Jerry Buttimer (Cork South Central, Fine Gael)
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I welcome the delegation from the Irish Medicines Board - Mr. Pat O'Mahony, chief executive, and Ms Ann O'Connor, director for human products authorisation and registration - to our meeting. I remind members and witnesses that mobile phones should be switched off.

Witnesses are protected by absolute privilege in respect of their evidence to the committee. However, if they are directed by it to cease giving evidence on a particular matter and continue to so do, they are entitled thereafter only to qualified privilege in respect of their evidence. They are directed that only evidence connected with the subject matter of these proceedings is to be given and asked to respect the parliamentary practice to the effect that, where possible, they should not criticise or make charges against a person or persons or an entity by name or in such a way as to make him, her or it identifiable. Members are reminded of the long-standing parliamentary practice to the effect that they should not comment on, criticise or make charges against a person or persons outside the Houses or an official by name or in such a way as to make him or her identifiable. I call Mr. O'Mahony to begin his presentation.

Mr. Pat O'Mahony:

I thank the Chairman and members. I am accompanied by my colleague, Ms Ann O'Connor, director of human products licensing at the Irish Medicines Board, IMB. It is a pleasure to be here. This visit follows from our presentation to the committee before the summer recess when we discussed metal hip implants. It is a pleasure to give the committee an overview of the IMB's role and remit.

Essentially, the role of the IMB is to protect and enhance public and animal health through the regulation of medicines, medical devices and health care products. We regulate a range of sophisticated health care product industry sectors and health care technologies. With the exception of controlled drugs, the legislation for all the areas we regulate is derived from European Union regulations and directives. The IMB was established on a statutory basis under the Department of Health in 1996. This had the effect of transferring the licensing function for medicines for human use to the IMB from the Minister for Health. Prior to that date, the Minister granted licences based on the recommendations of the IMB's predecessor, the National Drugs Advisory Board, which had been in existence for 30 years. The IMB has developed a strong reporting relationship with various Ministers and departmental officials and we provide support and assistance for the various policy areas on a regular basis. The founding legislation, primary legislation from the Oireachtas, provides our legal basis. It directs that the IMB is largely a self-funding organisation. The committee will be aware that we charge fees for the majority of our services - 85% of our budget is fee - derived - and that this is the funding model for regulators of these sectors throughout Europe and internationally.

The IMB has many responsibilities. In the case of medicines, we approve and monitor clinical trials at the beginning or at an early stage of development. Then we review data submitted for the licensing of medicines. We inspect and license manufacturing sites and wholesalers. This is limited to medicines for human consumption because the Department of Agriculture, Food and the Marine covers the wholesale of veterinary medicines. We monitor medicines throughout their full life cycle, which is important for vigilance.

The IMB is the central contact point for the reporting of adverse reactions, which is known as pharmacovigilance. We receive reports from Irish patients and health care professionals and ensure companies notify us of all reports they receive, as they are legally obliged to do. Every report made to us is independently and individually assessed by our pharmacovigilance experts and added to the cumulative data for every product on the market in Ireland. We provide continued expert assessment of the overall benefit-risk of medicines in use by patients. Our adverse reaction data for individual products is submitted to EU and World Health Organization, WHO, databases, to which we have access. This access gives us valuable worldwide licensing and safety data for thousands of products.

We sample and test products from the marketplace. We oversee the recall of products that pose a risk to the health of patients and enforce the legislation for patient safety, when required, up to and including taking prosecutions for serious breaches. We have an inspections programme of manufacturing facilities and provide export certification support. Exports in the various areas of medicines, medical devices and so on are now valued at more than 50% of all Irish export earnings. We issue export and good manufacturing practice certificates which facilitate exports throughout the world.

The IMB is also the competent authority for the blood directive, under which we assess applications and authorise activities relating to the collection, testing, processing, storage and distribution of human blood and blood components. We also carry out site inspections to ensure compliance with the safety and quality requirements of the legislation. In addition, the IMB is the competent authority for tissues and cells directives, advanced therapies and cosmetics.

Members will recall from our appearance earlier this year that the IMB is also the competent authority for the regulation of medical devices. Our remit in this case relates to vigilance and surveillance and begins after a medical device is placed on the market in Ireland. Unlike our role in the case of medicines, it is not a function of the IMB to license or authorise medical devices.

Recently the IMB has been designated by the Minister as the competent authority for two new areas of interest, namely, the protection of animals used for scientific purposes and organ donation and transplantation. The two relevant directives are due to come into effect shortly. We have added an appendix to the presentation to set out the way various additional functions and duties have been added to the IMB during the past 16 years.

I offer some background information on how medicines are licensed. Members will be aware that pharmaceutical companies may make an application for product approval to the European Medicines Agency, EMA, for a licence which permits that medicine to be sold throughout Europe. The EMA is based in London. To date, up to 500 medicines have been approved through this route. In practice, this involves every application being assessed by experts drawn from EU member states and the work of these experts is co-ordinated by the EMA. The IMB contributes significantly to this European assessment process on behalf of Irish patients and is the lead rapporteur for Europe for several of these medicines. Our involvement is greater than our size would otherwise dictate and we are performing well in this regard. We also contribute to the work of the various expert scientific committees at the EMA and, consequently, have access to a larger pool of specialist opinion to augment our own expertise. Ultimately, this benefits Irish patients taking medicines. Including the 500 medicines authorised through the European system, there are more than 6,000 human medicines and more than 1,000 veterinary medicines approved in Ireland. Members will appreciate that the majority of medicines are actually approved at national level by the IMB, either solely for marketing the product in Ireland or for a restricted number of member states. This occurs through two legal arrangements in place derived from the mutual recognition directive or the decentralised procedures directive. The IMB also contributes strongly at this level.

