The Department of Health (DoH) has announced that Genomics England, a new body launched today, will oversee arrangements for DNA code sequencing in relation to lung and paediatric cancer as well as rare and infectious diseases. The Department said that individuals' privacy rights would be respected.
"Genomics England will manage contracts for specialist UK-based companies, universities and hospitals to supply services on sequencing, data linkage and analysis," DoH said. "It will set standards for obtaining patients’ consent and also strictly manage storage of personal data in accordance with existing NHS rules designed to securely protect patient information. It will have the independence and clout to drive innovation across systems and healthcare economies."
Sir John Chisholm, the former chair of the Medical Research Council, will chair Genomics England. He said that the new DNA sequencing project has the potential to deliver real health benefits.
"Genomics England will create a dataset of anonymised whole genome sequences matched with clinical data at a scale unique in the world," Sir John said. "Participating patients will have the opportunity to benefit from clinical insights derived from the sequencing of their genome while at the same time contributing to knowledge which will be valuable to the whole patient community. It is from that knowledge that world leading therapeutic products and processes will become available to all patients."
"It is estimated that up to one in 17 people is born with or develop a rare disease during their lifetime. At least 80%of rare diseases have an identified genetic component, with 50% of new cases of rare diseases being identified in children. However, it can take considerable time and expense between a patient first presenting to a doctor and receiving an accurate diagnosis. The time taken to sequencing a whole human genome has been reduced to one to two weeks and will become more affordable for routine use as the price continues to fall," he said.
"Through partial sequencing in research projects of affected children or in infections, such as HIV, TB and Hepatitis C, scientists are already on the way to developing more effective treatments that personalise care," Sir John added.
In its health sector strategy for England published last year, DoH outlined plans to make it easier for health and care service providers and private sector biomedical scientific researchers to access medical data.
At the time it said that better sharing of medical data would help deliver improved patient services and better inform research. Under its plans only anonymised information would be made available and only in cases where individuals' consent had been given.
A new research body, the Clinical Practice Research Datalink (CPRD), has also been set up to bring together anonymised medical records from different sources and make the data available for sale to private sector businesses. Patients would be able to opt out if they did not wish their data to be used.
However, in a freedom of information disclosure earlier this year, DoH said that there is a procedure through which companies can access identifiable information about patients whose data is used by the CPRD even if patients did not consent to such disclosure.
Under Section 251 of the NHS Act 2006, approvals can be given to process non-anonymised patient information for medical purposes without the consent of individuals concerned. This sanctioning is justified where it is deemed necessary or expedient for the processing to take place in the interests of improving patient care or in the public interest, according to the Act. Researchers can apply to the Health Research Authority for a Section 251 approval, whilst the Health Secretary is responsible for assessing Section 251 requests for all non-research purposes.
Privacy group Ethics and Genetics has previously expressed concern about possible marketing practices companies could engage in if they were able to link anonymised medical data to individuals.