[READERS WILL NOTICE HOW THE TONE OF INTERNAL COMMUNICATIONS BETWEEN THE MEMBERS/ REPRESENTATIVES OF KNOWLEDGE ECOLOGY INTERNATIONAL (KEI), AN ANTI-INTELLECTUAL PROPERTY NON-GOVERNMENTAL ORGANIZATION, ABOUT THE RESULTS OF RECENT MEETINGS CONVENED AT THE WORLD HEALTH ORGANIZATION BY THE INTERGOVERNMENTAL WORKING GROUP ON INTELLECTUAL PROPERTY AND HEALTH, CHANGED FROM ‘NEGATIVE’ TO ‘POSITIVE’, SUCH THAT, THE LATER PUBLICIZED ARTICLES RELEASED THROUGH INTELLECTUAL PROPERTY WATCH, GRADUALLY CREATE A ‘POSITIVE SPIN’.]
The following exchange was reflected on the listserv of ip-health@lists.essential.org .
[FRANCISCO ROSSI SETS FORTH TO HIS COLLEAGUES THAT THE WHO IGWG MEETING WAS AN UTTER FAILURE B/C THEY COULD NOT, AT SUCH MEETING, SECURE COMMITTMENTS ON ANTI-PATENT INITIATIVES. YET, HE TRIED TO PLACE A 'POSITIVE SPIN' ON THE OUTCOME...]
On Mon, 2008-05-05 at 15:07 +0000, Francisco Rossi wrote:
[Picked text/plain from multipart/alternative]
From: Francisco Rossi
To: ip-health
Subject: RE: [Ip-health] FT: WHO fails to strike drug deal
Date: Mon, 5 May 2008 15:07:38 +0000
Dear All:
I just want to introduce some reflexions on IGWG outcomes, because I believe there are some elements to take into account. Despite I could have reasons to be especially disapointed, from a personnal perspective, I think we need to be more objective and balanced. Certainly any assessment of IGWG outcomes is related on expectations.
If we expected a radical re-formulation of IP worldwide, IGWG was a major failure. If our expectations were oriented to introduce alternative incentive models instead of prevelent ones, meeting was a failure.
In the other hand, if we read the meeting as an step on a process to put developing countries points of view in the table. IGWG was a major sucess. If we read the meeting as a strong movement on the WHO secretariat to take very seriously IP issues, meeting was a major success.
I was commenting with some friends that in the past we were working very reactive against TRIPS, and then against FTAs and Trips plus measures. Reactive and in a defensive Perspective. Now, despite the UN lenguage in most of the agreements and consensus, there is a open door for the negotiation on Innovation, IP and Public health.
Certainly developed countries and interested industries were there to obstacle any movement. And they worked pretty well. By from my personal point of view they lost a lot. And I would like to highlight the developing world countries leadership on that.
Just to re-open this discussion.
Best to all
Francisco Rossi
------------------------------------------------------------------------------------------------
[IN COMFORTING, FRANCISCO ROSSI, JAMIE LOVE OF KEI POINTS OUT THE 'POSITIVES'...]
From: James Love
Reply-To: james.love@keionline.org
To: Francisco Rossi
Cc: ip-health
Organization: http://www.keionline.org
Date: Mon, 05 May 2008 16:56:02 -0400
This is a response to the comment by Francisco Rossi.
The IGWG negotiations involve a wide range of topics, and people will see useful text in several areas, although also important areas where there is no progress yet, as reflected in the 18 paragraphs still with brackets. There is also relatively weak language in some parts.
In terms of new incentives, good language on incentives has in fact moved ahead. For example:
-----------
5.3(a) explore and, where appropriate, promote a range of incentive schemes for research and development including addressing, where appropriate, the de-linkage of the costs of research and development and the price of health products, for example, through the award of prizes,
with the object of addressing diseases which disappropriately affect developing countries (consensus)
---------
It was difficult to get 5.3(a). But there is now very good language, on what we consider a key issue.
7.1, while not as strong as the language in the deleted 7.3, is also useful.
". . .examine current financing and coordination of research and development, as well as proposals for new and innovative sources of financing to stimulate R&D related to Type II and Type III diseases and the specific R&D needs of developing countries in relationship to Type I
diseases."
In the closing plenary, Barbados said it was assured that its proposals for prizes would be covered by the language in 7.1 (new and innovative sources of financing to stimulate R&D). The Barbados intervention led to a procedural question by the USA, followed immediately by substantive support for the Barbados position by India.
There is also plenty of useful language in other sections of the document on this topic, including the front parts (some of which were changed from the draft now on the web).
My own view is that very good progress has been done on the topic of new incentive nechanisms that are not linked to prices of products. This was aided in part by the generally favorable response to substance and concrete nature of the Barbados/Bolivia prize proposals.
What the IGWG did not do was fund anything, not only for prizes, but for grants and other push funding, or AMCS (which are no longer mentioned in the text) or anything else. The US and Europe did not want to talk about money at this meeting. For a number of groups that are looking for something important for funding neglected diseases, this was a major flaw in the negotiations so far. The idea of a biomedical treaty is alive, and the expert working group on financing R&D will carry the conversation forward, but this is clearly a delay that is driven by a lack of political commitment to spend new money in this area.
The debates in May at the WHA will focus on the 18 important paragraphs where there is no consensus. People can usefully begin focusing on these paragraphs, and push their delegations to do the right thing.
Jamie
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http://www.ip-watch.org/weblog/index.php?p=1024
Intellectual Property Watch
2 May 2008
WHO Members Inch Toward Consensus On IP, Innovation And Public Health
By Kaitlin Mara and William New
Members of the World Health Organization (WHO) gathered this week to address innovation and intellectual property issues in public health saw hope for agreement on a strategy paper focused on the needs of developing countries, particularly on neglected diseases. But with two days remaining in the negotiations, difficult issues on intellectual property rights and the action plan remained unresolved.
The WHO Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (IGWG) is meeting from 28 April to 3 May, as a part of its resumed second session (the second session begin in November 2007)(IPW, WHO, 9 November 2007). The current round of negotiations is under mandate to create a consensus document for presentation at the World Health Assembly, which will take place later this month.
Draft Global Strategy on Public Health, Innovation and Intellectual Property as of start of 2 May, 2008 [pdf]
In her opening remarks to the IGWG, WHO Director-General Margaret Chan said that an “agreed framework can make the cycle of product discovery, development and delivery more efficient and more sensitive to health needs in the developing world” by giving the international community a “common tool” to leverage against health problems. She stressed the importance of the negotiations moving forward “as rapidly and efficiently as possible,” and urged a continuation of the “sense of urgency” seen in past months.
