LEAD STORY. Can govts vaccinate themselves against outbreaks?

It happened with Ebola, and then with Zika. Drug-makers have been criticised for not working on vaccines or medicines until forced by heath emergencies.

But the journey does not end with developing the right drug. In fact, a whole new bunch of complications then crops up — who gets the medicine first, especially if there is a shortage; how will it be priced; and who would own the research data.

Having seen several such instances, GlaxoSmithKline, the world’s biggest vaccine maker in volume terms, is batting for a “new model” to proactively plan for the research and manufacture of vaccines so that governments can be better prepared for public health emergencies.

The timeline to produce a vaccine is usually long, and there is a delicate demand-supply balance, explains Thomas Breuer, GSK Plc’s Chief Medical Officer (Vaccines), making a case for a “third space” to tackle such emergencies.

Recent disease outbreaks have seen companies put their ongoing vaccine research on hold to tackle the immediate emergency, he says. “We have to create a research site in a planned forward-looking way to develop potential new candidates without disrupting other activities.”

Detailing the GSK experience, Breuer says, “We have a dengue vaccine in development and currently because there is no other mechanism we put this on the backburner to address an acute public health emergency. But this is not clever.”

‘Not lucrative’ The outbreaks of Zika and Ebola were first reported from Brazil and West Africa. But as governments grappled with the local impact and their spread, the gravity of lack of medical preparedness hit home hard.

“Our current system of research and development (R&D) is failing patients for a range of health needs across the developing world — as medical tools are either unaffordable, not suited to the conditions of developing countries, or they simply do not exist,” says Rohit Malpani, Director (Policy and Analysis) with humanitarian organisation Medecins Sans Frontieres’ Access Campaign.

In the case of Ebola, despite nearly four decades of outbreaks, not a single drug, diagnostic or vaccine was available when it assumed epidemic proportions, he says, adding that even today, no medical tool is available for use in case of a new outbreak.

“‘At present, pharmaceutical companies do not focus on diseases that predominantly affect developing countries; not just for Ebola but also a range of neglected diseases such as tuberculosis. This is because the current incentive system, which is based on monopolies and high prices as a means to recover investments, steers companies away from urgent public health needs that are not lucrative.” Malpani explains.

The bio preparedness proposal may provide some resources for R&D that can respond to health emergencies and outbreaks. “Yet, it does not scratch the surface of the deeper failures of our current system of medical innovation,” he says. Ultimately government-led responses are needed to meet patient demands around the world.

Next week, at a WHO meeting chaired by India in Geneva, governments will be looking at some initial solutions to help improve monitoring, coordination and financing of research and development, with an eye to ensure affordability and suitability of new medicines and vaccines to meet patient needs in developing countries, he points out.

Supply constraints Explaining supply constraints, GSK’s Breuer says in the pneumococcal vaccine or a higher combination paediatric vaccine, for example, production from start to finish takes more than two years. So from a supply standpoint, there are safety stocks (bulk and finished product).

But all of a sudden if the Indian government finds it is short on locally produced vaccine and steps up demand for it in large numbers and wants it delivered by next week — that’s totally impossible, he says, adding that no one can act on a moment’s notice, except in an outbreak situation.

A WHO-type entity can help pre-empt and direct research in the direction most needed, he says. “We need a momentum to do that and, I believe, Ebola and Zika have created such a momentum and there are discussions around it,” he says.

Davinder Gill, chief executive with Hilleman Laboratories, explains how a global model could work. (Hilleman Labs is a joint-venture between drugmaker Merck Sharp and Dohme and the Wellcome Trust.) Following an outbreak, nascent ideas in biotech labs would get funded to develop the product; regulators would fast-track its approval.; and governments must commit to pick up the supply. The biggest concern for companies making such products is whether governments will pick up their supply, says Gill.

But whether indeed these mechanisms deliver better medicine to patients is something that will be tested as newer health crises beset governments across the world.

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