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Paying for pharmaceutical registration in developing countries.

Warren A Kaplan1, Richard Laing

  • 1Boston University School of Public Health, Boston, MA, USA.

Health Policy and Planning
|August 15, 2003
PubMed
Summary
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Drug regulatory authority (DRA) fees in developing countries are often too low to cover costs or influence approval times. Analysis suggests fees could be increased without harming the pharmaceutical industry.

Area of Science:

  • Health economics
  • Pharmaceutical policy
  • Regulatory science

Background:

  • Drug regulatory authority (DRA) fees are policy tools impacting approval speed, staff retention, and market dynamics.
  • Current fee structures often do not reflect the true cost of pharmaceutical regulatory processes.

Purpose of the Study:

  • To analyze the relationship between new drug registration fees and economic indicators in developing/non-OECD countries.
  • To assess the impact of current fee levels on pharmaceutical markets and approval timelines.
  • To provide recommendations for optimizing DRA fee structures.

Main Methods:

  • Scaled new drug registration fees of DRAs from 34 countries against Gross National Product (GNP) per capita and total government health expenditure per capita.
  • Analyzed the correlation between registration fees, market share, and drug approval times.

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Main Results:

  • Most DRA registration fees in developing/non-OECD countries are below their GNP per capita or represent a small fraction of healthcare spending.
  • Current fees show little correlation with drug approval times in these nations.
  • A $1000 registration fee corresponds to approximately $85 million in total pharmaceutical market share.

Conclusions:

  • DRA registration fees in developing countries are generally set too low and could be increased without negatively impacting the pharmaceutical industry.
  • Recommended fee levels range from 1-5 times GNP per capita.
  • Fees should be based on accurate cost accounting for services provided, considering potential trade implications and industry incentives.