Sign-on letter to DOS and USTR for Thai compulsory licensing dispute

by James Packard Love

This is a letter that will be sent to Honorable Condoleezza Rice, Secretary of State, and Ambassador Susan Schwab, United States Trade Representative, asking that the United State cease any opposition or interference with the Thai efforts to use WTO flexibilities to buy generic AIDS medicines. The letter will be sent on Wed, December 20, 2006.

You can find the letter, and instructions for signing on, here:
http://www.cptech.org/ip/health/c/thailand/2riceschwabthaicl.html

Letter asking USTR to not interfere with the Thai government decision to issue a government-use license on patents covering the AIDS drug Efavirenz

by Julie Patel

The following is the link to the letter sent by Consumer Project on Technology to Ambassador Susan C. Schwab, requesting the United States Trade Representative not to interfere with the Thai government's decision to issue a government-use license on patents covering the AIDS drug Efavirenz.

First IGWG Meeting ends; new expert selection process for next meeting

by Ben Krohmal

The involvement of NGOs and experts at future IGWG meetings was discussed on the fifth and final day of the first IGWG meeting. Greater future involvement of NGOs seems a distinct possibility, and the legal council of the Secretariate has said that experts for future meetings may be nominated by member states. This is a promising development. Experts for this meeting were selected by the Secretariat, and selection process has been widely criticized for lacking transparency and failing to include experts from developing countries. The meeting ended with plans for a new strategy and plan of action document to be issues by the Secretariat in February, with input from member state submissions, followed by a second meeting or series of meetings at a date/dates to be determined.

Netherlands Issues Non-paper

by Ben Krohmal

Day four of the IGWG meeting is now underway. A revised version of the document "Elements of a Global Strategy and Plan of Action" was released at 7:30am Geneva time. The new version is divided into two separate papers: "Elements of the global strategy and plan of action: Elements of a Global Strategy" and "Elements of a global strategy and plan of action: Elements of a plan of action" (new version not available online, old version is here). Now in the afternoon session, The Netherlands has obtained approval from the EU to submit a non-paper on the "Elements" document(s) that is now being distributed by the Secretariat as the meeting adjourns. The non-paper addresses recommendations from the CIPIH report that are absent in the "Elements" documents. The text appears below:


Non Paper of The Netherlands

A/PHI/IGWG/1/Conf.Paper No 1

7 December 2006

Elements of a global strategy and plan of action

Elements of a plan of action

2) Prioritizing research and development needs

Extract from text	Comment
bullet 4: conduct research on affordable [to be defined]	definition should refer to the definition of ‘affordable’ in Essential medicines (affordable to people in their communities)
Elaboration of the above areas of action should consider recommendations …	include CIPIH recommendations 2.7, 2.8
Absence of reference to medicines as global public good	Include reference.
Absence of reference to gaps in translational research	Include reference

3) Promoting R&D

Elaboration of the above areas of action should consider recommendations …	include CIPIH recommendations 3.7 (open source), 4.5, 5.7 (International Conf on Harmonisation)
Elaboration of the above areas of action should consider recommendations should consider… and 3.6	Request specific action: WHO should actively undertake work on the issues in 3.6 (R&D treaty)

4) Building innovative capacity

preamble para: In further elaborating this element of the plan, activities proposed should take into consideration the work and mandates of other agencies such as WIPO and WTO	Request specific action: WHO should not shy away from making recommendations to these two agencies
bullet 5: Promote patent pools of upstream technologies	include reference to downstream patent pools

5) Transfer of technology to improve innovative capacity

bullet 4: Article 66.2 of TRIPS	include a reference to paragraph 7 of the Doha Declaration
In elaborating the plan for this area of work consideration should be given to taking advantage of work underway in universities, research institutions and PPPs	include a reference to the Philadelphia Consensus Statement, the recent call by prominent scientists and student groups which outlines how universities can improve access to medicines and transfer of knowledge to the developing world by changing their licensing policies and intellectual property rights. It may be useful for the IGWG to consider the development of best practices models for such licensing.
Absence of references	As with other sections include at end references to specific CIPIH recommendations, including 5.4, 5.8 (clinical trials)

