The Health (Pricing and Supply of Medicines) Act 2013, which was commenced in June of last year, provides the statutory basis for the introduction of a system of generic substitution and reference pricing. Under the Act, the Irish Medicines Board (IMB) is responsible for the assessment of interchangeability of medicines.
In deciding whether to add a group of medicinal products to the List of Interchangeable Medicinal Products, the IMB must be satisfied that each medicinal product which falls within the group:
(a) has the same qualitative and quantitative composition in each of its active substances as each of the other medicinal products which fall within the group;
(b) is in the same pharmaceutical form as, or in a pharmaceutical form that is appropriate for substitution for, each of the other products in the group; and
(c) has the same route of administration as each of the other medicinal products which fall within the group.
In addition, the Act provides that the IMB is not permitted to add a group of medicinal products to the List of Interchangeable Medicinal Products where:
- there is a difference in bioavailability between the medicinal products and the interchangeable medicinal products which currently fall within the group of interchangeable medicinal products which may lead to a clinically significant difference in efficacy between them, and
- any of the medicinal products cannot be safely substituted for any one or more of the other medicinal products in the group.
I would like to emphasise that in making a decision to add a medicinal product to a group of interchangeable medicinal products or a group of medicinal products to the List of Interchangeable Medicinal Products, the IMB is obliged to have regard to the criteria as set out in the Act.
To further enhance the patient safety aspect of generic substitution, Section 13 of the Act allows a prescriber to indicate on a prescription that a branded interchangeable medicinal product should, for clinical reasons, not be substituted.
It is also important to point out that generic medicines must meet exactly the same standards of quality and safety and have the same effect as the originator medicine. All of the generic medicines on the Irish market are required to be properly licensed and meet the requirements of the IMB.
A key objective of the Act is to enable patients to opt for lower cost interchangeable medicines. In general terms, when a pharmacist is presented with a prescription for an interchangeable medicine, which is not the subject of a clinical exemption, the pharmacist is obliged to offer the patient the opportunity to agree to substituting the prescribed product with an interchangeable medicine which is in stock in the pharmacy and is of lower cost to the patient or the HSE, as the case may be. The patient may either accept the interchangeable medicine offered by the pharmacist or opt to receive the branded interchangeable medicine where prescribed. Alternatively, the patient may opt to go to a different pharmacy to receive a less expensive interchangeable medicine.
The Act also allows the HSE to set a reference price for groups of interchangeable medicines. Eligible persons under the community drug schemes, including the Drug Payment Scheme, will only face an additional charge where a reference price has been set for a group of interchangeable medicines and the medicine dispensed is priced higher than the reference price and is not the subject of a clinical exemption.