Further pressure for resolution has been placed on negotiators by some developed countries who would like to see the IGWG discussions end this week, and to pull the WHO back from involvement with IP issues, according to some participants. Others thought that the negotiations should not be rushed, and one developing country official said, “I hope we don’t do in haste what we will repent later.”
This week’s debate is the result of several years of intensive discussion at the WHO on policies to address the problem that the existing intellectual property system lacks economic incentives for the private sector to invest in research and development (R&D) for diseases primarily affecting those who cannot afford to pay the higher prices necessary to recover R&D costs.
But a larger issue of the role of the WHO in discussions relating to intellectual property is underlying the talks. Many feel the issues belong primarily in the World Trade Organization, World Intellectual Property Organization, or in national laws. But others see the WHO with the lead on public health issues as having been sidelined in global debates as they relate to IP and public health, even as those debates have resulted in rules that have possibly had a pejorative effect on public health.
“The IGWG is a historic opportunity and this should not become a historic failure for lack of response,” Médicins sans Frontières’ Tido von Schoen-Angerer told the plenary. “Governments, and the WHO, must not abdicate from their responsibilities, or pass the buck to others. We are asking you to strengthen WHO’s role in intellectual property and health, to change the way R&D is prioritised and financed so that paying for the research does not equal prohibitive prices, and to take measures to increase generic competition.”
Draft Text Taking Shape
While most negotiations have happened behind closed doors, on 1 May WHO members met as a whole in an attempt to hammer out consensus on the draft global strategy on public health. The talks were able to cover elements two, three and four out of the eight-element draft strategy - covering, respectively, promoting research and development, building and improving innovative capacity, and transfer of technology - and had begun to discuss element five, on the application and management of intellectual property to contribute to innovation and promote public health.
Remaining aspects of element five are expected to be contentious, according to some participants. In general, consensus is being achieved through a relative weakening of provisions, often, but not always, along north-south lines. Compromises involved the insertion of phrases like “possible” and “appropriate.”
The morning’s negotiations focussed on element two, promotion of research and development. Convergence was reached on accessibility to libraries and technical support to create compound libraries in developing countries (Article 2.2.b), and the related article (2.4.c) on the creation of open databases and compound libraries. The United States sought to delete the second article as it felt it was redundant, sparking discussion on the issue.
The dissemination of publicly or donor-funded medical inventions and know-how (Article 2.4.d), and the “incorporation of research exemptions in legislation of developing countries” for public health purposes (Article 2.4.e) were both contested by the United States. Korea agreed with the US on 2.4.d, as one of the suggested ways to disseminate medical know-how was through open licensing and the Korean delegate was unsure if his country had a policy allowing for such licensing.
Brazil and India felt that open licensing was a useful addition to the paragraph, and India mentioned that the use of open source technologies in India was very effective. Jamaica supported India and Brazil. A distinction also was made between proprietary and non-proprietary databases. A compromise was reached with the language “including but not limited to open licensing.”
On 2.4.e, which reads “consider the incorporation of research exemptions in legislation of developing countries to address public health needs, consistent with the TRIPS and the Doha declaration on TRIPS and Public Health,” the United States asked for the paragraph to be deleted, as such issues would be dealt with in the IP chapter (element 5). Delegations pointedly asked the US delegation to explain its problem with research exemptions, as they are covered in both the TRIPS agreement and in US legislation. Japan supported the United States, which argued that the term ‘research exemptions’ was not well-defined, and it was unclear as to its actual scope.
The encouragement and promotion of traditional knowledge (and traditional medicines) was another key debate. Suriname wanted to ensure that traditional medicine is protected from being carried away from its nations of origin and brought back as patented matter. The traditional knowledge clause in element 5, Article 5.1.f, on the creation of digital libraries of traditional knowledge in order to prevent misappropriation, caused much disagreement. Some delegates were uncertain if discussions on traditional knowledge even belonged in the WHO negotiation. Others could not see how a digital database could prevent misappropriation, as it would offer greater access to the knowledge. Several new suggestions were offered, but after lengthy discussion no convergence was forthcoming so the chair suggested interested parties meet outside the plenary. Kenya is chairing this side session.
Another discussion in element 5 reflected a debate that has arisen at other institutions in Geneva that the training on IP in developing countries, such as of patent examiners, should fully reflect public health priorities.
Element 5 seems likely to be difficult to negotiate, with upcoming discussions on provisions such as how to address research involving humans. Delegates on 1 May discussed Article 5.1 and several of its subsections, but had trouble reaching consensus on several topics. In addition to traditional knowledge, a clause on strengthening “education and training in the granting, application and management of intellectual property from a public health perspective” also presented a problem. The US wanted to strike the word “granting” from the paragraph, and other members proposed adding specific references to flexibilities contained in the TRIPS agreement and other instruments. Consensus was unable to be reached.
Under Article 5.1, on the management of intellectual property in a manner that maximises health-related innovation, Suriname was concerned about the ethics of clinical trials, citing examples in which such trials have been conducted in developing countries, aiding medical innovation on drugs that were subsequently out of the price range of individuals who had participated in trials. Suriname wishes to add “maximises health related innovation and access” to the clause; consensus is pending agreement on that addition.
Civil Society Views
The hottest points of disagreement have tended to arise over practical solutions for solving this problem, reflected in the wide variation in proposals from civil society groups addressing negotiators. Public interest advocacy group Knowledge Ecology International’s Jamie Love has suggested prizes and prize funds replace [correction: his position is that they would coexist, see comment below] patents for neglected diseases, and expressed disappointment that most references to such systems in the strategy paper appeared to be surrounded by brackets indicating lack of consensus on their presence in the text. Love suggested that if the governments are not ready at this point in time to achieve real improvements, then perhaps the process should wait for another time.
International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) Director General Harvey Bale said the industry group wants to preserve strong intellectual property protection, which it says promotes innovation, and instead focus on market incentives outside of IP, such as advanced market commitments (AMC) and “fast track” approval for drugs targeting developing country diseases. An AMC is a guarantee of a market in the event a medication or vaccine is developed in order to incentivise the development of health solutions in diseases or for areas where the existence of a market is uncertain or too small to compensate for R&D costs.
Health Action international also said that WHO must have a clear mandate to work in IP and health, and that the final draft strategy should not dilute flexibilities in IP enforcement already guaranteed under the WTO’s Trade-Related Aspects of Intellectual Property Rights Agreement. The European Generic Medicines Association and the International Generic Pharmaceutical Alliance, represented by Greg Perry, said data exclusivity must not be used to create market exclusivity beyond patent protection.
“IGWG must systematically address innovation and access to medicines” and should “delink the cost of research and development from the price of developed products,” said Sarah Rimmington of Churches’ Action for Health. The role of WHO should be strengthened on IP and issues in health, and the organisation should “provide active guidance, specifically on TRIPS flexibilities.”
