Proposed Model for Reference Pricing and Generic Substitution: Discussion

By virtue of section 17(2)(l) of the Defamation Act 2009, witnesses are protected by absolute privilege in respect of their evidence to this committee. If witnesses are directed by the committee to cease giving evidence on a particular matter and they continue to do so, they are entitled thereafter only to a qualified privilege in respect of their evidence. Witnesses are directed that only evidence connected with the subject matter of these proceedings is to be given. They are asked to respect the parliamentary practice to the effect that, where possible, they should not criticise or make charges against any person or entity by name or in such a way as to make him, her or it identifiable.

I would like welcome the following groups in attendance today for a discussion on a proposed model for reference pricing and generic substitution, namely, the Department of Health and Children, the Irish Medicines Board, the Irish Osteoporosis Society and the Association of Pharmaceutical Manufacturers of Ireland. You are all very welcome. We have read your papers and they have been circulated to committee members. I would like you to give a synopsis of the written presentation that you have made. When we have heard the four presentations, we will go to committee members for questions. I believe Ms Cody from the Department of Health and Children will start.

Ms Teresa Cody

I would like to thank the Chairman and members of the committee for their invitation to appear before the them today.

Public expenditure on pharmaceuticals in Ireland is almost €1.6 billion. This accounts for approximately 11% of public health expenditure. Due to our ageing population and increased usage of medicines, we can expect upward pressure on our drugs bill for our health services. A number of steps have been taken in recent years to improve value for money, while ensuring that patients can continue to access necessary medicines. These measures have included reductions in the wholesale and retail mark-ups paid under the community drugs schemes; reductions in the prices of off-patent medicines and increases in the rebates paid by pharmaceutical manufacturers.

Further savings of €200 million were announced last week by the Minister as part of the budgetary measures. The constructive engagement of the pharmaceutical sector on this occasion and over the past year is very much appreciated. The Minister has also recently initiated a consultation process to review payments to pharmacists.

Significant progress has been made to control pharmaceutical expenditure. However, further savings can be achieved by increasing the rates of generic usage and promoting competition between suppliers of off-patent medicines. In a report on the pharmaceutical sector last year, the European Commission urged member states to consider policies to facilitate the uptake of generic medicines and improve price competition. This is particularly relevant for the Irish market, which has low rates of generic usage in comparison with other countries.

In October 2009, the Minister for Health and Children appointed Mr. Mark Moran to chair a joint Department and HSE working group to examine options for the introduction of a system of generic substitution and reference pricing in Ireland. At the moment, when a specific brand of medicine is prescribed for a patient, a pharmacist can only supply that particular brand, even when less expensive versions of the same medicine are available.

Under the proposed model, pharmacists would be permitted to substitute medicines which have been designated as interchangeable. Generic substitution is used in many countries to control pharmaceutical expenditure and provide patients with greater choice. In some instances, patients may require a particular brand, for example if they have swallowing difficulties. In these instances, it is proposed that the prescriber will be able to indicate on the prescription that the specified brand should not be substituted.

Not all medicines are suitable for substitution. Substitution will only be permitted where it is safe to do so. No decisions about the interchangeability of medicines will be taken until a robust statutory framework is in place and any decisions will be evidence-based and be guided by patient safety considerations.

A common reimbursement price, or reference price, is set for a group of interchangeable medicines. Eligible patients do not face any additional costs for products priced at or below the reference price. If a patient would like to receive a particular brand that costs more than the reference price, then the patient can pay the additional cost of that product. When a prescriber has refused substitution for clinical reasons, patients do not face any additional costs if the required product costs more than the reference price.

The group's work was informed by pricing and reimbursement policies in other countries. The group also consulted extensively with stakeholders. These included the Irish Pharmaceutical Healthcare Association and the Association of Pharmaceutical Manufacturers of Ireland, retail pharmacists, hospital pharmacists, nurses, medical practitioners, patient and consumer groups. The working group met with these organisations and also received a number of written submissions.

The Minister for Health and Children published the group's report in June, and it sets out a proposed model for the operation of a system of interchangeable medicines and reference pricing. It also identifies the legislative and administrative changes required.

Over the next five years, a number of high volume medicines are expected to come off patent. These reforms will ensure that lower prices are paid for these medicines, resulting in significant savings for taxpayers and patients.

Government approval has been received for the drafting of heads of a Bill to provide for the introduction of reference pricing and to permit generic substitution by pharmacists. The general scheme and heads of a Bill are being drafted and a regulatory impact analysis, which will include consultation with all relevant stakeholders, is also being undertaken. These reforms will result in a more sustainable system of pharmaceutical pricing and reimbursement, and will help to ensure that patients continue to access innovative and affordable medicines.

Mr. Pat O’Mahony

I thank the Chairman and the committee for giving us the opportunity to appear here today. I will give a brief introduction and then my colleague Dr. Elaine Breslin will say a few short words.

The Irish Medicines Board is set up to protect and enhance public and animal health through the regulation of medicines, medical devices and health care products. We are the regulator in that sector. Our objective is to ensure, consistent with current medical and scientific knowledge, a positive benefit-risk profile for all medicines available in Ireland, and to participate in systems designed to do this throughout the European Union. Before a medicine can be authorised, an application must be made to the IMB containing all of the necessary data supporting its quality, safety and efficacy. The IMB staff then, with the assistance of our expert committees, review the scientific aspects of the application and reach a conclusion on the benefit-risk balance of the medicine before arriving at a decision on authorisation.

Following the authorisation and use in clinical practice of a medicine, the IMB monitors the type and frequency of reported side effects. Health care professionals, patients and consumers report suspected adverse effects and quality defects to the IMB. In addition, there is a legal responsibility on the holders of authorisations to notify the IMB of all events with potential safety consequences for their medicines. The IMB also monitors the quality of medicines by conducting inspections at sites of manufacture and by random sampling in the marketplace. In addition to these regulatory activities, the IMB has an enforcement function across a range of medicines legislation. However, I must point out that we have no role in reimbursement or in setting the prices of medicines.

Under European and Irish legislation, all medicines must be authorised before being marketed. Medicines marketed in Ireland must be authorised by the IMB and information on authorised medicines is available from the IMB website. Marketing authorisations may be obtained in a number of ways, including: national procedures, which are just for the Irish market; mutual recognition or decentralised procedures, which provide approval in a range of countries in Europe; and the centralised procedure, through the European Medicines Agency, EMA, under which medicines are authorised for the entire European Community. Both reference medicines and generic medicines are authorised through all of these categories.

Medicines are classified into two broad categories - reference and generic, as we are discussing today - depending on the data submitted for authorisation. The data requirements for these dossiers are harmonised in law across the European Community. With the Chairman's permission, I will ask Dr. Breslin to say a few words on the differences between these categories.

Dr. Elaine Breslin

A reference medicine is one that has been authorised following the submission of a dossier containing full pharmaceutical, pre-clinical and clinical data. Such products are also referred to as innovator, branded or original medicines. Following authorisation, reference medicines are entitled to a ten-year period of market protection before the introduction of a generic medicine. A generic medicine contains the same quantity of active substance and is used in the same dose to treat the same disease as a reference medicine, however, the data submitted for authorisation are reduced. The dossier for a generic medicine contains full pharmaceutical data, but the clinical data are usually limited to a study demonstrating bioequivalence with the reference product.