In addition to our EU partnerships, the IMB has in place co-operation agreements with several sister regulatory agencies throughout the world. This allows for the early exchange of information and expert knowledge on products, safety data and emerging trends and issues to the benefit of Irish consumers and patients. Regulators with which we have arrangements include the US Food and Drug Administration, Health Canada and the authorities in Mexico, Singapore, Switzerland, Australia, New Zealand and Japan. We are negotiating an arrangement with the authorities in Brazil.

The presentation includes a short note on some of the key issues and challenges we see which I will summarise briefly. The first relates to changing demographics and disease burden and new science and new therapies that are being developed. These changes are a constant challenge for the IMB. Thus, it is essential that we have in place the appropriate skill set and expertise to assess and monitor new products to ensure a positive benefit-risk balance for patients, while supporting research and innovation. Globalisation of the market in all the sectors we regulate is a reality. Therefore, our international reach and networks are vital to enable the IMB to do the job of regulator effectively.

Within this global context, we face the ongoing challenge of the availability of counterfeit products, many of which are available for purchase on the Internet, in respect of which consumers and patients have no real level of protection or assurance in what they might be buying. This continues to receive considerable attention nationally and internationally and the IMB has warned consumers repeatedly about this issue online and in the broadcast and print media. If we have time, I am keen to discuss the new European directive on what are termed falsified medicines. The directive will take effect next year.

Patient engagement is a significant focus for the IMB and will be into the future, as are transparency, communication and the provision of reliable information in order that health care product users as well as health care professionals can make informed decisions.

The new EU pharmacovigilance legislation for human medicines is a relevant development in this regard and aims to ensure that members of the public become better informed about the benefits and risks of taking medicines. That legislation has been in place since July 2012.

It would be very useful for the committee to have an insight into what the public thinks about medicines. It is heartening to know that research we have carried out shows that nine out of ten consumers have confidence in the safety of the medicines they purchase and have very high trust in pharmacists, GPs and consultants. The figures are in the high 90s. In particular, they are very willing to seek the advice of their pharmacist. However, our research also tells us that four out of ten health care professionals think consumers are not adequately aware of the risks that come with taking medicines. Health care professionals also believe that up to 90% of patients who come to them for advice do so after using the Internet to self-diagnose. Our research with consumers also indicates widespread use of the Internet to access health information. This poses challenges. The increasing use of mobile technology and near instant access to information have implications for regulators on how we publish information and how we position ourselves as the most credible source of information. In this regard, the IMB has developed a suite of leaflets for members of the public both in print and online. One of these leaflets deals specifically with the area of accessing medicines online while another is focused on the purchasing of medical devices over the Internet. We are attempting to deal with that information deficit.

In our relationship with Government and other State bodies we provide advice across all the areas for which we regulate. We work closely with sister agencies where our expertise can bring benefits to discussions and expert insights across common areas of focus. This includes all agencies operating in the health sphere and development bodies such as the IDA and Enterprise Ireland where we are very involved in dialogue with companies that are considering establishing manufacturing operations here.

We support various important Government initiatives. An ongoing example, which is pertinent at present, is the initiative on generic substitution of medicines. The Bill currently before the Houses provides that the IMB will determine and publish the lists of medicines that are interchangeable and we look forward to assisting in this initiative. One of our information leaflets for consumers deals specifically with generic medicines. We are acutely aware that resources for health budgets are constrained and will do whatever is within our remit to assist in this area.

Members may be aware that there are substantial challenges from time to time with regard to availability of certain medicines and that shortages pose a particular risk for patients and added cost to the system. We continue to contribute within our remit to the work of the Department of Health and, in particular, of the HSE colleagues on this important topic. We have also established in the past year a consultative panel to examine the status of certain medicines as over-the-counter or prescription-only and to make recommendations to the IMB to change the legal status where appropriate. This membership consists of interested stakeholders including the Department, the HSE, health care professionals and patient representatives.

Health technology assessment, reimbursement and pricing are not in our remit.

Chairman, you will be aware that during the Presidency, from 1 January, the IMB will host up to 20 meetings of European counterparts across the various areas we regulate and we have ambitious plans for these meetings to contribute to public health and safety improvement in Ireland and for the entire European system. We will also provide support to the policy units in the Department in the areas of clinical trials, medical devices, precursor chemicals and cosmetics, where new legislative proposals are expected to come before the European Council during the Irish Presidency.

The board of the IMB, which comprises nine members, is appointed by the Minster for Health. It considers strategic matters including corporate policy, planning and finance while also reviewing reports from the statutory advisory committees and the audit committee. In addition, it notes the licences for all medicines as approved by the management committee, which consists of me as chief executive and my senior directors. In the event of a proposal to refuse a licence, the final decision rests with the board.

