Maire Devine (Sinn Fein) | Oireachtas source

This is a heartbreaking but potentially lifesaving topic. Last week we heard the personal testimonies of distraught parents of seriously ill children whose survival they see in the prescription of Orkambi. Yesterday, there were hundreds of people, some of them extremely ill, outside Leinster House, dragged onto the streets to demand what could be a lifesaver for them. They are desperate people in a desperate situation.

I do not envy the Minister or his position. We disagree on much politically but on matters such as this, politics is put to one side and we work together for a collective goal. The single biggest problem in providing this drug to cystic fibrosis sufferers is mass global pharmaceutical companies and their unrelenting quest for mega profit. These companies do not care about the hundreds of people that were outside these buildings yesterday or about Finn, who is two and a half years old and has been hospitalised 38 times.

Disturbingly, these protests and personal stories probably help the drug companies and their financially unrealistic demands of governments around the world. They can literally charge whatever price they like for the drugs they produce in patent. Playing roulette and brinkmanship with people's lives on the basis of money is abhorrent and morally wrong. We need cool heads to prevail and a determination to deliver this life-saving drug to extremely ill people in a cost-effective manner. What is most important is that it is delivered and precious lives are saved.

I am under no illusion about the scale of this problem. Today it is Orkambi and tomorrow it will be the next life-saving drug. Shamefully caught in the middle is a precious human life that needs to be saved. The HSE and the Department of Health need to establish a working group that will bring forward appropriate decision criteria for the reimbursement of orphan medicines and technologies. This approach should include an assessment system similar to that for cancer therapies established under the national cancer control programme, NCCP. This recommendation was contained in the National Rare Disease Plan for Ireland 2014–18. Two years into this period we learn that the terms of reference for this group are only being developed. We need to continue this without delay.

The cost of this drug, Orkambi, has been determined by the HSE at €392 million over five years. Vertex, the drug company, has seriously disputed this amount and it is publicly known that Vertex is willing to negotiate. It needs to be transparent about how much it will accept for this drug. Ireland sets the cost per quality adjusted life at €45,000. This is a long way off from the cited cost of €160,000. These large drug companies argue that the thresholds used to calculate cost effectiveness are too low.

Governments need to take back control of mass research. We cannot allow pharmaceutical companies hold our Government or any other government to ransom for profit while playing with peoples' lives. Pharmaceutical companies by their very nature and desire for high margin profit are specifically targeting orphan drugs because of the small concentrated group of patients they can treat in line with the low volume, high margin business model that they can manipulate. We are cognisant of the fact that Orkambi was rejected not because it did not work or because the authorities are not aware of the very real lives of Irish citizens and their debilitating illnesses such as cystic fibrosis, but because of the huge price tag put on it by Vertex. We have to promote reviewing the ten-year exclusivity granted to pharmaceutical companies which, along with generous tax credits, also face less intensive regulatory practices to get these drugs off the ground.

Once these drugs are approved, pharmaceutical companies are effectively given a licence to print money. They have a ready made audience and provision of treatment becomes extremely emotive because of the rarity of the illnesses backed up with strong, intensive lobby groups eager to secure previously unavailable treatments. This is done in good faith out of care for loved ones or indeed to secure their own lives. The major problem is the despicable greed of the pharmaceutical industry.

Vertex says it has yet to turn a profit on this drug but its trading figures tell a different story. The priority for us is to secure Orkambi for our very ill citizens. We should create risk-sharing arrangements where the manufacturer must share risk with the purchaser, co-operate with other countries to negotiate more powerfully and increase bargaining power.Co-operating with other countries will also enable us to present a larger patient pool.