K. Vijay Raghavan, chairperson of CEPI’s interim board, and secretary, department of biotechnology (DBT), spoke in an interview about India’s public health concerns, indigenous vaccine preparedness, raising funds for CEPI, and why the country may be primed to capitalize on a drug approval process overhaul. Edited excerpts :
As chairperson of the interim board, what is your vision for CEPI?
Epidemics of emerging infectious diseases are a significant and growing threat to life, health and prosperity. They can arise anywhere at any time, and in a world of denser cities, increased mobility and ecological change, their disruptive impact is increasing. They are among the most pressing health security issues that the world faces today.
Recent outbreaks, such as Ebola and SARS, have claimed thousands of lives and cost billions of dollars, both to countries that were directly affected and those that contributed to responding. Ongoing outbreaks of Zika will pose devastating health and economic impacts for years to come.
All these events have exposed serious flaws in the world’s capacity to prepare for epidemics, and to react when they strike. For known and as yet unknown diseases, vaccines offer the potential to be deployed rapidly and on a scale to prevent both disease and its spread.
The interim board and the secretariat are working to bring key stakeholders and funders to the table. The time to bring partners together to make possibilities real is now. CEPI will be a sustainable gap-filling partnership to proactively develop vaccines to insure us against many future infectious threats.
The World Health Organization had agreed on focusing on about 10 priority pathogens with the initial work to focus on three to four diseases. Which are the diseases that CEPI will initially focus on?
There have been several recent prioritization lists made by the WHO, by the National Institutes of Health in the US and the Foundation for Vaccine Research supported by the US National Academy of Sciences, but all of these focus only on the potential public health impact of vaccines. CEPI’s approach is a little different, because we will work in areas where the vaccines are not being taken forward because of the expectation of “market failure", in that vaccine companies have decided not to pursue further vaccine development because costs of development will be greater than any possible returns on investment.
The diseases that CEPI will focus on will be decided by the Scientific Advisory Council, which will have its first meeting in October 2016. The council and teams that preceded its establishment developed a set of criteria based on the principles of gap-filling and public health impact.
The idea of CEPI stemmed from Wellcome Trust director Jeremy Farrar’s call to establish a global vaccine-development fund wherein he had asked for $2 billion to launch the fund. Apart from donations, how does CEPI intend to raise funds to invest in research and development, trials, production (and surge) if and when required?
CEPI’s preliminary cost-modelling estimates are that in order to advance 10 vaccine candidates to the end of phase 2 development in five years may cost more than $2 billion, and a multi-source financing model is envisaged. Direct unrestricted grants or donations to the CEPI Fund will be complemented by dedicated funds such as research and development grants restricted for the purpose by donors or advance market commitments. We will also explore a model similar to the Gavi Alliance’s International Finance Facility for Immunization, known as IFFIm, which uses long-term donor pledges to issue vaccine bonds on the capital markets.
The money raised from investors helps fund Gavi programmes and affords the flexibility to access funds when needed. Given that Ebola costs for the three countries most affected was estimated by the World Bank to be $4 billion, even one epidemic for which a CEPI product can be used will be enough payback.
Traditionally, India has not been a massive contributor to global health efforts and its indigenous vaccine development capabilities have been limited. How does that impact India’s contribution to CEPI?
India is a global leader in vaccines. It produces over 40% of the vaccines that are used for routine immunization of children globally against diphtheria, pertussis, tetanus, polio, measles and rubella. Indian vaccine manufacturers are leaders in low-cost, high-volume manufacturing and the global recognition of the ability to make high quality vaccines at low cost was evidenced by the production of a meningitis vaccine by an Indian company that has. in a few years, wiped out disease from the “Meningitis Belt" in sub-Saharan Africa.
However, in terms of value, the Indian vaccine industry is only 2% of the global vaccine market, because few new vaccines are developed and tested in India. Low margins on existing vaccines provided to public immunization systems lead to low investment in R&D on new platforms and targets. Despite recognition of these lacunae, little has been done to systematically address the gaps that significantly limit the ability of the Indian vaccine industry in value addition, competitive advantage and in enhancing health security, particularly in terms of a vaccine based response to disease outbreaks.
At DBT, in addition to partnering with CEPI, we will partner with the Indian vaccine industry to facilitate their ability to compete on global stage, not just in manufacturing but also in development and use of new platform technologies.
Will India contribute in raising funds for CEPI? What is the scale of funds that you are looking to raise, and from where?
Yes, we will be contributing in raising funds for CEPI. The size of the commitment is as yet undecided, as is the case for most donors. CEPI will have an announcement at Davos, at which we expect the government of India to participate.
Closer home, NITI Aayog has asked the government to update the drug approval process followed in the country. It has asked for the streamlining of the process which could potentially include scrapping the Review Committee on Genetic Manipulation under the DBT. Does India’s drug approval process require significant overhaul?
NITI Aayog is doing an excellent job in formulating and streamlining policy. There are three aspects of the regulatory process. Science, regulatory science and society.
Society on the one hand needs medicines and crops that are safe and effective and on the other hand demands and needs to be assured that due process has been followed. The process must be based on science and must have a clearly laid out set of steps.
All three aspects are dynamic and need constant revision and calibration. The goals of regulation must be the assurance that products are safe as delivered. Safety requires trials based on science—the safest aircraft is one which never takes off. So trials must be sensible and calibrated.
India has an excellent regulatory system that is constantly being enhanced and improved as science and regulatory science changes. Being relatively new here, we also have a great opportunity to be more efficient and correct compared to older systems.
India is seen as a major generics exporter in the world, but questions have been raised about India’s stance on intellectual property rights. How can India reconcile itself to the domestic demands of ensuring public health while offering adequate support and protection to innovation in the pharmaceutical industry?
In the non-generics sector, the issue you raise is one of compulsory licensing/pricing. India has used this “weapon" only rarely as compared to even the US. While one can debate where and when this is to be used, the fundamental issues are two. Can Indian industry compete in being innovative and inventive? And secondly, can we provide affordable health care for our population?
The answer to the former is yes, we are seeing trends that point to major novel drug and vaccine development efforts coming from India. The answer to the second question needs to be addressed comprehensively by the states and by the centre. Pricing can deal with specific emergencies but cannot deal with the bigger issue.
There is a new Drugs and Cosmetics Act on the anvil. Will the department of biotechnology be playing a part in shaping the new Act?
Yes, we work closely with other ministries who are leading this.