Access To Medicines Project

In the latest issue of the Global Access to Medicines Bulletin, you can read about Colombian civil society's efforts to make generic versions of an important treatment for HIV/AIDS available. You can also learn how a small group of countries are quietly negotiating a new international treaty -- known as the Anti-Counterfeiting Trade Agreement (ACTA) -- that may interfere with efforts to promote generic and price competition in the pharmaceutical industry.

Click here to subscribe to the Global Access to Medicines Bulletin.

Download an .rtf version of the bulletin here.

A text version of the bulletin appears after the continuation of this post.
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A Tug-of-War, A Funeral, and Drug Prices

By Antigone Barton | Wednesday, August 6, 2008, 03:05 PM
Palm Beach Post
[Intenational AIDS Conference Blog]

MEXICO CITY — This morning we had a funeral procession at the International AIDS conference, complete with a black-draped coffin followed by sobbing, wailing, black-robed people wearing ghastly white masks and carrying signs chastising pharmaceutical company Abbott for causing the death of their loved one, “Por Falta Katetra.” (Of Lack of Kaletra)

Kaletra (generically it is called lopinavir/ritonavir) is one of the best drugs around for AIDS patients, activists say, with few side effects, low resistance build-up, and it doesn’t need to be refrigerated, which is critical in the hot climates where the epidemic has rampaged.

But Abbott keeps it expensive, and that makes sustaining treatment as well as enrolling more patients for treatment difficult. Abbott’s reluctance to negotiate its high prices has kept the company in the sights of treatment access activists for years. Attendees at the 2004 International AIDS Conference in Bangkok still recall how the drug company’s posh booth in the exhibit hall disappeared, suddenly, just one strip of paper left waving pathetically from a remaining support brace.

No one can recall an Abbott booth at the Toronto conference, although the company bought space there, and activists can’t find one this year.

This morning’s funeral however, was followed by an afternoon “tug-of-war,” with patients living with HIV and in need of Kaletra on one side, and the pharmaceutical giant on the other.

An international coalition of over three-dozen patients' and public health advocacy groups sent a letter today to representatives of the Colombian government, endorsing Colombian civil society groups' recent request for an open compulsory license on AIDS medicine lopinavir/ritonavir (marketed by Chicago-based Abbott Laboratories under the trade name Kaletra). The coalition includes groups from six continents, and chapters of such public health stalwarts as Medecins Sans Frontieres (MSF, Doctors Without Borders), Health Action International, Health GAP and ACTUP, as well as law programs, medical students and patients' organizations.

Text of a news release about the letter, and the global sign-on letter itself, follow below.

Groups Urge Colombia To Issue AIDS Drug License

By Ed Silverman // August 6th, 2008 // 4:06 pm
Pharmalot

An international coalition of patient and public health advocacy groups has sent a letter to representatives of the Colombian government, endorsing a recent request by several Colombian civil society groups for an open compulsory license on Abbott’s Kaletra AIDS medicine.

Kaletra currently costs the Colombian public sector about $1,683 per patient annually, and prices for private health organizations reach $4,449, according to the groups. Peru and Bolivia, by contrast, pay less than $800 for a generic version. Through a recent accord with the Clinton Foundation, prices in the region could fall to $550, and by issuing a compulsory license and allowing generics firms to compete with Kaletra, the Colombian government could save $1 million annually, the groups contend.

The coalition issued its letter today at the International AIDS Conference being held this week in Mexico City, and the groups include Doctors Without Borders, Health Action International, American Medical Student Association, Health GAP and ACT UP, among about two dozen others. We are awaiting a reply from Abbott.

The United States, the European Union, Japan, South Korea, Canada, Mexico, Australia and New Zealand are now negotiating a new treaty known as the Anti-Counterfeiting Trade Agreement (ACTA).

The text of what they are negotiating remains secret, but there's a lot to be worried about. An over-reaching treaty in this field could require Internet Service Providers (ISPs) to monitor all consumers' Internet communications, interfere with fair use of copyrighted material and undermine access to low-cost generic medicines, among many other dangers.

