§ Lord Walton of Detchantasked Her Majesty's Government:
Whether they support the proposal, contained in the draft European Union directive on clinical trials, that Phase 1 trials carried out by the pharmaceutical companies to study the absorption, distribution, metabolism and excretion of a drug under development should in future be subject to a formal regulatory process; and [HL1366]
Whether they support the proposal, contained in the draft European Union directive on clinical trials, that the definition of an "investigational medicinal product" should be changed so that a product which has a marketing authorisation being used in a clinical trial would have to be labelled with the same information as an unlicensed product being used in such a trial; and [HL1367]
118WAWhether, in relation to the draft European Union directive on clinical trials, they support the proposal for the definition of an investigator or sub-investigator which does not clearly specify the requirement that a qualified physician must be responsible for all trial-related medical decisions; and [HL1368]
Whether they support the proposal, contained in the draft European Union directive on clinical trials, that the definition of an adverse event involving abnormal laboratory findings should not require that such findings should be potentially or actually clinically significant. [HL1369]
§ The Minister of State, Department of Health (Baroness Jay of Paddington)The draft European Union Directive on clinical trials is currently being negotiated in the European Council and discussed by the European Parliament. If the text were to be adopted as currently drafted it would require an unwelcome change to current United Kingdom regulatory practice on Phase 1 trials (studies on healthy volunteers).
The definitions of "investigational medicinal products", "investigator" and "adverse event" are contained in guidelines adopted by the International Conference on Harmonisation (ICH). The UK has, as part of the European Union and together with the United States of America and Japan, taken a decision to adopt these various guidelines. The European Commission has accepted in discussions of the text of the directive that the relevant ICH guideline definitions should be replicated in this text.