(AGENPARL) – mer 03 luglio 2024 TRANSCRIME
Joint Research Centre on Innovation and Crime
Project CAPSULE
Collecting and sharing information on
the Consumers’ Awareness about the
Purchase of SUbstandard and falsified
medicines onlinE to support better
e-commerce practices.
SUMMARY REPORT1
July 2024
Author: Marco Dugato2
Università Cattolica del Sacro Cuore – Transcrime
This study was funded by Michigan State University’s
Center for Anti-Counterfeiting and Product Protection
(A-CAPP) through external research gifts
Center for Anti-Counterfeiting
and Product Protection
1. This document is a short version of the full report of the project CAPSULE.
2. With the contribution of Mirko Nazzari (UCSC-Transcrime) and Domenico Di Giorgio (AIFA)
Graphic project: Ilaria Mastro
Introduction
The proliferation of online sales, intensified by the COVID-19 pandemic, has significantly increased opportunities
for the illicit market of substandard or falsified medicines (SFMs)(OECD and EUIPO 2020; Europol2021;
Ahmed et al. 2022; ; EUIPO and Europol 2022; Jillani, Reinhard, and Hertig 2023). Criminals exploit consumers’
vulnerabilities through deceptive advertisements, posing considerable risks to public health and undermining
regulatory efforts aimed at ensuring the safety and efficacy of pharmaceutical products (Winter, Saunders, and
Hart 2003; Barbaranelli et al. 2015; Kennedy 2020).
Furthermore, diverse regulatory landscapes across different countries can exacerbate the problem
(Sogomonjan and Forcht Dagi 2023). Stringent regulations may inadvertently limit access to legitimate
channels for purchasing medicines online, thereby driving consumers toward illicit sources. Conversely, lenient
regulatory frameworks may create loopholes that facilitate criminal deception, allowing illegitimate operators
to thrive in an environment with minimal oversight and enforcement.
Existing efforts to combat the proliferation of SFMs primarily focus on targeting the online supply of illicit
medicines, aiming to disrupt the activities of illicit vendors and websites selling counterfeit or unlicensed
pharmaceutical products (Lavorgna 2015; Kennedy, Haberman, and Wilson 2018; Kennedy, Petlakh, and Wilson
2018). However, these enforcement actions often neglect to address the demand side of the market.
Understanding consumers’ experiences and exposure to SFMs online is crucial for developing effective
regulatory interventions and awareness campaigns. By gaining insights into consumers’ behaviors, perceptions,
and purchasing patterns, policymakers and regulatory authorities can devise targeted strategies to mitigate
the risks associated with online pharmaceutical sales.
Empirical understanding of consumer awareness and experiences with purchasing substandard and falsified
medicines online is limited, with most studies focusing on developing countries (Lybecker 2007; Alfadl, Ibrahim,
and Hassali 2012; Barbaranelli et al. 2015; Ofori-Parku and Park 2022). However, the issue extends globally, as
demonstrated by the widespread availability of fake medicinal products during the COVID-19 pandemic (Ziavrou,
Noguera, and Boumba 2022; EMA 2023).
Project CAPSULE seeks to bridge this knowledge gap by investigating consumers’ exposure, awareness, and
attitudes toward the online sale of medicines.
The research questions addressed by Project CAPSULE include:
1. To what extent are consumers exposed to online advertisements for medicines, and how common is the
purchasing of medicines online?
2. What is the level of consumers’ awareness and attitude toward the sales of medicines online, as well as the
associated risks?
3. How proficient are consumers in distinguishing between legitimate products and SFMs advertised online?
4. Which factors influence consumers’ exposure to or attitude toward the purchase of medicines online, as well
as their ability to distinguish between legitimate products and SFMs?
By investigating these research questions, Project CAPSULE aims to provide policymakers, regulatory
authorities, brand owners, and e-commerce platforms with insights into the demand for medicines online. These
insights can inform the development of targeted interventions, including awareness campaigns, regulatory
enforcement measures, and improvements to online product listings, to effectively combat the proliferation of
SFMs and safeguard public health.
