Speech by Minister Harris to the BioPharma Ambition conference, Dublin Castle

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Introduction & IPHA Agreement

Good afternoon.

I want to begin by thanking the joint organisers – the Irish Pharmaceutical Healthcare Association (IPHA), BioPharmaChem Ireland, and the National Institute for BioProcessing Research and Training (NIBRT)  –  for inviting me to speak at this event. It’s a source of real pride to myself and my colleagues in Government that Ireland has managed to establish itself as a place of global importance for the biopharmaceutical industry.

Thank you in particular to Seamus Fives, chairman of BioPharmaChem Ireland,

Dominic Carolan, CEO at the NIBRT, and Leisha Daly, president of the IPHA. I know that Leisha and certain other members of the association’s board spent a considerable amount of time – probably longer than they would have liked – in the confines of the Department of Health in recent months working hard to reach a new drug pricing and supply agreement with the State.

Thanks to this new agreement, signed in July, our Health Service Executive (HSE) is already paying less for medicines, and will continue to make savings on its drugs bill over the next four years. This means that the HSE will be much better positioned to meet the increasing demands of Irish patients for existing medicines, as well as to invest in new, innovative medicines of the kind developed by the biopharma sector.

I believe the new agreement brings certainty and represents a good deal for the association and a good deal for the State, and I’d like to acknowledge the commitments that the IPHA has made on behalf of its member companies.  This country has a strong track record in providing access to new and innovative medicines for Irish patients, and I’m sure that we can all agree that Ireland should remain to the fore among its European peers in terms of early access to new medicines in an affordable manner.

A key element of this framework agreement is a revised set of principles and processes for the assessment and reimbursement of new medicines in Ireland. This included greater detail on the stages of the assessment process, changes to the parameters of the Health Technology Assessments used by the HSE when considering applications for reimbursement, as well as the introduction of an affordability clause intended to capture the five-year cost of reimbursing any given drug. Both industry and the State will benefit from greater certainty and transparency surrounding the assessment process, and this will be supported by an annual shared horizon scan process to determine the pipeline of new medicines.

While the Government has a duty to focus on the affordability of new drugs, we are also fully aware – and appreciative – of the importance of medicines in creating better outcomes for patients within the Irish healthcare system. This is particularly true when it comes to tackling chronic diseases. Between 2000 and 2014, Ireland’s age-standardised death rates from circulatory diseases have fallen by 50%, while death rates for respiratory disease, including lung cancer, have fallen by 45% over the same period. New medicines have clearly played a major part in improving mortality rates for chronic diseases, and will continue to do so into the future.

One area in particular that I would like to touch on today is biologic medicines. As you are all aware, biologic medicines represent an area of huge growth in the pharmaceutical industry, and biologics can often provide new treatments for previously untreatable conditions. According to a recent report by the IMS Institute for Healthcare Informatics, the global market for biologic medicines is projected to exceed $390 billion by 2020, by which time biologics will account for more than a quarter of pharmaceutical sales by volume.


This dramatic growth in the biologic sector is also driving growth in the area of biosimilar medicines.  These medicines will have a significant impact on health systems across the world as they will enable patients to access a greater range of medicines while ensuring greater competition in the biological medicines market, helping to balance the issues of access and affordability.

Officials in my Department are currently assessing the whole area of biosimilar medicines and are developing a policy to support the introduction of biosimilar medicines in Ireland. I know that they have already met with representatives from the Health Products Regulatory Authority, and that the authority has indicated that it supports the prescribing of biosimilars. I believe that new clinical data in this area is expected early next year, and this will help to shape our policy.

The HSE’s Medicines Management Programme also issued a position paper earlier this year supporting the development of biosimilar medicines and the appropriate introduction of biosimilars into clinical use in Ireland. So it looks as if the stars are aligning to a certain degree in this area.

We are looking to create the right market conditions that will enable the biosimilar industry to grow, just as the rest of the pharmaceutical industry has been supported to grow.  Once our policy on biosimilars is fully formed, it will have the benefit of providing clarity for industry about the Government’s wish to see biosimilars developed for use in the Irish healthcare system.

Pharma Industry

In more general terms, I’d like to acknowledge the significant contribution that the pharma industry has made to the Irish economy, not least in the last few years as the Government worked to lead the country out of recession. Thanks to the growth of the industry here in recent decades, Ireland has become the largest net exporter of medicines in the European Union, with annual pharmaceutical exports of more than €30 billion. Nine of the ten largest pharmaceutical companies now have operations in Ireland, and collaborative clusters in pharmaceutical, biotechnology, medical devices and diagnostics have been a key factor in the growth of the sector in recent decades.

The Government greatly values the industry’s ongoing contribution to the economy in terms of investment, jobs and exports, as well as its contribution to the health services.

