Transparency as Industrial Strategy: What’s at Stake for “Made in Italy” Life Sciences

by | Aug 6, 2026 | Compliance, Vector Health

Author


May Khan

May Khan
Director
Vector Health Compliance

May Khan leads the Compliance Services team at Vector Health, a SaaS company focused on life sciences compliance. Her experience includes global transparency reporting, Sunshine Act strategy, and HCP risk monitoring. At Vector, she coordinates cross-functional teams focused on data integrity, customer service, and regulatory alignment.

 

Vector Health Compliance
Your Leading Partner in Global Sunshine Compliance

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Italy did not become Europe’s leading pharmaceutical CDMO market by manufacturing value by accident, and it will not remain there by accident either. Manufacturing leadership and regulatory credibility are no longer separate conversations.

A Manufacturing Powerhouse Few People Talk About

Italy ranks first in Europe for pharmaceutical CDMO manufacturing value, accounting for approximately 24% of the European market. It is also one of the EU’s largest pharmaceutical producers, with production reaching €56.1 billion in 2024 and exports reaching €53.8 billion.

Italy ranks sixth globally for medicine exports. According to figures released for the OpportunItaly initiative, it also ranks first in Europe—and second worldwide—for patent productivity. Under the initiative’s broad definition, the Italian life sciences sector accounts for more than 10% of national GDP.

In 2025 alone, Italian pharmaceutical exports to the United States increased by 54% to €15.7 billion. Against that backdrop, OpportunItaly was presented at BIO International Convention 2026 as a platform connecting international buyers and investors with Italian businesses.

Reputation Is Now Part of the Supply Chain

Multinational manufacturers do not invest hundreds of millions of euros in Italian facilities purely because of labour costs or geography.

Eli Lilly’s €750 million investment programme in Italy, linked to its major manufacturing presence in Sesto Fiorentino, Sanofi’s continued investment in Scoppito and Anagni, and Boehringer Ingelheim’s Bidachem manufacturing site in Fornovo San Giovanni all demonstrate confidence in Italy’s manufacturing expertise, workforce and industrial infrastructure.

They also underline why the broader governance environment matters to the country’s long-term investment proposition. As global buyers, regulators and institutional investors place greater emphasis on regulatory predictability and accountable business practices, a credible and fully operational Sunshine Act could strengthen Italy’s wider investment proposition rather than remain a separate compliance line item.

The Cost of Being the Slow Adopter

Italy has real cause for confidence in its manufacturing story, but the Italian Sunshine Act’s prolonged implementation timeline is a reminder that industrial leadership and regulatory follow-through do not automatically move at the same pace.

Law No. 62/2022 required the technical implementing decree within three months of the law’s entry into force and the establishment of the Sanità Trasparente register within six months. Although the Ministry has developed the platform and published access information, the register has not yet entered full legal operation.

France and Belgium have operated statutory transparency systems for years, while the Netherlands maintains a longstanding central register based primarily on industry codes of conduct.

If Italy’s rollout continues to lag while its manufacturing footprint keeps growing, it risks a mismatch that becomes its own reputational story: hard infrastructure and export strength racing ahead of the governance systems meant to support public and institutional trust in that growth.

Public Confidence Is a Manufacturing Input Too

It is tempting to treat transparency reporting as an obligation that sits downstream of manufacturing—a compliance function bolted onto an otherwise industrial story.

A more accurate framing is that public confidence is itself an input to manufacturing success.

Patients need to trust the medicines coming off Italian production lines. International payers and health systems need to trust the clinical relationships behind the products they reimburse. Foreign investors evaluating whether to expand a plant in Emilia-Romagna or Lombardy are also likely to consider regulatory predictability, institutional capacity and the wider governance environment surrounding that investment.

Italy’s structural advantages—including the codice fiscale as an officially assigned and verifiable identifier, established healthcare-professional data processes and the experience Farmindustria member companies have developed through EFPIA-aligned disclosure—give it the raw material to turn Sanità Trasparente into a genuine differentiator rather than a lagging obligation.

The Path Forward

Treating the eventual launch of Sanità Trasparente as a strategic inflection point, rather than a bureaucratic checkbox, is the clearest way for Italy to protect the industrial narrative it has spent the last decade building.

Experience in the United States and France shows that mandatory, granular disclosure can make financial relationships more visible, support independent scrutiny and create stronger incentives for organisations to examine how those relationships are governed.

Transparency is not a substitute for effective controls, but it can become an important part of a market’s accountability infrastructure.

For an industry that now represents one of Italy’s most important economic engines, getting transparency right is not a side project. It is part of what keeps “Made in Italy” credible on the label of every medicine it exports.