There are three statutory advisory committees, also appointed by the Minister, for human medicines, medical devices and veterinary medicines. The statutory role of these committees is to provide advice to the board in cases where it is proposed to refuse to grant a licence for a medicinal product on any grounds relating to its safety, quality or efficacy. There is also a variety of sub-committees. These are listed in the briefing note. More than 100 experts contribute to these various committees and the role they play, on a voluntary basis, is of immense value to the IMB.

We are also fortunate to have a cadre of highly qualified, experienced, specialist staff across the various areas we regulate. We have in place a robust quality management system and our organisational performance is routinely benchmarked against our European peers. We have an established performance management programme for all our staff and we seek excellence in all we do. We work hard to meet timelines for our work and we have state-of-the-art IT enabled solutions for both patients and industry to report adverse reaction reports, submit online applications of various types and for monitoring staff and organisational performance.

Finally, the IMB has a strategic plan for the period 2011-15. It was adopted by the board at the end of 2010 and is available on our website. As well as dealing with the regular running of the board it sets out five high level strategic objectives. They are to enhance health care product safety and patient outcomes by effective risk management and market surveillance; to deliver clear, relevant and timely communications to patients, consumers and health care professionals; to improve service delivery within a high quality, risk-based regulatory framework; to influence legislation and policy development at European and international levels for the benefit of public and animal health; and, to build future capabilities to meet evolving regulatory requirements and scientific and technological advances. We are on target across each of these objectives in terms of our work delivery and planning.

Thank you, Chairman. We would be pleased to take any questions.

Billy Kelleher (Cork North Central, Fianna Fail)
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I welcome the witnesses to the committee. It is evident that we have a difficulty with regard to the cost of medicines, both wholesale and retail, in Ireland. I was disturbed to read in the IMB report that it has established a consultative panel to examine the status of certain medicines as over-the-counter or prescription-only. I did a quick check and discovered that the IMB almost never delists prescription-only medicines and seems to be inactive in that area. Why is the IMB one of the few medicines boards in Europe that never seems to delist medicines from prescription-only to over-the-counter? Is that because of a mindset or a lack of resources, or is it simply something the board never thought of previously? Expensive medicines are a major difficulty for families and for the State itself.

A person must study for between five and seven years to become a pharmacist but apart from being allowed to sell lipstick and nail varnish, they have a very small role in the area of medicine and of dealing with the public. We must examine this area in detail. Pharmacists are a wonderful resource and should be more involved with prescribing medicines, perhaps at a lower grade. A pharmacist could have a role in repeating prescriptions for a recurring non-serious illness, where the original prescription was given by a doctor. Families are in huge difficulty regarding the cost of medicines. The programme for Government contains a commitment that primary care will be free and available to everyone. Meanwhile, every day families are deciding not to go to the doctor, because the visit will result in a huge pharmacy bill followed by another huge bill if the condition does not improve and a further prescription is required. Mr. O'Mahony may say that is anecdotal evidence, but it is happening daily.

The IMB has a role in trying to reduce the cost of medicines.

A problem arises, however, if the board does not regularly review the list of prescription-only medicines, as other medicines boards in Europe do. In that situation, where drugs are not delisted to over-the-counter status on an ongoing basis, we are left with an automatically inflated pricing system. This is an issue which the board is obliged to consider. When do the delegates expect the consultative panel that was established in the past year to begin making recommendations to the board in this regard and when, thereafter, will the board be in a position to begin delisting medicines?

Pharmacists are a wonderful resource and there is a central role for them in the delivery of community health care. In terms of the Government's stated commitment to the establishment of primary care teams and so on, pharmacists are eminently qualified to play a key role and have already invested strongly in communities, towns and villages throughout the country. Their function should be reviewed as part of broader Government policy in regard to the delivery of health care. I understand the Government is engaged in ongoing discussion with the pharmaceutical companies in regard to generic drug substitutions. Given the apparent reluctance, as I have observed, on the part of the IMB to recognise the need to review the status of prescription-only drugs on a regular basis, how confident can we be that the board will engage in regular reviews of developments in regard to interchangeable generic drugs?

Jerry Buttimer (Cork South Central, Fine Gael)
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It is important to emphasise that pharmacists do more than sell medicines.

Billy Kelleher (Cork North Central, Fianna Fail)
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Of course. I am talking about the role of the Government-----

Jerry Buttimer (Cork South Central, Fine Gael)
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I accept that. I am merely clarifying matters for the benefit of members and witnesses.

Billy Kelleher (Cork North Central, Fianna Fail)
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My questions relate to Government policy in regard to what pharmacists are permitted to do. There is undoubtedly an issue in this regard. There was great reluctance, for example, to permit pharmacists to administer the flu vaccine, despite such services being an obvious area of involvement for them. My point is that the Government seems concerned with seeking to limit their role.

Jerry Buttimer (Cork South Central, Fine Gael)
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My concern is to protect the Deputy.

Billy Kelleher (Cork North Central, Fianna Fail)
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I thank the Chairman.

