Co-authored by Madhur Sachan, former Research Fellow at Central Drug Research Institute and member of Universities Allied for Essential Medicines (UAEM)
Antimicrobial resistance (AMR) in diseases including tuberculosis, malaria, HIV and influenza poses an alarming threat to human progress. Globally, 480,000 people develop multi-drug resistant tuberculosis each year, and drug resistance is complicating the fight against HIV and malaria, as well. However, in a post-antibiotic era where drug resistance could kill 10 million people annually by 2050, it is depressing that only two new classes of antibiotics have been developed in the last 40 years.
The failure to produce new, effective and affordable antibiotics highlights the inadequacy of the current profit-driven model of innovation...
AMR is a global health threat and is seriously evident in India. A poor public health infrastructure, high burden of disease, and unregulated sales of antibiotics have fostered a rapid rise in the nation. Even though mechanisms such as increasing drug regulation, communication campaigns to educate physicians and patients, and generating robust data on the extent of resistance have been suggested in the past, combating AMR demands nation-wide action and global governance. This antibiotic crisis is a symptom arising from the current profit-driven research and development (R&D) system. Therefore, a holistic and sustainable, needs-driven R&D system, established through a global R&D Agreement is the need of the hour. This new model for R&D delinks the cost of R&D from the prices of medical products and would help avoid future AMR crises.
Consider the example of tuberculosis: only two new drugs for tuberculosis have been delivered to the market in the last five decades. In addition to the lack of funding in tuberculosis R&D, 98% people are unable to access the developed innovations due to high prices and lack of registration in high-burden regions. Although India has already prepared a standard treatment protocol to restrict prescription sale of TB drugs, the implementation has been ineffective due to poor monitoring efforts.
Biomedical research and development should be needs-driven and evidence-based and be guided by the principles of affordability, effectiveness, efficiency and equity. In September 2016, after 10 years of debate, a UN High-Level Panel on Access to Medicines (UNHLP) restated the need for a real reform of the R&D system and recommended an R&D Convention for this purpose. Last year, more than 450 academics, including four Nobel laureates, joined Universities Allied for Essential Medicines (UAEM)'s call for this R&D reform, in a letter to the World Health Organisation. In spite of the profit-driven motives of many Big Pharma-allied representatives from the United States and certain European countries, countries like Brazil, India, and Thailand are still making efforts to move forward with the UNHLP recommendations.
Most academics today support a different biomedical R&D system, based on principles of open access, open sharing and fair pricing, as well as incentives and mechanisms to encourage R&D of essential medicines according to needs of people worldwide. UAEM's Re:Route project summarizes alternative proposals to circumvent the limitations of the current system, and addresses R&D issues ranging from the lack of R&D for neglected tropical diseases to high prices of cancer medications.
Most academics today support a different biomedical R&D system, based on principles of open access, open sharing and fair pricing...
AMR has become such a large problem and it could have been proactively prevented. As a country, India is taking steps to combat this menace by initiating the red line campaign and developing a National Action Plan on AMR under the stewardship of WHO India and National Centre for Disease Control. However, the implementation of these efforts will not be possible without a strong will and political commitment. The failure to produce new, effective and affordable antibiotics highlights the inadequacy of the current profit-driven model of innovation, which relies on patent-protected monopolies to generate large profits through high-priced sales. A profit-driven system of R&D conflicts with the need to use antibiotics judiciously. During this ongoing crisis, many countries are committed to a UN Political Declaration on AMR this year. Yet, the Political Declaration on AMR is limited to an issue that has already become a crisis: it is not a holistic and sustainable solution unless we adopt an alternative patient-centric R&D framework.