View of IMPACT OF HIGH PRICE OF DRUGS ON SOCIETY : A DISCUSSION

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ACCENT JOURNAL OF ECONOMICS ECOLOGY & ENGINEERING Available Online: www.ajeee.co.in

Vol.03, Issue 01, January 2018, ISSN -2456-1037 (INTERNATIONAL JOURNAL) UGC APPROVED NO. 48767

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IMPACT OF HIGH PRICE OF DRUGS ON SOCIETY : A DISCUSSION

PROFESSOR (DR) RAVENDRE KUMAR PATANI AND ASHUTOSH KUMAR SRIVASTAVA PROLOGUE

Drug prices of laboratory created drugs are now major hurdles to the government in the global era of drug patenting which is supported by global economic legal compliance, like WTO, TRIPs, etc After the decision in the case of Parmanand katara Vs Union of India, it is onus on government to provide Right to health to citizens of India and on the other hand as a welfare state, India has to take care of economic growth of country as well. So the government has to take care of Drugs patenting issues in such a balancing manner to equate both the issues without friction in motion.

Problem of high pricing of drugs have different dimensions

1. Impact of High pricing of narcotic drugs on society

2. Impact of High pricing of Curative Drugs/Patented Drugs on society.

1. IMPACT OF HIGH PRICING OF NARCOTIC DRUGS ON SOCIETY:

Pace of Crime generally increase in society due to need of such drug in society, due to high price people do more economic crime to get money or does more heinous crime to get money, It Promotes Criminal actions in society like Drugs Smullugings etc and emerging forms of crime, such as cybercrime, trafficking in cultural artifacts and environmental crime etc.

PATIENT STRUGGLE ON HIGH PRICING OF CURATIVE DRUGS: ONE SIDE OF COIN

The pharmaceutical industry, after a long drought, has begun to produce more innovative treatments for serious diseases that can extend life and often have fewer side effects than older treatments. Last year, the Food and Drug Administration approved 41 new drugs, the most in nearly two decades. For few of the poorest Indians, medicines are covered by government programs or financial- assistance funds paid for by Social Agencies. For those in the middle class, it is a different story. So the Developing Country like India facing different Situation because there is no such huge risk sharing business of health Insurance,

people pay through their pocket or borrow from banks , relatives or money lenders, means they do not share risk , instead of it they shift their burdon on others. So developing a policy to raise prices faced by consumers, and to ensure that it has the desired incentive effects, is a tall order, It’s better to do it the right way — selectively — than crudely.

PATIENT STRUGGLE ON HIGH PRICING OF CURATIVE DRUGS: THE OTHER SIDE OF COIN THE NEW BENEFITS OF COMPETITION

Competition among research-oriented companies brings comparatively better medicines to patients, but it also has become so intense that, for the first time, blockbuster drugs are rapidly becoming obsolete. The breakthrough hepatitis C therapy, telaprevir (Incevik), was withdrawn from the market only four years after approval, when sofosbuvir (Sovaldi) became available. Competitive market forces have helped Medicare Part D achieve substantial savings: 2013 spending was 50% below projections ($50 billion versus $99 billion).In the context of these new realities, we need creative and practical solutions on multiple folds : i. ii. PRICING THAT PROMOTES MUCH-

NEEDED INVENTION

“Innovation” is an overused term. Most health care innovations, such as standardized surgical protocols or antimicrobial stewardship, are refinements that improve efficiency while enhancing quality of care. Medicines and vaccines, in contrast, are necessary inventions. Consider the economic burden of Alzheimer’s disease:

The current U.S. annual expenditure of

$200 billion will balloon to $1.2 trillion (in current dollars) by 2050. Does anyone seriously believe that more efficient hospital, nursing home, and home care will avert the crisis? I can imagine only one solution: new drugs that arrest, delay, or prevent Alzheimer’s. Yet only 7% of Alzheimer-drug trials are NIH- funded, despite a failure rate of 99%

among the 400+ clinical trials of 33 agents in the past decade. What company

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1 will gamble on agent #34 without adequate incentives?

PRICING THAT SUSTAINS A PROVEN BUSINESS MODEL

Very few organizations can undertake the arduous, risky, expensive process of drug R&D. There is a common misconception that NIH research is responsible for most drug breakthroughs. In reality, the pharmaceutical industry’s investment in R&D (more than $50 billion in 2012) far exceeds the NIH’s total budget (about $30 billion in 2012). NIH-funded basic research is foundational. However, although the NIH work sometimes generates drug “leads,” industry’s enormous investment is what translates those basic advances into actual treatments for patients. Explaining the investment and persistence needed for successful R&D is challenging. The path is long, not linear, and littered with failures. Only 20% of approved medicines generate revenues that exceed average R&D investment. Consider this comparison: In 2013, Apple spent $4.5 billion on R&D, or 2.6% of net sales.

