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Reflector is Pharm Exec's Brussels correpsondent.
Europe slow to action on emerging technologies, but the complex issues clouding EHRs and gene editing, for example, offer pause.
Europe slow to action on emerging technologies, but the complex issues clouding EHRs and gene editing, for example, offer pause
Intheir perpetual game of catch-up with technology, European Union regulators recently trumpeted their plan to speed up the exchange of patients’ health data through a standard format for electronic health records (EHRs). This is the latest step in Europe’s slow journey toward making better use of digital technology in the health field-a journey which has so far generated more rhetoric than results. There was certainly no holding back on the visionary language about this data exchange plan: the scheme will support “the digital transformation of health and care in the EU by seeking to unlock the flow of health data across borders.”
The triumphant note may be a little exaggerated.
For a start, all the EU can really do in this field is to shout encouragement from the wings. The real players in any European health game, the national authorities, continue to amble around the stage in more the less direction they choose and at whatever speed they will. And so far, like in a mediocre theatrical improvisation, unity of purpose among the member states-and still less unity of action-is conspicuously absent.
The limits of Europe’s progress are easily demonstrated. A skeletal digital infrastructure design carried the first exchanges of patient summaries and e-prescriptions only in January of this year-and only between Estonia and Finland. The best hope at present is that 22 countries may be able to join in the exchange by 2021.
However, from another perspective, the EU’s slow progress may be more of a virtue than a vice. The scale of the challenges in shifting to EHRs is emerging with increasing clarity in countries beyond the EU that have moved faster on putting this type of data exchange into practice. There are particularly dismaying suggestions in a recent report from the US, the paragon of progress often held up in Europe as a model in digital adoption. Ten years on from the US boom in EHR adoption, the evident drawbacks are conditioning the heady optimism about their surefire capacity for making simultaneous improvements in economics, efficiencies, and quality.
In terms of sheer numbers, EHRs have been a huge success in the US, with adoption by more than nine out of every 10 hospitals. But growing US experience is revealing that physicians don’t like them. EHRs are complicated and often time-consuming to use. And they are unforgiving, because they demand 100% accuracy in manipulation. As the study puts it: “The average ER doctor will make 4,000 mouse clicks over the course of a shift, and that the odds of doing anything 4,000 times without an error is small.” This is fueling concerns about doctor burnout, itself branded an incipient public health crisis.
In addition, the distinct systems don’t interact well, so even when data is comprehensive and totally accurate, data transfer is often incomplete or inaccurate. The report details cases of fatalities and serious injuries ascribed
to faulty data transmission between distinct agencies and providers. The complexity of the systems can generate complex liability litigation: was the doctor or the software company to blame for a data error? And it highlights the absence of built-in corrective mechanisms in the systems. The report cites the practice of doctors opting for manual workarounds to their EHRs-such as writing essential data on a paper towel and leaving it on their colleagues’ computer keyboards. EHRs didn’t take away paperwork; the systems just moved it online, one is quoted as saying.
Even the promise that EHRs can put all of a patient’s records in one place can be a two-edged sword, because with so much data continually added, vital elements can easily be concealed in an almost endless series of menus and lists. The software has also been used, contends the report, to falsify health insurance and reimbursement claims.
But despite years of evidence of malfunctions-accidental or deliberate-there is no central database to study these incidents to improve safety, and, suggests the report, a conspiracy of silence among providers is concealing the true extent of the failings. It depicts “a $3.7 trillion healthcare system idling at the crossroads of progress” amid “a slew of unintended consequences.”
Against that background, the cautious EU steps may seem more understandable. Focusing-even if painfully slowly-on getting agreement on a standard for the crucial data exchange system suddenly seems not so misplaced.
The technology challenges become all the more acute when ethics rather than practicalities are at stake-and the debate over human genome editing provides a perfect example. In mid-March, the World Health Organization (WHO) held the first meeting of its expert panel to develop global standards for governance and oversight of human genome editing.
The panel was set up last December “to examine the scientific, ethical, social, and legal challenges associated with human genome editing (both somatic and germ cell).” The committee is tasked with providing advice “on appropriate oversight and governance mechanisms, both at the national and global level.” That seems a reasonable approach to such a contentious issue.
But some striking nuances on how to handle such challenges emerged just days before the meeting, notably in an energetic correspondence on the subject in Nature, including a preemptive call for a worldwide moratorium on heritable genome editing from scientists from the US, China, Canada, France, Germany, Italy, and New Zealand. There should be “a fixed period during which no clinical uses of germline editing whatsoever are allowed,” they wrote. “This period would provide time to establish an international framework…as well as allowing for discussions about the technical, scientific, medical, societal, ethical, and moral issues that must be considered before germline editing is permitted.”
They argued that it “is essential to include those representing perspectives outside science and medicine-including people with disabilities; patients and their families; economically disadvantaged communities; historically marginalized groups; religious groups; and civil society at large.”
Steve Bates, CEO of the UK-based biotech industry lobby, the BIA, has taken issue with this approach, not out of any reluctance about wide-ranging debate, but because, he argues, exactly such a wide-ranging debate has already taken place in the UK, and has built “a British ethical framework and consensus around this emerging area of science.” In other words, it may make sense to put a temporary ban in place where no such discussions have been held. But it doesn’t need to be worldwide.
Bates has marshaled support for his view from some of the UK’s authorities on the subject, who coincide in questioning the merits of a worldwide moratorium. “A moratorium on the clinical use of germline genome editing is neither necessary nor useful,” said an innovation guru. A lawyer added: “It is understandable that a moratorium is attractive to those working in countries that lack coherent regulation. In the UK, however, the law very clearly allows the use of genome editing in embryos for research, but equally clearly prohibits its clinical use in embryos. As such, a moratorium is unnecessary in the UK and may risk causing confusion about where the boundaries lie.” And the president of the Academy of Medical Sciences, Sir Robert Lechle, said: “Using the term ‘moratorium’ is unhelpful and any timeframe for a fixed term ban would be largely arbitrary.”
Bates’ conclusion provides an interesting perspective on the relevance of international collaboration in such sensitive areas: “The UK is fortunate to benefit from a democratically controlled, expert and scientifically informed, peer-reviewed regulatory environment, with a free press, that can navigate the risk/benefit profile of this and other emerging technologies.”
Perhaps a two-edged sword in some parts of the world needs to be safely sheathed-but in others it can be safely brandished.
Reflector is Pharmaceutical Executive’s correspondent in Brussels