Università Cattolica del Sacro Cuore

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1 Università Cattolica del Sacro Cuore The role of Regulatory Affairs in drug development Francesco Mazza, Director of Legal, Fiscal & Compliance Affairs in Farmindustria Rome, May

2 Who we are

3 Who we represent 200 pharmaceutical companies holding MAs 40% italian owned 60% foreign owned Our mission: Represent the voice of companies to promote competitiveness and scientific development, communicate their value to Institutions, to public opinion and to all stakeholders at national and European level.

4 What we do Farmindustria, being an Association of pharma companies, based upon the principles of direct participation of companies and open and shared dialogue represents the legitimate needs, and provides support service

5 Key figures of pharma sector in Italy Pharma industry in Italy by nationality of ownership (% on total) 40% Italian-owned companies 200 companies, member of Farmindustria, representing 90% of industrial value of pharmaceutical sector in Italy 63,500 employees (90% graduates), 43% women, and 66,000 in upstream sectors 6,100 R&D employees, 53% women 60% foreign-owned companies Note: average of turnover, employees, investments in manufacturing and R&D, foreign sales, taxation 30 billion of manufacturing value, 73% of which due to export ( 22 billions) 2.6 billion in investments, 1.4 of which in R&D and 1.2 in hi-tech plants and machinery Source: elaboration of Istat, Eurostat data

6 Pharmaceutical and upstream sectors by Regions Lombardy 28,000 direct employees, Lombardia ranks 1 st for pharmaceutical and biotech firms; 18,000 employees in upstream industries (chemicals, machinery, paper) Piedmont and Liguria 2,000 direct employees and 7,000 in upstream industries (machinery, chemicals, packaging) Tuscany 6,000 direct employees 4,000 employees in upstream industries (glass, chemicals) Lazio 16,000 direct employees 47% of regional export (87% of hi-tech export) 6,000 employees in upstream industries (chemicals, packaging) Fact&figures of pharmaceutical industry and upstream sectors in Italy 130,000 employees 6.6 bln of salaries (including social contributions) 44 bln of production value 3,4 bln of R&D, plants and machinery investments Veneto 3,000 employees, 7,000 in upstream industries (machinery, chemicals, packaging) Emilia Romagna 3,600 direct employees and 7,000 in upstream suppliers (machinery, chemicals, glass). Parma: pharma ranks third for export Campania 900 direct employees and 3,000 in upstream industries Marche 2,900 employees in pharma companies and upstream suppliers. Ancona: export to more than 40 countries Ascoli Piceno: pharma accounts for 70% of total export Abruzzo 1,400 direct employees (100 in R&D) and 1,300 in allied industry Puglia Centres of excellence of major international companies (3,000 employees in pharma companies and related industries). Bari and Brindisi pharma export accounts for 25% of total Sicily About 1,000 direct employees and 2,500 in related industries. Catania: pharma accounts for 14% of total export Source: elaboration of Farmindustria, Istat data

7 Italy is the second pharma manufacturer in EU (aiming at becoming the first) Pharmaceutical manufacturing overall value ( billion, 2015 estimates) In 2015 Italy ranks second in Europe for pharmaceutical production, with the expectation to become the first manufacturer in the medium-term Among the Big Eu Italy accounts for 26% of total pharma production and 19% of total sales 0 Source: elaboration of Istat, Efpia data

8 The role of pharmaceutical industry in Italy for the economy of the country GDP and pharmaceutical production (var. %) 12% 10% 8% 6% 4% 2% 0% -2% -4% The comparison with GDP shows the importance of the pharmaceutical industry for Italy s economy Furthermore, from 2010 to 2015 the pharma ranks first among manufacturing sectors for growth of: industrial production (+11%) (manufacturing average: -7%) export (+57%) (manufacturing average: +23%) -6% Pharmaceutical production GDP productivity* (+21%) (manufacturing average: +5%) (*) labour productivity: added value per employee Source: elaboration of Istat data

9 The largest growth of export in Europe: export as the engine of pharma companies in Italy Pharma export: trend for the big Eu countries (% change) +57% From 2010 to 2015 pharma export in Italy has grown more than all big Eu countries and more than Eu 28 average +33% The performance of export is the result of an increased quality of medicines and vaccines exported all over the world: in the average value at export registered a growth of +34% (compared to +22% of Eu average): 0% 10% 20% 30% 40% 50% 60% Source: elaboration of Istat, Eurostat data

10 Exporting a paradigm shift (this slide was shown to Global CEOs at a meeting with the Italian Government, May 2016) Farmindustria long term strategy Over the last 5 years Farmindustria has decided to play attack to shift a paradigm in the pharmaceutical sector that definitively needed to be changed FROM A cost to society TO A winning card for the economy Pharmaceuticals as a cash machine for NHS No cuts and pharma savings reinvested for innovation A silos-based approach to healthcare A holistic view of health, outcome-based

