This article is part of our special report Big data revolution and EU healthcare.
The adoption of an outcome-based approach regarding the remuneration of medicines should take into account the entire chain, including the distributors, René Jenny, President of the European Healthcare Distribution Association (GIRP), told EURACTIV.com.
“If you have an outcomes-based approach to remuneration, we need to be sure that we can still deliver the products. There’s a need to have a proper consideration of the remuneration throughout the chain and the distribution side,” Jenny said on the sidelines of the “Entrepreneurship in Healthcare: Powering Innovation” event in Dublin (28 May).
“This has to be part of the discussion, as it’s not only about the outcome but also the physical access to the product,” he added.
Jenny stressed that when it comes to the outcome-based approach to drugs remuneration, all depends on different therapies.
He noted that in some of the therapies this will not be the case and will not reduce the expenditure on medicines. But in cases, like hepatitis, the price is high but the outcome is great.
“If you look at the classical therapy for hepatitis, you have to take your pill every day for the rest of your life. If you take the new medication, you take it once and it’s finished. It may cost 25,000 euros for example, but with one pill, you clearly save costs.”
He explained that some countries have already put in a reimbursement scheme under which in every 4/5 cases that are solved positively with innovative medication they reimburse the manufacturers.
“It’s not the only solution for the future, but it’s good to discuss it and get something positive out of that.”
Digitisation and healthcare data
As far as the digitisation of the healthcare sector is concerned, GIRP’s president emphasised that a collective approach should be adopted to have a successful outcome.
“No single stakeholder alone can deliver to the digitisation of the sector; collecting real-world evidence or packaging in the right way. So, we see ourselves as a critical link among different operators. We can provide this platform of collaboration and boost partnerships.”
However, he was critical of the fact that there was no harmonised approach among member states when it comes to healthcare data, which according to him, results in higher costs.
“In Germany, they are not able to put together patients’ data record and unfortunately it’s not limited to this country. Estonia, on the other hand, has an advanced agenda when it comes to e-health, patients’ record. This is an approach that could bring cost reduction in the healthcare systems.”
He also pointed out that in the near future some problems may emerge with the General Data Protection Regulation, regarding access to patients’ records.
‘Contemporary’ healthcare challenges
Referring to the future of entrepreneurship and innovation in healthcare, Jenny warned that the main challenge is the lack of an EU single market on pharmaceuticals in Europe.
“We have been discussing this challenge for years in the EU and it’s a bit bizarre. We have a different market in registration and in pricing. We have some registrations covered by the EMA but then we have to go to each country separately to have a final assessment and authorisation and negotiate the price,” he said.
He added that a serious challenge was the increasing regulation that affects the full chain, both distributors and manufacturers.
“In 2013, we had the Good Distribution Practices (GDP) story, which was a totally new approach, and certain aspects still remain unclear concerning the technical interpretation,” he noted.
“The Falsified Medicines Directive (FMD) is also challenging. During this conference, one stated ‘we hope it will be ready’,” he added, stating that last but not least, for innovation and digitization, the price pressure on the medicines has consequences for the full chain.
He explained that regulation needed to focus on the proportionality aspect: “How far does it go? Often, it’s disproportional to the objective and could be an obstacle to entrepreneurship. There must be enough room for innovation.”