Regulatory policy

Shionogi, Active Citizenship Network and MEPS call for urgent policy implementation in EU member states at European Parliament event to tackle growing threat of antimicrobial resistance

OSAKA, Japan and AMSTERDAM–(BUSINESS WIRE)–Shionogi & Co.,Ltd. and its European subsidiary, Shionogi BV (hereafter “Shionogi”), last week organized an event in the European Parliament in the run-up to Global Antimicrobial Awareness Week, partnering with MEPs, Active Citizenship Network and the interest group of MEPs on “European patients’ rights and cross-border healthcare” to discuss initiatives to tackle antimicrobial resistance. The event reinforced the need for urgent attention and collaboration from pharmaceutical companies, political stakeholders and governments to bring policy change and innovation to address this growing problem.

The European Health Union has declared antimicrobial resistance to be one of its top three priority health threats in the EU requiring urgent attention and action. In the context of the review of the pharmaceutical legislation and the European Council recommendations on antimicrobial resistance planned for the fourth quarter of 2022, the event brought together high-level European policymakers to discuss the innovation framework for the development of new antibiotics on the basis of concrete examples of initiatives. carried out by national health authorities to combat AMR. The event also explored collaboration and governance models to achieve better implementation of actions and best practices for a holistic approach to AMR.

“The meeting was crucial in raising awareness of antimicrobial resistance and the need for new innovations to address unmet needs. I call on patient organisations, industry, the European Commission, academia and healthcare professionals to work together to drive policy change and put in place a common response to this growing societal challenge,” said MEP Aldo Patriciello.

“The inclusion of AMR in the work program of the future Swedish Presidency of the Council of the EU and the prioritization of the subject by the European Health Emergency Preparedness and Response Authority (HERA) provide an opportunity to advancing policy action to improve management, monitor resistance patterns across Europe and encourage innovation.These actions should be fully integrated into One Health strategies providing solutions for human, animal and environmental health. The involvement of civil society and patient advocacy groups is also crucial in the development and implementation of AMR plans” commented Mariano Votta, director of Active Citizenship Network, the European branch of the Italian NGO Cittadinanzattiva.

MEP Fabio Massimo Castaldo also affirmed the importance of developing a predictable regulatory environment to incentivize private investment in new antibiotics, in addition to establishing rapid supply and purchase mechanisms for medical countermeasures. relevant in the event of a crisis in order to respond to emerging threats and to better prepare European health systems. He stated that “With the adoption of the Global Health Strategy and the review of the pharmaceutical legislation, the time has come for action, and as members of the European Parliament we will examine these proposals in depth to ensure that they meet the necessary objective and ambition.”

In 2019, bacterial AMR was directly responsible for 1.27 million deaths and associated with almost 5 million deaths.2 Future projections of the impact of unresolved AMR reach 10 million deaths per year by 2050.3 Antibiotics are crucial for all aspects of modern healthcare, from routine surgeries to chemotherapy and organ transplants. Unless urgent action is taken, we could face a future in which a lack of effective antibiotics could make routine medical procedures unsafe, make more complex interventions and procedures impossible, and reduce our ability to respond to infectious disease outbreaks. Tedros Adhanom Ghebreyesus, Director General of the World Health Organization (WHO) called it a “Slow tsunami that threatens to wipe out a century of medical progress”.

We know that fostering innovation is key to driving antimicrobial R&D and a pipeline of new and effective antibiotics, and this is needed at both European and local level. We have seen specific examples of successful models that have been implemented in European countries and we urge other EU Member States to follow suit and consider similar incentives to help address the challenges faced during the marketing of new antibiotics.commented Mark Hill, Senior Vice President, Global Head of Value and Access, Shionogi.

Although the development of antibiotics is a long, expensive and uncertain process, commercialization can also be difficult. Once started, it is understandable that there is often a low frequency of use driven by the need for responsible management to prevent the development of resistance. Low usage leads to limited revenue, which in turn limits further marketing and research into new products. Due to these economic challenges, many large pharmaceutical companies are no longer active in the development and commercialization of antibiotics, and several smaller biotechnology companies have filed for bankruptcy. Shionogi strongly supports the introduction of new models of incentives, funding, and value-for-reimbursement assessment to restore a viable commercial market to address the economic challenge faced in bringing new antibiotics to market, while by promoting responsible management.