6) Management of intellectual property

preamble para: The plan of action should address the development of capacities for the management of intellectual property and technologies in developing countries	Include the caveat expressed in CIPIH recommendation 5.3 “fully taking into account the needs of recipient countries and their public health policies”
bullet 1: enact legislation in developed and developing countries for application for the flexibilities provided for in TRIPS	Strengthen text with reference to CIPIH recommendation 4.13 including “the right of governments to use compulsory licensing”
bullet 2: establish or work within national and/or regional institutional frameworks to promote and manage intellectual property	Remove “to promote”
bullet 5: Strengthen education and training in management of IP	Include the caveat expressed in CIPIH recommendation 5.3 “fully taking into account the needs of recipient countries and their public health policies”
bullet 6: assure that bilateral trade agreements do not seek to incorporate “TRIPS +” protection	Strengthen text with reference to CIPIH recommendation 4.21 including “that ministries of health be properly represented in the negotiation”
Absence of references	As with other sections include at end references to specific CIPIH recommendations

7) Improving delivery and access

bullet 7: Devise ways to curb counterfeiting of medicines and technology	Remove. Not a CIPIH recommendation. Counterfeiting is most effectively combated by ensuring that high quality medicines are made affordable
bullet 11: continue to consider price of treatment for communicable diseases particularly of secondline drugs for HIV/AIDS	Refer to original wording of CIPIH recommendation 4.8 “Continuing consideration needs to be given…”
Elaboration of the above areas of action should consider recommendations …	Include references to CIPIH recommendations 4.1, 4.2, 4.3, 4.7, 4.8, 4.9, 4.15, 4.16, 4.19 (parallel importing), 4.20, 4.23 and 4.27

8) Ensuring sustainable financing mechanisms

bullet 4: establish a funding mechanism for research and development for neglected diseases, while avoiding duplication with existing programs	Remove “while avoiding duplication with existing programs”. This gives the misleading impression that there are extensive existing programmes.
Absence of references	As with other sections include at end references to specific CIPIH recommendations

APPENDIX

1. Text of CIPIH Recommendations Excluded from “Elements of a global strategy and plan of action” (A/PHI/IGWG/1/4)

• 3.5 Governments should continue to develop forms of advance

purchase schemes which may contribute to moving later stage vaccines,

medicines and diagnostics as quickly as possible through development

to delivery.

• 3.7 Practical initiatives that would motivate more scientists to

contribute to this field through “open source” methods should be

supported.

• 4.1 Governments need to invest appropriately in the health delivery

infrastructure, and in financing the purchase of medicines

and vaccines through insurance or other means, if existing and new

products are to be made available to those in need of them. Political

commitment is a prerequisite for bringing about a sustained improvement

in the delivery infrastructure and health outcomes. Health systems

research to inform policy-making and improve delivery is also

important. The integration of traditional medicine networks with

formal health services should be encouraged.

• 4.2 Developing countries should create incentives designed to

train and retain health-care workers in employment.

• 4.3 Developed countries should support developing countries’ efforts

to improve health delivery systems, inter alia, by increasing the

supply of their own trained health-care workers.

• 4.6 All companies should adopt transparent and consistent pricing

policies, and should work towards reducing prices on a more

consistent basis for low and lower middle income developing countries.

Products, whether originator’s or generic, should be priced

equitably, not just in sub-Saharan Africa and least developed countries,

but also in low and lower middle income countries where there

are a vast number of poor patients.

• 4.7 For noncommunicable diseases, governments and companies

should consider how treatments, which are widely available in developed

countries, can be made more accessible for patients in developing

countries.

• 4.8 Continuing consideration needs to be given to the prices of

treatments for communicable diseases, particularly of second-line

drugs for HIV/AIDS treatment.

• 4.9 Governments of low and middle income countries where

there are both rich and poor patients should formulate their funding

and price regulation with a view to providing access to poor people.

• 4.10 Governments need to prioritize health care in their national

agendas and, given the leverage to determine prices that patents confer,

should adopt measures to promote competition and ensure that

pricing of medicines is consistent with their public health policies.

Access to drugs cannot depend on the decisions of private companies

but is also a government responsibility.

