EFPIA, EBE and Vaccines Europe Back EU Leadership in Sustainable, Collaborative Fight Against AMR
The launch of the European Commission’s Action Plan on Antimicrobial Resistance (AMR) confirms the EU’s determination to take a leading role in combatting this phenomenon, by proposing concrete and innovative solutions to benefit patients worldwide.
Our industry’s commitment to combatting AMR is embodied in the Davos Declaration of January 2016, and the subsequent Industry Roadmap from September 2016. Against the backdrop of the European Commission’s Second Action Plan on AMR, we now call upon governments, multilateral institutions, the private sector and civil society to follow through on the momentum provided by the UN, G7, G20 and the 67 national AMR action plans, sponsored by governments around the world to implement concrete policy actions.
As part of this global effort, the European pharmaceutical industry reaffirms its commitment to support a comprehensive, multi-sectoral approach to this critical issue and urges that the private sector be fully involved in the “One Health Network”. It is only through concerted action across all sectors and stakeholders that we ultimately will find effective solutions.
The Action Plan identifies the key issues. We applaud the European Commission’s commitment to work in partnership with Member States, industry and the Innovative Medicines Initiative (IMI) to tackle AMR. We also welcome the clear actions and measures concerning prevention and surveillance in the second Commission Action Plan on AMR, which also should be included in national Action Plans and will support such national efforts. We are also pleased to see the Commission’s acknowledgment of the role of vaccines in the fight against antimicrobial resistance, by its promotion of the uptake of vaccination in humans as a public health measure to prevent infections and subsequent use of antimicrobials.
Industry furthermore is committed to measures aimed at reducing the environmental impact resulting from the production of antibiotics. We have initiated several health-based commitments and are working through the AMR Alliance, the PSCI and the Eco-Pharmaco-Stewardship (EPS) initiative to develop concrete solutions. Industry remains open to dialogue with all stakeholders responsible for the environment to elaborate an environmental monitoring approach. Together with other actors we also continue to work on tackling the improper disposal of antibiotics, through the medsdisposal campaign.
The research-based pharmaceutical industry underlines additionally the importance of dialogue between innovators and regulatory authorities to identify and create the necessary regulatory frameworks to support the development of innovative treatments and prophylactic strategies. Specifically for vaccines, a multi-stakeholder reflection would help identify where the regulatory framework should be adapted to accelerate access to vaccines targeting nosocomial pathogens.
While we can achieve a lot through prevention, improving stewardship and streamlining regulation, we need new interventions. Industry stresses that the right incentives must be introduced across the lifecycle of novel antibiotics and vaccines to stimulate R&D, support innovation and ensure that the growth of resistance is sustainably managed and controlled.
In order to focus efforts on addressing unmet medical needs, we call upon the European Commission – in discussion with all relevant sector stakeholders – to develop a European priority pathogens list, aligned with the existing WHO list, to help guide research priorities and stimulate R&D in Europe.
In this context it will be essential to continue the work undertaken on “push” mechanisms.
Concrete examples of the value of such co-operative efforts and their contribution to the fight against AMR are embodied within the Innovative Medicines Initiative (IMI), the world’s largest public–private partnership in the life sciences sector. The EUR 700 million New Drugs 4 Bad Bugs (ND4BB) programme comprises 7 projects that accelerate discovery and the development of new antimicrobials, contribute to understanding resistance, create robust clinical trials infrastructure in Europe and support rational use of antibiotics. ND4BB represents an unprecedented partnership between industry, academia and biotech organisations to combat antimicrobial resistance, showing the collective stakeholder commitment to this effort.
We will also need appropriate “pull” mechanisms, which reward the successful development of new antimicrobial medicines. Industry welcomes the Commission’s commitment to support research into the development of new economic models. Industry is keen to engage with Member State governments and the European Commission on the design of these models to address the risk and uncertainty that come with the development of new antibiotics and vaccines.
EFPIA Director General Nathalie Moll said: “Industry is committed to playing its part in addressing this extremely urgent public health issue. All of industry, from SMEs to large companies, stands ready to invest in the fight against this alarming phenomenon. In order to enable this, we must create the right environment for investment in the fight against AMR. Ultimately, we cannot rely on innovation alone to solve the problem and will need a combination of scientific solutions and incentives, backed by sustained, collaborative stakeholder effort to get it right.”
European Biopharmaceutical Enterprises (EBE) represents the voice of biopharmaceutical companies of all sizes in Europe and is a specialised group within the European Federation of Pharmaceutical Industries and Associations (EFPIA). Established in 2000, EBE is recognised as the leading biopharmaceutical association in Europe.
The European Federation of Pharmaceutical Industries and Associations (EFPIA) represents the pharmaceutical industry operating in Europe. 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.
Vaccines Europe (VE) is a specialised group within the European Federation of Pharmaceutical Industries and Associations (EFPIA), the professional association of the pharmaceutical industry in Europe. Formed in 1991, VE has 12 members, which are research-based vaccine companies as well as small and medium sized enterprises operating in Europe, which account for a large share of human vaccines used worldwide. VE operates through the Vaccines Europe Board, five working groups: Regulatory, Research, Access, External Affairs, Influenza; and the National Vaccine Industry Network.
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Magdalena Rodriguez de Azero