The European Union’s long-awaited reform of pharmaceutical regulations known as the ‘pharmaceutical package’ was unveiled yesterday after months of consultation and debate.
The headline news was the revelation that the European Commission has stopped short of imposing a ban on the practice of repackaging - which would have effectively ended the parallel trade in medicines.
The overarching elements are a series of legislative reforms aimed at hiking patient safety through the development of a strengthened system of safety monitoring for patients, efforts to tackle the growing issue of counterfeit medicines, and allowing drugmakers to provide direct-to-consumer (DTC) information on their products, something that is currently banned in the EU but allowed in the US.
These legislative proposals still have to be reviewed and ratified by the European Parliament and Council, a process which could take months.
Other elements include projects to increase transparency in national pricing and reimbursement decisions, initiatives to boost pharmaceutical research in the EU, and greater cooperation with international trading partners on issues such as patient safety.
Groups such as the European Federation of Pharmaceutical Industry Associations (EFPIA) have argued that repackaging provides a weak link in the supply chain to allow the entry of counterfeit medicines, and had argued for a ban as part of a basket of anti-counterfeiting measures in the package.
Parallel traders take advantage of the different prices of medicines between EU member states, buying up stocks in low priced countries and selling them on - at a discount - in countries where the price is higher. That practice requires the drugs to be repackaged to comply with the requirements of the destination country – for example the inclusion of a patient package insert in the correct language.
Commissioner for Trade and Industry Guenter Verheugen seemed to favour a ban in recent months. But it seems that parallel traders won a reprieve because of the impact on their businesses and the cost-savings afforded to EU healthcare systems through the use of parallel-traded medicines.
An impact assessment found that the cost of a ban on repackaging would lead to a loss in turnover for parallel traders of €3.2bn-€4.5bn and lead to the loss of 9,000 jobs, in addition to the removal of cost-savings by healthcare systems.
While the numbers for the latter are controversial, estimates range from €100m-€600m of savings a year. Typically around 10 per cent of medicines dispensed in western European countries are parallel imports, according to figures from the European Association of Euro-Pharmaceutical Companies (EAEPC) which represents the interests of parallel traders.
Heinz Kobelt, Secretary General of EAEPC, welcomed the proposals and said the repackaging element had been “all too bluntly an attempt to eliminate competition by parallel trade instead of eliminating counterfeiting.”
Patient information proposals watered down
The relaxing of the ban on drugmakers communicating with patients directly does not go as far as in the US. They will only be able to do so within specified media, such as certain health-related publications and websites, and a ban on DTC advertising through television or radio remains in place.
There will also be strict controls on the type of information that can be imparted, limited for example to wording that is already present in the patient information leaflet.
Commenting on the proposals, Commissioner Verheugen, said: “Everything we are suggesting today builds on the needs and interests of patients European citizens should benefit from safe, innovative and accessible medicines.”
“They should be best informed about available medicines and treatments – since their health is at stake. We wish to restore the EU's traditional role as the pharmacy of the world. ”