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By Rohan George , Research Consultant, Centad
Background
Despite enormous progress in the prevention, diagnosis and treatment of diseases, developing countries still remain largely excluded from the benefits of modern science. Caught in a cycle of poverty and diseases, people in the hardest-hit countries are facing shorter life expectancies and economic decline. The issue of better access to healthcare products for poor populations has been the subject of many World Health Assembly resolutions. In May 2006, member states asked the WHO to establish an Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (IGWG).
The Working Group's mandate is to prepare a global strategy and plan of action on essential health research to address conditions affecting developing countries disproportionately. The resulting global plan of action will be presented to the World Health Assembly in mid-2008. The Secretariat for Public Health, Innovation and Intellectual Property was established in September 2006 to facilitate the functioning of the IGWG. The Working Group, composed of WHO member states, held its first session on December 4-8, 2006, in Geneva. The Working group has so far completed two sittings. During the previous meetings countries had submitted their versions of the draft text which have been assimilated into the present text for further discussion. The IGWG is going to meet again on April 28, 2008.
Against this backdrop, Centad felt that it was desirable to bring together key stakeholders across the areas of public health, intellectual property and innovation to reflect critically on the Draft Global Strategy and Plan of Action adopted at the Second Session of the IGWG and to seek negotiating inputs for the upcoming Third Session of the IGWG. In furtherance of this objective, Centad organised a series of two consultations. The first informal consultation, organised on February 20, 2008, was held at the office of Centad and had representation from individuals who were part of the Indian delegation at IGWG, WHO (India) and WHO SEARO as well as from public health groups. The meeting covered various perspectives and recommendations on important issues to be covered at the next round of IGWG negotiations. (To view the report of this meeting, click here)
A subsequent, formal meeting was held at the PHD Chamber of Commerce and Industry, on April 17, 2008. A number of participants from the areas of civil society, government, academia, and research attended the meeting. The meeting addressed the actual text of the Draft Global Strategy and Plan of Action and provided detailed inputs and recommendations for negotiation of the draft.
The important points of the discussion are presented below. Relevant provisions from the December 14, 2007, draft of the IGWG Draft Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property are included in the endnotes.
Session 1: Introduction and Opening Remarks
Introduction: Mr K M Gopakumar, Centre for Trade and Development (Centad)
Mr Gopakumar provided a brief introduction to the consultation by noting that the consultation itself reflects the concerns of all the parties assembled there on the upcoming Intergovernmental Working Group (IGWG) meeting. He reminded the participants that their concerns on the eight elements to be discussed as part of the IGWG Draft Action plan would reflect as the input of civil society members to the Government. He also noted that the Draft Action Plan was not a treaty, but rather a strategy document and that therefore certain elements within the text had already been incorporated by consensus. Accordingly, there would be no need to spend time on the provisions that had already been decided by consensus, but on the bracketed texts. He also noted that as the document would not be a treaty, the plan of action for the document would be important as all monitoring would occur through the plan of action and the indicators contained therein. As of now, the fields for most of the indicators are empty.
Opening Remarks: Ms Aradhana Johri, Joint Secretary, Department of Health, Ministry of Health
Ms Johri began by noting the importance of defending the current position regarding the negotiations in the IGWG. She provided some background on the earlier IGWG consultations by noting that the IGWG broke into two Groups: Group A, which focussed on Intellectual Property, Rights, and Group B, which focussed on the other seven elements of the IGWG Draft Action Plan. This fact highlighted the importance of intellectual property in the IGWG negotiations. The broad spectrum of opinions ranged from the US on one end and the Brazilian position on the other. The speed of negotiations was at the rate of approximately one paragraph per day. This is reflected in the extensive square bracketing throughout the document as well as the referendum added by the US. She also noted that the main text had already been frozen by consensus between all the countries and accordingly, could not be touched. It was more important, therefore, to discuss the text within the square brackets. The rest of the document was also open for discussion. Ms Johri also noted that while it would be useful to discuss those negotiating points that should be striven for, it was vital to keep in mind two perspectives from which to examine all provisions:
i) The direct national interest, and;
ii) The interests of the developing countries
Ms Johri also requested the participants to provide comments on the Draft Plan of Action and points within such as timelines, stakeholders and suggested activities.
Ms Johri then proceeded to highlight some of the contentious issues that would benefit from discussion, such as:
I. The listing of diseases into Types 1, 2 and 3. The Indian Country position was derived from the CIPIH, and indicated that while the focus on research and development should be on diseases of Type 2 and 3, access should be provided to Type 1.
II. The prevalence of TRIPS plus intellectual property provisions in a number of bilateral investment treaties
III. Alternatives to intellectual property rights as incentives to innovation. The US in the course of negotiation wanted the draft to refer to such measures as 'complementary'. However, the developing countries preferred the language to reflect the concept of an 'alternative' but were willing to settle for the term 'additional' as a compromise.
IV. Data protection versus data exclusivity in the protection of clinical test trial data.
Session 2: Issues in Research and Development
The session on research and development, encompassing elements 1, 2 and 3 of the Draft Plan of Action, was facilitated by Dr Amit Sengupta. Dr Sengupta began by pointing out that elements 1, 2 and 3 of the Draft Plan of Action were interconnected from the perspective of R&D. The text within these elements has also mostly not been negotiated. Dr Sengupta began by flagging off some important issues for consideration. He noted that element 1 discussed the identification of gaps and of the scope of the disease. Element 2 dealt with a range of measures including finance, private and public research. Some of the contentions referred to the kind of mechanisms of public-private participation within Research and Development, but were more to do with the intellectual property related provisions in Research and Development. Another issue of importance was that of open source methods and the sharing of compound libraries. According to Dr Sengupta, the main areas of interest within this section of the negotiation were:
• Working around the intellectual property system
• Ways to promote open source research initiatives
• Building innovative capacities related to science and technology, clinical trials and the regulation of intellectual property and medicines
• The migration of health professionals and the responsibility of developed countries in such migration
• Traditional knowledge and genetic resources, the discussion on standards and safety concerning the same and the offering of traditional medicine related provisions in square brackets
Dr Sengupta noted that the IGWG constituted an area where people would have a lot to contribute. He also highlighted the importance of India's role in these negotiations, as an opinion leader. While India was currently playing catch up, if they were to promote an agenda of open source research, the results would play out in India's interest.
