UPA’s failure to protect the common man’s constitutional right to life is becoming murky by the day. It is not only the food security on which the UPA Government has let down the common.
On August 24, it rubbed salt in the wounds of patients by issuing a discussion paper on compulsory licensing of patented drugs instead of first providing patent-expired, essential medicines at affordable prices.
Ensuring availability of a few latest medicines at reasonable prices by forcing foreign drug firms to licence their patented technology to specified Indian companies (compulsory licensing) is a small issue. The bigger and pressing issue is providing all essential drugs and other patent-expired medicines to the masses at affordable prices.
UPA continues to drag its feet over extending the span of statutory price control to 374 essential bulk drugs from the present 74 drugs. The enhanced price control is envisaged in as in the draft National Pharmaceuticals Policy (NPP), 2006.
NPP itself was prepared following an interim order from the Supreme Court on March 10, 2003 issued in response to a special leave petition against Karnataka High Court verdict, restraining implementation of 2002 drug policy that sought to reduce price control.
Supreme Court stated: “We direct that the petitioner (Union Government) shall consider and formulate appropriate criteria for ensuring essential and life saving drugs not to fall out of the price control and further directed to review drugs, which are essential and life saving in nature till May 2, 2003”.
Subsequently, Health Ministry prepared National List of Essential Medicines (NLEM) 2003 comprising 354 drugs as compared to the earlier list that mentioned 279 essential drugs. The Government, however, at present is contended with regulating the prices of 74 bulk drugs and their formulations (the form in which medicines are sold by chemist) through Drugs (Price Control) Order (DPCO) 1995.
In its first spell, UPA claimed that draft NPP 2006 was in keeping with the promises it gave to Aam Adami in its National Common Minimum Programme (NCMP) that was unveiled in May 2004.
NCMP stated: “The UPA Government will take all steps to ensure availability of life saving drugs at reasonable prices. Special attention will be paid to the poorer sections in the matter of health care.”
Such promise was blacked out from the Congress Party’s manifesto for 2009 Lok Sabha Polls. This promise also did not figure in the UPA’s reforms agenda for the next five years unveiled by The President, Pratibha Devsingh Patil in June 2009.
Instead of approving draft NPP 2006, the Cabinet referred it to a group of ministers (GOM) in January 2007. GOM continues to sit tight over the policy.
UPA obviously does not have the courage to take on influential domestic and foreign drug companies that continue to post super-profits year after year. It has not even realised that the delay in imposing price control over NLEM comprising 354 drugs amounts to contempt of the Supreme Court.
An NGO consortium has already stated that it would drag the Government to the Supreme Court on contempt charges and plead for price control over 354 drugs.
The discussion paper on compulsory licensing issued by Department of Industrial Policy and Promotion has made only a passing reference to NPP 2006. The Paper says: “the draft policy proposed a slew of measures. These included enacting a new law to exercise more effective price control /monitoring of the prices of drugs, creating a National List of Essential Medicines consisting of 354 drugs, strengthening the drug regulatory system, limiting trade margins and negotiating prices for patented drugs. The draft policy has not yet been finalised.”
The 26-paper has listed four options to ensure supply of patented drugs in India at reasonable prices. The options include compulsory licensing, invoking relevant provisions of the Competition Act, regulating acquisition of wholly Indian owned drugs by multinational corporations (MNCs) by amending foreign direct investment norms and increasing ambit of National Pharmaceuticals Pricing Authority (NPPA) and “vest it with the power to regulate the prices of a larger number of drugs than the present 74.”
It continues: “The first option is a focused and sharp response – which can be invoked when a single critical drug is either unavailable per se or unavailable at reasonably affordable prices. The other three options deal with broader issues and will not be discussed here. This paper exclusively discusses the first option-the issue of compulsory licences.”
The discussion paper is considered a trial balloon to bring about much bigger changes in the Patent Act, which was last amended in 2005 to make it fully compliant with trade related aspects of intellectual property rights (TRIPs) regime of World Trade Organisation (WTO).
Reports in business press indicate that Prime Minister’s Office (PMO) had last month circulated a note on proposals to amend Patent Act. The reports state that the note has been prepared following a submission from an organisation representing the interests of foreign drug companies in India. And PMO has preferred to remain silent on these reports that have selectively quoted the note.
In referene to PMO note, a business daily has quoted Health Minister Ghulam Nabi Azad as saying “we are opposed to any move that seeks to extend the patent of medicines beyond 20 years.”
The Union Government has amended Patents Act four times first in 1999, second in 2000 and third in December 2004 through Patents (Amendment) Ordinance and finally in 2005.
In its report submitted to Parliament on August 4, 2010, Parliamentary Standing Committee (PSC) of Heath Ministry has thrown its weight behind the patients and made a rational case for bring all essential drugs under price control.
PSC said: “Medicines are the only item where the decision to buy is not taken by the purchaser but by a third party ie, doctor. Therefore, if prescribers and producers join hands and take advantage of a patients’ helplessness, only the State can stop them.”
PSC has in fact gone one step ahead of recommending price control over all essential drugs. It has implicitly recommended regulation of prices of other drugs by calling for a ceiling on the total profit earned drug companies.
An analyst says the profit ceiling would prevent companies from shifting their operations from price-controlled products to market-priced ones.
UPA has, however, continues to look the other way even as hundreds of patients die every day solely due to their inability to buy expensive drugs.