A £180 million Biomedical Catalyst fund to bridge the ‘valley of death’ between the discovery of medical innovations and their commercialisation, as well as further moves to open up National Health Service patient data for clinical research, are part of the latest package of measures announced by the government to bolster the UK’s life science industry and attract inward investment.
While these initiatives were generally welcomed by industry, the broader medical research community and venture capitalists, the suggestion that NHS patient data should be “automatically included in clinical research”, albeit with an opportunity for patients to opt out, re-ignited debate in the media about patient confidentiality and NHS privatisation,
Despite claims that the NHS was effectively being pawned off to industry for use as its personal laboratory, in practice the latest proposals on patient data added little to what had already been flagged up in the government’s Autumn Statement last month and the Plan for Growth in March, as well as discussed and piloted for some time within the National Institute for Health Research’s (NIHR) Research Capability Programme.
Nonetheless, privacy campaigners, lawyers, the Labour opposition, the British Medical Association and lobbying groups such as Patient Concern challenged the government’s insistence, backed up by industry, that patient data would be properly anonymised and protected.
Even with the proposed safeguards in place, patients might still be identifiable, whether by accident or design, these critics maintained. Others just objected to the basic principle of putting even more personal data into commercial hands.
Catalyst fund
The three-year Biomedical Catalyst fund put forward as part of the government’s strategy for health innovation and the life sciences will be jointly managed by its Technology Strategy Board (TSB) and the Medical Research Council (MRC), with oversight from a steering group comprising senior translational experts from academia, the NHS, industry and the investment sectors, as well as director-level representatives from the MRC and TSB.
The aim is to nurture innovative technologies from the academic or commercial sectors from initial research in universities through to commercial development in small- and medium-sized companies, where they will be able to attract private equity.
As such, the initiative was particularly welcomed by the BioIndustry Association (BIA). The significance of the move to the continuing viability of small biotechs was also highlighted by fund managers SV Life Sciences.“Successful early-stage biotech companies are being increasingly bought directly by big pharmaceutical companies because the smaller companies do not have the cash to invest in their own life-changing new drugs, while the pharmaceutical companies have both the cash and expertise to developing such drugs,” noted managing partner Kate Bingham.
Over the last three years, SV Life Sciences has sold three UK biotechnology companies to major pharmaceutical companies for more than US$600 million, Bingham added.
If these operations had been given access to additional funding for clinical development, “they could potentially not have sold so early to the pharma industry, and built themselves in to independent UK based biotech companies, keeping jobs and value in the UK”.
TSB funding
Under the new programme, the Technology Strategy Board will receive additional funding of £90 million, which will be aligned with existing academic translational funding from the MRC to deliver a total of £180 million.
The TSB will work in partnership with the MRC to encourage collaboration between MRC-funded scientists and high-technology companies, especially small and medium-sized enterprises (SMEs). The MRC said it was particularly keen to help SMEs engage more with clinical proof-of-concept studies, “where partnerships with academic research groups and patient participation are vital”.
The Biomedical Catalyst fund will provide staged investment while also allowing partly developed applications to enter the ‘pathway’ at any stage. It will be “a well publicised, simple funding scheme, with rigorous scientific, clinical and commercial tests, that gives credibility and visibility to help companies to move more quickly to commercial success, revenues and sustainability”, the TSB and MRC promised.
As MRC chief executive Sir John Savill pointed out, a growing number of organisations are involved in life sciences in the UK and the “emerging ‘open innovation’ model of research and development results in companies engaging with the wider research environment”.
While this trend “encourages creativity and innovation, it also means it is now more important than ever to ensure that public investment is maximised and supports the most promising developments, for both patient benefit and commercial success”, he added.
Patient data
The patient data proposals, which the Department for Business, Innovation and Skills said were “in response to calls from research charities and clinicians for government to get patients more involved in supporting the research agenda”, will involve a consultation to amend the NHS Constitution so that patient data are “automatically included in clinical research, but giving patients a clear opportunity to opt-out if they wish to do so”.
This will link into the launch of the Clinical Practice Research Datalink (CPRD) under the Department of Health’s Research Capability Programme, which since 2008 has been considering ways in which data captured by the NHS as part of routine care could be used to support clinical research.
A partnership between the Medicines and Healthcare products Regulatory Agency (MHRA) and the NIHR, the CPRD will be established within the MHRA to service the specialised needs of the research and life science communities, providing access to linked data for the entire NHS population in England and enabling clinical trials in primary care through an integrated electronic case report form/electronic health record (eCRF/EHR) system.
