PHARMACEUTICALS : FAKE MEDICINES: PARLIAMENT WRAPS UP PACKAGE.

The second component of the pharmaceuticals package, which deals with falsified medicines, has officially completed its passage through the European Parliament: MEPs validated at first reading the agreement on the draft directive negotiated with the Council in late December 2010. The directive, which tightens the surveillance of medicines in legal trading channels, is slated to enter into force in late 2012 or early 2013, although certain technical provisions might take longer to implement. A period of up to five or six years is allowed for the required technical adaptations, such as the establishment of a common safety feature to allow checks of the authenticity of a medicine, to identify individual packages and to detect traces of tampering.

Currently there are a number of distinctive signs to certify the authenticity of a medicine, but these vary from one member state to the next. With this directive, a single identifier will be affixed to all prescription medicines in the European Union, unless they have been proven to be risk-free through a risk assessment. For non-prescription drugs, the principle is reversed: they will not be covered by the system unless they represent a risk to health.

Generally speaking, the directive introduces stricter standards for the entire supply chain, both for wholesale distributors of medicines and for brokers involved in their purchase and sale. Wholesalers, for example, will be subject to stricter record-keeping requirements, while brokers may have to undergo repeated inspections.

These standards are not limited to European Union territory: the manufacture of active substances, for instance, will be subject to a code of best manufacturing practice whether the ingredients are manufactured in the Union or imported (which is often the case). The manufacture and distribution of European medicines for export to third countries will have to meet the same criteria as those applying to imports.

For infringements, the directive provides that member states must establish penalties that "must not be less strict than those applying to infringements of national law of a similar nature and importance". This means that member states will have free rein in determining the stringency of penalties. The Commission will evaluate such measures within five years.

INTERNET SALES

From the patients' point of view, another sizeable change will be closer surveillance of the sale of medicines via the internet. Only Denmark, Germany, the United Kingdom, Sweden, Portugal and the Netherlands currently authorise the sale of prescription drugs via the web. Although the directive does not harmonise any of the rules in force for online sales, it does introduce a common logo to identify websites operating legally in this sphere. These sites will have to show a link that sends users to the site of the national authority that gives additional information on legal sites.

BEUC REACTS

The compromise was adopted by 569 to 12, with seven abstentions, reflecting a strong consensus among MEPs. The European Consumers' Organisation BEUC applauds adoption of the directive but urges the EU to monitor its cost-effectiveness and compliance with data protection rules in connection with implementation of the safety feature.

The Council will have to formally endorse the agreement in the coming weeks, although its Committee of Permanent Representatives (Coreper) gave its support to the new directive, on 21 December 2010.