Hildegarde Naughton (Galway West, Fine Gael)
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166. To ask the Minister for Health if he will request that the manufacturers of statins sold here to make available the essential underlying research data used by each of the manufacturers regarding the adverse effects associated with statins. [45461/17]

Simon Harris (Wicklow, Fine Gael)
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The Health Products Regulatory Authority (HPRA) is the competent authority responsible for the regulation of human medicines in Ireland. Under European and Irish legislation, before a medicine can be placed on the Irish market, the manufacturer must seek an authorisation from the HPRA or, in the case of certain medicinal products, the European Medicines Agency. A determination on an application for authorisation of a medicinal product is based on a rigorous scientific assessment of the application against the criteria of quality, safety and efficacy, legal and regulatory requirements. I have no role in the process of medicinal product authorisation.

All pharmaceutical companies seeking marketing authorisations for their medicines must provide evidence in a dossier which includes information from pre-clinical studies, clinical trials and manufacturing and testing data. The format of the dossier and type of data to be submitted is laid down in EU and national legislation and guidelines. Authorisation thereafter is made on the basis of initial and continuing benefit versus risk balance for specific therapeutic indications, having regard to the quality, safety and efficacy of the product for the proposed conditions of use.

The Summary of Product Characteristics for each medicine includes detailed information on the use, dosing recommendations, precautions for use, and the known side-effects of the medicine concerned. Information on the research data submitted to the competent authority is included in a number of sections, particularly section 5.1. The summaries for all products are accessible from the HPRA website (www.hpra.ie), including those for the statins authorised in Ireland, namely atorvastatin, fluvastatin, pitavastatin, pravastatin, rosuvastatin, and simvastatin, which are authorised under a range of brand names and in various strengths. The package leaflet for patients reflects the information described in the summary, but is required to be presented in an abbreviated and easy-to-read format.