The International Alliance of Patients Organizations called for IGWG recognise patients and patient organisations as key stakeholders.
MSF’s von Schoen-Angerer urged that the medical R&D process be government-led, and said it appeared wealthy countries objected to a proposed R&D fund without offering alternatives.
Kaitlin Mara may be reached at kmara@ip-watch.ch. William New may be reached at wnew@ip-watch.ch.
-------------------------------------------------------------------------------------------------
http://www.ip-watch.org/weblog/index.php?p=1027
Intellectual Property Watch
6 May 2008
WHO IP And Health Group Concludes With Progress; Tough Issues Remain For Assembly
By Kaitlin Mara and William New
The World Health Organization (WHO) negotiations on public health, intellectual property and innovation ended Saturday with substantial progress toward consensus on a draft strategy but with a plan of action remaining and the most contentious articles in the strategy still under brackets - indicating lack of agreement - as the paper goes to the World Health Assembly.
The air in the room was cautiously optimistic as WHO Director General Margaret Chan’s closing comments praised the assembled delegates at the 28 April to 3 May Intergovernmental Working Group on Public Health, Innovation, and Intellectual Property (IGWG) for reaching consensus on 107 paragraphs (many through deletions) that had been unresolved at the meeting’s start Monday.
The group’s mandate from the 2006 Health Assembly was to agree on a strategy and plan of action to boost research and development of, and access to, treatments for diseases disproportionately affecting developing countries, in time for this year’s annual assembly. If sufficient agreement is reached on the remaining items and the plan of action, implementation of the strategy should follow.
But there was also a sense from many delegates that substantive work lies ahead, and some nongovernmental organisations expressed disappointment at the IGWG’s perceived lack of strong commitment to public health, and the potential lost opportunity to make a profound difference.
While the global strategy being drafted by the group is not legally binding, it is being taken seriously by governments and other stakeholders because it could have a significant impact on policy. “It is a political document,” said one official. “It can have a lot of weight.”
Both developing and developed countries representatives found positive things to highlight about the IGWG, though it is clear that outcomes are not yet guaranteed and large gaps remain between what different stakeholders want from the draft strategy. Much of the work was done in closed informal sessions, often into the night, participants said.
Some key outcomes or debates were the proposed creation of an expert group on financing and the coordination of R&D, a mention of prizes as a possible alternative incentive for research and development, and policies on human clinical trials, competition, counterfeit medicines, and the role of the WHO on international IP and innovation issues.
Also significant was the apparent removal of advance market commitments, which would have created a mechanism for ensuring a market for new drugs, sources said. One source also said there was now a separation of provisions relating to access from those relating to intellectual property rights.
Ambassador Tom Mboya Okeyo of Kenya said the outcome’s impact will take time to see but that it was a good step. He noted consensus on provisions on access to medicines, and on flexibilities in the international IP system to accommodate access. Also agreed were several provisions that could strengthen innovation on essential medicines and encourage sustainable financing mechanisms, and provisions that could help protect traditional medical knowledge, all of which are important to developing countries, he said. The next challenges are in ensuring the key actions outlined in the strategy are implemented quickly, he said, adding that he hoped the WHO director general could mobilise funds for that purpose.
Suriname delegate Miriam Naarendorp called the week’s outcome the “start of the battle,” with the plan of action and implementation issues still to come. However, it was an important start, as, Naarendorp said, the IGWG was able to identify issues important to developing countries, and that the developing nations “stood firm on things that mattered” and had created a document that the WHO could not ignore.
An official from a leading developing country praised the outcome as successful as “so many member states agreed on so many things.” And a third developing nation delegate added that “we’ve made tremendous progress here [and] I expect we will get it finished at the World Health Assembly.” The assembly meets from 19 to 24 May.
A key developed country source was more concerned that the IGWG seemed to have averted potential negative consequences, saying that “the possibility of impact on the IP system has been reduced” and that “there were a lot of proposals that could have undermined innovation.”
Nongovernmental groups had higher hopes going into the meeting, for an outcome with profound effects on health product development for the poor. Over one hundred civil society organisations and patients groups signed a “joint declaration” (pdf) stating that “health is a fundamental human right and a necessary condition for human dignity” and calling for the IGWG to find sustainable solutions to encourage both innovation in healthcare and access to the fruits of that innovation, and several eminent academics signed a similar statement asking for IGWG delegates to consider “the exploration of new and innovative mechanisms that seek to correct the deficiencies of the current system” of drug development and delivery.
Draft Strategy Text Advances
The latest available version of the draft strategy was from the start of the last day, 3 May. Click here to read the 3 May version [pdf].
Delegates were able to reach full consensus on five out of eight elements within the draft global strategy, which includes principles for using the intellectual property system to maximise public health impact, particularly in innovation related to developing country diseases. Full consensus sections were element 1, on prioritising research and development needs; element 2, on promoting research and development; and element 3, on building and improving innovative capacity.
Article 3.4 outlines ways to support “policies that will promote innovation based on traditional medicine,” as well as Article 3.5.b, which encourages “the establishment of award schemes for health-related innovation.”
Article 5.3.a, which also saw consensus, mentions prizes as an innovation incentive, an issue important to developing countries and some nongovernmental participants. Barbados and Bolivia submitted a document at the outset of the week’s meeting proposing alternative incentive schemes for drug innovation in the form of prize funds for inexpensive tuberculosis diagnostic testing, for a Chagas disease treatment, for priority medicines and vaccines, and for cancer treatments. The document also calls for a global agreement on funding clinical trials as public goods.
Element 4, on transfer of technology, was largely agreed upon, with the exception only of element 4.1.b, which reads “promote transfer of technology and production of health products in developing countries through investment and capacity building, including by providing guidance on appropriate technologies.” As of the end of 2 May, this article was listed “consensus pending USA.” One developing country official said that in general the United States was “a bit tough” in negotiation, referring to the fact that the country was often the sole voice blocking consensus (though there may have been others unspoken). The US delegation included an IP negotiator from the US Trade Representative’s office.
Element 7, on promoting sustainable financing mechanisms, also reached full consensus, as did element 8, on the establishment of monitoring and reporting systems. The agreement on element 7 was reached only after a lengthy debate, Barbados said during the IGWG’s closing plenary session. Article 7.3, which detailed several strategies for the establishment of a global R&D fund to address gaps in diseases affecting developing countries, including the use of prizes and rewards as well as earmarked funds for patent buyouts to ensure access to medicines, was deleted by consensus.
