Dáil Éireann Debate, Tuesday - 25 July 2023
1174. Deputy Jim O'Callaghan asked the Minister for Health if he will take steps to ensure that the drug bedaquiline which treats multi-drug resistant tuberculosis becomes widely available after the patent expires in 2023; and if he will make a statement on the matter. [35956/23]
View answerTwo new Framework Agreements on Pricing and Supply of Medicines 2021-2025 were signed in December 2021. These Agreements provide stability to the medicines reimbursement market for the State and for Industry, thus facilitating sustainable and affordable access to medicines for patients in Ireland over the next 4 years.
Negotiations towards these new Agreements with industry began in May 2021, against a backdrop of a growing annual drugs budget, up from €1.95bn in 2016 to almost €2.25bn by 2020.
The multi-annual agreements with the Irish Pharmaceutical Healthcare Association (IPHA) and Medicines for Ireland (MFI) represent an important step in facilitating access to innovative new medicines for patients. The IPHA represent the originator and on-patent biopharmaceutical industry; MFI represent the non-originator, and off-patent biopharmaceutical industry in Ireland.
There are a number of clauses set out in both agreements in detail, which provide clear pricing rules for applicant companies, that have been agreed between the State and main Pharmaceutical Industry representative groups in Ireland as appropriate and intended to provide a predictable environment for Marketing Authorisation Holders (MAHs) to supply their products (and prevent shortages). These are grossly summarised as:
The pricing application form for new medicines is based on a basket of 14 countries (13 EU Member States and the UK). Pricing is permitted to be no more than the average price based on the pricing in these 14 countries.
The pricing of non-patented medicines (i.e., generic, biosimilar or hybrid medicine marketed in Ireland) is based on the originator medicine at a specific time point.
Under the terms of the agreement, there is scope for the Department of Health, the HSE, and industry to continue to maintain their engagement throughout the lifetime of the agreement on all matters pertaining to the agreement.
The Agreements are the product of extensive collaboration between the State, HSE, and Industry. They remain current and appropriate for their purpose since their signing in December 2021.
