Tuesday, 23 July 2019

Ceisteanna (1367)

Louise O'Reilly

Ceist:

1367. Deputy Louise O'Reilly asked the Minister for Health the amount of counterfeit medication that has been confiscated in each of the years 2011 to 2018 and to date 2019; the types of counterfeit medication involved; and if he will make a statement on the matter. [32668/19]

Amharc ar fhreagra

Freagraí scríofa (Ceist ar Health)

Since 2013, following the transposition of the EU Falsified Medicines Directive (Directive 2011/62/EU), the term ‘counterfeit’ has not been used. Instead, this Directive introduced the term ‘Falsified medicinal product’. This has a meaning of ‘any medicinal product with a false representation of :-

(a) Its identity, including its packaging and labelling, its name or its composition as regards any of the ingredients including excipients and the strength of those ingredients

(b) its history, including the records and documents relating to the distribution channels used, but does not include unintentional quality defects and is without prejudice to infringements of intellectual property rights;”, and

(c) its history, including the records and documents relating to the distribution channels used, but does not include unintentional quality defects and is without prejudice to infringements of intellectual property rights.’

The World Health Organisation, the Council of Europe’s Medicrime Convention and the United Nations Office of Drugs and Crime (UNODC) Good Legislative Practice Guide on Falsified Medical Products use similar definitions. The term ‘counterfeit’ is now only used in relation to intellectual property rights. In relation to the falsification of medicines, it is public health that is the priority. The HPRA does not have any enforcement powers in respect of any legislation dealing with intellectual property rights.

The following detentions of medicines that have been illegally manufactured, kept for supply or supplied have been made in the period since 2011:

Year

Total Deductions

2019 *Jan to May

208,253  

2018

619,213 

2017

948,915

2016

673,906

2015

1,136,494

2014

730,056

2013

919,965

2012

758,276

2011

762,641

The HPRA categorises medicines that are subject to enforcement actions under their therapeutic category, not on whether they are falsified or unauthorised or otherwise illicit. The HPRA has prosecuted persons in relation to falsified and unauthorised medicines and the illegal supply of authorised medicines. It is not feasible to extract the data requested under the term falsified. It should be noted that the total detentions each year are classed in the HPRA’s Annual Report as falsified and illegal.