Out-Law News | 13 Nov 2014 | 4:12 pm | 3 min. read
Life sciences specialist Helen Cline of Pinsent Masons, the law firm behind Out-Law.com, said that steps need to be taken to protect patient privacy and win patient trust. Without that trust it will be difficult to gain the necessary permission to use patient data in research projects which have the potential to deliver better and more personalised medicines, she said.
Cline was commenting after Genomics England announced that it was seeking researchers, NHS clinicians and medical students to join a new 'Clinical Interpretation Partnership' (CIP) to work on its 100,000 Genome Project. Under the scheme, as many as 100,000 people's DNA is to be sequenced as part of research into the treatment of a number of chronic illnesses.
"Genomics England is embarking … on a unique partnership that will bring together researchers and the NHS at the earliest possible stage of the programme to accelerate translation of the findings into earlier diagnoses for patients and prime the potential for therapies in the future," Genomics England, the body behind the 100,000 Genome Project, said.
Cline said this initiative together with other big data projects could impact on the way pharmaceutical companies develop drugs.
"The drug development model is changing," Cline said. "Drug discovery is being reoriented around patients as our understanding of how different patients respond to different drugs and diseases becomes increasingly sophisticated. The power inherent in big data projects such as that being undertaken by Genomics England is that prevention, diagnosis and treatment of disease could be refocused from the population-level, one-size-fits-all paradigm, to a personalised approach: ‘the right drug, for the right patient, at the right time’".
"However, these new capabilities to gather, analyse, disseminate and preserve vast quantities of data raise new concerns about the nature of privacy and the means by which individual patient privacy might be compromised or protected," she said.
"The technology is at hand to apply big data to health but it is clear that, from the patient perspective, establishing trust is essential if the techniques and tools of big data are to be successfully applied to health. However, it is equally important that data protection laws are not too prescriptive, since the key to extracting value from big data is to be able to apply new tools and to conceive new methods and approaches for converting data into insightful information," Cline said.
These complex issues have been considered by Genomic England's advisory group on ethics (7-page / 475KB PDF), Cline said.
Professor Mark Caulfield, chief scientist at Genomics England, said that the body wants to work with a "coalition of intellects" to tap into the data being collected in the 100,000 Genome Project.
"Typically it is only when researchers publish their research that it is considered for adoption into healthcare, which often takes a long time," professor Caulfield said. "It is our hope that introducing this novel interactive approach at the earliest phase of the 100,000 Genomes Project will lead to more rapid diagnosis and possibly new treatments for individuals affected by rare disease, cancer and infection."
The CIP initiative received the backing of the UK government.
Life sciences minister George Freeman said: "We want to make the UK the best place in the world to discover 21st century medicines which is why we have invested in the 100,000 Genomes Project. Now we need the expertise of researchers and NHS professionals to interpret the data from the project so we get maximum benefit for patients and their families. I encourage researchers to come forward to participate."
Professor Dame Kay Davies FRS, chair of the CIP Board, said researchers that join the CIP scheme would only have access to the "very large dataset" gathered through the 100,000 Genomes Project via "a secure data centre". Teams with varying skillsets will be put together to analyse the data under the project.
"These partnerships will include leading disease experts, experts in ethics and social sciences, computer scientists and health records researchers and will harness the knowledge and talent within the NHS and the research community to help tackle disease areas that we still know little about," Genomics England said. "The UK scientific community is being asked to propose ‘teams’ that will constitute multidisciplinary clinical, academic and training domains offering high calibre skillsets to this endeavour. Disease domains are expected to focus on areas we are working on and some examples include rare heart disease, breast cancer and rare inherited neurological disease."