Why medicine comes at a price . . .

Wednesday, 6 March 2013

Have you ever lost someone to cancer? If you have not, count yourself fortunate. I certainly have, as, I suspect, most of you reading this. And as we speak, I have two dear friends who are battling the big C in opposite corners of the globe.

And I know that for every one of us who has been in that position, there is very little any of us would not do to save the life of a loved one.

An interesting story linked to this thought process emerged out of India this week. But before I get to it, we first need to go back a few years to December 2005 when the US Food and Drug Administration approved a new drug called Sorafenib for the treatment of advanced kidney cancer.

The drug, co-developed and co-marketed by pharmaceutical giants Bayer and Onyx under the trade name Nexavar, “prolongs progression-free survival in patients with advanced clear cell renal cell carcinoma in whom previous therapy has failed” to quote the New England Journal of Medicine.

In other words, it is a bit of a wonder drug for halting growth of particular types of kidney cancer when nothing else has worked.

Two years after being approved for treatment of kidney cancer, Nexavar was also approved for treatment of some liver cancer with similar magic bullet effects.

Nexavar, however, is expensive by any standard. A month's supply of 120 tablets costs about US $5 500 – R50 037 per month in our terms or Rs 301 908 in India.

According to Bloomberg, the drug had global sales of 792 million euros (close to R10 billion) in 2012.

Bayer has been selling the drug at a 10% discount in India. But even at that price, it is clearly out of reach for most people.

Last year, the Indian drug regulatory authorities took the extraordinary step of bypassing Bayer's patent rights and granting a licence to an Indian pharmaceutical manufacturer, Natco Pharma, to produce a generic version of the drug at a substantially cheaper price of US $175 per month.

Bayer appealed the decision to India's Intellectual Property Appellate Board. This week, they lost.

Médecins Sans Frontière (“doctors without borders”) welcomed the decision. “…the decision means that the way has been paved for compulsory licences to be issued on other drugs, now patented in India and priced out of affordable reach, to be produced by generic companies and sold at a fraction of the price,” said MSF's India Campaign Manager Leena Menghaney. “We hope that, in the near future, compulsory licences will be issued for the newest drugs to treat HIV and affordable generic versions will be available not only in India, but in the rest of the developing world.”

I felt a cold shiver run over me.

Don't get me wrong. I am no fan of the pharmaceutical companies. I've no doubt that they price gouge and rake in outrageous profits.

But it is their right to do so.

In the words of P H Kurian, Controller of Patents in Mumbai: “The patent system is a carefully crafted bargain that rewards an inventor in lieu of his contribution towards the society.

“The benefit derived by the society, inter alia, in granting such a comprehensive right to the inventor for twenty years, is the enrichment of knowledge in public domain, which can be utilised to invent further. This cycle goes on and on to take the nation towards socio-economic prosperity.

“Without the presence of a Patent system, the inventor will not be encouraged to disclose his invention to public and may prefer to keep it as a trade secret, which may result in innovative sluggishness, thereby adversely affecting the prosperity of a nation.”

I'm in complete agreement with those sentiments.

But Kurian then goes on to add: “From its very nature, a right cannot be absolute. Whenever conferred upon a patentee, the right also carries accompanying obligations towards the public at large.”

And therein lies the problem.

When one enters into a contract, there is a reasonable expectation on the part of the party providing a service that the contract will be honoured. For pharmaceutical companies, it gives one a sense of comfort that massive investments in research and development, testing, marketing, liability insurance will be recovered over the 20 year period of the patent.

Bayer's right to this security has been removed in the name of the greater good. But why stop there? Why not refuse to pay companies that build public housing because it is in the greater good? Why not refuse to pay school teachers because it is in the greater good? Why not refuse to pay farmers and just take their crops because feeding the nation is in the greater good?

Our deal as humanity with the providers of intellectual capital is that we will protect their rights for 20 years. We cannot, and should not, break our word. If we do so, people will not trust us and will withhold their intellectual capital except where such rights can be guaranteed.

Do we want a world where we are denied access to life-saving drugs because our governments kill the goose that lays the golden egg?