WHO Members Agree On Need To Improve IP And Public Health Process 30/01/2007 by Tove Iren S. Gerhardsen for Intellectual Property Watch 1 Comment Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to email this to a friend (Opens in new window)Click to print (Opens in new window)By Tove Iren S. Gerhardsen At last week’s meeting of the World Health Organization (WHO) Executive Board, member states expressed dismay with the process of a public health and intellectual property working group and agreed that the spirit they set out with had to be re-found. WHO responded that activities will be stepped up before the next meeting of the group, laying out the next steps including a possible public hearing in late summer. The WHO Intergovernmental Working Group On Public Health, Innovation and Intellectual Property (IGWG) was discussed on 26 January as part of the 22-30 January meeting of the 34-member Executive Board. The IGWG met for the first time on 4-8 December 2006, and its mandate is to boost research and development (R&D) into neglected diseases through a voluntary plan that is to be ready by May 2008. During the meeting, a Brazilian official said that the agreement (resolution WHA59.24), on which the working group is based, had been reached “in the spirit of Geneva,” at the World Health Assembly in May 2006, but unfortunately this was not the case for the first meeting in December (IPW, Public Health, 11 December 2006). The Executive Board meeting was supposed to note a progress report on the working group and forward it to the May World Health Assembly. But the issue of intellectual property, innovation and public health became one of the most talked-about items on the board’s agenda. Proposal Prompts Debate; WHO Lays Out Working Group Roadmap Debate was prompted by a proposed draft resolution on immediate action points for the global plan, submitted by Kenya and Switzerland on the first day of the meeting. In the words of Kenya, “informal and very intensive consultations” on the proposal and the IGWG took place throughout the week. The proposal (EB120/Con.Paper No.3) suggested early implementation issues related to the global plan, which could be started immediately and run until May 2008. While two proposed issues were directed to member states, 10 targeted WHO, such as to help developing countries strengthen programmes for health research (IPW, Public Health, 23 January 2007). Kenya and Switzerland did not formally table the proposal after all. Kenya asked to postpone the proposed resolution as informal “consensus has gradually emerged” that it was premature to discuss this resolution at this point. Countries opposing discussion of the resolution argued that time should be spent discussing the process of the IGWG, rather than the technical language of the resolution. But the debate on the process of the IGWG prompted by the proposal during the week, continued. A number of countries argued that the process had to be strengthened and the preparatory process before the next meeting, scheduled for October 2007, improved. Several countries, including Brazil, Kenya, and the United States criticised the December working group, with one delegation arguing it left a negative spirit that needs to be overcome. Kenya said that those who attended the December meeting were “not very happy with the process.” Kenya said the process should move faster, and pointed out that the goal of creating a plan of putting more resources into R&D for neglected diseases was of paramount importance to Africa. “Nothing has changed at all,” a Kenyan official told Intellectual Property Watch. “There was consensus that the speed has not been optimum and there was [a] need to improve the same. The bureau will address this and [the WHO] secretariat will do its part to ensure that IGWG2 [October 2007 meeting] is a success.” WHO Sets Path Forward After member states discussed the IGWG, WHO’s Howard Zucker read out a proposal for the next steps for the group and the process (EB1200/INF.DOC./5). Zucker, assistant director-general for health technology and pharmaceuticals, is in charge of the group together with the “bureau” or officers of the group consisting of Chair Peter Oldham of Canada and five vice-chairs. The plan calls for further comments from governments, formation of a pool of experts and concerned entities, and additional consultations and meetings. A progress report on the December meeting was issued on 25 January, following a 15 January letter asking member states for additional inputs on a global strategy and plan of action, as well as suggestions relating to the pool of experts, by the end of February 2007, according to the document. The inputs and suggestions will be incorporated into a revised working document, which will be available to member states for review in July 2007, according to the document. “The intention is to provide all views from the different players in the documents from [the WHO] secretariat,” the Kenyan official said. Based on the proposals from member states, the WHO director general and the working group officers will “identify a pool of experts and concerned entities, ensuring a balanced representation between