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https://www.facebook.com/DeputySimonHarris/videos/1689878901029285/?sw_fnr_id=151271955&fnr_t=0
“I WAS DELIGHTED to be able to announce in the Dáil this evening that today (11 April) the HSE and Vertex have reached an agreement in principle which will see Orkambi and Kalydeco made available for cystic fibrosis patients here in this country from next month.
“I know it has been an extraordinarily difficult time for cystic fibrosis patients, their families and their friends as they awaited this news, but finally we have an agreement. In the next few days Vertex and the HSE will work on the contractual terms to make sure we have the best and most robust deal possible…
“I want to thank and commend all of the many advocates right around this country – people with cystic fibrosis, mothers, fathers, brothers, sisters and friends who advocated and campaigned for certainty for themselves or their loved one in terms of access to new medication.”
Those were the words of Health Minister Simon Harris on 11 April, a historic day for cystic fibrosis (CF) campaigners in Ireland. After a long-running battle, hundreds of patients were set to gain access to Orkambi and Kalydeco.
Cystic Fibrosis Ireland has said around 590 people here have the potential to benefit from Orkambi (patients aged 12 and older) and Kalydeco (children aged two to five).
About 1,200 children and adults have CF in Ireland, which has more cases of the condition per head of population than any other country. It’s an inherited chronic disease that primarily affects the lungs and digestive system and can greatly impact the lifespan of those with the debilitating condition.
People who had already been granted access to Orkambi through a trial, such as Jillian McNulty, said the medication had been life-changing.
The cost of Orkambi, about €159,000 per patient per year, was the primary sticking point in the talks. In 2016, the National Centre for Pharmacoeconomics (NCPE) assessed the drug and didn’t deem it cost-effective.
The medicines watchdog estimated that the drug would cost the State more than €390 million over five years. This figure was rejected by Vertex last December – the company said it was “incorrect, unrealistic and does not reflect discussions to date with the HSE”.
Records discussing the financial aspects of the agreement have not been made public due to the “confidential and commercially sensitive information” they contain, according to the HSE.
Last year Germany struck a deal with Vertex to pay €133,000 per patient per year for Orkambi.
As previously outlined by Fora, the CF ‘market’, for want of a better word, is underserved because it affects a relatively small number of people, and biopharmaceutical drugs that treat it are costly and take longer to develop.
The road to achieving the agreement had many twists, and negotiations proved fraught at times as people worked tirelessly behind the scenes.
Documents released to TheJournal.ie under the Freedom of Information Act show how tensions built between the HSE and Vertex as staff edged closer to striking a deal.
This website previously published emails exchanged between the Department of Health and Vertex about the agreement.
‘A direct attack’
Amid the celebrations on 11 April, the wording of the agreement was still being bashed out between the HSE, the Department of Health and Vertex – even into the late hours.
On 11 May – shortly after 11pm – Carl-Michael Simon, the Vice President of Vertex’s international legal section, emailed Shaun Flanagan, Chief Pharmacist of the HSE’s Corporate Pharmaceutical Unit, a revised draft of the agreement.
The following day – just after midday – Flanagan replied to Simon, raising several issues with the draft.
Flanagan wrote: “I’m going to be direct and stark because fundamentally we may have serious problems as a result of this draft and it may be unintended and a misunderstanding of issues of principle.”
He said there were clauses within the Vertex draft “which not alone fail to recognise DoH/HSE sensitivities and concerns flagged throughout [the] process, they trample directly over them”.
Flanagan said the clauses could, if one was so inclined, be “interpreted as a direct attack on those sensitivities”. He wrote that some of them “fetter statutory responsibilities”, saying this was “an issue clearly flagged to Vertex as something that was impossible for HSE to accept (it’s legally impossible)”.
Flanagan said elements of draft agreement were “unacceptable” and “a breach of faith around the goodwill we thought both sides were investing in the process over the last few weeks”.
“It, as written, could indicate to us, Vertex weren’t listening because it doesn’t bear any resemblance to verbal options we threw over and back in [the] room,” he wrote.
