Dear Bolton NHS Foundation Trust,
Freedom of Information request regarding the Incliseran drug trial by injection, known as Orion 4
I would like to submit the following questions in respect of the above trial now that Bolton patients have received invitations to take part in the trial:
The press release 13th January 2020 ` New heart drug to be made available for NHS patients` (www.gov.uk) states that “ NHS England will agree to a population level commercial arrangement “. What benefit will Bolton Foundation Trust receive... any benefit from this commercial arrangement, either financial/shares in the pharma company or otherwise? Please supply information.
Is the basis for the commercial arrangement, the initial and ongoing transfer of patients` medical records to a third party, and the work done by the Trust in carrying out the injections?
How have patients been selected for inclusion in this drug trial , were such issues as co morbidities or allergies/suitability of patient considered ?
Were selected patients informed [before being selected and sent appointments, if they were sent appointments] of the drugs trial in a clearly written letter, about what benefits or side effects they might experience if they wanted to become involved Before appointments were made ?
How is GDR/Data Protection Act 2018 complied with [ for instance some patients will opt out of data sharing how is this managed?]. How does the 3rd party comply with GDR/Data protection laws ?
FREEDOM OF INFORMATION
Subject: Incliseran drug trial by injection
Thank you for your email dated 24^th January 2020 where you requested
information about Incliseran drug trial by injection.
The information you requested is enclosed.
Please find information attached.
If you have any queries or concerns please do not hesitate to contact the
Freedom of Information Department. It would be helpful to quote the above
reference number in any future communication.
If you are unhappy with the service you have received in relation to your
request and wish to make a complaint or request a review of our decision,
you should write to The Chief Executive, Bolton NHS Foundation Trust, The
Royal Bolton Hospital, Minerva Road, Farnworth, Bolton. BL4 0JR.
If you are not content with the outcome of your complaint you may apply
directly to the Information Commissioner. Generally the Information
Commissioner cannot make a decision unless you have exhausted the
complaints procedure provided by Bolton NHS Foundation Trust. The
Information Commissioner can be contacted at The Information
Commissioner's Office, Wycliffe House, Water Lane, Wilmslow, Cheshire. SK9
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