Caoimhghín Ó Caoláin (Cavan-Monaghan, Sinn Fein)
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I welcome Mr. O'Mahony and Ms O'Connor to the meeting. The regulation of medicines is an increasingly important area of activity, with new products being developed on a continuous basis. This creates challenges for both regulators and Government, not least in the area of cost. In the course of Question Time in the Dáil earlier this year, my colleagues and I pressed the Minister for Health, Deputy James Reilly, and the Minister of State, Deputy Kathleen Lynch, on the difficulties for patients regarding access to new and developing cancer treatments and medicines and the need to ensure speedy access thereto for all who need them. In this regard, we pointed the Ministers to the clear disparity across Health Service Executive regions in terms of access to medicines, with Tysabri cited as an example. My understanding is that this matter has not been resolved and it remains the case that some HSE regions are not fulfilling their obligations in terms of the right of patients to access that particular drug. Does the Irish Medicines Board have a function in this regard and has it been involved in addressing this disparity across HSE regions?

The chart included in the delegates' presentation is useful and welcome. What would be even more useful, however, would be a chart setting out the relationship between the Minister and the Department, the HSE, the IMB, the National Centre for Pharmacoeconomics and the Irish Pharmaceutical Healthcare Association. It is often very unclear to members of the public how each of these bodies relates to the others in terms of specific roles and responsibilities.

The delegates' presentation includes a specific statement that health technology assessment reimbursement and pricing are not part the board's remit. My final point relates to the latter aspect. The delegates have said they are looking forward to assisting in the implementation of a scheme for generic substitution following the passage of relevant legislation through the Oireachtas. As it stands, however, the massive disparities in the cost of medicines as between this and other countries apply not only in respect of on-patent drugs but also their generic equivalents. The potential of the new legislation to realise critical savings in terms of health expenditure will be washed away if this issue is not addressed. As a Border resident, I am aware that the cost of medicines is substantially cheaper under the National Health Service system in the North in the case of both on-patent medicines and their generic substitutes. Constituents have cited instances in which medicines, both on-patent and generic, in pharmacies south of the Border are charged at up to 12 times their cost in the North. This is a very worrying situation which must indicate gross profiteering on the part of the pharmaceutical companies and distributors in this jurisdiction. The delegates have indicated the IBM has no role in regard to pricing, yet they are anxious to participate in the implementation of the generic substitution plan following the passage of legislation through the Oireachtas. Surely they cannot be blinkered to the facts to which I have referred?

Séamus Healy (Tipperary South, Workers and Unemployed Action Group)
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The issue of costs has been raised by previous speakers. It is not entirely clear from what Mr. O'Mahony has said what measures, if any, the board can take in this area. The key issue for the public, particularly those within easy distance of the North or with regular access to European markets, is that the difference in cost between medicines sold in this jurisdiction and elsewhere is absolutely astronomical. One can purchase medicines in Spain and elsewhere for as little as 10% of the cost of the same drugs in this jurisdiction. Will Mr. O'Mahony indicate what the board can do to address this situation? As Deputy Ó Caoláin pointed out, these cost differences apply in the case of generic as well as patented medicines.

The delegates indicated that the board has a regulatory function in regard to clinical trials. What are the general protocols in this regard? A suggestion was made in regard to the regulation of blood. I understand that while blood taken from haemochromatosis patients in many European countries is used, it is discarded here.

Is that the case and, if so, what is the basis for it? Will Mr. O'Mahony indicate whether it can be done differently?

Peter Fitzpatrick (Louth, Fine Gael)
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I thank Mr. O'Mahony for coming before us. Why are Irish citizens forced to pay more for medicine than their counterparts in other countries? The HSE is paying up to 12 times as much as the NHS in Britain in respect of the same generic drugs. For example, it paid 42% more than the NHS for the commonly prescribed anti-depressive Lexapro. The HSE pays €44 for 20 Lexapro tablets, while the NHS pays €31 for the same number. It paid more than €16 million for this drug in 2010. In 2000 some €576 million was spent on prescribed drugs in this country. By 2010 this amount had increased to €1.9 billion. Will Mr. O'Mahony comment on why this is the case?

Ciara Conway (Waterford, Labour)
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The issues in respect of pricing have been well covered. Mr. O'Mahony indicated that prior to the Irish Medicines Board's establishment, it was officials in the Department of Health who advised the Government in this regard. What was the thinking behind removing responsibility for this matter from the Department? What evidence is there to show that this is a better way of operating? Is this just a case of another Government Department being hollowed out in order to create a separate organisation? I am concerned in respect of the communications strategies that are in place with the Department, particularly in the context of their effectiveness. What steps are taken to ensure the relevant information gets to those charged with prescribing and pharmacists in order to ensure that people will - at the right time - be given drugs which represent the best value for money?

Mr. Pat O'Mahony:

There was a strong emphasis on pricing in members' questions. As I made clear at the outset, pricing is not a function of the IMB. Like everyone else, however, those of us who work for the board have views on this matter. In the first instance, I wish to explain what is happening in respect of the switching issue to which Deputy Kelleher referred. I will then outline the position with regard to pricing and generic substitution.

The statistics in respect of switching in Ireland are probably as good as those which obtain in any of the other European countries with regard to the number of products that have been switched in recent years. Products are authorised as either prescription, over-the-counter in the pharmacy or for general sale in grocery stores. The rules, regulations and directives generally provide that a certain number of medicines - injectables or whatever - can never be switched from prescription. The rules also provide that when they are first licensed, new medicines are generally classified as prescription-only. This is for the first number of years while broader knowledge is being acquired about their safety profiles, etc.

Jerry Buttimer (Cork South Central, Fine Gael)
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Is there a set number of years for which they remain on prescription only?

