Generic Substitution

The Health (Pricing and Supply of Medical Goods) Act 2013, which was commenced on the 24th of June 2013, provides for the introduction of a system of generic substitution and reference pricing. The key aim of the legislation is to ensure value for money in the supply of medicines; therefore, the medicines that will be reviewed first are most costly to patients and the Exchequer. This legislation will promote price competition among suppliers and ensure that lower prices are paid for these medicines resulting in further savings for both taxpayers and patients.

Previously, when a specific brand of medicine was prescribed for a patient, a pharmacist could only supply that particular brand, even when less expensive generic versions of the same medicine were available. The Act now permits pharmacists to substitute medicines prescribed, provided that they have been designated as safely interchangeable by the Irish Medicines Board (IMB).

Generic substitution coupled with reference pricing provides patients with an incentive to opt for the cheapest available product, but does not impose any unavoidable additional costs on patients.

Generic substitution

Under the legislation, the Irish Medicines Board IMB has statutory responsibility for establishing and maintaining a list of interchangeable medical products. In doing so, the Board is required to have regard to a comprehensive set of qualifying conditions, all of which must be complied with before a decision is taken to make a medicinal product interchangeable.

In addition, Section 13 of the Bill provides that where a branded interchangeable product is prescribed for a patient and the prescriber is satisfied that the medicinal product, should for clinical reasons, be exempted from substitution, the prescriber shall write ‘Do not Substitute’ on the prescription. In these cases, the pharmacist must dispense what is written on the prescription, i.e. is not permitted to substitute with any product in the same group of interchangeable products.

Generic substitution is being introduced incrementally with the IMB prioritising those medicines which will achieve the greatest savings for patients and the State. The IMB is in the process of reviewing an initial 20 active substances, which equates to approximately 1,500 individual medicines or approximately 20% of the products currently reimbursable under the GMS and other community drug schemes (and account for 57% of the overall ingredient cost of off-patent drugs). They include statins, proton pump inhibitors, angiotensin-converting-enzyme (ACE) inhibitors and angiotensin II receptor blockers. The full list is set out in the following table:

Anastrozole Lansoprazole Pantoprazole Ramipril
Atorvastatin Lercanidipine Perindopril Risperidone
Candesartan Losartan Pravastatin Rosuvastatin
Clopidogrel Olanzapine Quetiapine Simvastatin
Esomeprazole Omeprazole Rabeprazole Valsartan

 

The first List of Interchangeable Medincal Products, containing groups of atorvastatin products, was published on 7 August 2013. It is expected that the initial 20 active substances will be assessed in early April 2014.

A further list of 20 priority products has now been identified (see table below) for assessment and it is anticipated that assessment of these products will be completed by the IMB by end 2014. This process will continue until all medicinal products on the reimbursable list have been assessed. Full details and information concerning the designation of products as interchangeable is available from the IMB here.

Acetylsalicylic   Acid Donepezil Montelukast Tamsulosin
Alendronic   Acid Doxazosin Oxycodone Telmisartan
Amlodipine Memantine Risedronic   Acid Tolterodine
Bisoprolol Metformin Sertraline Venlafaxine
Diclofenac Mirtazapine Sildenafil Zopiclone