Disease Classification
The discussion on disease classification examined the appropriateness of current classification and country positions with regard to actions proposed to be taken on the basis of such classification. It was observed that India should stand by its position on Type II and III diseases. Latin America differed on this position as they have a higher prevalence of Type I diseases. According to the Latin American countries, there is no scientific basis for the protection of certain varieties over others.
On the basis of this observation it was noted that it would be important to link the scope of diseases under the IGWG to the elements. The IGWG is currently looking to see that all extra efforts would be transferred to Type II and Type III diseases. The dangers of highlighting, at the very beginning of the document, that protection would only be available for Type II and Type III diseases, would be that the scope of application of the IGWG would be limited at the outset. It was also noted that it would be better to exclude the lists of diseases covered as such a limitation would restrict the operation of government in areas like intellectual property protection and TRIPS flexibilities. This concern may arise in the form of emerging diseases, and the fear that it would be necessary to go through diplomatic processes in order to change the negotiating text to include such diseases. The risks of classifying diseases such as diabetes as Type I diseases was highlighted through the example of larger numbers of elderly people below the poverty line in India eating only starch foods as they were cheaper and easily available, and the corresponding risk of the emergence of diabetes as a result. Another concern raised over the list of disease classifications was that it would set priority areas, which would result in the restriction of scope of operation of the IGWG to the list. Similar instances had occurred during the Doha Round over HIV, tuberculosis etc.
Element 2.2 i - Open Source Research
The discussion around open source research covered the creation of alternative frameworks to encourage open source research initiatives. The importance of open source research for the creation of open access to information and products relating to public health was highlighted. The following language recommendations were made concerning the drafting of Element 2.2:
• The word 'feasible' should not be included in Section 2.2(a) as it qualifies the commitment to open source research.
• Ideally, the word 'voluntary' should also be removed from the draft of Section 2.2(a) as it would hinder cooperative efforts to promote open source research.
• Section 2.2(c) is entirely included within brackets. Efforts should be made to remove it from these as the provision is vital to the strengthening of public health oriented research.
Element 3.2 – Health Workforce Migration
It was observed that Element 3.2(c) ii mentioned 2 approaches to addressing health workforce migration. While the former approach recognised the problem through international cooperation and sought to mitigate the effects on developing countries of such migration of health professionals, the latter merely urged developed countries to mitigate the effects of such migration through methods such as 'strengthening health systems' in the country of origin. The former approach was recommended to be tried for over the latter.
Traditional Knowledge and Traditional Medicine
The discussion on traditional knowledge and traditional medicine highlighted the importance of traditional medicine in the developing country context. One important example that was highlighted was that of Kerala where 63% of the population depended on Ayush and other traditional medicines for medical aid. It was agreed that an emphasis on local medicinal systems was important.
Traditional Knowledge Digital Library
It was noted that the discussion on traditional medicine had covered the Traditional Knowledge Digital Library and similar traditional knowledge databasing systems. However, the proposal around these systems was opposed by the Brazilians on the grounds that if information on traditional knowledge was made available online, it would be easy for countries with relaxed norms of patentability such as the US to steal such information. US companies would be fully capable of pursuing their interests independently under such a system. In addition, even if the possibility of litigation was available, it would be a situation where such litigation would be under the US system, with the nuances of US law which would be cumbersome and expensive. It was agreed that the idea of a traditional knowledge database was risky and should not be supported in negotiations as it could be counter-productive. This problem is exacerbated by the fact that a number of patents based on traditional knowledge are granted on isolations of ingredients occurring in traditional knowledge. The traditional knowledge digital library may serve as a useful database to obtain isolations from which it would be possible to obtain leads to create isolations. However, the TKDL system is already in place in India, and accordingly, it is of greater importance to encourage companies and countries to collaborate on traditional knowledge outside the WTO forum.
Element 3.4 iii
The problems with creating an international protection framework for traditional knowledge were highlighted, especially in the absence of a well developed Access and Benefit Sharing system. It was noted that there were risks involved in the creation of an intellectual property system for the protection of traditional knowledge. Additionally, it was noted that the concept of a sui generis system for the protection of traditional knowledge was inherently unclear. Accordingly, it was recommended to rethink provisions relating to the former interpretation of Element 3.4(b).
The emphasis on a standards based system for traditional knowledge was also addressed, with observations that such a system may be bad for the existing traditional knowledge support system. Only larger companies with greater capital and infrastructure would benefit from a formalised standards system and procedure. Smaller players would in all probability be adversely affected. It would be better to allow companies to establish their own system of standards. However, as a recommendation for modification of Element 3.4(c) of the existing draft, the phrase 'evidence based' in the context of standards was preferred over 'high' standards.
Session 3: Transfer of Technology and IP Management
Mr K M Gopakumar of Centad facilitated the discussion on Transfer of Technology and Intellectual Property Management. The session encompassed elements 4 and 5 of the IGWG Draft Plan of Action.
