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Monday, September 29, 2008

Universities Allied for Essential Medicines: Can a Student Group Influence University Technology Licensing Policies?

by: Stephen Moyer, Associate Editor, MTTLR

Introduction


Image Biotic lensbaby by Sparky.
Used under a Creative Commons BY-NC 2.0 license.

The contributions of research universities to worldwide scientific progress have traditionally been focused on basic scientific discoveries, rather than efforts to ensure that their scientific discoveries actually reach people throughout the world.. Universities Allied for Essential Medicines (UAEM)1 is a non-profit organization that works with faculty and student groups to help ensure the availability of essential medicines in poor countries.2 Among other activities, UAEM hopes to persuade universities to commit to the principle that when they license university-developed medical-related technologies to private companies, a condition of the license will be that the private company agree to make medicines that are created using the university-developed technology available to the developing world at the lowest possible cost.3

The history of this movement stretches back to 2001 when Yale University students became aware that an important anti-HIV medication, stavudine (also known as d4T), that had been developed at Yale and licensed by Yale to the pharmaceutical company Bristol-Myers Squibb (BMS), was not available to many HIV-positive patients in South Africa because of its high cost. 4 The high cost of the drug stemmed at least in part from the fact that it was under patent protection in South Africa.5 After Yale students and others petitioned Yale and BMS not to enforce the patent in South Africa, BMS ultimately agreed to the proposal, which thereby enabled the sale of much cheaper generic versions of the drug. 6

From this experience (which received a substantial amount of national publicity 7) and the understanding that universities are a major source of scientific discoveries that lead to the development of new medicines,8 students at Yale and other universities became convinced of the need for a national organization that would seek to persuade universities to ensure that university-developed scientific advances do not fail to reach people in developing countries because of intellectual property protection of the drugs.

UAEM’s Argument


The general proposition that drug companies should make medicines available to low income countries at the lowest possible cost is easy to support on a humanitarian level, but the proposition may appear less realistic on a practical level: pharmaceutical research and development are costly, as is the manufacture of drugs. Patent protection for new drugs is understood to be integral to the ability of pharmaceutical companies to generate income, recoup their costs, and make drug development profitable to fund on-going research. UAEM argrees that patent protection of new drugs is indeed necessary and appropriate in developed countries, but argues that patent protection of new drugs in developing countries can be harmful. First-world prices are prohibitive for most third-world consumers – drug companies do not realize significant amounts of income from poorer countries, precisely because the high prices result in comparatively small amounts of drugs sold.9 Therefore, UAEM argues that universities and drug companies can make their drugs available to developing countries at low cost, realize higher volumes of sales, and still generate nearly the same profits as they would by selling higher-cost versions of the drugs in these countries. 10

Philadelphia Consensus Statement and Annual Meetings


In 2006, UAEM drafted a concise document that captures the major goals of the organization, the “Philadelphia Consensus Statement” (PCS).11 The PCS is a collection of recommendations that UAEM urges universities to adopt, the key recommendations being that, in addition to ensuring that university-developed technologies are available to developing countries, universities should also promote research into diseases that primarily affect developing countries, and that universities should measure their success at research based on its “impact on human welfare”, rather than just its scientific or income-producing value.12 UAEM obtained support of many prominent individuals and organizations for the PCS, with a list of initial signatories to the PCS that includes multiple Nobel prize winners, university leaders, and international organizations.13

UAEM has held national meetings every year since 2005 to further develop and coordinate its efforts; this year’s meeting will be held at the University of California-Berkeley, on October 17-19, 2008.14

Some Criticisms of UAEM’s Approach


While most people support UAEM's mission, some are concerned that UAEM’s efforts regarding university technology licensing may be ineffective or even counter-productive towards the overall objective of increasing access to medicines.

