Italy, Europe’s fourth largest pharma market at a size of EUR 23.446 billion, has a highly decentralised healthcare system, with the country’s 20 regions negotiating market access for medicines individually following central regulatory approval. This creates significant complexities for the representatives of Big Pharma looking to roll out their latest products in the country. Here, five Italy country managers weigh in on the challenges inherent in the current system and how they are attempting to overcome them.
Merck Italy Managing Director and President Jan Kirsten highlights how his affiliate has embraced agility to sidestep the complexities of the Italian market access landscape.
In the interest of Italian patients, where there is an urgent unmet need, we try to create early access programs
“Compared to other countries in Europe, but also outside of Europe, the system is complex,” he admits. “Often it is easier to launch somewhere else because in Italy, you start to get the regulatory approval and reimbursement on a national level, but then you must ensure access in 20 regions separately, which are acting as small dedicated healthcare systems. If you do not have an agile team that has thought through the whole plan before, you can lose months.
“In the interest of Italian patients, where there is an urgent unmet need, we try to create early access programs. This can give the patients access to therapies which are still in the reimbursement process, free of charge. That is a great example of agility applied to the most important aspect of our mandate: helping patients.”
Nicoletta Luppi, senior VP & managing director at MSD, hopes that lessons can be taken from the COVID-19 pandemic to speed up access to medicine across her country.
It is not acceptable that you have or do not have access to innovation depending on the region you live in
“Pharmaceutical expenditure must be centralised,” she opines. “Regions can maintain the responsibility of organising and providing services based on the resources they receive from the national level, but pharmaceutical spending must be centralised, and its governance as well. It is not acceptable that you have or do not have access to innovation depending on the region you live in.
“With COVID-19 we saw an example of equality across the regions when vaccines were made available to the population at the same time regardless of the region because they were organised centrally by the Minister of Health.”
Not Insurmountable Hurdles
Stephane Brocker, Ipsen’s country president and managing director admits that roadblocks exist in Italy but feels that they can be overcome by companies that manage to spell out the value that their products can bring to patients and to the healthcare system as a whole.
While there are administrative issues of regional access following national reimbursement and registration, these have never been true roadblocks for Ipsen because we have managed to communicate the innovative value of our products
He notes that “Healthcare in Italy is highly regionalised, with a lot of different decision makers spread throughout the system. However, in the past few years we have seen an attempt to codify and streamline patient journey management, ensuring a smoother process between diagnostics, treatment, and follow-up. This is still ongoing.
“What is clear is that the decentralisation of our healthcare system means that some regions and hospitals go faster than others in creating and implementing these kinds of processes, which adds a layer of complexity. Companies must therefore equip themselves to be able to track and monitor these processes as much as possible.
“We are fortunate to be bringing forward very innovative products. While there are administrative issues of regional access following national reimbursement and registration, these have never been true roadblocks for Ipsen because we have managed to communicate the innovative value of our products.”
Several ‘payback’ measures, whereby pharma companies are required to return a percentage of their profits to the state, are in place in Italy and have received heavy criticism from the industry. However, Amgen GM Soren Giese is confident that the tide is turning on this issue.
Thankfully, over the last two years, there has been some re-modulation of the system and this year the government has increased its spending on hospital products, as well as for the Innovation Fund
“Paybacks are a big topic but the signals we are receiving from the government are positive,” he states. “The problem with the payback is that it applies only to innovative products in the hospital channel. Over the last 10 years or more, not a single euro has been paid back in the retail channel. This creates somewhat of a penalty on innovation and de-incentivises companies from bringing innovative products to market here. We believe that this should be discussed. Thankfully, over the last two years, there has been some re-modulation of the system and this year the government has increased its spending on hospital products, as well as for the Innovation Fund.”
Ripe for Reform
Marcello Cattani, country lead, president & managing director for Italy & Malta at Sanofi, is similarly critical of the payback system and suggests that the extra capital these measures free up could be better utilised.
Reform will bolster our competitiveness across the pharma value chain
“In the hospital sector, funding is relatively low compared to patient demand, which needs to be addressed,” says Catani. “The system could work a lot better; for example, savings coming from paybacks currently go to the regions where they are often addressed and not used on areas like schools and social services. While these are, of course, important issues, there needs to be a reassessment of how funds could better be allocated to ensure patient access to innovation. The fact that companies in the hospital sector are paying back around EUR 1.25 billion per year is impacting Italy’s ability to attract investments within Europe. Reform will bolster our competitiveness across the pharma value chain.”