Pharma unhappy with French 'made in EU' proposal

19-Nov-2015 - Last updated on 19-Nov-2015 at 04:55 GMT

Made in France? Gov calls fro European label measures for drugs

France's government has proposed new labelling for medicines that would indicate whether the contents were manufactured in or outside Europe.

The proposal - which was submitted to the European Commission last month - would allow pharma manufacturers to place a pictogram on the label of a product to indicate whether its active ingredient, excipients, production or packaging was sourced in the EU.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) is not enamoured with the idea, however, saying that implying a link between a medicine's country of origin and level of quality is "very misguiding."

"'A better approach would be to focus on enforcing the current legislation and standards and ensuring that they are being adhered to," the trade body told the Politico journal.

The pictogram would consist of a rectangle with black edges, divided up into four equal parts corresponding to the four categories listed above and reflecting the complex and international nature of pharma production.

If the component or operation took pace in the EU or a member state of the European Free Trade Association (EFTA), the category would bear the word 'Europe' in white on a blue background. Otherwise, it would carry a black cross.

Increasing public confidence?

France's Ministry of the Economy, Industry and Finance said in its notification to the Commission that the aim is to increase the confidence of the public in the quality of their medicinal products, "about which doubts remain in the public opinion."

It draws a distinction between products made wholly in the EU and those in which one or more stages of manufacture have taken place outside Europe, saying that in the latter case "for mainly practical reasons, the checks carried out by the competent authorities of the EU are not the same."

France's move comes at a time of increased concern about the quality of medicines made outside the EU, particularly generics, and follows an import ban on 700 products into the EU after quality compliance issues were raised at contract testing laboratory GVK Biosciences.

Incidents like that, as well as other high-profile cGMP violations affecting the likes of Wockhardt and Ranbaxy, have dented the reputation of drugs made outside the EU, said the notification.

"Many of our fellow citizens do not have the same trust in the competent authorities of non-member states as they do in the competent authorities of the EU," it noted.

Politico notes that the origins of the 'Made in EU' label go back to 2013 and an accord between French pharma producers and government aimed at boosting the competitiveness of the domestic drug industry.

In the interim, work has been ongoing to bring the proposal into a form that does not conflict with EU trade policies, it suggests.