• 4.11 Corporate donation programmes can be of great value in a

number of fields in collaboration with the actions of governments

and nongovernmental organizations. However, addressing health

needs in developing countries requires more structured and sustainable

actions by governments and other parties that stimulate accessibility

to products, while generating new treatments and products

adapted to the needs of developing countries.

• 4.12 Governments should remove any tariffs and taxes on healthcare

products, where appropriate, in the context of policies to enhance

access to medicines. They should also monitor carefully the

supply and distribution chain to minimize costs that could adversely

influence the prices of medicines.

• 4.14 Developed countries, and other countries, with manufacturing

and export capacity should take the necessary legislative steps to allow

compulsory licensing for export consistent with the TRIPS agreement.

• 4.15 The WTO decision agreed on 30 August 2003, for countries

with inadequate manufacturing capacity, has not yet been used by

any importing country. Its effectiveness needs to be kept under

review and appropriate changes considered to achieve a workable

solution, if necessary.

• 4.18 Developed countries and the WTO should take action to ensure

compliance with the provisions of Article 66.2 of the TRIPS

agreement, and to operationalize the transfer of technology for pharmaceutical

production in accordance with paragraph 7 of the Doha

Declaration on the TRIPS Agreement and Public Health.

• 4.19 The restriction of parallel imports by developed countries is

likely to be beneficial for affordability in developing countries. Developing

countries should retain the possibilities to benefit from differential

pricing, and the ability to seek and parallel import lower

priced medicines.

• 4.21 In bilateral trade negotiations, it is important that governments

ensure that ministries of health be properly represented in the

negotiation, and that the provisions in the texts respect the principles

of the Doha Declaration. Partners should consider carefully any

trade-offs they may make in negotiation.

• 4.22 Governments and concerned international organizations

should promote new purchasing mechanisms to stimulate the supply

of affordable new products and to enhance the number of suppliers

in order to provide a more competitive environment.

• 4.24 Countries should provide in national legislation for measures

to encourage generic entry on patent expiry, such as the “early working”

exception, and more generally policies that support greater

competition between generics, whether branded or not, as an effective

way to enhance access by improving affordability. Restrictions

should not be placed on the use of generic names.

• 4.25 Developing countries should adopt or effectively implement

competition policies in order to prevent or remedy anti-competitive

practices related to the use of medicinal patents, including the use of

pro-competitive measures available under intellectual property law.

• 4.26 Bilateral trade agreements should not seek to incorporate

TRIPS-plus protection in ways that may reduce access to medicines

in developing countries.

• 4.27 Governments should take action to avoid barriers to legitimate

competition by considering developing guidelines for patent

examiners on how properly to implement patentability criteria and,

if appropriate, consider changes to national patent legislation.

• 5.5 Developed countries should comply with their obligations

under article 66.2 of the TRIPS Agreement and paragraph 7 of the

Doha Declaration.

• 5.7 The process of the International Conference on Harmonisation

currently lacks immediate relevance to the needs of many developing

countries, but those countries should maintain their participation in

the process. In the meantime, developing country governments and

regulatory institutions should give support to regional initiatives,

tailored to the current capacities of their member countries, which

offer more scope for lifting standards over time, exploiting comparative

advantages, avoiding duplication, sharing information and facilities,

and promoting appropriate standardization without erecting

barriers to competition.

• 5.8 WHO has an important role to play, in collaboration with

interested parties, in helping to strengthen the clinical trials and

regulatory infrastructure in developing countries, in particular in

sub-Saharan Africa, including the improvement of ethical review

standards.

• 5.9 Apart from the European & Developing Countries Clinical

Trial Partnership, donors together with medical research councils,

foundations and nongovernmental organizations, need to offer more

help to developing countries in strengthening clinical trials and regulatory

infrastructure.

• 5.11 All countries should consider how best to fulfil the objectives

of the Convention on Biological Diversity. This could be, for instance,

through the establishment of appropriate national regimes for prospecting

for genetic resources and for their subsequent utilization

and commercialization; contractual agreements; the disclosure of

information in the patent application of the geographical source

of genetic resources from which the invention is derived and other

means.

