Response to Consultation on Amendment to the Medicines for Human Use (Clinical Trials) Regulations

Alzheimer Scotland is a national charity representing the interests of Scotland’s estimated 63,000 people with dementia, and their carers. We aim to be the voice of and for people with dementia and their carers, to influence the improvement of public policies and to promote and provide high quality services for people with dementia and their carers.

Alzheimer Scotland has consulted with key individuals within the organisation and agrees with the changes proposed in the Consultation on Amendment to the Medicines for Human Use (Clinical Trials) Regulations 2004. We make the following key points.

• People with dementia should be entitled to the same treatment as other people
• Any treatment given must be in the best interest of the person with dementia
• Not being involved in the trial may exacerbate the person’s dementia; for example, in the case of head injury
• The following should be seen as good practice in this area.

As a safeguard, the personal or professional representative should be bound to act in keeping with the principles of the Adults with Incapacity (Scotland) Act 2000, including trying to establish the present and past wishes of the person with dementia. Part of the procedure should include checking the Office of the Public Guardian’s database to ensure that no one is a registered guardian or has power of attorney for the adult. In office hours this can be done with a phone call and the document e-mailed to hospital.

This response may be made freely available.