Friday, 6 September 2019

Questions (1050)

Kevin O'Keeffe


1050. Deputy Kevin O'Keeffe asked the Minister for Health the progress made in the swift provision of new medicines to persons with multiple sclerosis here. [35824/19]

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Written answers (Question to Health)

The HSE has statutory responsibility for medicine pricing and reimbursement decisions, under the Health (Pricing and Supply of Medical Goods) Act 2013. The Act specifies criteria for decisions on the reimbursement of medicines. As Minister, I have no role in this statutory process. I do, however, understand the following in terms of the timelines for the provision of medicines for patients, in Ireland:

The development and provision of new medicines for treating conditions, including Multiple Sclerosis (MS), follows an important, scientific, and robust series of procedures. Under European and Irish legislation, the manufacturer must seek authorisation to market the product for human use from the European Medicines Agency (EMA) and/or Health Products Regulatory Authority (HPRA) in Ireland. European legislation, including Regulation (EC) No 726/2004 clearly sets out the defined timelines in processing such applications.

Once licensed for human use, the manufacturer may then seek taxpayer funding for the provision of their medicine in each Member State. For this they apply for inclusion of their medicine on each Member State’s respective public healthcare schemes. Typically, Member States consider the additional benefit of the applicant medicine compared to existing treatments available and the additional cost compared to the cost of existing treatments in their decision.

In Ireland, under the 2013 Health Act, a company must first submit an application to the HSE to have the medicine added to the Reimbursement List. It is further outlined in the Framework Agreement on the Supply and Pricing of Medicines that the HSE will decide within 180 days of receiving the complete application, to either add the medicine to the reimbursement list, agree to reimburse it as a hospital medicine, or refuse to reimburse it.

HSE decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific, and economic grounds, on the advice of the National Centre for Pharmacoeconomics (NCPE). The NCPE uses a decision framework to systematically assess whether a drug is cost-effective as a health intervention. Working in the interests of the people of Ireland, patients and taxpayers alike, the HSE strives to reach a decision in as timely a manner as possible. However, because of the significant monies involved, it must ensure that the best price is achieved, as these commitments are often multi-million euro investments on an on-going basis.

Where a manufacturer has failed to meet the requirements of the 2013 Health Act, it can lead to a negotiation process. The purpose of those negotiations is to assist the applicant manufacturer in meeting the statutory requirements in as swift a time frame as possible.

There are currently a number of medicines for the treatment of MS making their way through the reimbursement process and they will be assessed in line with the 2013 Act.