The EU’s War on Drugs
European authorities are gaining new weapons in their fight against counterfeit medicines and new synthetic drugs. At the end of October, the world's first international treaty to make dealing in counterfeit medicines and devices a criminal offence was opened for signature. A few days earlier, the European Commission announced it would be overhauling European Union rules on illicit drugs in order to take stronger action against new psychoactive substances in particular.
The Council of Europe's Medicrime Convention breaks new ground in efforts to clamp down on counterfeit medicines. Three years in the making, the convention was immediately signed by a dozen countries as soon as it became possible to do so on 28 October at a conference in Moscow examining ways to tackle the growing phenomenon.
The new convention is not designed to add further protection to the intellectual property rights of bona fide drug manufacturers since these are extensively covered by existing legislation. Nor does it impinge on EU and national responsibility for ensuring the safety and efficacy of medicines. Instead, it addresses the harm which counterfeit medicines can cause to the health of individuals.
As Kristian Bartholin, a Council of Europe official involved in drafting the convention, explains: "We want to do something different and shift the focus on to the protection of public health. Counterfeiters have no qualms at all in putting poison in medicine." As an example, he cited pills which had been coated in yellow paint used for road markings to give them the necessary distinctive colour and had caused liver failure.
The convention makes it a criminal offence to manufacture, supply, offer to supply or traffic in counterfeit medical products; to falsify documents; to manufacture and supply medical products without authorisation; and to market medicines without complying with industry standards.
Countries signing up to the convention will be required to have the necessary criminal law in place to investigate and punish any crimes detected. It will be up to national authorities to determine the level of penalties to be applied, but these will include prison sentences and confiscation of assets. One of the convention's strengths is that it positively encourages cooperation between the competent health and law enforcement authorities in different countries and makes it possible to extradite suspects from one jurisdiction to another.
Since the counterfeiting of medical products and devices is a global phenomenon, the Council of Europe has taken the rare step of inviting countries other than its 47 members to sign up to the convention. It has regularly informed the World Health Organisation of progress in drafting the convention and will explain to other countries in the months ahead the benefits it can bring.
According to the WHO, counterfeit medical products account for less than 1% of market value in developed countries where efficient regulatory control mechanisms exist. But this can rise to over 50% in developing countries. In some parts of Europe, such as the Balkans and Russia, they represent between 6% and 20% of the market.
While the Council of Europe has opened a new front in the fight against counterfeit medicines, the EU is looking to strengthen its defences against illegal drugs. It aims to do so by putting forward a package of measures in the months ahead. This will include legislation on new psychoactive substances which could include temporary bans and a clamp down on internet sales; improving definitions of offences and sanctions to target cross-border drug trafficking; new laws on drug precursors; measures to deprive drug traffickers of their illegal financial gains; and an emphasis on closer international cooperation.
According to a recent pan-European Eurobarometer survey, 5% of young people have used new synthetic drugs. Use is highest in Ireland (16%), Poland and Latvia (9%) and the UK (8%). At the same time, the survey revealed that throughout the EU, a large majority of 15 to 24-year olds favour banning the substances.
In another development, the European Parliament is drawing attention to the need to step up the fight against resistance to antimicrobial agents in human medicines. It has called on the European Commission to "propose without delay a legislative framework for action against antimicrobial resistance" by promoting responsible use initiatives.
In particular, it is emphasising the need for prudent use of antimicrobial agents both for humans and animals by ensuring these are only used when effectively needed for the actual treatment of disease, while respecting the correct level, frequency and duration of the dosages. MEPs are also calling for more monitoring and research into antimicrobial resistance.