Element 4 iv
Element 4.1(a)
It was agreed at the outset that the intent of Element 4.1(a) would be strengthened if the word 'devise' were utilised instead of the phrase 'explore the need for', due to the fact that the phrase 'explore the need for' merely expressed a broad intent to pursue new mechanisms for technology transfer, whereas 'devise' indicated a statement of will.
Element 4.1(b)
It was determined that the phrase 'essential' was deemed too restrictive in the context of technologies for research and production, and that therefore, the term 'available' would be preferred.
Element 4.1(d)
The assembled parties agreed that the term 'promote' provided a stronger expression of intent than 'encourage' in the context of a commitment to disseminate health related patent information.
Element 4.2(b)
The debate around technology transfer related to natural products hinged on the difference between the phrases 'make arrangements to promote technology transfer' and 'support technology transfer from North to South'. It was agreed that the latter phrase conveyed a stronger intention than the former. However, an alternative phrase 'make arrangements to support technology transfer from North to South' was suggested.
Element 4.3
With regard to the initial language of element 4.3, it was agreed that the word 'key' in the context of the phrase 'health related technology' was restrictive, and accordingly, should be removed. It was also determined that the phrase 'in a rational and health-oriented manner' in the context of development of mechanisms to manage intellectual property was ambiguous and vulnerable to exploitation, and should accordingly be removed.
Element 4.3(b)
In the context of developing alternative mechanisms for innovation, it was agreed that the word 'voluntary' should be removed, as it precluded the option of compulsory obligations to create alternative mechanisms for innovation promotion. It was also agreed that the word 'disproportionately' within the phrase 'for diseases that disproportionately affect developing countries' added ambiguity and restriction, which should be removed from the draft text.
Element 4.3(c)
The parties agreed that element 4.3(c) was important for the creation of policies to maximise access to medicines. Accordingly, though the term was currently bracketed, it was determined important to insist on the inclusion of the phrase.
Element 5
Element 5 is said to contain 3 primary aspects:
• The development of developing country capacities for intellectual property management
• Assisting developing countries to properly utilise their flexibilities under the TRIPS Agreement.
• Promoting alternative incentives for research and innovation.
It was also noted during the meeting that intellectual property provisions were initially proposed to be incorporated into all the elements of the Plan of Action. However, the developing countries pushed for all such provisions to be incorporated into element 5.
Element 5.1 v
Element 5.1(a)
It was agreed that in order to place a firmer obligation to ensure information sharing and capacity building, the latter interpretation of Element 5.1(a) should be rejected. It was also noted that there was a need for greater specificity as to what kind of information was proposed to be shared. It was also proposed that the phrase 'public health oriented' be implemented into the language of element 5.1(a).
Element 5.1(f)
The latter interpretation of element 5.1(f) was deemed to be a more suitable alternative as the former indicated an obligation to be placed upon developing nations to create traditional knowledge databases while the latter placed an obligation on all parties (and in effect, developed countries) to ensure that traditional knowledge databases were referred to during the patent examination procedure.
Element 5.1(h)
It was proposed that element 5.1(h) was important in the context of the debate over data protection. It was also agreed that the placement of this provision within element 5 should be retained, and any efforts to move the section into elements 1, 2 or 3 should be discouraged.
Element 5.1(i)
The discussion over this provision concerned the pitfalls of creating a coordination committee. There were concerns that, depending on the mandate of the committee, it could be used to subordinate the WHO to the operation of the WIPO and the WTO. For instance, if the committee is required to approve documentation or placed within other roles of importance, WHO which is tied to the WTO and the WIPO could weaken the potential of the WHO itself. It was determined that a safer option would be to strengthen the WHO independently rather than to subordinate it to the WTO or the WIPO. Accordingly, it was agreed that the interests of WHO independence would be better served with the removal of this provision.
Element 5.2 vi
It was noted that element 5.2 of the Draft Plan of Action was heavily bracketed and that even the introduction to the section contained 3 alternate texts. It was noted that the 3 rd interpretation of the introduction utilised the words, 'upon request' in the context of provision of technical and policy support by the WHO. It was proposed that this language be removed as the phrase could reduce the ability of the WHO to take suo moto action when required. In addition, the phrase 'as appropriate' served to qualify the commitments in element 5.2 even further, and it was deemed preferable to remove such qualifying language. It was also agreed that the usage of 'upon request' which appeared in the other versions of the introduction as well, should be removed if required. It was determined that the first interpretation may be the most effective, provided that mentions of the phrases 'in collaboration with the WTO' were removed from the scope of operation of the WHO in the introduction and if the 'Doha Declaration on Public Health' were added to the agreements under which support for application of flexibilities was to be provided.
Element 5.2(b)
It was noted that element 5.2(b) could be contentious in the context of the negotiations to come. Nevertheless, it was noted that the latter interpretation of this element would provide stronger provisions by broadening the scope of agreements within which TRIPS plus provisions were proposed to be implemented, and increased the obligation not to introduce TRIPS plus provisions in national legislation.
Element 5.2(c)
The house proposed, with regard to element 5.2(c), that the word 'ensure' provided a stronger commitment than the words 'encourage' or 'promote'. It was also agreed that it would be important to maintain the inclusion of the Doha Declaration within the list of flexibilities involved. Though it was agreed that all the included 'and' texts should be supported, it would be of importance to create a priority of texts that should take preference of inclusion over others during negotiation.
Element 5.3 vii
It was noted that the word 'alternative' occurring throughout element 5.3 was important to maintain, due to the strong difference in its connotations from the word 'complementary'. 'Complementary' denoted an additional system to the prevailing standard, while the word 'alternative' acknowledged that the existing system did not sufficiently address the needs of certain parties and that accordingly, alternative systems would be required. The CIPIH, in its earlier meetings, had agreed that the IP system had failed to deliver.
