Building a Bio-economy
Building a Bio-economy International Best Practices, Lessons Learned and Evidence from the Field Prof Meir Pugatch IPKM Chair, Univ. of Maastricht; Managing Director, Pugatch Consilium Opening Plenary June 20, 2017 BIO Convention San Diego, CA
Seven enabling factors for biopharmaceutical innovation
Regulatory environment Intellectual property
Market & commercial incentives
Infrastructure for R&D
Human capital
Technology transfer frameworks
Bioeconomy
Source: Pugatch Consilium (2017)
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Rule of law
When it comes to enabling innovation, some are near the summit while others are just starting the climb… Biopharmaceutical Competitiveness & Investment (BCI) Survey, 4th edition, 2017
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Market access, IP and localization = key policy gaps Biopharmaceutical Competitiveness & Investment (BCI) Survey 2017 Scores Newcomer Markets
Risks losing out further due to pricing policies!
Mixed conditions
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Though exceptions exist, biopharma innovators face: Strict price regimes & weak • reimbursement Underdeveloped/sluggish • regulatory systems Localization • Erosion of IPRs • Limited R&D capacity •
Policy conditions affect competitiveness in “mature” markets too Biopharmaceutical Competitiveness & Investment (BCI) Survey 2017 Scores Mature Markets
Innovation increasingly de-prioritized + uncertainty and regulatory delays
Gaps in biopharma IPRs + draconic market access terms
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Why do policy conditions matter: $100 billion reasons Clinical trials intensity around the globe Russia 3,703
UK 13,545
Canada 17,021 US 102,699
South Korea 8,123
Turkey 2,532
China 9,868
Mexico 2,717 Colombia 1,029
India 3,121
Brazil 5,730
Peru 872 Chile 1,256
Indonesia 331 Thailand 2,151
Argentina 2,217
South Africa 2,338
Ecuador 115
* As registered in Clinicaltrials.gov database in June 2017
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Japan 29,800 (NIPH)
Singapore 1,810 Australia 5,701
IP rights, innovation & economic activity
A robust IP regime matters for high-value job creation!
Source: Pugatch Consilium/ GIPC (2017), ILOSTAT (2016)
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Thank you!
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Seven enabling factors for biopharmaceutical innovation
Regulatory environment Intellectual property
Market & commercial incentives
Infrastructure for R&D
Human capital
Technology transfer frameworks
Bioeconomy
Source: Pugatch Consilium (2017)
2
Rule of law
When it comes to enabling innovation, some are near the summit while others are just starting the climb… Biopharmaceutical Competitiveness & Investment (BCI) Survey, 4th edition, 2017
3
Market access, IP and localization = key policy gaps Biopharmaceutical Competitiveness & Investment (BCI) Survey 2017 Scores Newcomer Markets
Risks losing out further due to pricing policies!
Mixed conditions
4
Though exceptions exist, biopharma innovators face: Strict price regimes & weak • reimbursement Underdeveloped/sluggish • regulatory systems Localization • Erosion of IPRs • Limited R&D capacity •
Policy conditions affect competitiveness in “mature” markets too Biopharmaceutical Competitiveness & Investment (BCI) Survey 2017 Scores Mature Markets
Innovation increasingly de-prioritized + uncertainty and regulatory delays
Gaps in biopharma IPRs + draconic market access terms
5
Why do policy conditions matter: $100 billion reasons Clinical trials intensity around the globe Russia 3,703
UK 13,545
Canada 17,021 US 102,699
South Korea 8,123
Turkey 2,532
China 9,868
Mexico 2,717 Colombia 1,029
India 3,121
Brazil 5,730
Peru 872 Chile 1,256
Indonesia 331 Thailand 2,151
Argentina 2,217
South Africa 2,338
Ecuador 115
* As registered in Clinicaltrials.gov database in June 2017
6
Japan 29,800 (NIPH)
Singapore 1,810 Australia 5,701
IP rights, innovation & economic activity
A robust IP regime matters for high-value job creation!
Source: Pugatch Consilium/ GIPC (2017), ILOSTAT (2016)
7
Thank you!
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