2. Comparison of Incompletely Represented CIPIH Recommendations to the Indicated Corresponding Text in “Elements of a global strategy and plan of action” (A/PHI/IGWG/1/4)

CIPIH recommendation	Corresponding text in A/PHI/IGWG/1/4
3.6 Recognizing the need for an international mechanism to increase global coordination and funding of medical R&D, the sponsors of the medical R&D treaty proposal should undertake further work to develop these ideas so that governments and policy-makers may make an informed decision.	3. “Strengthen product regulatory capacity in developing countries, including improvement of ethical-review standards and clinical trials capacity.” And 5. “Establish a funding mechanism for research and development for neglected diseases.”
4.16 Companies should adopt patent and enforcement policies that facilitate greater access to medicines needed in developing countries. In low income developing countries, they should avoid filing patents, or enforcing them in ways that might inhibit access. Companies are also encouraged to grant voluntary licences in developing countries, where this will facilitate greater access to medicines, and to accompany this with technology transfer activities.	4. “Frame policies emphasizing affordable innovations adapted to realities of health-care delivery in developing countries.”
5.10 Digital libraries of traditional medical knowledge should be incorporated into the minimum search documentation lists of patent offices to ensure that the data contained within them will be considered during the processing of patent applications. Holders of the traditional knowledge should play a crucial role in deciding whether such knowledge is included in any databases and should also benefit from any commercial exploitation of the information.	2. “Promote discovery science in order to identify, validate and build up a sustainable portfolio of new products, whose development is facilitated through the screening of compound libraries for diseases relevant to the public health needs of developing countries.”
6.2 WHO should continue to monitor, from a public health perspective, the impact of intellectual property rights, and other factors, on the evelopment of new products as well as access to medicines and other health-care products in developing countries.	6. “Measure performance and progress towards objectives and targets of the global plan.”

"Open Ended" IGWG Drafting Groups

by Ben Krohmal

The IGWG has just resolved that there will be "open ended" participation in the groups that will draft preliminary documents to come out at the end of this IGWG meeting, where open ended means "those who wish to participate may participate." No word yet on whether this includes NGO's or other non-member state delegations. The documents are expected to be "Elements of a Plan of Action" and "Elements of a Global Strategy."

Updated 11:30am EST:

South Africa asked if "those who wish to participate" includes everyone in the room. The Chair clarfied that his expectation had been that no NGO's would be included, that official experts could be included if requested by a member state, and that the European Commission would be included. However, he noted that there was little precedent on this issue, and that his suggestion was open to debate. South Africa, speaking on behalf of the AFRO region countries, responded by arguing that NGO's be able to participate in drafting groups upon the request of member states. Norway requested clarfication of the rules, and the Chair explained that WHO Constitution rule 86 gives the Chair the flexibility to include NGOs in drafting groups. The U.S. weighed in that NGO participation could be appropriate, assuming drafting groups would be responsible for distilling information and not negotiation. Kenya offered further support for the inclusion of NGOs, stating that NGOs' expertise is greatly needed by many of the member states. As the afternoon session ends, it appears that NGOs will be permitted to participate in the drafting groups.

Musical Chairs doesn't disrupt policy discussion at IGWG

by Ben Krohmal

While the highlight of this morning's IGWG session was the statement of Iran on behalf of the Eastern Mediterranean Regional Organization (EMRO), the session began and ended with disputes over seating arrangements (statement link forthcoming). It had been suggested that seating be switched from a quasi-alphabetical setup to one with members of each regional group seated together. The U.S. delegation expressed approval for the proposal on the condition that new seating blocks include only member states, while Finland, on behalf of the EU, insisted that the European Commission delegation be permitted to sit with the EURO regional group. As the meeting reconvenes, seating has been rearranged, and the U.S. appears to have won out for now as the European Commission is still seated at the back.

