by Peter O'Donnell
BRUSSELS, 28 June (APM) - Europe's top health official delivered some tough talk to the European drugs' industry chiefs as he addressed them on Thursday evening at the end of their celebratory annual conference in Brussels.
After a day in which industry speakers and guests delivered a series of upbeat messages about the achievements of the industry, its tighter focus on the patient, its determination to ease access, its appetite for exploiting new science and its readiness to continue building partnerships, EU health commissioner Vytenis Andriukaitis struck some very discordant notes.
As their after dinner speaker in a fashionable - and as he acknowledged, beautiful - restaurant in Flanders, he told them they were not doing enough.
Without explicitly dismissing the day's heady talk about breakthroughs, he made clear his dissatisfaction with what had been done so far for rare diseases and children.
"I would like to recall the responsibility of the pharmaceutical industry, which should go beyond the letter of the law in order to fully consider the usefulness of products they develop in relation to children," he said.
"There is no justification as to why the knowledge and better understanding accumulated over the last decade in developing anti-cancer medicines for adults should not be fully used to the of benefit children."
Andriukaitis followed this up with a sharp reminder about the questions hanging over the industry's use of research incentives - the same incentives that had been the leitmotif of the day's conference, during which the industry speakers had repeatedly insisted on the absolute necessity of retaining them.
"We have started to jointly evaluate the EU regulations on orphan and paediatric medicines," he said, pointing out to his audience that it was high time to check on whether the incentives are delivering.
Have they catered for innovative medicines for unmet medical needs?, he asked. Can they accommodate scientific progress and new business models? And how are they being used in practice?
Just a week earlier, he told his industry audience, he had insisted to a group of experts that, for all the schemes' merits, "it is even more important that we listen to critical voices, recognise the flaws in the system, and examine its effectiveness".
Then he had drawn attention to assessing "the financial consequences for companies and society", and had emphasised that "we are aiming for value".
He had noted "a number of unintended consequences" - including "to extend the effective protection period for your innovation far beyond what was envisaged", and so preventing generic versions from coming to market and impeding affordability for patients.
The commissioner's other target over the dessert in the fashionable restaurant was access to medicines - and his take on it was very different from the aspirational messages that had flowed from industry speakers during the day's proceedings, who had studiously avoided any reference to the tough questions of pricing.
"There are substantial differences in the level of access to affordable treatments - both between and within member states", and "they increase health inequalities across Europe and negatively affect our societies".
"This has to change!", he declared: "Affordable and available medicines are needed for every European citizen!"
He demanded "effective solutions in ensuing available, affordable and innovative medicines everywhere in the EU" - including "sustainable pricing".
And he gave explicit backing to the need to "tackle transparency of public research funding and of pricing" - particularly in light of "the rising voices calling into question the real costs for the development of medicinal products, given the amount of public funded research".
"Industry should provide a financial return of public funding in case of successful drug development and, most importantly - the injection of public investment needs to be accounted for in the prices!"
To do this, "we need a higher level of commitment from all players, including industry" - whose oft-invoked vision of 'Health for All' "needs to be more than just a well-meaning slogan", he said.
In addition, "shortages of medicines in the EU are an increasing problem with great impact on patients across Europe", and "I would like to underline the role and responsibility of the pharmaceutical industry to prevent these shortages".
Hinting at the possibility of regulatory change "which might not be of industry liking", he said "there should not be a situation when a company refuses to market a medicine in one or another member state because of a small market or another trivial reason".
Andriukaitis was not without some good words for his dinner hosts: "I welcome EFPIA's shared vision for the future of health in Europe," he said.
"Let me take this opportunity to thank you for your contribution" to ongoing discussions, he added. "EFPIA and its members play a very important role."