Dr. Kieran Harkin:

We are grateful for the opportunity to address the topic of fair and equitable access to medicines. Members will be aware that health systems across the world are faced with the challenge of delivering safe and effective care within the context of limited budgets. This is certainly the case in Ireland, with our growing and ageing population. This challenge is compounded by spiralling medicine costs and the ever-increasing demand for access to new, high-tech and innovative medicines. It is clear that unless addressed, the current system of medicines development will continue to heap financial pressure on a strained health system and will put pressure on Governments to reimburse medicines at any cost. It will also continue to deny patients access to essential medicines.

Members will be familiar with examples of problems of access to orphan drugs such as Orkambi, Spinraza and Pembro, which are now almost household names. The greatest economic challenges arise, however, when high price tags are attached to drugs that are used to treat more common diseases. Hepatitis C treatment drugs were introduced to Ireland in 2014 with a list price of €80,000 for a 12-week course. At that time, an estimated 20,000 to 50,000 patients were in need of treatment, which carried an estimated budget impact of €4 billion. Fortunately the monopoly was broken and with the arrival of a number of similar drugs, the price was significantly lowered. I draw the committee's attention to our written statement in which we had mentioned a price of €46,000 per treatment course. I have since been informed that this figure was much higher and was, in fact, €80,000 in 2014.

The difficulties we currently face will appear minimal when new cancer treatments come onto the Irish market. CAR T-cell therapies, for example, will appear with a price tag of $475,000.

I must make it clear that while we are aware that much great work is being done to maximise efficiencies and to create opportunities within the current system, we believe that ultimately the drugs development model is in need of radical reform. The fundamental problem with the current model is that a patent holder is permitted to demand as high a price as the market will bear for the duration of the associated 20-year monopoly. We believe that inherently within the current system lies a power imbalance whereby the interests of the pharmaceutical industry take precedence over the interests of the public. This is a case of the tail wagging the proverbial dog.

Mr. Robbie Lawlor will continue this presentation.