Access To Medicines Project

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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By Lynne Taylor
PharmaTimes

Delegates at the annual Assembly of the World Health Organisation (WHO) have backed a major new initiative which aims to promote new approaches to pharmaceutical R&D and enhance access to medicines. Their approval of the Global Strategy on Public Health, Innovation and Intellectual Property was described by WHO director-general Dr Margaret Chan as “a major breaktbrough for public health that will benefit many millions of people for many years to come.”

“This is pro-active public health at its very best,” added Dr Chan, as she close the 61st World Health Assembly (WHA) on Saturday (May 24).
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By Ed Silverman
Pharmalot


The World Health Organization’s member governments overcame a rift between rich and poor nations this weekend on how to manage intellectual property and endorsed a strategy to help developing countries gain access to more life-saving meds, Reuters reports.

At the agency’s annual policy-setting meeting in Geneva, governments also called for WHO Director-General Margaret Chan to finalize a plan to boost incentives for drugmakers to tackle diseases that mainly afflict the poor. “This is a major breakthrough for public health that will benefit many millions of people for many years to come,” Chan said at the end of the week-long WHO meetings, Reuters writes.

The intellectual property resolution requests that Chan “finalize urgently the outstanding components of the plan of actions, including timeframes, progress indications and estimated funding needs” to be reviewed at the next WHO assembly in May 2009.

The endorsement included agreement on exploring R&D incentives such as prizes; encouraging future talk about an R&D treaty; encouraging developing countries to adopt and implement legislation to prevent and penalize anti-competitive practices regarding patents; and encouraging creation of a global patent database, according to Essential Action, a public health advocacy group.
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FOR IMMEDIATE RELEASE
May 24, 2008

For More Information Please Contact:
•Sarah Rimmington, Attorney, Essential Action
(Tel) +41 (0)78 847 0562 (in Geneva until May 29, 2008)
(email) srimmington@essentialinformation.org


** Sarah Rimmington, Essential Action Comment at the Close of the 61st World Health Assembly regarding the Just Completed Negotiations of the World Health Organization's Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (IGWG)**


The world community has taken a bold step today by agreeing on a way forward to reform a global system of medical research and development that has largely failed to meet the needs of people in developing countries.
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Intellectual Property Watch
By William New

The 61st annual World Health Assembly on Monday opened auspiciously with speeches on the world’s biggest political issues, current disasters and looming global threats, but little room for intellectual property issues.

IP issues did arise in a press briefing with US Health and Human Services Secretary Michael Leavitt, however.

Some 2,500 people from around the world are at the UN in Geneva for the 19-24 May assembly, according to the WHO.

WHO Director General Margaret Chan in her afternoon opening speech highlighted the health problems of the natural disasters in Myanmar and China, praising the outpouring of support but cautioning, “We must all brace ourselves for more humanitarian crises in the immediate and near future.”
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The World Health Organization is currently considering a major overhaul of its publications policy. There are serious problems with some of the proposed changes. If adopted, these changes may give commercial or ideological interests leverage to subvert the WHO's ability to issue evidence-based public health materials, contrary to the constitutional mandate of the Organization. They would also undermine the agency's flexibility, and interfere with regional and country offices' ability to respond quickly to local circumstances.

Essential Action recommends that the policy be revised before approval.

An Essential Action briefing note on this issue is available here as an rtf document: Publicationpolicybriefingnote.rtf

A pdf version of the briefing note is available here: Publicationpolicybriefingnote.pdf

House Oversight and Government Reform Chairman Henry Waxman has today sent a letter to World Health Organization Director General Margaret Chan regarding the WHO's proposed publication policy.

A pdf version of the letter is here: Chan5.19.08WHO.pdf

An html version of the text follows on the continuation of this post.

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