Legislation to enable the introduction of reference pricing and pro-generic initiatives has now been passed by both houses of Ireland's parliament (Oireachtas) and is expected to take effect next month.
Welcoming the passage of the Health (Pricing and Supply of Medical Goods) Bill 2012, Health Minister Dr James Reilly said the legislation gives effect to the government's commitment that reference pricing and greater use of generics will be introduced "to reduce the state's large drug bill and the cost to individuals of their medicines. It will promote price competition and deliver lower medicine prices for both the state and patients," he said.
Currently in Ireland, if a specific brand of medicine is prescribed for a patient, the pharmacist must supply that brand - they cannot supply cheaper generic versions. However, under the Bill, they will now be permitted to substitute medicines which have been designated by the Irish Medicines Board (IMB) as interchangeable.
"It is only where the IMB is satisfied that a medicinal product satisfies all the conditions set out in the Bill that it can do so," noted Alex White, the Minister of State with responsibility for primary care at the Department of Health.
"To further enhance patient safety, the bill allows a prescriber to indicate on a prescription that a branded interchangeable medicinal product should, for clinical reasons, not be substituted," he added.
The Bill also introduces a reference pricing system which will establish the prices that the Health Service Executive (HSE) will pay for products supplied to patients under the General Medical Services (GMS) and community drug schemes. If patients wish to receive a brand that costs more than the reference price, they will have to pay the additional cost out-of-pocket, but in cases where substitution is prohibited for clinical reasons, patients will not pay any additional costs if the prescribed product costs more than the reference price.
Currently, usage of generics in Ireland is very low - patients in the UK are four times more likely to use them - and a third of medical cardholders in Ireland, who now account for more than half the population, are not using generics. However, Teva Pharmaceuticals Ireland has this month launched a campaign to help raise awareness of generic medicines and provide assurances on their safety, quality and affordability.
The campaign, Understandgenerics.ie, is supported by 400 pharmacies nation-wide and fronted by veteran television presenter Gay Byrne. It includes a video at http://bit.ly/hlgenerics.
"Through Understandgenerics.ie, I learned that generics are approved in exactly the same way as all other medicines, guaranteeing that generics meet the required safety and quality standards," says Mr Byrne. "With generics, the name, packet or colour of your medication may change, but what's inside is essentially the same, only more affordable."
However, a group representing people with epilepsy has been campaigning strongly to have anti-epilepsy drugs (AEDs) excluded from substitution, and has expressed strong concern that this exemption was not included in the final Bill.
The risks associated with switching from branded AEDs to generic AEDS, or more particularly from one generic version to another, have been highlighted "on numerous occasions," says the group, Epilepsy Ireland.
"It has been extremely frustrating to see a series of amendments voted down which would have offered safety and reassurance to people with epilepsy. A golden opportunity to enshrine the rights of people with epilepsy has been missed,” says the group's chief executive, Mike Glynn.
The challenge now for Epilepsy Ireland is to ensure that the IMB does not designate AEDs as interchangeable, he said. The group will also launch an education campaign to educate people with epilepsy about staying safe, to inform prescribers of the need to write "do not substitute' on AED prescriptions and to ensure that pharmacists do not switch AEDs, said Mr Glynn.
However, he added, Epilepsy Ireland has received reports that AED switching has been taking place even before the Bill was passed.
- The new legislation also sets out statutory procedures governing the supply, reimbursement and pricing of medicines and other items to patients under the GMS and community drugs schemes. It will allow the HSE to attach conditions to the supply of certain items, provided that any restrictions are evidence-based and in the interests of patients and ensuring value for money, the government adds.