13/14 December 2022
The trade press has extensively covered the counterfeit case of Harvoni, a medicinal product from Gilead. The background circumstances as well as the consequences to be drawn from this incident are of interest here.
What happened? In short, it can be said that Harvoni tablets which were not approved for the German market were discovered in German pharmacies. A patient had returned his tablets to a pharmacy in Dortmund because they were white instead of orange. A closer examination revealed that the tablets contained the correct active ingredient content (see also the article in the German "Apotheker Zeitung" no. 28 dated 10. July 2017). Apparently, these were tablets which had not been produced by Gilead for the German or the European market. The packaging for the German market was fake. This was detected among others because of spelling mistakes (such as "Deutchland" instead of "Deutschland"). At least, that's what DAZ.online (German only) learned from Gilead Germany. The creator of the fake packaging is unknown so far.
The GDP impact of counterfeit medicinal products
However, it is known how the fake (since not approved for Germany) medicinal products ended up in the pharmacy. And this is where the GDP requirements (Good Distribution Practice) come into play. These demand that goods may only be obtained from a wholesaler if he has a valid authorisation for the wholesale trade of pharmaceuticals. Apparently, this is exactly where the GDP requirements were not followed, since the Dutch wholesaler from whom the goods were purchased had no wholesale authorisation from the competent authority. It doesn't matter whether the purchaser of the goods had not asked for the authorisation of the Dutch wholesaler or whether the wholesaler had even presented a falsified wholesale permit - according to GDP, the purchaser is always responsible. § 5.2. of the GDP Guideline demands: "Where medicinal products are obtained from another wholesale distributor, the receiving wholesale distributor must verify that the supplier complies with the principles and guidelines of good distribution practices and that they hold an authorisation for example by using the Union database."
Wholesale Distribution Authorisation must be verified
The case demonstrates how important it is to systematically implement the requirements of § 5.2. of the GDP Guideline. For the Dutch wholesaler had in turn purchased his goods from a trader in Portugal who also did not hold a wholesale authorisation from the Portuguese authority. The importance of the EU database EudraGMDP must be stressed once again here. If the seller of a medicinal product cannot be found in this database, extensive verification is required - in case of doubt, the relevant supervisory authority of the country where the seller is located must be contacted. A copy of a wholesale authorisation that the seller may have presented does not count as solid evidence, as it is easy to create such a document on any PC nowadays.