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Public health driven innovation & access to antibiotics & diagnostics

 

A public health driven approach for development and delivery of new antibiotics and diagnostics and where access for people in low- and middle-income countries is central will take stronger root among governments and international institutions

An end-to-end approach to innovation

Photo: Shutterstock.

Why is this important?

The traditional model for financing biomedical research & development (R&D) through volume-based sales is not working for the development of new antibiotics since they have to be used sparingly. Several reports from the World Health Organizations (WHO) have found that antibiotic innovation is not keeping pace to address priority, drug-resistant pathogens. Most of the big pharmaceutical companies have exited the field because of scientific challenges in developing novel antibiotics and more lucrative opportunities in other therapeutic areas like cancer drugs. The political interest from governments in addressing the exit of large pharmaceutical companies has not been commensurate with the scale and urgency of the growing problem of resistance development with existing antibiotics.

Discussions how to fix model focuses too much on financial returns

Discussions on how to fix the model have mostly been concerned with the financial returns sought by large pharmaceutical companies’ interests. However, re-enlisting these companies would miss the mark: in the WHO analysis on antibacterial agents in clinical and preclinical development, almost all of those commercial entities bringing new antibiotic candidates forward in the preclinical pipeline are micro-, small- or medium-sized institutions, not large pharmaceutical companies.

Paying companies for their Research and Development investments upfront means these investments do not need to be recouped through sales profits. Low-cost production and public health driven distribution models can therefore be established from the day the drug receives market authorization. Infograph: Zellout
Paying companies for their Research and Development investments upfront means these investments do not need to be recouped through sales profits. Low-cost production and public health driven distribution models can therefore be established from the day the drug receives market authorization. Click to enlarge. Infograph: Zellout

Missing end-to-end approach to antibiotic R&D

Existing efforts by either the industry or governments fail to take an end-to-end approach to R&D that aims to de-link the cost of R&D from sales revenue and ensure sustainable access to effective antibiotics for all. An end-to-end approach entails a diverse set of measures and incentives, from priority setting to addressing scientific challenges, through clinical trials, access and distribution.

Grossly inequitable global access to health commodities

The last two years have been marked by grossly inequitable global access to health commodities during the COVID-19 pandemic. It has become crystal clear that while lifesaving biomedical innovation may happen quickly once governments set clear priorities and provide significant investment, equitable and timely access to emerging end-products for all countries does not automatically follow in a market-driven system. The involvement of LMICs is critical in informing a new way forward for coordinating, prioritizing and financing of R&D. This can serve the global health needs of both rich and poor and provide timely, equitable and – in the case of antibiotics – sustainable access.

How can ReAct achieve change?

Use policy opportunities to advance an end-to-end approach to antibiotic innovation

We will use policy opportunities at global, regional and national levels to advance an end-to-end approach to antibiotic innovation and advocate for initiatives that address global access and align incentives to overcome different bottlenecks in bringing novel treatments to market. This can build upon efforts and lessons learned from the response to the COVID-19 pandemic.

Examine role of complementary technologies

We will examine how developing and scaling complementary technologies, such as diagnostics and vaccines, might play a greater role in curbing antibiotic resistance.

Build a coalition of academia and civil society organizations for a public health driven approach

We will continue to build a broader coalition of academia and civil society organizations to advocate for a public health driven, end-to-end approach for health technologies addressing antibiotic resistance and to oppose policy proposals that do not take account of ensuring access as well as stewardship in low- and middle-income countries.

What do we want to see?

Concrete elements of an end-to-end approach underway in partnership institutions

A policy dialogue with concrete elements of an end-to-end approach to address antibiotic resistance will be underway in some intergovernmental, funder and/or public-private partnership institutions.

Better understand of barriers for complementary technologies

A better understanding of the barriers for developing and scaling access to complementary technologies – diagnostics and vaccines that might reduce the need to use antibiotics – will lead to more public health driven investments in this field. These might include identifying scientific challenges, establishing the relative cost-effectiveness of such interventions, supporting market-shaping approaches, and adapting these technologies to low-resource settings.

Initiatives addressing obstacles in the R&D chain

Specific initiatives addressing obstacles in the R&D chain (for example overcoming barriers in the early discovery and research phases) are launched and supported, and existing ones garner sufficient financial and political support to enable a more effective end-to-end approach.

Access to antibiotics – production & procurement

Child's hands holding antibiotic pills.
Do we want sustainable access to effective antibiotics? If so – it is time to act. Photo: Shutterstock.

Why is this important?

Once a novel antibiotic is brought through clinical development, there are several challenges with the current approach to global production, registration, and supply of antibiotics that need to be addressed. Limited access to already existing antibiotics is another serious challenge in low- and middle-income countries.

Both supply and demand side contribute to antibiotic shortages

Several reasons on both the supply and the demand side contribute to antibiotic shortages arising. On the supply side, the current global supply chain is fragile and relies on only a few manufacturers based in a few countries. For some antibiotics, there are just one or two major manufacturers of the active pharmaceutical ingredient (API) supplying global production; therefore, disruptions can lead to global stockouts and shortages. A lack of transparency in the global supply chains makes it difficult to assess the full extent of the current system’s fragility.

Low resource settings – insufficient budget commitments

In many low- and middle-income countries the situation is often aggravated due to a number of factors, one being insufficient budget commitments. There is often an overreliance on a public supply chain system that is under-resourced with a weak capacity in forecasting, procurement and distribution. Challenges with the cold-chain system are another key aspect. Furthermore, the lack of WHO pre-qualifications which is very expensive is another limitation to sustained access. Many health structures suffer from chronic stock-outs. All these result in poor treatment options for patients and can be a driver of resistance when treatment providers are forced to prescribe alternative antibiotics.

Countries take steps to address antibiotic shortages

A number of countries are taking national steps to address shortages. For example, in July 2020, the government of India decided to incentivize the local production of 53 medicines, including several antibiotics, key starting materials, and APIs, in order to avoid future supply disruptions of key medicines. Similarly, the European Union is considering reshoring API production for essential drugs, including antibiotics, to Europe.

Challenge: Fragmented and unpredictable demand

On the demand side, fragmented and unpredictable demand forecasting and procurement are problems in many countries, especially where these functions are decentralized. Such fragmentation of demand and procurement can limit a country’s ability to secure adequate supply. Pooled procurement entities, like UNICEF and PAHO’s Revolving Fund for Vaccine Access in collaboration with the vaccines pillar of the Access to COVID-19 Tools Accelerator (COVAX) Facility, have begun to reshape how supply chains might work to scale access to health commodities.

How can ReAct achieve change?

Focus on systems thinking

We will elaborate and advocate for systems thinking drawing on the interplay of production, procurement, and pricing to ensure access to antibiotics and other health technologies both at the global level and in AMR National Action Plans implementation.

Analyze and address challenges in the pharma value chain

We will analyze and address challenges in the pharmaceutical value chain, from production to procurement, including environmental aspects as well as trade and technology transfer at the regional and national levels in selected low- and middle-income countries.

What do we want to see?

Key stakeholders to focus on access to antibiotics and other health technologies – pursuing an end-to-end approach

Key stakeholders would pay increased attention to addressing access, not just excess, of antibiotics and other health technologies to tackle antibiotic resistance in pursuing an end-to-end approach, such as production and procurement in a selected number of low- and middle-income countries.

Increased engagement local production

There will be increased engagement among national, regional and intergovernmental organizations on the issue of local production, including new incentives towards manufacturing and on initiatives such as pooled procurement.