At the same meeting, the Commission provisionally adopted the following seven draft guidelines, the figures in square brackets corresponding to the numbers of the draft guidelines proposed by the Special Rapporteur, and the commentaries thereto: 1.1 (definition of reservations), 1.1.1 [1.1.4] (subject of reservations), 1.1.2 (cases where reservations may be formulated), 1.1.3 [1.1.8] (reservations with territorial scope), 1.1.4 [1.1.3] (Upon communication of 1.1.7 [1.1.1] (common formulation of a reservation) and draft guideline without title or number on the relationship between the definition and admissibility of reservations (A/53/10). The guide to the practice of contractual reservations includes an introduction, the text of the guidelines with explanations on treaties, an annex to the dialogue on reservations and a bibliography. The guidelines are divided into five parts: definitions; Procedure; admissibility of reservations and interpretative declarations; the legal effects of reservations and interpretative declarations; and reservations, acceptance of reservations, objections to reservations and interpretative declarations in case of succession of States. At its forty-eighth session, in 1996, the Commission had before it the second report of the Special Rapporteur (A/CN.4/477, Add.1) and a bibliography (A/CN.4/478). The report deals with the question of the unity or diversity of the legal regime, from reservations to treaties, in particular reservations to human rights treaties. The Special Rapporteur also proposed a draft resolution of the International Law Commission on reservations to normative multilateral treaties, including human rights treaties, which was sent to the General Assembly to draw attention to the legal aspects of the issue and to clarify their aspects. The Committee did not have time to consider the report and the draft resolution. The Committee therefore postponed its discussion of the item to its next session (A/51/10). First, the drug must be an investigational drug (as defined in existing legislation) for which a phase I trial has been completed.
Although the law does not define « completed », we would interpret it to mean that the essential information for which the Phase I trial was conducted is available to guide patient and physician decisions. In this context, we argue that a reasonable definition of a « completed » Phase I study would include: the study is permanently closed for new patient enrollment, the database is locked, the maximum tolerated dose (MTD), the recommended Phase II dose, and dose-limiting and non-dose-limiting toxicities have been identified, and these data have been reviewed and reviewed by the sponsor and submitted to the FDA. Without this, the correct dose for treatment, as well as the potential risks and benefits, could not be reliably provided and appropriate informed consent could not be obtained. At its fifty-third session, in 2001, the Commission again had before it the second part of the fifth report (A/CN.4/508/Add.3, Add.4), which dealt with procedural issues relating to reservations and interpretations. After considering the report, the Committee referred the draft guidelines to the Drafting Committee (A/56/10). At its fiftieth session, in 1998, the Commission had before it the Special Rapporteur`s third report (A/CN.4/491, Add.1, Add.2, Add.3, Add.4, Add.5, Add.6) dealing with the definition of reservations and interpretations of treaties.