Brussels, 18 April 2012
Medicines in Europe Forum’s Response to the Concept Paper on the Delegated Act on the Detailed Rules for a Unique Identifier for Medicinal Products for Human Use, and its verification.
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The Medicines in Europe Forum (MiEF) welcomes the opportunity to respond to the public consultation on the Concept Paper on the Delegated Act on the Detailed Rules for a Unique Identifier for Medicinal Products for Human Use (1) and would like to highlight particularly worrying elements of the concept paper.
General comments
First, the MiEF wishes to remind that there is no evidence quantifying and qualifying the extent of falsified medicines in the European Union (2). The only related data available at EU level concerns counterfeit medicines; as reported by the European Union’s authorities counterfeit medicines represent only 2.29% of all counterfeits seized at EU borders (equivalent to 3.1% in volume) (3) . From these, the large majority (more than 60%) are postal deliveries from online pharmacies located outside the EU, which remain outside the remit of the Falsified Medicines Directive.
The MiEF also wants to emphasise that modest prices for medicines would significantly decrease the profitability of defrauding. Reforming of the current system where unjustified exorbitant prices are granted would reduce incentives to produce counterfeit medicines (4) .
MiEF therefore requests caution: is the palliative solution of costly investments aimed at ensuring extensive traceability all along the logistics channel a proportionate answer to fight with efficiency against counterfeits medicines? MiEF encourages the EU Commission to carefully consider the benefits and risks of such a delegated act, before implementing sophisticated and costly safety measures. Such investment could affect medicines’ price and the sustainability of wholesalers and community pharmacies without any benefit for public health. Moreover, the data gathered (i.e. information on the number and types of medicines delivered by a particular community pharmacy) could be used by pharmaceutical companies for commercial purposes (i.e. to monitor their promotional strategies, the effectiveness of their sales representatives, etc.)
> Download the complete response (pdf, 196 Ko)
The Medicines in Europe Forum
References:
1 - European Commission Health and Consumers Directorate-general "Delegated Act on the Detailed Rules for a Unique Identifier for Medicinal Products for Human Use, and its verification” Concept paper submitted for public consultation. Brussels, 18/11/2011 (Sanco.ddg1.d.3(2011)1342823). Pdf : 19 pages. http://ec.europa.eu/health/files/counterf_par_trade/safety_2011-11
2 - Prescrire Editorial Staff "Counterfeit drugs: recognising the real issues" Prescrire Int 2009; 18 (101): 135-1 - 135-5. > Pdf (Prescrire International subscribers only)
3 - European Comission. Report on EU customs enforcement of intellectual property rights. Results at the EU Border 2010. Taxation and Customs Union. Accessed on 18 April 2012. http://ec.europa.eu/taxation_customs/resources/documents/ customs/customs_controls/counterfeit_piracy/statistics/statistics_2010.pdf.
4 - Velásquez G "Rethinking The R&D Model forPharmaceutical Products: A Binding Global Convention, Policy Brief 8, April2012. www.southcentre.org
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©Prescrire May 2012
