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Medicinal Products Licensing

Dáil Éireann Debate, Wednesday - 19 December 2012

Wednesday, 19 December 2012

Questions (10, 17)

Niall Collins

Question:

10. Deputy Niall Collins asked the Minister for Health the actions taken to date and his future plans to tackle counterfeit medicine; and if he will make a statement on the matter. [54535/12]

View answer

Niall Collins

Question:

17. Deputy Niall Collins asked the Minister for Health the actions taken to date and the future plans the Gardaí have developed to tackle counterfeit medicine; and if he will make a statement on the matter. [55493/12]

View answer

Written answers

I propose to take Questions Nos. 10 and 17 together.

The Irish Medicines Board (IMB) is responsible for the regulation of medicines in Ireland. It works with all stakeholders, including the industry and law enforcement agencies, to ensure as far as possible that counterfeit or falsified medicines do not reach the public.

IMB enforcement officers work in cooperation with An Garda Síochána and the Revenue Customs Service throughout the year to detect counterfeit and illegal medicines coming into the State and to investigate instances of illegal supply of medicines over the Internet from retail outlets not authorised to supply medicines, or illegal supply of medicines on the illicit market. Prosecutions have been brought by the IMB and by the DPP against persons breaching regulations under the Irish Medicines Board Acts 1995-2006 relating to the unauthorised manufacture, importation and supply of medicines, to protect public health and protect against the health risks associated with counterfeit medicines.

Falsified medicines represent a serious threat to global health and call for a comprehensive strategy both at European and international level. The IMB is part of a global rapid alert system on medicines in the authorised supply chain, which monitors and acts on reports of counterfeit medicines that are detected in the supply chain from the manufacturer through to the patient. The IMB participates in two further rapid alert systems, one EU and one global, which deal with counterfeit medicines in illegal markets and pharmaceutical crimes.

For the last five years the IMB, Revenue Customs Service and An Garda Síochána have participated in a unified interagency operational approach in Ireland called Operation PANGEA. This is an international initiative coordinated by Interpol, to tackle the internet supply of counterfeit and illegal medicines. The principal focus of Operation PANGEA is the protection of public health. The IMB is represented on the global organising committee for this operation. The activity conducted during this operation is ongoing throughout the year in Ireland with the Revenue Customs Service detecting illegal supplies of medicines at ports and airports and working with Gardaí in investigations to identify criminal activity and prevent harmful internet-supplied medicines getting to unsuspecting members of the public purchasing online.

Memoranda of Understanding exist between State agencies to support this collaborative approach to combating counterfeit medicines, such as that between the IMB and Revenue Customs Service. The Irish Medicines Board (Miscellaneous Provisions) Act, 2006, provides that Revenue Customs Service officers have enforcement powers under the Act to enable them to adequately respond to instances of illegal importation of medicines, medical devices and other healthcare products. This has proven to be a very positive approach and is evidenced by the amounts of illegal medicines detained annually at the entry points to the State. Further, the Gardaí continually work to identify supply lines of controlled drugs in order to prevent them getting into the drug abuse market.

To date, no counterfeit medicines have been detected in the legitimate medicines supply chain in Ireland. However several instances of counterfeit medicines have been found in the UK and other EU countries over the last ten years even though these countries have been active in taking significant steps to deter this activity.

At an EU level, it is recognised that, as falsifications become more sophisticated, the risk to EU patients increases every year. The new Falsified Medicines Directive, Directive 2011/62/EU, will come into effect from the 2nd January 2013. The transposition of the Directive into Irish law is in progress. This new legislation will further tighten the regulatory regime to prevent the possibility of infiltration of counterfeit medicines into medicines wholesalers and pharmacies and is intended to further protect patients. It introduces tougher rules to improve the protection of public health with new harmonised, pan-European measures to ensure that medicines are safe and that the trade in medicines is rigorously controlled. These new measures include:

-An obligatory authenticity feature on the outer packaging of key medicines;

-A common, EU-wide logo to identify legal online pharmacies and make it easier to distinguish between legal and illegal online pharmacies throughout the European Union;

-Tougher rules on the controls and inspections of producers of active pharmaceutical ingredients; and

-Strengthened record-keeping requirements for wholesale distributors.

These new measures will be progressively introduced over the next few years.

The public can be assured that the area of counterfeit medicines is constantly under review. The different State agencies, in particular the IMB, An Garda Síochána and Revenue Customs Service, are working in a cooperative manner to deter, detect and investigate instances of illegality regarding medicines and will continue to do so.

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