Falsified medicines

Falsified medicines (the term 'falsified' is used to distinguish the issue from IP violations, so-called 'counterfeits') are a major threat to public health and safety. As falsifications become more sophisticated, the risk that falsified medicines reach patients in the EU increases every year. Falsified medicines represent a serious threat to global health and call for a comprehensive strategy both at European and international level.

General Information 

Major developments

 

 

General Information 

Falsified medicines are fake medicines that pass themselves off as real, authorised medicines. Falsified medicines might contain ingredients, including active ingredients, which are of bad quality or in the wrong dose – either too high or too low. As they have not been properly evaluated to check their quality, safety and efficacy - as required by strict EU authorisation procedures - this could be detrimental to your health. Falsified medicines (the term 'falsified' is used to distinguish the infringement to intellectual property rights, so-called 'counterfeits') are a major threat to public health. As falsifications become more sophisticated, the risk that falsified medicines reach patients in the EU increases every year.

Legal framework

Following adoption by the Council and the European Parliament, the new legislation on falsified medicines (823 KB)  български (bg) čeština (cs) dansk (da) Deutsch (de) eesti keel (et) ελληνικά (el) español (es) français (fr) italiano (it) latviešu valoda (lv) lietuvių kalba (lt) magyar (hu) Malti (mt) Nederlands (nl) polski (pl) português (pt) română (ro) slovenčina (sk) slovenščina (sl) suomi (fi) svenska (sv) was published on 1 July in the Official Journal of the European Union.
The new legislation will be applicable on 2 January 2013. This legislation is the outcome of the legal proposal that the Commission put forward in December 2008.
The new legislation introduces tougher rules to improve the protection of public health with new harmonised, pan-European measures to ensure that medicines are safe and that the trade in medicines is rigorously controlled.
To this end, these new measures include:

• An obligatory authenticity feature on the outer packaging of the medicines : this feature will be decided at a later stage via a delegated act;
• A common, EU-wide logo to identify legal online pharmacies. This would make it easier to distinguish between legal and illegal online pharmacies throughout the European Union;
• Tougher rules on the controls and inspections of producers of active pharmaceutical ingredients; and
• Strengthened record-keeping requirements for wholesale distributors

Implementation

Directive 2011/62/EU provides the basis of a number of implementation measures by the Commission. An overview is here(25 KB).

Directive 2011/62/EU introduces obligatory 'safety features' to allow, inter alia, verification of the authenticity of medicinal products for human use ('unique identifier'). The Directive places the Commission under an obligation to adopt delegated acts setting out the details relating to inter alia the unique identifier.  A concept paper(93 KB) has been rolled out for public consultation with a view to preparing both the impact assessment and the delegated act.

Moreover, Directive 2011/62/EU introduces EU-wide rules for the importation of active substances: According to Article 46b(2) of Directive 2001/83/EC, active substances shall only be imported if, inter alia, the active substances are accompanied by a written confirmation from the competent authority of the exporting third country which, as regards the plant manufacturing the exported active substance, confirms that the standards of good manufacturing practice and control of the plant are equivalent to those in the Union. The requirement of a written confirmation is waived for third countries listed by the Commission in accordance with Article 111b of Directive 2001/83/EC. Article 111b(2) of Directive 2001/83/EC provides that the Commission adopts an implementing measure to apply these requirements. A concept paper (52 KB)has been rolled out for public consultation with a view to preparing this implementing act. 

Regarding the written confirmation, a draft template has been published for the purpose of a public consultation. This draft template is available here(47 KB).

Directive 2011/62/EU places an obligation on Member States to take appropriate measures to ensure that manufacturers of active substances on their territory comply with good manufacturing practice ('GMP') for active substances. It also places an obligation on the Commission to adopt, by means of delegated acts, the principles and guidelines of good manufacturing practice for active substances. This concept paper(35 KB) is being released for public consultation with a view to preparing the delegated act on principles and guidelines of good manufacturing practice for active substances in medicinal products for human use.

Background documents:

On 10 December 2008 the Commission adopted a legislative proposal to amend Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use. The aim of this initiative is to address, in particular, the risk of falsified medicines entering the legal supply chain of medicines in the EU. The legal proposal was adopted as part of the pharmaceutical package.

For more information on the legal proposal, see below:

Press release(81 KB)  Deutsch (de) français (fr)

Brief background information(25 KB)

Summary of the proposal(18 KB)  български (bg) čeština (cs) dansk (da) Deutsch (de) eesti keel (et) ελληνικά (el) español (es) français (fr) italiano (it) latviešu valoda (lv) lietuvių kalba (lt) magyar (hu) Malti (mt) Nederlands (nl) polski (pl) português (pt) română (ro) slovenčina (sk) slovenščina (sl) suomi (fi) svenska (sv)

The proposal

The Commission "proposal for a Directive of the European Parliament and of the Council amending Directive 2001/83/EC as regards the prevention of the entry into the legal supply chain of medicinal products which are falsified in relation to their identity, history or source", was adopted on 10 December 2008.

Text of the proposal (Directive) - COM(2008) 668 final

Public consultation

A public consultation on combating counterfeit medicines was launched by the Commission on 11 March 2008.

Text of the public consultation.

A summary of the responses to the public consultation is contained in Annex 9 to the impact assessment report(993 KB).

Responses from stakeholders.

Impact assessment report

The Commission carried out a study to asses the economic, environmental and social impacts of the proposals. The final impact assessment report(993 KB) was adopted by the Commission on 10 December 2008.

Executive summary of the impact assessment report

 

For more information, please consult:

• Video EU fights Fake Medicines
• Q&A Directive on falsified medicines

 

Fasified  medicines - Major developments