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Center For Disease Dynamics, Economics & Policy

Regulatory Landscape for Antimicrobial Resistance

Regulatory Landscape for Antimicrobial Resistance

CDDEP, in collaboration with the AMR Industry Alliance (AMRIA), is undertaking a landscape analysis to better understand critical regulatory challenges associated with AMR innovation in three middle-income countries with a high AMR footprint and pharmaceutical market growth: India, Brazil, and South Africa.

An assessment of the current state of antibiotic development paints an alarming picture of failing markets resulting from slow clinical uptake of drugs, relatively small numbers of target infections to support existing drugs economically, and an excess of recently approved and pipeline agents with redundant spectra. Although there has been some improvement in the last decade, pharmaceutical research and development have not responded to the growing need for new antibiotics. Given the likely scenario that some of the antibiotics in the pipeline will not be approved and that resistance will eventually develop to those that do, there are too few drugs in development to meet the projected clinical need. 

Innovative economic models that serve as incentives for developing new antibiotics fall into the categories of ‘push’ and ‘pull’ incentives. Push incentives consist of grants, subsidies, or tax incentives aimed at lowering the costs related to antibiotic R&D. A combination of push and pull incentives is required to ensure sustainable progress in the antibiotic pipeline.

However, other regulatory mechanisms could support AMR innovations. These include addressing regulatory hurdles to ensure timely introduction of new antibiotics and continuous access to existing ones, both of which are especially relevant in countries with less mature regulatory infrastructure experiencing high pharmaceutical market growth.  Some of the main regulatory barriers include lack of regulatory harmonization between countries and within-country coordination, lack of standards for the development of new antibiotics, and cost of clinical trials:

  1. Lack of regulatory harmonization across countries leads to unnecessary duplication of work and higher costs to bring a drug to the market. Regulatory harmonization through collaborations, work, and data sharing would significantly benefit countries with low national regulatory resources by reducing the time required for drug approval and increasing their decision-making confidence.
  2. Poor coordination between the different stakeholders within the countries; scientists, funders, regulators, and industry tend to work in parallel rather than together, hampering efforts to identify new chemical entities (molecules) that can enter clinical trials.
  3. Insufficient clarity on standards for accelerating the design and launch of potential and new antibiotics. For example, there is confusion regarding criteria for non-inferiority clinical trials or adaptive post-marketing trials to test antibiotic efficacy in patient sub-groups with multi-drug resistant infections.
  4. The high cost of conducting clinical trials in multiple countries represents a significant barrier, particularly in limited-resource settings.

The landscape analysis aims to provide an insight into the current climate for antibiotic R&D and regulatory perspectives related to introducing new antibiotics in South Africa, Brazil, and India.  The findings will be informed by literature and document reviews, and semi-structured interviews with stakeholders from national and international organizations, including the World Health Organization (WHO), the European Medicines Agency (EMA), the United States Food and Drug Administration (FDA), and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA).