In defence of TPP - Environment and Intellectual property

In this post I'll tackle the  issues raised against the TPP in the areas of environment and intellectual property.

The opposition to the TPP from environmental activists comes from two contradictory positions - one is that any promotion of trade and economic activity leads to degradation of the environment and therefore must be stopped. The second argument is that the TPP does not go far enough to make environmental and climate change issues at the heart of any trade deal.

The first argument is not worth debating, for it is a loony left idea that deserves contempt. Denying the opportunity of economic advancement to the world's poor should be treated as a crime; for that is what it is. It would be far better if these activists were to specify how growth can happen with minimum effects on the environment (for eg what energy sources could be acceptable) and what the trade offs and choices should be. This they do not do and simply oppose everything. Such a position is not worth a shouting match.

The second argument is worth serious consideration. The US over many bilateral trade agreements has been pushing the following principles

* A binding agreement that countries would not lower their environmental standards in order to attract investment

* That their obligations under other multilateral climate control agreements would override any provisions of the Free Trade Agreement

* A long list of prohibited activities - like logging, deforestation, trade in wildlife, etc

In the TPP negotiations, the US is actually on the defensive as internally the Republicans will block any deal that contains significant provisions on climate change. Countries like New Zealand and Australia which are far more advanced on climate change issues are pushing for tighter provisions. These will have to be negotiated through, but given that the US is such an important player, it is unlikely that they would be able to do much progress. The activists are right to push for greater environmental standards. But the TPP is the wrong place to fight this. They should force the US, which single handedly screwed up the Kyoto Protocol, to come with an alternative.

I approach the second issue of intellectual property rights with some trepidation as that would mean arguing with Medicines Sans Frontiers (MSF) , a saintly organisation, which I am neither competent nor entitled to do. The issue is primarily of patent protection to pharmaceuticals. The US would like patent protection similar to what it has inside its own country. This would mean high prices for drugs for a long time in other countries and inhibition of development of far cheaper generic drugs. As this would disproportionately hurt the poor, MSF has been objecting to patent advancement through Free Trade Agreements. It is a difficult and thorny issue on which there are no easy answers . I am ducking this issue as this is not a big issue with the opposition to the TPP in the US, which is the prime theme of this series of posts. To its credit, the US negotiating team is trying to promote the principle  of "active window" - a period of time which would be longer for developed countries and shorter for developing countries when patent protection would exist and after that the country would be free to promote generics. That might be the best compromise.

This is probably an easy post - neither of these issues are ones on which US politicians should  kill the TPP. Despite the lunacy of a not insubstantial number of US politicians, this is unlikely to happen.

Tomorrow I will conclude this series with examining the secrecy surrounding the negotiations which is common cause made both by my good friend and Elizabeth Warren !!

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A tough ethical issue

Businesses are often considered as machines without a heart. But even businesses face some gut wrenching ethical issues , where the "right" course of action is by no means obvious.  Take the case of the compassionate care issue face by pharmaceutical companies.

Drugs produced by pharmaceutical companies are marketed after years, and sometimes, decades of clinical trials. They have to be approved by a regulating body - in the case of the US, the FDA - before they can be made available for use by doctors and patients. This is a justifiably stringent process.

It is therefore obvious that at any point in time, there are a number of experimental drugs which are at various stages of testing or approval. They may or may not finally make it to the market place. But the fact of their existence, their performance in the trials, the stage of FDA approval (relevant since most drugs are discovered in the US) are all fairly common knowledge and often in the public domain.

The ethical issue comes when there is say a terminally ill patient who does not have much time left and where conventional approved forms of treatment have failed. The patient, or his family, makes the appeal to a pharmaceutical company for an experimental drug that is not yet fully tested and has not been approved by the FDA. Is it ethical for the company to release an experimental drug for such a patient ? They may not even be making the drug outside of the lab as yet. Should they actually produce it in a pilot facility to make it available ?

I learnt from this news article that hundreds of such requests actually come to the FDA every year . The regulator examines each such request and apparently they are mostly approved. But for any serious evaluation of a request, they need time and that is probably what the patient does not have. Even if there was a little time, the patient and the family would be understandably anxious to try the treatment tomorrow if possible. So, even with an FDA approval of the case, how does a company respond to such a request.

On one hand, it is absolutely cruel to withhold a possibility of a chance, however slim, from somebody who will otherwise die. The case for release of experimental drugs is very strong. It doesn't need any further elaboration.

But consider the risks. Doctors will be the first to tell you that there are many grey cases where it is not easy to determine if the patient is terminally ill. What if there are are horrendous side effects which are not yet known - at what stage of experimentation of a drug is it OK for it to be released to a live patient. What about the risks of lawsuits - after all we are talking about the US a notoriously litigious society. What about the risks that companies may simply use terminal patients as clinical trials if compassionate care becomes widespread. What about non terminal cases (say Parkinson's or Alzheimer's, which are non fatal but horrible diseases) where an experimental treatment might drastically alter the quality of life.

Thorny ethical issues. I would hate to be in a position making the decision. Johnson & Johnson, a famously ethical company has moved to set up an independent panel to be organised by the New York University to decide on each case. That is probably the best course of action, but each decision would be extremely difficult to make.

What do you think - in which direction would you lean ?

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The $1000 pill

How do you price a drug ?  Its a question almost impossible to answer without vehement and justifiable criticism, whatever your answer may be. Nothing typifies this better than the absolute storm raging over Sovaldi.

Sovaldi is a new drug introduced as a cure for Hepatitis C, which was hitherto very difficult to cure. Almost a miracle drug with something like 90% success rate.  In six months it has already become the largest selling drug in the world. In these six months, it has clocked sales of $5.7 billion. Its maker, Gilead, has seen a 50% jump in share price.  Fantastic, you would think.

The only fly in the ointment is that each pill costs $1000 in the US. Or Rs 60,000 if you prefer. You need to take the pills for a six week period, twice a day. That's a bill of $ 84,000. In the rupee equivalent it sounds even more expensive - Rs 50 lakhs.

A veritable storm of accusation and counter argument has arisen. $ 1000 a pill ?? That is criminal argue the opponents. The big bad corporate world is simply gouging the sick to make greedy profits. Bad Bad.

Counters the company - the $ 84,000 treatment bill is significantly cheaper than any alternative which can all be proved to be more expensive with lesser chances of success.  This is therefore a cost saving to patients and instead of being deified, the company is being villified, they say.The trouble with this argument is that the alternative is really liver failure.

This being the US of A, there are all sorts of complications. Medicaid, their programme for providing free medicines for the poor, estimates that it would cost it $ 55 bn if every person eligible for Medicaid and is suffering from Hepatitis C is given this medicine. And the law says no drug that has been approved by the FDA can be withheld from Medicaid.  Of course, there isn't the $ 55bn lying around.  It has also been estimated that the premiums for Medicare (their programme for the elderly) could go up by upto 8% on this single drug alone.

Free market and freedom of pricing is a fundamental tenet of the capitalist world. America, to its credit, defends this even under difficult circumstances. The pharmaceutical industry is a special one - most research results in failure and blockbuster drugs are extremely rare. For every success there are probably 100 failures. If you do not allow blockbuster drugs to make very high profits, there will not be the pipeline of innovation. For all the noise from the rest of the world, the fact is that most of medical innovation comes from the US.

What about the rest of the world, indeed. In previous cases phramaceutical companies have been pilloried for pricing drugs so expensive in the third world that the most needy have no access to them. Gilead, mindful of these pressures, has priced the drug at $11 a pill in Egypt. This has resulted in a storm of protest in the US. If you can sell it for $ 11 in Egypt, why are you charging me $ 1000, shout the American customers (insurance companies, actually, for it is they who foot the bill in the US). They are cursing that America is subsidising the rest of the world on medical innovation. Gilead is shaking its head saying heads I lose, tails you win.

So back to the basic question - how do you price a drug. Yes, free markets and freedom of pricing is important. Yes, huge profits are the attraction for costly R&D which mostly fails. And yet when something succeeds, it creates a monopoly and it is an accepted principle in capitalism that monopolies will be regulated by the government. It is also a fact that, unlike in other product categories, the consumer does not have freedom of choice and is in an extremely vulnerable position at the time of consumption.  Difficult issues to grapple with.

The last body you would expect to give a sane solution to this, is the US Senate, filled with pompous gasbags of doubtful literacy and questionable intelligence. But in this case, this blogger is actively looking to the US Senate to provide an opinion. For the issue has been taken up by Ron Wyden , one of the (only ?) respected, principled Senator from Oregon (Sriram take a bow for electing him). He is one of the few capable of producing a position of substance.

What do you think. Even this blogger, a champion of free markets and rewarding innovation, is blanching at the thought of a $1000 pill. The logic may be impeccable. But to swallow Rs 60,000 twice a day .......

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The ethics of medical marketing

Is it ethical to sell medicines in the same way as you sell soap ? A trivially put , but troubling question. Consider the arguments for and against.

The problem in the medical industry is that the consumer, in most cases, is absolutely ignorant and is completely reliant on a doctor's opinion. But it is not the doctor who is paying - it is the consumer. At the time of consumption, the consumer is usually also not in a frame of mind to make rational , sensible choices. He is at his most vulnerable and therefore it can be argued that freedom of choice, a basic underpinning of capitalisim is, by definition, a contradiction in terms when it comes to a medical product

The basics of the medical industry is predicated on a few facts

• New discoveries are extremely costly - be it a drug or a medical device.
• Most nations grant a patent for a new discovery which enables the inventor to enjoy a monopoly for a fairly long time
• Once the patent expires, the product is subject to the same pressures of competition, demand and supply as any other product in any other industry. 
• There is very little product differentiation that is possible - formulations being legally regulated. Consequently, distribution and selling become the primary marketing tool for companies.

The industry is also peculiar in that the consumer is forced to consume - if it were possible, the consumer would prefer not to consume any medical product at all.  Given that it is the doctor who "forces" the consumer to consume, the backlash of customer dissatisfaction is also on the doctor - at the very least a virulent negative opinion against the doctor and more likely in the US for example, a lawsuit.

If that is so, is it correct for aggressive sales practices, usually found in most industries, to flourish in the medical industry as well ?  Most of the aggression on sales is towards doctors which raises even more ethical questions - should the doctors be influenced so heavily in their decision making. Every major drug company has been caught in questionable sales practices.  GlaxoSmithKline has been accused of bribery of medical professionals in China. Eli Lilly was charged with the same thing in Brazil. Pfizer sponsored incentive trips for Bulgarian doctors - euphemism for holidaying in Greece. Glaxo again took US medical professionals for "conferences" in Hawaii. Amgen offered discounts to  doctors to shift from competing products but allowed them a way to claim full price from health insurers.  Johnson & Johnson has been fined a colossal $2.2 billion for marketing practices stretching over 10 years in the US. Is anybody still left  who hasn't been fined ?

Almost every patient who sees a doctor in India complains of over testing and over prescription. Aggressive sales practices of medical companies and hospitals have certainly contributed to this "disease". One doctor I know, quit a hospital, because he was given a target for generating revenues through tests and prescriptions, regardless of whether the patient needed it or not.

While it would be easy to condemn all sales practices, these are a fundamental and essential part of the capitalist system. We would not bat an eyelid on any of them in other industries like telecom or clothing, or whatever. Its because the industry is the medical industry that there is unease. Although die hard loony leftists will argue against this, it is undeniable that capitalism and free markets have made incredible medical advances possible. If you simply ban all selling , and therefore dampen the means of achieving the profit motive, the industry would inevitably stagnate and then decline.

So where should the line be drawn. What is the difference between educating a doctor on a new drug or the effectiveness of an existing drug  and pushing him to prescribe it. We would, of course,  encourage a "soft sell" but would frown on a "hard sell" - the difficulty is to determine what is "soft" and what is "hard". These are extremely tough issues on which there isn't an easy answer. Doesn't mean that we shouldn't grapple with, or debate about, them.

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The Swine Flu vaccine dilemma

Novartis claimed last week that had made the first batch of the vaccine for the H1N1 virus that is the cause for swine flu. What caught my attention was Novartis refusing the call of the World Health Organisation to give the vaccine free to poor countries. Novartis says whoever buys, must at least cover costs. Click here for FT’s reporting of the story.

The issue raises a dilemma for which there are no easy answers. For both sides are right.

From the WHO’s point of view, this is about saving lives. They’ve just declared a global pandemic. Many millions could die. Here’s a way of preventing the disease. In poor countries, people just can’t pay for the vaccines. So if you price the vaccines, they simply won’t use it. So is it ethically OK to let many die when you could possibly prevent it ?

From Novartis’ point of view, they are a commercial organization, not a charity. There is a cost to producing the vaccine. What they are saying to the poor countries is, at least cover costs. If they simply produced every life saying drug and distributed free to people just because they were too poor to pay for the cost, they would soon be out of business themselves. Why would they even want to take up research on swine flu vaccine if they kneow they would lose their shirts because of it.

One answer could be that governments buy the vaccines and distribute free to the poor. But then governments don’t have the money either. What’s so special about swine flu. The common flu kills hundreds of thousands of people every year. Shouldn’t we be distributing common flu vaccines to everybody free. And why not Tuberculosis vaccines, or vaccines against other killer diseases ? There is definitely not enough money amongst governments to distribute every vaccine free.

This is not an easy dilemma. So what is to be done.

I have a humble suggestion. The concept of open source, in the IT world, lends a powerful model. People around the world voluntarily come together and donate their expertise for free. And such projects coexist with the business world where companies charge for a similar product or service. Consumers are free to chose.

In the case of the vaccine, the cost is all in the intellectual property of creating the vaccine. The actual manufacture costs a pittance. So why not create an open source platform for the researchers of the world to collaborate voluntarily. That way Novartis can create and produce drugs and vaccines in the normal business way. The open source guys will create for free.

Both have a place in the world. The on line world has shown us that.

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