A bioequivalence study is performed in healthy volunteers. The volunteers receive single doses of the reference and generic medicine, and blood samples are taken to determine the handling of the medicines by the body. The reference and generic medicines are considered bioequivalent if they produce the same level of active substance in the body. When a generic medicine is demonstrated to be bioequivalent to a reference medicine, its benefits and risks are considered the same as those of the reference medicine and it can usually be substituted for the reference medicine. In cases in which there are concerns about substitution, the prescribing physician and dispensing pharmacist will be able to ensure that patients receive appropriate management and advice.

Bioequivalence data are used to support generic applications through each of the procedures mentioned by Mr. O'Mahony. Generic medicines on the Irish market have been authorised using all of these procedures. We have provided a sample public assessment report with our briefing document.

A guideline on the investigation of bioequivalence has been developed by EU member states to ensure that harmonised criteria apply across the European Union. We have provided a reference to this information in our briefing document. The guideline is updated regularly in line with scientific knowledge. The IMB has developed an information leaflet on generic medicines for consumers, which is also attached to the briefing document.

As the competent authority for medicines in Ireland, the IMB works closely with its national expert committees and the scientific committees of the European Medicines Agency and the heads of medicines agencies to ensure that all medicines authorised through the EU procedures have a positive benefit-risk profile and are safe and effective. The authorisation process for reference and generic medicines is grounded in EU legislation. Authorised generic medicines on the Irish market have fulfilled EU criteria and are considered to have the same benefits and risks as reference medicines.

Dr. Carey is leading for the Irish Osteoporosis Society.

Dr. John Carey

I thank the Chairman and members for the opportunity to present on behalf of the Irish Osteoporosis Society. I would like to give a quick introduction before proceeding. I am accompanied today by Ms Aoife Ní Eochaidh, a board member of the society, who is a chartered physiotherapist and specialist in women's health issues, and another IOS board member, Ms Maureen Murphy, who has osteoporosis and has suffered some of the consequences of generic substitutions. I am a consultant rheumatologist, and I know few people in the room. I have worked in the field of osteoporosis for a long time and I have been involved in clinical research, trials and observational studies for diagnosis, management and treatment of osteoporosis. I have written research papers, review articles and book chapters. I currently see many patients with osteoporosis with my colleagues in Galway, where we run an outpatient osteoporosis service, fracture liaison programmes, an in-patient consultation service, bone densitometry services and research. We also run a certification course in bone densitometry every year, which is recognised by international societies.

The Irish Osteoporosis Society wishes to have osteoporosis medications included with anti-epileptic drugs in being exempt from substitution with generics. The rationale for generic substitution is that a designated interchangeable medicine will have the same quality and clinical efficacy as the branded equivalent.

For the information of members I will explain briefly what osteoporosis is and how we treat it. Osteoporosis is a disease of men and women which results in fragile bones that are easy to break with very little trauma - for example, upon coughing, sneezing or bending down to tie shoes. The problem with osteoporosis is fractures, which means broken bones. The lifetime risk of fractures for a 50 year old white female today is one in two for the rest of her life and one in five for a man. Fractures are associated with increased morbidity - that is, associated medical problems such as pain, suffering and depression - and mortality, which is the risk of dying, and increased risk of future fracture. Fractures are preventable, and the goal of treatment is solely fracture prevention. More post-menopausal women suffer fractures each year than the total number of women who develop breast cancer, suffer a stroke or a heart attack, or die from cardiovascular disease. This has been shown in multiple studies of hundreds of thousands of women.

Osteoporosis is a major problem in Ireland. We estimate that about 300,000 people have osteoporosis currently; there are approximately 20,000 osteoporosis fractures annually in Ireland. Treating such fractures is expensive. We spend more than €225 million annually treating them. This number is projected to double by 2020 and triple by 2030. Of note, we spend approximately €25 million on preventive measures such as medications. Hip fractures are the single greatest fracture problem in osteoporosis. Of the 106 bones in the average skeleton, the hip bone suffers the most serious consequences of breakage. There are about 3,000 such breakages in Ireland annually and more than 300 per year in the hospitals where I work. The average hospital stay for a person with a broken hip is about 18 days, at a cost of about €13,000. Fewer than a third of these patients go directly home from hospital, and fewer than 50% regain fully functional independent living. Around 35% of men will die in the year following a fracture, and 20% of women.

The doctor is the best placed person to prescribe medications for any disease, depending on an individualised clinical assessment of fracture risk, the effectiveness - which encompasses not just efficacy but compliance and ease of administration - and safety of a drug, including side effects, any additional disorders or concerns the patient may have, and cost. Cost represents not just the direct cost of the medicine but also indirect costs incurred through the pros and cons of the treatment option offered.

Osteoporosis treatment encompasses a multi-faceted approach rather than just drug treatments. Approved osteoporosis therapies have been shown to reduce the risk of fracture and to improve quality of life and to reduce the risk of dying, or mortality. Unfortunately, many patients with osteoporosis are not diagnosed or treated for their osteoporosis before or after their fracture and hence the number of fractures we encounter. Approved therapies are not all the same. There are differences in quality and there clearly are demonstrable differences in dissolution times, bioavailability and in active ingredients, resulting in different efficacies and side-effect profiles. This is not true of any drug in particular but of both branded and generic drugs. Only 1% to 2% of oral bisphosphonates are actually absorbed, if taken correctly, and they are not straightforward to take. Clinical efficacy of approved therapies have different indications because they have different efficacies. Some drugs are approved for prevention, some for treatment, some are approved for men, others for women and others for both, while some are approved for corticosteroid-induced osteoporosis.

Similar to other conditions, non-compliance is a big problem in osteoporosis and this appears to increase when generic medications are substituted. There are well-established scientific methods for designing and analysing studies to compare medical therapies, which can be complex and costly. The important clinical outcome in osteoporosis studies is demonstration of fracture prevention. There are no published studies showing equivalent efficacy for generic osteoporosis medications. Generics often are approved based on the results of small studies, even single-dose bioavailability studies in healthy subjects. This is not adequate to establish clinical safety and efficacy in osteoporosis patients who may have complex medical problems. While not many studies are available, those that do exist suggest that generic osteoporosis medications may be less efficacious, may cause more side effects and thus may be more expensive in the long run.

As I stated, osteoporosis is an expensive disease for the patient and the State. The best way to make cost savings in respect of osteoporosis is to promote bone health and to implement effective fracture prevention strategies, including use of proven therapies. Any perceived cost savings through the use of cheaper medications may be offset or actually made worse in the long run because of ancillary medication use and complications of substitution.

I invite Ms Sandra Gannon from the Association of Pharmaceutical Manufacturers of Ireland to give its presentation.

