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Confronting Apocalyptic Risks of Broken Antibiotics Pipeline

Alarmed by the real health, economic and security risks associated with “superbugs” that are resistant to antibiotics — the lynchpins of modern medicine — President Obama has included antimicrobial resistance as a focus of his 26-nation partnership Global Health Security Agenda.  He has just announced a September 2014 White House international conference on antimicrobial resistance (AMR).  In June, President Obama and G7 leaders committed to drive forward the development of a Global Action Plan on Antimicrobial Resistance (AMR GAP) with the World Health Organization (WHO).

Health Ministers from 194 countries have directed the WHO to consult widely with governments, industry and others and to complete a Global Action Plan with concrete targets by May of 2015.  They specifically asked WHO to collaborate with the UN Food and Agriculture Organization (FAO) and the World Organization for Animal Health (OIE) on an approach that brings together human health, animal health, and agriculture.

WHO’s Director General Margaret Chan’s statements indicate that the impacts and costs of the AMR crisis are already here.  At a 20-nation meeting of Ministers in June, she stressed, “Drugs that were once lifesavers are now worthless. Hospitals have become hotbeds for the transmission of highly resistant superbugs, increasing the risk that hospitals kill rather than heal. For a growing number of serious infections, doctors are empty-handed. The rise of resistance has vastly outpaced the development of replacement drugs.”

In recent years, the global availability, use and overuse of antibiotics in both humans and animals became widespread.  Hundreds of millions of lives have been saved by antibiotics, but with little real attention to the inevitable counter-threat of superbugs that become resistant to these life-saving drugs.  Now, global leaders see that despite this crisis, the pipeline of new antibiotics is nearly empty and investment in new antibiotics has been slashed — the antibiotics market is broken.  Clearly these “wonder drugs” have been undervalued.

The failure to develop a robust, long-term pipeline of effective new antibiotics, treatments and diagnostics for infections means that diseases that had become survivable and procedures that are now safe, routine and low cost are becoming life-threatening once again and treatment costs are rising.  Terrorists, leaders also fear, will try to take advantage of these vulnerabilities and the rise of “superbugs” to inflict great harm.  The current and potential costs of a failure to address AMR are very high.

Why is this market failure occurring?  By definition, antibiotics are taken for relatively short periods to treat infections.  Unlike companies which make new drugs for long-term, chronic diseases, those which develop new antibiotics fall victim to their own success.  It is very expensive to develop new antibiotics, and as they eliminate diseases and provoke resistance, they lose their market value.  UK Chief Medical Officer Sally Davies warns of the possibility of a post-antibiotic “apocalyptic scenario” and stresses that,  “This is an issue of markets and economics.”

Academic and industry experts are now urging a new business model that rewards the development of new antibiotics, even if their use is carefully controlled, and limited.  Such experts argue that governments may need to commit in advance to purchase new antibiotics for a period of years and to help to defray R&D costs;  fiscal incentives and longer patent periods may be part of the mix as well as higher payments (including reimbursements) and “orphan drug” approaches to facilitate getting new antibiotics to market more quickly and at lower cost.  Experts believe that governments will most certainly also have to implement new regulations aimed at preventing infection and controlling the use of antibiotics in humans and animals.

We are in what amounts to an innovation-based arms race against anti-microbial resistance.  The discussion and development of a 2015 AMR Global Action Plan (AMR GAP) by the World Health Organization (WHO), the U.S. and other governments and stakeholders will impact medical practices, pharmaceutical companies, animal husbandry and fisheries industries, agriculture and the global food chain, and security considerations worldwide.  WHO is holding an online public consultation over the next two months, with opportunities to engage likely available thereafter.  WHO and its Member States need to get the Global Action Plan right, and to do so they must hear from those with interest and expertise.

© 2022 Covington & Burling LLPNational Law Review, Volume IV, Number 190

About this Author

Anne Pence, International Advisor, Covington Law Firm
Senior International Adviser

Constance Anne Pence, a non-lawyer, is a senior international advisor in Covington’s Washington, DC office. As a policy-oriented economist for over 20 years, Ms. Pence has tremendous experience advising sovereign and corporate clients, as well as coalitions in both domestic and international policy settings. Before joining Covington, she was the special advisor to the newly-created USG Millennium Challenge Corporation.  Ms. Pence also served with the U.S. State Department for 16 years.  For eight of those years she was the Department’s G8 Summit policy coordinator in the Office of the...

Daniel L. Spiegel, Covington, regulatory and public policy lawyer
Senior Of Counsel

Ambassador Daniel Spiegel was instrumental in the recent opening of the firm’s Seoul office where he spent a significant amount of time and remains deeply involved in Covington’s Korea practice.

He regularly counsels multinational corporations on complex market entry strategies in Asia and other regions.

Mr. Spiegel's international policy practice enables him to provide domestic and foreign clients with a broad range of legal services, strategic advice, and representation in their relations with both government and multilateral organizations such as the...

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