Reinforcing the criminalisation of fake medicine trafficking: a legislative priority worldwide

To fight more effectively against the traffic of fake medicines, every country should have a sufficiently tough legislation to defend the health of its people. Unfortunately this is not the case today, and most countries do not have a list of violations incurring sufficiently heavy penalties to deter those who produce or sell counterfeit medicines.

According to WHO, 30% of countries have little or no regulatory control for this. For many, the legislative system makes no distinction between drug counterfeiting and other forms of counterfeiting: they see it only as a violation of industrial property and do not take into account the serious harm it can do to people’s health. The penalties incurred for falsifying medicines are therefore often the same as those of a petty criminal who sells counterfeit DVDs or designer T-shirts and handbags.

The need for an international initiative

From a legal or law-enforcement point of view, the fight against the trafficking of fake medicines relies essentially on national legislation and the authorities of the States in charge of enforcing laws. It often neglects certain international legal aspects. Yet the combat must also be fought on this other level. Just like in the illicit drug trade, the criminals openly flout the borders and take advantage of the insufficient cooperation between police and legal institutions in the various countries in combating an essentially international traffic. The international community was therefore duty bound to find an answer to improve the legal harmonisation and cooperation between the countries.

Medicrime, a major step forward…

The year 2010 saw the creation of the “European Committee Convention on counterfeit medical products and similar crimes involving threats to public health”. Better known as the “Medicrime Convention”, its creation marked a major step forward in the fight against this traffic, as it is for the moment the only international tool that criminalises the manufacturing, supplying, offering to supply and trafficking of counterfeit medicines.

The Convention, resulting from an increased awareness within the European Community, is intended to be signed and ratified by all the countries in the world. It provides a framework for international cooperation and proposes measures aimed at improving the coordination of actions at national level.

… but not yet the full answer

Unfortunately, the Medicrime Convention is not yet the full answer to the problem. Open for signature and ratification in October 2011, now, three years later, it has only been signed by 23 countries – including 19 State Members of the Council of Europe – and ratified by just four. But the Medicrime Convention will not enter into force until it has been ratified by a minimum of five States, at least three of which must be members of the European Council. It is therefore not yet legally binding, and the slow pace of ratification is for the least discouraging. A greater number of ratifying countries will of course lend greater credibility to a Convention of this kind and increase its ability to become a natural part of the international legislative landscape.

Towards the emergence of a “model law” in 2015

Organised crime, public health, intellectual property, Internet commerce, safety of pharmaceutical products and healthcare systems: counterfeit drugs cause a large number of problems in a wide variety of fields. Which is why the creation of a modern, comprehensive legal arsenal that is capable of waging an effective war on this traffic requires top-level expertise and sophisticated skills in several specialist areas.

But the scale of the task is likely to dissuade a number of States from committing to introducing sanctions for this kind of counterfeiting. Which is why a simple and practical initiative aims to break down the barriers and help to rally the countries around this ambition: the introduction of a “model law”.

Created on the initiative of the UNODC, the World Bank, the European Council and IRACM, this “model law” offers a legal instrument that will enable States who so wish to reform and modernise their national legislation against counterfeit medicines.

The text has been drafted by the best international experts and addresses all the aspects of the problem: definition, violation, doses and harmonisation of the penalty scale. Transposed into a country’s national law and promulgated by its parliament, a law like this provides all the necessary guarantees for a fair and effective fight against this traffic.

The model law will be finalised and made available sometime in 2015, and will help to harmonise legislation worldwide. Similar models have already proved effective in combating other types of trafficking.

That is why IRACM and the institutions involved in the drafting are convinced that this initiative will allow us to take a vital step forward in the fight against the fake medicine trade.