english.prescrire.org > Annual Prescrire Awards > The Prescrire Awards for 2009 > The 2009 Prescrire Awards for Drugs, Packaging and Information > Prescrire looks back at drug packaging in 2009: A few advances > EMA withholding information: about packaging too

The Prescrire Awards for 2009

The 2009 Prescrire Awards for Drugs, Packaging and Information

Prescrire looks back at drug packaging in 2009: A few advances
EMA withholding information: about packaging too

In 2009, a review of Prescrire’s requests for information addressed to the European Medicines Agency (EMA) between 2005 and 2008 revealed the agency’s reluctance to provide clinical data (1). 

In April 2009, Prescrire asked EMA for the labelling mock-up of the blister packs for telbivudine (Sebivo°), as the pharmaceutical company Novartis had been unwilling to provide it (2,3). On 5 June 2009, EMA refused to send us this mock-up, stating that the European right of access to administrative documents did not apply to this document, on the grounds of protection of commercial interests and intellectual property rights (2). Prescrire repeated its request on 9 June 2009, arguing that packaging mock-ups are technical documents held by EMA. They are just a two-dimensional representation of the authorised packaging. They show little industrial information, which could easily be concealed, if necessary. On 2 July 2009, EMA confirmed its refusal with no further explanation. 

A drug regulatory agency is responsible for patient protection, not the commercial interests of pharmaceutical companies, and must guarantee free access to clinical data, including pharmacovigilance data and packaging mock-ups. Ideally, marketing authorisation (MA) decisions should include a complete representation of all packaging items.  

©Prescrire April 2010

"Drug packaging in 2009: a few advances" Prescrire Int 2010; 19 (107): 135-137

References:
1- Prescrire Editorial Staff "Legal obligations for transparency at the European Medicines Agency: Prescrire’s assessment over four years" Prescrire Int 2009; 18 (103): 228- 233.
2- Prescrire Rédaction "Lettre à l'EMEA": 23 April 2009 + 9 June 2009: 2 pages au total + European Medicines Agency "Lettres à Prescrire" 5 June 2009 + 2 July 2009: 2 pages.
3- Novartis "Courriel à Prescrire" 29 May 2009: 4 pages.