‘A contract both sides could stomach’
Flanagan said there were legal issues with the draft agreement, noting: “We were crystal clear that we cannot sign up to anything that fetters the powers of the HSE under the 2013 Health Act which represents the will of our Houses of Parliament and our lawyers have been and will always be 100% crystal clear on same. We know this because we get that advice every time anything comes near the Act.”
He said if he was incorrect in his “assumptions”, Vertex should withdraw the draft and work on it again over the coming weekend.
Continuing with the very direct tone of the email, Flanagan wrote: “Just in case my benign interpretation is incorrect, PLEASE do not make the mistake of interpreting efforts by HSE staff over the last few weeks to be conciliatory (to make sure we could arrive at a contract that both sides could stomach) as a sign of weakness or softness that can be leveraged.
In our view, Vertex are now in danger of snatching defeat from the jaws of victory. There are clauses added which are fundamentally unacceptable, are re-negotiations or are resiling from issues of principle discussed and agreed in principle and not flagged as problems in face to faces [sic] over last fortnight or so.
Writing in all caps, he added: “IF THIS CONTRACT WERE TO BE THE ONE WE HAD TO SHARE WITH OUR GOVERNANCE STRUCTURES most Senior personnel will interpret it as Vertex seeking to renege from a deal.
“Within the room with Vertex, I can and did try to make a judgement around the tolerance level that the Health System could accept but I also know when the line has been crossed — the draft crosses it not on the margins but by a wide distance.
“I’ll try to keep the lid on my side over the weekend but I can’t guarantee that. The DOH is asking for the contract on a daily basis as are my internal HSE governance structures.
“If I release this contract I wouldn’t care to think of what might happen so I’d prefer if you would formally rescind the draft so that I can truthfully say we’re still waiting for it.”
An hour later, Vertex’s Senior Vice President Simon Bedson replied to Flanagan saying he had discussed the situation with Carl-Michael Simon and they were “confident that most of the issues in your email can be addressed”.
It was agreed to set up a teleconference call for the following Monday morning to discuss the outstanding issues.
‘Significant challenges remain’
Earlier in the negotiations – on 27 March – Bedson wrote to Flanagan saying that Vertex representatives were “increasingly perplexed” by the fact they had not received feedback from the HSE about their most recent proposal.
“As you are aware, it is now 11 weeks since Vertex submitted our most recent proposal to the HSE and, notwithstanding much press coverage and the encouraging statements made by the Minister, we are increasingly perplexed that we have yet to have receive any reaction or feedback to our proposal.
We continue to receive daily calls from patients and their families, desperate for a solution to make these medicines available to the individuals who need them.
“We are under significant pressure to provide an update to their enquiries and, while we understood that due process would take some time, they, like us, are increasingly frustrated that we are unable to provide them with any meaningful information,” Bedson wrote.
On 31 March, Flanagan emailed Bedson stating: “Following on from a detailed internal review within the HSE, a detailed engagement with HSE legal advisors and engagements with government departments, significant challenges remain in relation to the commercial offering received in January 2017…
It is clear from the outcome of this internal process that a significant improvement in both the commercial and the contractual elements of the current offer will be required.
Flanagan noted that the HSE’s proposed approach to overcoming these challenges would “include proposals to secure access for Irish CF patients to any additional new medicine from Vertex in a timely manner over the lifetime of the agreement”.
He said the HSE was also looking to “reduce the budget impact in year 1 and from year 4 onwards to a more sustainable level”.
Flanagan said the approach would also include proposals to “ensure that the publicly available pricing details and processes are clearly and transparently better or at least equal to [the] publically [sic] available details of any offering elsewhere in the EU”.
Flanagan told Bedson he and his team had “cleared our diaries for next week to enable the maximum availability to engage with you to reach agreement on the outstanding issues”.
‘Extremely disappointed’
Replying to Flanagan the next day, Bedson expressed disappointment with the situation.
