Brian O'Shea (Waterford, Labour)
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Question 106: To ask the Minister for Health and Children if her attention was drawn to the problem regarding the sale here of counterfeit pharmaceuticals (details supplied); and if she will make a statement on the matter. [9071/09]

Brian O'Shea (Waterford, Labour)
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Question 107: To ask the Minister for Health and Children the discussions she has had with the World Health Organisation in regard to the global pharmaceutical counterfeiting industry (details supplied); and if she will make a statement on the matter. [9072/09]

Mary Harney (Dublin Mid West, Progressive Democrats)
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I propose to take Questions Nos. 106 and 107 together.

I am advised by the Irish Medicines Board (IMB) that no counterfeit medicines have been identified in the legal supply chain in Ireland. The IMB, in cooperation with Revenue, focus on the illegal supply of medicines by Internet websites with a view to protecting public health. The IMB inspects manufacturing and distribution facilities to ensure that all medicinal products made available through the legal supply chain are of good quality and safe.

Ireland participates in a range of initiatives and actions focused on preventing counterfeit medical products from gaining access to the Irish, European Community and other international markets. The sale of counterfeit pharmaceuticals is not just a challenge for national governments. This illicit trade is cross-border and transnational by its very nature and as such can only be successfully tackled by way of appropriate actions by the international community.

My Department and the IMB participate in the Council of Europe (CoE) initiatives to prevent counterfeit medical products entering the market. Two CoE groups are actively attended by IMB experts on pharmaceutical crime. One such group has just completed the first draft of a convention on counterfeit medical products. The draft will be negotiated among member states with a view to having it put before the CoE Council of Ministers in 2010. The other CoE group has developed and delivered multi-sector training in the investigation of counterfeit medical products. IMB officials and Irish Revenue Customs received this training during 2008.

My Department and the IMB also support the World Health Organisation (WHO) initiative known as the International Medical Product Anti-Counterfeiting Task Force (IMPACT). Ireland participates in the Permanent Forum on International Pharmaceutical Crime (PFIPC), which is the enforcement advisor to WHO/IMPACT Enforcement Committee.

In 2008 and 2009, as part of "Operation Pangea", (involving 11 countries and Interpol) the IMB participated in the International Internet Day of Action, which targeted rogue Internet websites that are suspected of supplying counterfeit medicines.

At EU level, a draft Directive on the prevention of the entry into the legal supply chain of medicinal products which are falsified in relation to their identity, history or source has been put forward by the EU Commission. The overall aim is to strengthen existing EU legislation (Directive 2001/83/EC) to protect EU citizens from the dangers of fake medicines. The proposed Directive will be considered at both European Parliament and the Council of Ministers as part of the co-decision procedure before it can be translated into law. Officials from my Department are fully involved in these discussions.