Barbados asked during the final plenary that it be officially noted that this consensus was predicated on an understanding by Barbados and the rest of the Caribbean group, as well as Bolivia, that these issues be addressed under 7.1.a. That article calls for the establishment of a “results-oriented and time-limited expert working group under the auspices of the WHO and linking up with other relevant groups to examine current financing and coordination of research and development, as well as proposals for new and innovative sources of financing to stimulate research and development” relevant to developing countries.
Element 5, on the application and management of intellectual property to contribute to innovation and promote public health, and element 6, on improving delivery and access, proved the hardest on which to reach consensus.
Still remaining to be resolved are issues of data-sharing, specifically through the creation of easy-to-use global databases on the status health-related patents (under article 5.1.c); on the training of patent examiners in intellectual property application and management, and possibly on TRIPS flexibilities (under article 5.1.e); on promoting competition to increase availability of health products under article 6.3, and particularly on support for the production/introduction of generic medicines (under 6.3.a). Another issue under debate in the strategy related to agreements that impose stricter intellectual property standards than agreements in the multilateral system (so-called TRIPS-plus provisions).
On 5.1.h, which originally stated, “establish measures to avoid unethical experiments involving human beings as a requirement for registration of medicines and technologies,” sparked a lengthy discussion on 2 May on the nature of ethics in human testing. Points discussed included: the difference between clinical tests for new drugs, or the bioequivalence tests done when generics are marketed, the ethics of testing new drugs against placebos when existing treatments are available for comparative testing (the Declaration of Helsinki, which lays out ethics of healthcare research, and says that new methods of treatment should be tested against the best existing treatments, where available, and not placebos), and the ethics of repeating a clinical test because the original tester has exclusive control over the results of first test and will not make the data public. Also of interest, especially to developing countries, was ensuring post-trial access to drugs by study participants, which the Declaration of Helsinki calls “necessary.”
The article eventually passed consensus on the condition it be moved from element 5.1 on information sharing and capacity building on health-related innovation to element 6.2, which covers ethical review and quality/safety regulation. The final text reads: “promote ethical principles for clinical trials involving human beings as a requirement of registration of medicines and health-related technologies, with reference to the Declaration of Helsinki, and other appropriate texts, on ethical principles for medical research involving human subjects, including good clinical practice guidelines.”
Other debates under element 5 included a provision on preventing anti-competitive practices related to IP rights, language on encouraging respect for flexibilities in the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), and a possible clause on counterfeit health products, including a definition. Some sources said an effort is being made to clarify the distinction between counterfeit products and generic products.
Also under element 5, a discussion was held on the role of the WHO on IP-related matters. Officials present from the World Intellectual Property Organization and the World Trade Organization signalled resistance to a proposal to create a formal coordinating body between agencies under Article 5.1.i. Creating a formal coordination effort would, a WIPO official said, just “add governance issues” to the already functioning informal collaboration that currently exists.
One participant said an informal relationship was seen as possibly minimising interagency turf battles. Still, some participants viewed the outcome as having strengthened the role of the WHO in IP issues. Consensus Article 5.1.f states, “strengthen efforts to effectively coordinate work relating to intellectual property and public health among the secretariats and governing bodies of relevant regional and international organizations (including WHO, WIPO and WTO) to facilitate dialogue and dissemination of information to countries.”
The traditional knowledge debate discussed earlier in the week (IPW, Public Health, 1 May 2008) was resolved after the Kenyan-led informal session came up with the text “facilitate, where feasible and appropriate, possible access to traditional medicinal knowledge for use a s prior art in examination of patents, including, where appropriate, the inclusion of traditional knowledge information in digital libraries.”
Lost Opportunities and Some Progress
Concerned entities and other nongovernmental organisations participating at the event were not entirely pleased with the outcome of the negotiating process.
Médecins Sans Frontières (MSF) sharply criticised the IGWG, saying it had “failed to take concrete action towards reforming a medical innovation system that largely disregards the health needs of millions of people in developing countries.” Tido von Schoen-Angerer, director of MSF’s access to medicines campaign said that negotiators had not “risen to the challenge” of “prescrib[ing] change to a broken system.” He called the working group a “lost opportunity,” particularly because there had been no consensus on the development of alternative research and development incentives.
Ethan Guillen, executive director of Universities Allied for Essential Medicines (UAEM) also expressed surprise at “the lack of bold commitment by most of the rich countries” and said “that there had to be stiff negotiations on the idea that the cost of medicines impedes access in the developing world makes you wonder if some negotiators hadn’t noticed that busloads of American retirees have to hop across the US border to Canada to get drugs they can afford.”
Sarah Rimmington, an attorney at public interest organisation Essential Action, said IGWG was meant to address how “the current corporate sector system of medical R&D, which is based on patent monopolies, has largely failed people in developing countries.” Rimmington said while the IGWG had taken an “important first step by agreeing to explore some common sense measures to address this failure,” such as innovation incentives not reliant on patent monopolies, consensus on actual implementation processes was not reached. This lack of agreement was, she added, largely due to “resistance from developed countries such as the United States, the EU, and Canada” and added that it “is hard not to wonder if pressure from the brand-name pharmaceutical industry - which is based in developed countries and remains ideologically committed to patent monopolies - influenced this disappointing outcome.”
[AS NOTED IN THE PRIOR ARTICLE DATED MAY 2ND, SARAH RIMMINGTON IS ALSO THE REPRESENTATIVE OF ANOTHER NON-GOVERNMENTAL ORGANIZATION THAT PARTICIPATED IN THE IGWG MEETINGS: Churches’ Action for Health.]
Jamie Love of Knowledge Ecology International said the IGWG “did next to nothing on identifying R&D priorities, estimating funding needs, or creating a framework for sustainable funding for priority R&D, three tasks central to its mission.”
Harvey Bale, director general of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), when asked about whether this meeting represented progress toward the goal of addressing the problem of neglected diseases, said it “has lost focus on that,” but added that there was hope it could come back. He stressed the importance of advanced market commitments, or guarantees of a market in the event a medication or vaccine is developed (which were deleted from the draft strategy). He also stressed the importance of partnerships for development that link companies and the public sector in coordinated research efforts.
But there were also some positive views. Guillen said his group was “pleased to see the advancement… of important issues like technology transfer” in the draft strategy and said UAEM is “hopeful that consensus recommendations on open licensing and other technology transfer provisions agreed to during this round will send a strong message to universities… to adopt policies that will free up the tools of innovation and make medicines discovered on campuses available at low-cost in the developing world.”
Love was pleased to see that advanced market commitments had come out of the draft strategy and prizes had been included.
