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Patient safety and data protection concerns highlight hesitancy.
Switching to electronic labeling is one of the avowed aims of the European pharmaceutical industry, backed by claims that paper leaflets are a costly and inefficient hangover from the pre-digital age. But European consumer representatives have come out firmly against any wholesale shift, taking up cudgels on behalf of pharmacists as well as patients. At the same time, European doctors are digging in their heels against over-enthusiastic embracing of digital care in a sign of growing unease in Europe over headlong pursuit of what industry likes to refer to as health innovation. And there are other indications of a creeping hesitancy within the European healthcare community that could spell trouble for many of the bold initiatives and ambitions now in play to speed healthcare innovation
Sylvia Maurer of BEUC, the influential European consumers bureau, has gone on the record with a list of the downsides she sees in moving to digital-only leaflets that patients can look up online. The official position of industry lobby European Federation of Pharmaceutical Industries and Associations (EFPIA) is that the paper patient information leaflets should be phased out in favor of electronic versions, on the grounds that electronic product information (ePI) ensures that healthcare professionals, pharmacists, and patients and their carers always have access to the latest European product information for medicines. But Maurer says that the current printed leaflet enclosed in each package is there “for very good reasons,” because it tells patients about dosage, side effects, and interactions with other drugs. She rejects the industry demand for all information to be provided digitally, and does not buy the argument that patients who want it in written form can ask a pharmacist for a printout.
The consumer spokesperson insists that patients’ attention to important instructions is at risk if data is provided only in digital form, since that will make the information less likely to be consulted, or it will be read selectively and with less attention. Patients will be deprived of the physical experience that helps reinforce messages. Requiring them to go online rather than having it at their fingertips is going to lead to fewer patients accessing the data, she warns.
European pharmacists take a more nuanced view, but are still highly cautious: their lobby group, Pharmaceutical Group of the European Union (PGEU), supports the use of ePI only “to complement but not to replace” printed leaflets. Printed material linked to each box “addresses the paramount need for immediate and equal access to information crucial to minimise risks, regardless of the equipment and ease with technology,” it says.
As technology and science advance, and new rules are brought into being, the anxiety generated by shifts in established practice grows sharper among many stakeholders. The European Patients’ Forum is not opposed in principle to the proposed European data-sharing legislation, titled European Health Data Space (EHDS), but its response is so heavily loaded with reservations and conditions as to suggest the opposite. Any new arrangements, it says, must be shaped to ensure control of health data “with the highest possible level of data protection,” to ensure patient safety at all levels, and to respect the differences between different health systems that the proposal is in fact intended to overcome. The European hospitals organization, HOPE, also conditions its support for EHDS with a stress on the importance of “the highest viable levels of personal data protection and fundamental rights” and “strong ethical governance.”
Prescrire, the respected French drug monitoring service, warns that “with the increase of digital health services and products, including artificial intelligence, clarity is needed on the legislation applied to these products to guarantee their safety, effectiveness, as well as the patients’ and user’s privacy and rights.” Prof. Ray Walley, GP, vice president of the European doctors organization CPME, has been lamenting the COVID-19 pandemic’s reshaping of remote work and its pressure for online interactions, and argues that “patient safety is too important to be sacrificed for immediacy and convenience.” In comments submitted to the European Commission in its recent consultation on EHDS, 300 statements of rejection, principally from the Czech Republic and Slovakia, warned against the EU centralizing its power through knowledge of the health status of its citizens.
Industry leaders seeking to drive innovation in healthcare can no longer rely on classic justifications of business imperatives and efficiency. Like it or not, they will have to become as astute in politics as in management.
Reflector is Pharmaceutical Executive’s correspondent in Brussels.