There was concern that squabbles over seating would dominate the afternoon session, but Thailand and India have gotten discussion underway with strong policy based statements. Following a metaphor about a sparrow made by the Chair, Thailand declaired that in this case, "The small sparrow is not afraid of the eagle." India followed with a statement in support of a "treaty arrangement" and supported EMRO's call for further discussion of alternative incentives for R&D. Norway then reminded member states that IP flexibilities in the TRIPS Agreement go beyond just paragraph 6, which was followed by an elaboration by a WTO representative. This represents an expansion of discussion on TRIPS flexibilities beyond the narrow focus in several previous statements, particularly by the European Commission. A very strong start for the afternoon session.

Chair Selected at IGWG

by Ben Krohmal

The WHO IGWG meeting got underway this morning with Assistant Director-General-Advisor to the Director General Denis Aitken presiding, with the intention that a chair and five vice chairs representing all six WHO regions be appointed after lunctime deliberations. The meeting has now reconvened,with the following appointments:

The chair is Peter Oldham, Counsellor of the Canadian Mission in Geneva. Vice chairs will be the Netherlands, Libya, Kenya, Singapore, and India. Kenya will serve as rapporteur.

Text of Thai compulsory license for Efavirenz

by James Packard Love

The text of the 29 November 2006 Thai compulsory license for Efavirenz is here.

Letter asking WHO review of the Essential Drugs List (EDL) as it relates to patented products

by James Packard Love

The following is the text of a letter to Dr. Margaret Chan, Director-General Elect, World Health Organization (WHO), asking for a review of the Essential Drugs List (EDL) as it relates to patented products. Jamie

Consumer Project on Technology
http://www.cptech.org

December 1, 2006

Dr. Margaret Chan
Director-General Elect
World Health Organization
20 Avenue Appia
1211 Geneva 27
Switzerland

Fax number: 41 22 791 4864
Email: chanm@who.int

Dr. Margaret Chan

We are writing to request a review of the manner in which the WHO Essential Medicines List is composed.

The intent of the Essential Medicines List (EDL) is to present “a list of minimum medicine needs for a basic health care system, listing the most efficacious, safe and cost-effective medicines for priority conditions,” where priority diseases themselves are identified in part on the basis of the potential for cost-effective treatment. Given that countries are free to use various means, such as compulsory licenses, to increase access to medical products that can improve the public health, it is appropriate to reassess the role that cost – especially as reflected under current patent medicine pricing regimes – plays in this evaluation.

Patents on drugs, which are tied to market costs, are clearly a factor in determining the EDL, as remarkably few patented medicines are listed. To examine this, we referenced every medicine that appears in the most recent WHO List, the 2005 14th edition, to the U.S. Food and Drug Administration Electronic Orange Book (http://www.fda.gov/cder/ob/) to check for patent status and the availability of generics.

The attached Table summarizes the patented drugs on both lists.[1] Only 14 (12 on the core list and 2 on the complimentary list) of the total 312 medicines on the EDL are under a U.S. patent that bars generic competition at the listed dose and route of administration.

While the Orange Book does not include all medicines, and while there may be some discrepancy between products under patent in the U.S. and those under patent internationally, this is likely an accurate representation of the WHO EDL that are under patent worldwide.

Of the 14 "essential" drugs that are patented, 11 are patented antiretroviral drugs used for the treatment of AIDS. There are only three patented drugs on the EDL (one on the core list, and two on the complementary list) for all other diseases -- evidence that patents have distorted prices considerably, and created enormous access barriers for the poor.

Drug industry representatives have used the WHO EDL to argue that rigid intellectual property protections are not a barrier to essential medicines, because “no” patented medicines are “essential” according to the WHO.[2] Of course this is a distortion; many patented medicines currently not on the EDL would be included were they available at generic prices – for instance the most recent list includes no patented anti-cancer drugs, and the core list includes no anti-cancer drugs whatsoever. The existence of a WHO “Essential Medicines List” which clearly does not contain many truly essential medicines may be confusing for public health officials and others and provide rhetorical fodder to those who oppose intellectual property flexibilities for health.

Simply put, the traditional intellectual property regime in place when the EDL was conceived in the 1970’s is no longer as firmly entrenched. The 1999 WHO Revised Drug Strategy, the 2001 WTO Doha Declaration on TRIPS and Public Health, the 2006 CIPIH report, the upcoming WHO Intergovernmental Working Group on Public Health, Innovation and Intellectual Property, and countless initiatives to address greater flexibility, including mechanisms other than rigid intellectual property rights for the promotion of medical innovation and the expanded use of compulsory licenses, are compelling testimonies to the importance and acceptance of the larger movement to overcome patent barriers when promoting "access to medicines for all."

