Drug discovery was far from the mind of Shane Ryan when he left school heading for a science degree in Trinity College Dublin. Back then, in the early 1990s, most science graduates were advised to work their way up the graduate ranks, culminating in a PhD and a career in academia.
But course modules in drug development piqued his interest early, coinciding with a Celtic Tiger surge in pharma investment in Ireland. In the event, he thinks that over 90 per cent of his graduating class headed straight into industry on the back of their primary degree.
Twenty-eight years into a career that has seen him work for top pharma companies Servier and Eli Lilly, he is now general manager of the Irish business of Japanese rare disease specialists Takeda. But he also serves as president of the Irish Pharmaceutical Healthcare Association (Ipha), the industry body representing companies that develop and manufacture medicines and vaccines.
In that role, he has spent the past several months locked in negotiations with the Department of Health on the renewal of the four-year accord between the two sides on the supply and pricing of medicines.
READ MORE
Pricing, as ever, is a headline issue for the State, with the Department of Health noting last week that “the sustainability of State expenditure on medicines is essential”.
That came as it announced the signing of four-year accords with both Ipha and Medicines for Ireland, whose members are involved in the generics business – off patent medicines that account for the majority of what we consume but cost a lot less.
The department noted that spending on medicines has grown substantially since 2021 and now accounts for almost €1 in every €8 of public health spending – or 12.5 per cent of the health budget. In the UK, the number is closer to 9 per cent but still less than the 15 per cent benchmark across the EU.
The new accord does feature many of the same provisions of its predecessor on how medicine prices will be set and then adjusted over time. But there is a greater focus on getting to grips with a drug approval process that has become sclerotic and also ensuring consistent reliable supply of approved drugs.
Access to the market has been a recurring issue for the industry. Almost all of the leading drug developers have a significant presence in Ireland. The pharmaceutical and tech sectors account for the lion’s share of the State’s huge corporation tax take, which has increasingly driven budgetary spending in recent years.
[ Minister for Health commits to faster delivery on new medicinesOpens in new window ]
A drug approval system that can take up to four times as long to complete as the timelines set down in legislation – putting Ireland among the laggards in drug approvals across Europe – has been an irritation.
“The industry obviously is a very significant contributor to the economic health of the country, and probably has been for the last nearly three generations now,” Ryan says. “The treatments [developed by the sector] have certainly been a huge contributor to citizen health, but in the last number of years I think we weren’t quite as dynamic as we could have been, right, in that [drug approvals] space.
“We have a very robust system to assess the value of medicine and everyone agrees with that. Where we get to in terms of agreeing a price between the manufacturer and the Government, I think that works for both sides. That necessarily hasn’t been the issue.
“The process from end to end has multiple steps. There is significant inefficiency in those steps. It was very difficult if we were approached by a physician, a patient organisation, or indeed a patient themselves, to say like when are we going to know about a given treatment? No one could say ...”
A commitment in the Programme for Government to improve access to new and innovative treatments was seen by Ipha as positive, as was subsequent engagement by Minister for Health Jennifer Carroll MacNeill.
The agreement published last week commits the Government to deliver decisions on new drugs in no more than 270 days by the end of next year and by the 180 days set down in the legislation by the first quarter of 2029.
“Now what we have is a realisation and a mandate that it can be done quicker, without losing the rigour or the robustness. Because we’re not saying that the process is overly rigorous or anything like that, we’re just saying that it takes too long and heretofore lacked transparency.”
As it happens, that hasn’t always been the Ipha line. There have been recurring complaints that the “value for money” assessment carried out by the National Centre for Pharmacoeconomics is not fit for purpose when it comes to gauging the value of medicines for rare diseases, which, given the small number of patients involved, will always struggle with a standardised value for money test.
And there has been frustration that a health service still tied to paper records makes it impossible to develop a pricing system more based on outcomes than on upfront cost.
But, for now anyway, there is little appetite to return to those battles.
“I think the commitments now are much more concrete and mapped out for both parties,” Ryan says. “So, we have confidence that we will see a significant speeding up of the system and quicker access to patients in Ireland over the course of the agreement.”
Medicine shortages have been a headline issue in recent years, not least high profile and recurring issues for women in securing reliable supplies of hormone replacement therapy (HRT) drugs as well as restrictions for a time in some pharmacies on supplies of paracetamol.
As of this week, the list maintained by the medicines regulator of drugs that are either out of stock or in short supply runs to 390 products.
The new agreement allows for representations to be made “where it becomes uneconomic for a supplier to supply a particular medicine” to adjust price among other things.
Money is not absent from the new agreement, of course, but its publication has not been accompanied by headline-grabbing figures for expected savings – such as the €700 million expected over the four-year life of the previous agreement. This time around, no specific figure has been mentioned.
“I think that the last agreement yielded probably more than €800 million in savings,” Ryan says when pressed on the issue. “That’s the estimate. It’s early doors now, but we’d anticipate that the current agreement with the measures involved will do something similar proportionately.”
Where the agreement does have much to say, as before, is on how medicines will be priced and how those prices will move (downwards) in line with other EU markets.