One concern is that it frequently may not be possible for a university to only license technologies to companies that are willing to make drugs available to developing countries at low cost; it can be difficult for universities to find any companies interested in licensing their technologies. The more restrictions the university puts on licensing agreements, these critics argue, the more difficult it may be for the university to find a party interested in licensing the university technology. 15

Another concern is that if companies agree to allow lower-priced generic versions of drugs to be produced in developing countries while those drugs are still patent-protected in developed countries, the generic drugs could be smuggled into developed countries, and severely damage drug sales there16. UAEM counters that there is not evidence that this type of transfer happens on a large scale, and that drugs can be marked with identifying source information, in order to minimize this problem. 17

Conclusion


Access to medicine remains a major problem worldwide – the World Health Organization estimates that about 10 million people die every year because they do not have access to existing medicines.18 Universities play a major role in developing new medicines, and it is consistent with the mission of universities to ensure that medicines developed on their campuses reach as much of the world’s population as possible. While it remains to be seen what impact UAEM’s efforts will have on universities’ technology licensing policies in the long term, UAEM has brought attention to the important connection between university research and global access to medicine.



1. Universities Allied for Essential Medicines
2. Universities Allied for Essential Medicines, About Us.
3. See Ethan Guillen and Rachel Kiddell-Monroe, Research Universities Must Act, Boston Globe, Oct 3, 2007.
4. Daryl Lindsey, Amy and Goliath, Salon.com, May 1, 2001.
5. See id.
6. Amy Kapczynksi, E. Tyler Crone, and Michael Merson, Global Health and University Patents 301 Science 1629,(2003).
7. See, e.g. Donald McNeil, Yale Pressed to Help Cut Drug Costs in Africa, New York Times, Mar. 12, 2001; Abigail Zuger, A Molecular Offspring, Off to Join the AIDS Wars, New York Times, Mar. 20, 2001.
8. Universities, Not Companies, Drive Biotech Advancement, UCSF Today, May 8, 2007.
9. Samantha Chaifetz, et. al. Closing the access gap for health innovations: an open licensing proposal for universities, 3 Globalization and Health 1, (2007).
10 David Chokshi Improving Access to Medicines in Poor Countries: The Role of Universities, 3 PLoS Medicine 0723, 0725 (2006).
11. Universities Allied for Essential Medicines, Philadelphia Consensus Statement, (2006).
12. Id.
13. Universities Allied for Essential Medicines, Philadelphia Consensus Statement – Initial Signatories.
14. Universities Allied for Essential Medicine, 2008 Conference Registration.
15. Erika Check, Universities urged to do more for poor nations, 444 Nature 412 (2006).
16. David Chokshi,Improving Access at 0725.
17. Id.
18. World Health Organization, Equitable access to essential medicines: a framework for collective action, WHO Policy Perspectives on Medicines, March, 2004.

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Monday, September 22, 2008

ICANN Ushers In New Era for Domain Names

by: Morgan Willard, MTTLR Associate Editor

This past June, the Internet Corporation for Assigned Names and Numbers voted upon and approved a set of measures that constitute sweeping changes for the way that the Domain Name System (DNS), the set of rules governing how internet addresses are located and assigned, works.

Specifically, the measures included two major expansions to how domain names will be registered in the future:

  1. Global Top-Level Domains (gTLDs), the universal extensions such as .com, .net, and .info that are appended to all web addresses, will no longer be restricted to a finite list that is voted upon and expanded by ICANN itself.
  2. Domain names will now accomodate non-Latin character sets such as Arabic and Cyrillic.

Both of these resolutions will have far-reaching implications for citizens of the internet.

Global Top-Level Domain Expansion

Hailed by ICANN as “a massive increase in the ‘real estate’ of the Internet”, it will soon be possible for companies and organizations to apply for the creation of a new gTLD. It is expected that there will be several different types of gTLDs that will quickly generate applications:

  • Generic Words: Categorical words such as the already existing .travel gTLD will likely spring up quickly to appeal to a wide variety of potential registrants. Expect to see applications for everything from .salon to .banana.
  • Regional Names: While countries are already able to get gTLD names through the Country Code Top-Level Domain (ccTLD) system, it is expected that a variety of other geographic and cultural communities will be interested in their own gTLD (imagine .nyc for New York City) similar to the existing .cat domain for the Catalan community.
  • Brands: Global brand names such as Amazon and Coca-Cola will likely be interested in having a gTLD of their own.

While the new system will open up many opportunities for enterprising organizations and possibly allow companies to stop sitting on a keyboard to create a short domain name, there are also valid concerns (especially for trademark holders) about such an open system.

