Challenges for effective public health measures

The fundamental challenges facing public health measures in India and developing countries have been to provide protective immunization at affordable cost to large and growing naïve population. The authors propose while saying that the country is not short on vision and entrepreneurship, the government needs to lend a helping hand similar to that in China by investing upfront in new ventures, and to minimize the risks to the private players so that vaccines can play a very important role towards this goal.

One of the fundamental challenges to implementing effective public health measures in India and indeed in any developing country is an assessment of disease burden in relation to the demographic trends in the region. While appreciating the fact that the disease burden increases with aging population, the challenge has been to provide protective immunization at an affordable cost to a large and growing naive population.

The viral epidemics of the recent times has exposed our under preparedness in tackling potentially large public health issues. If the incidence of mortality and morbidity of the recent epidemics is the yardstick to assess the extent of our preparedness for the future, we have to completely overhaul our systems to reduce the adverse socio-economic impact and to mitigate the high strike rate that such epidemics can potentially have on our fragile healthcare systems. The healthcare problems that confront developing countries are manifold. The alarming increase in the use of antibiotics in the hospital and in the community has caused widespread drug resistance. The situation is further exacerbated by the lack of robust diagnostics that hampers rapid administration of appropriate therapy, particularly in life threatening situations.

In the developing world, the international and national efforts in addressing communicable disease problems have been largely geared towards developing vaccines for tuberculosis, malaria and HIV. After decades of research, the continued high mortality and morbidity due to these diseases in the developing countries underlines the lack of scientific breakthrough in providing effective prophylactic protection.

However, recent clinical data have provided a glimmer of hope that it is possible to develop vaccines for these invasive pathogens. Furthermore, advances in vaccine research including novel adjuvants, directed vaccine delivery and prime–boost regimes have led to the development of new generation vaccines for difficult to treat diseases such as tuberculosis.

The threat of new emerging infections has particularly challenged the intellectual, logistical and manufacturing capabilities in the developing countries and left the field wide open for new players to emerge in the vaccine industry. It is heartening to see that the developing countries vaccine manufacturers have seized the initiatives that new diseases offer, and have taken up the challenge to develop new vaccines.

Notable efforts in India are development of vaccines for meningococci, pneumococcal infections, malaria, Dengue, Japanese encephalitis virus, rotavirus, cholera, typhoid, influenza and for Chikungunya virus. In the next decade or so, the strategic efforts to increase the affordability and accessibility of the vaccines would largely focus on increasing the operational efficiency in manufacturing, accelerated clinical development for vaccine licensing, new manufacturing platforms, bold translational research initiatives, innovative process engineering, development of thermostable vaccines to circumvent the cold chain, novel combination vaccines and development of novel adjuvants and vaccine delivery systems for antigen sparing and nanotechnology based applications.

The public research institutions should increasingly contribute to study of molecular epidemiology of infectious agents that would aid the development of robust vaccines. An assessment of vaccination in relation to demographic trends in the region, burden of disease information and post-marketing surveillance would be vital to development of new generation vaccines. The bane of biotechnology industry is capital intensive research and product development. The industry is still at an infancy stage in this country has the numerous regulatory hurdles to contend with. Where the industry does not have the resources for bold new ventures, there is an increasing and welcome trend towards licensing agreements and strategic partnerships to expand the product pipeline, and this trend is likely to continue in the near and long term.

Over the next decade or so, institutional efforts to accelerate vaccine research and development would continue to place emphasis on public-private partnership to leverage the fundamental knowledge base in academic institutions and to couple it with expertise in product development and commercialization by the private partner. Despite the enormous spending in the past decade in the public-private partnership mode, very few research ideas have actually been translated to tangible products.

There is a growing appreciation that private R&D could indeed play a significant role in development of new products. While this is a welcome trend, the institutional support to initiatives in the private sector has been lukewarm at the best. In the current intellectual property regime, there is an increasing realization that it is indeed a wake up call for the industry to create a strong innovative platform for vaccine research and development, in order to survive in the business, and any potential worth in future would be gauged by the intellectual property that is accrued to the organization.

While the country is not short on vision and entrepreneurship, the government needs to lend a helping hand similar to the trend in China and elsewhere in the region by investing upfront in new ventures, and to minimize the risks to the private players. Only this would spur innovation and enterprise. Otherwise the perceived risks would continue to force the biotechnology industry to tow the biosimilar pipeline at the cost of innovation and enterprise in the country.

The Government can additionally help simplifying the complicated statuatory procedures and approvals to accelerate the speed and realization of revenues from bold initiatives. Considering the capital expenditure involved innovation, the biotech sector should be treated on par with IT industry on income tax exemption, especially during the incubation period. If the government supports these initiatives, we will see a surge of entrepreneurs who will be willing to take risks and help India become the hub of vaccine innovation and research. We have certainly made a beginning, but have a long way to go.