He wrote: “It won’t surprise you that I am extremely disappointed to learn that the HSE, after 11 weeks of no contact and after 9 months of discussions, still have ‘significant challenges’ with our proposal — a proposal which was developed with input and direction from the HSE — to provide access to Kalydeco and Orkambi for all eligible patients.
“We believe our proposal meets all the criteria you requested and is, by any measure, a “transformational” proposal.
“We are further surprised because this news runs counter to the feedback received directly from you and your team as part of this process, media reports and indeed statements made by [Health] Minister [Simon] Harris and (then) Taoiseach Enda Kenny that “finalisation of the contractual and commercial details of the arrangements” is expected within weeks,” Bedson wrote.
He said Vertex was awaiting “transparent and constructive feedback from you at the earliest possible opportunity”.
We remain committed to reaching a solution that would make both Kalydeco and Orkambi available in Ireland, without compromising the significant investment needed to help the two out of three CF patients who still need medicines like these. This is a transformational and sustainable proposal that we believe meets all the criteria requested by the HSE.
Stressing the time-sensitive nature of the negotiations, Bedson wrote: “As you know Shaun, Cystic Fibrosis is a chronic disease that is characterised by a progressive loss of lung function starting at birth. For people living with CF, each day matters and there is an urgent need for transformative medicines like Kalydeco and Orkambi.
“We continue to receive daily calls from patients and their families, desperate for a solution to make these medicines available to the individuals who need them. This has gone on for long enough, and we hope we can reach an agreement in the coming days.”
At various points throughout the negotiation process, representatives from Vertex wrote to the HSE and Department of Health expressing their concerns about media reports indicating the HSE was set to reject proposals by the company.
‘We went back hard’
On 28 April, Flanagan emailed a number of HSE employees including John Hennessy, the HSE’s Primary Care National Director.
Flanagan informed them that representatives from the HSE spent three hours with Vertex and their lawyers that day “clarifying and explaining the intent of various clauses in the contract”.
He wrote: “There was a little bit of an attempt by them to renegotiate but we went back hard on any such attempt and made it clear there is nothing as far as we are concerned in our draft contract that didn’t feature in negotiations but if they disagreed to flag clearly any item and we’d look at it and provide back up and details of when it was discussed.”
Flanagan added that he had been in touch with Philip Watt, CEO of CF Ireland, “to let him know we are sorting out contracts”. He said the final contract was likely to be completed within the next week or two.
The outstanding issues appeared to have been ironed out by 1 June , when Vertex released a statement saying it had reached a long-term reimbursement agreement with the HSE regarding Orkambi and Kalydeco.
In the press release, Bedson stated: ”We are pleased that these additional Irish CF patients will finally join the thousands of others around the world who are already benefitting from Orkambi and Kalydeco.
We thank the leaders in Ireland for working with us toward an innovative reimbursement agreement that provides access to these important medicines and also recognizes the need for Vertex’s continued investment in the research and development of new medicines for those people with CF, many of whom are still waiting for a treatment for the underlying cause of the disease.
In an email sent to Vertex at the time, the HSE said that while it was “happy for Vertex to proceed” with issuing its statement, the HSE would not be issuing its own statement, rather “confirm the agreement has been signed in the event of any queries”.
TheJournal.ie was refused access to certain documents on the grounds they contained commercially sensitive or personal information.
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Really picky I know, but why do news reports always say ‘one of the biggest’ or ‘one of the richest’? In this case it could be the hundredth biggest or the actual biggest….which makes quite a difference.
@Mary Murphy: that’s one of the most interesting questions I’ve seen in the journal.
@Mary Murphy: a bit like “a number of casualties have been reported”
@Mary Murphy: It has to sound sensational.
@Mary Murphy: completely agree, a bit like saying over €4,000 was stolen when it was €4100. Is it not easier to type the exact figure?
@Mary Murphy: completely agree, a bit like saying over €4,000 was stolen when it was €4100. Is it not easier to type the exact figure?
Echo!