Mr. Pat O'Mahony:

Typically it is five years.

Jerry Buttimer (Cork South Central, Fine Gael)
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Is there any review mechanism which can be used during that period in order to switch these products?

Mr. Pat O'Mahony:

In general they are prescription-only for the five years. The most important issue in respect of how the landscape has changed - this gets to the kernel of the question - is that the prerogative remains with the companies to make applications in respect of switching. Let us be clear about this; if we were to determine that a particular medicine should be switched from prescription-only to being available on an over-the-counter basis, in legal terms we are prevented from insisting on this with the company involved. That is an extremely important point. Until approximately two years ago, the decision on whether a medicine should be prescription-only resided - through the various Schedules to the relevant legislation - with the Department. However, it was transferred to us as a specific task at that point. That is what led us to start thinking more proactively about the concept of switching. The consultative panel was established in order to draw out opinion from the broader stakeholder groups, including patients, public health professionals, doctors, pharmacists, the Department, the HSE and nurses.

I was asked if a policy exists in respect of switching. The Department has made it clear that where medicines can be switched from prescription-only to being safely available on an over-the-counter basis - in other words, where they can be provided by pharmacists without patients being obliged to go directly to doctors for full clinical examinations and proper diagnoses - then, at the lowest cost in circumstances where benefit-risk is maintained, the trend should be to switch. That is the current position. Deputy Kelleher stated that IMB has never delisted, which is not correct. We have switched quite a number of medicines over time.

Billy Kelleher (Cork North Central, Fianna Fail)
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I stated that the IMB is slow to delist rather than that it never delists.

Mr. Pat O'Mahony:

Okay. The statistics indicate that approximately 50% of the applications we receive in respect of delisting are successful in the context of achieving positive outcomes. In the other 50% of cases, the products are maintained as prescription-only for a further period.

Jerry Buttimer (Cork South Central, Fine Gael)
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How does that compare with other EU countries?

Mr. Pat O'Mahony:

I am always very frank about these things. In that context, there are much more restrictive regimes in some European countries. The biggest comparator of which people in Ireland are aware relates to the UK, with which we have a common border. Approximately five years ago the UK Government took a principled policy decision to push for the switching of medicines. It encouraged applications for switching and made a very positive move to drive the policy through in order to switch as many medicines as possible. As a consequence of this, it received more applications and it switched more medicines as a result. Cholesterol-lowering medicines are widely used throughout the world and in the UK people can go direct to their pharmacies in order to purchase these products. These medicines are, therefore, largely available over the counter in the UK but in the main are still prescription-only here.

Everyone is now very conscious of costs. As I stated at the outset, the IMB is not immune in this regard. Our procedures are robust and we are bound by timelines. If we receive an application to switch a certain product, we deal with it in the appropriate period. Our judgments are based on benefit-risk factors, namely, whether a medicine can be delivered safely at the level of the pharmacy. Another point which is important to note and of which we are very aware is the fact that regulation of community pharmacies has changed, very substantially, in light of the new pharmacy legislation. There are now much more stringent controls in place in respect of pharmacies. In our view, it is now safer to make certain medicines available in pharmacies than might have been the case five years ago. There is a definite trend in this regard and it will help improve circumstances.

A number of very specific questions were asked in respect of pricing. As already stated, pricing is not my brief. However, we are fully aware of what goes on. In that context, the industry engages in a dialogue with the Department and prices are agreed in respect of on-patent medicines during that period. This exclusivity or patent protection is set under European rules and expires after ten or 11 years. Thereafter, generics are licensed. Most generic products are licensed directly by the IMB and when applications in this regard are received, they are dealt with in a very timely manner. Members are correct: there is very little price differential between generics and innovators in this country at present. In the context of the new Health (Pricing and Supply of Medical Goods) Bill 2012 and generic substitution, our role will be to determine the medicines that are interchangeable. In other words, if there is a patented medicine for a particular indication, if this has gone off-patent and if there are five generic products licensed, our job will be to publish a list and indicate whether all of these six medicines - the original and the five generics - are all interchangeable. We already have in place a list of priority medicines in respect of which decisions will be made, as quickly as possible, when the legislation - in its final form - is enacted. Setting what is called the reference price will not be our function. Responsibility in this regard will rest with the HSE and the Department. If, for example, a medicine costs €10 at present, I have no idea with regard to the level at which the reference price will be set. Our task will be to indicate which medicines are interchangeable.

Jerry Buttimer (Cork South Central, Fine Gael)
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Should the IMB have a role in respect of price setting?

There are various attitudes to that internationally. Typically, pricing is not within the remit of the medicines regulator. The regulator is asked to focus on the safety of patients and the quality of the medicines. I understand two equivalent agencies in Europe have a role in this area: the agency in Denmark and the agency in Italy, which has a small role. Most agencies are like ours in that this role is done by somebody else. The regulator is set up to access the safety, quality and efficacy of medicines and deal with the manufacturing sites, distribution and so on.

On the question of the independence of the regulator as an independent agency versus the Department, although I note Deputy Ciara Conway who raised this issue has left the room, that is a philosophical policy debate. It has happened across all the developed world that medicines regulation has been moved to independent stand-alone agencies, the argument being that they can develop, have resources and run their business and that lets Departments deal with policy issues and the regulator deal with regulatory issues. There is nothing we are doing that could not be done within the Department if the necessary staff were in place and there was a legal basis to provide for that but the model I outlined is the one that exists across the developed world.

