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EU Presents Medicine Initiative to G8

June 3, 2003

On the final day of the Evian summit, European leaders attempted to convince their fellow G8 members to adopt new EU measures aimed at stopping essential medicines from being diverted away from needy patients.

A new EU regulation ensures that medicine gets to the poorest patientsImage: AP

While G8 leaders gathered at the Evian summit for the final day of talks wrestled with topics such as international terrorism and the ailing global economy, representatives from the European continent brought a subject from their own agenda to the collective table.

European leaders intended to use the summit to press the other leading industrial nations to adopt EU regulations, which would ensure that life saving drugs make it to where they are most needed and that they are available at affordable prices.

In the last days of May, the European Council adopted a regulation that enables exporters of pharmaceuticals and essential medicines to deliver their products to developing nations at strongly reduced prices while ensuring that the goods will not be diverted back to the EU. It is a measure that is intended to supply the world's poorest countries with much needed drugs in the fight against the crippling tuberculosis (TB), HIV/AIDS and malaria epidemics.

This latest move by the EU is seen as the next step in the Program for Action, which was launched in February 2001 to address the health crises affecting developing nations across the globe. The long-term strategy was designed to promote poverty reduction in a bid to block the spread of the three major communicable diseases targeted in the initial focus. EU sources say that drug initiatives to fight other diseases will be added to the program's hit list in time.

Tiered prices for drugs

The new regulations agreed on by the Council would allow pharmaceutical producers to significantly increase the export of medicines for TB, anti-retroviral HIV treatments and drugs to combat malaria at lower, so-called 'tiered' prices, while keeping the drugs at the same price in the EU.

To stop the re-importation of vital medicines from developing nations, a total of 76 poor and under-developed countries have been added to the EU's prohibited list, and are, therefore, banned from re-importing drugs back into the Union.

The majority of the countries on the list cannot afford to produce the drugs they need on a local scale and those who can -- namely within the EU -- need the security of a working system that ensures discounted and imported drugs reach their intended destination and don't flood European markets. The EU's new regulation would provide that very security.

"This regulation is an important contribution to a global partnership ensuring cheap, yet sustainable, supply of key medicines to the populations of poor countries," said EU Trade Commissioner Pascal Lamy after the European Council announced the measures in May.

Lamy added that, under the new regulation, commercial drug companies would sell their goods at prices just over their production costs, while public and private donors would provide the funding for research and development. The EU would provide the necessary legal framework to make sure the drugs are not diverted back, he said.

Monitoring at borders

In an attempt to monitor the drugs included under the new regulation, exporters are being invited by the EU to add their product names to a tiered price list run by the European Commission. To keep a watchful eye on the drugs on the list, the EU intends to brand them with a logo that can be easily identified by customs officials.

Products on the list and/or branded with the logo will not be allowed back into the EU for the purposes of free circulation, re-exportation, warehousing or trans-shipment. The lack of such prohibition is a serious problem within the current framework.

In order to be approved to export under the regulation, medicines will have to be made available at a 75 percent reduced price or at the cost of production plus 15 percent.

Benefit of expanding markets

The voluntary system has been developed because the EU cannot force producers to reduce their prices. EU sources have expressed a hope that the pharmaceutical industry will see the benefits of expanding their markets through the listing procedure, which will, in turn, lead to more making use of it and increasing deliveries through the EU program to poor nations.

Speaking at the unveiling in Brussels last month, the EU Commissioner for Development and Humanitarian Aid, Poul Nielsen, welcomed the regulation as a means to increase the supply of essential medicines to the poorest patients. He added, "This measure should be seen as part of a wider plan to improve the health situation in developing countries."

It is hoped that other nations will put similar measures in place and step up their contributions in the fight against deadly diseases. Any willingness to adopt such regulations by the G8 leaders and those of other developed countries would be a welcome start.

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