Ms Sandra Gannon

I thank the Chairman and members for the opportunity to make a presentation on behalf of the Association of Pharmaceutical Manufacturers of Ireland, APMI, which acts on behalf of indigenous over-the-counter, OTC, companies and generic companies in Ireland. As the Irish Medicines Board already has provided a comprehensive definition of generics, I will move on to the benefits that generic medicines give. Obviously, the main benefits is that of cost containment. In particular, according to the latest OECD information, Ireland has the highestper capita expenditure on drugs in the European Union and given its rapidly ageing population, there obviously is significant concern about how the country can continue to fund its drug costs. Generic medicines are instruments that are used globally and in a number of European Union member states in particular to be able to fund sustainable health care.

Generic medicines account for 50% of the total volume of medicines in the European Union but account for only 18% of the total value. This should be contrasted with the position in Ireland, in which generic medicines account for 12% of the volume of medicines and approximately 8% of the cost of the total medicines bill. In addition to the cost containment element, the use of generics obviously enables states and payers to be able to treat patients with new innovative medicines. Furthermore, it creates competition because once a product comes off patent, one moves from a single supplier to a multi-supply position. This also ensures security and continuity of supply. Consequently, the problems being faced by Ireland at present in respect of unlicensed medicines will in general, with the introduction of multiple suppliers, cease to be an issue.

Furthermore, the European Union high-level pharmaceutical forum investigation found that a strong generic industry stimulates innovation. This is one reason for the European Union sector inquiry in 2009 because it was evident that innovation within Europe was in decline. In the main, this was because of strategies that were being employed to block and delay the introduction of generics. The generic industry also substantially funds the regulatory authorities and it is estimated that in Ireland, approximately 30% to 40% of the Irish Medicines Board's revenue stream comes from the generic companies. Finally, the generic sector is a significant employer. Of the 24,500 people employed in the industry in Ireland, 2,000 are from the generics industry and at a European Union level, 150,000 people are employed by generic companies.

I refer to some of the key facts pertaining to generics. The Irish Medicines Board has referred to the licensing cornerstones, which are quality, safety and efficacy. Obviously, as licensed products, generic products must fulfil those criteria. Furthermore, once a licence is approved, the producers also are monitored continuously through the process of pharmacovigilance. In addition, they are audited in respect of their manufacturing, distribution and regulatory processes.

I refer to the claims that have been made by a number of people with a vested interest in retaining thestatus quo in Ireland, which is a very pro-branded approach, and in particular to the claims that have been made by the Irish Osteoporosis Society in the public domain. The same studies that the society presented to the joint committee have been presented in 2007 by MSD, that is, by the originator and manufacturer of alendronate. These studies were found by the French regulatory authority, AFSSAPS, to be flawed. In addition, the Irish Medicines Board has stated that there were methodological limitations to the studies in respect of the number of patients involved, etc. The APMI questions the funding sources and rationale for the Irish Osteoporosis Society making these claims. We know that Merck Sharpe & Dohme, the originator-----

We are wandering into a very dangerous area here. I would prefer if-----

Ms Sandra Gannon

Okay. I will also point out that of the 35 million packs of alendronate dispensed in 2009, 80% of them were for generic medicines. The APMI also refers the joint committee to the European Union sector inquiry, which found that a toolbox of strategies are being employed by originator companies to maintain their revenue streams from medicines for as long as possible. Among the findings of the inquiry was the point that interchangeability issues were used to limit generic erosion. Moreover, of the 700 reported cases involving patent litigation between originator and generic companies, 60% were won by the generic companies. The recommendations from the sector inquiry obviously included increased scrutiny under anti-trust law, monitoring of the sector and the levelling of the playing field for generics, including the introduction of legislation that would facilitate generic uptake, such as prescription by substance, rather than by brand name.

In summary, our position is that generics are well-known, safe and proven medicines, which allow for cost containment. They drive competition and innovation, secure supply and increase competition within the pharmaceutical sector and afford patients increased access to innovative medicines.

We will take a series of questions to all the participants, starting with Deputy Reilly.

I welcome the witnesses and note it is very useful to have everyone in the same room. I will start with a question to the representatives of the Department of Health and Children. In general, Fine Gael supports the safe use of generics and has long cried out for more use of generics. My single question to the departmental representatives is, why has it taken so long to prepare legislation for drug reference pricing? As for the APMI, why are generics so expensive in Ireland in comparison with elsewhere, both in Europe and even across the Border? Earlier this year, it was revealed in respect of a single statin that the brand leader cost €28 per month, the branded generic cost €27 per month but the same drug cost approximately £1.40 in the North of Ireland. I accept that 8% of the employees involved in the industry represents a serious number of jobs in Ireland and Fine Gael certainly would not wish to imperil that. Unfortunately, neither can one have a situation in which one pays ten to 20 times more for generics in this State than is being paid elsewhere in the European Union. The representatives of the APMI should address this point. This is a general question for whoever would like to answer it: how can we increase the use of generics? One problem with generics which we need to address is that a branded generic is required for people who are on long-term medication to avoid confusion. One of the safety issues with regard to compliance is that the patient must recognise the tablet as his or her blood pressure tablet, or whatever it is, and if the tablet keeps changing every month to another generic which is a different shape or size or colour, catastrophe can follow. In addition, how can we reduce the unnecessary use of drugs, particularly antibiotics and non-steroidal anti-inflammatories?

I am particularly interested in the contention of the Irish Osteoporosis Society that the use of generic alendronate is not safe. We have heard what Ms Gannon has had to say in that regard, but I would like to hear the opinion of the Irish Medicines Board, a regulatory body which is held in extremely high esteem by those in the medical profession, who depend upon it for direction on the safety of the medicines they use. Any undermining of its reputation would be extremely serious. I would be grateful if Dr. Breslin would outline her views on alendronate and her opinion on whether alendronate, as distinct from all other generics other than epilepsy drugs, should be excluded.

Ms Gannon of the APMI mentioned that generic medicines constitute 50% of all drugs used in the EU but 18% of the total drug cost, while in this country they account for 18% of the volume and 10% of the cost. Quickly multiplying by three, I conclude that 54% use of generics would represent 30% of the drugs bill here, which is nearly twice what the proportion is elsewhere. I would like to know why we are paying so much for generics in this country and why they cannot be brought down in price.

I welcome the groups. I must point out that the Irish Pharmaceutical Healthcare Association was also invited but was unable to attend, so there is not a complete balance in the room. In addition, we have received a written submission from the Irish Pharmacy Union and we will be taking its views into account.

I do not want to repeat any of Deputy Reilly's questions. Do the witnesses have a view on how much could be saved by generic substitution or reference pricing? The ESRI suggested a possible saving of €77.7 million in 2011. There is also the issue of the 300 commonly used off-patent proprietary medicines, whose prices were reduced in February 2010. This question is mostly directed at the representatives of the Department of Health and Children. Has this been factored into the Government's projected savings announced at budget time? How much of a saving is expected? How much will come from that particular measure and how much will come from the proposals to introduce reference pricing legislation?

I reiterate the comments of Deputy Reilly about Fine Gael from the perspective of the Labour Party. We also believe there are savings to be made and we are determined to ensure we take whatever actions are necessary to make these savings while ensuring people's safe use of medication.

I also wish to ask the representatives of the Department whether they have had any feedback on the report that was published earlier this year. I read it last week and there is a list of specific medications that can be safely substituted or reference priced. Has anybody disagreed with the findings of the report?