Università Cattolica del Sacro Cuore (UCSC)-Transcrime led project CAPSULE, which was funded by Michigan
State University’s Center for Anti-Counterfeiting and Product Protection (A-CAPP) through external research gifts.
Methodology
Project CAPSULE gathered information from two representative samples of regular internet users in Italy and
Spain through a Computer Assisted Web Interviewing (CAWI) survey. The survey aimed to assess respondents’
awareness, attitudes, and experiences regarding online purchases and advertisements of medicine.
The questionnaire consisted of closed-ended questions and an experimental section. In the experimental
section, respondents were shown three different pictures of actual online advertisements for medicines or
similar products (i.e. dietary supplements), including at least one legitimate and one illicit advertisement.3
Respondents were asked to determine the legitimacy of each advertisement. Then, a recall question prompted
respondents to re-evaluate one of the images for which they had provided a judgment and confirm or revise their
initial responses. The questionnaire underwent validation and testing with a pilot group of 107 respondents (55
in Italy and 52 in Spain) before full-scale data collection.
The complete survey was administered to 2,107 regular internet users in Italy and Spain who were aware of
the possibility of purchasing medicines online and had been exposed to online medicine advertisements or
had purchased at least one medicine online. Respondents were selected from two online panels based
on geographical and socio-demographic variables, aligning with the overall Italian and Spanish population
distribution. Initial outreach reached a larger pool of potential respondents (3,610), with several individuals
excluded after the first questions for not meeting inclusion criteria. Data on the characteristics of excluded
respondents and their responses to screening questions were collected and analyzed.
Quality checks were implemented to filter out unreliable responses, and replacements were made to maintain
the expected sample size. Data collection began on January 11, 2024, and concluded on January 26, 2024.
Responses were analyzed using descriptive statistics and logistic regression models, considering
independent variables like sex, age, education, and a composite indicator measuring mistrust in online sales.4
Results have been discussed and validated with representatives from national health regulatory authorities in
both countries and academic experts on pharmaceutical crime.
Table 1 Number of respondents by type and inclusion criteria
Italy
Spain
Contacted respondents
1,254
2,356
Aware of the possibility of purchasing medicines online in Italy/Spain
1,151
1,268
Made an online purchase OR Have seen at least one online advertisement
1,058
1,065
Made an online purchase
Have seen at least one online advertisement
1,055
1,052
Excluded due to additional quality checks
Final samples
*Some respondents may have both seen an advertisement and made a purchase online.
3. Images were randomly chosen from a pool of six (three legitimate and three illicit) for each country, ensuring equal representation of each
image in the sample. The language of the advertisements corresponds to the nationality of the respondents.
4. The composite indicator assessing the level of mistrust of respondents in purchasing products online is defined as a linear aggregation of
five items encompassing judgements about regularity, attitudes, and perceived safety of online purchases.
Results
The following subsections present the findings of the Project CAPSULE.
Awareness and Attitudes Toward Online Medicine Sales
• Awareness toward online purchase: out of the initial 3,610 respondents reached, Italians exhibited
significantly higher awareness of the possibility of purchasing medicines online compared to Spanish
respondents (92% versus 54% of the initial national samples).
Awareness by demographics: older and more educated respondents showed significantly higher
awareness of online purchasing of medicines.
• Sources of awareness: most respondents became aware of online medicine purchases through websites
(62% in Italy and 48% in Spain), followed by word of mouth from friends and relatives (30% in Italy and 33% in
Spain), social networks (26% in both countries), and advertising emails (19% in Italy and 18% in Spain).
• Knowledge of regulations: the majority of respondents knew that legitimate online medicine sales in Italy
and Spain are limited to non-prescription drugs (73% in Italy and 66% in Spain). Many considered this the
most appropriate option (72% in Italy and 74% in Spain).
• Acceptability of risky purchases: no significant disparities were found between the national samples
regarding acceptable circumstances for purchasing online medicines with uncertain origins. About 40% of
respondents in both countries found it unacceptable under any condition.