Deputy Healy asked specifically about our role in clinical trials. On the question of the use of blood from patients with haemochromatosis, I do not know the answer to that. I do not have that information to hand but I will be happy to provide it by e-mail. I will ask Ms Ann O'Connor to deal with the topic of clinical trials and our role in how that is operated.

Ms Ann O'Connor:

I thank Deputy Healy for his question. The clinical trials carried out are controlled under a clinical trials directive which is transposed into Irish law by statutory instruments. If someone wants to do a clinical trial in Ireland, be it an academic body or a big manufacturing company, they can apply to the IMB. There is a period of 60 days allowed once we receive the application to assess it and come forward with either a positive or a negative outcome, and in the intervening period there would be some level of correspondence with the applicant to clarify questions. The trials can be divided into four phases, with phase one trials being the very early stage and the phase four trials being products on the market that are being further investigated. It is all controlled under a legal framework. Generally what we get on the applications are the protocols and the investigators' brochures. There is a system around it. The legislation on this area in Europe is being reviewed to change it to a regulation, which will mean there will be a uniform application of the legislation in Europe. In the clinical trials, we receive predominantly a large number of applications for cancer drugs, respiratory medicines and some cardiology products. We see these on an ongoing basis. We take them every month and deal with them in a 60-day timeframe.

Mr. Pat O'Mahony:

I would add that the role then extends beyond approving the clinical trial to taking reports of any adverse outcomes during the clinical trial and to inspection of the clinical trial sites. We have inspectors who are trained in this area and we inspect sites on a cycle. When a trial is finished the close-out reports are made. Professor Crown is an expert in this area.

John Crown (Independent)
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I would have to say that the IMB has a very good reputation internationally for this aspect of its work in terms of dealing with clinical trials applications expeditiously and efficiently. Ireland is perceived by international academic organisations as being a user-friendly place to do high-quality clinical trials.

Billy Kelleher (Cork North Central, Fianna Fail)
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I want to get to the bottom of an issue. Mr. O'Mahony said that a company would apply for a drug to be changed from having a prescription-only to an over-the-counter classification. In the interests of being proactive, is it not within the remit of the IMB to say that medicine X or medicine Y could be available over the counter? I was not trying to be facetious earlier when I spoke about lipstick and nail varnish products but the difficulty is that most people who go to a pharmacy to get medication must have a prescription in their back pocket. That is the reality of life. People have to go to the doctor to get a prescription for almost everything. I am speaking from my experience as a parent and of what I have seen when I have gone abroad to other countries. It is possible to buy some medicines in other civilised countries around the world that are not available on a prescription-only basis but it seems the difficulty here is that there is very little delisting of products. We must compare practices here with those in general in the UK, with which we have a border, as well as similar set-ups in the delivery of health care. There seems to be a very slow move towards the delisting and supply of over-the-counter medicines. That is my concern. Mr. O'Mahony will know that if I want to buy medication that is priced at €7 or €8, which is available over the counter in other countries, it will cost me €62 because I will have to go to a GP to get a prescription for the medication and pay him €55. That is the reality. We have the new pharmacy Act, computer software data and various systems available but the Department seems incapable in terms of general health policy in that pharmacists play no role in this respect other than in the dispensing of medication. That resource is under-utilised. These are highly professionally qualified and capable people. The IMB has a role in this respect in terms of pushing for the availability of over-the-counter products. Why would a company not want to have its product available over the counter? It beggars belief that a company would say it would prefer its product to be available on a prescription-only basis. That would surely limit its market availability.

Caoimhghín Ó Caoláin (Cavan-Monaghan, Sinn Fein)
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I raised the issue of the disparity between the HSE regions in terms of access to specific drugs, to which Mr. O'Mahony did not respond. I cited the drug Tysabri and I would like to know if the IMB has any role or function in this regard. It is hugely important that people have access across the board and that there is equal access in every region irrespective of where one lives.

On the point in regard to the chart and the relationships between the various organisations, I do not know who would undertake to put that in place. The IMB might consider that.

The 2005 directive on blood and blood products is one of the elements of the IMB's work programme. To follow up on Deputy Healy's question, it is sadly the case here, although not in other jurisdictions, including in the United States, that blood taken in venesections of those who have haemochromatosis is disposed of - it is literally discarded - yet their blood is rich in iron, which is the problem. Many other people go to the pharmacy to buy over-the-counter medications to substitute their deficiencies in iron. There is no reason this could not be addressed. It is wasteful. There is a cost involved and the international best practice should be applied here. Will the IMB play a role in that?

John Crown (Independent)
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I will make a brief point, more for the information of the committee members than for the IMB witnesses. There are two separate issues I would not like to see get blurred. We as a nation have to look critically at the issue of drug pricing. I am committed, wearing both this hat and my day job hat, to our moving wholesale to generic prescribing. I am very comfortable with generic prescribing and I believe we need to do that. The reality is that if we do not find a way to save some money on some of the drugs for which we have generic alternatives, we will not have the money available to pay for other drugs which are coming on stream and which may be expensive.

