Simon Harris (Wicklow, Fine Gael) | Oireachtas source

I thank the Seanad for giving me an opportunity to address this important issue today. I look forward to listening to the contributions of Senators. I hope it is clear that everyone here shares the absolute objective of securing access to this medicine for Irish patients at an affordable price. Irish cystic fibrosis patients should have access to innovative treatments. This is the clear objective of the HSE, which is negotiating on behalf of Irish patients. I consider it essential for the HSE to receive the full support of all public representatives in its efforts. When negotiations of this nature are taking place, we should not forget that the HSE is the only party in the room that negotiates on behalf of Irish patients. This is not about attacking big pharma. This is about supporting Irish patients and supporting the people who are working to get the very best deal for Irish patients.

It is unacceptable that cystic fibrosis patients have been used as pawns in this process. It is regrettable that many of them and their families have been put through a harrowing time. The company in this case has refused from the outset to put a fair and reasonable price on its treatment, in line with the price guidance provided not by the Government, the HSE or the Department of Health but by Professor Michael Barry and his team in the National Centre for Pharmacoeconomics. The company has refused to give absolute certainty to patients on managed access schemes or programmes that they will continue to receive their treatment for the rest of their lives, regardless of the outcome of the commercial negotiations with the HSE. It has actively sought to place Irish cystic fibrosis patients in the centre of its commercial negotiations with the HSE, with a view to maximising the return for its executives and shareholders. This type of behaviour is not unique to this drug, unfortunately, and is certainly not unique to Ireland. Similar pricing strategies have been employed in the past. My counterparts in other EU member states inform me that this type of behaviour is evident in their countries too.

As Senators will be aware, I attended a meeting in Lisbon yesterday to discuss drug pricing, innovation and the sustainability of European health systems. I took the opportunity to raise directly the situation in respect of Orkambi and the manner in which the company is treating cystic fibrosis patients and their families in Ireland. It was clear from my discussions with health Ministers from other countries that the current situation is not sustainable. Advances in medicines have played a key role in improving the overall health of Irish people. However, health care systems throughout Europe are quickly reaching a point at which patients cannot access new and innovative medicines because of the pricing strategies of manufacturers. Innovation is not of any use if patients cannot access it. As we have seen with medicines like Orkambi, the price the company is seeking to charge means innovative products may never reach the patient. This is not acceptable. Equally, it is not acceptable that health systems are finding themselves unable to afford the prices being quoted. This can be viewed as a funding problem or a pricing problem, but my view is that it is primarily a pricing problem. If we are to ensure innovative medicines are available to patients with unmet needs, companies like Vertex need to fundamentally reassess their pricing models. I appeal to them today to do so.

I will focus on price because it is the main barrier to access in this instance. The National Centre for Pharmacoeconomics has independently assessed the evidence and benefits of this treatment. Based on a detailed examination of costs and benefits, including reductions in other treatments, the national centre considers that an annual price of €30,000 per patient would be appropriate. At this price, the HSE would pay €15 million a year for Orkambi, or €75 million over the next five years. This is a significant investment. Any public statement from the company on prices should be compared to these figures. There has been an attempt to undermine these figures as inappropriate for this type of treatment. I remind the House that at €30,000 per patient per year, this would be one of the most expensive treatments in Ireland. In fact, it would be sixth on the high-tech drugs list in this country. I am not in any way attempting to undermine the benefits of the treatment. I am doing the opposite - I am acknowledging its benefits for Irish patients. Unfortunately, the price the company has put on this product is many multiples of the figure I have mentioned. Despite the company's claims, in the absence of verifiable evidence to the contrary it appears that the main driver of the price is an estimate of the maximum amount that this country can pay and is not connected to the health benefits of the treatment or the cost of bringing the medicine to the market.