Element 5.3(a)
The different possibilities for alternatives to the patent system were discussed, including the prize fund. The prize fund was determined to be an alternative to the patent system that would allow for the contribution of a prize for research and development. It was noted that whatever would be the outcome of such an exercise, funding would be essential and that outcomes were ultimately dependent on capacities. Another alternative that was criticised was the Advanced Market Commitment Scheme, which sought to pay large amounts of research and development grant money to companies to develop their product. The funding of corporate research and development through grants would ultimately create a problem. This was a problem that was agreed to exist within all existing systems of intellectual property alternatives, as they promoted corporate involvement in development. One alternative that was discussed was the system of open source alternatives to the patent system. Another proposal addressed the misappropriation of domestic technology and wondered whether existing systems would address such a situation. It was explained that in many situations, people obtained a patent by the appropriation of traditional knowledge. A useful method of recovering such knowledge could be the appropriation of traditional knowledge into the public domain through a 'copyleft' system. The reason for this was due to the fact that Access and Benefit Sharing (ABS) mechanisms for the appropriation of traditional knowledge were largely useless. The linkage of recompense for traditional knowledge misappropriation with monetary compensation was explained by the proposer to be largely a trap.
Element 5.3(c), (d), (e), (f), (g) – Data Exclusivity
The discussion around data protection within the context of the Draft Plan of Action revolved around the utility of data protection/exclusivity provisions within the scheme of Plan of Action. It was proposed that it may be preferable not to discuss data exclusivity within the draft at all, and thereby, to delete the provisions relating to it under Element 5.3. However, it was pointed out that data exclusivity as an option was expressly ruled out by the CIPIH, and accordingly, it would be useful to discuss it within that context in the Plan of Action. In addition, the issue was deemed to be of too much importance to ignore discussion. It was determined that a discussion around data protection would be important, but not within the context of element 5.3. Rather, it would be preferable to discuss data protection within the context of element 5.1 instead.
Texts to be Considered along with Element 5
Element 2.3(f)
It was proposed that in the context of element 2.3(f), and in the overall context of the Draft Plan of Action, the addition of the phrase “in collaboration with the WTO and WIPO” could be counter-productive. It was agreed that if inter-organisation collaboration was to occur through the plan, it would be better to provide a broader scope for such collaboration, allowing for the possibility of collaborating with such organisations as the UNCTAD or the UNDP. Accordingly, it was recommended that the phrase 'in collaboration with the WTO and WIPO” be amended to “ in collaboration with other international agencies”.
Element 3.2(d)
It was also agreed that the provisions of element 3.2(d) were of little relevance to the overall draft, and that therefore they could be removed if required.
Session 4: Improving Delivery and Access
Ms Kajal Bharadwaj facilitated the discussion on Improving Delivery and Access, which incorporated element 6 of the Draft Plan of Action.
Element 6
Paragraph 38 viii
It was observed that there was a general lack of consensus, throughout the draft as well as within paragraph 38, on whether bilateral agreements should be included within the ambit of the strategies proposed for the Draft Plan of Action. It was proposed that it was of importance to create a consensus on bilateral agreements and to include them within the ambit of the Plan of Action. However, it was also pointed out that it would be preferable not to get stuck on the issue as it may not be an essential issue in the larger context of the negotiations. However, it was countered that unless developing countries stood together to lobby against bilateral agreements, it would be hard to establish consensus against them.
Element 6.1 ix
Element 6.1(a)
The word 'essential' as bracketed within the provision, raised some discussion due to the argument extended that not all health products could be said to be essential. Infrastructure development and financing of essential products was preferable to the same benefits being extended to drugs that may not be essential at all. It was pointed out that as there was no 'list' of essential drugs, it would be up to the individual member countries to decide what was essential for it. This was determined to be acceptable.
Element 6.1(b)
The bracketing of the phrase 'if necessary' was noted in element 6.1(b). It was observed that the reason for such bracketing was due to the assumption made by some member countries that certain least developed countries had already developed sufficient infrastructure not to require protection under this provision. However, this was agreed to be an erroneous assumption and it was agreed that this phrase should be removed from the provision.
Element 6.1(d)
It was agreed by the gathered parties that in the context of a commitment to delivery and access to medicines and health products, it would be preferable to use the word 'guarantee' over the other alternatives present within the draft provisions of this element. It was also agreed that the phrase 'in order to' reflected the commitments within the draft better than 'with a view to'.
Element 6.1(g)
It was observed that pooled procurement was a system that could really be useful in reducing drug prices. However, it was also noted that such a system was not without its issues, and that it would be important to determine which parties would be involved in the pooled procurement process.
Element 6.2 x
Element 6.2(a)
The meaning and import of element 6.2(a) was widely debated. While some perspectives saw it as a useful provision to question the ethical basis of data exclusivity, others noted that despite its provisions concerning fasttrack approval and its possibilities for getting the benefits of research and development to the public, it could be used as a provision to strengthen drug regulation in developing countries. In the context of the latter concern around this provision, it was agreed that it may be preferable to leave out the provision.
Element 6.2(f)
It was recommended, in the context of minimising the consequences of counterfeit drugs, that while the word 'substandard' should remain within the draft, the word spurious is targeted towards generics industries and should accordingly be removed.
Element 6.2(g)
It was agreed that element 6.2(g) should be removed from the draft Plan of Action as the concept of harmonisation was dangerously subjective and could be utilised in a manner that would set benchmarks and standards for the lowest common denominator.
Element 6.3 xi
Element 6.3(a)
It was initially debated as to whether the application of element 6.3(a) should be focussed on developing countries alone by the addition of the line 'in developing countries' at the end of the provision. However, this proposal was dismissed as all countries should be able to obtain access to generic medicine.
