It is encouraging that India was reported to be the fourth largest funder of research and development (R&D) in neglected diseases as per the G Finder Survey which tracks global investments in R&D for the neglected diseases (The Hindu, January 24). This reflects the government’s commitment towards addressing the innovation problem in neglected diseases.
Neglected diseases are mostly tropical infectious diseases, and the market size for drugs for such diseases is small due to their limited geographical incidence. To highlight the common problem of lack of innovation for drugs, diagnostics and vaccines for this basket of diseases, WHO started addressing these as neglected diseases from late 1980s. Some examples of neglected diseases are malaria, tuberculosis, leishmaniasis (kala azar), dengue, leprosy, lymphatic filariasis and diarrhoeal diseases.
These diseases face an innovation deficit as they are neglected in R&D efforts of the pharmaceutical industry. However, it is not just the neglected diseases in the developing world that face this innovation deficit. Several rare diseases that affect the developed markets are called “orphan diseases.” These are called orphans because the pharmaceutical industry does not find it profitable to develop and market products intended for only a small number of patients suffering from rare diseases.
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Innovation model
This innovation deficit is caused by the prevailing model of pharmaceutical innovation. Drug discovery came about as a key component of modern medicine towards the end of the 19th century. Till mid-20th century, this was mostly carried out in academic settings. By the middle of the 20th century it became an endeavour that was largely driven by pharmaceutical companies. The second half of the 20th century saw consolidation of pharmaceutical entities leading to multinational pharmaceutical companies who drive innovation in the pharmaceutical sector. The business model of pharmaceutical innovation is market driven, and the governments have adopted a hands-off policy letting the market forces to work. However, the outcome of this process, namely, new drugs, diagnostics or vaccines are subject to strict regulatory control by the governments.
Orphan diseases comprise both rare diseases and neglected diseases. They are orphans of research focus, market interest and even public health policies. The reasons why these diseases have been ignored for so long are better understood today. The industry-led model works well in cases of diseases with markets that ensure adequate return on investment. If the market size is not attractive, industry will not invest in such cases. This leads to market failures resulting innovation deficit.
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When market fails, public policies must be put in place to address the issue. For this reason, governments and patient organisations in the developed markets have emphasised the need for providing policy incentives to encourage innovation to develop solutions for the “orphaned” rare disease patients. Both the U.S. and European Union have policies to support drug development for orphan diseases. The U.S., the U.K., Denmark, France, Italy, Sweden and Spain have public policies for treatment of rare diseases. The policy approach has been to treat such diseases as a class and tailor suitable policies.
India may learn from the above global examples treating neglected diseases as a class requiring special policy intervention to address the innovation deficit. A comprehensive policy supporting research, development and marketing and treatment of neglected disease aiming at their elimination is required if India aims to meet the Sustainable Development Goals.
Incentives
The thrust in funding research should be followed up with policies that incentivise industry to take up drug development. The Orphan Drugs Act of the U.S. has a basket of policies from drug development grants to tax credits, fast track approvals by regulatory agencies, seven-year market exclusivity, fee reductions for regulatory approvals to priority review vouchers.
Establishing a biomedical observatory which records and monitors the ongoing R&D in neglected diseases will help the government to ensure effective disbursal of the limited resources, identify research gaps and take corrective measures. The current thrust in internal resource generation in the national laboratories have the unintended effect of diverting research to diseases with market. A sustained and long-term funding commitment to neglected diseases will address this issue. If the Prime Minister’s slogan of ‘Jai Anusandhan’ has to reach its benefits to the poor and neglected patients, there should be a comprehensive policy to address the innovation deficit in neglected diseases.
(The author is an IRS officer who was earlier with CSIR’s Open Source Drug Discovery programme. Views expressed are personal.)