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Country Perspectives: Italy

04:00 EDT 12 Jul 2019 | LillyPad

This post is the third in a series featuring Lilly’s people from across the EU, in which we explore the state of healthcare in their countries, the EU elections and their implications, and more. Today, we have 4 questions with Concetto Vasta, Senior Director of Corporate Affairs and Market Access at Lilly Italy.

1. Why is Italy a good place for a biopharmaceutical company to invest?

Italy has all of the fundamentals required for a biopharmaceutical company to thrive. It is the 6th-largest pharmaceutical market in the world, which makes it very attractive. Italy also has a highly educated workforce in the life sciences (and beyond) which provides the talent the biopharmaceutical industry requires. In parallel, our industry has been present in the country for a long time, which means there is a history of high-quality scientific and manufacturing know-how specific to biopharma. In addition, Italy’s regulatory framework supports innovation, especially through the protection of intellectual property, so when a company invests it can do so safe in the knowledge that its work will be protected. Lastly, I’d mention the tradition and scope of public-private partnerships that we are able to forge here, which is highly beneficial to all parties in the health arena as it is a win-win approach

2. How would you rate patient access in Italy to new and exciting innovations?

According to the EFPIA Patient W.A.I.T. Indicator 2018 survey, the average time between EU marketing authorization and patient access in Italy is 402 days. This is around the European average, but the second slowest amongst similarly large markets in the EU (Germany, Spain, France, and the United Kingdom). These delays in access create inequalities compared to other countries in Europe, and mean patients miss out on treatments which can enhance and even prolong their lives. Moreover, after national approvals by the Italian regulatory agency (AIFA), additional approvals are needed in all Italy’s regions, which causes further delays and creates intra-regional disparities within the country. Inequalities based on where someone happens to live breach the principle of equality and right to health that are hallmarks of the Italian Constitution. For this reason, enhancing access is one of the most important priorities in healthcare, and the Italian trade association for our industry, Farmindustria, has it at the top of its agenda. Ultimately, the fix is political, and we hope that Italian institutions will do their utmost to improve current access levels.

3. What is Lilly Italy looking for in the next EU mandate?

More than anything, we hope that the EU will help to maintain and even boost existing levels of innovation. Also, we hope that current funds for innovation in national healthcare budgets will remain sizeable. While this is a national prerogative, we still feel that it is a discussion that could be raised to the European level, so that member states can more easily compare the positive effects of innovation funding. Last but not least, we would like to see improvements in conditions for clinical research across the EU, especially a well-designed framework of rules, with standardized processes that can facilitate clinical trials.

4. Looking into your crystal ball, what are your hopes for healthcare in 10 years? 

The next-generation medicines our industry has been developing over the past few years – like regenerative, one-shot, gene-therapies, and others – will have dramatic effects on healthcare. Many new therapies will dramatically change the lives of patients by eradicating diseases, or at least making them completely manageable. This will of course also result in enormous long-term savings for both healthcare and welfare budgets. But these new therapies are expensive to develop, and many remain early-phase. The ethical implications of these costs are being questioned at scientific and political tables, in relation to the sustainability of healthcare systems. Governance structures created for the biopharmaceutical industry many years ago to manage ‘old’ therapies are in many cases no longer applicable, given how different the new therapies are today and will be tomorrow. My hope for the next 10 years, for Italy and the rest of Europe, is that we will be able to adapt biopharmaceutical governance and regulatory systems in order to respond to advances in scientific research, and ultimately make life-saving and enhancing medicines available for increasing numbers of patients, while maintaining the sustainability of healthcare systems.

Lilly Italy first opened 60 years ago at Sesto Fiorentino just outside Florence, where we have been based ever since and now employ around 1,200 people. Our manufacturing plant is one of Italy’s most innovative plants for the production of biotechnology drugs, currently producing close to 50% of Lilly’s insulin and dulaglutide auto-injectors worldwide. This makes us the top biopharma company in Italy in terms of export volumes (98% of production). We marked our anniversary on July 10th this year with an institutional event at our Campus where we will deliberate on the state of the biopharmaceutical sector in Italy, future trends in R&D, and how healthcare systems should adapt to ensure sustainability.

Original Article: Country Perspectives: Italy

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