Element 6.3(b)
It was agreed that it would be preferable to remove the bracketed portions of this text as all countries had an obligation to provide essential medicines and treatments at affordable prices and a right to avail the same.
Element 6.3(c)
Concerns were expressed over the content of provision 6.3(c) as it was seen to be a ploy on the part of the pharmaceutical lobbies to reduce tariffs and taxes on drugs. It was also observed that international policy should not force changes in national policy and legislation.
Element 6.3(d)
Some concerns were expressed with the provisions of element 6.3(d) due to the fact that it may lead parties to be further tied into the perspectives of the TRIPS Agreement.
Element 6.3(e)
It was debated as to whether it would be prudent to involve pharmaceutical companies within the ambit of the Plan of Action by encouraging pharmaceutical companies to adopt transparent and equitable pricing policies. However, it was concluded that such a move could not hurt.
Element 6.3(g)
There was a debate around the third interpretation of element 6.3(g), specifically in the context of whether such a provision would be useful for the exploration of options on competition policies for anticompetitive practices. However, it was noted that due to the direct impact of these issues with the WTO negotiations, it may be safer to go slow on systems involving competition law. It was pointed out, however, that most developing countries do not even consider the use of competition law to address pharmaceutical industry and patent exploitation. While it was proposed that the matter may be better resolved by leaving such issues to the industrial policy of individual member countries, it was argued by another member that such a provision would encourage members to put in place legislation that would prevent anticompetitive practices related to medicinal patents.
Element 6.4 xii
It was agreed that element 6.4 was acceptable aside from the fact that efforts to increase awareness among users, doctors and pharmacists regarding generic products should be done keeping in mind essential drug policies. Accordingly, it was agreed that the phrase ' in keeping with essential drug policy' should be added at the end of the provision.
Session 4: Sustainable Financing Mechanisms
The session on sustainable financing mechanisms was facilitated by Ms Ellen t'Hoen, Medecins Sans Frontieres and by Mr K M Gopakumar, Centad. The session discussed the provisions of Element 7 of the Draft Plan of Action on Ensuring Sustainable Financing Mechanisms.
Element 7
Element 7.3: The R&D Fund xiii
A number of concerns were expressed in the context of element 7.3. It was revealed that there had earlier been a proposal by the IFPMA which were lobbying for the R&D fund for the most infectious diseases as a major outcome of the negotiations. The fund seems like a good idea at the outset as the fund envisions as a system for raising money from donors to provide to neglected diseases. However, there exists a catch in this system as the fund in operation may exist as an operation to funnel money into pharmaceutical companies.
It is perceived that the R&D fund may actually become the only concrete outcome of the IGWG, and that those countries that wish to support the fund may be asked to drop other negotiating positions in favour of the fund. It was feared that the fund may morph into a system of corporate welfare.
It was expressed that while the fund may still be a good concept, it required clarification in the form of a treaty. The option of creating a treaty is already provided in Element 3, and accordingly, it may be better to create a transparent mechanism for such funding through a legal document like a treaty. It was also suggested that the option of deleting the provisions relating to the fund existed, and more emphasis placed on negotiations for transfer of technology and other areas of concern. However, it was countered that creating qualifying language and ensuring that the fund achieves its purpose is preferable to the deletion of the fund. Also, it was pointed out that it was impossible to avoid global or national pharmaceutical companies as the majority of the world's drug development capacities lay with them.
The importance of leadership within the fund was seen as a vital issue. Establishing a Chair for the fund and ensuring balanced international participation in the management of the fund were key factors. It was also noted that India perceived the fund as a concrete effort. Accordingly, it would be better to lobby for a realistic fund, rather than to drop it.
On the basis of the discussions around the R&D fund, a number of proposals were forwarded. It was agreed that:
I. while realising the limitations of the R&D fund, it is important not to oppose it.
II. It may be a more effective move for India to agree to an R&D fund only within the context of an R&D treaty. The treaty, however, would take a long time to formulate.
III. While it may realistically not be possible to oppose the R&D treaty, it may be better to propose it in a form which makes all the conditions within the treaty more acceptable to developing country and national interests.
IV. It was noted that though the negotiations around the treaty were important, it was essential not to trade off other equally important commitments for the sake of the treaty.
V. It was also noted that the provisions for the fund should not be accepted in their present form.
It was considered to be of importance to speak to the African group of countries to convince them that the fund is a good idea. It is vital to create a dynamic between like-minded countries like India before the IGWG occurs.
Final Interventions
At the end of the meeting, it was agreed that negotiations at the IGWG must proceed with caution. The R&D fund required a great deal of analysis before any commitments were mane. The need for focussing on health information systems was highlighted as current mechanisms for monitoring and information were insufficient. Systems needed to be put in place to strengthen the health information system and the disease surveillance and disease burden system. Emphasis was also placed on the need for proper outcome assessments, examining all strategies from the perspective of development goals. The need for creating a space for alternatives to the intellectual property regime was also noted. It was observed that it may be possible for outcomes from the meeting to dilute flexibilities provided under the TRIPS, and that such outcomes should not occur. Traditional medicine and a greater examination of the issues concerning traditional medicine should also be examined more closely. It was also noted that health groups were concerned about issues concerning data protection and data exclusivity. It is essential to note that the concepts of innovation, access and the rational use of drugs must go together, and not be exclusive of each other.
