Michael Healy-Rae
Question:279. Deputy Michael Healy-Rae asked the Minister for Health the condition that Roaccutane is originally made for; and if he will make a statement on the matter. [19166/15]
View answerTuesday, 19 May 2015
Questions (279, 284, 286, 287, 288, 289)
Michael Healy-Rae
Question:284. Deputy Michael Healy-Rae asked the Minister for Health if he is satisfied and finds the list of side-effects provided for Roaccutane adequate; and if he will make a statement on the matter. [19178/15]
View answerMichael Healy-Rae
Question:286. Deputy Michael Healy-Rae asked the Minister for Health the correspondence, agreement, conditions the Health Products Regulatory Authority made with a pharmaceutical company (details supplied) prior to the marketing of Roaccutane in 1983, and post-1983; and if he will make a statement on the matter. [19181/15]
View answerMichael Healy-Rae
Question:287. Deputy Michael Healy-Rae asked the Minister for Health if any members of the Health Products Regulatory Authority had or have a declared interest in his political party prior to, or since, 1983; and if he will make a statement on the matter. [19183/15]
View answerMichael Healy-Rae
Question:288. Deputy Michael Healy-Rae asked the Minister for Health the laws that were, and are, in place that ensure that any doctor or other medical personnel, or hospital or faculty, are required to report adverse drug reactions, associated with Roaccutane, since 1983; the authority these reports are submitted to; and if he will make a statement on the matter. [19187/15]
View answerMichael Healy-Rae
Question:289. Deputy Michael Healy-Rae asked the Minister for Health if the Health Products Regulatory Authority is compromising public safety, where Roaccutane is concerned; and if he will make a statement on the matter. [19188/15]
View answerWritten answers
I propose to take Questions Nos. 279, 284 and 286 to 289, inclusive, together.
Roaccutane (isotretinoin) is authorised for treating severe forms of acne which have been resistant to other standard therapies. It should only be prescribed by or under the supervision of doctors with expertise in using the product and with a full understanding of the risk of therapy and the monitoring requirements.
When first authorised for use in Ireland in 1983, roaccutane was authorised for the management of cystic or conglobate forms of acne vulgaris, or for use in cases of severe acne which have failed to respond to adequate courses of accepted therapy.
Under European and Irish legislation, all medicinal products must be authorised before being marketed. As part of the marketing 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. Relevant Irish Regulations set out the requirements for companies and the procedure for the Health Products Regulatory Authority (HPRA) in assessing applications.
Following assessment by the HPRA approval is given on the basis of a favourable benefit versus risk balance for the approved specific therapeutic indication. The approved conditions for use are contained in the product information for patients and their doctors.
Following authorisation, any change, for example new indications, updated safety information or product changes requires approval on foot of a formal application to vary the authorisation and the submission of relevant supporting data.
Once a medicine is approved and placed on the market, European and Irish legislation provides for ongoing monitoring of its benefits and risks. This monitoring includes review and evaluation of suspected adverse reaction reports at National and EU level. Roaccutane was most recently reviewed at EU level in April 2011 when further warnings regarding skin reactions were added to the product information for patients and their doctors. The risk of depression associated with the use of roaccutane was also reviewed at that time. However the existing comprehensive information on the risk of depression associated with roaccutane and the monitoring requirements provided on the product information were considered sufficient. The inclusion of these, and other side effects and warnings, in the product information are on the basis of information on use of the product including reports of side effects from patients.
The information for patients and for their doctors includes detailed advice on the risks associated with use of roaccutane and recommendations to minimise their occurrence. The package leaflet advises patients to tell their doctor if they ever had any mental illness (including depression, suicidal behaviour or psychosis), or if they take medicines for any of these conditions. It also advises them to contact their doctor immediately if they have signs of any of these problems.
The information for doctors lists potential psychiatric disorders. It emphasises that particular care needs to be taken in relation to patients with a history of depression and that all patients should be monitored for signs of depression during their treatment with the product and referred for appropriate treatment as necessary. The benefits of treatment are considered to outweigh its risks when the product is used in accordance with the product information.
Monitoring of benefits and risks of medicines takes place through a system known as pharmacovigilance. The EU passed new legislation in 2010 and 2012 to improve the overall efficiency and effectiveness of the system and this legislation has been fully transposed into Irish legislation. One of the goals of the new legislation is to provide access to more information related to the benefit-risk aspects of taking a medication as well as providing opportunity for patients and consumers to directly report suspected problems.
The national regulatory medicines authorities (in Ireland the HPRA) 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, which is responsible for the overall co-ordination of pharmacovigilance activities across the EU.
Reporting of adverse events has been a function of the HPRA since its establishment as the Irish Medicines Board in 1995 and prior to 1995 by the National Drugs Advisory Board.
Reporting of suspected adverse reactions by health professionals is undertaken on a voluntary basis with all health professionals strongly encouraged to report a suspected adverse reaction. These reports may be submitted at any time to the HPRA. The HPRA regularly reminds health care professionals about reporting in its Drug Safety Newsletter and further information on reporting and access to reporting forms is available on the HPRA website.
Reporting of suspected adverse reactions however is only one of a number of ways of identifying new adverse reactions. Individual reports of suspected adverse reactions alone are rarely sufficient to confirm that a certain reaction is caused by the medicine in question. Other factors such as the extent and conditions of use of the medicine, the nature of the reaction, the condition being treated, any new conditions arising and other medicines taken by the patient have to be taken into account. Further data is usually required, including worldwide spontaneous case reports, clinical trials and epidemiological studies, to confirm the reactions and help determine their significance.
Under the Irish Medicines Board’s Acts 1995 and 2006, members of the HPRA are appointed by the Minister for Health. In the case of 1 position, i.e. the chairperson of the HPRA’s Advisory Committee for Veterinary Medicines, the appointment is subject to the consent of the Minister for Agriculture, Food and the Marine.
The Deputy will be aware that in 2011 this Government introduced new arrangements for appointments to State Boards which have contributed to greater openness and transparency in the appointments process. Further reforms were announced by the Government in November 2014 whereby all appointments will be advertised openly on the State Boards portal operated by the Public Appointments Service (PAS), meet specific criteria necessary for the effective performance of the role and be processed in a transparent manner.
Each member of the HPRA Authority brings to the HPRA essential expertise in areas such as human and veterinary medicines, pharmacy, medical devices and finance. The members are highly qualified and well respected professionals in their field and political affiliation is not a consideration. I would also like to refer the Deputy to the detailed and extensive provisions in place governing ethics in public office, conflicts of interest and codes of conduct which govern the activities of all appointees to State Boards, including the HPRA.
Since its foundation in 1995 the HPRA has played a key role in ensuring that health products used by Irish patients are safe. I am satisfied that the HPRA operates to the highest standards of probity, accountability and transparency in its dealings with pharmaceutical companies, health professionals and patients alike.