Or maybe, just maybe it could be because until it breaks of all they know is that it’ll be really, really big but they don’t know exactly how big. So instead it giving it a top ten listing its helpful to say one of the biggest because when it does break off it will be.
Enter it into the munster champioship to challenge kerry
Antarctica has grown in mass by 40% in the last 20 years. A Global warming hoax delivering billions of hard earned money through Carbon Tax to the 1%.
Stop reporting this global warming horse manure.
Research HAARP weather manipulation and make up your own minds.
@JohnnyD: what about area? It’s always interesting when people don’t mention area when talking about Antarctica
@JohnnyD: Johnny, such nonsense may be amusing to the educated but it is also dangerous and creates doubt in the ignorant when this is a very real and proveable thing that is happening.
Note also that Climate Cange adversely affects the poorest communities so any work to slow it down or mitigate against it helps the poor, not enriches the rich.
@JohnnyD: Wonderful a huge ice chunk of Antarctica is about to break off as a result of global warming which will trigger even bigger break off of ice raising sea levels and you think it is a hoax. Antarctica is melting from below at an unprecedented rate. http://www.nationalgeographic.com/magazine/2017/07/antarctica-sea-level-rise-climate-change/
Stephen Hawking has stated we are on route towards a Venus type hell hole of 150 degrees.
@Fozz: It never rains in Antarctica well it used not too -but it sure does now http://www.truth-out.org/news/item/41136-it-s-raining-in-antarctica-while-trump-slashes-climate-science-funding
@JohnnyD: Lies and more lies.
Interesting to note that you shoved HAARP in there, as if one global conspiracy in a comment wasn’t enough.
@JohnnyD:
What has Arctic ice done over the same period?
@JohnnyD: Oh God go away with your conspiracy theories. This claim has been widely disputed and the methodology challenged. See for example http://blogs.discovermagazine.com/d-brief/2017/05/16/is-antarctica-gaining-or-losing-ice-nature-may-have-settled-the-debate/#.WV5QDusrJxA
But even if this were so it is accepted that climate change will produce warming in some areas and varying results in other areas. Climate is not weather and the climate is warming.
Galway isn’t that big.
Yes it is that size.
@Frank Reynolds: How many Longfords would you fit in it?
How did they do that? Only asking because, you know… actual Galway…
@Guill Ire: We have to go down to Roscommon and start pushing.
An effort to restrict pollution is a worthy cause but the notion of controlling the planet’s temperature by doing or not doing something is about as sane as trying to stop darkness coming on each evening.
Behind all the fuss is a very childish notion that experimental sciences scale up such as the idea that a common greenhouse equates to the planet’s atmosphere -
http://www.met.ie/education/pdfs_eng/YP%20Fun%20Facts%20Climate%20Change.pdf
This is the so-called ‘scientific method’ via Newton , it began its existence as a rule but snowballed rapidly through the notion that the fall of an apple (experiment) equates directly with planetary orbital motion (universal qualities) hence the ‘universal theory of gravitation’ -
“Rule III. The qualities of bodies, which admit neither [intensification] nor remission of degrees, and which are found to belong to all bodies within the reach of our experiments, are to be esteemed the universal qualities of all bodies whatsoever.” Newton
It is unfortunate that adults can’t get to the actual issue of which ‘climate change’ is just another system of an overreaching systemic failure.
@Gerald Kelleher: it’s a shame you don’t believe any science after Newton. The problem is though, the results are all around us and you’re just saying “Newton is wrong about what caused them” can you see how strange that is? Also the greenhouse effect is real but is only called that so that lay folk like myself can loosely grasp the concept
@Dave O Keeffe: There are always kids running around with the notion of experts/lay folk however some readers should back themselves and their common sense to spot that ‘climate change’ is merely a symptom of an overreaching agenda that began with the ‘universal theory of gravity’ where planetary motion was squeezed into the fall of an apple much like they try to squeeze the planet’s atmosphere into the conditions found in a common greenhouse.