iRelevant Extracts from the IGWG Draft Global Strategy and Plan of Action, December 2007
(To view the complete plan of action click here: http://www.who.int/gb/phi/pdf/igwg2/PHI_IGWG2_CP1Rev1-en.pdf )
i (2.2) promoting upstream research and product development in developing countries
(a) support discovery science, including [where feasible and appropriate,] [voluntary] open-source methods, in order to develop a sustainable portfolio of new products;
ii(3.2) Framing, developing and supporting effective policies that promote the development of capacities for health innovation (consensus)
(c) [encourage international cooperation to develop effective policies for retention of health professionals including researchers [in developing countries] and [provide developing countries and their institutions with support to alleviate the [negative] impact of health workforce migration taking into account the work of WHO and other relevant organisations]
or
[urge Member States to mitigate the adverse impact of the loss of health personnel through migration, including means for the receiving developed countries to support the strengthening of health systems, in particular human resource development in the countries of origin]
iii(3.4) supporting policies that will promote innovation based on traditional medicine within an evidence-based framework in accordance with national priorities and taking into account the relevant provisions of relevant international instruments (consensus)
(a) establish and strengthen national and regional policies to develop, support, promote [and protect] traditional medicine.
(b) [promote [protection and] documentation of traditional knowledge and natural genetics resources] [in an international sui generis protection framework]
or
[encourage and promote national and international policies on traditional medicine to facilitate prior art for patent regimes and disclosure and benefits sharing ]
[(c) [encourage [all countries to ensure]]/[ensure] high standards of safety and efficacy for traditional medicine and promote and fund research for standardization of traditional medicine systems.]
iv(4.1) promoting transfer of technology and the production of health products in developing countries (consensus)
(a) [[explore the need for [devise] [to develop and implement alternative] new [increase and improve] mechanisms, or] make better use of existing[ones]/[mechanisms] to facilitate transfer of technology and technical support [to build and improve innovative capacity for research and development, particularly in developing countries].]
[(b) devise a list of [essential] technologies related to research and local production of health products relevant to developing countries].
(c) promote transfer of technology and production of health products in developing countries through identification of best practices, and investment and capacity building provided by developed and developing countries where appropriate. (consensus)
(d) [encourage]/[promote] the dissemination of [health related] technological and other information contained in patents and published patent applications, as well as published information related to patent status, oppositions, revocations and nullifications.]
(4.2) supporting improved collaboration and coordination of technology transfer for health products, bearing in mind different levels of development (consensus)
(a) encourage North–South and South–South cooperation for technology transfers, and collaboration between institutions in developing countries and the pharmaceutical industry; (consensus)
[(b) [make arrangements to promote technology transfer] / [support technology transfer from North to South] related to research and development on natural products [for therapeutic use]];
(c) facilitate local and regional networks for collaboration on research and development and transfer of technology; (consensus)
(d) continue to promote and encourage technology transfer to least-developed country members of the WTO consistent with Article 66.2 of the Agreement on Trade-Related Aspects of Intellectual Property Rights; consensus)
(e) promote the necessary training to increase absorptive capacity for technology transfer; (consensus)
(4.3) [promote transfer of key health related technology] / [developing mechanisms to manage intellectual property] in a rational and health-oriented manner] in order to promote transfer of and access to key technologies [, including sharing of patent databases]
(a) examine the feasibility of [voluntary] patent pools of upstream and downstream technologies to promote innovation [and access to] health products and medical devices [for diseases [disproportionately] affecting developing countries]
(b) [consider [and if feasible develop]] additional [voluntary] effective, sustainable and complementary [or alternative] mechanisms [including appropriate patenting and licensing policies] to promote innovation of [and access to] products [of relevance to public health needs of developing countries]/[ for priority diseases in developing countries]/ [for diseases that disproportionately affect developing countries]] [, for instance, licensing guidelines and policies that promote humanitarian and access objectives.]
(c) [encourage appropriate patenting and licensing policies that maximize access to innovations for development of products of relevance to the public health needs of developing countries]
or
delete subparagraph (c) or move to element 5
v(5.1)
[(a)] [supporting information sharing and capacity building in the application and management of intellectual property with respect to health related innovation and the promotion of public health in developing countries]
or
[Encourage and support the application and management of intellectual property in a manner that maximizes health-related innovation, especially to meet the R&D needs of developing countries,]
(b) [promote and support national, regional institutional frameworks as well as international cooperation, to build and strengthen capacity to manage and apply intellectual property, in a manner oriented to public health needs and priorities of developing countries] (consensus pending decision by the USA)
(c) [to compile, maintain and update user friendly global databases on the status of health-related patents in all countries and facilitate widespread access to these databases, in particular by developing countries, [as well as]/[to] strengthen national capacities of analysis and the quality of patents.]
