Rahim Rezaie: A neglected resource for neglected diseases

Rahim RezaieWhat does a recently developed meningitis vaccine, the the anti-malarial drug ASMQ, and balaglitazone have in common?

The meningitis vaccine is a partnership involving the Program for Appropriate Technology in Health (PATH), the WHO and the Serum Institute of India (Pune).  ASMQ was developed by Drugs for Neglected Diseases initiative (DNDi), a public-private-partnership (PPP) including Brazil’s Fiocruz (Rio de Janeiro).  Balaglitazone is a lead drug candidate undergoing phase III clinical trials for type II diabetes. Discovered by India’s Dr. Reddy’s laboratories and co-developed with Denmark’s Rheoscience (Roedovre), it has the potential to become the first major FDA-approved innovative drug out of an emerging markets company.  

These examples add to many others that demonstrate how innovative capacity in the south of India can help to advance southern health challenges; making resultant products more accessible.

Shantha Biotechnic’s (Hyderabad, India) hepatitis B vaccine is a classic example of how a process innovation helped reduce the price of this vaccine from over $20/dose US in India in the early 1990s to $1 upon its launch in 1997, with further price reductions since. One can imagine the impact of such a change on the estimated 40 million Indians who carry the hepatitis-B virus and the 100,000 infants that die annually from related causes (http://www.whoindia.org).

A growing number of domestic companies in China, India, Brazil, and South Africa, have innovative health products in the pipeline. Many more have served to make diagnostics, vaccines, and therapeutics more accessible to local and global populations through affordable innovation; in both technical and business model terms.  Some of these accomplishments have been illustrated in a series of papers our group has published in Nature Biotechnology focused on biopharmaceutical sectors in China, India, Brazil and South Africa, where we have studied approximately 90 such firms to date (http://www.mrcglobal.org/projects/publications).

In an article we published in this month’s issue of the Nature Biotechnology journal, entitled “Global health or global wealth?” my co-author Peter A. Singer and I ponder the future trajectory of health enterprises in the emerging markets as related to global health.

Collectively, emerging economy companies and their growing capacity to innovate represent a tremendous, but largely unrecognised, resource to advance health needs of the poor.  They are innovating close to the “coalface” of global health problems, making appropriateness, translation, uptake and affordability of resulting solutions more likely. Examples cited above testify to this potential.

Increased costs associated with developing innovative products together with the lure of more lucrative markets may compel many biopharmaceutical firms in the emerging market to abandon the needs of the poor. But developing country firms can pursue both goals – of global health and global wealth – in parallel, provided targeted support mechanisms are instituted to enable product development for the poorest market segments.

A series of measures are needed to bolster international and domestic support for continuing the success of firms in finding solutions to pressing health concerns in developing countries. These include greater integration of these firms into existing instruments aimed at stimulating global health innovation, such as public-private partnerships, advance market commitments, prizes and patent pools. Furthermore, there is need for initiatives and proposals targeted specifically at emerging economy firms to help engage more companies in global health. 

A “global health accelerator” mechanism, – to help health entrepreneurs in emerging economies commercialise health products most relevant to global health – adoption of orphan drug-like legislation by emerging markets, and new financing sources and mechanisms targeted at emerging market entrepreneurs are steps that can harness and strengthen the latter’s capabilities in the interest of global health.

Lastly, desired efforts need to be implemented with a sense of urgency. When it comes to innovation, emerging market biopharmaceutical firms, at this stage of their development, can be likened to teenagers.  The key message we offer is that as they chart a career path, they can do well and do good at the same time.  However, to succeed in both they need the right mix of incentives and supports. 

The global health community, international aid donors, and national governments, in the emerging markets themselves should not miss the opportunity to nurture Southern companies whose business models include global health.  These companies offer the potential to scale up global health efforts to new levels and to maximize accessibility of resultant vaccines, diagnostics and therapeutics to some of the poorest market segments in the developing world. 
Statement of disclosure:
“The author has completed the Unified Competing Interest form at <http://www.icmje.org/coi_disclosure.pdf> (available on request from the corresponding author) and declare:

“Rahim Rezaie has been supported through a Genome Canada Grant and a Doctoral Research Award from the Canadian Institutes of Health Research for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous 3 years; no other relationships or activities that could appear to have influenced the submitted work.”

Rahim Rezaie is a PhD candidate at the University of Toronto and is based at the McLauglin-Rotman Centre for Global Health.  He studies biopharmaceutical innovation by indigenous enterprises in China, India and Brazil.