The following Life Sciences Q&A provides comprehensive and up to date legal information covering:
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.
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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Practical completion marks the end of the construction period of a project, when the works are 'finished' and the employer can occupy and/or use them. Practical completion also typically marks the start of the defects liability period/maintenance period.As explained below, practical completion is an
What is a res judicata?A res judicata is a decision given by a judge or tribunal with jurisdiction over the cause of action and the parties, which disposes, with finality, of a matter decided so that it cannot be re-litigated by those bound by the judgment, except on appeal.Final judgments by
Produced with input from Rebecca Cousin of Slaughter and May on market practice.This Practice Note summarises the rules and guidance in relation to parties who are, or may be presumed to be, acting in concert for the purposes of The City Code on Takeovers and Mergers (the Code). In particular the
This Practice Note considers the doctrine of forum non conveniens, also referred to as the appropriate forum or the proper place for a dispute to be determined. This doctrine is of relevance when determining whether the courts of England and Wales have jurisdiction to hear a dispute and is applied
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