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Government and Industry Collaboration in AIDS Drug Development (1994) / Chapter Skim
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OVERCOMING OBSTACLES TO COLLABORATION AND PROMOTING HIV DRUG DEVELOPMENT
Pages 12-16

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From page 12...
... Indeed, many NIH and industry collaborators are frustrated by this unwieldy process and view it as a disincentive to continued participation in the NIH CRADA ~2 program.~ OVERCOMING OBSTACLES TO COLLABORATION AND PROMOTING HIV DRUG DEVELoPMENT23 Pharmaceutical executives and government officials are committed to improving collaborative research efforts. Both groups also believe that the relationships must be as clear, consistent, and stable as possible.
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From page 13...
... They also surveyed the political landscape of government and industry collaboration, focusing particularly on the issue of"reasonable pricing." "Reasonable Pricing" Considerations Pharmaceutical executives argue that NIH should simply remove the "reasonable pricing" clauses from all CRADAs. At a minimum, they say, NIH could eliminate the pricing provisions in HIV/AIDS research collaborations as a test case and monitor the number and products of collaborative research projects that result.
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From page 14...
... Intellectual Property Rights Because patents are a keystone of the pharmaceutical industry, its representatives propose that both CRADAs and CTAs should automatically guarantee prospective property rights or licenses to industrial partners. Companies receiving patents would pay the government appropriate royalties agreed upon in advance.
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From page 15...
... Finally, government in turn needs to recognize and accept the role that access to these data plays in the corporate planning process and find ways to either accommodate necessary access or develop and adhere to a more consistent policy that similarly limits access by NIH staff. Streamlining the CRADA Process NIH also recognizes the need to simplify, clarify, and accelerate the negotiation process involved in developing CRADAs, and officials reported that a streamlined review and approval process for NIH CRADAs should be in place shortly.
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From page 16...
... If the majority of pharmaceutical companies object to congressional solutions, some observers predict that research collaborations and, in particular, investments in HIV drug development will diminish. Because many companies view HIV drug research and development as an inherently risky venture, further erosion of an already fragile research enterprise could hamper efforts to develop more effective treatments for HIV infection and AIDS.
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Key Terms

  • industry representatives
  • research collaborations
  • clinical trials
  • drug development
  • nih staff

  • hiv drug
  • contractual agreements
  • patent rights
  • financial planning
  • pricing concerns

  • aids drug
  • companies view
  • industry collaboration
  • using contract
  • risky venture

  • avoid regulations
  • pricing provisions
  • patrick gage
  • promoting hiv
  • cooperatively developed

  • planning purposes
  • industry argue
  • industry executives
  • martin delaney
  • create incentives

  • companies object
  • anthony fauci
  • achieve broad
  • process involved
  • access available


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