Q&As

Is a pharmaceutical company sponsor of a clinical trial obliged to provide access to the trial medicine free of charge once the trial is finished?

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Published on LexisPSL on 17/10/2017

The following Life Sciences Q&A provides comprehensive and up to date legal information covering:

  • Is a pharmaceutical company sponsor of a clinical trial obliged to provide access to the trial medicine free of charge once the trial is finished?

Assuming no clear commitment was made to provide free post trial access to the trial medicine in the patient informed consent forms (ICFs) used in the trial (and assuming no separate representations were made to the patients in that regard), there is no general legal obligation for a pharmaceutical company to provide free access to the investigational medicinal product once the clinical trial is finished.

Clinical Trials Directive

The Clinical Trials Directive 2001/20/EC (EU Directive), currently in force, references the 1996 version of the Declaration of Helsinki (DoH), which contains no provisions on post-trial access. Post-trial access language ( ie, ‘at the conclusion of the study, patients entered into the study are entitled to be informed about the outcome of the study and to share any benefits that result from it, for example, access to interventions identified as beneficial in the study or to other appropriate care or benefits’) was included

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