• Motivations for risky purchases: in both countries, the main declared motivations for purchasing potentially
illicit medicines included the unavailability of the same medicine through other channels (23% in Italy and
26% in Spain) and cost savings (19% in Italy and 18% in Spain).
• Reliance on Internet for health information: despite high trust in healthcare professionals in both
countries, over half of the respondents frequently rely on the Internet for obtaining medicine information
(58% in Italy and 52% in Spain), and about 40% of respondents seek specific health solutions or look for
alternative treatments.
• Distinguishing dietary supplements from medicines: only about one-third of the final sample correctly
differentiated dietary supplements from medicines (34% in Italy and 32% in Spain). This highlights the
difficulties in distinguishing between medicines and other similar products subjected to different regulations.
• Convenience or trust: most respondents found purchasing medicines online convenient (71% in Italy and
61% in Spain), but expressed low trust in receiving the correct products if purchased online (78% in Italy and
80% in Spain).
• Concerns about counterfeit medicines: Italians are less concerned about counterfeit medicines online than
Spaniards, who also show more skepticism about the safety and effectiveness of medicines purchased online.
Experience with Online Medicine Advertisements and Purchases
• Exposure to online advertisements: respondents showed a high exposure to online advertisements for
medicines, with 85% of Italian and 75% of Spanish respondents reporting having seen at least one form of
online advertisement for medicines (Figure 1, pg.5).
• Online purchases: Italian respondents were more likely to have made an online purchase (69%) compared
to Spanish ones (52%).
Figure 1 – Have you ever purchased medicines online or noticed online advertisements related to medicines? (N 2,419)
Italy
Spain
Italy
Spain
I have seen at least one online advertisement
I made an online purchase
Dashed lines depict a 90% confidence interval around estimated percentages.
• Advertised medicines: flu treatments were the most advertised medicines in Italy, whereas in Spain there
was also high visibility for weight loss and performance-enhancing products (Figure 2).
• Purchased medicines: in Italy, flu treatments wewe the most popular online purchases, while in Spain, they
ranked second to performance-enhancing drugs. Spanish consumers bought more weight loss and smoking
cessation products than Italians, who, conversely, purchased more chronic pain and cholesterol management
medicines.
Figure 2 – Which types of medicines5 have you seen in online advertisements (N 1,922) and/or have you
purchased online (N 1,439)?
Advertisement
Purchase
Medicines for treatment of flu
Weight loss medicines
Performance-enhancing medicines
(e.g., sports or concentration)
Cholesterol management medicines
Medicines for chronic pain
Smoking cessation medicines
Erectile dysfunction medicines
Other
Vaccines or medicines
against Covid-19
Antidepressants
Anticancer medicines
Error bars depict a 90% confidence interval around estimated percentages.
5. The categories of products were chosen and defined to encompass a broad range of the most commonly sold licit and
illicit medicines online, while also accounting for slight differences in the definitions of medicine between Italian and Spanish
regulations.
• Popular channles: websites were the primary channel for both advertisement exposure and purchases,
followed by social networks and e-commerce platforms.
• Trends in online purchase: a comparison with a previous survey conducted in 2015-2016 by AIFA and
Sapienza University of Rome revealed a significant increase in online medicine purchases in both
countries.
• Trends in perceptions and safety concerns: here was also a notable increase in the percentage of
respondents viewing the possibility of purchasing medicines online positively. However, concerns about
the safety of medicines purchased online remained consistent between the two surveys.
Ability to Recognize Illicit Online Advertisement
• The experiment: an experimental section of the survey assessed respondents’ ability to distinguish
between legitimate and illicit online advertisements. The results show notable similarities between the two
countries.
• Overall recognition: approximately half (53%) of the online advertisements were correctly categorized
as legitimate or illicit, with only about one respondent out of five correctly identifying the legitimacy of all
three proposed images.
• Legitimate advertisements: legitimate advertisements were correctly identified more often, with about
63% of the shown images in both countries correctly recognized. However, in a considerable number of
cases, respondents were unable to provide a judgment on the proposed images (29% in Italy and 27% in
Spain) (Figure 3).