My main question is to the representatives of the Irish Medicines Board. In their presentation, they mentioned the different marketing authorisations and talked about national procedures, mutual recognition, decentralised procedures and centralised procedures. This is the nub of the pricing issue in Ireland. Does a pharmaceutical company have the power to say it wants a national procedure or that it does not want a centralised procedure? Mutual recognition would mean that a drug authorised in Northern Ireland, for example, could be used in the Republic, which would mean we could have the sort of prices they pay up there. Can the company itself choose the kind of authorisation for which it applies?

Why does the Single Market not apply to the sale of drugs? I can go on holidays to Spain, buy a drug, bring it back home and take it here. I know there are safety issues and so on, and I am not for a minute suggesting the regulations should not be in place. However, if something is safe for me to buy in Spain, should it not be safe for me to buy in Ireland? Why do we treat drugs differently in different EU countries when this does not apply to other commodities? This is a complex area, but the question asked by the general public is simple: why can I get the same drug considerably cheaper in another European country than here? I would like this to be clarified.

I am also interested in the view of the Irish Medicines Board on the issues with regard to osteoporosis drugs. We do not want any decision to be made that would have a negative effect on people with osteoporosis. I am not an expert, so I do not have the capacity to answer that question.

I thank our visitors for their contributions. We must all ensure that patients receive the medicines that are appropriate to their needs. I favour generic prescribing where the prescriber is satisfied that the generic drug is as effective as the proprietary drug. Indeed, there is an obligation on the prescriber to prescribe generic drugs unless there is a good reason he or she should not. Some 25% of the total budget goes on health spending, and ultimately it is members of the medical profession who decide where most of it is spent. If a professional prescribes a branded product where there is an equally efficient generic that costs much less, he or she is spending money that could have been spent on a priority need in another area. Thus, there is an obligation to consider generics.

I would like to hear the view of the Irish Medicines Board on the question of an exemption for osteoporosis drugs similar to that for anti-epileptic drugs. I would like to think the prescriber would be satisfied with the medicine he or she was prescribing, and we must ensure this is the case.

This brings me to an important question in the overall context of what we are trying to achieve. I take it that the doctor who signs the prescription is responsible for what is prescribed. I am concerned that many doctors and GPs are sent prescriptions from hospitals, often written by non-consultant hospital doctors who are new to the hospital scene. Sometimes they are for generics and sometimes for proprietary brands. I am not sure whether all GPs sit down and analyse the prescriptions and make their own decisions on what should be prescribed; many of these prescriptions go straight to the pharmacist. With more co-operation and co-ordination, it should be possible to have a more streamlined system so that patients get a regular supply of similar products. If the medication is generic, perhaps the pharmaceutical manufacturers might consider how they use colour, shape and size because patients on long-term medication will be confused if they receive a different tablet every month. That would not be in anyone's interest.

I began practising as a dispensary doctor. Dispensaries received a combined purchasing list from the then Department of Local Government and we could only prescribe medicines that were on the list. The Department did its homework when deciding what could be used. In respect of a national formulary, better co-ordination is needed between hospital doctors and general practitioners to ensure a degree of standardisation. Is there any reason we should not tender between the various manufacturers of generic pharmaceuticals for formularies or combined purchasing arrangements?

I welcome the witnesses. As a layperson, I will not comment in depth. It goes without saying that generics are worthy of consideration from an economic perspective. Significant savings can be made in the general medical service by using generics instead of brand name products. Several pharmacists told me about this when we were having the row about the cost and distribution of medicines.

If a GP writes a prescription, pharmacists will be allowed to choose between a brand medicine or its generic alternative. If a problem arises, is the pharmacist covered legally or could litigation ensue? I accept that both generic and brand medicines have been tested and are up to standard but what is the legal position? This issue was brought to my attention by pharmacists who were worried about their potential exposure.

As the witnesses can see, there is a strong degree of political consensus on the need to achieve significant savings in the cost of medication. However, the public must also have confidence in any new system. If we are advocating a move towards generic prescribing, we need to ensure absolute confidence among the public. The representatives of the Irish Osteoporosis Society, who are welcome, raised legitimate concerns and it would be valuable if we could address them during the course of the meeting. Going beyond the concerns of the society and the implications of medication in the area of epilepsy, is it the Irish Medicines Board's contention that generic products are always equivalent to branded drugs? In the example of a person with a complex medical history who may be prescribed a cocktail of drugs for a range of conditions, are the witnesses confident that varying that cocktail from branded to generic medicines would never impact negatively? Perhaps the officials from the Department of Health and Children will begin by responding to the questions pertinent to their Department.

Ms Teresa Cody

I will begin and Ms Pidgeon may make a statement as well. Deputy Reilly asked about the time it has taken to produce the Bill. While the working group's report, which was published in June, set out core principles for the legislation, the introduction of reference pricing is a complex issue that requires careful drafting. It has taken some time to produce the heads of the Bill but the work is well advanced and we expect to bring the legislation to the Government early in the new year.

Deputy O'Sullivan asked about the savings that can be achieved through reference pricing. The use of reference pricing can deliver long-term savings on the State's drugs bill. Direct savings will ensue from limiting reimbursement to the reference price alongside indirect savings from price competition within the reference groups. Various figures, ranging from €200 million to €300 million, have been suggested for the savings that can be made immediately from reference pricing. However, in 2009 the HSE spent €168 million on off-patent drugs where a generic substitute was available but not dispensed. If generics had been dispensed in each case, the estimated saving would have been approximately €17 million, or 10%.

It must also be borne in mind that the prices of off-patent medicines have declined significantly since 2009, which means reference pricing will not have a significant impact on medicines that are already off patent. As members will be aware from the price reductions that occurred earlier this year, many generics are now 39% below their original prices. While the scope for immediate savings has been reduced as a result of these measures, the potential remains for significant reductions in the price of medicines coming off patent in the next three to five years. Reference pricing can deliver greater savings than the current system of off-patent price cuts over a shorter timeframe. For example, 21 medicines with an ingredient cost of approximately €300 million in 2008 are due to come off patent between 2011 and 2015. While the level and timing of the savings which accrue will depend on competition, we can assume they will be significant. Therefore, while €17 million might have been saved in 2009 through generic substitution, this year's reduction of 40% suggests that the estimated savings will be between €7 million and €10 million in a full year.

Deputy O'Sullivan also asked if feedback had been received on the areas where substitution might not be appropriate. We have not received feedback other than from the Irish Osteoporosis Society, and many of the contacts were made before the report was finalised and submitted to the working group.

Deputy O'Hanlon raised the issue of hospitals prescribing in the community. The HSE is developing prescribing protocols for clinicians across care groups.

Deputy Aylward asked about indemnity for pharmacists in respect of substitution. This is one of the issues we will address with regard to the legislation.

I thank Ms Cody.

Mr. Pat O’Mahony

I thank the Chairman and the committee members for the various issues they raised. I will answer some of them and, as has been requested, I will hand over to Dr. Breslin to speak about alendronate and issues with regard to osteoporosis. The Chairman asked whether all generics are interchangeable and about patients on complex regimes. The view of the IMB is that patient care and safety is always at the core. A range of issues crop up in specific circumstances so a clinical judgment must always be made. Any scheme put in place would always have to allow a prescribing clinician to rule that given the specific circumstances or compliance issues of a particular patient, there may be a need to continue use of an innovative medicine. As Deputy Reilly stated, one does not want to change to a different product every month and an issue is raised about compliance in particular. The net point we are trying to make on generics is that the medicine performs in the same general way as the innovator. We appreciate that not everything is absolutely interchangeable and we set this out as best we could in our information leaflet.