11 Priorities Transparency Compliance Value of Research and Development and manufacturing Intellectual Property (Patent and Trademark) Sustainability Big Data/Health Data Data Privacy

12 The actors The fundamental role of Regulatory Affairs From the very beginning

13 Why the pharmaceutical sector is an asset for the Country More Health Eeconomic growth Higher educational levels Upstream Direct Contribution Higher productivity for healthier workers Innovation, appropriateness, compliance to therapies, access to treatments, freedom to prescribe Pharmaceutical sector Vaccines and prevention Less surgical procedures Less hospitalization Lower risks of disability Saving for Welfare HCS sustainability Welfare in the Pharma sector

14 Considerable increase in medical innovation with over 7000 medicines under development CAR-T therapies Gene therapy Alzheimer s treatments Combination therapies Cell therapy Antibacterial treatments Source: Health Advances analysis; Adis R&D Insight Database. March 2015, compiled by PhRMA

15 Many meanings for access to innovation Patients & Families Healthcare providers increased quality of life better health outcome better disease management Policy Makers INNOVATION BENEFITS Pharma more effective treatment options for individual needs proactive healthcare agendas reduced welfare costs Clinicians Payers effective use of resources Society incentive to invest in innovation challenges and benefits for all stakeholders

16 Challenges for the future Healthcare systems are required to provide rapid, effective, fair, equitable and sustainable patient access to new medicines What can be done to get prepared Understand what is coming through the industry pipeline and Horizon Scanning at country level Discuss with all stakeholders involved the various implications Inform policymaking, healthcare service management and budget planning

17 Develop new knowledge in selected areas adapting regulatory pathways early and ongoing consultation on clinical trial design and manufacturing processes; supporting temporary access while waiting confirmation of clinical benefit valuing + rewarding innovation adapting financing models flexible HTA and P&R processes would allow for provisional access to be provided in case of uncertainties at launch overcome limitations of annual and siloed budgets with new finance schemes new approaches to treatment and delivery of services facilitating the optimal delivery of innovation, with integrated care and manufacturing facilities and early-diagnosis centres evidence through Real World Data robust data capture systems to generate RWE on patents outcomes for temporary access

18 Pharma research in Italy: a network of excellence for health and quality of life N of medicines in development globally (for many diseases) Cancers 1,813 Neurological disorders Infectious diseases Immunological disorders Cardiovascular diseases Mental health disorders Diabetes HIV/AIDS ,329 1,256 1,120 More than 7,000 medicines in development globally, with the contribution of research in Italy: in biotech (324 products in development), vaccines, plasma protein therapeutics, advanced therapies, rare diseases and sex-difference medicine Innovation is the result of the network between companies and public-private partnership, non-profit, universities. As demonstrated by three examples of excellence: the first medicine in Europe based on stem-cells is Italian the first gene therapy medicine ex-vivo is Italian the first immunogene therapy (HSCT) for adult patients with high-risk heamatological malignancies Source: Farmindustria, EY, PhRMA

19 R&D pharma investment in Italy are growing also thanks to a more attractive ecosystem R&D pharma expenditure in Italy ( million) 1,450 1,400 1,350 1, % In 2015 pharma companies invested 1,4 billion, the 7% of national total In the last two years investments have grown by 15%, and 75% of companies claim an additional increase in the near future 1,250 1,200 1,150 1, Pharma companies in Italy invest 15% of their added value, 10 times more than the national average. The sector drives the country to Europe 2020 goal (3% of national added value) Source: elaboration of Farmindustria, Istat, Bain&Company data

20 Clinical trials: the door of innovation, opportunity and resource for the country Clinical trials in Italy: share of Eu total (% on total) In 2015 pharma companies invested 700 million in clinical trials, in NHS structures Italy could become a hub for clinical trials, thanks to the scientific expertise and the excellences in industry, universities and NHS structures Investing in clinical trials not only means new medicines and innovative therapies for patients: it also guarantees to NHS important resources and savings, since companies bear all the costs connected to clinical trials (for 1 invested in oncology trials, NHS saves 2,2 ) Source: elaboration of Farmindustria, Aifa data

21 Conclusion Certainty of the rules Centrality of the decisions taken. Respect of intellectual property, patents and brands, where clarity, in compliance with all rules, constitutes an advantage for all the players of the sector, for the Administration, and last but not least, for the safeguard of citizens health. Safeguard of Research, that means offering innovation and better access to medicines. Without patents there would be no research and without Research there would be no new medicines.

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