The participants at this National Interest event kicked off their discussions by observing that the pharmaceutical industry is one of the main agents of modernization and innovation in Italy, with its success rooted in the historical events and conditions that have helped shape the current Italian model.
The delayed industrialization of the country has ensured that the prevailing historical model of growth in the pharmaceutical industry has been the “Latin” one, based on the pharmacy profession winning over the trust of the public and making the leap from the preparation of galenicals to specialty products sold even to peers. Much credit for the consolidation of the Italian industry is to be attributed to the state, which – stirred into action by public health issues – has been a driver of this process, including as a producer, as the case of quinine and the fight against malaria demonstrate.
Despite the Italian pharmaceutical industry being marked by certain peculiar features, such as a lack of patent protection for pharmaceuticals until 1978 that slowed down its consolidation, it is now credited as the second-largest European producer after Germany, with a secure foothold in foreign markets in a strategic sector that has shown enormous resilience in times of crisis.
Figures were cited pointing to constant growth in production – with an increase of 7.4% even in the first four months of 2018, accompanied by a rise in exports of 6.3% – and to investment in research of 2.8 billion euro a year, up 22% in the last three years. Its leading position is confirmed by several outstanding achievements, with three of the six advanced therapies approved to date in Europe originating from Italy, 282 biotech drugs currently under development in Italy, and 20% of clinical studies in the EU being conducted in Italy. It was suggested that these prevailing virtues are also corollaries of massive investment in ICT and process innovation, which has led the pharmaceutical industry to be the first in the country to embrace the Industry 4.0 paradigm.
Given this scenario, it was felt that the pharmaceutical sector could – within the life sciences ecosystem – serve as a prime mover, generating and spreading innovation, knowledge, and health. Nevertheless, it was acknowledged that this is a particularly complex feat to accomplish in a sector which, while definitely resilient to external shocks, is subject to very rapid change due to scientific and technological progress.
The participants emphasized the necessity – in order to maintain this position – of focusing on excellence and on developing local production specializations so as to generate the critical mass needed for a winning edge, resorting also to “hub & spoke” models for mutual enrichment between different centers of production. More generally, proximity was identified as a decisive factor for the development of innovative and game-changing solutions, precisely because it triggers those cross-fertilization mechanisms that are antecedents to the generation of ideas.
Cited as one of the challenges to be addressed was the chronic difficulty in Italy of transforming scientific discoveries into patents and subsequently into products stemming from technology transfer constraints and giving rise to a need to review certain training curricula and invest in specialized administrative staff shared between various academic institutions. It was felt that the situation is further compounded by a system of rules that are ineffective due to their sheer number and often contradictory nature, and by reason of their being predominantly geared towards a siloed logic.
Lastly, it was stressed that the issue of governance, given the proliferation of regulatory authorities and bodies, along with the need for a stable regulatory and political framework that facilitates the attraction of investors, both continue to be important.
Hence, in order to facilitate growth and boost innovation, it was deemed crucial to invest more in soft factors (human capital and, in general, training for new professions), as well as in the interoperability of IT systems, thereby making it possible to exploit available data sources that are currently disjointed. Finally, it was felt that looming in the background is the most significant and complex challenge, namely, that of legitimizing science in the face of waves of anti-scientific or a-scientific sentiment, through the development of new communications metrics that are capable of conveying the true value of scientific discoveries.