Patented medicines currently available only at prohibitive prices may nonetheless offer the “potential for cost-effective treatment” as countries have the opportunity to legally produce or import generic versions. More critical to the evaluation of cost effectiveness under the emerging system is the true marginal cost of production, which bears little or no relationship to the market price in developed countries.

We believe that it is more appropriate that the Essential Medicines List reflect the opportunity that many countries have to obtain currently patented drugs at generic prices by assessing cost-effectiveness not only on the basis of current market prices, but also on the basis of potential generic prices if countries were to avail themselves of their right to exercise TRIPS flexibilities, including the granting of compulsory licenses. Developing countries in particular might stand to benefit from a model WHO Essential Medicines List that does not exclude essential patented medicines by ignoring the potential that those drugs could be obtained more cheaply. A welcome side-effect of this change would be an “Essential Medicines List" that more fully reflects the range of truly essential medicines, where essential reflects both the need for treatments and the costs of meeting those needs unburdened by patent rents.

We recognize that the current WHO Essential Medicines List (EDL) is designed to avoid high priced (less cost effective) patented medicines, that some national laws that reference the EDL create obligations for public outlays, and that these outlays may not be justified at the higher prices for patented medicines. The WHO could easily address this problem by creating a category within the EDL for medicines that are essential "if available at generic prices," an option that is clearly relevant for many developing countries.

We therefore propose a review of the policies and considerations that shape the WHO Essential Medicines List, to examine how the list should address medicines that are current under patent but could be manufactured or imported at generic prices.

Thank you for your consideration of this request.

Sincerely,



James Love
Director
CPTech
1621 Connecticut Avenue
Suite 500
Washington, DC 20009

CC: Bill Kean, Howard Zucker, Hans Hogerzeil, Malebona Matsoso

Attachment
ESSENTIAL DRUGS LIST PRODUCTS UNDER PATENT

CORE LIST
DRUG INDICATION
Abacavir Antiretroviral
Didanosine Antiretroviral
Lamivudine Antiretroviral
Stavudine Antiretroviral
Efavirenz Antiretroviral
Nevirapine Antiretroviral
Indinavir Antiretroviral
Ritonavir Antiretroviral
Lopinavir + ritonavir Antiretroviral
Nelfinavir Antiretroviral
Saquinavir Antiretroviral
Proguanil Malaria prophylaxis

COMPLIMENTARY LIST
DRUG INDICATION
Levofloxin Multi-drug resistant tuberculosis
Eflornithine Antiprotozoal for trypanosomiasis

FOOTNOTES

[1] Background information on the actual U.S. patents is available on request.

[2] The first comprehensive analysis of the patent status of the WHO essential drugs list was a August 2001 PhRMA survey on patents in Africa, presented by Tom Bombelles on September 30, 2001, at the American Society of Law, Medicine & Ethics (ASLME) conference on Law and Human Rights, in Philadelphia. This data was later updated, and presented in a 2004 article in Health Affairs, by Amir Attaran. "How Do Patents And Economic Policies Affect Access To Essential Medicines In Developing Countries?," Health Affairs, 23, no. 3 (2004): 155-166. Our letter to Health Affairs addressed logical fallacies in the Attaran article. James Love, "Drug Patents In Poor Countries," Health Affairs, 23, no. 5 (2004): 279. An example of the pharmaceutical industry use of the data on low patent coverage for the WHO essential drugs list is the May 4, 2004 IFPMA Press Release, "New Peer-Reviewed Study Shows That Patents on Essential Drugs Are Rare in Low-to Mid-Income Developing Countries," available on the web at http://www.ifpma.org/News/NewsReleaseDetail.aspx?nID=973, which reads in part: " 'By showing that the actual patenting of essential medicines in low- to mid-income developing countries is, in reality, quite rare, he gives policy-makers the opportunity to move away from a debate overly focusing on intellectual property rights and public health', notes Dr. Bale."