Nicoletta Dentico, policy and advocacy manager at the Drugs for Neglected Diseases Initiative (DNDi) said “the outcome of this intense week-long negotiation shows that some uncertain lights are looming, but still in a forest of thick shadows” that research on essential medicines still faces the “resistance of those who have set the direction of innovation so far” but that hopefully the “"spirit of Geneva” [would] clear, in the face of poor people’s needs, the shadows.”
MSF has said that, as the IGWG failed to arrive at strong conclusions, it is now up to the World Health Assembly “to translate bold ideas into concrete action.”
Kaitlin Mara may be reached at kmara@ip-watch.ch. William New may be reached at wnew@ip-watch.ch.
The following exchange was reflected on the listserv of ip-health@lists.essential.org .
[FRANCISCO ROSSI SETS FORTH TO HIS COLLEAGUES THAT THE WHO IGWG MEETING WAS AN UTTER FAILURE B/C THEY COULD NOT, AT SUCH MEETING, SECURE COMMITTMENTS ON ANTI-PATENT INITIATIVES. YET, HE TRIED TO PLACE A 'POSITIVE SPIN' ON THE OUTCOME...]
On Mon, 2008-05-05 at 15:07 +0000, Francisco Rossi wrote:
[Picked text/plain from multipart/alternative]
From: Francisco Rossi
To: ip-health
Subject: RE: [Ip-health] FT: WHO fails to strike drug deal
Date: Mon, 5 May 2008 15:07:38 +0000
Dear All:
I just want to introduce some reflexions on IGWG outcomes, because I believe there are some elements to take into account. Despite I could have reasons to be especially disapointed, from a personnal perspective, I think we need to be more objective and balanced. Certainly any assessment of IGWG outcomes is related on expectations.
If we expected a radical re-formulation of IP worldwide, IGWG was a major failure. If our expectations were oriented to introduce alternative incentive models instead of prevelent ones, meeting was a failure.
In the other hand, if we read the meeting as an step on a process to put developing countries points of view in the table. IGWG was a major sucess. If we read the meeting as a strong movement on the WHO secretariat to take very seriously IP issues, meeting was a major success.
I was commenting with some friends that in the past we were working very reactive against TRIPS, and then against FTAs and Trips plus measures. Reactive and in a defensive Perspective. Now, despite the UN lenguage in most of the agreements and consensus, there is a open door for the negotiation on Innovation, IP and Public health.
Certainly developed countries and interested industries were there to obstacle any movement. And they worked pretty well. By from my personal point of view they lost a lot. And I would like to highlight the developing world countries leadership on that.
Just to re-open this discussion.
Best to all
Francisco Rossi
------------------------------------------------------------------------------------------------
[IN COMFORTING, FRANCISCO ROSSI, JAMIE LOVE OF KEI POINTS OUT THE 'POSITIVES'...]
From: James Love
Reply-To: james.love@keionline.org
To: Francisco Rossi
Cc: ip-health
Organization: http://www.keionline.org
Date: Mon, 05 May 2008 16:56:02 -0400
This is a response to the comment by Francisco Rossi.
The IGWG negotiations involve a wide range of topics, and people will see useful text in several areas, although also important areas where there is no progress yet, as reflected in the 18 paragraphs still with brackets. There is also relatively weak language in some parts.
In terms of new incentives, good language on incentives has in fact moved ahead. For example:
-----------
5.3(a) explore and, where appropriate, promote a range of incentive schemes for research and development including addressing, where appropriate, the de-linkage of the costs of research and development and the price of health products, for example, through the award of prizes,
with the object of addressing diseases which disappropriately affect developing countries (consensus)
---------
It was difficult to get 5.3(a). But there is now very good language, on what we consider a key issue.
7.1, while not as strong as the language in the deleted 7.3, is also useful.
". . .examine current financing and coordination of research and development, as well as proposals for new and innovative sources of financing to stimulate R&D related to Type II and Type III diseases and the specific R&D needs of developing countries in relationship to Type I
diseases."
In the closing plenary, Barbados said it was assured that its proposals for prizes would be covered by the language in 7.1 (new and innovative sources of financing to stimulate R&D). The Barbados intervention led to a procedural question by the USA, followed immediately by substantive support for the Barbados position by India.
There is also plenty of useful language in other sections of the document on this topic, including the front parts (some of which were changed from the draft now on the web).
My own view is that very good progress has been done on the topic of new incentive nechanisms that are not linked to prices of products. This was aided in part by the generally favorable response to substance and concrete nature of the Barbados/Bolivia prize proposals.
What the IGWG did not do was fund anything, not only for prizes, but for grants and other push funding, or AMCS (which are no longer mentioned in the text) or anything else. The US and Europe did not want to talk about money at this meeting. For a number of groups that are looking for something important for funding neglected diseases, this was a major flaw in the negotiations so far. The idea of a biomedical treaty is alive, and the expert working group on financing R&D will carry the conversation forward, but this is clearly a delay that is driven by a lack of political commitment to spend new money in this area.
The debates in May at the WHA will focus on the 18 important paragraphs where there is no consensus. People can usefully begin focusing on these paragraphs, and push their delegations to do the right thing.
Jamie
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http://www.ip-watch.org/weblog/index.php?p=1024
Intellectual Property Watch
2 May 2008
WHO Members Inch Toward Consensus On IP, Innovation And Public Health
By Kaitlin Mara and William New
Members of the World Health Organization (WHO) gathered this week to address innovation and intellectual property issues in public health saw hope for agreement on a strategy paper focused on the needs of developing countries, particularly on neglected diseases. But with two days remaining in the negotiations, difficult issues on intellectual property rights and the action plan remained unresolved.
The WHO Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (IGWG) is meeting from 28 April to 3 May, as a part of its resumed second session (the second session begin in November 2007)(IPW, WHO, 9 November 2007). The current round of negotiations is under mandate to create a consensus document for presentation at the World Health Assembly, which will take place later this month.
Draft Global Strategy on Public Health, Innovation and Intellectual Property as of start of 2 May, 2008 [pdf]
In her opening remarks to the IGWG, WHO Director-General Margaret Chan said that an “agreed framework can make the cycle of product discovery, development and delivery more efficient and more sensitive to health needs in the developing world” by giving the international community a “common tool” to leverage against health problems. She stressed the importance of the negotiations moving forward “as rapidly and efficiently as possible,” and urged a continuation of the “sense of urgency” seen in past months.
Further pressure for resolution has been placed on negotiators by some developed countries who would like to see the IGWG discussions end this week, and to pull the WHO back from involvement with IP issues, according to some participants. Others thought that the negotiations should not be rushed, and one developing country official said, “I hope we don’t do in haste what we will repent later.”
This week’s debate is the result of several years of intensive discussion at the WHO on policies to address the problem that the existing intellectual property system lacks economic incentives for the private sector to invest in research and development (R&D) for diseases primarily affecting those who cannot afford to pay the higher prices necessary to recover R&D costs.
