Alex White (Dublin South, Labour) | Oireachtas source

Group 1 amendments broadly deal with a timeframe for decisions of the Irish Medicines Board on the inclusion of products on the list of interchangeable medicinal products and the reimbursement list. I do not know if I should read out the various amendments but I can deal with them by way of summary if Senators wish. These are amendments Nos. 1 and 3.

Section 5 of the Bill provides that the authorisation holder of a medicinal product may apply to the Irish Medicines Board to have a product added to a group of interchangeable medicinal products or to add a group to the list of interchangeable medicinal products. It sets out that the board shall have 180 days to make decisions on such applications and allows the board to request further information from the authorisation holder if necessary. As originally drafted, the 180 day period did not begin to run until such time as this additional information was provided. In addition, section 18 provides that a supplier of an item may make an application to the HSE seeking the inclusion of a product on the list of reimbursable items. The HSE shall agree a reimbursement price with the supplier and make a final decision for inclusion on the list within 180 days. The HSE may seek further information from the supplier as part of the application process.

As originally drafted, the 180 days did not begin to run until the further information requested was supplied. This was not fully in compliance with article 6 of Council Directive 89/105/EEC relating to the transparency of measures regulating the pricing of medicinal products. Article 6 of the directive provides for the suspension of time limits pending receipt of additional information rather than setting the clock back at zero. This article must be interpreted as applying to any decision influencing the amount of coverage by reimbursement systems, including decisions on reference groups or groups of interchangeable medicinal products as well as pricing decisions.

Sections 5(3)(b) and 18(3)(b) were amended to provide for a clock stopping arrangement so that decisions on interchangeability and reimbursement are taken within a total timeframe of 180 days. This means that if additional information is sought on day 49, for example, the clock will begin to run again at day 50 on receipt of the information. The amendments bring these sections into line with the transparency directive as indicated.