access to high-quality antibiotics and vaccines for all. We also called 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. There is a clear need for global coordination of stewardship, conservation, hygiene, and the creation and use of new commercial and incentive models for antibiotics, vaccines and diagnostics, to be delivered through local action. We are pleased to see many of these objectives reflected and developed in the Final Report, and we welcome the collaboration called for by the Review team. Without collective action, we cannot expect real change.
Industry hasn’t been standing still with regard to developing new medicines to address drug resistance. There are currently 34 antibiotics and infection preventing vaccines in our global pipeline [2] and in 2014 alone the industry spent more than $137 billion collectively on all aspects of R&D [3], with 3.7% focused on anti-infectives [4]. The investment, time and risk required by companies to discover and develop new antibiotics and vaccines needed for drug resistance is substantial and poses a unique challenge. For this reason, the industry has underscored the imperative need for a sustainable business model for these critical medicines, without which any interventions to develop new medicines will be limited.
We welcome the critical link the Review on AMR team has made between research investment and market based incentives to create a sustainable market that will deliver the next generation antibiotics and vaccines. Such push and pull incentives have already delivered success in other disease areas and must be used as a starting point for similar collaboration in antibiotics and vaccines to fund innovation on a global scale.
The report highlights existing initiatives such as the Biomedical Advanced Research and Development Authority [5] (BARDA) in the US, and the Innovative Medicines Initiative [6] (IMI) in Europe, the biggest life sciences public private partnership in the world, targeting bottlenecks in drug discovery to deliver new cures and new ways to tackle infectious and rare diseases. As part of IMI, New Drugs for Bad Bugs [7] a €696 million fund where industry directly contributes €345 million ‘in-kind’ has led the way in combating the scientific, regulatory, and business challenges that are hampering the development of new antibiotics. Comparable public and private funded initiatives on a global scale will be fundamental in this fight, yet the impetus this Final Report provides should also ensure that all local partners act now and commit to allocating funding and finding paths that work for their situation.
The Final Report covers several options to raise the funding required to tackle resistance, we will look at all of these options with a view to whether they are balanced, sustainable, likely to encourage investment into the area and encourage good science in the interests of patients. One of the options highlighted is a ‘pay or play’ payment levy on pharmaceutical companies to fund market entry rewards. The potential imposition of a tax on just one segment of the life sciences sector to fix a supply-side issue will significantly undermine current goodwill, cooperation, and the large voluntary investment and initiatives that are already underway. Ultimately, this approach may lead to less productive collaboration and innovation, and ignores the universal responsibility for finding a solution that all of society relies on. We need to be working towards incentives that support additional investment rather than punitive payments.
In an age of global austerity and the unique scientific, economic and environmental challenges presented by AMR, a new sustainable model that rewards innovation and shares the risk equally will be challenging to implement, but the overwhelming benefit of solving this problem requires all partners to now come together as equals and define the right set of proportionate and fair solutions.
The world is rightly impatient for a resolution to antibiotic resistance. Resistance undermines both our ability to fight infectious diseases and much of modern medicine, which has rarely faced such a grave threat. Only by working together can we deliver an effective and sustainable global response.”
Notes to Editors
[1] Global Pharmaceutical Industry Calls On Governments To Work With Them To Beat The Rising Threat Of Drug Resistance, AMR Review, January 2016
[2] Rethinking the way we fight bacteria, IFPMA, 2015
[3] International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). The Pharmaceutical Industry and Global Health Facts and Figures 2014. 81 (Geneva, 2014)
[4] Thomson Reuters CMR International Pharmaceutical R&D Factbook 2014; Drawn from the Industry R&D Investment Programme and reproduced with permission in the Adapting the Innovation Landscape UK Biopharma R&D Sourcebook 2015.
[5] Biomedical Advanced Research and Development Authority:http://www.phe.gov/about/BARDA/Pages/default.aspx
[6] Innovative Medicines Initiative: http://www.imi.europa.eu/
[7] New Drugs for Bad Bugs: http://www.imi.europa.eu/content/nd4bb
Media enquiries
Mario Ottiglio│Director Public Affairs, Communications & Global Health Policy│IFPMA│+41 22 338 32 00│m.ottiglio@ifpma.org│
About the ABPI
The ABPI represents innovative research-based biopharmaceutical companies, large, medium and small, leading an exciting new era of biosciences in the UK.
Our industry, a major contributor to the economy of the UK, brings life-saving and life-enhancing medicines to patients. We represent companies supplying around 90 per cent of all medicines used by the NHS, and are researching and developing the majority of the current medicines pipeline, ensuring that the UK remains at the forefront of helping patients prevent and overcome diseases.
The ABPI is recognised by government as the industry body negotiating on behalf of the branded pharmaceutical industry, for statutory consultation requirements including the pricing scheme for medicines in the UK.
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 41 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 IFPMA
IFPMA represents the research-based pharmaceutical companies and associations across the globe. The research-based pharmaceutical industry’s 1.3 million employees research, develop and provide medicines and vaccines that improve the lives of patients worldwide. Based in Geneva, IFPMA has official relations with the United Nations and contributes industry expertise to help the global health community find solutions that improve global health.