Same difference: Drug chief ’s dismay at delays on copycat offer
It said, however, that the HSE is running a separate biosimilar strategy in its acute hospitals drugs management programme, and that this is “making considerable progress using a collaborative approach led by hospital pharmacists”.
It did not give a specific answer when asked when legislation will be introduced.
Another source of frustration for McKeon is Brussels, where manufacturing rules are depriving Europe – and Ireland – of jobs, he says.
As of now, generics manufacturers cannot start making a drug in the EU until a drug has come off patent.
That, McKeon says, has had the effect of benefiting other countries, where the drug can be manufactured and stockpiled before the patent expires, and then sent out to market as soon as the time comes.
“Everybody outside the EU can start manufacturing when they feel like it, and on the day when the patent goes off all the product can come in.
“We’re actually shooting ourselves in the foot with this and that’s one thing that we push really hard on, saying they need to get rid of that.
“We’re not going to start selling before the patent goes off but we just want to have the ability to [be ready to go on day one],” McKeon says, adding that some of that new manufacturing could come to Ireland.
Mylan likes being here, he says. It likes the education system, the access to markets, and even simple things like the location between the US and Asia which means the time zone is convenient for dealing with various parts of the world.
He reports into Mylan’s regional division, which covers Europe – a rapidly expanding part of the company which has seen turnover go from $1bn to $4bn since purchasing Meda. That’s meant much more focus from head office in the United States.
Despite President Donald Trump’s drive to bring US jobs and profits home, Mylan’s plan for Europe and Ireland hasn’t been affected, McKeon says.
“The vision that Mylan have about coming to Europe and growing the market is still there, that hasn’t changed at all no matter what Trump says.
“I mean he has repatriated some of the profits – to be honest that doesn’t affect us [in Ireland] because that’s sitting somewhere else, that’s sitting in some treasury in Holland or somewhere,” McKeon says.
Another potential threat to the Irish operation is of course Brexit, and all the potential disruption that new customs arrangements would entail.
McKeon says his business and others are working with the health authorities to identify any potential medicine shortages.
He says the company doesn’t have much products coming out of the UK, but some does come through Britain to Ireland and this might require changing logistics arrangements in order to take account of any potential customs delays. “We should be OK and the country should be OK,” he says.
Less of a threat and more of a challenge is changes in the way drugs are being prescribed,” McKeon says.
“If you look at some of the stuff that’s being developed from an AI point of view, from a diagnostic point of view, you could have people in Germany diagnosing your diseases,” he says, referring to online doctor services like, for example, Irish firm Videodoc.
But despite being a “drug pusher”, as he puts it, for the last 40 years, he believes Irish people are too reliant on the pharmaceutical industry.
“We are not taking responsibility for ourselves health as a nation, we don’t really do that. We think there’s a pill for very ill. Although I’ve been a drug pusher for 40 years I don’t believe there’s a pill for every ill.
“And we are becoming very dependent on health support for all sorts of things ... a huge amount of education needs to be done.”
McKeon began his career as a pharmacist, but quickly moved into the drugmaking side of the industry, joining a business called Knoll.
He worked for a number of different firms before eventually setting up the Irish subsidiary of a Swedish company called Meda, which grew strongly over a 10-year period.
“I was managing the UK and Ireland for Meda up to three years ago, and then Mylan bought us out and they said: ‘Look we’re a big entity in Ireland and we need somebody to come back and run Ireland’. That suited me fine to come back home rather than doing that commute over and back to Stansted. So for the last two-and-ahalf years I’ve been back managing Mylan over here.”
Having worked across a number of areas in a pharma industry career, from finance, to marketing, to regulatory affairs, he says sales is the hardest role of all. Nevertheless that’s what he sees his key function as: managing and motivating Mylan’s Irish sales team in selling the company’s products to pharmacists and medical providers.
But regulatory affairs is becoming more and more important, which is probably a factor behind his outspoken comments on this country’s biosimilars strategy.
How much longer he’ll have to wait for the business opportunity to properly manifest itself is anyone’s guess.
Owen McKeon, country manager (Ireland), Mylan. Picture by Frank McGrath