New ABPI guideline for patient data published

The Association of the British Pharmaceutical Industry has published a new guideline for the use by drugmakers of patient records. Carol Wilson, the ABPI's legal director, explained that "secondary use of data by medical researchers can bring many benefits for patients, including discovery of therapeutic uses of existing medicines and quicker medicines development." However, she added: "patients need to be assured information about them is being used responsibly, securely and ethically. These guidelines aim to balance these considerations and promote trust by ensuring researchers adopt the best practice in handling personal information."

A spokesman for the ABPI told the Marketletter that the document is primarily for use by research professionals as a reference tool. He added that an example of a drug developer benefiting from secondary use of patient data might be Avastin (bevacizumab), which is co-developed by Swiss drug major Roche and its majority-owned US biotechnology firm Genentech, and marketed as an anticancer agent. The drug has been recommended for off-label use in cases of wet age-related macular degeneration by some health care providers, including the US health insurance giant, United Healthcare. Avastin is cheaper than some of the approved drugs for wet AMD.

The text of the new guideline can be found on-line at: http://www.abpi.org.uk/publications/pdfs/Guidelines_SecondaryUseData.pdf.