Collectively representing almost 400 companies operating in Italy, Farmindustria, Egualia (formerly Assogenerici) and Assobiotec respectively promote the interests of innovative pharmaceutical companies—both foreign and Italian-owned— the generics, biosimilars and value-added medicines sector, and biotech. Massimo Scaccabarozzi, former President of Farmindustria; Michele Uda, director general of Egualia, and Leonardo Vingiani, managing director of Assobiotec discuss some of their top priorities.
Maintaining Italy’s role as a manufacturing leader
“The first priority for our industry is to remain the European leader in terms of production … The production value of our industry stands at EUR 34 billion, a number that jumps to EUR 65 billion if we add the production of the companies that work with us; even the CDMOs are European leaders. Italy has a key role to play in the EU objective of guaranteeing continuity of supply during emergencies, says Massimo Scaccabarozzi.
Leonardo Vingiani of Assobiotec, on the other hand, warns that from a biotech perspective: “If the country does not improve the production of biotechnology in the next decade, Italy risks to lose its leadership in the manufacturing space.”
Michele Uda, director general of Egualia puts forth the need for further public investment: “There is a piece of European legislation that is blocking pharma manufacturing investment from public authorities. The industry across the continent wants to be able to respond more efficiently in future pandemics. However, being competitive at a global level will require public-private partnerships, just as companies and governments have done for vaccine manufacturing scale-up. Italy is already first in Europe regarding manufacturing capabilities and volume for pharmaceuticals. The Italian manufacturing network is based on small and medium-sized enterprises, which require help to scale up their capacity.”
Improving deficiencies in the Italian system
Uda discusses the deficiency in pharma expenditure and the burden of paybacks for the generics side of the industry: “Resources available for pharmaceutical expenditure are not enough; Italy is spending 19 percent less than other European countries. In addition, we have a payback system that forces companies to give money back if the ceiling of the public budget is crossed. The two elements I just outlined are putting the long-term sustainability of the system in question. If we take off-patent medicines sold through tenders as an example, companies offer products at the lowest price possible while navigating a challenging process and can be asked to pay back at the end of the year. Because of that, many companies are avoiding many tender opportunities.”
“Italy needs a different governance model because the current one, put in place in 2007, is penalizing, through clawbacks, companies that invest. We must get away from that model and rather invest more money to make the healthcare system more efficient,” agrees Scaccabarozzi.
Reducing bureaucracy for clinical trials
With respect to the stifling multi-regional bureaucracy that makes investing in Italian clinical trials challenging, Scaccabarozzi asserts: “Italy accounts for 20-23 percent of all clinical trials conducted in Europe [but] if Italy wants to increase its involvement in clinical trials, it must be able to reduce the bureaucracy at a national level, increase the speed at which centres enrol patients and apply the new European model. I believe that the industry will always choose places where R&D activities are supported by the government.”
Scaccabarozzi links the need for infrastructure investment to Italy’s Resiliency and Recovery plan: “We need to invest in infrastructure. Italy’s Resiliency and Recovery plan will be a unique opportunity to do that. Our country has the perfect mix: more than 200 pharmaceutical companies, of which 43 percent are Italian owned. An important characteristic of Italian companies is their high level of internationalization as 70 percent of their business comes from abroad. On the other hand, international companies have invested in R&D and manufacturing, not only commercial activities. The institutions and the government should capitalize on this in order to continue to attract investment.”
Vingiani, commenting on the need to increase the value of biotechs says: “Despite a lower investment in science than some other European countries, Italy and its researchers have created a good environment for science. However, the country needs to better focus on translating the knowledge and the quality of the knowledge into value for products and companies.”
With respect to generics and biosimilars, investment needs to be stimulated, according to Uda: “The generics and biosimilar industries have always been attractive to investors and … there are plenty of small and medium-sized companies that add value and could go to the next level if provided with the opportunity,” states Uda.
Building on lessons learned from the pandemic
All three association leaders agreed on the necessity to build on takeaways from the COVID-19 pandemic. “What we are taking home as a lesson from this pandemic … is the need to sharpen the strategic role of health moving forward and the need to reorganize the national healthcare system. While Italy already has an extraordinary universal healthcare system, different stakeholders have realized that we must invest more, looking at it not as cost but rather as an investment,” says Scaccabarozzi.
“The pandemic stressed the importance of life sciences. This situation created a new environment in which spending on the life sciences was viewed as an investment rather than an expense. This highlighted for the government the critical value of investing in the life science industry and its innovation. Collaboration is important in this regard to become a leader for the production and creation of knowledge that could be critical for health. This changed the attitude of society toward the life science industry with the pandemic forcing us, unprepared, into a new type of collaboration,” claims Vingiani.
“The pandemic showed us the importance of putting patients at the centre,” says Uda.
Addressing talent issues
Industry organization leaders also pinpointed the talent issues that must be addressed in the country: “The main difficulty is creating suitable conditions to attract Italian talent working abroad back to the country. Currently, together with other stakeholders such as venture capitalists, we are working to create better framework conditions for top Italian biotech talent to return home,” says Vingiani.
“Another aspect is the specific legislation in Italy that prohibits researchers from moving freely between university and industry. A cultural problem remains: research and business are considered separate. The truth is that they are linked and the movement between business and university needs to be opened to properly educate both sectors,” he continues.