But a larger issue of the role of the WHO in discussions relating to intellectual property is underlying the talks. Many feel the issues belong primarily in the World Trade Organization, World Intellectual Property Organization, or in national laws. But others see the WHO with the lead on public health issues as having been sidelined in global debates as they relate to IP and public health, even as those debates have resulted in rules that have possibly had a pejorative effect on public health.
“The IGWG is a historic opportunity and this should not become a historic failure for lack of response,” Médicins sans Frontières’ Tido von Schoen-Angerer told the plenary. “Governments, and the WHO, must not abdicate from their responsibilities, or pass the buck to others. We are asking you to strengthen WHO’s role in intellectual property and health, to change the way R&D is prioritised and financed so that paying for the research does not equal prohibitive prices, and to take measures to increase generic competition.”
Draft Text Taking Shape
While most negotiations have happened behind closed doors, on 1 May WHO members met as a whole in an attempt to hammer out consensus on the draft global strategy on public health. The talks were able to cover elements two, three and four out of the eight-element draft strategy - covering, respectively, promoting research and development, building and improving innovative capacity, and transfer of technology - and had begun to discuss element five, on the application and management of intellectual property to contribute to innovation and promote public health.
Remaining aspects of element five are expected to be contentious, according to some participants. In general, consensus is being achieved through a relative weakening of provisions, often, but not always, along north-south lines. Compromises involved the insertion of phrases like “possible” and “appropriate.”
The morning’s negotiations focussed on element two, promotion of research and development. Convergence was reached on accessibility to libraries and technical support to create compound libraries in developing countries (Article 2.2.b), and the related article (2.4.c) on the creation of open databases and compound libraries. The United States sought to delete the second article as it felt it was redundant, sparking discussion on the issue.
The dissemination of publicly or donor-funded medical inventions and know-how (Article 2.4.d), and the “incorporation of research exemptions in legislation of developing countries” for public health purposes (Article 2.4.e) were both contested by the United States. Korea agreed with the US on 2.4.d, as one of the suggested ways to disseminate medical know-how was through open licensing and the Korean delegate was unsure if his country had a policy allowing for such licensing.
Brazil and India felt that open licensing was a useful addition to the paragraph, and India mentioned that the use of open source technologies in India was very effective. Jamaica supported India and Brazil. A distinction also was made between proprietary and non-proprietary databases. A compromise was reached with the language “including but not limited to open licensing.”
On 2.4.e, which reads “consider the incorporation of research exemptions in legislation of developing countries to address public health needs, consistent with the TRIPS and the Doha declaration on TRIPS and Public Health,” the United States asked for the paragraph to be deleted, as such issues would be dealt with in the IP chapter (element 5). Delegations pointedly asked the US delegation to explain its problem with research exemptions, as they are covered in both the TRIPS agreement and in US legislation. Japan supported the United States, which argued that the term ‘research exemptions’ was not well-defined, and it was unclear as to its actual scope.
The encouragement and promotion of traditional knowledge (and traditional medicines) was another key debate. Suriname wanted to ensure that traditional medicine is protected from being carried away from its nations of origin and brought back as patented matter. The traditional knowledge clause in element 5, Article 5.1.f, on the creation of digital libraries of traditional knowledge in order to prevent misappropriation, caused much disagreement. Some delegates were uncertain if discussions on traditional knowledge even belonged in the WHO negotiation. Others could not see how a digital database could prevent misappropriation, as it would offer greater access to the knowledge. Several new suggestions were offered, but after lengthy discussion no convergence was forthcoming so the chair suggested interested parties meet outside the plenary. Kenya is chairing this side session.
Another discussion in element 5 reflected a debate that has arisen at other institutions in Geneva that the training on IP in developing countries, such as of patent examiners, should fully reflect public health priorities.
Element 5 seems likely to be difficult to negotiate, with upcoming discussions on provisions such as how to address research involving humans. Delegates on 1 May discussed Article 5.1 and several of its subsections, but had trouble reaching consensus on several topics. In addition to traditional knowledge, a clause on strengthening “education and training in the granting, application and management of intellectual property from a public health perspective” also presented a problem. The US wanted to strike the word “granting” from the paragraph, and other members proposed adding specific references to flexibilities contained in the TRIPS agreement and other instruments. Consensus was unable to be reached.
Under Article 5.1, on the management of intellectual property in a manner that maximises health-related innovation, Suriname was concerned about the ethics of clinical trials, citing examples in which such trials have been conducted in developing countries, aiding medical innovation on drugs that were subsequently out of the price range of individuals who had participated in trials. Suriname wishes to add “maximises health related innovation and access” to the clause; consensus is pending agreement on that addition.
Civil Society Views
The hottest points of disagreement have tended to arise over practical solutions for solving this problem, reflected in the wide variation in proposals from civil society groups addressing negotiators. Public interest advocacy group Knowledge Ecology International’s Jamie Love has suggested prizes and prize funds replace [correction: his position is that they would coexist, see comment below] patents for neglected diseases, and expressed disappointment that most references to such systems in the strategy paper appeared to be surrounded by brackets indicating lack of consensus on their presence in the text. Love suggested that if the governments are not ready at this point in time to achieve real improvements, then perhaps the process should wait for another time.
International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) Director General Harvey Bale said the industry group wants to preserve strong intellectual property protection, which it says promotes innovation, and instead focus on market incentives outside of IP, such as advanced market commitments (AMC) and “fast track” approval for drugs targeting developing country diseases. An AMC is a guarantee of a market in the event a medication or vaccine is developed in order to incentivise the development of health solutions in diseases or for areas where the existence of a market is uncertain or too small to compensate for R&D costs.
Health Action international also said that WHO must have a clear mandate to work in IP and health, and that the final draft strategy should not dilute flexibilities in IP enforcement already guaranteed under the WTO’s Trade-Related Aspects of Intellectual Property Rights Agreement. The European Generic Medicines Association and the International Generic Pharmaceutical Alliance, represented by Greg Perry, said data exclusivity must not be used to create market exclusivity beyond patent protection.
“IGWG must systematically address innovation and access to medicines” and should “delink the cost of research and development from the price of developed products,” said Sarah Rimmington of Churches’ Action for Health. The role of WHO should be strengthened on IP and issues in health, and the organisation should “provide active guidance, specifically on TRIPS flexibilities.”
The International Alliance of Patients Organizations called for IGWG recognise patients and patient organisations as key stakeholders.
MSF’s von Schoen-Angerer urged that the medical R&D process be government-led, and said it appeared wealthy countries objected to a proposed R&D fund without offering alternatives.
