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Government and Industry Collaboration in AIDS Drug Development (1994) / Chapter Skim
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IMPEDIMENTS TO COLLABORATION IN HIV DRUG DEVELOPMENT
Pages 7-11

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From page 7...
... IMPEDIMENTS TO COLLABORATION IN HIV DRUG DEVELoPMENT'3 Pharmaceutical research and development is an inherently risky, timeconsuming, and costly venture. The process spans 13.5 years on average,l4 and only about 20 percent of all drugs that enter clinical testing ultimately reach the marketplace.~5 On average, the after-tax research and development cost per new "Article 5.04 of the Model PHS Exclusive Patent License Agreement states: "DHHS has responsibility for funding basic biomedical research, for funding medical treatment through programs such as Medicare and Medicaid, for providing direct medical care, and more generally, for protecting the health and safety of the public.
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From page 8...
... Government and industry representatives agree that although federal policies governing collaborative research were generally implemented with good intentions, these policies have sometimes led to contentious negotiations or inhibited research collaboration altogether. The single most significant obstacle cited by pharmaceutical executives is the role that government has assumed in setting prices for jointly developed products.
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From page 9...
... Faced with this uncertainty and the consequent inability to predict expenses, pharmaceutical companies that can afford to pursue research and development independently of government collaboration appear increasingly likely to do so. NIH also collaborates with industry through Clinical Trial Agreements (CTAs)
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From page 10...
... A Bnstol-Myers Squibb executive expressed general satisfaction with the collaboration, but noted the company's worry that government may alter its position under continued political or public pressure and exercise more burdensome requirements at indeterminate times in the future. NIH administrators readily acknowledge that the institutes lack the appropriate expertise to undertake meaningful analyses of pnvate-sector product pricing decisions.~9 20 Moreover, NIH recognizes that there is no statutory authority for government agencies to participate in the pricing of products developed under CRADAs or CTAs.
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From page 11...
... Under CTAs, however, the government generally does not assign intellectual property rights in advance to the industrial collaborator. In fact, most federal agencies interpret the licensing regulations and statutes as not permitting them to assign rights to future inventions outside of the CRADA mechanism; however, several workshop participants disagreed with this interpretation.
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Key Terms

  • patent rights
  • jointly developed
  • research collaborations
  • pricing provisions
  • industry executives

  • clinical trials
  • nih officials
  • policies governing
  • industry representatives
  • licensed product

  • executives maintain
  • exclusive patent
  • assign rights
  • crada mechanism
  • federal policies

  • obstacle cited
  • pharmaceutical companies
  • initial research
  • inventions outside
  • predict expenses

  • congressional office
  • similar products
  • model phs
  • developed products
  • dosing strengths

  • products marketed
  • research leads
  • legal authority
  • contentious negotiations
  • ensure broad


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