Does the proposed ACTA contain provisions that would result in these harmful effects?

There's no way to know, because the treaty text remains secret. There is no legitimate rationale for such secrecy, which denies people around the world an opportunity to comment on and influence the negotiations.

Essential Action is asking organizations and individuals from around the world to sign on to a letter to ACTA negotiators, asking that they immediately make public the draft text of the treaty. The text of the letter, with initial signatories, is below.

If you would like to sign the letter, please send your name, affiliation (if any), city/country and email address to Sarah Rimmington of Essential Action at: . Please specify if you are signing in your individual capacity or on behalf of an organization. **Please note: Our deadline for accepting signatures is Wednesday, August 20, 2008.**

Activists Take on Abbott Laboratories in a Tug-of-War for Access to AIDS Medicines in Colombia
International advocates stage tug-of-war to call for Compulsory License for Kaletra

Protest at 2:30pm CDT (3:30pm EST) outside Banamex Media Center (International AIDS Conference (IAC), Mexico City)
3pm CDT (4:00pm EST) Press Conference in Room 1 (Azteca)

Contacts:
Peter Maybarduk, Essential Action
(in México)
+52 55 1902-1954
maybarduk@gmail.com

David Morales Alba, Comunicación Positiva
(en México)
+52 55 2819-2970
david.morales@comunicacionpositiva.org

Mexico City, Mexico - Wednesday, August 6, 2008 at 2:30 PM, at the entrance to the IAC press center -
A large international coalition of activists, people living with HIV/AIDS, and medical and law students are calling on the Colombian government to live up to its humanitarian responsibility to provide access to generic AIDS medications.

People with HIV in clinical need of treatment and their allies will have a tug-of-war with drug-maker Abbott Laboratories, a competition that only the Colombian government can decide.

"My government must not let its people die when there exists a simple, affordable solution to helping people with HIV/AIDS live normal lives," says Francisco Rossi of Colombian NGO IFARMA-HAI (Health Action International).

On 16 July, 2008, an alliance of Colombian civil society groups filed a request for their government to issue an open compulsory license on the life-saving anti-retroviral drug lopinavir/ritonavir, patented and sold by Chicago-based Abbott Laboratories as Kaletra. Several months earlier, on 7 April, 2008, Colombian civil society asked Abbott directly to voluntarily license its patent and allow generic competition. To date, Abbott has not responded to the groups' request.

The Colombian government is empowered under WTO (World Trade Organization) and Andean Community rules to issue compulsory licenses, authorizing generic competition with patented medicines to protect public health, in exchange for a reasonable royalty to the patent holder.

"The Colombian government must partner with patients, instead of with Abbott, following the example of the many countries that have issued compulsory licenses," says Mary Carol Jennings from the American
Medical Student Association (AMSA). "This means making generic medications available at low cost to people whose lives depend on them."

Following the tug-of-war, the coalition will host a press conference in Press Conference Room 1 ("Azteca") announcing the support of dozens of patients' groups and public health advocacy organizations from around the world for the Colombian compulsory license request.

Kaletra currently costs the Colombian public sector approximately $1683USD per patient, per year, and prices for private health organizations reach $4449. Peru and Bolivia, by contrast, pay less than $800 for generic lopinavir/ritonavir. Through a recent accord with the Clinton Foundation, prices in the region could fall to $550. By issuing a compulsory license and allowing generics firms to compete with Abbott's Kaletra, the Colombian government could save well over $1million USD annually. These savings could be invested in scaling up HIV/AIDS treatment and strengthening Colombia's health system.

Mesa de Organizaciones que trabajan en VIH/SIDA (en Bogotá)
+57-1-338-4991 licencia.obligatoria.colombia@gmail.com *

On July 16, Colombian health organizations filed requests for an open compulsory license on the AIDS drug lopinavir/ritonavir (Abbott's Kaletra) with the Colombian government. The NGOs delivered request letters to the Superintendencia de Industria y Comercio, which houses the patent office, as well as to the office of the President of the Republic. Additionally, the NGOs delivered a letter to the Ministry of Health, requesting a declaration of public interest in access to lopinavir/ritonavir.

