In an upcoming EU reform of pharma policy, the pharmaceutical industry is pushing to replace paper leaflets in our medicines with digital leaflets that you can find online, but we don’t think that’s a good idea because of obvious downsides.
The Commission’s review of the General Pharmaceutical legislation will look at how patients will be informed in the future about dosage of medicines, what side effects and combination effects they may have with other medicines. Today, this is being done based through a written, standardised leaflet enclosed in each package of medicines for very good reasons. While electronic product information can have undeniable benefits for patients[1], health care professionals, regulators and industry alike and is welcome, the industry wants a ‘paradigm shift’: it wants that ALL information is only provided digitally and those patients who would still like a printout can ask their pharmacist.
Digital leaflets come with real advantages but they should complement, not replace, paper leaflets.
Waiting longer in the pharmacy: inconvenient, burdensome, unacceptable….
Unfortunately, more and more policy makers seem open to such a radical change. The overall trend towards digital information worries many of my colleagues, including those working on food policy for example regarding alcohol labelling, on safety policy for cosmetics, toys, detergents and general product safety but is also a big problem from a general consumer perspective as it places barriers to making an informed choice.
Pharmacists have more urgent things to do than to print out leaflets. Beyond giving good advice to patients and listening to their worries, they also need to spend more and more time every week on finding alternatives to missing medicines. This would not be good use of their time as the Pharmaceutical Group of the European Union (PGEU) makes this crystal clear in their recommendable paper on electronic product information.
Giving only digital information may lower patients’ attention to important instructions
Neuroscience has shown that something we can touch and experience sticks better in our brains. A printed leaflet is more likely to be consulted because we have a physical copy and the messages will stick better in our brains. Digital information, on the contrary, is read often selectively and with less attention. The principle of least effort also says that people prefer solutions which are simpler. So making it harder for patients to access information about their medicines, by requiring them to go online rather than having it at their fingertips or to have to ask to print out the leaflet, is likely to lead to fewer patients accessing the information.
It adds a step for people to access the information they need and can affect the safety of patients and of society overall.
Just imagine if fewer people know that certain medicines can lower their attention in traffic or at the workplace.
Digital technology is not clean
There are other downsides to replacing paper leaflets with digital ones for medicines. The argument that digital technology is cleaner than printed leaflets is the one I buy least: servers on which electronic information is being stored need enormous amounts of energy, every scan of a code with a mobile phone needs energy and the infrastructure of the internet has a tremendous additional negative environmental impact such as overconsumption of resources, loss of biodiversity and chemicals pollution.
Going digital has nothing to do with a ‘dematerialisation’: just think of all the mobile phones, chargers, modems which often do not even last for two years before becoming obsolete.
Wood on the contrary is a renewable resource, people seem to be more and more willing to sort their waste and paper can be, and is, recycled at large scale. Moreover, the leaflets in medicine packages are printed on thinner paper and are optimized in terms of space.
Not everyone is online, and internet may not always be available
Not everyone can afford a smartphone or have access to an internet subscription. Parts of the EU are still without proper broadband access. It may also be that energy is not constantly available, either because of blackouts or because of cyberattacks. And the elderly are less likely to get on their smartphone and get the information they need from a leaflet in seconds, as they tend to be less confident with technology.
And yet it is the elderly who are statistically most likely to require medicines.
We should also not forget that patients have special needs which may make it difficult to operate a smartphone. And here I am not only speaking about the obvious such as a broken arm wrapped into a plaster.
Don’t track, use or sell patients’ data for advertisement purposes
It is crucial that patients’ privacy and personal data is protected. For example, if companies create a scannable code and print it on a box of medicines, there could be little control of what companies include in such code, what they can access about patients and monetise, despite the European General Data Protection Regulation and the ePrivacy Directive. Even if the information would be stored on a public server such as that of national health authorities or the European Medicines Agency, it would still be the companies who create and provide the code.
For example it could come with a link or app embedded which could be a gateway for companies to exploit patients’ data, which are of very sensitive nature.
What we need are safeguards in the legislation to prevent this from happening.
Digital information must follow the principles of data protection and privacy by design and by default and there must be clear prohibitions not to use QR codes or any other similar technology for commercial purposes. These recommendations are essential because otherwise there will be patients who, because of mistrust, would avoid scanning the instructions for certain medicines and thereby lose out on being informed.
What the EU pharma reform must do for consumers
The downsides of replacing paper leaflets with digital leaflets for medicines are obvious. They should be complementary.
To protect patients in the EU, the upcoming legislative proposal for the General Pharmaceutical legislation should include the following:
- Printed information must continue to be included in the box for prescription and non-prescription medicines.
- Digital information should be given as a complement for regulator-approved medicines only and must be stored at the European Medicines Agency or national health authorities publicly available and for free of charge.
- There must be privacy and data protection by design and by default to have patients’ trust. Industry should not have any opportunities to use digital product information for processing data for commercial purposes such as advertisements. To this end, the legislation must foresee clear safeguards such as prohibiting the use of QR codes for other purposes than giving essential information about the medicine.
[1] Digital information can help people who are visually impaired and updates to safety information can be quickly included into the leaflet. Digital information can also provide additional language versions which are not available in a specific country in the printed version.