• Illicit advertisements: illicit advertisements were correctly identified in only four out of ten responses
(43% in Italy and 42% in Spain).
• Demographic influence: older respondents and consumers with lower trust in online sales exhibited
lower accuracy in identifying both legitimate and illicit advertisements.
• Consistency of responses: when asked to confirm one of their previous answers regarding the legitimate
nature of the advertisements, respondents generally confirmed their initial judgment, especially if their
previous answer was correct.However, 20% to 25% of respondents changed their original answer declaring
that they were no longer able to distinguish the legitimacy of the advertisement.
• Evaluation criteria: respondents declared to assess the possible illegality of an online advertisement
primarily by looking at the absence of the label certifying authorization from the Ministry of Health, followed
by the absence of a medicine description or the presence of errors in the medicine description. Photos and
packaging details were deemed relevant by only a minority of respondents in both countries.
Figure 3 – Type of provided answers on the total number of legitimate (N 3,162) or illicit (N 3,159)
advertisements.
63% 63%
Italy
Right answers
43% 42%
Right answers
29% 28%
33% 32%
8% 9%
Spain
Legitimate
Illicit
I cannot distinguish
Legitimate advertisement
Legitimate
Illicit
I cannot distinguish
Illicit advertisement
Conclusions and
Recommendations
Project CAPSULE provided insights into Italian and Spanish consumers’ behavior and attitudes towards online
medicine sales. These results could lead to more targeted and effective actions by both public authorities and
private stakeholders. Specifically, the study highlights:
• An increase in awareness and practices regarding online medicine purchases was observed compared to
a previous survey conducted in 2015-2016, aligning with the worldwide increased in e-commerce and online
pharmacies market share (TMR 2022). Italian consumers exhibited higher awareness and trust in online
medicine purchases compared to Spanish ones.
• Elderly respondents were found to be more aware of online medicine purchases but less capable of
recognizing the legitimacy of the advertisements. This highlights the need for targeted awareness campaigns
aimed at older populations, who may have increased internet access but limited knowledge to identify
potential threats in online purchases.
• Younger respondents showed better identification of illicit advertisements but expressed lower trust in
healthcare professionals and a higher tendency to use the Internet to retrieve health-related information.
This underscores the importance of efforts to enhance trust in medical professionals and reduce exposure to
unreliable information or deceptive practices.
• While consumers in both countries demonstrated good overall knowledge of regulations governing online
medicine sales, they faced challenges in distinguishing medicines from other health-related products. This
highlights the need for improved product labeling and consumer education to prevent misguided purchases.
• Differences in advertised and purchased products were observed between Italy and Spain. This may
suggest variations on both the demand and supply sides of the market that should be monitored to ensure
that advertising and selling practices are compliant with national regulations.
• Websites are the primary access points for both advertising and purchases, with social media and
e-commerce platforms having a secondary, but not negligible, role. Specifically, social media emerges as a
prominent platform for advertising medicines online.
• This highlights the predominant risk coming from illicit online pharmacies and deceptive websites, but also
suggests the need for collaboration between authorities, pharmaceutical companies, and online platforms
to prevent illicit activities and protect consumers.
• Enhancing the security of legitimate websites requires a consumer-centric approach to help identify
potential weaknesses and mitigate or prevent criminal threats. This is particularly relevant given the negligible
percentage of legitimate websites compared to illicit ones (Limbu and Huhmann 2023). Therefore, there is
a need to design crime-proof websites, incorporating unique features like the Ministry’s logo, and launch
campaigns to increase consumer awareness about them.
• The design of informative campaigns should consider the diverse needs of the target populations, and
the channels used by consumers to access health-related information. This underscores the necessity of
defining communicative strategies that extend beyond institutional channels.
• Continued research in this area is crucial to understand evolving consumer behaviors and market dynamics,
allowing for the development of effective countermeasures tailored to specific regions and market changes
over time.
References
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Contemporary Issues with Restricting FDA-Approved Medication Access.” The Journal of Medicine
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