-Why Major Pharmaceutical Companies Are Abandoning Antibiotics Production?
By Davis Buyondo
Kampala, Uganda
In recent times, big pharmaceutical companies have pulled away from creating new antibiotics. In their place, smaller biopharmaceutical firms have stepped up to take on this important task. Nevertheless, these courageous companies are grappling with various difficult challenges.
Until these problems are solved, the world, including countries like Uganda, will be in a risky situation where the supply of life-saving antibiotics keeps diminishing steadily.
The gravity of this global predicament came up during a recent global webinar organised by the Centre for Science and Environment (CSE), on August 24, 2023.
It was established that antibiotic resistance, a silent pandemic, is causing existing antibiotics to lose their effectiveness, leaving healthcare professionals with dwindling treatment options.
In 2019 alone, approximately five million deaths worldwide were attributed to antibiotic-resistant infections, a statistic that sends shockwaves through healthcare systems, economies, and livelihoods.
According to Sunita Narain, Director General of CSE and a member of the Global Leader’s Group on Antimicrobial Resistance (AMR), there’s an urgent need for new antibiotics.
Narain noted that major pharmaceutical companies have redirected their focus towards more profitable areas like cancer, autoimmune diseases, and metabolic disorders, leaving the development of antibiotics in the hands of smaller biopharmaceutical companies.
However, the burden on these smaller entities is immense, and their success hinges on receiving adequate support. During the discussions, key stakeholders and experts from India shed light on the formidable challenges faced by small and medium-scale antibiotic developers.
These challenges span scientific, financial, and regulatory spheres. Some of the main obstacles include a critical need for significant funding, ensuring that global rules and regulations are in sync, simplifying the process of testing medicines in real-world conditions, and creating faster ways to approve these life-saving antibiotics.
“In addition to the big funding for antibiotic innovators, there is a need for regulatory harmonisation at the global level so that the innovators can well use the data generated,” said Vasan Sambandamurthy from Bugworks, a biopharmaceutical company engaged in developing two traditional antibacterial agents.
He also mentioned the importance of allowing clinical trials for innovative drugs in India and establishing faster approval processes that clearly define how life-saving antibiotics can qualify. These measures can stimulate innovation and provide valuable assistance to companies involved in antibiotic discovery.
Sachin Bhagwat, a representative from Wockhardt, a company engaged in the development of four conventional antibiotics, emphasised the significance of finding the correct balance when choosing which projects to endorse.
This balance, he added, should be struck between supporting a feasible and distinct product addressing immediate unmet needs and investing in an innovative drug, which, though promising, carries a higher risk of potential failure in the long run.
“There has to be an emphasis on nurturing the discovery talent. If the current situation continues, we won’t be able to do much even if we put in all resources,” he cautioned.
From Gangagen Biotechnologies Pvt Ltd, T.S Balganesh said there is a pressing issue regarding sourcing funds for antibiotic development.
According to him, Western interests may not show enthusiasm for providing funding if pathogen resistance isn’t a significant concern in their region.
As a result, this circumstance places them in a complete dependency on funding sources from India or neighbouring countries. “The problem of commercialization is different from the problem of development. There are problems at several levels. We need to break it down and address each of them,” he added.
In response to these concerns, Jitendra Kumar, representing the Biotechnology Industry Research Assistance Council (BIRAC), highlighted a range of initiatives that have been put into action.
He expressed a strong commitment to addressing the challenges associated with Antimicrobial Resistance (AMR), acknowledging it as a global pandemic and an undeniable crisis.
Kumar reassured that BIRAC is dedicated to this cause and is actively working on solutions, pledging to do everything possible from their end to combat the AMR crisis.
Implications for Developing Countries
The global challenges in antibiotics development have profound implications for developing countries like Uganda. These nations often face a unique set of circumstances and vulnerabilities that make them especially susceptible to the consequences of antibiotic resistance and the scarcity of new antibiotics.
Uganda, like many developing countries, grapples with a high burden of infectious diseases. Antibiotics are critical tools in managing diseases like malaria, tuberculosis, and bacterial infections, which are prevalent in these regions.
The dwindling efficacy of existing antibiotics exacerbates the challenge of treating these diseases, potentially leading to increased morbidity and mortality.
Still, in countries with limited healthcare resources, the economic consequences of antibiotic resistance can be devastating. Increased healthcare costs, prolonged hospital stays, and reduced workforce productivity can strain already fragile economies. As the crisis deepens, the economic toll on developing countries may become unsustainable.
Furthermore, developing countries often struggle to ensure equitable access to healthcare, including antibiotics. The challenges faced by small and medium-sized antibiotic developers can further restrict the availability of new, effective antibiotics in these regions. Therefore, reduced access to antibiotics can lead to inadequate treatment, exacerbating the spread of antibiotic-resistant infections.
Another consequence involves the necessity for regulatory standardization and the creation of transparent clinical trial and approval pathways, which are essential for ensuring the efficient delivery of new antibiotics to patients in developing nations. The absence of globally recognized guidelines and streamlined procedures can impede access to innovative antibiotics.
In terms of research and innovation, developing nations can derive benefits from active participation in worldwide endeavours aimed at addressing antibiotic resistance. Initiatives that support research and innovation within these regions can contribute to the formulation of solutions tailored to local needs and bolster the capacity to combat antibiotic resistance.
Uganda’s AMR National Action Plan 2018-2023
Through the Ministry Of Health, the Republic of Uganda launched its National Action Plan to address Antimicrobial Resistance (AMR) for the period spanning 2018 to 2023.
This action plan was formulated in collaboration with the Global Antibiotic Resistance Partnership (GARP) under the Center for Disease Dynamics, Economics & Policy (CDDEP) and the Ugandan National Academy of Sciences.
It outlines five strategic initiatives aimed at raising public awareness regarding AMR, enhancing infection prevention and control measures, ensuring responsible access to and utilization of antimicrobial substances, instituting robust AMR surveillance systems, and fostering investments in research and innovation.
The NAP’s implementation is closely coordinated and monitored by the Uganda National Antimicrobial Resistance Committee, which will also track the progress of various interventions. While the government’s commitment to this endeavour is pivotal, the plan envisages a significant role for the private sector, civil society organizations, and the general public.
These stakeholders are expected not only to support government initiatives but also to actively engage in the execution of the proposed interventions. This collaborative approach underscores the comprehensive response required to effectively combat the global challenge of antimicrobial resistance.
WAAW Theme 2023
The theme for World Antimicrobial Awareness Week (WAAW) in 2023 will remain “Preventing Antimicrobial Resistance Together”. It is building upon the successful theme from the previous year.
This selection was the result of an extensive online survey involving stakeholders from various domains such as human, animal, plant, and environmental health, who provided valuable input to shape this year’s campaign theme.
Antimicrobial Resistance (AMR) poses a significant threat to the well-being of humans, animals, plants, and the environment, affecting all facets of life. Therefore, the theme for this year underscores the imperative of collaborative efforts across sectors to safeguard the effectiveness of these essential medicines.
However, the battle against AMR is a global endeavour, demanding a comprehensive “One Health” approach to address its challenges effectively.
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