Seán Fleming (Laois-Offaly, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

358. To ask the Minister for Health the reason there is a shortage of Eltroxin, which is used to treat thyroid conditions; the steps the Health Service Executive is taking to resolve this problem; if the Health Service Executive is using an unlicensed alternative medicine, as occurred during previous shortages; the cost of this alternative relative to the cost of Eltroxin; the reason the HSE has allowed the situation to arise where there is only a single supplier of Eltroxin in the Irish market; and if he will make a statement on the matter. [47305/14]

Seán Fleming (Laois-Offaly, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

362. To ask the Minister for Health if Eltroxin, a medication used to treat thyroid conditions, is subject to parallel exporting, that is being imported into Ireland and then re-exported to other EU states; the reasons this occurs; his views on whether this is contributing to the extreme shortage of its availability; if the Health Service Executives plans to introduce competition and alternative suppliers into this market to ensure continuity of supply for patients into the future; and if he will make a statement on the matter. [47357/14]

Kathleen Lynch (Cork North Central, Labour)
Link to this: Individually | In context | Oireachtas source

I propose to take Questions Nos. 358 and 362 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.

Before anyone is allowed to market a medicine in Ireland they are required to apply for a marketing authorisation from either the Health Products Regulatory Authority (HPRA) or the European Medicines Agency (EMA). The HPRA and EMA examine the safety, quality and efficacy of medicines. The Marketing Authorisation Holder (MAH) for Eltroxin is Amdipharm Mercury Company Ltd. (AMCo)) and it is the only supplier of the brand Eltroxin in Ireland.

On 19 November 2014, the Health Service Executive (HSE) received a query from a pharmacy in relation to the availability of Eltroxin 50 mcg. At that time, the supplier AMCo had not notified the HSE of any issue with the supply. The HSE immediately contacted the company with regard to the supply of Eltroxin.

The HSE has implemented emergency reimbursement arrangements to deal with this shortage. If pharmacists are unable to access Irish market authorised packs of Eltroxin the HSE is reimbursing imported alternatives (subject to the alternatives being reasonably priced) under existing protocols. The HSE has also been in discussion with other suppliers and expects on the basis of current feedback from suppliers that imported stocks would be available at the same price as the Eltroxin price if the shortage were to continue long term. It should be noted that the HSE cannot obligate any generic supplier to enter the market. Additionally the HSE has been working closely with AMCo and has required it to provide weekly reports of stock availability of all strengths of Eltroxin Tabs until supply is re-established to an acceptable level.

The Health Products Regulatory Authority (HPRA) became aware of a shortage of Eltroxin 50mcg tablets during the week of 1 December 2014. It understands that the 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. A regulatory request from the MAH was approved by HPRA on 5 December 2014 to allow the release of four batches of Eltroxin 50mcg tablets to the market to resume supply of this medicine. The four batches were at the distributor in Ireland at the time of approval of the variation and are expected to supply the market for 3-4 months. It is expected that a similar regulatory request will be made by the MAH to the HPRA during the week of 8 December 2014 to ensure continued supply of Eltroxin 100mcg tablets. In the meantime, prescriptions for Eltroxin 100mcg can be met with the Eltroxin 50mcg tablet product.

Parallel exporting is the exporting of medicines intended for use in one market to other countries in the 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 Sept 2011 the HPRA wrote to the majority of wholesalers regarding the public service obligations contained in the Medicinal Products (Control of Wholesale Distribution) Regulations, 2007. The HPRA is following up on the possibility of Eltroxin product being parallel exported from Ireland.