I would like to familiarise the committee with the term "biosimilars". These are genetically engineered or manufactured versions of certain drugs that are biological products, such as proteins or glycoproteins. They are not exactly generic; the molecular structures are slightly different, but they will have the same effect. Because the revolution in molecular medicine has now been ongoing for nearly 20 years, we are now getting the first of these biosimilars, which are the biological equivalent of generics. We will be under considerable pressure not to move in this direction, with some potential for misinformation, but I believe we should.

I would like to qualify slightly what my colleague Deputy Kelleher said. Although we see certain drugs available over the counter in many of the countries to which we travel on holidays, this is not always appropriate. The big example people always talk about is antibiotics. I believe that from the point of view of individual health and concerns about the development of resistance of bacteria to antibiotics, there should be medical regulation of the prescription of antibiotics.

It is not obvious to me that there is a big problem right now. I can think of some drugs which in truth probably should be made available over the counter, but it is not obvious to me that there is a big problem in this regard in terms of tardiness in delisting drugs as prescription-only. In response to Deputy Kelleher, part of the reason companies make the decision is to do with liability issues. The companies can have issues of liability if something is prescribed or given inappropriately. At least with a prescription they have an extra level of protection that the product is being used wisely.

Mr. Pat O'Mahony:

I apologise that one or two of the earlier issues were not addressed. I did refer to haemochromatosis. I accept the additional clarifying remarks. I will go back and speak with my senior people about the topic and with the IBTS, to see what precisely can be done and where we stand in terms of international best practice.

Caoimhghín Ó Caoláin (Cavan-Monaghan, Sinn Fein)
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Will Mr. O’Mahony come back to the committee on the matter?

Mr. Pat O'Mahony:

I will. On the idea of preparing a chart, I have made a note of this and put an asterisk beside it. We would be very pleased to take up the suggestion of a chart to help the public understand who does what in this whole area. We can undertake to do that. I did not comment on the differences between HSE regions because we have no role or function in that regard, nor on how decisions are made on the introduction of reimbursement for a particular medicine. It is not our brief.

On whether we will be proactive on switching, while the company makes the application and then we assess it and deal with it, the reason we established the consultative panel was to draw out opinion from across the various stakeholders to raise awareness of the issue. Our ambition is that we will be able to say that in our opinion, particular classes of medicines could be delivered safely over the counter in pharmacies. We fully support the comments about the expertise available. My question is whether companies will respond to that and if legislation should be changed to facilitate it.

I was asked why companies would not want their products reimbursed. That is a complex issue. Again, it is not for me to say, but one of the big issues is that when a medicine moves from prescription-only to over-the-counter, it is no longer on the reimbursement list. Suddenly, a medicine that was prescribed by a doctor, dispensed by a pharmacy and paid for in the reimbursement scheme is no longer available and patients must pay for it themselves. That is an important issue. This is something we have raised in discussions at senior level. We must make informed choices as a country on whether certain medicines can be delivered at the OTC level in the pharmacy, with all of the supports that are available, and whether we should automatically delist them from reimbursement, because that is a disincentive to companies to agree to the change. In addition, a patient might still choose to go to the doctor and have another medicine prescribed that will be reimbursed so that they do not have to pay the pharmacy for it. Pricing is not our area, but we have suggested in discussions at a senior level that the restriction of reimbursement to prescription medicines is another area that should be examined in the current, evolving environment. That is something on which the committee might be able to take a view if it is discussing the matter with colleagues from the Department of Health or the Health Service Executive. We have raised it with them as something we consider might be significant.

Jerry Buttimer (Cork South Central, Fine Gael)
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Will the Health (Pricing and Supply of Medical Goods) Bill tackle the issue?

Mr. Pat O'Mahony:

The text I have seen does not tackle that issue. Reimbursement is dealt with separately. It is currently a policy issue between the Department and the HSE. The matter could be teased out.

Billy Kelleher (Cork North Central, Fianna Fail)
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That is the kernel of the issue. If a prescription-only medicine that is recommended by a GP becomes an over-the-counter medicine, surely people on medical cards should still be reimbursed for it? That would be the logical conclusion. I accept it is a policy issue, but that is the kernel of it.

Jerry Buttimer (Cork South Central, Fine Gael)
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It is all about profit and money as well.

Mr. Pat O'Mahony:

It is a fundamental issue in the debate.

Billy Kelleher (Cork North Central, Fianna Fail)
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That is why the role of the pharmacist should be expanded to include the prescription of certain medicines to ensure that large amounts are not bought morning, noon and night, and that there are controls in place. We must move to such a system because it can be expensive for families to go to GPs.

Jerry Buttimer (Cork South Central, Fine Gael)
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It is expensive for families. Is it the case that, as a nation, we are over-prescribing, and that GPs in some cases are handing out prescriptions to appease people? Is that a fair comment?

Mr. Pat O'Mahony:

There is much discussion on it and comparisons are drawn in the literature about prescribing patterns in different countries. It can be difficult sometimes to ascertain the position as statistics can be misleading. There is a perception that we are over-prescribing certain categories of medicine.

Jerry Buttimer (Cork South Central, Fine Gael)
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It is more than a perception. I refer in particular to reports about medication prescribed in the mental health area. My view is that we are over-prescribing. I might be wrong but that is my perception.

