London, January 5 2015: Richard Bergström, Director General, EFPIA argued passionately in favour of the homogenisation of European HTA bodies and regulation, during a recent interview with Paul Simms, Chairman, eyeforpharma. Asserting that harmonisation would be the only way for market access to make a step improvement, Bergström explained that it was in everyone's interests, not just those of pharmaceutical companies.
All stakeholders need to invest in larger, more wide-ranging data collection and analysis. That includes pharma companies themselves: "You better make sure you spend wisely, because if you are going to pour in billions into Real World Data systems, they need to deliver. They must be sustainable and sustained over time, because we can't, for each individual, country and product go in and do a bolt-on data capture and then after one year close it down.
"As an industry, we can't have a Slovenian Real World data system; we can't have a separate one for Austria, etc. We need to build a pan-European standardised model and for that to happen you need to have an agreement."
Bergström believes that pharma companies have now largely worked out how to cope with understanding patient need and remodelling their company around that need, albeit admitting there was still a lot more urgent work to be done to see out existing plans. When pushed on where the next frontier lies for pharma executives, Bergström states: "What the industry really needs next is to understand healthcare systems – especially where access is concerned. Pharma hasn't really figured out how to engage the healthcare system. The skillset needed is a further understanding of healthcare, how it works, who does what, and who makes decisions. We need to understand how these people budget, how they forecast a budget for a product 2 years from launch. The industry and the payer come from two different worlds, but their conversation needs to move far beyond price negotiations.."
The other fundamental need for collaboration stems from the need to class innovation, and to prepare better national price reimbursement negotiations. The HTAs and payers need to figure out what is valuable to who and, combined with the issues above, this can only become sustainable with a more joined up approach.
"This is coming strongly from the EMA, from the top payers, from the regulators. This is what they want; a new interface. And therefore the industry needs to also get its act together in figuring out what that interface should look like."
When asked if he thought this standardisation is inevitable, Bergström agreed that is was and that we need to prepare for it. In June 2015, the industry will be coming together in Amsterdam to engage in hands-on discussions around these issues at eyeforpharma's Market Access and Pricing Excellence flagship conference. Bergström's keynote speech as part of an eight-speaker panel – featuring key regulatory and HTA stakeholders from the UK, Spain, Italy, Belgium and the Netherlands – will address this situation in more detail. Ultimately, he asks that this meeting provide "the roadmap for the practical approach the industry needs to move forward on this matter".
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