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Drug discovery is a multifaceted process involving extensive screening, testing, and optimization of lead compounds to identify potential new drugs for therapeutic use. It combines several approaches, including screening large numbers of natural products, chemical modification of known active molecules, identification of new drug targets, and rational design based on biological mechanisms and drug-receptor structure. These approaches are carried out in both academic research laboratories and...
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Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System
05:10

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Published on: December 11, 2016

The patents-based pharmaceutical development process: rationale, problems, and potential reforms.

John H Barton1, Ezekiel J Emanuel

  • 1Department of Clinical Bioethics, National Institutes of Health, Bethesda, Md 20892-1156, USA.

JAMA
|October 27, 2005
PubMed
Summary

The current patent system for drug development limits access and misallocates resources. Reforms like tiered pricing and increased public funding could improve drug accessibility and innovation.

Keywords:
Analytical ApproachBiomedical and Behavioral ResearchHealth Care and Public Health

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Area of Science:

  • Pharmaceutical industry
  • Health economics
  • Drug development policy

Background:

  • The pharmaceutical industry faces criticism regarding drug pricing, access, and research priorities.
  • Fundamental questions exist about the value and fairness of the current patent-based drug development system.
  • Issues include financial barriers to access, high profits, and misallocation of resources.

Purpose of the Study:

  • To critically evaluate the existing patent system for drug development.
  • To identify major problems within the current system that affect drug accessibility and innovation.
  • To propose potential solutions and complementary reforms for a more equitable and effective system.

Main Methods:

  • Analysis of the pharmaceutical industry's patent system and its associated criticisms.
  • Identification of six major problems with the current patent-based drug development model.
  • Categorization of potential solutions into pricing, industry structure, and development incentives.

Main Results:

  • The patent system can hinder drug access, distort research priorities towards market demand, and lead to resource misallocation.
  • The system may result in insufficient overall investment in research and development relative to profits.
  • Existing issues include market failures and discrimination against certain patient populations.

Conclusions:

  • Reforms are needed to address drug pricing, industry structure, and development incentives.
  • Recommended reforms include post-approval comparative testing, international tiered pricing, increased government funding, and buy-out systems.
  • Targeted experiments are suggested for conditions with limited innovation.