Kathleen Lynch (Cork North Central, Labour) | Oireachtas source

I move amendment No. 141:

In page 105, to delete lines 3 to 5.

This amendment proposes to remove section 118, concerning clinical trials, from the Bill. Decisions on clinical trials involving persons who lack capacity should more appropriately be addressed in legislation under the remit of the Department of Health. Having reviewed the matter, I have concluded that it would not be desirable to prevent persons who lack capacity from participating in clinical trials. If we did so, it might prevent a treatment from being developed which could be to their benefit, such as a drug for Alzheimer's disease. The key issue is not to prevent people who lack capacity from participating in clinical trials but rather to ensure that if they do so, there will be robust safeguards in place. There is already an extensive framework in place to protect subjects participating in clinical trials, including incapacitated subjects, in the EU (Clinical Trials on Medicinal Products for Human Use) Regulations 2004, SI 190/2004, as amended. In addition, the clinical trials regulation, EU No. 536/2014, which is due to come into force in 2016, also contains extensive provisions relating to the protection of subjects. For this reason, I propose amendment No. 141, which will delete section 118 from the Bill.

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