Michael Healy-Rae (Kerry South, Independent)
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529. To ask the Minister for Health if he will provide the details of what dictates or requires the product information for Roaccutane to be reviewed and updated; the number of times this has been done since its authorisation in 1983; the way the Health Products Regulatory Authority and its European Union counterparts have worked with a pharmaceutical company (details supplied) to facilitate availability of appropriate product information in association with Roaccutane since 1983; if he will provide all data, documentation and details relating to this; and if he will make a statement on the matter. [28326/15]

Michael Healy-Rae (Kerry South, Independent)
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530. To ask the Minister for Health if he will provide details of all licence renewal applications for Roaccutane since its authorisation in 1983; and if he will make a statement on the matter. [28327/15]

Michael Healy-Rae (Kerry South, Independent)
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531. To ask the Minister for Health if he will provide all data documents, details and standards of quality, as part of the marketing authorisation for Roaccutane submitted by a pharmaceutical company (details supplied) to the Health Products Regulatory Authority in 1983, prior and post, and in order of submission; and if he will make a statement on the matter. [28328/15]

Michael Healy-Rae (Kerry South, Independent)
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532. To ask the Minister for Health the laws in place governing the immediate reporting by health care professionals of adverse drug reactions in regard to Roaccutane, since its authorisation in 1983; if he will make it a criminal offence if adverse drug reactions are not reported immediately; and if he will make a statement on the matter. [28329/15]

Michael Healy-Rae (Kerry South, Independent)
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533. To ask the Minister for Health the fee, as regulated and approved by the Minister for Health, that is paid for licence renewal; to whom and by whom this fee is payable; if he will provide details of all approvals from the Minister for Health, and of a pharmaceutical company's (details supplied) involvement in regard to Roaccutane since 1983; and if he will make a statement on the matter. [28330/15]

Michael Healy-Rae (Kerry South, Independent)
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537. To ask the Minister for Health the regulations and agreement that were made between the Minister for Health, a pharmaceutical company (details supplied) and the Health Products Regulatory Authority, in association with Roaccutane, since 1983, and prior to marketing; the reason Roaccutane received unlimited marketing authorisation on 10 July 2009; and the role and involvement the Minister for Health, the company and the Authority have. [28362/15]

Michael Healy-Rae (Kerry South, Independent)
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538. To ask the Minister for Health the pregnancy prevention programmes that have been in place for Roaccutane since 1983; the role the Health Products Regulatory Authority and a pharmaceutical company (details supplied) have; the details of same; and if he will make a statement on the matter. [28363/15]

Kathleen Lynch (Cork North Central, Labour)
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I propose to take Questions Nos. 529 to 533, inclusive, 537 and 538 together.

Under European and Irish legislation, all medicinal products must be authorised before being marketed. They are issued with a Marketing Authorisation (MA). Roaccutane was first authorised for use in Ireland on 19 April 1983. Comprehensive standards of quality for applications for MA's are contained within EU and Irish legislation, and regulatory guidance documents. These were comprehensively referenced in my answer to PQ 26769/15. The same legislation covers all data requirements as well as pharmacovigilance requirements.

The product information requirements, including their format and content, are also detailed in these guidance documents. Both are approved as an intrinsic part of the licensing of a medicine and continuously updated to reflect the current state of knowledge of the medicine concerned and the risks associated with its use, as new data become available and is assessed by the HPRA and/or its European counterparts.

The package leaflet is subject to user-testing to ensure its ease of readability by patients. Package leaflets are available in the medicine’s packaging and on the HPRA and other websites. Any changes to the licence document or product information deemed necessary after assessment of applications are made by the company concerned. There have been numerous updates to the product information for Roaccutane; currently available records indicate at least 27 updates to these documents, with multiple changes made to them in the context of some of these updates.

There is currently no fee for the renewal of MA's. Rather, companies pay the HPRA an annual maintenance fee of €650 for the first 10 MA's they hold and €812 for additional authorisations; this is to cover all aspects of routine dossier management and maintenance, including the work associated with on-going pharmacovigilance activities. Information on the renewal of the authorisations for medicinal products was provided in my response to PQ 18776/15.

Roaccutane was last renewed on 10 July 2009 with an unlimited MA. Unlimited MA's are a requirement of the legislation as explained that same response of May 2015. An unlimited authorisation does not preclude changes to the product information for healthcare professionals and patients. Changes can be made, when required, on the basis of ongoing pharmacovigilance activities and assessments.

Part of this ongoing pharmacovigilance is the monitoring, review and evaluation of reported adverse drug reactions. Reporting of adverse events has been a function of the HPRA since its establishment as the Irish Medicines Board (IMB) in 1995, and prior to 1995 by the National Drugs Advisory Board (NDAB). Reporting of suspected adverse reactions by healthcare professionals (e.g. doctors/dentists/pharmacists/nurses) and patients/carers is undertaken on a voluntary basis, with all groups strongly encouraged to report when they consider a medicine may have contributed to the effects experienced. WHO data indicates that Ireland was ranked tenth highest reporter across 121 participating countries during 2014, reflecting the active contribution of Irish healthcare professionals to the reporting programme. Given these levels of reporting and the very positive response of healthcare professionals to requests for reports over the years, it is not considered that a mandatory based system of reporting by healthcare professionals is appropriate or necessary. The HPRA does however continue to regularly remind health care professionals about reporting adverse drug reactions via its Drugs Safety Newsletter.

Since it was first authorised for use in Ireland, Roaccutane (isotretinoin) has been contraindicated in women who are pregnant or breastfeeding. Use of isotretinoin has also been consistently contraindicated in women of childbearing potential since the product was first authorised, unless all of the conditions specified in the product information are met.

An EU wide Pregnancy Prevention Plan (PPP) was introduced in October 2003 to further reduce the potential risk of pregnancy in women by expanding the available information and highlighting the well-known and documented risks related to use in women of child-bearing potential. These measures include supplementary information distributed to prescribing doctors, pharmacists, other relevant healthcare professionals and patients, including the following:

- Physician’s guide to prescribing Roaccutane to female patients;

- Physician’s checklist for prescribing to female patients;

- Patient information brochure;

- Important information for patients prescribed Roaccutane on contraception; and

- Pharmacist’s guide to dispensing Roaccutane.

The PPP applies across all EU member states and is monitored and reviewed at EU level. The company submits the information gathered through the PPP on a yearly basis to the competent authority for each EU member state (i.e. HPRA in Ireland). The European Medicines Agency’s (EMA’s) Pharmacovigilance Risk Assessment Committee (PRAC), (at which Ireland is represented by the HPRA) assesses the data provided to consider any need to strengthen/amend the PPP as part of the regular review of the effectiveness of these risk minimisation measures.

Licence applications and licence renewal applications contain commercially sensitive information. The HPRA has a duty to protect confidential information submitted by companies, healthcare professionals and patients and cannot release the information requested without third-party consent.