Medicine: Experimental Drugs

Lord Patel Excerpts

Monday 10th June 2013 Lords Chamber

[Earl Howe]

My Lords, this will very much depend on a case-by-case analysis of the drug in question. If there is a very promising new drug that is a breakthrough medicine, where there is no alternative treatment, there may be a case for considering that more favourably than a drug for which there is a readily suitable alternative. As I mentioned earlier, the menu of options available to us, such as an early access scheme for unlicensed medicines and an adaptive licensing scheme within European Union rules for licensed medicines, can perhaps be tailor-made to suit the drug in question.

[Lord Patel]

Does the Minister agree that there are two separate issues: one is doctors’ and nurses’ ability to prescribe off-label drugs, which is allowed, and for which the doctor takes responsibility; and the second is using a drug that might be promising for treatment and doing research on it, which requires research protocol to be followed? Neither is permissible under current regulations.

[Earl Howe]

My Lords, the noble Lord is right that the two issues are distinct. It has always been the case that a doctor can, under his or her own professional responsibility, in certain circumstances, prescribe an unlicensed medicine. However, he is also correct that clinical trials need to take place within a framework of proper ethical and organisational approval.