The compulsory license request comes three months after Colombian civil society requested an open license for lopinavir/ritonavir directly from Kaletra manufacturer and patent holder Abbott Laboratories. To date, Abbott has not responded to the groups' request.

Below is translation by Essential Action's Peter Maybarduk of the letter Colombian NGOs delivered to the Superintendencia de Industria y Comercio yesterday in Bogotá. The original Spanish follows.

The letters were accompanied by appendices and a technical document, approximately twenty pages in length, analyzing potential cost savings, legislation, drug quality, license procedures, human rights and AIDS treatment accords, lopinavir/ritonavir indications, and the medicine's importance to national programs. These will be posted on this site soon.
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On May 24 in Geneva, World Health Organization member countries took an important step forward in advancing an innovation reform agenda, adopting a Global Strategy on Public Health, Innovation and Intellectual Property at the organization’s annual meeting following several rounds of negotiations over a two-year period. The strategy commits WHO and countries to explore some common-sense measures aimed at spurring the development of medicines and other products that will meet priority health needs of people in developing countries, and making those products available on an affordable basis.

The latest issue of Essential Action's Global Access to Medicines Bulletin discusses which measures were adopted, which were dropped, and whether the final strategy could contribute to bridging the R&D gap in developing countries.

An .rtf version of the bulletin is available here. The text of the bulletin follows on the continuation of this post.
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By Peter Maybarduk
The Chronicle of Higher Education
Letters to the Editor

To the Editor:

Sheldon Elliot Steinbach's "Academe Should Oppose Speedier Approval of Generic Drugs" (The Chronicle, April 25) places universities' highly uncertain financial interests in technology licensing ahead of their public missions to promote the public good through, for example, ensuring that the fruits of university research are publicly available and affordable. If, as Steinbach recommends, universities support legislation to require long periods of marketing exclusivity for biologic medicines, the result could be a financial windfall for brand-name biologics companies at significant — and, in some cases, deadly — public cost.
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May 29, 2008
by Sangeeta Shashikant
South-North Development Monitor (SUNS) #6485


Geneva, 29 May (Sangeeta Shashikant) -- Both developed and developing countries vigorously questioned the WHO Secretariat during the WHO's Executive Board meeting on 26 May on its publications policy and called for further discussion on the matter.

Among the questions raised at the WHO's 123rd Executive Board meeting were the need and rationale for the new publications policy, what the present policy is, and what will be the criteria for determining which issues have "policy implications for the Organisation" and which comprise "controversial health related issues" and thus have to go through additional clearance by the Director-General's Office.

Other concerns raised included how the centralization of the clearance process may remove the clearance authority of the WHO's Regional Directors, the broad definition of the term "publications" as it covers "materials that are issued by WHO to the public in whatever format and through whatever channel" including advocacy and training materials, and how the policy will affect timely support by WHO to countries.

Concerns about "self-censorship" as a result of the policy and transparency in the process were also raised.

A comment was also made that insisting on "evidence-based" publications was not always possible in the medical field.

Many delegations called for the need to have more discussions and to assess the implications of the policy, before it was implemented.

However, it is not clear whether the policy will be subject to further discussion and what the Secretariat intends to do about the various concerns and clarifications raised, since the meeting "noted" the Secretariat's report, following what some persons who follow WHO processes closely now call a "trust-me" speech by the WHO Director-General Dr. Margaret Chan.

Some delegations indicated that they intend to follow up on the matter, as they were dissatisfied with the explanations provided. They said that, in particular, the explanation did not specifically address what criteria will be used to determine publications containing issues that have "policy implications for the Organisation" and what constitutes "controversial health related issues" (which require clearance from the Director-General's office) and why the differential treatment of publications was needed.
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