HealthManagement, Volume 13, Issue 5/2011
The EU’s War on Drugs
Author:
Rory Watson
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.