Academic journal article Houston Journal of International Law

Prescription Drugs: India Values Their Compulsory Licensing Provision-Should the United States Follow in India's Footsteps?

Academic journal article Houston Journal of International Law

Prescription Drugs: India Values Their Compulsory Licensing Provision-Should the United States Follow in India's Footsteps?

Article excerpt

  I. INTRODUCTION

 II. RECENT PATENT LEGISLATION IN INDIA AND THE
     UNITED STATES
     A. International Agreements Leading to India's
        Revised Act
     B. India's Compulsory Licensing Provision in the
        Revised Act
     C. Patent Rights and Consumer Protection in the
        United States: Past Attitudes
     D. Current Compulsory Licensing Proposals in the
        United States

III. THE INDIAN PHARMACEUTICAL MARKET
     A. Access and Administrative Struggles
     B. Poised Manufacturers and Potential Consumers
     C. International Respect
     D. Compulsory Licensing Effects on the Indian
        Pharmaceutical Market

 IV. THE U.S. PHARMACEUTICAL MARKET
     A. Imperfect Competition
     B. Informational Problems
     C. Access
     D. Compulsory Licensing Effects on the U.S.
        Pharmaceutical Market
  V. PROPOSED PRESCRIPTION FOR THE UNITED STATES

I. INTRODUCTION

Americans struggle on an ongoing basis with the high prices of prescription drugs. (1) Prescription drug prices are generally higher in the United States than in any other country. (2) There are few signs of prices going down. (3) Americans frequently hear stories about senior citizens who are forced to choose between food and their medications. Americans also frequently hear about the large profits drug manufacturers make from drugs under patent. (4)

Congress and the individual state legislative bodies are beginning to fight back against high prices. Proposals from state legislators include adjusting existing state subsidy plans; modifying drug discount plans; expanding the federal 340B drug pricing program; (5) regulating pharmacy benefit managers (PBMs), restricting marketing and advertising by pharmaceutical companies, interagency purchasing in bulk, and requiring transparency from the pharmaceutical companies by posting their clinical trials data. (6) However, the pharmaceutical lobby (PhRMA) in the U.S. Congress remains strong. While states propose and pass various laws, no federal laws to dramatically impact drug pricing have gone into effect. (7) The more high-profile solution to re-import drugs from other countries at lower prices via bussing and internet pharmacy remains illegal. (8)

Some state legislators have been trying a different tack, one that does not simply regulate, but that would fundamentally change the patent system. The tension between prices charged to consumers and property rights of patent holders is ever present. A few bills have been proposed that allow compulsory licensing of drugs by individual states. (9) "Compulsory licensing is generally defined as the granting of a license by a government to a third party to use a patent without the authorization of the patent holder." (10) Compulsory licensing has been used as a cost-cutting and access-assuring mechanism in many countries off and on for years. (11) This Comment will examine how it is used in India and in what form it has been proposed in the United States.

India provides a useful example because it has many of the same issues of price and access to drugs as the United States, but, unlike the United States, its patent system contains a compulsory licensing provision. Although India's patent regime took effect in 1856, (12) India, just in the last year, increased its patent protection to be in line with that of the United States. (13) As a compromise between the drug companies and the health organizations, India's legislation retains the compulsory licensing provision. (14)

The recent patent regime changes in India spotlight the constant tension on an international level between economic development and the idea of a right to health. (15) This clash was arguably not only over patent rights but also between developed and developing nations. (16) The Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement tries to unify, perhaps artificially, countries around the world to establish basic ground rules for intellectual property rights in the modern global world. …

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