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Clinical trials initiative: patients or patents? The pharmaceutical industry fears that WHO's clinical trials initiative may limit companies' ability to compete and dent profitability, as compliance--which is voluntary--will mean having to apply for patents earlier than they currently do. Some companies have pledged to adhere to the recommendations, nonetheless. Others may resist.

Article Excerpt
WHO's newly proposed rules on the disclosure of data when researchers register clinical trials they are planning has drawn a mixed reaction from corporations, academic and other institutions funding pharmaceutical R&D.

The pharmaceutical industry fears that companies may refrain from doing R&D in certain fields, firstly, because they would not want to make sensitive information public too early--as required under the initiative--as it would become available to their competitors, and secondly, if they are unable to protect their innovations with patents.

The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) stated clearly it does not agree with the final vision WHO presented on 19 May of how the International Clinical Trials Registry Platform (ICTRP) initiative will work (see Bulletin Vol. 84, No. 6, June 2006) but that it was prepared to work with WHO to develop a new concept that addresses these industry concerns.

"Whilst the industry shares other stakeholders' concerns about ensuring adequate transparency," IFPMA Director Harvey Bale tells the Bulletin, "it believes that the WHO position is a reflection of the views of some stakeholders, but it is not a consensus".

"The IFPMA, in...