INTERVIEW WITH MEP MARISA MATIAS : COUNTERFEIT MEDICINES: COMPROMISE REFLECTS EP'S DESIRES.

The second section of the pharmaceuticals package, concerning prevention of entry into the legal supply chain of counterfeit medicinal products, will soon be wrapped up: on 16 February, MEPs will adopt their position at first reading during the Strasbourg plenary, the result of a compromise with the Council. With just a few days remaining before the vote, Portuguese rapporteur Marisa Matias (GUE-NGL, Portugal) has welcomed the amendments made to the Commission's initial proposal. In accordance with the Parliament's desires, the new directive anticipates specific measures for sales via the internet, as well as a common safety measure and sanctions for the falsification of medicinal products.

What is the general objective of this directive?

The text aims to increase the safety of patients, who are confronted by a growing number of falsified medicinal products. According to current border controls, which are random, the proportion of counterfeit medicines identified has increased by almost 400% compared with 2005, whereas 1% to 3% of medicinal products sold in pharmacies are falsified. Counterfeit medicinal products are now silent killers because, ultimately, people are purchasing preparations without active pharmaceutical ingredients, which do not treat those suffering from cancer, for example. With the new directive, there will be a system, which will make it possible to strengthen controls throughout the entire chain, from production to acquisition.

On the internet, one in two medicines is falsified. How will the new directive tackle this?

In the beginning, the Commission did not want to include internet sales in the directive's field of application. It believed that the proposal aimed to prevent counterfeit medicines from being introduced into the legal supply chain, which excluded this medium, since it is considered to be non-legal' in several member states. However, this is not the case in all countries (UK, Germany or Belgium) and it thus mattered to Parliament that this point should be considered in the directive. The compromise therefore anticipates the setting up of awareness campaigns as well as a common logo in order to identify whether or not a website is safe. This logo will be linked to a national website, which will itself be linked to a Community website. We are delighted by this progress.

Another victory for Parliament is the introduction of a safety measure. How will this be set up and who will assume the costs associated with it?

According to the compromise, all prescription medicines will be required to adopt a safety measure, unless there is clearly no risk. For non-prescription medicines, it is the contrary: by definition, they are not subject to the measure, unless they represent a health risk.

The form that this measure will take is not yet clear and it will be up to the Commission to define it following an impact study. It will most likely be a question of a unique identification number, such as a serial number. As for the costs, they must be largely borne by manufacturers.

Is this the death of small manufacturers of generic and homeopathic medicines?

No, not at all. On one hand, because these medicinal products have a great chance of being on the list of prescription medicines which are not subject to the safety measure since they are not falsified so much. And on the other hand because, with this new directive, legal manufacturers will have access to a larger market share, which will enable them to pay off the costs, in the knowledge that the market share for counterfeit medicines is estimated to be 45 billion.

Parliament, on the other hand, has not secured the application of penal sanctions for crimes of falsification. Are you satisfied with the compromise?

Yes: we started with absolutely nothing. It's true that, in the beginning, we wanted sanctions that were at least equivalent to those usually applied to narcotic crimes. But member states were opposed to this because it would have meant having to amend their legislation; they even rejected the introduction of a few sanctions. Finally, the sanctions must not be inferior to those applicable in case of infringement of a national law of similar nature and importance. Therefore, if one country decides to consider falsification as equivalent to the sale of narcotics, then the sanction must be the same for both crimes. I hope that this will lead to a levelling-out and not a snowball effect. In any case, we have the guarantee that the Commission will undertake an evaluation of the sanctions in five years.

All that remains is to settle the matter of information to patients', the third section of the pharmaceuticals package. How do you envisage this dossier, also proposed in 2008?

This section took a different path to the first two since, with Linda McAvan (S&D, UK, rapporteur on pharmacovigilance), we had a mandate to negotiate with the Council at first reading. In my case, this was not easy but I must acknowledge that negotiations were facilitated by the Belgian Presidency. Belgium already has legislation relating to falsification [as do Italy, the United Kingdom, Germany and Greece - Ed].

In the case of this third section, development of the proposal for a directive and regulation will really depend on negotiations. But a fair amount of progress has already been made since the distinction between advertising and information was made by the rapporteur and I think that the direction that was taken is the right one.