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September 2017


‘Orphan Drugs Act’ a crying need in India

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Orphan drugs are those used in the treatment of rare diseases (orphan diseases), hence the term orphan drugs. These drugs aren’t a lucrative proposition; therefore pharmaceutical companies do not spend a lot on their research and development. Given the challenges inherent in bringing any new medicine to market – which when research failures are accounted for, is estimated to cost over $1 billion per successfully marketed product, it is understandable that in the past, private (and public and voluntary) sector, enterprises often focused their attention on developing and supplying treatments for diseases that affect relatively large numbers of relatively affluent people. Though the percentage of patients suffering from ‘Rare Diseases’ in India is reportedly higher than the world average, unfortunately, even today, such cases get little help from our government.

Access to multi-modal treatment options is inadequate and 40-60% of the facilities and oncologists are concentrated in the top 7-8 metropolitan cities of India hampering equitable access to treatment.

  • Only 40 out of 640 districts in India have Linac installations.
  • India has only 200-250 comprehensive cancer care centers (0.2 per million population in India vs 4.4 per million population in the US), 40% of which are present in eight metropolitan cities and fewer than 15% are government operated.
  • In addition, there is a significant shortage of oncologists in India. India has only one oncologist per 1,600 new cancer patients in India, as against one per 100 and 400 new cancer patients in the US and UK respectively.

The prevalence of cancer in India is expected to increase from an estimated 3.9 million in 2015 to an estimated 7.1 million people by 2020. Real cancer incidence in India is expected to increase by 30-35% over the next five years. This should light a fire under our government and health services and a push for orphan drugs to treat cancer conditions is needed.

Cancer incidence and prevalence is so high, one might believe that it doesn’t come under rare conditions but this needs to be realized that cancer is used as a collective word for all malignant conditions that can affect the human body, and a majority of them fall under the ‘orphan diseases’ category. 1983 signaled the importance of ‘Orphan Drugs’ with the ‘Orphan Drugs Act (ODA) in the U.S. A. A decade after, in 1993, Japan took similar initiative followed by Australia in 1999. Currently, Singapore, South Korea, Canada and New Zealand also have their country-specific ODAs. India must encourage its domestic pharmaceutical industry to get engaged in research to discover drugs for rare diseases by putting an ‘Orphan Drugs Act’ in place, extending financial support, tax exemptions and regulatory concessions like smaller and shorter clinical trials, without further delay.

The Price of Staying Alive with Cancer

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The World Trade Organisation and Big Pharma believe that the intellectual property of the companies must be protected, and came up with Trade-related Aspects of Intellectual Property Rights (TRIPS). In India, all drugs were generics before 2005 because there were no product patents for pharmaceuticals. India became fully TRIPS compliant in 2005 through the introduction of pharmaceutical patents, with legislation that included safeguards to protect public health. Basically, this means that if a company has patented a drug, they have a monopoly on it and there can be no generic forms or cheaper alternatives of the drug. This leads to an exorbitant price hike of the drug, leading to less and less people being able to afford it. Since patents on drugs tend to push prices up, governments, with their duties in mind, must ensure that the introduction of product patents does not jeopardize access to drug to the common people.

In India, the price control along with the amendment of patent laws in early ‘70s resulted in a declining impact on prices and the section 3 (d) amendment led to various patent rejections. Case in point, Novartis filed a suit against the ‘Union of India’ in 2006 for rejecting a patent on their drug Glivec (Imatinib mesylate). After seven long years, a landmark decision by a two-judge bench of the Indian Supreme Court upheld the rejection of the patent application (1602/MAS/1998) filed by Novartis AG for Glivec in 1998 before the Indian Patent Office. Pfizer Inc. said at the time it was, “concerned about the environment for innovation and investment in India.” Another such rejection was when officials withdrew patent protection for an emphysema drug marketed by Germany’s Boehringer Ingelheim GmbH. In 2012, India’s Intellectual Property Appellate Board revoked a Roche Holding AG patent for a hepatitis C drug saying technology involved in the drug’s invention was “obvious” and could be replicated easily.

While the possible price increase in the post WTO regime is highlighted in most of the studies, the non-introduction of new-patented drugs in India due to the weak protection regime is not discussed adequately. One of the advantages of the product patents is that the stronger patents will provide access to the latest inventions in drugs, which the developed world will not shy away from introducing in India.

If the companies wish to continue pushing for stronger product patents, they can bring down production costs by “making in India”. Meanwhile, better insurance coverage and government subsidies will further help bringing down costs of patented drugs.

To the common man, easy access to cheap drugs is the requirement as of today. Due to the low purchasing power being the foremost thought during any expenditure by the average Joe, the patent rights for health care products need to change in India, even if it means that we get newer drugs later than most.