Michael Healy-Rae (Kerry South, Independent)
Link to this: Individually | In context | Oireachtas source

147. To ask the Minister for Health if Health Products Regulatory Authority employees held a position with a pharmaceutical company (details supplied) prior or since 1983; and if he will make a statement on the matter. [18761/15]

Michael Healy-Rae (Kerry South, Independent)
Link to this: Individually | In context | Oireachtas source

148. To ask the Minister for Health if a pharmaceutical company (details supplied) financially supported the Health Products Regulatory Authority, or any of its employees, since 1983; and if he will make a statement on the matter. [18762/15]

Michael Healy-Rae (Kerry South, Independent)
Link to this: Individually | In context | Oireachtas source

149. To ask the Minister for Health his views on correspondence (details supplied) regarding the incidence of adverse drug reactions; and if he will make a statement on the matter. [18763/15]

Michael Healy-Rae (Kerry South, Independent)
Link to this: Individually | In context | Oireachtas source

151. To ask the Minister for Health the licence renewal obligatory process for the drug Roaccutane; and if he will make a statement on the matter. [18776/15]

Michael Healy-Rae (Kerry South, Independent)
Link to this: Individually | In context | Oireachtas source

152. To ask the Minister for Health if the renewal of a licence for Roaccutane can be objected to; and if he will make a statement on the matter. [18777/15]

Michael Healy-Rae (Kerry South, Independent)
Link to this: Individually | In context | Oireachtas source

154. To ask the Minister for Health the value of the modest gifts with regard to the Health Products Regulatory Authority that are acceptable; the names of the members of the Authority who have received gifts; and if he will make a statement on the matter. [18779/15]

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

I propose to take Questions Nos. 147 to 149, inclusive, 151, 152 and 154 together.

Employees of the Health Products Regulatory (HPRA) are prohibited from holding any position with a pharmaceutical company while employed by the HPRA. Employees are also prohibited from having a financial or other beneficial interest in any company or organisation operating in a sector that the HPRA regulates.

Any employee who previously worked in a regulated company is restricted from all activities relating to that company for a period of time of up to five years depending on their role in that company, seniority of their position, relationships with persons in the company or level of contact with persons in the company, and any other relevant factor. They are also prohibited from ever taking part in any activity relating to a medicinal product, medical device or cosmetic that they helped develop in any previous employment or relating to any competitor products for the same active substance or class of substances.

HPRA policies and procedures govern the declaration of interests, when staff join, on an annual basis and at any time that interests may change (e.g. with respect to a household member). There is a structured evaluation of any declared interest and appropriate outcomes depending on the evaluation. Checking for any restrictions is an integral part of all procedures for assigning work.

All pharmaceutical companies pay fees for their licence applications. The fees are set out in Regulations approved by the Minister for Health. No company may provide financial support to any employee. This is clearly stated in the Conflict of Interest Policy on the HPRA website.

Roaccutane has been closely monitored at both national and European level since it was first authorised, with issues related to its safety highlighted and communicated to healthcare professionals as appropriate.

The HPRA, together with its EU counterparts has worked with the pharmaceutical company to facilitate availability of appropriate product information for Roaccutane, which includes detailed and comprehensive advice regarding the risks associated with its use and recommendations to minimise the occurrence of these risks. The product information has been reviewed and updated since Roaccutane was first authorised for use in Ireland in 1983, as required. The HPRA has also communicated the outcome of regulatory reviews and updated recommendations regarding Roaccutane to healthcare professionals through its Drug Safety Newsletter on a number of occasions, all of which are accessible from the HPRA website

The product information for Roaccutane highlights the requirement that it should only be prescribed by or under the supervision of physicians with expertise in the use of systemic retinoids for the treatment of severe acne and with a full understanding of the risks of therapy and the monitoring requirements associated with its use.

The product information also specifies the circumstances where Roaccutane is contraindicated (i.e. when it should not be used).

The requirements for specific monitoring of the patient to reduce the risk of adverse reactions and to facilitate their early detection and management are described in detail in the product information in relation to psychiatric disorders, severe skin reactions, allergic reactions, effects on liver enzymes, serum lipids and the pregnancy prevention programme. Monitoring in these circumstances is through on-going review of the patient by the prescribing doctor, as part of their clinical practice.

The HPRA and the company have legal obligations to share reports of serious, suspected adverse reactions associated with use of Roaccutane within 15 days of first notification. These reports are in turn submitted to the European Medicines Agency and the World Health Organisation to facilitate review in the context of global safety experience and to support early detection of new and emerging reporting trends.

The relevant renewal requirements have changed over time. When Roaccutane was first licensed, companies were required to apply for renewal of their marketing authorisations every five years. Marketing authorisations became subject to one further renewal, following which authorisations remain valid for an unlimited period, unless one additional five-year renewal was considered necessary on justified grounds relating to pharmacovigilance (drug safety). Roaccutane was last renewed on 10 July 2009 with an unlimited marketing authorisation.

Requirements for renewal application have changed over time. The current requirements are included in the European Commission’s ‘Guideline on the processing of renewals in the Mutual Recognition and Decentralised Procedure’ and the accompanying ‘EU Application form for renewal of a marketing authorisation.’

The HPRA prohibits the acceptance of money as cash, cash vouchers or cash equivalents from any industry or sector regulated by the HPRA. Gifts may not be solicited, directly or indirectly. Only gifts of very modest value are acceptable in limited circumstances or where it is the custom in the country concerned to give such gifts and where to decline may cause offence. The Conflict of Interest Policy on the HPRA website provides detailed guidance and requirements.