Counterfeit Medicines - legislative update

The Directive on Medicinal products for human use: prevention of the entry into the legal supply chain of falsified medicinal products (amend. Directive 2001/83/EC) has been adopted by the Council of the European Union. The Directive was agreed upon under the Belgian Presidency on its first reading with only one abstention (from Latvia).

The directive will introduce increased safety features for prescription medicines including increased safety features which would allow them to be tracked throughout the supply chain. Also, manufacturers are obliged to ensure that the active ingredients contained in medicines are safely produced regardless of whether or not they are produced in the European Union. They are obliged to inform the competent authorities if they suspect medicinal products of being falsified.

In the case that falsified or dangerous medicines do enter into the legal supply chain Member States are obliged to have processes in place to recall them. These rules should be in effect within 18 months of the adoption of the directive.

The Directive on Medicinal products for human use: prevention of the entry into the legal supply chain of falsified medicinal products (amend. Directive 2001/83/EC) was voted upon in EP Plenary on 15 February 2011, following a debate on the issue the previous day. The rapporteur Marisa Matias MEP (Portugal, Gue/NGL) had managed to get overall consensus from all parties on the report which was adopted with a resounding majority of 569 to 12, with 7 abstentions.

It was repeated time and again that the amount of falsified medicines in the legal supply chain has grown exponentially in recent years and the Directive is essential to combating this highly profitable illegal trade. Following the implementation of the Directive pharmaceutical companies will be required to stamp each package with a serial number that can be tracked across the European Union from the manufacturing plant to the pharmacy.

During the debate prior to the vote, and the explanation of votes which followed it, many MEPs expressed their satisfaction that a compromise has been reached yet there remained a couple of issues on which they felt that the Directive could have gone further to ensure the safety of patients. In particular they were concerned that, by omitting to make the inspection of factories producing active ingredients of medicines in third countries obligatory, there was risk of a loophole which would allow falsified medicines into the European market.

One very important element of the Matias report was the addition of internet sales to the directive. Although internet pharmacies are not legal in all Member States, those in which they are legal will be obliged to feature a common logo and a link to the website of the National Competent Authority. However, as such logos are easily counterfeited, it remains to be seen if this is an effective measure.

Related EPHA articles EPHA Position on Counterfeit Medicines

Link to dossier in Legislative Observatory

The ENVI Committee met on Tuesday 27 April to approve measures to restrict sales of falsified medicines in the EU. The draft report was adopted by 51 votes to 0.

Addressing several weaknesses in the European Commission’s proposal, the ENVI Committee extended the scope of the legislation to include internet pharmacies and to enforce mandatory safety features for all prescription drugs. MEPs, led by Rapporteur Marisa Matias (Portugal, GUE/NGL), inserted measures designed to increase the number of inspections and the severity of sanctions, to clarify the definition of a falsified medicine, and to exclude patent infringements and intellectual property issues from the legal framework.

Amendments were also introduced to apply costs proportionately across all actors, a consideration which EPHA strongly supported, so as to ensure that increased safety measures do not result in increased inequality of access and affordability for patients. Emphasis was placed on the need to implement public awareness campaigns to educate European citizens about the danger of purchasing medicines over the internet and how to do so safely.

The European Parliament will vote on report during its June plenary session.

A comparison of the EPHA and ENVI positions can be found below.

** Update: Draft Reports on Falsified Medicines are available in the European Parliament**

Marisa Matias MEP (GUE/NGL, Portugal) is the Rapporteur for the ENVI Committee on the Falsified medicines proposed directive, and her draft report can be found here. The Rapporteur from the IMCO Committee is Regina Bastos MEP (EPP, Portugal), her draft opinion is available here.

**Update December 2009- EPHA releases its Position on Counterfeit medicines**

On 8 December 2009, EPHA released its position on counterfeit medicines, which was developed followed an extensive consultation of the EPHA membership. The position is available here.