(d) stimulate collaboration among pertinent national institutions and relevant government departments, as well as between nationa , regional and international institutions, in order to promote information sharing relevant to public health needs. (consensus)
(e) [to strengthen education and training in the granting, application and management of intellectual property from a public health perspective including use of flexibilities contained in the TRIPS Agreement]
(f) [developing countries should be encouraged to develop Traditional Knowledge digital library]
or
[WHO to encourage Member States to use traditional knowledge digital libraries for their patent examination procedures in order to prevent misappropriation of traditional knowledge]
(g) [urge active and effective participation of health representatives in IP-related negotiations in order to ensure that the outcomes of such negotiations incorporate all the flexibilities important to address public health needs
(h) [establish measures to avoid unethical experiments involving human beings as a requirement for registration of medicines and technologies]
(i) [to create a Coordination Committee among WHO, WIPO and WTO for looking at solutions on the issue of public health and intellectual property]
vi (5.2) upon request, [WHO, in collaboration with WTO, to provide] / [providing] support for application of the flexibilities consistent with the Agreement on Trade-Related Aspects of Intellectual Property Rights
or
[Encouraging WHO to provide as appropriate, upon request, in collaboration with other competent international organizations, technical and policy support to countries that intend to make use of the flexibilities contained in the agreement on Trade-Related Aspects of Intellectual Property Rights and other international agreements in order to promote access to health products, and to implement the Doha Ministerial Declaration on the TRIPS Agreement and Public Health and other WTO instruments]
or
[Upon request, provide as appropriate, technical and policy support to countries that intend to make use of the flexibilities contained in the agreement on Trade-Related Aspects of Intellectual Property Rights and the Doha Ministerial Declaration on the TRIPS Agreement and Public Health, and other international agreements related to health;]
or
[Upon request as appropriate provide, in collaboration with other competent organizations support to developing countries that intent to make use of the flexibilities contained in the agreement on Trade-Related Aspects of Intellectual Property Rights]
(a) promote [[legislation] / [a legal framework] to apply] / [legislative and regulatory measures to incorporate] flexibilities consistent with the Agreement on Trade-Related Aspects of Intellectual Property Rights [, affirmed by the Doha Declaration on TRIPS and Public Health, and with] and other international agreements [related to health], [by means including the [use of compulsory licensing and] dissemination of best practices]
or
[consider, whenever necessary, adapting national legislation in order to use to the full the flexibilities contained in the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) WHA 56.27 paragraph 1 (2)] [upon request and in collaboration with appropriate organizations, encourage the use of flexibilities consistent with relevant international agreements, including through the dissemination of best practices]
or
[to consider, whenever necessary, adapting national legislation to apply flexibilities consistent with the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and other international agreements, by means including the dissemination of best practices in collaboration with WIPO]
(b) [WHO and WTO to] [promote]/ [discourage] bilateral trade agreements that do [not] incorporate “TRIPS-plus” protection in ways that might reduce access to [affordable] medicines in developing countries or [avoid the incorporation of TRIPS-plus measures in any trade agreements and in national legislation that may have negative impact on access to health products or treatments in developing countries]
or
delete subparagraph (b)
(c) [encourage][promote] trade agreements that take into account the flexibilities contained in the Agreement on Trade-Related Aspects of Intellectual Property Rights (as recognized by the Doha Declaration on the TRIPS Agreement and Public Health)[ and the WTO decision of 30 th August 2003].
and
[identify ways and means to fully implement the flexibilities contained in the TRIPS Agreement and the Doha Ministerial Declaration with a view to ensure access to medicines]
and
[recommend the participation of health authorities in intellectual property negotiations with a view to reaffirm all the flexibilities and safeguards related to public health and to prevent decisions that may negatively affect access]
and
[take necessary legislative steps in countries with manufacturing and export capacity to allow compulsory licensing with the aim of facilitating access to medicines consistent with the Agreement on Trade-Related Aspects of Intellectual Property Rights and the Doha Declaration on the TRIPS Agreement and Public Health]
and
[effectiveness of the WTO Decision on Implementation of Paragraph 6 of the Doha Declaration in relation to export to countries with insufficient or no manufacturing capacity should be kept under review and appropriate changes considered to achieve a workable solution, if necessary]
and
[request WHO to provide information to Members on all mechanisms and flexibilities in the TRIPS Agreement that can be used for the export of medicines manufactured without the permission to the patent owner, including the WTO Decision of 30 August 2003]
and
[take necessary legislative steps to allow compulsory licensing for export consistent with the Agreement on Trade-Related Aspects of Intellectual Property Rights and the Doha Declaration on the TRIPS Agreement and Public Health]
and
[WHO to formulate guidelines for operationalization of the mechanism provided in the annex of the proposed Article 31 bis of the Agreement on Trade-Related Aspect of Intellectual Property Rights]
and
[support incorporation of appropriate provisions in the TRIPS Agreement to prevent misappropriation of traditional knowledge]
vii (5.3) [exploring]/[examining and promoting [complementary]/[alternative] incentive schemes for research and development
(a) [explore]/[examine] and implement [complementary] / [alternative [and/or additional]] incentive schemes for research and development that separate the incentives for innovation from the prices of health-care products [for example, the prize fund model] / [including, but not limited to, the prize fund model] [, and that are consistent with domestic regimes for protecting intellectual property and rights]
or
[explore and implement complementary incentive schemes for research and development that address the linkage between the cost of research and development and price of health products]
or
(b) [expand]/[consider the use of] the advance-market commitment approach [if appropriate and affordable] based on a participatory approach]
(c) assess the impact of data-exclusivity [and data protection on access to medicines] regulations [in countries wherever it is provided]
or
[assess the impact of data-exclusivity regulations on access to drugs in developing countries, taking into account the incentive of such a protection for pharmaceutical companies to register new products on the relevant market.]
(d) [developing countries should adopt or effectively implement policies in order to prevent or correct anti-competitive practices related to the use of patents for health products, including the use of pro-competitive measures available under the intellectual property law]
[(e) examine [and devise] [mechanisms] /[measures] to comply with the requirements of the Agreement on Trade-Related Aspects of Intellectual Property Rights for the protection of undisclosed test data against unfair commercial use.]
[(f) consider measures to ensure the strict application of the patentability criteria in order to obtain the best interpretation for public health as stated in paragraph 4 of the Doha Declaration on TRIPS and public health]
[(g) avoid restrictions for the use of or reliance on undisclosed test data in ways that would exclude fair competition or impede the use of flexibilities built into TRIPS]
viii 38. International [and bilateral] agreements that may have an impact on access to health products in developing countries need to be regularly monitored with respect to their development and application. Any flexibilities in such agreements[, and the ones contained in the TRIPS agreement and reaffirmed in the Doha Declaration,] that would permit improved access need to be considered for action by national authorities in the light of the circumstances in their countries. The impact of such actions on innovation needs to be monitored.
ix(6.1) encourage increased investment in the health-delivery infrastructure and financing of health products in order to strengthen the health system (consensus)
(a) invest in developing health-delivery infrastructure and ensure financing of [essential] health products.
