Alex White (Dublin South, Labour) | Oireachtas source

I move amendment No. 1:

In page 14, subsection (3)(b), lines 30 and 31, to delete all words from and including “the” in line 30 down to and including “run” in line 31 and substitute the following:“the running of the period of 180 days referred to in subsection (2) is, upon the giving of the notice referred to in paragraph (a) to the applicant, suspended”.

Section 5 provides that the authorisation holder of a medicinal product may apply to the Irish Medicines Board to have the 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 it to request further information from the authorisation holder if necessary. As currently drafted, the 180-day period does not begin to run until such time as this additional information is 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 for 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 currently drafted, the 180 days shall not begin until the further information requested has been supplied. This is 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 the additional information rather than setting the clock back at zero. This article must be interpreted as applying to any decision which influences the amount of coverage by reimbursement systems. This includes decisions on reference groups or groups of interchangeable medicinal products as well as pricing decisions. Accordingly, I am proposing to amend sections 5(3)(b) and 18(3)(b) 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 the clock will begin to run again at day 50 on receipt of the information. This brings these sections into line with the transparency directive.