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

2. 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

3. Legislative Process

4. 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

5. 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

6. 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

7. Health (Pricing & Supply of Medical Goods) Bill

8. 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

9. 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

10. 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

11. 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

12. 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

13. 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

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