n a controversial move, France has asked the European Commission to allow new labeling on medicines that would indicate whether products and ingredients come from Europe or elsewhere. But the effort is likely to divide drug makers amid concerns about the quality of prescription drugs.
The stated reason for the request is to bolster transparency, because French consumers may have “doubts” about their medicines, according to the filing by the French government. And the notice singled out generic medicines, in particular.
Why would French consumers have such concerns?
The push appears to be an attempt by the French government to bolster its domestic pharmaceutical industry, which includes Sanofi, one of the world’s largest drug makers. This is not a new notion – the government reached a deal five years ago to promote French drug makers.
The filing also follows the recent suspension of some 700 mostly generic drugs by the European Union. The EU acted after French regulators questioned the reliability of clinical trial data generated by GVK Biosciences, a contract research organization in India that conducts studies for drug makers. The French National Agency for Medicines and Health Product Safety, or ANSM, in May 2014 found anomalies in the way GVK monitored electrocardiograms for nine clinical trials.
That episode was closely watched because it emerged at a time when the Indian pharmaceutical industry has undergone intense scrutiny by overseas regulators. Much of the focus has been on manufacturing, since several drug makers – such as Ranbaxy Laboratories – were cited for shoddy quality control and some products were banned from the US and the UK.
The request by the French government calls for rather specific labeling. A pictogram would be placed on each product showing where ingredients were made, production took place and packaging was completed. Different symbols would be used to signal whether an activity took place in Europe or elsewhere, according to the filing made with the EC.
“European citizens place their trust in the competent authorities of the EU to carry out the appropriate checks at the different stages of manufacture of a medicinal product,” the filing states. “However, for mainly practical reasons, the checks carried out by the competent authorities of the EU are not the same when one or more stages of manufacture take place outside the EU.”
But the move, which was reported by InPharma Technologist, has the potential for dividing the pharmaceutical industry, given that so many drug makers rely on other companies that are based in India and China, for instance, for supplies or production.
In a carefully worded statement, the European Federation of Pharmaceutical Industries and Associations trade group, which represents a raft of drug makers that do business across the continent, called the proposal “interesting.”
The trade group, in fact, maintains that existing legislation already ensures that all medicines marketed within the European Union meet safety and quality standards. As a result, the EFPIA argued that such labeling should remain optional and not become a “technical barrier to trade.”