As I see it, one of the biggest factors in your industry’s contribution to health in this country is the pursuit of excellence in research and development. The health services in Ireland employ around 100,000 people, many of them highly qualified health professionals, delivering a complex range of interventions with hugely important consequences – usually very positive consequences. The knowledge-intensive nature of modern health delivery means that R&D must be absolutely embedded in health service delivery.

One of the key players in achieving this is the Health Research Board (HRB). As the primary funder of health research in Ireland, the HRB allocates approximately €35 million a year to research in our universities and health system, and manages an awards portfolio in the region of €150 million.

Irish health researchers are successfully competing at the highest level for EU funding, as evidenced by their success in securing over €30 million in funding from Europe’s flagship research programme, Horizon 2020.

And just last week, I had the pleasure of announcing the Wellcome – HRB Irish Clinical Academic Training Programme, an exciting new programme to advance clinical research capability among doctors in Ireland. This all-island collaborative partnership will support the intake of eight postgraduate trainee doctors a year for a five-year period, providing fully integrated clinical and research training up to consultant level.

In the long term, patients will be the real winners from this programme, which will fundamentally improve both the number and calibre of Clinician Scientists working in Irish universities and health services.

Universities and hospitals also have a key role to play in the conduct of clinical trials, and I know that this is an area that the organisers of today’s event have identified for further growth. The Health Products Regulatory Authority (HPRA) is already making great strides in this area:  the Authority approved the commencement of 108 clinical trials relevant to human medicines in 2015, compared to 80 trials in 2014, with cancer and blood disorders to the forefront among the key clinical research areas.

Health Service

As many of you will know, I’m still relatively new to the role of Minister for Health. Suffice to say there’s rarely been a dull moment. While there are many challenges, there are great things happening every day across our health service.  My focus as Minister is to ensure the great work continues but also to seek to overcome the challenges evident across our system. No one expects the health system to be fixed overnight, or even within the lifetime of a government, but we need to have a direction of travel. The health service needs and wants reform and a long-term vision but it doesn’t want a vision that changes every time the Minister changes.

From my perspective, one of the key elements in the Programme for Government was the establishment of an Oireachtas Committee to develop a cross-party consensus on a long-term, strategic vision for health care and future health policy in Ireland. In June, the Dáil agreed to establish the Committee on the Future of Healthcare, and the Committee produced an interim report in August setting out its proposed goals, work schedule, and specific objectives.

The Committee has now begun to meet in public session, and will meet regularly over the coming months with a view to presenting a final report to Dáil Eireann in January of next year.


While the health service is my first priority, I’m also acutely aware of the other social and economic challenges that Ireland is facing, and will continue to face in the coming years. One of those challenges is Brexit. Given the international nature of your industry, I’m sure that many of you are busy making plans to position your companies to meet this challenge, and if possible, to turn it into an opportunity.

I know that my colleague, the Minister for Jobs, Enterprise and Innovation has already spoken to you this morning about the opportunity we see for even greater investment by the pharmaceutical industry in Ireland.

From a health perspective, one of the more interesting opportunities afforded by Brexit is the chance to submit a bid to bring the European Medicines Agency (EMA) to Ireland. Given the importance of the EMA’s work, which most of you will know far better than myself, it’s important that any disruption to the agency’s work should be kept to a minimum when it relocates from London, probably within the next couple of years.

Ireland can boast an excellent track record in regulating medicines and medical devices, and this is due in no small part to the work of the HPRA, which enjoys an international reputation in regulatory compliance.

The HPRA, previously known as the Irish Medicines Board, has played an important role in the work of the EMA since the agency’s foundation, and I understand that HPRA staff currently contribute to a wide range of committees and working parties at the EMA, including holding the Vice Chair position on the Pharmacovigilance Risk Assessment Committee the Chair of the Committee for Medicinal Products for Veterinary use.

As well as having a proactive and committed national medicines agency in the shape of the HPRA, Dublin offers many other advantages as a location for the EMA, including a thriving pharmaceutical sector; excellent air connectivity with other EU capitals; and a highly educated, English-speaking workforce.

With all these factors, and more, supporting Ireland’s claim to host the EMA, my Department  –  together with the HPRA, IDA Ireland, and a number of other agencies and stakeholders – has already begun to lay the groundwork for preparing a formal bid, and I know that your industry will support our efforts to bring this prestigious agency to Dublin.


Given the remarkable growth of the pharmaceutical industry in Ireland in recent years, it is easy – even for a Minister for Health – to become distracted by talk of finances and percentages, and to forget that the most important person in your business and mine will always be the patient. Ultimately, it will be patients who benefit from the kind of innovation that drives your industry, and this event sends a clear message as to how highly you value innovation. Your industry has made remarkable advances in medicines in recent decades, and I applaud your commitment to continue making these advances, which can save lives and improve the quality of life for countless numbers of patients in Ireland and across the world.

Finally, thank you again for inviting me to speak today. I hope that you enjoy your lunch, and the remainder of the conference programme.