The European Commission’s proposed pharmaceutical strategy leaves it to the countries to decide whether drugs’ package leaflet is in paper format electronic, or both. However, having only electronic leaflets might put patients’ safety at risk, Luxembourgish MEP Tilly Metz has warned.
The revamp of the bloc’s regulatory framework for pharmaceuticals, presented by the Commission on 26 April, aims to unlock timely and equitable access to safe and effective medicines for all EU citizens while at the same time boosting the attractiveness of the EU pharmaceutical industry.
The proposal for a new directive and regulation that replace the 20-year-old pharmaceutical legislation deals with competitiveness, innovation, availability, and accessibility of medicines. But it also touches on package leaflets that provide medication instructions, including dosage, storage or potential side effects.
Currently, information is provided on a standardised leaflet enclosed in each package of medicines but Article 63 in the directive says that “member states may decide that the package leaflet shall be made available in paper format or electronically, or both”.
As the proposed directive “has a general objective to guarantee a high level of public health by ensuring the quality, safety and efficacy of medicinal products for EU patients,” MEP Tilly Metz from the Greens, one of the six shadow rapporteurs for the new regulation, warned that having only electronic leaflets would put some patients at risk.
“There is a risk, a safety risk. It reduces the safety of medicine if we introduce that,” she told Euractiv in an interview, listing connection issues, digital access, and digital literacy as some of the reasons.
According to Eurostat, in 2021, only a bit more than 50% of people in the EU aged 16 to 74 had at least basic digital skills. The share of people with those skills was the highest in the Netherlands and Finland, nearly reaching 80% in both, while on the other side of the scale, in Romania it stood at under 30%, and around 31% in Bulgaria.
That lack of digital skills might make the information provided only electronically inaccessible for some, according to a survey conducted by consumer cluster Euroconsumers in Belgium, Italy, Portugal, and Spain.
The majority, nearly 80% of over 4,000 participants who responded to a paper questionnaire, disagreed with the suggestion of replacing paper leaflets inside drug packages with QR codes.
Respondents felt that having only electronic access to information would disadvantage older people (81%) and would make society too dependent on the Internet (70%).
Metz already voiced her concerns in a debate on 20 September in Parliament’s Public Health Committee (ENVI) on behalf of Danish Green MEP Margrete Auken, who is a shadow rapporteur for a new directive.
“We are not keen on the idea of digital leaflets, especially when it comes to antimicrobials. Here, all info should be written on the immediate packaging of the drug,” Metz told the meeting.
Asked by EURACTIV what is the optional solution, Metz said: “For us, it’s very clear that the digital leaflet should only be a complement and not a substitute.”
“As a complement – yes. But not to replace the paper leaflet.
Based on the proposal, she said, the countries can pick either or both formats for providing the information. “There should be a harmonised approach in the EU. […] It’s not really in the interest of the of the patient here,” Metz said.
Not buying the Commission’s proposed solution
The Commission’s proposal states that if the package leaflet is only made available electronically, “the patient’s right to a printed copy of the package leaflet should be guaranteed upon request and free of charge and it should be ensured that the information in digital format is easily accessible to all patients”.
This risks putting an additional burden on the pharmacists, which is why Metz called the solution “quite unrealistic”.
“We know that pharmacists have a high workload, often they are confronted with medicine shortages and have to find a substitute for that,” Metz said. Her comment touches on the drug shortages that hampered access to medicines across the EU last autumn.
Adding additional tasks to pharmacists would also affect customer satisfaction as it would “increase the people’s waiting [time] in the pharmacy”.
She added that this would also mean requiring pharmacies to invest in printers.
Another concern voiced by Metz is the possible misuse of digital leaflets for commercial purposes.
“We have to make safeguards that it is not used for commercial purposes so that it really only contains the needed information,” she stressed, adding that this could also confuse patients.
“First of all, you get some advertisement [online] and then they look at what you were looking at. And later on, you get an advertisement saying: ‘Oh, you have high blood pressure. We can suggest these vitamins,'” Metz gave a scenario, calling for this to be prevented.
Having the digital version of the leaflet is seen as useful by 35% of respondents to the Euroconsumers survey, going up to 43% in Italy and Spain.
One of the reasons for that is the environmental impact. Around 61% agree that QR codes are better for the environment than paper leaflets.
But Metz is not convinced as servers for storing information and smartphones for scanning QR codes would need energy. Additionally, pharmacies would still be using paper for printing information for those who request it on paper.
“It is a kind of greenwashing,” she said. “We have really to look at the whole picture.”
[Edited by Zoran Radosavljevic]