Ms Ann Horan:

I thank the Chairman and members for the opportunity to address the committee. I will use my opening statement to explain the process which led to my selection as chairperson designate of the Health Products Regulatory Authority, HPRA, and my qualifications and suitability for the role. I have also been asked to give a short briefing on the work of the HPRA and my ambitions for the authority.

The role of chairperson of the HPRA, a part-time non-executive role, was advertised in early October on the Public Appointments Service website, publicjobs.ie. As a current HPRA board member, I decided to apply for the role and, in mid-December, I was honoured to receive a call to advise that I had been selected by the Minister of State, Deputy Kathleen Lynch, as her preferred candidate. I subsequently received a letter confirming my selection and an invitation to appear before the committee today. As part of the application process, I was required to write a letter to the Minister for Health outlining my suitability and qualifications for the role. I am using much of the same wording here to make my case to this committee.

Over the past five years, I served as a board member of the HPRA and chairperson of the audit committee. During that time, I gained a clear understanding of the work of the authority, its strategic direction and imperatives and a healthy respect for the management and team of experts who run the day-to-day operations of the HPRA. At board meetings, I have always been vocal and challenging while remaining constructive and supportive of management in the performance of their roles. I have been called on a number of times for advice by the chief executive and the director of finance and I am generally invited to participate on key committees including the performance evaluation committee and the selection committee for the new chief executive. I was instrumental in securing the approval of the board for a number of key initiatives and I have an excellent attendance record and always prioritise my board meetings above other diary commitments.

A copy of my CV was circulated to the committee in advance of this meeting and I do not intend to go through the details now although I am of course happy to take questions. In summary, my career experience to date includes senior executive roles in banking, small business, regulation and education. I have served on boards including Dublin City University, the Institute of Bankers, South Dublin Chamber of Commerce and chaired associations including the UK based Factors and Discounters Association and the International Women’s Forum. I am a chartered certified accountant, FCCA, and I have a master's degree in finance from Dublin City University. These roles developed my expertise in the areas of leadership, strategic planning, financial control, risk management, corporate governance and technology and helped improve my communication, decision-making, influencing, negotiation and people management skills. I have proven ability to operate in both the public and private sectors and I have direct experience in the areas of regulation and investment management.

In January 2015, after six exciting and successful years establishing and running, as chief executive, the DCU Ryan Academy for Entrepreneurs, I decided that my work was done and that it was time to hand over the reins. I took time out in 2015 to enjoy a better quality of life, travelling and spending time with my family and friends and limited my professional time to a small number of voluntary roles in various organisations, including the HPRA, the South Dublin Chamber of Commerce and South Dublin County Council.

I decided not to return to a full-time role for the time being but to take on one serious part-time challenge. The role of chairperson of the HPRA was my first choice in this regard having spent the past five years growing to appreciate and understand the organisation. I have the time and interest to lead the board at what I see as an exciting time in its history and I feel I would be an ideal person to support the new chief executive, Dr. Lorraine Nolan, who took up her role earlier this month.

My fellow HPRA board members are experts in the fields of human and veterinary medicines and medical devices. I look forward to employing my business and governance skills in particular in leading the board and ensuring the HPRA and our various stakeholders benefit from the guidance and leadership of this group of experts.

I will move on now to the work of the HPRA and our strategic plan. The HPRA is the independent regulator of health products in Ireland. Our role is to protect and enhance public and animal health, by assessing the safety, quality and effectiveness of health products on behalf of the public so as to ensure the benefits they provide outweigh any potential risks. We regulate a wide range of health products, including human and veterinary medicines, medical devices, blood and components, tissues and cells, organs for transplant and cosmetics. For some products, such as medicines, we regulate across the entire product life cycle from clinical trials right through to use by health care professionals, patients and animal owners. For others, our role starts when the product first comes to market. We monitor these products and act upon any safety issues that are identified. In all cases, our core focus is on effective regulation. This means harnessing the best scientific and clinical knowledge available to us through our specialist staff and experts nationally and our participation at European committees.

In addition to protecting public health, a robust regulatory system is important for Ireland as a major international location for the life science sector. We know that the pharmaceutical industry alone accounts for over 50% of all exports, with nine out of ten of the largest pharmaceutical companies having operations here. Ireland also has a large and vibrant medical device manufacturing industry. The HPRA’s regulatory role supports the sector’s continued success by monitoring compliance with good practice and adherence to legal requirements.

The HPRA board approved a new strategic plan for the period 2016 to 2020 at its meeting in December. The timing of this plan coincides with the term of my proposed appointment as chairperson. Our five-year vision, as expressed in this plan, is to be a leader in effective and innovative regulation, both nationally and internationally, and a recognised centre of excellence for the quality, efficiency and scientific rigour of our work. Through successful implementation of this plan, we will continue to optimise our regulatory processes and systems to keep pace with product and manufacturing developments and play our role in enhancing access to health products and providing high-quality, timely information to health care professionals and their patients. Underpinning all of this will be a focus on recruiting, retaining and developing the best scientific and administrative staff to deliver on our core mission of protecting and enhancing public and animal health.

Over the period of the plan, changes in the regulatory environment will provide challenges and opportunities for the organisation. The most significant of these relates to European and national legislation. Medical device legislation will be substantially revised, as will the legislation for veterinary medicines. Increasingly, efficiencies will be gained within the European Union by centralised assessments and more effective solutions will be possible through EU co-operation on issues such as medicine shortages - which affect many countries as well as Ireland - and early access to new medicines which have important benefits for patients. Our communication and stakeholder engagement will be shaped by society’s growing expectations of regulators, while technology advances have the potential to transform the manufacturing and capability of health products. These advances will challenge us to ensure that we continue to regulate innovative products effectively.

I see my role as chairman to work with the board to support the chief executive and the executive team in the implementation of the plan. Specifically, I will work to ensure that the HPRA has sufficient resources and expertise to carry out its functions effectively. I will use my leadership position on the board to ensure that the authority benefits from the expertise and knowledge of the board and the various scientific advisory committees. Communications is an important aspect of my role and I will ensure that the HPRA has an effective communications policy and that we work closely with our colleagues in the Departments of Health and Agriculture, Food and the Marine and the HSE for the benefit of patients and the public good.