The Health (Pricing and Supply of Medicinal Goods) Bill 2012 will have significant consequences for all stakeholders in the pharmaceutical supply chain when enacted. The proposed changes include establishing groups of medicinal products which are interchangeable for prescription purposes, the introduction of reference pricing, and generic substitution for medicinal products. The principal features of the Bill are:
Interchangeable Medicinal Products
- The Irish Medicines Board (IMB) will establish a list of groups of interchangeable medicinal products. All medicinal products which fall within such a group will be interchangeable with each other for prescription purposes.
- An application to add a medicinal product to a group of interchangeable medicinal products (or to add a group of medicinal products to the list of interchangeable medicinal products) may be made by the authorisation holder of that product or by the IMB of its own initiative or at the request of the Minister for Health or the HSE. Authorisation holder is defined to include the holders of a Product Authorisation, a Marketing Authorisation, or a parallel import licence.
- To add a medicinal product to a group of Interchangeable medicinal products the IMB must be satisfied that the product has the same qualitative and quantitative composition in each of their active substances; is in the same pharmaceutical form (or in a pharmaceutical form that is appropriate for substitution) and has the same route of administration as the other medicinal products within the group.
The IMB will be prohibited from adding a medicinal product to a group of interchangeable medicinal products in circumstances where:
- the product contains more than two active substances.
- the product is a biological rather than a chemical entity.
- there is a difference in bioavailability between the product to be added and the current products within the group which may lead to a clinically significant difference in efficacy between them.
- the device (if any) for the administration of the medicinal product has significantly different instructions for use from the products currently within the group.
- the product cannot safely be substituted for each of the interchangeable medicinal products which currently fall within the group.
- The Bill will empower the HSE to set a reference price for a group of interchangeable medicinal products. The reference price will apply only to listed items, i.e. the medicinal products within the group which are on the HSE reimbursement list for the purposes of Section 59 of the Health Act, 1970.
- The HSE is obliged to review the reference price fixed for a group of interchangeable medicinal products at least annually but not more frequently than every 3 months and may set a new reference price.
The criteria which the HSE will be required to take into account in setting the reference price or reviewing the reference price for a group of interchangeable medicinal products are:
- the ability of suppliers to meet patient demand.
- the value for money afforded by the products.
- the equivalent prices (if available) of the relevant products based on a basket of 27 member states where one or more of the products is marketed.
- the relevant prices of therapeutically similar listed items.
- the resources available to the HSE.
- The HSE will be entitled to use a competitive tendering process to set the reference price for a relevant group of interchangeable medicinal products.
- The Bill recognises that where a reference price for a group of interchangeable medicinal products is set under the legislation there is no obligation on a supplier to supply a listed item at the reference price.
- The Bill provides for substitution of more expensive medicinal products, which have been prescribed for a patient, with lower cost medicinal products from within a group of interchangeable medicinal products, unless the prescription is for a branded medicinal product which has been marked “do not substitute” indicating that it is subject to a clinical exemption from substitution.
- The Bill outlines pharmacists’ duties in relation to prescriptions for interchangeable medicinal products under brand names, where the prescription is not subject to a clinical exemption, and describes four scenarios. In each case the pharmacist is obliged to offer the patient substitution of the branded product with the cheapest medicinal product from within the group of interchangeable products then in stock. If there is more that one product then in stock the pharmacist must first offer the cheapest and then the next cheapest product and so on. If the patient agrees to substitution the pharmacist is obliged to effect the substitution of the cheapest product selected by the patient.
- Where a prescription is for an interchangeable medicinal product under a common name the pharmacist is obliged to dispense the medicinal product in stock which is the lowest cost.
- Where a prescription is for a medicinal product which is not an interchangeable medicinal product and is issued under a common name a pharmacist is obliged to dispense the medicinal product which meets the requirements of the prescription which is the lowest cost unless the patient requests another medicinal product in which event the pharmacist is obliged to dispense the product requested by the patient.
- The Bill provides for the exclusion of liability on the part of a pharmacist who has effected a substitution in accordance with the provisions of the legislation and prohibits the bringing of proceedings on the grounds of substitution.
- The Bill preserves a pharmacist’s professional discretion not to dispense any medicinal product, including a substitute medicinal product, where in his or her professional opinion the use of the medicinal product may be prejudicial to the health of the patient.
- The Pharmaceutical Society of Ireland is charged with the supervision of pharmacists in their compliance with the Bill when enacted and any regulations under it. Failure to comply with their duties and obligations under the legislation will be a ground for complaint against a registered pharmacist.
- The Bill provides for a clinical exemption to substitution. Where the prescriber of a branded medicinal product is satisfied for clinical reasons that the product should not be substituted he or she is obliged to write legibly and by hand on the prescription beside the name of the medicinal product "do not substitute ".
- The Minister may make regulations to require prescribers, who issue prescriptions for patients under the GMS or other schemes under Section 59 of the Health Act 1970, to state his or her clinical reasons for the clinical exemption.
- Failure of a doctor or a nurse to comply with the regulations will be a ground of complaint to the Professional Practices Committee of the Medical Council and of the Nursing and Midwifery Board.
- A patient who is offered but refuses substitution of a medicinal product with the least expensive interchangeable product then in stock will be liable to pay the difference between the price of the more expensive product supplied by the pharmacist and the reference price which has been fixed for the group of interchangeable medicinal products. A patient will also be liable for any additional pharmacy costs arising.
- A patient will also be liable for a balancing payment where he or she presents a prescription for a medicinal product, which is not an interchangeable medicinal product, under its common name and refuses to accept the least expensive medicinal product in stock which meets the requirements of the prescription but requests and is supplied with an alternative product which is more expensive.
- These provisions will apply to patients to whom the GMS or other scheme under Section 59 of the Health Act 1970 apply.
The above is a general overview of key aspects of the Health (Pricing and Supply of Medicinal Goods) Bill 2012 as published in July. We will continue to keep you updated on any significant amendments to the Bill as it progresses through the Irish parliament.