Italy did not become Europe’s leading pharmaceutical CDMO market by manufacturing value by accident, and it will not remain there by accident either. Manufacturing leadership and regulatory credibility are no longer separate conversations.

A Manufacturing Powerhouse Few People Talk About

Italy ranks first in Europe for pharmaceutical CDMO manufacturing value, accounting for approximately 24% of the European market. It is also one of the EU’s largest pharmaceutical producers, with production reaching €56.1 billion in 2024 and exports reaching €53.8 billion.

Italy ranks sixth globally for medicine exports. According to figures released for the OpportunItaly initiative, it also ranks first in Europe—and second worldwide—for patent productivity. Under the initiative’s broad definition, the Italian life sciences sector accounts for more than 10% of national GDP.

In 2025 alone, Italian pharmaceutical exports to the United States increased by 54% to €15.7 billion. Against that backdrop, OpportunItaly was presented at BIO International Convention 2026 as a platform connecting international buyers and investors with Italian businesses.

Reputation Is Now Part of the Supply Chain

Multinational manufacturers do not invest hundreds of millions of euros in Italian facilities purely because of labour costs or geography.

Eli Lilly’s €750 million investment programme in Italy, linked to its major manufacturing presence in Sesto Fiorentino, Sanofi’s continued investment in Scoppito and Anagni, and Boehringer Ingelheim’s Bidachem manufacturing site in Fornovo San Giovanni all demonstrate confidence in Italy’s manufacturing expertise, workforce and industrial infrastructure.

They also underline why the broader governance environment matters to the country’s long-term investment proposition. As global buyers, regulators and institutional investors place greater emphasis on regulatory predictability and accountable business practices, a credible and fully operational Sunshine Act could strengthen Italy’s wider investment proposition rather than remain a separate compliance line item.

The Cost of Being the Slow Adopter

Italy has real cause for confidence in its manufacturing story, but the Italian Sunshine Act’s prolonged implementation timeline is a reminder that industrial leadership and regulatory follow-through do not automatically move at the same pace.

Law No. 62/2022 required the technical implementing decree within three months of the law’s entry into force and the establishment of the Sanità Trasparente register within six months. Although the Ministry has developed the platform and published access information, the register has not yet entered full legal operation.

France and Belgium have operated statutory transparency systems for years, while the Netherlands maintains a longstanding central register based primarily on industry codes of conduct.

If Italy’s rollout continues to lag while its manufacturing footprint keeps growing, it risks a mismatch that becomes its own reputational story: hard infrastructure and export strength racing ahead of the governance systems meant to support public and institutional trust in that growth.

Public Confidence Is a Manufacturing Input Too

It is tempting to treat transparency reporting as an obligation that sits downstream of manufacturing—a compliance function bolted onto an otherwise industrial story.

A more accurate framing is that public confidence is itself an input to manufacturing success.

Patients need to trust the medicines coming off Italian production lines. International payers and health systems need to trust the clinical relationships behind the products they reimburse. Foreign investors evaluating whether to expand a plant in Emilia-Romagna or Lombardy are also likely to consider regulatory predictability, institutional capacity and the wider governance environment surrounding that investment.

Italy’s structural advantages—including the codice fiscale as an officially assigned and verifiable identifier, established healthcare-professional data processes and the experience Farmindustria member companies have developed through EFPIA-aligned disclosure—give it the raw material to turn Sanità Trasparente into a genuine differentiator rather than a lagging obligation.

The Path Forward

Treating the eventual launch of Sanità Trasparente as a strategic inflection point, rather than a bureaucratic checkbox, is the clearest way for Italy to protect the industrial narrative it has spent the last decade building.

Experience in the United States and France shows that mandatory, granular disclosure can make financial relationships more visible, support independent scrutiny and create stronger incentives for organisations to examine how those relationships are governed.

Transparency is not a substitute for effective controls, but it can become an important part of a market’s accountability infrastructure.

For an industry that now represents one of Italy’s most important economic engines, getting transparency right is not a side project. It is part of what keeps “Made in Italy” credible on the label of every medicine it exports.

Author


May Khan

May Khan
Director
Vector Health Compliance

May Khan leads the Compliance Services team at Vector Health, a SaaS company focused on life sciences compliance. Her experience includes global transparency reporting, Sunshine Act strategy, and HCP risk monitoring. At Vector, she coordinates cross-functional teams focused on data integrity, customer service, and regulatory alignment.

 

Vector Health Compliance
Your Leading Partner in Global Sunshine Compliance

Recent Blogs