Members of Congress have proposed, or are in the process of proposing, several legislative initiatives. Among them, Representative Ron Wyden has offered a twofold approach. One step would establish an enforcement mechanism for negotiating “reasonable prices” for products resulting from CRADAs or NIH grants to private research institutions and universities. A second measure, designed to create incentives for industry to collaborate with government in clinical research, would authorize NIH to enter into CTAs with companies and would stipulate up front that the institutes will not claim intellectual property rights or assert “reasonable pricing” provisions for products that result from the collaborations.

Although industry representatives supported the proposal to eliminate the possibility of pricing considerations in CTAs, they questioned the basis for attaching “reasonable pricing” clauses to all CRADAs. Workshop participants agreed that differentiation among the various types of CRADAs is important with respect to application of “reasonable pricing” considerations. Although some CRADAs include a critically important invention or intellectual contribution from government, others involve situations in which government acts more like a contractor than an inventor, providing little more than screening techniques or other testing procedures. Thus, industry maintains that it is critical to avoid regulations or requirements that would assume similar major government contributions and rights in all CRADAs. Instead, the rights of government should be commensurate with its actual contributions. For example, in collaborations in which government has had a minimal role in developing a pharmaceutical product (i.e., a company discovers and patents a drug, but then brings it to government for additional screening or clinical evaluation), “reasonable pricing” provisions are less defensible. Industry executives argued that a broad, generic assertion of government rights or involvement in pricing decisions is likely to discourage industry from entering into such research collaborations. Indeed, some companies have already cited pricing clauses as the reason for their refusal to participate in CRADAs.24

The message, then, is that NIH and industry must find ways to work together to resolve pricing concerns in ways that reduce industry 's anxiety about achieving a sufficient return on investment and allow government to protect public interests. Congressional staff cautioned that continued failure to achieve practical and mutually agreeable solutions could lead to unilateral action by Congress. 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.


Seenote 17.

The National Academies | 500 Fifth St. N.W. | Washington, D.C. 20001
Copyright © National Academy of Sciences. All rights reserved.
Terms of Use and Privacy Statement