Ms Maria Egan:

Any new product that has a medicinal use must go through very rigorous clinical trials and they must be approved at the various stages to prove the benefits of the product outweigh any risks to the patient. As Deputy O'Connell has stated, even when a product receives approval from the medicines regulator, it does not mean the monitoring stops there. It is continuously monitored in the wider population.

The HPRA oversees a pharmacovigilance system for all medicinal products. Some products are particularly high risk. It is the responsibility of the pharmacist to ensure patients are made aware of any side effects they may experience and what to do if they experience those side effects. Patients are also encouraged to report their experiences to their doctor or the pharmacist. This information is constantly collated and reviewed. At national and European levels, medicines are constantly reviewed to determine whether they remain safe for use and to ensure their benefits continue to outweigh the risks. We are constantly learning, particularly so in terms of products such as the one we are discussing, because they are different. While they remain different they need to be monitored by the experts to ensure if they are to be used they are safe to use.