On 20 July 2016, following much debate and lengthy negotiations, the Irish Government, the Health Service Executive ("HSE") and the Irish Pharmaceutical Healthcare Association ("IPHA") signed the Framework Agreement on the Supply and Pricing of Medicines (the "Agreement") .
The new Agreement, which came into effect on 1 August 2016, governs the supply and pricing of medicinal products that are included on the HSE Reimbursement List , supplied to, or reimbursed by, the HSE, State-funded hospitals or any other publicly-funded entities and State agencies providing similar services ("Hospital Medicines"), or subject to an application for inclusion on the Reimbursement List, or for supply or reimbursement as a Hospital Medicine.
APPLICATION TO NON-IPHA MEMBERS
The previous Agreement stated that the agreement applied to "all suppliers" of products that fall within the scope above. However, the 2012 Agreement did not define the term "supplier" nor did it differentiate between IPHA member companies and non-IPHA member companies.
The new Agreement applies only to IPHA member companies (listed in Schedule 2 of the Agreement). The HSE and IPHA member companies may now only rely on the provisions of the new Agreement by agreement.
We would anticipate that many non- IPHA members will take account of the pricing criteria in the new Agreement when submitting an application for pricing approval or come to their own arrangements with the HSE. This would not depart radically from previous practice under the 2012 Agreement.
Section 21(2) of the Health (Pricing and Supply of Medical Goods) Act 2013 (the "2013 Act") allows the HSE to take account of a number of different factors, only one of which is the terms of the Agreement, when considering the proposed price of a product submitted by a supplier.
The Agreement purports to reflect this position by stating that the Agreement does not create legal relations or legitimate expectations which can be enforced by or against the parties. The Agreement also states that it will not limit the HSE's powers under the 2013 Act, allowing the HSE to take into account other factors when assessing the proposed price of a medicinal product.
Outlined below are a number of notable differences between the new more comprehensive Agreement and its predecessor.
Four year term
The Agreement is for a period of four years rather than the previous three year term.
Extension of the number of nominated EU...