Dáil Éireann Debate, Tuesday - 27 January 2015
363. Deputy Billy Kelleher asked the Minister for Health further to recent media reports, when the investigation into the severe shortage in supplies of commonly used medicines, including Eltroxin, will commence; the expected timeframe for completion of the investigation; and if he will make a statement on the matter. [3550/15]
Amharc ar fhreagra364. Deputy Billy Kelleher asked the Minister for Health the terms of reference for the Health Products Regulatory Authority investigation into the severe shortage in supplies of commonly used medicines; and if he will make a statement on the matter. [3551/15]
Amharc ar fhreagra365. Deputy Billy Kelleher asked the Minister for Health his views on the practice of Health Products Regulatory Authority approved licence holders exporting medicines to the UK and other export markets; the reasons such exporting is taking place; his plans to ensure this practice does not continue to adversely affect the supply of medicines domestically; and if he will make a statement on the matter. [3552/15]
Amharc ar fhreagra366. Deputy Billy Kelleher asked the Minister for Health the steps being taken to ensure that the supply of Eltroxin is adequately maintained prior to the completion of the Health Products Regulatory Authority investigation into severe shortage in supplies of commonly used medicines; and if he will make a statement on the matter. [3553/15]
Amharc ar fhreagraI propose to take Questions Nos. 363 to 366, inclusive, together.
Eltroxin, which contains the active substance levothyroxine, is a long established medicine that is used to control hypothyroidism, congenital hypothyroidism and juvenile myxoedema. It is marketed in tablets containing 25, 50 and 100 micrograms and is the subject of a marketing authorisation in Ireland.
The Health Products Regulatory Authority (HPRA) became aware of shortages of Eltroxin tablets during the week of 1 December 2014. On becoming aware of the shortage the HPRA contacted the manufacturer. This was not however a formal investigation but part of the HPRA's activities in managing disruption in supply of a medicine. It is understood that this shortage was due to a regulatory non-compliance by the manufacturer. The non-compliance was that a registered in-process test was not being applied during manufacture of current batches of Eltroxin. Over the following days, a number of ‘fast track’ regulatory requests (variations), submitted by the manufacturer, were approved by the HPRA in order to allow for the release of batches of tablets onto the Irish Market.
As part of its routine post marketing activities, the HPRA continues to monitor and investigate issues relating to disruption in supply. In the event of a shortage of a medicine to patients, HPRA will attempt to minimise the impact on patients by:
- working with pharmaceutical companies to resolve manufacturing and distribution issues;
- sharing information with the HSE and international partners about alternative sources of supply;
- seeking input from the HSE, patient groups and healthcare professionals on the impact of medicine shortages, to support decision-making;
- taking measures to allow alternative medicines or suppliers to be used;
- having in place a fast track regulatory mechanism (known as ‘batch specific request’) to permit packs of a medicine intended for another market to be modified to meet the requirements of the authorisation to market the product in Ireland;
- operating a notification system relating to the sourcing by distributors of exempt (unauthorised) medicines to meet the special needs of patients. This can include the sourcing of an exempt alternative where there is a shortage of the authorised product.
Parallel exporting is the exporting of medicines intended for use in one market to other countries in the European Economic Area (EEA). EU law provides for the free movement of goods across borders within the EU so the practice of parallel import and parallel export of medicines is legal. Member States may restrict the free movement of goods only in exceptional cases, for example when there is a risk resulting from issues such as public health, environment, or consumer protection. In September 2011, the HPRA wrote to the majority of wholesalers regarding the public service obligations contained in the Irish Medicines Regulations. The HPRA closely monitors the situation and if it is found that a product shortage may have been due to parallel trading, the HPRA will investigate.
At present, the HPRA is not aware of any shortage in supply of Eltroxin in Ireland. It continues to work with the manufacturer concerned to ensure that sufficient stocks of this, and other of its products, are available for patients in Ireland. Based on the information available to the HPRA the shortage of Eltroxin tablets in December 2014 was not caused by parallel trade of the product.