Genuine climate research includes all planets of the solar system and the common traits which define climate for all planets regardless of composition or distance from the Sun. The only way to contend with the expensive nonsense of the greenhouse climate bandwagon is to expand climate research to all planets and discover why the Earth’s climate is what it is.
The Met Eireann take on climate fits in with the empirical method but that is simply modellers having fun with the wider population while getting paid for it.
@Gerald Kelleher: Gerald , you forgot to add the occasional ‘mwah ha ha’ and ‘silly little folk out there’ to those comments. In the hughly unlikely event that you misunderstand something … about the lay population, nearly everybody here understands that all modelling systems are only representative, including Newtonian and Earth climate models. Newtonian physics worked perfectly as a tool up to a point, and is still quite useful sometimes, so while the mechanistic view of the world is long dead, some of the tooling can still be very useful.
@Greg Blake: Ignore Gerald, Greg. Gerald is of the opinion that he, and only he, is right, and every single other person on the planet is wrong. A few months back he quite literally stated that only he alone knows the truth. In a to-and-fro between myself and him he argued with me over linguistic etymology, an area of study in which I am educated and he is not. When he was beaten in the argument he turned to belittling me rather than any argument I presented (classic case of deflecting and playing the man and not the ball). The facts of the matter are that Gerald believes in pseudoscience, posts links to back up his opinions which generally actually agree with standard scientific models and he’s also a religious fundamentalist. Better to ignore him.
@Greg Blake: Newton was the Nigel Farage of astronomy – making it up as he went along and mangling astronomical insights as he did so in order to push predictive science at an experimental scale up to an astronomical level.
Again, people should back themselves against the voodoo and bluffing of theorists where astronomy and terrestrial sciences are concerned.
The great discovery of Copernicus was that the Earth overtaking the outer planets causes them to temporarily fall behind in view hence the Sun is stationary and the Earth moves -
https://apod.nasa.gov/apod/ap011220.html
Newton botched this by trying to assert that a hypothetical observer on the Sun accounts for the observed motions of the planets -
“For to the earth planetary motions appear sometimes direct, sometimes
stationary, nay, and sometimes retrograde. But from the sun they are
always seen direct,…” Newton
The Royal Society academics could talk a good game and no doubt some here will fall for the superior/inferior intellect sort of thing that the professors like to project but anyone with common sense gould figure out from that statement that Newton is entirely stupid with the insight of Copernicus which accounts for the orbital motion of the Earth and a Sun centred system.
@Brian Ó Dálaigh: Don’t be silly, to be confident and competent is astronomy and terrestrial sciences only requires reminding people what is known -
“You cannot teach a man anything, you can only help him find it within himself.” Galileo
Haha it only takes Gerald one or two comments to bring any argument back to the earths rotation- his obsession. Amazing that all of the ‘modern science’ that he claims are nonsense have allowed scientists to launch probes and satelites and a space station and the Hubble telescope, etc. Using precise calculations that Gerald doesn’t believe should work. Somehow all those theories seem to be working for them! But yeah, Gerald knows the truth and all of them are wrong.
@Ross Stewart: These are all empirical slogans that are easy enough to dismiss with time and if the right people show up. All predictive astronomy is based on the calendar system which simply means that one year does not equate to one orbit of the Earth around the Sun. If things were normal there would be people who could discuss why predictive astronomy is useless in matters of climate and other planetary topics while you dummies mix astronomy with engineering achievements.
@Gerald Kelleher:
You have an unhealthy obsession.
@Avina Laaf: Coming from an anonymous person who believes one 24 hour day doesn’t equate to one complete rotation of the Earth I would say that means next to nothing. This is the mindless world of modelling and you among others believe I have much to say about what happened and where it started.
Gerald, the fact that things can dock with the space station that is travelling at 17150 mph around the earth relies on scientists knowing exactly how fast the earth rotates down to microseconds. Amongst many other modern theories which you no doubt disagree with too. The fact that you think this is just engineering shows your ignorance on the matters- sorry to have to burst your bubble.
