Wednesday, 2 December 2009
Department of Health and Children
I propose to take Questions Nos. 177 and 178 together.
The supply of prescription only medicinal products by Internet suppliers (online) is prohibited in Ireland by the Medicinal Products (Prescription and Control of Supply) Regulations, S.I. 540 of 2003, as amended. While it is impossible to ascertain exactly the extent and value of medicine purchased online here, in 2008 the Irish Medicines Board, working in cooperation with Revenue Commissioners Customs Service, intercepted almost 3000 instances of imports of prescription only medicinal products supplied by Internet websites. These imports were detained. This amounted to a total of 393,067 tablets and capsules. Each intending purchaser was advised of the legal position as outlined above. All these supplies were unlawfully made. The Irish Medicines Board's focus is to prevent the supplies reaching the consumer so as to protect public health. In doing so it cooperates with other agencies nationally and worldwide in the combating of pharmaceutical crimes and to identify the suppliers and put them out of business wherever they may be operating.
12 instances of confirmed counterfeit product were found in 2008 among the almost 3000 online supplies. Due to the extent of diagnostic and analytical work that would be involved in examining the contents of each package in order to determine if it was genuine or counterfeit, it is not possible to accurately estimate the actual amount of counterfeit product within those supplies. It should be noted that these products were supplied to individuals, apparently for their own use, and were not in bulk for re-supply.
The Irish Medicines Board monitors the legal supply chain closely through inspection and authorisation of manufacturers and wholesalers of medicinal products. Wholesalers must comply with European guidelines on Good Distribution Practice which include a requirement to have a procedure to check for counterfeit products and to report any suspicions to the IMB. Particular obligations are placed upon each wholesaler to establish the legitimacy of its suppliers, and its systems for doing so are examined during IMB inspection. The IMB works closely with the Pharmaceutical Society of Ireland and with the Health Service Executive in relation to the supply of medicinal products in pharmacies and joint activities have been conducted in this regard. The IMB also monitors general sale medicines that are available in non-pharmacy retail outlets. To date, no counterfeit medicinal products have been found on the legal supply chain in Ireland.