Misinformed campaign against Glivec

More than ten years have passed since Digamber Bhalerao (name changed to protect identity) walked into my office with his wife, looking for Novartis to support his drug treatment for his CML (chronic myeloid leukaemia). Yet it seems like just yesterday.

The Bhaleraos hailed from Dhule in Maharashtra and had been importing Glivec even before it received marketing approval in India. They were finding it increasingly difficult to fund the treatment and had come to meet me looking for support.

Glivec had not been launched in India and Novartis was looking to introduce a patient assistance programme in the country and around the world. Digamber Bhalerao became the first recipient of a patient assistance programme yet to be launched.

The ever-grateful Bhaleraos often came to see me when they came to Mumbai for their follow-up treatment. I was always happy to meet them, but admit to feeling embarrassed when they said that the Novartis office was their temple for they had found their saviour there.

Thus began the Glivec International Patient Assistance Programme (GIPAP) way back in 2002.

Ten years on, the programme and Glivec continue to touch thousands of lives. Glivec was the first pharmaceutical product to receive Exclusive Marketing Rights in India in November 2003 and all of us at Novartis felt justifiably proud.

After all, it was a breakthrough drug and was anointed as the “magic bullet” by Time magazine. It was, and is, a drug that forever changed the way cancer is treated.

In 2006, however, Glivec was denied a patent, following the introduction of a product patent law in India. Since then Novartis has pursued the appropriate authorities and the Courts seeking a patent for Glivec. Historically, patents have helped advance scientific innovation, which in turn has led to new medicines for people suffering from diseases without effective or in many cases, any treatment option. And, they continue to do so.

BEFORE THE COURTS

The GIPAP, meanwhile, continued to provide Glivec completely free of any charge to every single patient who was prescribed the drug for an approved indication, was uninsured, did not have any reimbursement and could not afford it.

To broaden the reach of the drug, a very generous co-pay programme was introduced. Today, more than 15,000 patients, representing around 95 per cent of patients prescribed Glivec, receive the medicine absolutely free of charge.

Since 2002 when we introduced the programme, Novartis has distributed Glivec valued at $1.7 billion completely free of charge to patients in India alone. This is significantly more than Novartis' annual earnings in the country over the same period!

Allow me to set the context for the case and the record straight. In 2006, after Novartis was not granted a patent for Glivec, we chose to go the Chennai High Court with two writ petitions — one challenging section 3(d), and the other challenging the non-grant of a patent to Glivec. In the first case the judges opined that they did not have the jurisdiction and Novartis should go before the WTO. Since that was not possible for a corporation, we decided to let matters lie.

Following due process for the second writ, we are now before the Supreme Court pleading our case for a patent for Glivec — a drug that has been patented in more than 40 countries around the world.

Why are we doing this? Novartis is contesting the non-grant of a patent for Glivec and seeking clarity on India's patent law to know what is patentable and what is not patentable and, further, to know whether India follows a predictable norm for patentability.

We believe that working through the judicial system is the legitimate and appropriate approach to gaining clarity on the unique aspects of India's patent law and have complete confidence in the Indian legal system and the Supreme Court to make the right decision based on the law of the land.

NO ‘EVERGREENING'

There have been attempts in some quarters to confuse the case in the public space by referring to ‘evergreening'. It is important to note that while the molecule Imatinib was patented in 1993 in countries where patents were being granted, this was not so in India because India did not have a product patent law at that time.

Importantly, Imatinib by itself was never a drug that could be consumed.

Novartis went on to develop the beta crystal form of Imatinib mesylate to make it suitable for patients to be taken in pill form that would deliver consistent, safe and effective levels of the medicines. By no stretch of imagination can Glivec be considered as an attempt at ‘evergreening'.

Before Glivec was launched world-wide in 2001, there was hardly any hope for leukaemia patients.

Dr Hagop Kantarjian, a Texas-based leukaemia specialist, stated recently: “Before the year 2000, when we saw patients with chronic myeloid leukaemia, we told them that they had a very bad disease, and their course was fatal, their prognosis was poor with a median survival of maybe three to six years ... Today when I see patients with CML, I tell them that the disease is an indolent leukaemia with an excellent prognosis, they will usually live their functional life span provided they take an oral medicine, Gleevec (known as Glivec outside the US), for the rest of their lives.”

It is important to understand that this case is not about changing the availability of existing generic medicines, but about protecting intellectual property to advance the practice of medicine and to serve patients' unmet needs.

As a leader in generics, Novartis is deeply committed to making low-cost quality generic medicines widely available around the world through its generics arm, Sandoz.

Novartis has always supported flexibilities in international trade agreements that allow for countries such as India to make exceptions to patent rights such as the issuance of a compulsory licence in case of a national health crisis.

It is equally important to note that several generic versions of Glivec will remain on the market regardless of the outcome of our case. This is because the grandfather clause in the Indian law allows generics launched before 2005 to stay on the market.

MISLEADING CAMPAIGN

Several articles in recent days have referred to protests at the Novartis global AGM and at Novartis offices around the world, likening them to the “Occupy Wall Street” movement.

Short of bordering on sensationalism, some of these articles have tended to make these protests seem larger than life.

The reality is that the protests have been very sporadic and limited in participation — nowhere near the intensity implied.

A recent opinion piece quoted from a news report in TheNew York Times dated June 5, 2003. I wonder why reference was made to an article dated nearly 10 years ago quoting out-of-date figures of patients on Novartis' patient assistance programme!

The same opinion piece expressed the view that Novartis should have addressed the issue of affordability for Glivec by reducing the price.

I reiterate what we have long stated — price in the case of Glivec is irrelevant because 95 per cent of patients who are prescribed Glivec receive it for free and the majority of the remaining 5 per cent are on a very generous co-pay programme.

Forty per cent of India's population lives on less than $2 per day. Medicines are unaffordable to them at any price.

What is critical, and of the utmost urgency, is for all stakeholders to come together to address the larger goal of healthcare for all.

Government needs to play a role here in addressing a host of issues including lack of diagnosis, healthcare infrastructure and distribution.

It is important to remember that existence of trained healthcare staff and infrastructure, cultural acceptability of treatment, accessibility of healthcare facilities and quality care all play a role in making medicines available.

I have often wondered why India, home to one of the most vibrant generic industries in the world, still has a significant proportion of its population – 65 per cent – without access to modern healthcare.

With an enviable economic growth and an increasingly prosperous middle class, the eyes of the world are on India now.

I believe the time is right for us to lay a stake in the ground and aspire boldly to be the pharmacy of the world, not just the developing world.

Then, Digamber Bhalerao and other patients like him will not need to come to large metros such as Mumbai for treatment and they will benefit from the overall goal of healthcare for all.

(The author is Country President, Novartis India.)

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