Kaitlin Mara may be reached at kmara@ip-watch.ch. William New may be reached at wnew@ip-watch.ch.
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http://www.ip-watch.org/weblog/index.php?p=1027
Intellectual Property Watch
6 May 2008
WHO IP And Health Group Concludes With Progress; Tough Issues Remain For Assembly
By Kaitlin Mara and William New
The World Health Organization (WHO) negotiations on public health, intellectual property and innovation ended Saturday with substantial progress toward consensus on a draft strategy but with a plan of action remaining and the most contentious articles in the strategy still under brackets - indicating lack of agreement - as the paper goes to the World Health Assembly.
The air in the room was cautiously optimistic as WHO Director General Margaret Chan’s closing comments praised the assembled delegates at the 28 April to 3 May Intergovernmental Working Group on Public Health, Innovation, and Intellectual Property (IGWG) for reaching consensus on 107 paragraphs (many through deletions) that had been unresolved at the meeting’s start Monday.
The group’s mandate from the 2006 Health Assembly was to agree on a strategy and plan of action to boost research and development of, and access to, treatments for diseases disproportionately affecting developing countries, in time for this year’s annual assembly. If sufficient agreement is reached on the remaining items and the plan of action, implementation of the strategy should follow.
But there was also a sense from many delegates that substantive work lies ahead, and some nongovernmental organisations expressed disappointment at the IGWG’s perceived lack of strong commitment to public health, and the potential lost opportunity to make a profound difference.
While the global strategy being drafted by the group is not legally binding, it is being taken seriously by governments and other stakeholders because it could have a significant impact on policy. “It is a political document,” said one official. “It can have a lot of weight.”
Both developing and developed countries representatives found positive things to highlight about the IGWG, though it is clear that outcomes are not yet guaranteed and large gaps remain between what different stakeholders want from the draft strategy. Much of the work was done in closed informal sessions, often into the night, participants said.
Some key outcomes or debates were the proposed creation of an expert group on financing and the coordination of R&D, a mention of prizes as a possible alternative incentive for research and development, and policies on human clinical trials, competition, counterfeit medicines, and the role of the WHO on international IP and innovation issues.
Also significant was the apparent removal of advance market commitments, which would have created a mechanism for ensuring a market for new drugs, sources said. One source also said there was now a separation of provisions relating to access from those relating to intellectual property rights.
Ambassador Tom Mboya Okeyo of Kenya said the outcome’s impact will take time to see but that it was a good step. He noted consensus on provisions on access to medicines, and on flexibilities in the international IP system to accommodate access. Also agreed were several provisions that could strengthen innovation on essential medicines and encourage sustainable financing mechanisms, and provisions that could help protect traditional medical knowledge, all of which are important to developing countries, he said. The next challenges are in ensuring the key actions outlined in the strategy are implemented quickly, he said, adding that he hoped the WHO director general could mobilise funds for that purpose.
Suriname delegate Miriam Naarendorp called the week’s outcome the “start of the battle,” with the plan of action and implementation issues still to come. However, it was an important start, as, Naarendorp said, the IGWG was able to identify issues important to developing countries, and that the developing nations “stood firm on things that mattered” and had created a document that the WHO could not ignore.
An official from a leading developing country praised the outcome as successful as “so many member states agreed on so many things.” And a third developing nation delegate added that “we’ve made tremendous progress here [and] I expect we will get it finished at the World Health Assembly.” The assembly meets from 19 to 24 May.
A key developed country source was more concerned that the IGWG seemed to have averted potential negative consequences, saying that “the possibility of impact on the IP system has been reduced” and that “there were a lot of proposals that could have undermined innovation.”
Nongovernmental groups had higher hopes going into the meeting, for an outcome with profound effects on health product development for the poor. Over one hundred civil society organisations and patients groups signed a “joint declaration” (pdf) stating that “health is a fundamental human right and a necessary condition for human dignity” and calling for the IGWG to find sustainable solutions to encourage both innovation in healthcare and access to the fruits of that innovation, and several eminent academics signed a similar statement asking for IGWG delegates to consider “the exploration of new and innovative mechanisms that seek to correct the deficiencies of the current system” of drug development and delivery.
Draft Strategy Text Advances
The latest available version of the draft strategy was from the start of the last day, 3 May. Click here to read the 3 May version [pdf].
Delegates were able to reach full consensus on five out of eight elements within the draft global strategy, which includes principles for using the intellectual property system to maximise public health impact, particularly in innovation related to developing country diseases. Full consensus sections were element 1, on prioritising research and development needs; element 2, on promoting research and development; and element 3, on building and improving innovative capacity.
Article 3.4 outlines ways to support “policies that will promote innovation based on traditional medicine,” as well as Article 3.5.b, which encourages “the establishment of award schemes for health-related innovation.”
Article 5.3.a, which also saw consensus, mentions prizes as an innovation incentive, an issue important to developing countries and some nongovernmental participants. Barbados and Bolivia submitted a document at the outset of the week’s meeting proposing alternative incentive schemes for drug innovation in the form of prize funds for inexpensive tuberculosis diagnostic testing, for a Chagas disease treatment, for priority medicines and vaccines, and for cancer treatments. The document also calls for a global agreement on funding clinical trials as public goods.
Element 4, on transfer of technology, was largely agreed upon, with the exception only of element 4.1.b, which reads “promote transfer of technology and production of health products in developing countries through investment and capacity building, including by providing guidance on appropriate technologies.” As of the end of 2 May, this article was listed “consensus pending USA.” One developing country official said that in general the United States was “a bit tough” in negotiation, referring to the fact that the country was often the sole voice blocking consensus (though there may have been others unspoken). The US delegation included an IP negotiator from the US Trade Representative’s office.
Element 7, on promoting sustainable financing mechanisms, also reached full consensus, as did element 8, on the establishment of monitoring and reporting systems. The agreement on element 7 was reached only after a lengthy debate, Barbados said during the IGWG’s closing plenary session. Article 7.3, which detailed several strategies for the establishment of a global R&D fund to address gaps in diseases affecting developing countries, including the use of prizes and rewards as well as earmarked funds for patent buyouts to ensure access to medicines, was deleted by consensus.
Barbados asked during the final plenary that it be officially noted that this consensus was predicated on an understanding by Barbados and the rest of the Caribbean group, as well as Bolivia, that these issues be addressed under 7.1.a. That article calls for the establishment of a “results-oriented and time-limited expert working group under the auspices of the WHO and linking up with other relevant groups to examine current financing and coordination of research and development, as well as proposals for new and innovative sources of financing to stimulate research and development” relevant to developing countries.
Element 5, on the application and management of intellectual property to contribute to innovation and promote public health, and element 6, on improving delivery and access, proved the hardest on which to reach consensus.
