Supply Of Medical Goods) Bill  IPHA Health (Pricing & Supply Of Medical Goods) Bill Patient Groups and Associations Briefing Wednesday 23rd May, 2012

Why do you need to be aware of the proposed Health Bill? Changes to the current system proposed in the Bill: Introduces the concept of interchangeable medicines and outlines what can or can’t be substituted Allows the HSE to both add and remove products from the reimbursement list Allows the HSE to set the price of products based on a wide range of criteria and also to conduct regular reviews (up to 4 times per year) Introduces the concept of patient co-payment for products above the reference price

Legislative Process

Legislative Process - Preparation Heads of Bill drafted by the Civil Service Draftman’s Office (AG) Working draft of the Bill Cabinet approval Publication of the Bill

Legislative Process – Oireachtas First Stage Second Stage Debate in the Dáil Third (Committee) Stage Select Committee (TDs only) Relevant amendments can be made Fourth (Report) Stage Review of amendments made Fifth (Final) Stage Bill passes to the other House Bill is Enacted

Legislative Process – post Enactment Various parts of the Act may be “activated” via Commencement Orders from the Minister Regulations (Statutory Instruments) are generated to specify the details of the operation of the policies and principles laid down in the Act These are laid before the Dáil library for 30 days and signed into force by the Minister

Health (Pricing & Supply of Medical Goods) Bill

Background Moran Report – May 2010 Programme for Government Timetable Publication before end of current Dáil session July 19th 2012 Debate in the Dáil Amendments at Committee Stage

Interchangeable Medicinal Products The IMB will designate which medicines are interchangeable (ATC level 5) Criteria will be outlined as to why products may not be interchangeable e.g. bioavailability, delivery devices Pharmacists must offer the lowest cost product to all patients, not just those on the Schemes, a patient can choose to co-pay Prescribers can preclude substitution for Clinical Exemptions, for which there will be criteria outlined Compliance by prescribers and pharmacists will be monitored

Reimbursement List The HSE will maintain a reimbursement list and only those products on the list can be supplied under the Schemes Items on the current list will automatically go on to the new list, but it will be reviewed in full Suppliers will apply to the HSE to be added to the list The Transparency Directive must be adhered to in terms of timelines

Reimbursement List The HSE can list or de-list products and can include conditions including cost-efficiency, appropriate use The HSE must provide details of decisions in writing Appeals may be made to the High Court within 30 days Clarified there will be an internal process

Pricing of Medicines In considering a price, the HSE must take into account the price in all other EU Member States as well as matters of a therapeutic nature and resourcing and budget issues. Pricing may be determined using competitive mechanisms The HSE may set Reference Prices for agreed products and may use a competitive process Reference Prices to be reviewed between one and four times per year Factors such as ability to supply and value for money must be taken into account

Implications for Patients Introduction of Generic Substitution Introduction of Patient Co-Payment Extent of powers given to the HSE Listing and de-listing of products Concepts of resource & budget Scope of the pricing basket May cause prices to drop so low as to cause supply issues Exporting of products Launch decisions IMB as the arbitrator on interchangability Lowest cost product to be offered in all cases

Associations Briefing  IPHA Patient Groups and Associations Briefing  Davenport Hotel Wednesday 23rd May, 2012