Mr. Pat O'Mahony:

Antibiotics come into the mix as well in discussions. Senator Crown referred to the need to control antibiotics to prevent the emergence of bacterial resistance. There is probably enough evidence to support the contention that we are over-prescribing in certain areas. The question is what one does if one is a busy GP and somebody comes to the practice with an expectation of a prescription, given our current culture. Will the person go down the road and get a prescription elsewhere? The medical profession must have such a debate in terms of their practice. The debate in that regard is ongoing.

One of the issues that has been discussed internationally, which is worth examining, is the area of medication reviews. It is not exactly our remit but we are interested in the area. If a patient is on a complicated regime of five, six or seven medicines, and he or she visits a GP on a monthly basis and has the prescriptions renewed and then the pharmacist dispenses the medicines, in some countries there is another dialogue, perhaps at the level of the pharmacy, to talk about the overall basket of medication he or she is taking. One might find that he or she is no longer taking one or other of the medicines because in his or her judgment it is not doing them any good or does not suit them. The medicine is still being dispensed and is still a cost to the state. The concept of medication reviews in a planned way is something that should also be examined in the evolution of this area.

Jerry Buttimer (Cork South Central, Fine Gael)
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By the same token, we as non-professional people who go to our GP must change our mentality on getting a prescription for X, Y or Z. Deputy Kelleher’s point is valid in that if one goes into one’s pharmacist they should be able to advise on what one should do even for something as simple as a head cold, rather than having to get a prescription to take Augmentin or whatever else.

Mr. Pat O'Mahony:

Deputy Kelleher's comments related to people who pay for a GP consultation, but a substantial number of people are on medical cards and do not pay but they are still taking up time with the GP. There is a cost to the system no matter whether the patient is a private or public one.

Billy Kelleher (Cork North Central, Fianna Fail)
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Yes.

Mr. Pat O'Mahony:

The same argument applies.

Billy Kelleher (Cork North Central, Fianna Fail)
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Does the IMB have the resources available to deal with generic substitution or will it require further resources?

Mr. Pat O'Mahony:

We work hard on strategic planning and staffing arrangements. We made a submission last year which was dealt with and now we have another submission about staffing with the Department. We have already committed to doing the part of the work we are asked to do on generic substitution. We have a few extra posts approved by the Department and the system to do that work and we are adequately resourced to do it.

Jerry Buttimer (Cork South Central, Fine Gael)
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On the issue of tanning injections and the dangers highlighted by the Irish Medicines Board under its remit, particularly for young children I refer to the parents who are being irresponsible has the board been robust in its campaigns warning of the dangers of using these products, particularly if they are bought on the Internet? Those products, and other counterfeit products, can be bought on the Internet. We all get spam e-mails about different types of Viagra, other tablets and so on. My inbox is inundated with a multiplicity of requests from God knows who and I am concerned about that because the Internet has become a tool that everyone from the age of three to 83 can use. We must be more vigilant about this issue.

Mr. Pat O'Mahony:

The issue of the availability of and access to counterfeit goods via the web is hugely important. We have an enforcement team which does a variety of work across the regulated and unregulated sectors and they put a great deal of time and energy into this area. We are constantly seizing product and have built up strong relations with Revenue Commissioners customs officers. We know that products are still coming into the market that we are not seeing; we are seeing only a part of it. We seize thousands of tablets every year.

The recent coverage on the injectable tanning product is very concerning. We warned about that two years ago and again recently. We were aware that the story was brewing again. A small number of people are using it. They are putting themselves-----

Jerry Buttimer (Cork South Central, Fine Gael)
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Is it a small number of people?

Mr. Pat O'Mahony:

It is a small number but that does not matter in the final analysis. I have been asked that question in the media and so on. We are concerned about everybody in the population. People can be ill-informed. They can consider that this is the right thing to do for themselves at the time. At a certain age they believe they are not vulnerable and that they can deal with these issues themselves. Our job as the regulator is to try to get out as much advice as possible. We have done a good deal in terms of publishing an information leaflet on this area and four, five or six times a year we issue press releases to the effect that these products should not be bought on the Internet because the area is not regulated. We know from our research and sampling that 50% or 60% of it is counterfeit. It has no ingredient or some other ingredient. It is very dangerous and the more we can do to highlight that, the better. It is a very important public health issue.

Jerry Buttimer (Cork South Central, Fine Gael)
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Has the board considered using social media as a means of interacting with people on the use of medicines and on the topic we are discussing?

Mr. Pat O'Mahony:

We had some discussions recently. We are not yet in that social media space. It is something we are beginning to examine. Some of our counterpart agencies have already moved into that space. There is a new generation that is very well versed in this area and it is something that we will certainly examine.

Jerry Buttimer (Cork South Central, Fine Gael)
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On the basis of Mr. O'Mahony's comments and his presentation about people self-medicating or self-diagnosing and seeking information, I suggest that he examine that as a new way of interacting with people. His presentation and this discussion have been very worthwhile but it has a limited audience. I hope we can broaden that through Mr. O'Mahony's ability to communicate with people.

Mr. Pat O'Mahony:

I thank the Chairman.

Jerry Buttimer (Cork South Central, Fine Gael)
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If there are no other questions or comments, I thank Mr. O'Mahony and Ms O'Connor. I forgot to mention that Mr. Nigel Fox, communications information manager, and Ms Ger McCarthy, account director, are in the Gallery. I thank the witnesses for attending. I remind members that we are adjourned until 9.30 a.m. next Thursday morning.