Still remaining to be resolved are issues of data-sharing, specifically through the creation of easy-to-use global databases on the status health-related patents (under article 5.1.c); on the training of patent examiners in intellectual property application and management, and possibly on TRIPS flexibilities (under article 5.1.e); on promoting competition to increase availability of health products under article 6.3, and particularly on support for the production/introduction of generic medicines (under 6.3.a). Another issue under debate in the strategy related to agreements that impose stricter intellectual property standards than agreements in the multilateral system (so-called TRIPS-plus provisions).
On 5.1.h, which originally stated, “establish measures to avoid unethical experiments involving human beings as a requirement for registration of medicines and technologies,” sparked a lengthy discussion on 2 May on the nature of ethics in human testing. Points discussed included: the difference between clinical tests for new drugs, or the bioequivalence tests done when generics are marketed, the ethics of testing new drugs against placebos when existing treatments are available for comparative testing (the Declaration of Helsinki, which lays out ethics of healthcare research, and says that new methods of treatment should be tested against the best existing treatments, where available, and not placebos), and the ethics of repeating a clinical test because the original tester has exclusive control over the results of first test and will not make the data public. Also of interest, especially to developing countries, was ensuring post-trial access to drugs by study participants, which the Declaration of Helsinki calls “necessary.”
The article eventually passed consensus on the condition it be moved from element 5.1 on information sharing and capacity building on health-related innovation to element 6.2, which covers ethical review and quality/safety regulation. The final text reads: “promote ethical principles for clinical trials involving human beings as a requirement of registration of medicines and health-related technologies, with reference to the Declaration of Helsinki, and other appropriate texts, on ethical principles for medical research involving human subjects, including good clinical practice guidelines.”
Other debates under element 5 included a provision on preventing anti-competitive practices related to IP rights, language on encouraging respect for flexibilities in the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), and a possible clause on counterfeit health products, including a definition. Some sources said an effort is being made to clarify the distinction between counterfeit products and generic products.
Also under element 5, a discussion was held on the role of the WHO on IP-related matters. Officials present from the World Intellectual Property Organization and the World Trade Organization signalled resistance to a proposal to create a formal coordinating body between agencies under Article 5.1.i. Creating a formal coordination effort would, a WIPO official said, just “add governance issues” to the already functioning informal collaboration that currently exists.
One participant said an informal relationship was seen as possibly minimising interagency turf battles. Still, some participants viewed the outcome as having strengthened the role of the WHO in IP issues. Consensus Article 5.1.f states, “strengthen efforts to effectively coordinate work relating to intellectual property and public health among the secretariats and governing bodies of relevant regional and international organizations (including WHO, WIPO and WTO) to facilitate dialogue and dissemination of information to countries.”
The traditional knowledge debate discussed earlier in the week (IPW, Public Health, 1 May 2008) was resolved after the Kenyan-led informal session came up with the text “facilitate, where feasible and appropriate, possible access to traditional medicinal knowledge for use a s prior art in examination of patents, including, where appropriate, the inclusion of traditional knowledge information in digital libraries.”
Lost Opportunities and Some Progress
Concerned entities and other nongovernmental organisations participating at the event were not entirely pleased with the outcome of the negotiating process.
Médecins Sans Frontières (MSF) sharply criticised the IGWG, saying it had “failed to take concrete action towards reforming a medical innovation system that largely disregards the health needs of millions of people in developing countries.” Tido von Schoen-Angerer, director of MSF’s access to medicines campaign said that negotiators had not “risen to the challenge” of “prescrib[ing] change to a broken system.” He called the working group a “lost opportunity,” particularly because there had been no consensus on the development of alternative research and development incentives.
Ethan Guillen, executive director of Universities Allied for Essential Medicines (UAEM) also expressed surprise at “the lack of bold commitment by most of the rich countries” and said “that there had to be stiff negotiations on the idea that the cost of medicines impedes access in the developing world makes you wonder if some negotiators hadn’t noticed that busloads of American retirees have to hop across the US border to Canada to get drugs they can afford.”
Sarah Rimmington, an attorney at public interest organisation Essential Action, said IGWG was meant to address how “the current corporate sector system of medical R&D, which is based on patent monopolies, has largely failed people in developing countries.” Rimmington said while the IGWG had taken an “important first step by agreeing to explore some common sense measures to address this failure,” such as innovation incentives not reliant on patent monopolies, consensus on actual implementation processes was not reached. This lack of agreement was, she added, largely due to “resistance from developed countries such as the United States, the EU, and Canada” and added that it “is hard not to wonder if pressure from the brand-name pharmaceutical industry - which is based in developed countries and remains ideologically committed to patent monopolies - influenced this disappointing outcome.”
[AS NOTED IN THE PRIOR ARTICLE DATED MAY 2ND, SARAH RIMMINGTON IS ALSO THE REPRESENTATIVE OF ANOTHER NON-GOVERNMENTAL ORGANIZATION THAT PARTICIPATED IN THE IGWG MEETINGS: Churches’ Action for Health.]
Jamie Love of Knowledge Ecology International said the IGWG “did next to nothing on identifying R&D priorities, estimating funding needs, or creating a framework for sustainable funding for priority R&D, three tasks central to its mission.”
Harvey Bale, director general of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), when asked about whether this meeting represented progress toward the goal of addressing the problem of neglected diseases, said it “has lost focus on that,” but added that there was hope it could come back. He stressed the importance of advanced market commitments, or guarantees of a market in the event a medication or vaccine is developed (which were deleted from the draft strategy). He also stressed the importance of partnerships for development that link companies and the public sector in coordinated research efforts.
But there were also some positive views. Guillen said his group was “pleased to see the advancement… of important issues like technology transfer” in the draft strategy and said UAEM is “hopeful that consensus recommendations on open licensing and other technology transfer provisions agreed to during this round will send a strong message to universities… to adopt policies that will free up the tools of innovation and make medicines discovered on campuses available at low-cost in the developing world.”
Love was pleased to see that advanced market commitments had come out of the draft strategy and prizes had been included.
Nicoletta Dentico, policy and advocacy manager at the Drugs for Neglected Diseases Initiative (DNDi) said “the outcome of this intense week-long negotiation shows that some uncertain lights are looming, but still in a forest of thick shadows” that research on essential medicines still faces the “resistance of those who have set the direction of innovation so far” but that hopefully the “"spirit of Geneva” [would] clear, in the face of poor people’s needs, the shadows.”
MSF has said that, as the IGWG failed to arrive at strong conclusions, it is now up to the World Health Assembly “to translate bold ideas into concrete action.”
Kaitlin Mara may be reached at kmara@ip-watch.ch. William New may be reached at wnew@ip-watch.ch.