Deputy O'Sullivan asked whether there is a single market for medicine. European medicines legislation is quite comprehensive, and effectively it is set out to provide for a single market in medicines. Prices vary from country to country regardless of whether a product is authorised. It is only when a product is authorised that one knows the prices are different. The fact that a product is licensed in Greece and Ireland has no bearing on the difference in price. Other issues with regard to the market not in our remit come into play.

A question was asked whether a company has a choice on which avenue it chooses to take between national application, mutual recognition or centralised. National application is becoming increasingly less utilised. Ireland has approximately 7,000 licensed medicines and Germany has more than 40,000. Markets vary quite a lot and the products brought onto particular markets also vary quite a lot. Companies make choices on the countries to which they bring their products and the system allows this for many products. Companies can decide to use national application or they can decide to use mutual recognition whereby they name a number of countries but not others. As these medicines will not go to the other countries, however, the pricing issue does not arise. Any company can use the centralised system and obtain authorisation for all Europe. It is quite expensive and a big piece of work. It is obligated for a range of products such as advanced therapies, biological vaccines, and cancer, diabetes and AIDS treatments. Legally, these must go through the European system and be approved for the entire European Union. For all other products, companies have a choice on what system they use. I will ask Dr. Breslin to speak about generic drugs and osteoporosis.

Dr. Elaine Breslin

I thank the Chairman and committee members for their questions. We have examined the publications cited in the correspondence from the Irish Osteoporosis Society which was circulated to us and, I understand, to others. We have responded to the Irish Osteoporosis Society. Our position is that there are significant methodological limitations on interpreting the results of the studies and their conclusions are likely to be confounded by a variability in the patient population rather than the drug. The potential differences in patient risk factors, the stage and severity of the disease and the clinical management and pharmaceutical care are all factors that have to be taken into account.

Specifically, one of the papers mentioned in the correspondence we received showed patients stopped taking their generic alendronate because of side-effects and therefore there was a reduction in the bone mineral density and in the efficacy. This was a retrospective study, essentially a chart review conducted in Germany with three patient groups. The data were uncontrolled because they were retrospective. The groups were not comparable as one group was given the generic only, one group was given the branded product, and the third group was given another branded bisphosphonate. The generic group could alternate between various generics so they were not controlled. The main focus of the study was bone mineral density but clinical considerations on concomitant diseases and medications were not studied and compliance with taking vitamin D and calcium, which are also used in the management of these disorders, was not controlled. The studies have quite significant limitations.

The other point raised was the dissolution or disintegration of a drug. I assure the committee that all the generics authorised in Ireland fulfil the European pharmacopoeial requirements for dissolution. It is part of the assessment process for medicines. As Deputies O'Hanlon and Reilly will know, the taking of any bisphosphonate drug is complex. It must be taken with quite a large volume of water, one must be standing up to take it and one must stay sitting or standing in a upright position for 30 minutes after taking the medication. Patients may not always be compliant with this. When the drugs were authorised initially there was some fuss about this and much was written in our newsletters advising people that it was terribly important that patients were informed of these side-effects. Especially with regard to the German paper I mentioned briefly, perhaps when the generics came on the market later the same high profile may not have been given to the circumstances around the particular use of bisphosphonate drugs of which alendronate is a member.

The Irish position is that the prescribing information for generic bisphosphonates is identical to the prescribing information for the branded version, Fosamax, so patients are aware, or ought to be made aware by their prescribing physician or dispensing pharmacist, of the particular circumstances I described earlier with regard to the volume of water and the need to be standing upright because they are important factors. An assumption made in the paper is that the patients stopped taking the generics because they suffered from side-effects but in fact it could be hypothesised that they were not warned about the importance of taking the drug in a particular way and therefore they developed the side-effects. We would take this opportunity to really enforce the importance of the patient information leaflet. Patients should be encouraged to review it and the side-effects. Prescribers should report side-effects or problems with the quality of the drug to us because it is our job to examine these.

We have received information on 106 side-effects with the branded alendronate drug and six with the generics. The reason we received so much with regard to the branded drug is because it has been on the market longer. Five additional side-effects are not attributed to either the branded version or the generic. All the side-effects are consistent with the known side-effect profile of the drug and we have never had a report of a lack of efficacy on either the generic or branded version of the drug. If there are problems with these drugs in the Irish market, we would like to hear about them.

I thank Dr. Breslin. Do the witnesses wish to say anything further?

Dr. Elaine Breslin

We would emphasise again the fact that a simple generic is interchangeable with a reference drug when it involves the same dose, active substance and formulation, but not all generic active substances are interchangeable. Sometimes additional data are required, especially if a different formulation, such as a controlled release formulation, is involved. If a patient is stabilised on a specific drug, it may not be a good idea to change it, particularly if that stability was hard won. The same applies if a patient is allergic to a component of a drug. Therefore, prescriber discretion is an important factor.

I thank Dr. Breslin. Who will be the next speaker?

Dr. John Carey

I will answer some questions although none was addressed to us specifically. Ms Ní Eochaidh may wish to respond afterwards. Committee members probably comprise both those who are very familiar with scientific research and those who are not. If one wishes to compare compound A with compound B it is irrelevant whether the two are generically branded or otherwise. There are robust scientific methods to do this. What one cannot do is to say this matters for A versus B but we do not really care about C and then employ a surrogate to assume the situation is exactly the same. One may or may not be incorrect. For example, if I have two rocks, one of which is covered in paper, the other in six inches of rubber, and I throw them at the television screen above us, the chances are the one which has the very different coating would be less likely to break the television screen than the one covered in paper. One cannot assume, even if the quantity of rock is the same in the two substances, that if I throw them at that television screen there will be the same effect. Similarly with drugs, one cannot assume that because they look the same, sound the same and may be the same they will have the desired clinical outcome in terms of safety and efficacy. That is important because when one looks at what is currently available as substitutions for osteoporosis, generic or otherwise, there are differences in how the drug is prepared and processed and how it disintegrates in the oesophagus, stomach or elsewhere. That affects absorption.

Our only stance in this regard is that we like to practise evidence-based medicine which is similar to best practice and accepted international standards for osteoporosis, not to those unique to individual countries. In evidence-based medicine, the best people in the world will not prescribe treatments for diseases that have not been shown to work. They use accepted validated scientific methods to assess them if there is no evidence available and if there are alternatives which have clearly been shown to work. When we prescribe treatments for osteoporosis patients we do not prescribe treatments that may be approved for osteoporosis unless they have been shown to work in those instances about which one would be concerned. We will not prescribe treatment for patients who may have contraindications or other reasons for which such treatments may not work. For example, not all drugs have been shown to reduce the risk of hip fracture so if I prescribe a treatment for osteoporosis and I am worried about hip fracture, as we have been in the past few weeks with people slipping and falling on the ice, I will not prescribe a treatment that has not been shown to reduce the risk of hip fracture, whether generic, branded or otherwise, if there is no evidence to support that stance. The Irish Osteoporosis Society physicians concur with that.

