Speaking at a meeting of industry groups in the European Parliament, MEP Jorgo Chatzimarkakis said the online trade in fake medicines is a growing illegal business and its omission from the European Commission's proposed directive is a "weakness".
80% of counterfeit medicines come from the Internet and this poses a significant health risk, he said, pointing to a World Health Organisation study which shows half of all medicines bought online are fake.
"I'm not happy that the Internet is not mentioned at all by the Commission – they leave it to the member states to stop Internet sales," he said.
Chatzimarkakis, a German Liberal, also warned fake drugs are increasingly being channelled through the legal supply chain. He said that countries allowing Internet drug sales should produce a list of reliable online pharmacies to help consumers avoid illegal medicines.
Leftist Portuguese MEP Marisa Matias, who is responsible for drafting a report on counterfeit medicines for the European Parliament's environment committee, said ignoring Web sales is "a major gap" in the directive.
She said parallel trade represents a large part of the medicines market and will be included in the regulatory framework. She said she would examine the practicalities of allowing parallel traders to repackage medicines for resale in other European countries.
Traceability key to beating bootleggers
Introducing new traceability measures is a central part of plans to fight counterfeit medicines, but there are some concerns over cost and data protection issues.
Pharmacists fear that commercially sensitive data on their prescribing practices collected by new computer systems could be exploited by drug makers. They are also worried that new scanning systems will add to their cost-base without bringing major benefits.
SMEs in the pharma sector are also concerned by the cost of adding traceability features to medicines. Claudia Glasow from Ursapharm, a German pharmaceutical SME, estimated new equipment and software could cost between €80,000 and €120,000 for every production line.
"We have 15 packaging lines so it could cost up to €1.8 million in order to comply with the technical requirements arising from the serialisation guidelines," she said.
There is also debate among industry groups as to which form of barcode would be most practical. Some argue for a radio frequency identification system, but problems with accuracy and the potential for radio waves to change the properties of medicines could make this impractical. Manufacturers and wholesalers prefer 2-D barcodes which are easily scanned and can be encrypted with detailed information.