(b) develop effective and sustainable mechanisms in least-developed countries in order to improve access to existing medicines, making full use of the transitional period until 2016 [, if necessary]
(c) prioritize health care in national agendas (consensus)
(d) encourage national health authorities to improve national management capacities [in order] / [with a view] to [guarantee] / [improve] / [increase] delivery and access to medicines and other health products with quality, efficacy, safety and affordability [ and to develop strategies to promote rational use of medicines]
(e) increase investment in human resource development in the health sector (consensus)
(f) develop effective country poverty reduction strategies that contain clear health objectives (consensus)
[(g) encourage pooled procurement mechanisms in developing countries]
x(6.2) establishing and strengthening mechanisms to improve ethical review and regulate the quality, safety and efficacy of health products and medical devices (consensus))
(a) [develop and] strengthen [ [medicines] / [drugs] regulatory authority] capacity to monitor the quality, safety and efficacy of [priority] health products [and services], and [accelerate] / [prioritize] the regulatory approval of [strategic] [life-saving] products [with potential utility] [for national public health programs][while maintaining quality and respecting ethical review standards]
(b) [conduct]/ [promote] operational studies to maximize the [therapeutic] value and use of new[and existing] products [and treatments in health systems] [in high disease-burden settings with inadequate health services]
(c) [develop and] implement national and international disease-control policies [that are based on evidence that use of new and existing products has an impact]/ [that make use of innovative medicines based on scientific evidence of efficacy, safety and comparative costs with regard to therapeutical and economical advantages offered by existing products that are used rationally for such diseases]
(d) comply with good manufacturing practices for safety standards, efficacy and quality of health products (consensus)
[(e) strengthen the WHO pre-qualification programme]
(f) [develop legislation and strategy against] / [minimize] the public health consequences of counterfeit and [substandard] / [spurious] products.
[(g) initiate a programmed action with ultimate goal of harmonization of processes employed by the regulatory authorities for drug marketing approvals. Such harmonizations should take into account the following elements: • level of socio economic development
• essential and non-essential drugs
• conventional and break-through drugs
• drugs for the treatment of neglected diseases
• the “fair treatment” interpretation of TRIPS article 39.3
• clarification of the working relationship between the drug regulatory authorities and patent offices]
xi(6.3) promoting competition and ensuring that pricing of medicines is consistent with public health [policies]/needs]
(a) support the production and introduction of [generic versions of] essential medicines in developing countries, including [development of] /[review of] national legislation to encourage [generic entry [on patent expiry]] /[their entry] [and which is consistent with international obligations concerning the protection of intellectual property rights]
(b) frame policies emphasizing [developing countries availing] essential medicines [and treatments available in developed countries] at affordable prices
[(c) [remove]/[review] tariffs and taxes on health-care products [, where appropriate,] [, including raw materials,] and monitor their supply and distribution chain]
or
[recommend that countries evaluate the reduction of tariffs, taxes and other costs on health products as a means to decrease final prices and to increase access]
or
delete subparagraph (c)
[(d) [take necessary]/[facilitate]/[encourage] legislative steps in countries with manufacturing and export capacity to allow compulsory licensing for export consistent with the Agreement on Trade-Related Aspects of Intellectual Property Rights and the Doha Declaration on the TRIPS Agreement and Public Health]
(e) encourage pharmaceutical companies to adopt transparent [and,] consistent [and equitable] pricing policies[, aiming to reduce prices for developing countries] [that increase access to quality, safe and affordable medicines by developing countries]
(f) [monitor pricing policies and](Rio suggest deletion) [stimulate the development of policies to monitor pricing by developing countries, to reduce costs and] strengthen WHO's work on pharmaceutical pricing.
and
[(g) utilize the flexibilities inscribed in the TRIPS Agreement especially on parallel importation (exhaustion of rights) and research exemption
(h) exploit expired or invalid patents to introduce generics in the market]
(i) promote use of generics in the developing countries]
or
[(g) reinforce and encourage the use of the Bolar Exception to stimulate entry into market of generics as soon as the patent expires.
(h) stimulate the immediate entry of generic products into the market, supported by the WHO and other UN bodies.
(i) develop specific measures to enable fast and efficient entry of generic medicines particularly in developing countries.
(j) support regional fora to strengthen the regulation and implementation of clinical trials using appropriate standards for medicines approval concerning diseases that affect developing countries.
(k) strengthen the endeavours of the WHO´s assurance programme, in particular the WHO prequalification programme, and promote its effectiveness in assessing the safety, quality and efficacy of public health products.]
or
[(g) 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 measures that favour competition available under intellectual property law]
xii[6.4 Increase awareness among users, doctors and pharmacists regarding generic products]
xiii [(7.3) Setting up a global R&D fund to address the identified R&D gaps in Type II and Type III diseases and the needs of developing countries in relation to Type I diseases. (a) of this fund, money will be earmarked and provided for research in the form of grants for R&D for these diseases in advance, as well as prize/rewards for path-breaking research after it is accomplished.
(b) of this fund, money will be earmarked and provided to buy out patents to ensure that health products are made available at affordable prices in developing countries.
(c) financing for this fund will come from contributions by countries, donors, industry and taxing of international financial transactions as agreed to by Member States.
(d) an operational mechanism will be set up for this fund as agreed to by Member States.]
or
delete proposed 7.3
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