In terms of patient safety there are two concerns about any intervention. We are focused on osteoporosis drugs, not generic drugs for other diseases for which there are many reasons to accept generic drugs. If a patient has a disease and there is a treatment that has been shown to work then if one gives an alternative that may or may not have equivalent clinical efficacy it may be unsafe to prescribe such treatment for that patient. That is stated in the document concerning treatments for which there is no data in terms of fracture benefit. The second factor is side effects. Obviously, if certain treatments have side effects or a greater propensity for them, that must be factored into the clinical decision making.

Unfortunately, there are very few studies that compare safety. They do not examine the efficacy of generic preparations versus branded ones. The only studies that have been done are concerning. All studies have limitations and strengths and there is no one size fits all. Many studies have been presented at international bone conferences in the past five or six years from countries where generic substitutions have been available. There have been radio nuclear studies with radio nuclear dye present in the various tablets which looked at the various solution times in the oesophagus and stomach and thereafter, and the absorption of the medications. Studies have also looked at other side effects patients experience, changes in bone density and factors that are more sensitive to change such as bone turnover markers. These have certainly raised concerns, albeit in the absence of good long-term studies.

Unfortunately, the flip side is also true. Observation studies, although they have limitations and are not the be all and end all, are used in regard to patient safety. Clinical trials for efficacy are only designed and powered to demonstrate efficacy although safety is a part of any big clinical trial. These trials cost billions of dollars to perform today. The largest clinical trial for osteoporosis medicine concerned hormone replacement therapy, HRT, and was completed after €1 billion was spent on the study alone. There were more questions than answers afterwards and the trial concerned only one form of HRT, not all treatments on the market. The reality is that phase 4 studies and observation studies tend to be better ways to demonstrate safety. If safety concerns are coming to light in these studies it does not mean either that everything is all bad or all good or that we should ignore them. I would put the patient at the heart of this and say if we have concerns for patient safety because we do not have any evidence that a certain treatment works, then we, as physicians, will not prescribe it. If there are concerns about safety we, as physicians, must factor that into account. This issue is not unique to branded, generic or any other form of medicine, whether made in Ireland or somewhere else.

That is our main concern. We have much anecdotal evidence from patients not just in regard to osteoporosis but in cases where medicines have been switched, as Deputy Reilly and other speakers mentioned. There is confusion for patients concerning how they take the medicine, when they take it, whether they should take it or stop taking it. There are causes of concern for patients in regard to side effects. Given there are safety concerns with some medicines, albeit the data to support this is not at all robust, these concerns have been a flag to patients who are very concerned when one gives them an alternative medication which has no data to support it either way.

As a last point, we know for a fact that for osteoporosis, the biggest crime today is that most patients are not evaluated and treated following a diagnosis or a fracture. That is the biggest problem. Our view is that the best thing we can do for patients is to promote programmes that prevent fractures and use evidence-based and internationally-accepted best practice treatments, whether these are generic, branded or otherwise. We absolutely agree that if there is a cheaper alternative which is equivalent we are all for it. It does not matter who makes it, we do not have an issue with that. Our point is that it is over-simplistic to say that because the drug costs a few euro less a week this will save money. The indirect costs associated may be much greater. Countries which have looked at this issue very carefully have shown that for osteoporosis - I do not speak for other medicines - the cost savings may not be there at all and, if anything, may cost more.

Ms Aoife Ní Eochaidh

I thank the Chairman for the opportunity to attend and speak today. I am a physiotherapist working in Galway and have the pleasure of being on the board of the Irish Osteoporosis Society. I work alongside Professor Moira O'Brien who is abroad in Singapore which is the reason I was nominated to fill her shoes today. They are big shoes. I hope the committee will bear with me as I make some of the points we have.

First, the IOS is only against generics for the treatment of osteoporosis. We are all for savings. I agree with many of the points made today but the society does not agree with others. I shall run through some of those raised. We do not agree that generic medicine for osteoporosis has been shown to be bioequivocal. We would therefore disagree with the points raised by the Irish Medicines Board and some of the points made by Dr. Breslin although we take on board the fact that many studies back these up. I appreciate the points that have been made in regard to some studies. Professor O'Brien has worked in this field and I know members will know her. They have been circulated with the evidence. Her view and that of the IOS is that the medicines are not bioequivocal.

The HSE is the main sponsor of the IOS. We are very grateful for that sponsorship and need that money. Our approach is that we provide education to try to prevent this awful disease. To return to the issue in hand, if this move were to go ahead and generics were to be used for osteoporosis, we would have concerns that patients would be placed at a much higher risk of fracture and developing side effects. I have a colleague here with me who is a board member and also a patient with osteoporosis. She experienced dreadful side effects and was admitted to hospital. That is one case I know of and that is definitely one of our concerns.

As regards what is happening abroad, some of the other speakers have mentioned that Ireland is perhaps a little slow in using generics, and that we should be using them. We held an international conference recently which was attended by our UK colleagues. There is a trend in Ireland whereby sometimes what is done in the health service abroad, including England, often comes in here. Having spoken to my colleagues across the board, be they doctors or physiotherapists, and those involved in the care of osteoporosis patients, they regret that generic medicines are used in the UK for the treatment of osteoporosis. They are trying to overturn that policy.

On a lighter note, we have had some analogies so let us talk about washing powder. One of my colleagues was talking about the nice television up there. We all know that if one uses a branded washing powder one will get better results. One may pay a little more but one will get better results. We are not talking about washing powder here, but medicine. We are talking about lives and, yes, costs are very important but where do we draw the line? Life and loss of independence must surely count for something.

The patients I see in my clinic may stop taking their medicines, whether generic or branded. One must take on board that that issue has to be addressed. Osteoporosis is preventable and treatable in the majority of people. There have been exceptions for mental health and epilepsy in the use of generics, which is why we are here today. We are here to ask the committee if osteoporosis medicines could be included with the anti-epileptic drugs where generic substitution is not approved.

Do Ms Gannon, Mr. O'Riordan or Professor Kelly want to take some of those questions which are relevant to themselves?

Mr. Rory O’Riordan

I would like to address the two commercial points mentioned by Deputy Reilly and Deputy O'Hanlon. One was about the price of generics in Northern Ireland and here. Deputy Reilly is right that in that particular case there is a differential, but the same product is more expensive in Belgium than in Ireland or Italy. Therefore, one is looking at the nearest market, which comprises 65 million people, while we are a market of 4 million people. It is all to do with the volume of the original market in which we are competing and the small share that we have in that market. If one takes it that half of all the medicines are off-patent and our penetration collectively of that half is 20%, and the originator has 80%, then ten companies are competing for 20% of our market when the original product continues to sail on years after the patent has expired, while retaining a majority of the market place.

