Thursday, 7 March 2019

Ceisteanna (153)

Thomas P. Broughan


153. Deputy Thomas P. Broughan asked the Minister for Health the work his officials are undertaking to improve the drug approval process; and if he will make a statement on the matter. [11367/19]

Amharc ar fhreagra

Freagraí scríofa (Ceist ar Health)

The HSE has statutory responsibility for medicine pricing and reimbursement decisions, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013 which specifies the criteria for decisions on the reimbursement of medicines.

After receiving market authorisation and in line with the 2013 Act, a company which would like a medicine to be reimbursed by the HSE must submit an application for reimbursement to have the medicine added to the reimbursement list.

As outlined in the Framework Agreement on the Supply and Pricing of Medicines, and in line with the 2013 Act, the HSE will decide, within 180 days of receiving the application (or a longer period if further information is sought from the company), to either add the medicine to the reimbursement list or agree to reimburse it as a hospital medicine, or refuse to reimburse the medicine.

Within the confines of the 2013 Health Act, there has been engagement between the Department, the HSE and the NCPE over the last number of months, which has resulted in a number of key changes to the assessment process.

In June 2018, the HSE leadership appointed a Technology Review Committee for Rare Diseases, which is responsible for:

1. Reviewing proposals received from industry or expert groups in Ireland for funding of new products for rare diseases or expanded indications for existing products for rare diseases and making recommendations on the implementation of the relevant recommendations from the National Rare Diseases Plan 2011-2018; and

2. Contributing to the development of clinical guidelines for relevant orphan medicinal products (OMPs) and supporting the implementation of guidelines with the National Drugs Management Programme Office where applicable.

The Committee’s recommendations for reimbursement of OMPs are not intended to replace any part of the existing medicines appraisal process, but rather to complement it.

The composition of the HSE Drugs Group has also recently been expanded to include two representatives from the National Patients Forum and more clinical expertise in the area of rare diseases.   These changes are intended to provide greater balance and transparency to the assessment process as a whole.

The challenge of securing affordable access to innovative medicines is not unique to Ireland. Over the past two years, my officials and I have been engaging with a number of EU forums in an effort to identify solutions to issues of medicine pricing, sustainability and supply. 

In June 2018, I signed the Beneluxa Initiative on Pharmaceutical Policy with Austria, Belgium, the Netherlands and Luxembourg. This Agreement is in line with my objective to work with other European countries to identify workable solutions, in an increasingly challenging environment, to secure timely access for  patients to new medicines in an affordable and sustainable way. 

My Department has completed a tender process for a review of the HSE reimbursement and pricing decision-making process and are in the process of appointing a consultancy firm to complete this review.