Róisín Shortall (Dublin North West, Labour) | Oireachtas source

Section 5(2) provides that the IMB shall have a maximum of 180 days after receiving an application from the authorisation holder of a medicinal product to determine whether it will add the medicinal product to a specified group of interchangeable medicinal products or refuse to add it. Section 5(3) provides that where the IMB is unable to make a determination under section 5(2) because it requires additional information from the applicant, the board shall give notice in writing to the applicant specifying the additional information it requires from the applicant and the maximum period of 180 days referred to in section 5(2) shall not begin to run until the applicant gives the board the additional information it requires to determine the application.

I appreciate the points made by the Senator but it is important to point out that we are talking about a maximum of 180 days. This is not in respect of new drugs coming onto the market. We do not want to deny people access to new drugs. As this measure relates to interchangeable drugs, the IMB can give careful consideration to that group of drugs that it will determine should be interchangeable. There are many factors to take into consideration in terms of the impacts of the various products, whether they have the same properties and ensuring that they have. If we are introducing a regime where the lowest cost product within a group is offered to a patient then we must be certain that it does what the branded product does and has the same kind of effect. The process does not have to take up to 180 days but, if necessary, and in order to get sufficient scientific information and all of the other information that is required to adjudicate on it then the IMB should be allowed to do that. We expect that in most cases the decision will be taken a lot sooner.