Shionogi is committed to maintaining momentum and leveraging collaborations with civil society, policymakers, industry, academia and healthcare professionals to champion innovation to collectively turn the tide in the fight against antimicrobial resistance.

Antimicrobial Resistance (AMR)

Antimicrobial resistance (AMR) is a major health burden that needs to be addressed urgently. Infections caused by carbapenem-resistant Gram-negative bacteria are often associated with a high mortality rate.3 If left unchecked, antibiotic resistance is expected to kill 10 million people each year by 2050, with a cumulative cost to global economic output of $100 trillion.3

Shionogi’s Commitment to Fighting Antimicrobial Resistance

Shionogi has a strong heritage in the field of anti-infectives and has been developing antimicrobial therapies for over 60 years. Shionogi is proud to be one of the few major pharmaceutical companies to continue to focus on the research and development of anti-infectives. The company invests the largest proportion of its pharmaceutical revenue in the R&D of relevant anti-infectives compared to other major pharmaceutical companies.4

For more information, please see: https://www.shionogi.com/global/en/sustainability/amr.html

About Shionogi

Shionogi & Co., Ltd. is a 142-year-old, research-driven, global pharmaceutical company headquartered in Osaka, Japan, dedicated to bringing benefits to patients based on its corporate philosophy of “providing the best medicine possible.” to protect health”. and well-being of the patients we serve. The company currently markets products in several therapeutic areas, including anti-infectives, pain, CNS disorders, cardiovascular disease and gastroenterology. Shionogi’s research and development currently targets two therapeutic areas: infectious diseases and pain/CNS disorders.

For more information about Shionogi & Co., Ltd., please visit https://www.shionogi.com/global/en/

Shionogi BV is the European headquarters of Shionogi & Co., Ltd. For more information about Shionogi BV, please visit www.shionogi.eu.

Forward-looking statements

This announcement contains forward-looking statements. These statements are based on expectations in light of currently available information, assumptions that are subject to risks and uncertainties that could cause actual results to differ materially from these statements. Risks and uncertainties include general domestic and international economic conditions such as general industry and market conditions, and changes in interest rates and exchange rates. These risks and uncertainties apply particularly to forward-looking statements relating to products. Product risks and uncertainties include, but are not limited to, the completion and interruption of clinical trials; obtain regulatory approvals; product safety and efficacy claims and concerns; technological advances; the adverse outcome of material litigation; domestic and foreign health care reforms and changes in laws and regulations. Additionally, for existing products, there are manufacturing and marketing risks, which include, but are not limited to, the inability to expand production capacity to meet demand, lack of availability of raw materials and the entry of competing products. The Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

© 2022 Shionogi Europe. All rights reserved.

References

1 Collaborators on Antimicrobial Resistance. Global burden of bacterial antimicrobial resistance in 2019: a systematic analysis. Lancet. 2022;399:629-655. doi: doi.org/10.1016/S0140-6736(21)02724-0. Available online: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)02724-0/fulltext. Last consulted in November 2022.

2 O’Neill, J.. et al. Antimicrobial Resistance Review. Combating drug-resistant infections globally: final report and recommendations. 2016 https://amr-review.org/sites/default/files/160518_Final%20paper_with%20cover.pdf Last accessed November 2022

3 Perez F, et al. “Carbapenem-resistant enterobacteriaceae: a threat to our most vulnerable patients”. Cleve Clin J Med. April 2013 ; 80(4): 225–33

4 Antimicrobial Resistance Benchmark 2021.https://accesstomedicinefoundation.org/media/uploads/downloads/61ee760d03810_Antimicrobial%20Resistance%20Benchmark%20report%202021.pdf Last accessed November 2022

Job code: NP-EU-FDC-0398

Date of preparation: November 2022