Brief History of Counterfeit medicines

The specific topic of counterfeit medicines first came into the EU sphere only in 2006 when the Commission first warned about fake drugs being sold on the internet. Following this the European Parliament released a resolution on the counterfeiting of medicines. Then, between the period of 2006 – 2007, speeches were given on the topic of counterfeit medicines first at the European Parliamentary Symposium, then at a European Parliament conference and finally at a WHO International Medical Products Anti Counterfeiting Task Force Conference held in Lisbon. Additionally, the years of 2007 and 2008 also spawned new research by the DG and the WHO. Then, in April 2008, a major development occurred as the WHO, supported by the Commission released background information to support a new legal proposal against counterfeit medicines to amend the current general directive 2001/83/EC. Past surveys have demonstrated that the counterfeit problem affects Africa (192,000 Chinese patients due to fake drugs) and Asia (192,000 Chinese patients due to fake drugs in 2001).  In addition, apart from other factors, it was noted that even though the above 2001 directive was in force, the counterfeit medicines discovered at EU borders has increased from 560,598 articles in 2005 to 4,081,056 in 2007. Recently, it has been estimated by a Pfizer survey that Western Europeans spend around 10.5 billion on illegal medicines, many of which are counterfeit and that between 50 to 90% of medicines bought online are fake. 

Current cover offered by general EU directive

At present, this area of counterfeit medicines is covered generally by Directive 2001/83/EC of the European Parliament of the 6^th of November 2001 which regulates the Community's medical products for human use. The main objective was to safeguard the health of the general public when it came to general medical products and to start the free movement of medical products across the EU. But one had to also make sure that this objective did not hinder the development of the pharmaceutical or medical industry.

Content of Recent Legislative Proposal which offers specific cover against counterfeit medicines

On the 10^th of December 2008, the Commission adopted three legislative proposals to revise Directive 2001/83/EC. The legislative proposals came about as a result of the ‘pharmaceutical package' which was originally created to ensure that the general public had access to safe and pioneering medicines.

One of the three legislative proposals relates to the protection of EU citizens from fake, unsafe medicines. The vital aim is to make sure that no fake medicines are legally distributed across and within the EU. In order to identity fake medicines, it is proposed that certain items have features that demonstrate that they can be legally distributed. For instance, the items could have individual product codes or seals. In addition, wholesale distributors who have been approved by the authorities could be listed in a database and be subject to compulsory audits by purchasers. The Commission has also suggested that companies who produce active pharmaceutical ingredients (API) should have to undergo an audit of their manufacturing process and have to comply with the relevant safety standards when importing this ingredient; It could be a possibility to tighten control at EU borders to reduce illegal distribution. Lastly, the member states should be given responsibility to improve their inspection systems relevant to medicines.

But, until now, no specific measure has been proposed to deal with illegal medicines being sold over the internet. However, at present, it is assumed that only member states have the power to decide whether they want to allow the sale of prescription drugs over the internet. The Commission has not yet proposed anything to regulate this field. Regulating this area could be a challenge, even for the member states, as this type of illegal activity over the internet is conducted by pharmacies present in third countries.

Public Consultation for the proposal

Previously, on the 11^th of March 2008, the Commission launched a public consultation on combating counterfeit medicines titled “Key ideas for better protection of patients against the risk of counterfeit medicines”. This survey was initially requested by the 125 respondents themselves as many believe that the problem of counterfeit medicines was larger than originally anticipated. Findings from this revealed that many thought API's and enforcement were causes of the extensive nature of counterfeit medicines and that serialization and not batch numbers or seals were an effective way of combating counterfeit medicines. It was also mentioned that the present distribution system for medicines makes it difficult to have counterfeit free zone. Additionally, it was indicated that not all actors in this system could be subject to audits and supervision of activities. There was support for creating a database of those who are compliant with the legal procedure for combating counterfeit medicines but not all were sure whether audits were the right way to record compliance. Most importantly, it was noted that technology evolves constantly and no measure to deal with counterfeit medicines should be fixed and incapable of changing.

Impact Assessment

The next task of the Commission involved carrying out an impact assessment report which looked into the economic, environmental and social impacts of the proposal. The suggestions in this assessment indicate that the Commission had taken into account the findings from the public consultation. This document does not represent the final belief of the Commission on counterfeit medicines. Instead the Commission just sets out different scenarios that could result from this policy option on medicines. This impact assessment was then also adopted at the same time as the legislative proposals.

Next Steps

Next, both the European parliament and the European Council will assess all these proposals in a co decision procedure. It will then be decided whether these proposals can be used to amend the 2001 Directive and whether policy could then become law.

Falsified Medicines Directive

This proposed directive/legislative proposal to counteract counterfeit medicines will come before the European Parliament in a full plenary session in May 2010. One of the new innovative measures proposed is the adoption of harmonized, pan European safety measures. These safety measures would have the goal of identifying, authenticating and tracing prescription medicinal products. These compulsory safety features is meant to take account of the risk of falsification in terms of price, composition of the product and other relevant conditions related to that product.

Calls for improvement in April 2010

The European Parliament's Internal Market Committee released an opinion calling for improvements to the Directive on Medical Products, specifically focusing on the area of falsified medicines. They requested a clearer definition of the term ‘falsified medicinal product' a broader focus on the legal supply chain including internet sales;  a more specific community database; and more severe sanctions against the  falsification of medicines.

There has been an increase in medicines falsified by identity, history or source in the European Union member states. The danger lies in the fact that the ingredients may be substandard, falsified, lacking or of the wrong dosage. In this regard they pose a major threat to EU citizens.

The Committee believes that the situation could be improved with an effective legislative basis in order to introduce better safety standards and tracking mechanisms, simplifying complicated procedures, increasing transparency, more effective data collection and evaluation procedures, more involvement of stakeholders and the establishment of best practices.

Next steps: Parliamentary Plenary on falsified Medicines set back to October 2010

The deadline for the European Parliament's vote on the Directive on falsified Medicines has been set back from June to October. The date is now currently set for October 6^th. The plenary will involve review and possible voting in of the amendment Directive, first set out in 2006. This will be the earliest possible date for the text proposal to become law. A lack of agreement will lead to a second reading of the draft Directive in each institution.

The draft Directive sets out new obligations, safety procedures, and strengthened regulation. Amendments proposed by the Parliament include widening the scope to include internet sales which have proved a major source of falsified medicines in the European Union, tougher sanctions and measures to block the export of falsified medicines, as well as a list of proposed definitions including falsified medicines, Active Pharmaceutical Ingredients and expedients.

Similar proposed amendments have been offered by the Council's Working Party on Pharmaceuticals and Medical Devices. The Council amendments also call for a transitional period of six years when a member state already has safety measures in practice.

Proposal for a Directive of the European Parliament and of the Council

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