Industry submitted the criticisms in response to draft GDP (good distribution practice) guidance the European Commission (EC) published in July. The draft is part of EC efforts to stop falsified medicines but could have implications for the cost of biopharma logistics services in Europe.
“These requirements would significantly increase the cost of the medicinal product supply chains”, logistics company UPS wrote in its response to the EC. UPS is concerned about the classification of any period when products are held at a site for longer than 24 hours as a regulated activity.
Several companies note that products are often at a site for longer than this over weekends. Each of these sites would need GDP authorisation and be subject to full oversight and regulatory inspection, UPS wrote.
Lisette Vromans, regulatory affairs scientist at Merck Sharp & Dohme, told the EC the requirement is “excessive and not realistic”. Over the weekend, particularly in countries where trucks are banned from the roads on these days, and on public holidays the rule would create “major problems”.
Bristol-Myers Squibb (B-MS) also criticised the proposed rule and said a transition period is needed so logistics can continue uninterrupted while GDP authorisations are pending. However, this assumes that the sites want authorisation.
“There is a risk that the carriers refuse to request the wholesale status and therefore less carriers are available for the pharmaceutical products shipments”, B-MS wrote in its response to the EC.
In the same section of the guidance as the 24 hour limit, paragraph 9.12, the EC says for a site to keep refrigerated products “for any period of time” it needs a wholesaler’s authorisation. Industry also criticised this rule.
Vromans told the EC the rule “will virtually be impossible to meet [because] all airports worldwide will require wholesale distribution authorisations to simply execute a transfer of cold chain products”.
To comply with the rule “would require considerable investment in either revising opening hours of the UPS GDP licensed facilities or for GDP licensing the hub of the transportation provider”, UPS wrote.
Another recurring point of contention is paragraph 3.4, which states that products destined for outside the European Union (EU) should be kept in segregated areas. B-MS said it will be “very difficult” to meet this requirement and other companies also questioned the rule.
“Why should medicinal products not intended for the union market be kept segregated from union products when standard warehouse controls are sufficient to prevent mix up of products for different markets”, Kerry Hawitt, associate director of quality compliance at Shire, wrote to the EC.