Answer to Written Question: Tackling the sale of counterfeit medicines in the EU

(Source: European Parliament)

EN

E-000810/2021

Answer given by Ms Kyriakides

on behalf of the European Commission

(31.5.2021)

The Commission is aware of counterfeit medicines. Nevertheless, Member States have reported very few incidents of the falsified medicines in the legal supply chain since the introduction of the falsified medicines Directive[1]. The placement of the unique identifier[2] and the introduction of the EU logo on online pharmacies[3] contribute to efficiently reducing the risk of falsification.

As far as vaccines are concerned, the distribution chain follows a specific pattern from the manufacturers to the distributors nominated by the Member States’ health administration.

Medicines non-compliant with EU laws can also be seized by customs when they enter or exit the EU customs territory. COVID-19 vaccines producers were reminded of the need to provide necessary information to customs in order to allow them to intervene in case of suspected counterfeit medicines.

In addition, the Commission’s proposed regulation for a Digital Services Act[4] sets out a horizontal framework laying down the responsibilities of online intermediaries for tackling illegal content, products and services, including counterfeit medicines offered by their users.

The Commission has also announced the development of an EU toolbox against counterfeiting[5], which sets out principles for joint action, cooperation and data sharing among right holders, intermediaries and law enforcement authorities. That toolbox aims to ensure coherent, effective and coordinated action against counterfeiting, both online and offline.

The Commission and the network of national consumer protection authorities[6] work with online platforms[7] to protect consumers against scam products using misleading health claims related to the coronavirus.


[1] Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products (OJ L 174, 1.7.2011, p. 74).

[2] https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32016R0161&from=EN

[3] https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32014R0699&from=EN

[4] https://ec.europa.eu/digital-single-market/en/digital-services-act-package

[5] COM(2020)760.

[6] https://ec.europa.eu/info/departments/justice-and-consumers/justice-and-consumers-funding-tenders/funding-areas/consumer-programme-cp/enforcement-consumer-protection/consumer-protection-cooperation-network_en

[7] The network of national consumer protection authorities (CPC network) endorsed a common position and established a structured dialogue with 11 online platforms. More details available at: https://ec.europa.eu/info/live-work-travel-eu/consumers/enforcement-consumer-protection/scams-related-covid-19_en

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