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.