There have been no measures, other than an incentivised scheme for GPs a couple of years ago, that actually drive any change for prescribers. So even though Deputy O'Hanlon is right in theory, and people should be conscious of this, in fact the prescribing habits are that the brand continues to be prescribed most of the time. We have the same registration and manufacturing costs for a market of 4 million people as for a market of 65 million people. The purpose of today's meeting is to ascertain whether this reference pricing scheme is a good idea. We think it is a very good idea. One will generate real savings by increasing the volume of generics used because our prices are always lower than the brand, so the more they are used the more savings one gets. That is not quite the same as driving down the price of the generic, because if one does not utilise the generic one will not save very much anyway as the volume we are talking about is so small to begin with.

Deputy O'Hanlon asked whether tendering was a good way to go. In a market of this size, it is absolutely not. In tendering, there is one winner of the tender and everybody else loses. That is a situation where one company gets 100% market share and the other companies get nothing. Therefore, one will quickly drop out of all those molecules in which there is nothing. The essence of generics is multi-sources of the same product to keep us competitive. If one creates a situation where one company monopolises the supply of Amoxiclav, for instance, then the rest of us will drop out and that becomes too expensive. I do not think that tendering is either a good short-term or long-term solution to the supply of medicines.

Do Ms Shannon or Professor Kelly have any points they wish to make?

Professor John Kelly

Yes. I thought the questions posed by the Deputies were very insightful. They asked the appropriate questions about the safety and efficacy of generics. I wish to reassure the various members of the committee about the methods of examination and testing of generic medicines. As Dr. John Carey said, there might be concerns. I can see where he coming from. He says that one is looking at bio-equivalents, blood levels and blood concentrations. He says that is a surrogate marker; the real point is the effect on the patient. When one is reducing blood pressure, it is very easy to say that when it gets into the blood stream it has an effect. Osteoporosis is very different, however. Less than 1% of each individual dose is absorbed which is a very small percentage. That is laid down in the bone over a long period of time - many months. It is quite difficult because there is a long period of time between the initiation of therapy and the response in the patient. That is what makes the examination of clinical trials very difficult. However, it is really science that will judge it. The answer is not in anecdotal reports, but in examining the mass of scientific and medical literature.

The cornerstone of generic approval is so-called bioequivalence, when the blood concentration is produced by one or within certain strictly defined limits, that come close to the blood concentrations produced by another. They do not have to be exact but they have to be statistically comparable. These statistics are well known and they are state-of-the-art.

It is not just the blood levels that are taken into account. The active ingredient must be the same and it must be comparable. The active ingredient that is used must conform to pharmacopoeial or other standards, so the raw substance or pure drug must be acceptable. The pharmaceutical testing has to be acceptable also. I know Dr. Carey said that the disintegration of some products is not the same. The fact is, however, that if disintegration - which is the tendency to break up - or dissolution - which is the ability of the medication to dissolve after the tablet breaks up - are not the same, the product will not be approved because the regulatory authority requires that. The chemistry, pharmaceutics and finally the clinical, namely, blood concentrations, must be the same. A generic will only be judged acceptable on that basis and in so far as one is able to say that those products are bioequivalent.

There are a small number of products where there are questions. They include some anti-epileptic drugs, but I suppose these would be excluded from automatic generic substitution by the Department of Health and Children. They may perhaps also include Warfarin, which is another agent where one must get the dose right. If there is any deviation a patient's blood clotting can be affected. There will be a mechanism for saying "No, we won't have generic substitution here", but for the vast majority there cannot be any question. Ireland has a small degree of generic penetration, 18%, which is down around where Portugal is. One must look at the vast majority of other European countries where the level is well over 50% and in many cases up to 80%, for example in the UK. If one looks at the gold standard of medicines' assessment, the Food and Drug Administration in the United States, I think generic penetration there is about 80% also. Therefore, it does produce savings for the patient.

Both Deputy Reilly and Deputy O'Hanlon made important points in respect of patient concerns. If one has any concerns about automatic generic substitution, one could say that it produces an intermediate step between doctor and patient, which is the pharmacist. Theoretically a patient could get a different product every month. Perhaps the Irish Medicines Board would agree that while the generics companies try to have a product which is similar in size, shape and colour to the reference product, that is not always the case. Certainly, patients could be concerned, for example, that the tablets dispensed are not the same as their blood pressure tablets, and that is something that could be taken into account. A letter from Australia to theBritish Medical Journal in the past few weeks pointed out that there was a question of patient acceptability. That can be overcome, perhaps by education or by reassurance from the physician. The easiest way to encourage generic substitution is to start with the physician. Mechanisms to encourage generic prescribing mean that one does not have so many concerns about requirements for generic substitution.

One point raised by Deputy O'Hanlon, which is not quite related to the topic under discussion today but which is a real concern, is the interface between the hospital and the general physician, and that is a problem. The problem is in ensuring that there is a seamless transition from the products that are prescribed in the hospital, in relaying such information to the general practitioner and in ensuring that the patient gets optimum care afterwards. In fact, in RCSI, a student of mine has just finished a PhD examining the transition between the hospital and the general practice interface using data from Tallaght Hospital demonstrating and discussing quite a few of the points of concern in that regard. However, that is a question for practice. In fact, it is a question for proper information systems to be set up.

I have nothing else to add other than to state that if one has a system which allows generics to be approved and considered to be equivalent in most respects to the branded equivalent, and if those generics are at the right price, one has wasted a great deal of effort by stating, "But we will not use them."

Ms Sandra Gannon

There is just one point I want to make on the current reimbursement model to give a concrete example in response to Deputy Reilly's question. In the case of the substance bicalutamide, for example, which is a high-tech product, there are three generic substances on the market offering in the region of a 30% saving versus the originator brand. It costs the State approximately €4 million pre-patent expiry. The total uptake of the generics is less than 4% of the total market. In that particular example, generics are offering substantial savings but, obviously, the mechanism is not there in the market to drive volume. The requirement is for a mechanism to drive volume in order for generics to be able to deliver savings.

The other matter on which I would comment is that some of the analogies being made today on generics and medicines, particularly those on washing power, are quite insincere. As the Irish Medicines Board has commented on the requirements for both generics and brands to obtain licences, the continued monitoring of all medicines in the market and the risk benefit analysis undertaken, it would lead me to point out that we need to take comfort from the fact that this is a highly regulated industry and some of these analogies are really quite unfair to the pharmaceutical industry.

Mr. Pat O’Mahony

I have a couple of follow-up points. The issue of information and education has come up in a few of the comments, and that is fundamental. In research the IMB did of the general public, we found there was a substantial lack of information among the general public of generic medicines and even when we explained what a generic medicine was, 40% of people stated that they had never heard of that product before. When we went to explain what the medicine was, however, and explain what a generic was, 78% stated they would be happy to accept it. There is a real issue of the need for education and information out there.

Who should be conducting that education campaign? Has the Irish Medicines Board a role in that?

Mr. Pat O’Mahony

We believe we have. We launched a consumer information leaflet which is available through pharmacies and also on our website, explaining the basic facts about generic medicines and we certainly think that is a useful contribution. I am sure others involved in health promotion and all of the societies, etc., have a role as well. That is one important point.

I was reassured in what I heard from the Department, not only now but also previously, that whatever scheme is established will allow for a scientific judgment to be made on generics that become interchangeable. While I appreciate the arguments I hear from the Irish Osteoporosis Society, there are, for example, seven generics of the osteoporosis medicine licensed on the Irish market and these products are licensed throughout Europe and they are interchangeable in a number of the countries.