The CPRD will complement the secure data linkage service to be set up by the Health and Social Care Information Centre, which will provide data extracts using linked data from primary and secondary care as well as other sources, gathered on a routine basis at an unidentifiable, individual level.
A pilot scheme, the Health Research Support Service (HRSS), paved the way for the launch of the Clinical Practice Research Datalink in October.
As things stand, the government explained, “getting patients’ consent for vital research is done on a study by study basis causing significant delays”. The new measures “will further improve the evidence used in research for the wider benefits of patients through the rate at which patients can be recruited for clinical trials”.
In his accompanying report on Innovation Health and Wealth, Accelerating Adoption and Diffusion in the NHS, the health service’s chief executive, Sir David Nicholson, noted that patient data “can provide great insight for health research, which in turn improves the quality of diagnosis, treatments and other interventions. It is a key goal of the NHS for every willing patient to be a research patient, enabling them to access novel treatments earlier”.The underlying principle in the healthy sector, he argued, should always be “to make data and information available unless there are good reasons not to do so. In considering this we need to balance the benefits of openness with our responsibility to protect patient confidentiality and safety, as well as taking into account the purpose and relative benefits of transparency, and the costs of providing data”.
Easing access
Objections aside, the government’s proposals are not so much about accessing patient data as easing, broadening and deepening data access while establishing productive links between currently siloed datasets in primary, secondary and tertiary care.
For example, the UK’s General Practice Research Database (GPRD) has been collecting anonymised longitudinal medical records from primary care since 1987, and these data are used for research by the pharmaceutical industry as well as clinical research organisations, regulators, government departments and academic institutions.
Data from GP practices were used in the HRSS pilot, the Department of Health confirmed. The aim of the CPRD, it added, is to “spread best practice from this initial work and build on what wealready know. The objective is to manage exisiting research data in farmore efficient manner, regardless of the sector in question”.
The Plan for Growth made clear the government’s intention to “build a consensus on using e-health record data to create a unique position for the UK in health research”. Linking the wealth of data available through the NHS would “create unique opportunities for research in the UK, including more powerful uses of anonymised data sets and aggregated prescription data linked down to GP practice level”, it stated at the time.
But that could only happen, the Plan added, if there was “robust protection for individual patients’ confidentiality and privacy”.
Confidentiality risk
Despite these assurances, the overriding theme of media reports in response to the government’s latest announcement was concern about patient confidentiality and the spectre of commercial businesses making hay with data that did not belong to them.
The British Medical Association, while acknowledging that anonymised health data could benefit patients, said it was “especially worried by recommendations that would grant researchers, possibly from large commercial companies rather than the patient’s healthcare team, access to patient records”.
“This could mean that details of an individual’s health status and treatment will be revealed if researchers are able to search through records and identify patients in order to contact them.”
There is a recognition within industry that anonymised data on relatively small numbers patients with an orphan disease, for example, might be susceptible to identification. This is where an opt-out would come into play, though.
Liz Fitzsimmons, senior associated at law firm Eversheds, said it was evident there were “tensions about the point at which statistical data can no longer be used to identify people, as was clear from the long running legal debate between the Department of Health and the Information Commissioner’s Office in relation to the disclosure of abortion statistics”.
The hope is that “the Code of Practice on Anonymisation which the Information Commissioner is currently developing helps to satisfy all parties in this debate, so patient confidentiality is sufficiently safeguarded while allowing the valuable data to be unlocked and utilised to fuel developments”, she added.
Lost, abused
Concerns have also been raised about data being lost, abused or corrupted, with Esther Smith, healthcare partner at Thomas Eggar, describing the government’s proposals as “a potential legal minefield, not just for the NHS and the private operators involved, but for the patients themselves”.
Alison Dennis, partner at Field Fisher Waterhouse, believes a number of legal hurdles will need to be crossed before the scheme can get off the ground. These relate to:• Data protection law. Patient data are classified as ‘sensitive’ data and afforded a high degree of protection. Moreover, data collected for one purpose (i.e., treatment) “should generally not be disclosed or used for a different purpose (e.g., drug development by private business)”.
Whether or not these become significant issues in the context of the government’sprogramme “really depends on whether the data that the NHS discloses to privatebusinesses comprise personal data or whether they are wholly anonymised”.
• Doctor-patient confidentiality. Guidelines from the General Medical Council “make it clear that patients have a right to expect that information about them will be held in confidence by their doctors”, Dennis noted. As such, doctors “may be placed in a difficult position if patients expressly state that they do not consent to their data being released for research purposes”.
• Competition law. If data are only provided to a select few interested companies, “this would mean they had an unfair advantage, triggering EU competition regulation”.
