Pharma access to UK patient records ‘still up for debate’
The decision about whether the pharma industry will be given access to anonymised patient records is still in the balance, according to NHS England.
The NHS care.data project aims to create a world-leading research database from millions of anonymised patient records, but growing concerns about the data falling into the wrong hands or patient anonymity being lost came to a head in February.
An outcry about the patient records being compromised, or being used by insurance companies to deny people insurance coverage have led to the project being halted.
Speaking at the ABPI annual conference in London yesterday, the chairman of NHS England Sir Malcolm Grant admitted the organisation hadn't anticipated the level of concern about the scheme.
He told the industry audience that NHS England had been 'taken aback' by some of the response to the plans.
"I don't think it has been a fiasco, but let me tell you it hasn't been easy," he said.
To allay fears about access to the data, the government will now pass legislation to regulate how the data is used and distributed. An independent committee will oversee its use, and all applications to use the data, and subsequent decisions, will be in the public domain.
The database had been planned to go live on 1 April, but the NHS England says nothing will be done until the Autumn when new safeguards are put in place, and further consultation is conducted.
Most professional bodies representing healthcare professionals, including the BMA, support the care.data project and its aims, but have also called for the case to be communicated more clearly to the public.
Access for the pharma industry
In February NHS England said it was reviewing many of the original elements of the vision for care.data – including whether or not the pharmaceutical industry would be allowed access to the database to help in its research.
Most stakeholders had agreed that access for pharma and other third party researchers was a vital component of the plans, and could provide a world-leading data source for research.
However there is a chance this part of the plan could be abandoned to reassure the public that patient records are not being misused.
Speaking to pharmaphorum, Sir Malcolm Grant confirmed that the question of pharma industry access was 'still up for debate' – and refused to express a personal opinion about whether the industry should have access, saying the subject was currently far too sensitive.
He added that one of the most commonly expressed concerns - that insurance companies could use the data to deny people insurance – was groundless, as individuals must already grant insurance companies access to their personal medical records in order to take out life insurance policies.
Grant said he felt that the degree of anonymisation of the data was one of the key issues which could be addressed to reassure public opinion.
Grant told the ABPI audience that he felt the public could be convinced of the scheme's potential to help improve patient care.
"If I could be satisfied that my data could improve the care of others, why wouldn't I do agree to it?" he said.
The NHS organisation overseeing the project is the Health and Social Care Information Centre (HSCIC), and last week released a list of third party organisations which had used existing databases.
Among them were pharma companies Bayer, Baxter, AstraZeneca and Roche, as well as private healthcare provider Bupa.
Tamiflu and trust
The debate about care.data coincided with a new controversy linked to the pharma industry concealing data on their drugs.
New analysis of Roche's flu drug Tamiflu released yesterday by the Cochrane Collaboration concluded that the drug was largely ineffective – a fact which the academic researchers said Roche had known and deliberately concealed.
Roche rejected the accusations, and the decision to spend hundreds of millions of pounds on stockpiling the drug in the UK was defended by the government.
While the controversy is not directly linked to the care.data concerns, it once again raised serious concerns about the trustworthiness of the industry.
Also speaking at the conference was ABPI chief executive Stephen Whitehead. Addressing the Tamiflu question from the outset, Whitehead defended the industry's overall record for disclosure, saying that it would soon reach 100% rate of disclosure of clinical trial data, in line with the UK industry's own self-regulatory guidelines.
However Whitehead also made clear his displeasure at Roche's handling of the issue – a notable break from previous refusals to break ranks.
He said all 'reasonable' requests from researchers for historical data should be honoured by pharma companies, and said he thought the Tamiflu request – which dated back to 2009 – should have been met by Roche.
Referring to Roche's repeated refusal to hand over the data, Whitehead said the 'cat and mouse game' it had conducted with the Cochrane group had done nobody any good.
Whitehead also expressed hope the controversy would not overshadow the other issues in hand, which included debate about how the NHS and industry could work together in partnership to address the huge challenges facing healthcare.
Watch this space for further reports on yesterday's ABPI Annual Conference