The Role of Patents, Universities, and Non-Profits in the Promotion of Health Care Access Nina Gandhi

From the Lab to the Marketplace Major players:  Public Research Institutions

From the Lab to the Marketplace Major players:  Public Research Institutions  Pharmaceutical Research Institutions

From the Lab to the Marketplace Major players:  Public Research Institutions  Pharmaceutical Research Institutions  Pharmaceutical companies

From the Lab to the Marketplace Major players:  Public Research Institutions Pharmaceutical Research Institutions  Pharmaceutical companies  ** Universities and Non-profit organizations

Key Terms: What is a patent?  A patent grants an inventor sole rights to an invention for a given amount of time. wordnet.princeton.edu/perl/webwn z/v/side_GreenIdea.jpg

Key Terms: What is a patent?  A patent grants an inventor sole rights to an invention for a given amount of time.  Drugs on patent = EXPENSIVE, exclusive  Drugs off patent = generic, normally inexpensive wordnet.princeton.edu/perl/webwn

Key Terms: What is licensing?  Licensing refers to contractual agreements granting permission for the use of intellectual property under specific conditions. place.wa.us/Business%20Licensing/business.jpg

Key Terms: What is the Bayh-Dole Act?  A way for a university or non-profit to own rights to its research and license out these rights Story_Bayh-Dole.jpg

Key Terms: What is the Bayh-Dole Act?  A way for a university or non-profit to own rights to its research and license out these rights  Bypasses government institutions ** Story_Bayh-Dole.jpg

Key Terms: What is the Hatch-Waxman Act?  Allows generic drugs into the market before patents expire. org/uploaded_images/Pres cription%20Drugs.jpg

Key Terms: What is the Hatch-Waxman Act?  Allows generic drugs into the market before patents expire.  Created ANDA process shared/Editor/assets/court_ room.jpg

Key Terms: What are the FDA and FTC?  FDA  Center for Drug Evaluation and Research

Key Terms: What are the FDA and FTC?  FDA  Center for Drug Evaluation and Research  Evaluates scientific research

Key Terms: What are the FDA and FTC?  FDA  Center for Drug Evaluation and Research  Evaluates scientific research  Approves of safety of drugs

Key Terms: What are the FDA and FTC?  FTC  Enforce “true in advertising” claims

Key Terms: What are the FDA and FTC?  FTC  Enforce “true in advertising” claims  Bureau of Competition

Key Terms: What are the FDA and FTC?  FTC  Enforce “true in advertising” claims  Bureau of Competition  Monitors relationship between drug companies and generics

From the Lab to the Marketplace Drug Research and Conception FDA Approval (NDA) Clinical Trials, Testing ($$$ and time) Patented Drug (lasts years) Availability of Generics BIG PHARMA + GOV’T REVENUE

The Role of Universities

Domestic Research, Outsourced Drug Rights  Universities receive funding through grants and awards. wu/images/money%203.jpg e/images/video-award-shelf.jpg

Domestic Research, Outsourced Drug Rights  Universities receive funding through grants and awards  Government makes an investment in research and expects new discoveries. content/uploads/government- grants.jpg

Domestic Research, Outsourced Drug Rights  The innovations are shared with Technology Transfer Offices (TTO’s)  Research patented by the university is licensed to pharmaceutical companies for production systems.sartoserver.de/media/ productpics/bioscipro_(novo)_ 23_copy.jpg

What Can Be Improved? Implications for Developing Countries and Accessible Global Health  AUTM’s 9th point  Universities should use research money for neglected diseases city.com/files/aa/32997/p/f/pov erty_3_0146.gif

What Can Be Improved? Implications for Developing Countries and Accessible Global Health  AUTM’s 9th point  Universities should use research money for neglected diseases  Ensure that underprivileged populations have access to these medicines ages/Africa_poverty-383x480.png

What Can Be Improved? Implications for Developing Countries and Accessible Global Health  Organizations that promote point #9:  Technology Managers for Global Health  Universities Allied for Essential Medicines ey.edu/image005.j pg

Role of Non-profit Companies (not an oxymoron anymore!)  Benefits of non-profit pharmaceutical companies  R&D team

Role of Non-profit Companies (not an oxymoron anymore!)  Benefits of non-profit pharmaceutical companies  R&D team  Research, clinical trials, prepare paperwork, etc.

Role of Non-profit Companies (not an oxymoron anymore!)  Benefits of non-profit pharmaceutical companies  R&D team  Research, clinical trials, prepare paperwork, etc.  No obligation to a specific demographic

Non-profit Example: Carolina Vaccine Institute  Develops vaccines for neglected diseases for developing countries

Non-profit Example: Carolina Vaccine Institute  Develops vaccines for neglected diseases for developing countries  Uses revenue to fund more research

Non-profit Example: Carolina Vaccine Institute  Develops vaccines for neglected diseases for developing countries  Uses revenue to fund more research  An example of universities and non-profits for the promotion of global health

From the Lab to the Marketplace Drug Research and Conception FDA Approval (NDA) Clinical Trials, Testing ($$$ and time) Patented Drug (lasts years) Availability of Generics BIG PHARMA + GOV’T REVENUE

How Universities and Non-profit Companies Fit In Drug Research and Conception FDA Approval (NDA) Clinical Trials, Testing ($$$ and time) Patented Drug (lasts years) Availability of Generics BIG PHARMA + GOV’T REVENUE Reduced $$$ and time Production and Distribution REVENUE University Research and Work of TTOs

What WE Can Do!  "When it comes to global health, there is no 'them'... only ' us.'" - Global Health Council