Opinion
Everyone points to the problem, but no one has a solution.

The city was Geneva and the setting was a meeting with Indian health authorities, including the Union Minister, who were attending the annual meeting of the World Health Organisation (WHO). Two of us from The News Minute were discussing with the Indian delegation issues relating to access, delinking cost and price of drugs, regulatory systems including monitoring in India and the criticism that the world’s largest pharmacy – India – was slipping in its standards of monitoring its lucrative generics manufacturing industry. Why, for example, could India, which accounts for 60% of vaccines produced globally, with some 55% of drugs being made in India exported, not dig in where issues of access really matter i.e. trade and market access?

The first awkward moment in our conversation came when it was announced that almost all pharmacies in India are accounted for and none sell prescription-only drugs over the counter (OTC). This is that moment when pride (my own in the potential strength of India’s pharmaceutical industry) and prejudice (of a growing international view that India’s generics are sub-standard and monitoring is weak) must give way to fact, as it did for me.

I said I can buy any drug in India without a prescription and cited the example of a revolutionary cancer drug Revlimid and where it was available in Delhi. The answer from the other side came along expected lines – that it was an aberration and the wrong would be corrected posthaste. Tell us which pharmacy was selling the drug illegally, we will take action, we were told – and it dawned on me that I could have put the pharmacy back home in trouble sitting far away in Geneva.

But here’s what was left lingering in the air, unaddressed – How was India going to monitor the millions of pharmacies across the country?

The drug continues to be sold over the counter in India, in some places out of an icebox that has experienced long power cuts. In responsible situations, the medicine is not administered without a blood test and determination of other vitals. Besides, how many pharmacies can an under-staffed and over-stretched health ministry monitor? More importantly, is monitoring and surveillance the job of a single ministry in a country of nearly 1.3 billion people? Many NGOs have asked how refrigeration and transport are linked to access. Cold chain - what cold chain? 

The other moment of awkwardness in the conversation came when we raised the issue of cost and price. As a media person, a former international civil servant in public health, the head of a company in Switzerland and a cancer graduate, I bring a broad angle to this issue. I have spoken to numerous public health experts from around the world over the years and whichever way you roll the dice, the answer boils down to money. Not just money as it is commonly understood but also the dollar value that is placed on a human life. What value do you place on a human life and how much are you willing to pay to protect it? When asked how exactly do we fund research if not through the market, we were met with platitudes, including ideas such as the ‘push’ and ‘pull’ mechanism.

Both, unfortunately, might not work. The ‘push’ mechanism depends on altruism on the part of the pharmaceutical industry and their original drug discoveries and breakthroughs to be shared without a serious return on investment (RoI) for them. The 'pull' mechanism is an invitation for researchers to compete for a corpus of resources to produce new cures and treatments which many believe is an invitation to skew research against facts. What happens if a prize-winning drug has defects after the lights have been switched off? There are no angels in public health - none. 

Here is what the two awkward moments point out to us. One, the Indian establishment does not want to address the lack of monitoring of pharmacies as a policy issue, but one of implementation, which can be sorted out by penalising offenders if and when they are reported. This comes from the lack of understanding that private pharma companies can be, and already are, an important part of the monitoring process. Two, no one, including the Indian health establishment, backing calls for delinking access from research, has any clue on how to fund R&D if the delinking is done.

And yet, conferences are being attended and resolutions are being passed by people who look at the pharmaceutical industry, either with adulation or fear, or in some cases, envy.  Collusion too, but that has its own language and you can spot it when diplomats chase brackets past midnight. It is almost impossible to have a discussion about the cost of a drug and its price with Indian public health officials without confronting a set of regurgitated scenarios or hyperbole. The situation internationally is not very different. A public health official who understands science, economics, policy, pricing and politics is rare. There are people who make the links, but they are to be found on the stratosphere. 

So, I try a different way, taking the manufacturing industry as an example. A company makes crankshafts. These are randomly checked by robots, and should a faulty piece emerge, the entire process is stopped to ferret out the defect. There is a cost attached to this delay. To date, nobody has worked out the math for me to know who picks up the tab in public health - companies, governments or end users? Going by the rule of thumb, if the R&D associated with getting a new molecule to the market is some $2 billion, at what point does the product interact with the market. Is the determination of cost an artificial starting point? For example, policy hawks and professors cite the example of Imatinib, a cancer drug that has a cost of production between $120 -$160 but a market price of anything between $30,000 and $100,000 annually. Where is the layering, why does it come in, where are the numbers - it does not make economic sense because somewhere along the discovery and production line, the product is not touching the market or not allowed to do so. Indian public health officials are unclear about where they stand vis-a-vis the market when posed this question. If market interaction is barred, then we are looking at a socialist system based on doles and hand-outs. Access has a very different meaning in this system of dachas. 

The overwhelming drift is that pharmaceutical companies are greedy. This is largely true of those based in the United States (US) where profits and only profits matter.  Europe has different layers of accountability because it does not follow a one-size-fits-all model. But, an increasing number of companies are looking at value-based pricing i.e. manufacturers make the money a country would save over the life time of a person receiving frontline drugs now. Some 90,000 Indian women die annually due to cervical cancer. A majority of these deaths can be prevented by vaccines that are now available in the developed and developing world including very poor countries. India is not equipped to collect, analyse and propose innovative payment models as that requires true multi-sectoral collaboration. Epidemiologists and economists, trade and market experts have to sit around a table to speak the same language i.e. access for patients.

The value determination in the pharmaceutical industry is unfairly held in an asymmetry of information with those knowing most skewing the debate and the dollars in their favour. This does not, for a moment mean that developing nations like India are ‘ignorant’ of the game for, it is a game. Public health bureaucrats do not understand business and many governments publicly claim an aversion to any association with the private sector while lining up for their dollar via foundations. Their worst 'public' enemy is markets. Experience has taught me that the more strident negotiators are in public, the greater the chances of a backroom deal. Key players have and will remain suspicious of each other. There’s money in manufactured confusion. There’s money in failure. There’s money in pretence.

The worst affected are patients and people especially in poor countries. They remain clueless about whether or not Big Pharma in their country or from outside is taking them for a ride. Steve Pearson, a Harvard lecturer turned non-profit head, proposes some actions. His shop, the Institute for Clinical and Economic Review (ICER), has one purpose - to secure prices of individual drugs under control and do the math about what is correct pricing. You would think his work would be welcomed with open arms. Wrong. He's up against patients and insurance companies who have called him everything, from an idealist to a scumbag to a rabble-rouser. Read here

So, what is the way forward? There are a few, but to engage them in any meaningful way, India must stop pretending that all is well within and the enemy is the big, bad pharmaceutical industry and its corollary called market mechanism. Enable an environment of trust and empathy where primary health becomes a political priority for the entire country. Speak to people who understand markets and keep egos out.

 

(Views expressed by the author are personal.)