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Parliamentary questions
21 June 2017
E-002776/2017
Answer given by Mr Andriukaitis on behalf of the Commission

1. As the Commission pointed out in its answer to Written Question E-008233/2016, the Falsified Medicines Directive(1) introduces stricter rules to improve the traceability of medicinal products to ensure that medicines are safe and that the trade in medicines is rigorously controlled. The directive primarily aims at addressing the problem of falsified medicines in the legal supply chain, and may indirectly help to tackle the infringement of Intellectual Property Rights (IPR), i.e. the problem of counterfeit medicines. The new measures include:

Obligatory safety features on the outer packaging of the medicines;
A common, EU-wide logo to identify legal online pharmacies, to make it easier to distinguish between legal and illegal online pharmacies throughout the EU.

The Commission is working intensively with the Member States through an expert group to ensure the smooth implementation of the safety features as of February 2019. The Commission will also continue to work with customs authorities, international partners and industry to ensure a high level of protection for IPRs in the EU(2).

International cooperation is also an essential component of the EU's strategy for the effective enforcement of IPR(3). Furthermore, the Commission is finalising an evaluation of the intellectual property rights (IPR) Enforcement Directive(4) which is also looking at the functioning of the enforcement framework for IPR for medicines.

2. The Commission maintains its website(5) as a tool to keep citizens informed of the ongoing work to continue to address counterfeit and falsified medicines and led a proactive communication campaign for the introduction of the EU common logo to identify legal online pharmacies.

(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 174/74, 1.7.2011.
(2)However, stopping goods at borders does not in itself provide for a long-term solution to address the problem of international trade of IPR infringing goods. Customs controls need to be combined with specific actions, including the conduct of investigations and the sharing of information to other authorities and agencies responsible for enforcing IPR, in order to enable those authorities and agencies to take the necessary action to stop production and to disrupt distribution networks.
(3)In this respect, the EU-China Action Plan concerning Customs Cooperation on IPR (2014-2017) signed on 16 May 2014 puts a specific focus on the enhancing of mutual administrative assistance mechanisms, including investigations Both sides also intend to share experiences, discuss working arrangements and practices to the strengthening of cooperation between customs and other relevant authorities and agencies in charge of the enforcement of IPR ‐such as the police and judiciary authorities — within their respective jurisdiction and cross border. The action plan should be extended for another period until 2020"
(4)Directive 2004/48/EC of the European Parliament and of the Council of 29 April 2004 on the enforcement of intellectual property rights; OJ L 195/16, 2.6.2004
(5)http://ec.europa.eu/health/human-use/falsified_medicines_en

Last updated: 27 June 2017Legal notice