UAEM@ucsd

Universities Allied for Essential Medicines

Talking Points

Here are some key facts about why we do what we do:

The Role of Universities:

  • university research is integral to the biomedical research and development pipeline
  • the pharmaceutical industry is dependent upon research universities; therefore, universities play a key role in improving access to medicines
  • a U.S. Senate Joint Economic Committee study concluded that the contribution of universities and other public research institutions was instrumental in developing 15 of the 21 drugs considered by experts to have had the highest therapeutic impact (1)
  • universities are ideal agents of an open licensing proposal because they are upstream in the development pipeline (and likely hold the rights to the key components of a variety of end products) and they have the potential to act collectively and create a strong negotiating position with industry
  • licensing revenues typically account for only 4% of university research funds – and this figure decreases significantly when other factors are taken into consideration (2); and university revenue from developing country markets would be vanishingly small
  • it is in the institutional principles of universities to create and disseminate knowledge that improves people’s lives throughout the world; for a university to truly consider itself a leader in global health, and to be true to its mission, it should look to how effectively its research agenda is translated to innovations useful to the global society

Developing Countries:

  • approximately 10 million people die needlessly each year because they lack access to existing essential medicines and vaccines (3)
  • patients in poor countries pay on average more than 70% of medicine costs themselves (4)

Pharmaceutical Industry:

  • the branded pharmaceutical industry in the U.S. derives only 5-7% of its profits from all low- and middle-income countries (6)

Equitable Access License (EAL): Open Licensing Approach

  • ultimate goal = achieve marginal cost pricing for health-related end products in low- and middle-income (LMI) countries
  • in short: university technology transfer agreements be written so that they facilitate generic competition by providing open licenses guaranteeing third-party manufacturers the right to compete in LMI markets, regardless of patents or other forms of exclusive rights
  • mechanism of the Equitable Access License (EAL):
    1. cross-licensing and grant back of rights between university and licensee
    2. notification by a third party of intent to supply an LMI market, triggering the provisions of the EAL
    3. grant back of rights for any subsequent developments made by the third party to the university
  • third parties (i.e. generic drug manufacturers) thus have market initiatives to narrow the access gap by offering low-priced, but still profitable, products
  • generic competition of drug production may be the most important factor in lowering prices in any given country (5)
  • an open licensing approach fosters more sustainable and locally appropriate supplies of low-cost medicines in developing countries than other methods (such as voluntary “at cost” pricing or a “fair pricing” approach)
  • in order to meet the health needs of patients in developing countries, EAL provisions must apply to all LMI countries (as defined by the World Bank) and must include the right to supply the private sector in these countries
  • under the EAL, universities would stand to gain a small but significant revenue stream from its share on royalties form end products that would otherwise not be sold in LMI countries

References:

(1) “The Benefits of Medical Research and the Role of the NIH.” Washington, D.C., Office of the Chairman, Senate Joint  Economic Committee, 2000.
(2) “AUTM Licensing Survey: FY2001.” Northbrook, Association of University Technology Managers; 2002
(3) “Equitable access to essential medicines: a framework for collective action.” Geneva, World Health Organization; 2004
(4) “The World Medicines Situation.” Geneva, World Health Organization; 2004
(5) “Surmounting Challenges: Procurement of Anti-Retroviral Medicines in Low- and Middle-Income Countries.” Geneva, Medecins Sans Frontieres; 2003.
(6) “Pharmaceutical Industry Profile 2005 – From Laboratory to Patient: Pathways to Biopharmaceutical Innovation.” Washington, D.C., Pharmaceutical Research and Manufacturers of America; 2005.

Advertisements

No comments yet.

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s

%d bloggers like this: