Dáil Éireann Debate, Thursday - 2 July 2015
160. Deputy Michael Healy-Rae asked the Minister for Health if the Health Products Regulatory Authority has been involved in any litigation, directly or indirectly, in respect of Roaccutane since its authorisation in 1983; and if he will make a statement on the matter. [26767/15]
View answer161. Deputy Michael Healy-Rae asked the Minister for Health the number of adverse drug reaction reports the national drugs advisory board has received in respect of Roaccutane since its authorisation in 1983; if he will provide a chronological list of these reports, identifiable by age, gender and year; and if he will make a statement on the matter. [26768/15]
View answer162. Deputy Michael Healy-Rae asked the Minister for Health the legislation that is, and was, in place to ensure correct pharmaco-vigilance where Roaccutance is concerned since its authorisation in 1983; and if he will make a statement on the matter. [26769/15]
View answer163. Deputy Michael Healy-Rae asked the Minister for Health the number of reports of serious, suspected adverse drug reactions associated with the use of Roaccutane within 15 days of first notification the Health Products Regulatory Authority has received; the number of these reports the authority has submitted to the European Medicines Agency and to the World Health Organization since its authorisation in 1983; if he will provide the details of these reports categorised by age, gender and year, chronologically; the legislative obligations for this; and if he will make a statement on the matter. [26770/15]
View answer164. Deputy Michael Healy-Rae asked the Minister for Health the number of clinical trials and the information a pharmaceutical company (details supplied) initially developed in respect of the drug Isotretinoin; if he has questioned this information; the correspondence he has had with the company and the National Health Service relating to it; and if he will make a statement on the matter. [26771/15]
View answer165. Deputy Michael Healy-Rae asked the Minister for Health the number of reports of serious, suspected adverse drug reactions associated with the use of Roaccutane within 15 days of first notification that a pharmaceutical company (details supplied) has submitted to the Health Products Regulatory Authority; the number of these reports the authority has submitted to the European Medicines Agency; if he will identify these reports by age, gender and year, chronologically; and if he will make a statement on the matter. [26772/15]
View answerI propose to take Questions Nos. 160 to 165, inclusive, together.
Under European and Irish legislation, all medicinal products must be authorised before being marketed. As part of the authorisation application process the applicant company must submit evidence that the medicine meets clear and predefined standards of quality, safety and efficacy, relevant to its proposed therapeutic use. This information is provided in a dossier and the type of data to be submitted is set out in EU Directives and guidelines. The procedure for assessing applications followed by the Health Products Regulatory Authority (HPRA), as the national competent authority and regulator for human medicines, and the requirements for companies making applications, is set out in relevant Irish Regulations.
In relation specifically to the drug isotretinoin, the information provided by the pharmaceutical company was in line with these legislative and regulatory guidelines at the time, and has been updated regularly since then through renewals of the authorisation, periodic safety update reports, variations, and European-wide review, as already detailed in a previous response to the Deputy. Roaccutane® was first authorised for use in Ireland on 19 April 1983.
It is standard practice that there is regular correspondence between pharmaceutical companies and the HPRA in the context of all of these regulatory procedures and post-marketing safety monitoring. Monitoring of benefits and risks of medicines takes place through a system known as pharmacovigilance (which includes review and evaluation of suspected adverse reaction reports, published literature and post-marketing safety studies).
The applicable pharmacovigilance legislation that is and was in place since the first authorisation of Roaccutane® in Ireland is as follows:
EU Legislation:
- Directive 65/65/EEC, amended by 75/319/EEC,
- Directive 2001/83/EC, as amended, including Directive 2010/84/EU,
- Regulation (EEC) No. 2309/93,
- Regulation (EC) No. 726/2004,
- Regulation (EU) No. 1235/2010,
- Regulation (EU) No. 520/2012.
Irish legislation:
- S.I. No. 261/1966 Medical Preparations (Control of Sale) Regulations, 1966, as amended.
- S.I. No. 210 of 1984 Medical Preparations (Licensing, Advertisement and Sale) Regulations, 1984, as amended.
- S.I. No. 43/1996 Medical Preparations (Licensing, Advertisement and Sale) Regulations, 1996, as amended.
- S.I. No. 540 of 2007 Medicinal Products (Control of Placing on the Market) Regulations, 2007, as amended.
All of this legislation is supported by a wide range of EU guidance documents. Those involving pharmacovigilance requirements and guidelines for marketing authorisation holders and national competent authorities are currently included in a series of Good Vigilance Practice Modules (I to XVI). Previous guidance for pharmacovigilance was described in Volume 9A of the Rules Governing Medicinal products in the European Union – Guidelines on Pharmacovigilance for Medicinal Products for Human Use.
Companies have an obligation to report suspected adverse reactions associated with the use of their products to the competent authority as a condition of their authorisation and the aforementioned pharmacovigilance legislation.
The national regulatory authorities in each EU Member State are responsible for gathering and evaluating national adverse reaction reports and in turn, submitting these reports to the European Medicines Agency (EMA), which is responsible for the overall pharmacovigilance activities across the EU.
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).
All reports of suspected adverse reactions received by the HPRA (and formerly the IMB/NDAB), either directly from healthcare professionals, patients and consumers, or via the marketing authorisation holder, were included in a chronological list of ADRs that was provided to the Deputy on 26 May 2015 in response to PQs 18759, 19167, 19177 and 19179-15. This listing includes information on age, gender and year, insofar as these details are available to the HPRA; however as previously highlighted, in most cases only limited information is provided to the HPRA in adverse reaction reports.
All ADRs included on the listing provided to the Deputy have been submitted to the World Health Organisation (WHO) and the EMA, in accordance with the applicable legislation, guidance and timelines in place for reporting at EU and national level, as appropriate.
Since 2000, there have been eleven cases brought with respect to Roaccutane® to which the HPRA/IMB was named as co-defendant.
