Fines and imprisonment for drug fakers in the EU

By Anna Lewcock

- Last updated on GMT

Related tags Member states European union

The European Parliament has backed proposed legislation to impose
hefty fines and penalties on criminals taking part in piracy and
counterfeiting activities.

If the proposals are officially approved, the directive will require all EU member states to consider all infringements of intellectual property carried out on a commercial scale as a criminal offence, and hand down the appropriate penalties.

According to a European Parliament spokesperson, parties found guilty of drug counterfeiting - which falls under the category of an offence carrying a health and safety risk - would suffer the most serious punishments under the proposed legislation.

"There are no special provisions on drugs in the text," In-PharmaTechnologist.com was told.

"However, counterfeiting medicines is considered as "serious crime" and therefore punished with the maximum penalty."

In this case, the maximum penalty would be at least €300,000 and/or four years' imprisonment.

Counterfeiting that does not fall within the terms of 'commercial scale' manufacture (fakes that are not deliberately infringing on intellectual property or produced to obtain a commercial advantage i.e. for personal, non-profit purposes) would fall outside the legislative sanctions.

Drug counterfeiting is a major and growing problem across the world, with serious health and safety risks to consumers and significant costs to the pharma industry.

However, as the proposed legislation is not just limited to drug products and covers all intellectual property including other heavily counterfeited products such as fashion accessories or music files, there is likely to be resistance among some member states, according to a representative speaking on behalf of the Parliament.

"Criminal sanctions are historically a national domain and some member states, the Netherlands for example, are really against the proposals as they do not see criminal sanctions as a community competence."

In a landmark move in September 2005, the European Court of Justice ruled that the community would be right to hand down criminal sanctions for environmental liability, covering events such as national disasters that have cross-border implications.

Aside from this, there was previously no explicit mention of criminal law that applied across all EU member states.

Following the 2005 decision, the European Commission decided to give its approval to EU community-wide criminal sanctions when it is seen as necessary.

The draft legislation covering infringements of intellectual property rights is in fact the first directive proposed following the Commission's interpretation of the Court of Justice judgment, which means that it could take a little longer to go through the approval process, according to the parliamentary spokesperson.

Harmonisation across all member states is quite a tricky objective given the differences in legal process and penalties within the bloc, but the proposed directive provides a framework within which there is some flexibility for member states to adapt protocols at a national level.

The EU directive, which has the support of the majority of the key groups, will now be voted on in the European Parliament's plenary session next month.

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