When considering the price sought by a company for a new medicine, the agreement says the HSE will consider the average price that medicine is available for to wholesalers in a basket of 13 western European countries. Those “nominated states” are Austria, Belgium, Denmark, Finland, France, Germany, Greece, Italy, Luxembourg, the Netherlands, Portugal, Spain and Sweden. The only notable absentees are the UK and Switzerland.
That’s not to say the HSE has to agree to fund the medicine at that average wholesale price, only, in the words of the agreement, to “have regard” to it.
Medicines already approved will be benchmarked against that same basket each year, with the UK price also considered just in this year’s assessment.
The agreement is central to how new medicines will be accessible to patients but Ryan insists there’s much more to pharma than just what this agreement might deliver over the coming four years.
He stresses the increasing importance of the patient voice in pharma. He’s not the first. The pharmaceutical industry and the Ipha organisation he heads has learned in recent years that it can have few more persuasive advocates than those patients who rely on its life-saving therapies.
He sees the new agreement as underscoring the strength of the patient voice. “I think our industry has evolved significantly in the last number of years to really lean into that. I mean every company will talk about that, that they are patient-centred, but I think that has been a significant shift.
“It’s brought a greater level of expectation and transparency to what we do,” he says.
More than most sectors, artificial intelligence (AI) holds out the prospect of revolutionising the drug discovery and development process.
One of the more contentious realities of the pharma business is the price of new medicines. While the sector is accused of banking outsized profits on their drugs, the industry insists the prices it sets for those drugs that successfully come to market must cover not only their development costs but also the cost of all those other treatments that fell away at different stages of the development process – plus a profit margin of course.
AI promises to accelerate the process of discovery and development.
“I think it represents a huge opportunity on a number of levels. If you consider the impact that it will have in terms of discovery of new medicine, there are already treatments as far along as phase three in clinical development that have used the latest technology to shortcut what would have been a much, much longer process,” Ryan says.
It should also, he says, reduce the number of failures. And significantly cut the huge expense of human clinical trials.
[ ‘Wrong on so many levels’: Are we paying too much for our drugs to be dispensed?Opens in new window ]
“Technology is going to reform that as well. We’ll have probably quicker interpretation of data, better design and the ability to decentralise trials a little bit more, so you won’t have patients that always have to show up at a hospital or a clinic; they can take part in a trial at home.”
Automation is already a key element of the end manufacturing process but Ryan sees AI reforming the regulatory process for drug approval, commercialisation and also track the real world effectiveness of those therapies.
“Across the board, the positive disruption that technology will bring is going to really help,” he says. “And yes, if that does happen as we anticipate, it should create a situation where we can bring much better value.”
It will also make it more economically viable to target medicines at areas of unmet need.
“There’s still an awful lot of promise but as the first molecules start to come through that have used the technology in their design process, as well as benefiting from the advances of tech through the whole cycle, I think, in the next five to 10 years we’ll have a very different ecosystem and expectation around how medicines get from discovery to the patient.”
Given Ireland’s high cost base, especially for labour and energy, there is constant pressure on the sector and IDA Ireland to move higher up the value chain.
The State remains a key player in the manufacture of successive generations of drugs – everything from Viagra and Botox to cancer blockbuster Keytruda and, now, the weight loss drugs Wegovy and Zepbound – but much of that is in the manufacture of active pharmaceutical ingredients and fill and finish operations, rather than in the development of the medicines.
“We’ve obviously seen a drift in terms of investment decisions, especially in R&D [research and development] moving out of Europe to the US and China,” Ryan says. For him, much of that is down to how Europe values and rewards innovation.
“I think over the years, from a European perspective, we probably haven’t valued medicines in the same way that we should have. We’ve seen a very significant downward pressure on pricing, So, to an extent I think we have been moving to undervalue medicines in Europe and potentially also underinvest.
“I think that is changing. I think the last 12 months even has changed that, with the realisation that, okay, the pharma sector, as per the Draghi Report for example, is a key strategic sector for Europe, and we need to be more competitive versus other regions in terms of how we incentivise and foster that.
“The agreement that we have here now with the Irish State speaks to the fact that there’s a realisation that innovation has a significant value, and we need to value that innovation appropriately.
“So, I think there is a bit of a rebalancing potentially over the next number of years, and I think ultimately that’s the right thing, a positive thing for Europe and for Ireland to be in the vanguard of that.”
CV
Name: Shane Ryan.
Age: 50.
Job: president of the Irish Pharmaceutical Healthcare Association and general manager of Takeda Ireland.
Family: Married to Clare. They have four children aged between 16 and 9.
Hobbies: Family comes first with much ferrying required for a range of extracurricular activities. His family has, he says, a long and strong generational kind of history in horses. That aside he is a keen supporter of the Limerick hurlers and Munster rugby “and keen to get over the blip of the last couple of years”.
Something you might expect: Living in Limerick but based in Dublin as part of a multinational group, Shane spends a lot of his time travelling.
Something that might surprise: “I went to St Munchin’s College in Limerick, which was a diocesan college. I think there might have been tongue-in-cheek expectations I would continue on into the priesthood, but I took a different path.”
