[Ip-health] Upcoming webinar - Is data exclusivity justified?: Evidence on the impacts on innovation and access to medicines

Marcela Vieira marcelacfvieira at gmail.com
Mon Sep 16 00:01:11 PDT 2019

Dear ip-health readers,

We are pleased to invite you to the next webinar organized by the Knowledge
Network for Innovation and Access to Medicines, a project of the Global
Health Centre at the Graduate Institute, Geneva.

*Is data exclusivity justified?: Evidence on the impacts on innovation and
access to medicines*

*Thursday 26 September*

*4:00pm-5:15pm CEST| 9:00am-10:15am COT| 8:00am-9:15am MDT*

*To join the webinar, please register here



   Reed Beall, Assistant Professor, Cumming School of Medicine & O'Brien
   Institute for Public Health, University of Calgary, Canada; Affiliated
   Faculty, Program On Regulation, Therapeutics, And Law (PORTAL), Division of
   Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham
   and Women’s Hospital and Harvard Medical School, Boston, MA, USA

   Mayra Vásquez, Pharmaceutical Chemistry, MSc Political Studies,
   International Consultant in Pharmaceutical Policy and Medicines prices.
   President National College of Pharmaceutical Chemists of Colombia, Regional
   Cundinamarca, Secretary DURG-LA (Drug Utilization Research Group)

   Miguel E Cortés G., Pharmaceutical Chemist; MSc Public health advisor,
   Specialist in international drug price referencing, UNOPS (United Nations
   Office for Project Services)

 Research papers

1) Pre-market development times for biologic versus small-molecule drugs,


2) Impact of 10 Years of Data Exclusivity in Colombia, IFARMA, 2012

    Full report in Spanish:

    Abstract in English: http://bit.ly/IFARMAdataexclusivity


The information required to register a medicine may be the subject of an
exclusivity period. This exclusivity period can delay the availability of
generic medicines by impeding competition from other suppliers and thus,
maintain high medicine prices. The length of exclusivity periods and the
types of technologies covered vary among countries. Countries that do not
provide this face constant pressure to do so during negotiations of trade
agreements. What is the justification behind data exclusivity? And what are
its impacts?

Reed Beall will present a recently published study (above), which reviewed
the pre-market development times for all new drugs approved in the United
States over the past decade. The study concluded that there is no evidence
showing that developing biologic drugs takes more time as compared to other
drugs despite claims pushing for longer exclusivity periods for biologic

The webinar also presents the Colombian experience in adopting data
exclusivity for medicines in 2002. Mayra Vásquez and Miguel Cortés will
present a study (above) that examined the impacts of data exclusivity 10
years after its introduction in the country. The study observed that the
data exclusivity period was responsible for an extra cost of US$ 412
million in medicines expenditures. It also found that providing data
exclusivity did not lead to faster entry of novel products in the Colombian
market, which is another argument frequently used to justify the adoption
of such provision.

The webinar is free and open to the public and will be held in English.
Participants will be able to pose questions orally or in writing, and the
speakers will respond to a selection of these during the second half of the
event. Recordings of all webinars will be made available at the
Portal on Innovation and Access to Medicines
<https://www.knowledgeportalia.org/webinars>. After registering, you will
receive a confirmation email with additional information on how to join the
webinar using the Zoom platform.

We hope you will be able to join us for this informative discussion. This
event is part of the webinar series of the Knowledge Network for Innovation
and Access to Medicines, a project of the Global Health Centre at the
Graduate Institute, Geneva. Suggestions for speakers and topics for future
webinars are welcome at globalhealthresearch at graduateinstitute.ch.

Marcela Vieira
Researcher and Project Coordinator of the
Knowledge Network for Innovation and Access to Medicines
Global Health Centre, Research
Graduate Institute of International and Development Studies
marcela.vieira at graduateinstitute.ch

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