Non-Latin Character Domain Names

Until the recent vote, all domain names had to be using the Roman alphabet. That is, even though there were country-specific TLDs for Russia (.ru) or China (.cn), the domain name itself had to be in the Roman alphabet. This was due to technical limitations: domain names previously used the ASCII (American Standard Code for Information Interchange) standard which is based on the English alphabet and does not allow for most non-English characters. In the future, the Unicode system will be used which allows for every character of every language to be represented.

This expansion will allow greater accessibility to the global internet community, as non-English-speaking users will now be able to access domains in their native language instead of having to learn and remember a different character set for interacting with the internet. However, there are some concerns that phishers (identity thieves) could create domain names using characters similar, but not identical, to their Latin counterparts to make domain names that may be misleadings to online users.

Further Analysis and Reading

For more information and analysis of the impacts of these changes, here are some useful links:

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Friday, September 19, 2008

Google Launches Highly Anticipated Chrome Browser; the Tech Community Reacts

by Sara Skinner, MTTLR Associate editor

Google launched a beta version of its new Chrome web browser on September 2nd. Prior to launch, Google released a comic book depicting the various engineering and design decisions that went into the browser. The result of all these innovations, Google claims, is a safer, smarter, faster way to surf the internet - but industry members and community watchdogs are raising security and privacy concerns.

One issue that plagues virtually all beta-version software is security problems that don’t emerge until the software is disseminated to a large number of users. The comic documents Google's efforts to eliminate as many security flaws as possible before launch by employing a “Chrome bot” to automatically test the browser more thoroughly. Google has also responded swiftly to address the emerging issues after launch, and released their first security update within a few days after the initial launch (although they were not forthcoming about which issues the update had addressed.)

One major source of concern for privacy advocates is the browser’s Omnibox, a multi-purpose search box/URL input field. The Omnibox helps users fine-tune their search and browse experience, but it also constantly sends information about users’ surfing and searching habits back to Google’s headquarters. About two percent of data sent back will be stored with the IP address of the computer that sent it. Users can avoid this by surfing Incognito (a privacy mode that turns off cookie storage) or by disabling the auto-suggest feature, but privacy advocates are worried about the amount of personal information being handled by Google — which the average user may not even realize is being collected.

The Terms of Service for the new browser have not been without controversy, either. When initially launched, Chrome’s terms granted Google extensive rights to user content. Google acknowledged that such restrictive terms were part of a standard boilerplate and shouldn’t have been included. The Terms of Service have since been revised and no longer grant user content rights to Google.

Some of the loudest opposition to the Chrome browser’s privacy practices is coming from privacy advocates in Europe where a user’s IP address is considered personal data. While Google has responded that its privacy data retention is governed by US law, it agreed to shorten its search bar IP retention policy to nine months. It is also working on a way to anonymize IP addresses and cookies when users search in the Google Omnibox.

Screen shot from September 14, 2008 (http://www.google.com/googlebooks/chrome/small_02.html).


Sources:
Scott McCloud & The Google Chrome Team, Google Chrome, Google, (last visited Sept. 14, 2008).
Stephen Shankland, Google Fixes Chrome Vulnerabilities—But Won’t Say Which, Cnet News, Sept. 8, 2008.
Explore Google Chrome Features: Incognito Mode, Google Chrome Help Center, (last visited Sept. 14, 2008).
Ina Fried, EFF: We’re Concerned About Google’s Omnibox, Cnet News, Sept. 3, 2008.
Ina Fried, Be Sure to Read Chrome’s Fine Print, Cnet News, Sept. 2, 2008.
Google Tweaks Chrome License Text, BBC News, Sept. 4, 2008.
Google, Google Chrome Terms of Service, Google, (last visited Sept. 14, 2008).
Peter Fleischer, Response to the Article 29 Working Party Opinion on Data Protection Issues Related to Search Engines, Google, Sept. 8, 2008.
Kurt Opsahl, Google Cuts IP Retention to Nine Months, Electronic Frontier Foundation, Sept. 9, 2008, (last visited September 14, 2008).
Ellen Nakashima, Google Promises Privacy Fixes in Its Chrome Browser, The Washington Post, Sept. 9, 2008.

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