Personal ViewWill longer antimicrobial patents improve global public health?
Introduction
Antimicrobial agents are valuable resources for global public health. As microbial resistance progresses, each new pharmaceutical molecule represents a potentially exhaustible innovation, similar in some ways to natural resources such as fossil fuels.1 Society could respond to antimicrobial exhaustion in two ways: (1) production of novel antimicrobial drugs through research and development (the supply-side production response), and (2) conservation of existing antimicrobial drugs through research, development, and implementation of prudent techniques of antimicrobial therapy to maximise effectiveness, delay resistance, and conserve resources (the demand-side conservation response). In recent publications, leading academic groups have evaluated the medical need for additional antimicrobial drugs. These groups include the Infectious Diseases Society of America (IDSA),2, 3 the European Society of Clinical Microbiology and Infectious Diseases (ESCMID),4 a European Union (EU) Intergovernmental Conference,5 the US Institute of Medicine,6 the UK Commission on Macroeconomics and Health,7 and others.8, 9 The groups find the research and development pipeline to be insufficient. Among a host of recommendations, several of these reports propose supply-side strategies such as extending patent terms for antimicrobial drugs and creating patent rights that can be transferred to other drugs, a “transferable intellectual property right” (TIPR) or “wildcard” patent.2, 3, 4, 5, 8 Wildcard patents have been proposed in two prominent bills in the US Congress, supported in part by such reports.10, 11
The case for wildcards and patent extensions is founded upon two claims. First, that we face an unprecedented drought in the discovery of novel antimicrobial classes, and second, that changes to the patent system are therefore indicated. In this Personal View, we examine both propositions. We review the claim that drug companies are failing to deliver new antimicrobial classes, but most importantly we highlight how patent extension will operate as a global tax on treatments for common diseases while inefficiently cross-subsidising antimicrobial research.
Section snippets
Is the antimicrobial research and development pipeline empty?
The following discussion is a Sisyphean task, an attempt to characterise the glass as half full rather than half empty. We recognise that resistance drives the clinical need for additional antimicrobial drugs, the importance of prudent use of antimicrobial drugs,12, 13 and that every physician would prefer to have better weapons against infectious disease. Our purpose in this section is quite limited; we seek only to question certain elements of the claims by IDSA,2, 3 ESCMID,4 and others,5, 6,
Will longer patents improve global public health?
We will now evaluate the claim that wildcards and patent extensions are the correct mechanisms to stimulate antimicrobial innovation and therefore improve global public health. The existing published work emphasises that the patent system entails both costs and benefits to patients and society.50, 51, 52, 53 Bad Bugs, No Drugs,2 and similar reports3, 4, 5, 8 did not adequately examine the potential costs of wildcards and patent extensions.
Alternatives to longer patents
We suggest that funds earmarked by the patent-based drug industry for wildcards and patent extensions could be more thoughtfully applied to other approaches with greater positive effect on global public health.
Conclusion
Health-care providers seek effective clinical options for patients with serious infections. Whereas the patent-based pharmaceutical industry seeks wildcard patents and patent term extensions, the public's health might be better served by increasing direct public funding for antimicrobial research, reimbursing providers for infection control, creating innovative diagnostic tests and antimicrobial drugs, and otherwise investing in conservation.
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2019, Ecological EconomicsCitation Excerpt :The late twentieth century witnessed incredible improvement in the treatment of bacterial infectious diseases, thanks to discovery of active compounds and affordable access to antimicrobials. Unfortunately, it has become less profitable to develop new antimicrobials compared to drugs for non-communicable diseases, for several reasons, including low likelihood of reaching the market and decreased value when resistance inevitably emerges (Outterson et al., 2007). As the antimicrobial pipeline dries up, the selection of resistant bacteria, unavoidably associated with antimicrobial use (AMU), has led to a situation where the treatment of some infected patients has become difficult, costly or even impossible (Boucher et al., 2013; Carlet et al., 2012; Laxminarayan et al., 2013).
Time for a change in how new antibiotics are reimbursed: Development of an insurance framework for funding new antibiotics based on a policy of risk mitigation
2017, Health PolicyCitation Excerpt :The impact on GDP would also be considerable [24]. We next modelled the impact on the base case eNPV of incentives previously proposed [25–31]. We examined: (1) public-private partnerships (PPPs), assuming public funding covered 50% of total R&D (pre- and post-launch) costs; (2) implementation of the Tier B regulatory pathway as set out by Rex et al. [11] with one phase III trial rather than two (standard) phase III trial for each of two indications; (3) use of both a PPP and Tier B; (4) 5-year extended market exclusivity, used in combination with the base case and each of (1) − (3).
Changing antibiotic resistance: sustainability transformation to a pro-microbial planet
2017, Current Opinion in Environmental SustainabilityCitation Excerpt :Conservation of treatable microorganisms and promotion of the many benefits humans derive from microbes are important twin sustainability narratives of limiting AMR [3]. Yet, historically [8,9], drug innovation and the need to ‘fix the pipeline’ of new drugs has been the dominant discourse [10–12,13••]. Meanwhile, the benefits of microbes continues to be overlooked and were not mentioned by a single word in the 2016 United Nations General Assembly (UNGA) declaration on AMR [14].
Regulatory Incentives for Antibiotic Drug Development: A Review of Recent Proposals
2016, Bioorganic and Medicinal ChemistryCitation Excerpt :Though certainly appealing to pharmaceutical companies, wildcard exclusivities could have astonishing cost implications. The cost of conducting an antibiotic trial would be in the tens of millions of dollars; the net profit from a wildcard voucher could be in the tens of billions.48 Proposed use of wildcard vouchers to antibiotics has recently been resurrected, although one analysis highlighted several flaws: (1) the duration of market exclusivity can potentially have tremendous costs (in terms of both patient access and affordability); (2) a significant mismatch between financial value and effort may result; (3) no clear method of rewarding transformative drugs exists; and (4) if vouchers are granted for antibiotics, other interest groups will lobby for inclusion.50