Alex White (Dublin South, Labour) | Oireachtas source

I thank Members for their important contribution to the debate on this Bill. I have taken careful note of all the insightful observations made in the course of the Second Stage debate. Some Deputies have indicated they intend to table amendments on Committee Stage. I assure them that I will carefully consider all such proposals and will respond to them in detail on Committee Stage.

However, I wish to refer briefly to some of the issues raised by Deputies during the Second Stage debate. A number of Members referred to the complexity of the legislation. While I accept this is complex legislation, I assure Members that this level of complexity is necessary to ensure the Bill provides a robust legislative basis to introduce generic substitution and reference pricing in Ireland.

Sometimes legislation has an extraordinary level of complexity and difficulty, with a lack of accessibility, but it is important that the legislation can withstand scrutiny or challenge. It must provide for as many eventualities as occur at this point, which necessitates complexity.

Deputy Kelleher asked if regulations will be made setting out the mechanism by which reference prices will be set. I advise that section 24(3) of the Bill sets out the process the HSE must pursue when setting a reference price for or reviewing a reference price for a group of interchangeable medicines. Therefore, there is no necessity to provide for regulations in the setting of reference prices. With regard to what basket of countries will be used as a reference by the HSE when setting reference prices, the Bill provides that the HSE shall have regard to the equivalent prices in all other member states in which a relevant product is marketed.

I note that some Deputies are concerned that overly emphasising the principle that prices will be set to protect and not jeopardise continuity of supply could result in prices not being sufficiently reduced. As I mentioned earlier, section 24(3) of the Bill sets out the process the HSE must pursue when setting a reference price or reviewing a reference price for a group of interchangeable medicines. Whereas the ability of the supplier to meet patient demand is a key criterion the HSE must have regard to when setting reference prices, particularly in a small market like Ireland, there are other criteria which the HSE must also take into consideration. These include the value for money afforded by the relevant product, the equivalent prices in all other member states where the product is marketed, the prices of therapeutically similar listed items and the resources available to the HSE. It is important to balance achieving best value for money for taxpayers with assuring continuity of supply for critical medical products. I am determined that this be done in the most cost effective and efficient manner as possible. Consequently, a core objective of this Bill is to achieve value for money while maintaining and improving levels of service.

A number of Deputies referred to the necessity to introduce measures to reduce the growth in volume of drugs prescribed under the community drug schemes. It is clear that the current rate of growth in the volume of items dispensed under the community drug schemes is unsustainable and needs to be addressed. In this context, it is essential that we control both the price and volume of medicines dispensed under the community drug schemes. There is substantial international evidence demonstrating the scope for improving the quality and safety of prescribing and dispensing practices and behaviours. In this regard, the HSE has established a clinician-led medicines management programme, the aim of which is to ensure that all people have access to the essential medicines they need, that the medicines are safe and effective and that they are prescribed and used rationally. An important task of the programme will be the focus on cost-effective prescribing and the reduction in drug expenditure through more rational prescribing. Proposed initiatives in this regard will include the identification of preferred medicines or medicines of first choice in high cost areas such as proton pump inhibitors and statins, as these two groups account for approximately 20% of all expenditure under the general medical services, GMS, scheme. Generic prescribing will also be promoted as it is generally accepted as the most cost-effective prescribing.

Another measure being considered is amending the misuse of drugs regulations relating to benzodiazepines and z drugs to ensure that these substances are used in an appropriate manner. Benzodiazepines, as a group of medicines, are commonly used to treat anxiety, sleep disturbances and insomnia and the so-called z drugs are used to treat insomnia. There is increasing evidence of dependence and inappropriate use of these medicines in Ireland. This problem is not unique to Ireland as statistics indicate overuse of these medicines is an international issue, with Europe having the highest average consumption of benzodiazepines internationally.

I will now turn to the crucial issue of safety of generic medicines. First, it is important that people are aware that generic medicines marketed in Ireland must be licensed and meet the requirements set down by the Irish Medicines Board in the same manner as originator medicines. Under the Bill, the Irish Medicines Board has responsibility for establishing and maintaining a list of interchangeable medicines, which will include both originator and generic medicines. In deciding whether to add a group of medicinal products to the list, the Irish Medicines Board must be satisfied that each medicinal product which falls within the group 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; 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 has the same route of administration as each of the other medicinal products which fall within the group. In addition, the Bill provides that the board is not permitted to add a group of medicinal products to the list of interchangeable medicinal products where, for example, any of the medicinal products cannot be safely substituted for any one or more of the other medicinal products in the group.

To enhance further the patient safety aspect of generic substitution, section 13 of the Bill allows a prescriber to indicate on a prescription that a branded interchangeable medicinal product should, for clinical reasons, not be substituted. A number of Deputies referred to the concerns raised by the organisation Brainwave with regard to generic substitution of epilepsy drugs. I am satisfied that the provisions in the Bill address concerns people may have with the safety of generic substitution, including those concerns raised by Brainwave. We are proposing to provide for a power of substitution, subject to a very strict regime, and there is no provision within the Bill constituting a direct decision to substitute a product. There is a provision for a power to be exercised by the Irish Medicines Board to introduce a substitution, which is an important distinction to be recognised by colleagues, particularly in the context of legitimate concerns about particular areas, such as people living with epilepsy. We will have the opportunity to tease out more detail on Committee Stage if colleagues bring amendments. The Bill does not in itself bring about any substitution but rather provides a legal framework within which the Irish Medicines Board may introduce substitution. Any decision would be subject to a very rigorous regime. I repeat the key message that must be communicated by all associated with the implementation of generic substitution: generic medicines must meet the same quality and safety standards as originator medicines and have the same benefits and risks as originator medicines.

I wish to reiterate my commitment and the commitment of this Government to maintain and improve access to medicines for Irish patients. As I have stated, this needs to be done in the most cost-effective and efficient manner. The core objective of this Bill is to achieve value for money while maintaining and improving levels of service. By cost-effective I mean paying the most appropriate price for a particular product and there is no longer any justification, if there ever was, for paying a premium for a particular brand of medicine when an equivalent medicine, as assessed by the Irish Medicines Board, can be supplied at a much more competitive price.

It is important to emphasise that patients will continue to be able to obtain their necessary medications from their community pharmacist and that patients and taxpayers will benefit from paying less for these medications. Moreover, this Bill also provides that if in the opinion of a prescriber there is a clinical reason why a medicine should not be substituted, the patient shall receive the prescribed medicine at no extra cost.

The second core element of this Bill is the placing of the current HSE reimbursement list on a statutory footing. This is a timely provision and shall support the introduction of a system of reference pricing and generic substitution. The general criteria set out in the Bill and the regulations to come from it will assist the HSE in making timely decisions regarding reimbursement, provide clarity for the pharmaceutical industry on the application process and ensure the HSE achieves best value in the provision of medicines under the GMS and community drug schemes. I thank the House and look forward to the Bill being further considered on Committee Stage.

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