Health Act

Question 1

List 3 objectives of the Health Act

Answer 1

• To establish a list of interchangeable medicines which can be substituted for each other to enable savings to be made for patients or the State, or both, where the lower priced medicines are supplied.
• To establish a list of drugs, medicines and medical and surgical appliances which can be supplied under section 59 of the Health Act, 1970.
• To establish mechanisms to set the prices of such drugs, medicines and medical and surgical appliances where they are so supplied. This is referred to as the reference price.

Question 2

Define reference medicine

Answer 2

Branded products, originator or proprietary medicines.
10 year period of market protection

Question 3

What is a generic medicine?

Answer 3

Data submitted are reduced, the dossier contains full pharmaceutical data but the clinical data are usually limited to a study demonstrating bioequivalence with the reference product.

Question 4

What is involved in a bioequivalence study?

Answer 4

• Healthy volunteers
• Single doses of reference and generic medicine
• Blood samples are taken

Question 5

When are medicines considered bioequivalent?

Answer 5

when they produce the same amount of active substance in the body when tested.

Question 6

List 4 criteria for interchangeable medicines

Answer 6

• Have the same qualitative and quantitative composition in each of their active substances
• Are in the same pharmaceutical form
• Have the same route of administration
• Have not more than two active substances.

Question 7

How many parts in the Health (Pricing and Supply of Medical Goods) Act 2013?

Answer 7

6

Question 8

What is Part 1 of the Health (Pricing and Supply of Medical Goods) Act 2013?

Answer 8

Preliminary and General

Question 9

What is Part 2 of the Health (Pricing and Supply of Medical Goods) Act 2013?

Answer 9

Interchangeable Medicinal Products
4 chapters

Question 10

What is Chapter 1 of Part 2 of the Health (Pricing and Supply of Medical Goods) Act 2013?

Answer 10

Establishment and maintenance of a list of interchangeable Medicinal Products

Question 11

What is Chapter 2 of Part 2 of the Health (Pricing and Supply of Medical Goods) Act 2013?

Answer 11

Duties of Pharmacists in relation to prescriptions for interchangeable medicinal products under branded name

Question 12

What is Chapter 3 of Part 2 of the Health (Pricing and Supply of Medical Goods) Act 2013?

Answer 12

Duties of Pharmacists in relation to prescriptions for interchangeable medicinal products under common name

Question 13

What is Chapter 4 of Part 2 of the Health (Pricing and Supply of Medical Goods) Act 2013?

Answer 13

Miscellaneous

Question 14

What is Part 3 of the Health (Pricing and Supply of Medical Goods) Act 2013?

Answer 14

Dispensing of Medicinal products under common name where they are not interchangeable medicinal products

Question 15

What is Chapter 1 of Part 4 of the Health (Pricing and Supply of Medical Goods) Act 2013?

Answer 15

Establishment and maintenance of
reimbursement list

Question 16

What is Chapter 2 of Part 4 of the Health (Pricing and Supply of Medical Goods) Act 2013?

Answer 16

Executive may attach conditions to supply of
listed items

Question 17

What is Chapter 3 of Part 4 of the Health (Pricing and Supply of Medical Goods) Act 2013?

Answer 17

Setting of relevant prices for items and listed
items

Question 18

What is Chapter 4 of Part 4 of the Health (Pricing and Supply of Medical Goods) Act 2013?

Answer 18

Executive to have discretion to supply non-
listed items to certain patients

Question 19

What is Part 5 of the Health Act 2013?

Answer 19

Reference pricing

Question 20

What is Part 6 of the Health Act 2013?

Answer 20

Miscellaneous

Question 21

List 3 excluded medicines from Health Act

Answer 21

• biological medicines
• more than 2 active ingredients
• unlicensed medicines

Question 22

List 6 drugs on HPRA list of molecules

Answer 22

Atorvastatin
Esomeprazole
Rosuvastatin
Omeprazole
Pravastatin
Lanzoprazole