**Update September 2009** European Parliament begins its discussion on the pharmaceutical package

The European Parliament has begun discussing the so-called Pharmaceutical Package in the ENVI and the IMCO committee in their first session since the introductory committee meeting in July 2009. The "Pharmaceutical Package", released by the Commission in 2008, could not be discussed in the previous legislature due to a lack of time.

On 1 September 2009 Günter Verheugen, Vice President of the Commission and Commissioner for Enterprise and Industry had presented the Pharmaceutical Package to the Environment, Public Health and Food Safety Committee (ENVI). The Package was presented along with several other Commission initiatives that the European Parliament will have to discuss in the coming term such as the banning of incandescent light bulbs and a review of carbon leakage.

The Commissioner had already presented the Pharmaceutical Package to the previous ENVI Committee (See **Update February 2009**) and did not talk at length on it this time. Mr Verheugen initially brushed over the two parts of the package, Counterfeiting and Pharmacovigilance that he considered as solid and focused on the most controversial part, Information to Patients.

When MEPs had the opportunities to ask questions there were mixed responses. Francoise Grossetete MEP (EPP, France) felt that the issue of Counterfeit medicines was very pressing and that it needed to be talked about urgently. She questioned whether the Commission’s proposals were enough and suggested that more stringent measures on re-packaging are required.

Matias Marisa MEP (GUE, Portugal), Rapporteur for the Counterfeit medicines proposal said that times have changed and it is time to start thinking about the victim, counterfeit medicines are a genuine public health threat. She said there needs to be traceability throughout the system, we need a clearer definition of what is meant by a counterfeit medicine and that we need to look beyond the active ingredients and look at the other ingredients such as the packing substances.

**Update February 2009** Gunther Verheugen addresses the European Parliament on pharmaceutical policy

On Tuesday 17 February 2009, Gunther Verheugen, European Commissioner for Enterprise and Industry, addressed the European Parliament’s Environment, Pubic Health and Food Safety Committee. In his 45-minute speech, Mr Verheugen gave an overview of all the DG Enterprise measures currently being discussed in the Parliament at the moment.

The Commissioner talked at length on the Pharmaceutical Package. He said that the pharmaceutical industry is a particularly "dynamic sector" and that it is particularly important for our "democratic development." He went on to say the health and safety of citizens is an absolute rule over competitiveness in the pharmaceutical market. Commissioner Verheugen said that health is DG Enterprise’s primary concern when it comes to the pharmaceutical industry.

Mr Verheugen said that the trade in counterfeit medicines is "rampant" and that the problems are more widespread and serious than solely the issues of security around internet pharmacies, as some have suggested. The Commissioner said that he wanted to instill confidence in pharmaceutical products and that patients need to feel safe in the knowledge that the products they are taking are safe and genuine. In order to achieve this he said that the traceability and safety monitoring must be improved and that the proposals on counterfeiting in the Package aim to achieve this.

December 2008 Pharmaceutical Package finally released

Following long delays and much anticipation from industry and health campaigners alike, the European Commission finally adopted the Pharmaceutical Package on 10 December 2008.

The Package contains four measures, three of them legislative, Pharmacovigilance, Information to Patients and Counterfeit medicines and one of them a Communication on the future of the pharmaceutical industry.

For more information please visit DG Enterprise’s website

Background

The EU Directorate General for Enterprise and Industry is preparing the Pharmaceutical Package, this contains 3 main legislative proposals : Counterfeit Medicines, Pharmacovigilance and Information to Patients.

The other parts of the package, initially thought to be less troublesome, have caused a great deal of controversy as well. The counterfeit medicines proposals (aimed at fighting the spread of counterfeit medicines) which would bring an end to the practice, legal under current competition law, known as parallel trade. Parallel trade allows drugs to be removed from the package, repackaged and then sold on, often at a lower price than the original. This practice has been called unfair by pharmaceutical companies and is currently the focus of a large corporate and legal fight.

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