On the reference to washing powers in the context of the discussion we are having today, as a regulator of medicines in a highly regulated marketplace, it is not in any way comparable to even a cosmetic, never mind a washing power.

Ms Ní Eochaidh was probably trying to communicate in layman's terms to those of us here who are not physicians or medics. I do not want to get into an argy-bargy on this.

I asked what initiatives there might be to increase the prescribing of generics and has any work been done on that. I suppose I am really directing that at the Department. Has any work been done on how we might avoid prescribing where it is not absolutely necessary?

I have a question for Ms Pidgeon, who was a member of the working group. I asked why there has been such a delay. The working group has only recently reported in May, but when was it put together?

I have a question on the legislation, which is not yet completely written. Am I correct in stating that under the legislation, pharmacists will be allowed to substitute a generic, assuming that it is substitutable and on the IMB's list, so that even if the general practitioner prescribes the branded medicine, the pharmacist will have the authority to substitute?

I have a question to cut to the core of the matter. We all indicate strong support for a move towards generics but we have respect for what is being said by the Irish Osteoporosis Society, which is a reputable body expressing concerns. Professor Kelly indicated that there might be exclusions from the generics, say, in the case of patients on Warfarin. We already have a proposal in respect of persons with epilepsy. Would there be a problem with the Department, the Irish Medicines Board or the RSCI school of pharmacy were the concerns of the Irish Osteoporosis Society to be reflected in some sort of derogation at this point pending absolute clarification of the issues that arise? Clearly, the society has concerns. Is that a reasonable question to pose?

Professor John Kelly

The Irish Medicines Board is the expert in this area. If the Irish Medicines Board is concerned about the bioequivalence of products, it will certainly say so and I believe that it would lead to scientific examination by the board.

Dr. John Carey

The Irish Osteoporosis Society appreciates everything that has been stated by everybody else and we respect everybody else's opinion. However, we are at pains to point out that there is over 20 different bisphosphonates. There is first order, second generation and third generation. All three classes of bisphosphonates have different mechanisms of action, although they are the same drug. Even within the same classes, clearly there are very different efficacies, there are different safety profiles and there are different absorption rates, and there are very different pharmacogenetics. That is a fact and the science is unequivocal on that basis.

Unfortunately, my understanding, and correct me if I am wrong, is that the rationale behind this was that it was a means by which a designated interchangeable medicine with the same quality and clinical efficacy can be dispensed. I would point out again that bioequivalence studies are not the same as fracture efficacy. There is no efficacy at a clinically equivalent level for patients with osteoporosis. If any medication, generic, brand or otherwise, comes out with that, the IOS is fully supportive of it. There is no patient safety data with bioequivalence studies and the few existing patient studies raise concerns. Perceived cost savings by saving a little money here on a drug may well be offset by far more fractures and all of the other problems. That is our position, as patients.

Do the other participants wish to make any concluding remarks?

Ms Teresa Cody

Mr. O'Mahony has already dealt with some of the issues to which I was going to refer.

Perhaps Ms Cody might deal with the questions posed by Deputies Reilly and O'Sullivan.

Ms Teresa Cody

On osteoporosis, the working group's report contains draft criteria regarding interchangeability. There was expert input in respect of the matter and there has been discussion on bioavailability and bioequivalence. However, no decisions regarding the interchangeability of medicines will be taken until the statutory framework is in place. Any decisions made at that time will be evidence-based and guided by patient safety considerations. The expert committee established to decide on our interchangeable medicines will, in the context of the decisions to be made, take into account all available evidence.

Is our discussion on the matter premature?

Ms Teresa Cody

No, it has been extremely helpful. It has been of great benefit to get the information out on what is happening with regard to reference pricing. It is important that there be both good information and good communication which will be vital in the context of implementation of a new system of reference pricing and generic substitution.

Deputy Reilly inquired about the initiatives to promote appropriate prescribing. He will be aware of past initiatives. I have mentioned that the HSE is working with multidisciplinary care groups in developing prescribing protocols across a variety of illnesses. That is the area on which are focusing our efforts in promoting appropriate prescribing. Deputy O'Sullivan posed a question to Ms Pidgeon regarding the report published earlier in the year.

Ms Ciara Pidgeon

The group which produced the report was established in November last year. Subsequently, a number of sub-groups were set up and these had a relevant input, as required. Represented on the group were the IMB, the National Centre for Pharmacoeconomics, the HSE, the Department and other interests. The group met a wide variety of stakeholders over two months and its report was published in June. Work on the legislation is ongoing and draft heads are expected early in 2011.

I thank our guests for making their case so well and being so succinct and straightforward in their replies to the questions posed by members.

Would it be possible to make some closing comments?

Yes, if the Deputy wishes to do so.

Will our guests be invited to return to the committee when the new system is up and running? I accept that none of the members currently serving on the committee might be still be on it at that stage.

I do not believe that will happen.

If they do return, it would provide an opportunity to evaluate how the system was operating.

Once the Department has done its job, I am sure the committee will be in a position to return to the matter to evaluate the level of success in implementation of the project.

Ms Aoife Ní Eochaidh

Perhaps Professor O'Brien might be available for that meeting. If he were, it would be of some assistance.

Ms Ní Eochaidh and Dr. Carey did very well in his absence; therefore, they should not be concerned.

I again thank our guests for coming before us. This has been one of the better meetings in which we have engaged, particularly in having matters clarified and elucidated upon. I would not like anyone to be under a misapprehension and must state I admire and value the work done by the Irish Osteoporosis Society. Osteoporosis is a serious illness, the level of which is often under-diagnosed. That is a major issue. If we get the message across in this regard as a result of this meeting, we will have done some useful work. However, one does not always obtain better results by using branded washing powder.

In the context of what Ms Cody stated, I accept the group was only established in November 2009. From a political perspective, we have been extremely lethargic in our approach to generic prescribing, particularly when one considers the hundreds of millions of euro which could be saved on an annual basis, a point highlighted by the Minister last week. Patients will always be placed first. However, there must be a realisation, particularly in the current economic climate, that in spending money unnecessarily in one area one will deprive people of treatment in other areas. That is the harsh reality. I agree with the representatives from the generic drugs companies that competition is essential. However, I cannot accept an almost twentyfold price differential in respect of some generic drug, particularly in some of the products available both here and across the Border. As a GP, I have often wondered why people coming out of hospital are prescribed the more expensive branded products. The answer is that usually the hospital involved will have done a deal with the relevant pharmaceutical company. Patients remain on the drugs in question for the duration of their recovery or perhaps longer and this gives rise to a huge cost for taxpayers.

I again thank our guests and wish them a happy Christmas. I look forward to seeing them all at some point in the future in order that we might thrash out any remaining issues.

If there are no other comments from members, I will bring proceedings to a close. Our next meeting will be held on Tuesday, 25 January, when we will have a discussion with representatives of the Diabetes Federation of Ireland, the Irish Endocrine Society and the Irish Human Rights Commission.

The joint committee adjourned at 4.20 p.m. until 2.15 p.m. on Tuesday, 25 January 2011.