@Ross Stewart: The thing about a clockwork solar system of Newton and his empirical drones is that the Earth’s rotation is modelled on stellar circumpolar motion -
https://www.youtube.com/watch?v=BYy0EQBnqHI
This modelling is known as RA/Dec which puts the conclusion on rotation at variance with the 24 hour system and Lat/Long system. In other words, academics can’t express the basic facts of a round and rotating Earth and easy enough to test.
As speeds across latitudes diminish from a maximum speed at the Equator, what is the maximum Equatorial speed of the Earth in miles per hour ?.
How do all their maths and calculations work out perfectly then Gerald? How is every launch into space not a disaster?
You have no answer but you’ll reply with more obtuse quotations..
@Ross Stewart: If you had sense, you would become familiar with the development of timekeeping and the references used for the calendar system first and then the 24 hour system and Lat/Long systems. This allows you to express the maximum Equatorial speed of the Earth without the slightest hesitation and then and only then allows you to see the usefulness of predictive astronomy without drawing awful conclusions as they did in the late 17th century.
The daily business of people on Earth relies on the relationship between clocks and the Lat/Long system which in turn is a human devised grid system express the rotation of the Earth at a rate of 15 degrees per hour, an inviolate fact challenged by the careless who have little or no regard for the development of timekeeping and its limitations.
How do their maths and calculations work out then Gerald? How is every launch into space not a disaster? It all relies on modern science that you deny with an unhealthy obsession.
As has it done many many times before
Governments world wide react to Global warming ,like the Captain of the Titanic ,”There is no need to be alarmed,Ladies and Gentlemen ,we are stopping briefly to take on a little ice”
Where is Al Gore?
@Rowe: creaming himself
@Rowe: sitting in his beach front mansion watching the sea level no rise. Same as the people of Tuvalu, The Maldives and Diego Garcia.
The scam is breaking up.
Sure ”tis only God above and God alone controls the weather….
Wonder if they’ll GPS tag it ? You’d think they’d have tone them all to track them
Ok, then name just one of those times
It would send the shivers up ye
Religion of peace my arse
@Daithí Uí Ciarmhaic: Don’t be glaciophobic.
@Daithí Uí Ciarmhaic: we all know these migrant icebergs reak havoc but liberal media are too afraid to report it
@Daithí Uí Ciarmhaic: we all know these migrant icebergs reak havoc but liberal media are too afraid to report it
@Darren Byrne: This iceberg is part of a dangerous separatist movement
Deport it!
@George Roche:
The new ICEIS
@Tweed Cap: We must apply diplomatic pressure to have their assets frozen
@George Roche:
Agreed but that will prove difficult in the current climate..
@Tweed Cap: And complete silence from the Antarctic regime in the midst of all this. Unbelievable.
@George Roche: let’s build an ice wall to keep it out
@Daithí Uí Ciarmhaic: Did ye even Read the article??!!
God sometimes the commenters on here…. !
@Séamus Ó Lochlainn: Irony alert
@Malachi: yep. Hence the !!!
Odd statement about the iceberg will not add to sea levels “as it melts” – while that’s true, the fact that the ice is at present on land (AFAIK) means when it breaks off and ends up floating this alone will cause a rise in sea level. Whether it then melts or not is irrelevant.
@Ross Stewart: that’s because Newton was the Nigel Farage of Astrology. And Gerald is now trying to find who was the Theresa May of Astrology.
@Gerald Kelleher: I’m leaning towards Brian’s views. I hate closed thinking and your opinion doesn’t sufficiently dispel other notions. Please provide something more tangible before ridiculing all of us dunces
@To Bren: There are always a few intelligent and independent people who can spot just how overreaching empirical modelling is -
“Rule III. The qualities of bodies, which admit neither [intensification] nor remission of degrees, and which are found to belong to all bodies within the reach of our experiments, are to be esteemed the universal qualities of all bodies whatsoever.” Newton
That is where it all began and where it ends.
What will the domino effect of this be and that is my second time to write that on here.
have your say