There has been a significant debate in recent days on the outcomes-based model, which is something I support. To put it simply, it involves the company having the confidence in its product to provide the treatment to all eligible patients, but not to seek payment until the treatment delivers benefits to Irish patients. The HSE has confirmed that Vertex has made it clear that it is not willing to engage in an outcomes-based model that addresses the HSE's core pricing concerns. This is very disappointing. If the company has the same level of confidence in Orkambi as many patients and all of us - we know it can make a difference to people's lives - it is time for it to put the product where its mouth is and to engage in an outcomes-based model. Vertex should provide the drug to every patient who could benefit from it and we will pay based on who can benefit from it. It is very disappointing that the company is not in a position to do this.

As Vertex is refusing to release the HSE from commercial confidentiality requirements, the HSE cannot provide this House and, more importantly, cystic fibrosis patients with a transparent understanding of Vertex's proposals in the negotiations. Taking account of the outcome of negotiations and having considered the recommendations of the National Centre for Pharmacoeconomics and other expert advice, the HSE's drugs committee has not recommended reimbursement for Orkambi. Where do we go from here? I repeat that we all share a unified view of wanting to make the most innovative treatments, including Orkambi, available to Irish patients. I want to assure cystic fibrosis patients loudly and clearly on the record of this House that this is not the end of the process. The HSE directorate will consider the drugs committee’s recommendation, taking into consideration the manufacturer's price offer. This decision will be made on objective scientific and economic grounds and in line with the Health (Pricing and Supply of Medical Goods) Act 2013, as passed by this House and the other House. This is the next formal stage in the statutory assessment process. The HSE has made it crystal clear that it is open to meaningful engagement with the company.

Drug companies and public relations companies have gone into overdrive in their efforts to assert that I will not attend negotiations. I want to make it very clear that this is a complete misrepresentation. The law of this land, as passed in 2013 by Senators in this House and by me and my colleagues in the Dáil, makes it clear that the HSE is the body with statutory responsibility for decisions on pricing and reimbursement of medicines. It carries out the negotiations. However, I have been in regular contact with the HSE. It is ready to make this happen. Vertex should do the same. It is not the case that there is one rule for Vertex and a different rule for every other drug company. Vertex must respect the laws of our country, our processes and our democratic decisions. The HSE does the negotiations. It is time to stop the spinning. If the company spent less time spinning in the media and more time engaging in a meaningful manner, we could try to get this matter resolved. When the spinning stops, we can get back in the room, start the talking and get on with making this happen. I want to assure Vertex and, more importantly, cystic fibrosis patients that the people from the HSE who are needed to help to make these decisions will be in the room. We should not try to politicise this. I ask Vertex not to interfere with our political system and the rules of our country.

As I have mentioned, this situation is not unique to Ireland. I am looking at every option to make progress with this issue and other issues in relation to drug pricing in collaboration with other countries. This is a very viable option. I have contacted health Ministers in four other countries - the UK, Scotland, Canada and Australia - where Vertex’s very high pricing has prevented reimbursement for cystic fibrosis patients. I believe there is potential for joint co-operation in seeking to have a positive influence on the manufacturer's pricing strategy. As I have outlined, I raised this issue with health Ministers in Lisbon yesterday. I will continue to do so as part of moves to consider pricing for expensive drugs across Europe. Despite the claims of the company, there is very significant value achievable to patients and health systems from such collaboration. We should be working at EU level in relation to this. It is nonsense for companies to say this will take years. The company in this case is negotiating with many countries and has failed to conclude negotiations with Canada, Australia, the UK, Scotland, the Netherlands and Ireland. It is right and proper for countries to talk to one another to share information and try to adopt a common approach. All health Ministers in the EU and beyond want to make this drug available to our patients. We are charged with looking after the interests of the patients in our countries.

I appreciate that this is a stressful time for cystic fibrosis patients and their families. I have had an opportunity to meet a number of them. I am in regular contact with some of them. I strongly urge Vertex to provide this drug at a fairer price for the benefit of our patients as quickly as possible. As Professor Michael Barry has said, it is time for the company to put its patients first and to significantly reduce its price to one that is fair, equitable and sustainable.I fully support the HSE in its efforts to reduce the price of medicines in order that our CF patients can be treated with it. I call on all public representatives, including Members of the Seanad, while rightfully highlighting the concerns of CF patients, to make sure that that concern is not accidentally diverted in a way that is used to help Vertex rather than our patients.