Merck spent nearly twice that amount,

$7.5 billion, representing 17% of net sales. Furthermore, it takes about five times longer (10 to 15 years) to develop a medicine than a smart phone. When I first joined the pharmaceutical industry, regulatory approval was the “finish line”

for R&D. Now drugs must be tested in clinical trials in multiple geographic locations. Large outcome trials, post- approval monitoring, and comparative- effectiveness studies have become routine. Such ongoing investment, added to R&D costs, helps explain why companies committed to research cannot compete with generics on price. Unless an appropriate return on investment is possible, biopharmaceutical companies will be unable to undertake the risky long-term R&D that addresses unmet medical needs and can yield overall cost savings.

PRICING THAT TAKES A GLOBAL VIEW Drug prices in the U.S., where the private market is less highly regulated, are typically higher for innovative drugs than in other developed countries (though the U.S. government mandates substantial discounts for Medicaid patients and other needy populations). U.S. prices are

substantially lower for generic drugs. In many other countries, health authorities set prices below market levels using criteria unrelated to the value of the drug to patients and society. As a result, the U.S. shoulders a substantial portion of the cost of inventing new medicines.

Pricing that reflects the true value of medicines across all developed countries would enhance the flow of inventions that meet important unmet medical needs worldwide.

iii.

iv. CONTINUED CORPORATE RESPONSIBILITY

Companies like Merck continue to offer assistance programs to U.S. patients who cannot afford certain medicines. We also consider a country’s level of economic development and public health needs when establishing our prices. When market-based solutions are not available, companies like Merck also often donate medicines, especially in low-income regions of the world. I have seen firsthand the benefits of international programs that help address and prevent HIV/AIDS, hepatitis B infection, and neglected tropical diseases such as river blindness.

A sustainable business model that drives innovation bolsters our ability to make such philanthropic efforts. Companies must take such responsibility in country like India

DRUG PRICE CONTROL MECHANISM AND CONSTITUTIONAL PROVISION IN INDIA

Patented Drugs are controlled as per provision of Indian Patent Act 1970, under the international compliance of TRIPs, in which India is signatory Country, and rectified International Charter under Article 253 0f constitution of India Therefore India amended their Patent Act in 1999, 2002, and in 2005 under compliance of TRIPs because a sovereign country accepted it as per the Article 51(c ) , and rectified as per article 253 of constitution of India .On the other hand state having duty to distribute the material resources to all under article 39 of constitution of India. After the decision in the case of Parmanand katara Vs Union of India, it is onus on government to provide Right to health to all its citizens in India under the extended interpretation of Article 21 of constitution of India So the accessibility of drug is not only the

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1 extended fundamental right of common citizen but also it is duty of State to make it available to every needed citizen Therefore government have to Procure the rights of Citizens not only from the criminal and their criminal activities relating to drugs , but also from drugs manufacturing companies who are selling essential drugs at high price and making their profits only .

GOVERNMENT INITIATIVES:

 Drug Price control Order 2009, 2013 etc are certain control mechanism by government

 Issue of Compulsory License to Indian Drug Manufacturing Companies.

 To prevent and control on ever greening by drug manufacturing companies so that poor section of society may be get benefited.

 Use of Bolar provision for manufacturing patented drugs by government for poor section of society.

ANALOGUE

The Indian economy was and continues to remain generic-oriented, a major concern being unafford ability of essential medicines. The Indian patent system balances provisions made towards innovators and generics, with many provisions primarily focusing on drug price control. The article analyses some of the provisions of the Indian Patent Act that directly or indirectly attempt to control drug pricing such as Section 3(d) preventing ever greening by innovators, compulsory licensing and Bolar provisions. Concluding note on such Discussion is Innovators originate from the society so that they must share their invention to the society. On the other hand Narcotic Drugs must be fully banned, should not be available to common person. So that crime can be control easily and criminal must be treated harshly. We have sufficient substantive law to regulate it so that we have to grab this problem by controlling through effective administration.

BIBLIOGRAPHY Books and Statutes

The Constitution of India 1949

The Narcotic Drugs and Psychotropic Substances Act, 1985

Indian Patent Act 1970

Indian Patent (Amendment) Act1999

Indian Patent (Amendment) Act2002 Indian Patent (Amendment) Act2005 TRIPs Agreement

Web Sources https://hbr.org/

https://www.wipo.int https://www.unodc.org/

REFERENCES

1. Dean , Faculty of Law & Governance , Jayoti Vidiya Peeth Women’s University , Jaipur

2. Research Scholar , , Faculty of Law &

Governance , Jayoti Vidiya Peeth Women’s University , Jaipur Research Scholar ,

3. Legislation for giving effect to international agreements Notwithstanding anything in the foregoing provisions of this Chapter, Parliament has power to make any law for the whole or any part of the territory of India for implementing any treaty, agreement or convention with any other country or countries or any decision made at any international conference, association or other body

4. foster respect for international law and treaty obligations in the dealings of organized peoples with one another; and encourage settlement of international disputes by arbitration

5. article39 (b) that the ownership and control of the material resources of the community are so distributed as best to sub serve the common good;

6. Article 39(c) that the operation of the economic system does not result in the concentration of wealth and means of production to the common detriment;

Article 21. Protection of life and personal liberty No person shall be deprived of his life or personal liberty except according to procedure established by law

7. provided in TRIPs Agreement