regions, developing and developed countries, and female and male experts,” the document said. For August and September, two proposals were made: To hold regional consultations on the working group, with the support of WHO regional offices (there are six of them), and possibly, with the opportunity for identified experts to participate, as well as hold a second Internet-based public hearing (the first was on 1-15 November 2006 (IPW, Public Health, 27 October 2006). In the run-up to the October meeting, the paper said, the officers of the working group “will continue to meet as necessary to consider other possible intersessional work and detailed arrangements for the second session.” WHO also would continue its work on implementing recommendations from the Commission on Intellectual Property Rights, Innovation and Public Health, the paper said. Thailand Proposal An informed source told Intellectual Property Watch that at the meeting, Thailand orally proposed to ask for the Executive Board’s decision to request the WHO secretariat “at all levels to pro-actively support the implementation of WHA59.24.” This would mean that the secretariat should provide, according to “the proposed text on the decision” (presented orally by Thailand): “Support to member states for their contributions to the content and processes in the drafting of the global strategy and plan of action, by mid-March; a summary, synthesis and elaboration of relevant documentations by end June 2007; support to member state contributions in the finalisation of the global strategy and plan of actions as a major input for the second meeting of the inter-governmental working group, through the regional mechanisms and intensive consultations.” “The text was not officially circulated as there was not enough time for a translation into all six official languages,” the source said. Although Thailand, in consultation with several member states, wanted the Executive Board to take a decision on this, the source said, “WHO said the proposals were already incorporated in the work of the secretariat, and in the end, it [did] not appear as the board’s decision as suggested.” However, the WHO director general “somehow promised,” the source said, that the proposals would indeed be part of the work of the WHO secretariat. During the meeting, the United States said it wanted to the see the Thai proposal in writing, and asked for guidance on what role the Executive Board had on the IGWG, and whether it would be able to take concrete actions. The WHO legal counsel said that the Executive Board was supposed to report on progress made in the IGWG to the May World Health Assembly, and it was entitled to discuss this report, if it saw it fit. It would be problematic if the board tried to change the process of the IGWG, the counsel said, but a recommendation to the WHO secretariat, such as that made by Thailand, would be within the authority of the board. WHO said Thailand’s statement could be provided in writing but first had to be translated into the six official languages of the United Nations. This was not done, however, leading to apparent ambiguity about the proposal’s status after the meeting, sources said. Thailand also said WHO had published a report identifying member countries’ proposed parts of the global plan that could be implemented immediately (which have not been agreed to), but the way forward on this was not clear. Thailand said that there had been “no single message” from the IGWG or the WHO secretariat about the need for submissions by February 2007, and only member states attending the December (some 100 out of more than 190 WHO member states) meeting knew about this. Thailand said official submissions would help the IGWG to move forward. Dismay with the Process Countries appeared to generally agree that the December meeting had not been very useful and the process had to be improved if the group were to meet its May 2008 deadline for the global strategy and plan of action. The United States said it shared the concern that the outcome of the December meeting was not as ambitious as anticipated and expected. The US emphasised that a strong preparatory process was needed before the next meeting in October. Portugal, on behalf of the European Union (EU), said the December meeting needs a timely and substantial follow up, and it hoped many member countries would submit their views. The official requested a matrix from the WHO secretariat on ongoing activities related to the plan and gaps, as well as proposals to key stakeholders and financial implications. A number of countries indicated their support for the IGWG, including Portugal, which will take over the European Union presidency after Germany (and which also called for a “full preparatory process”), and WHO Director General Margaret Chan. Tove Iren S. Gerhardsen may be reached at tgerhardsen@ip-watch.ch. Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to email this to a friend (Opens in new window)Click to print (Opens in new window) Related "WHO Members Agree On Need To Improve IP And Public Health Process" by Intellectual Property Watch is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.
Murray Skolsky says 31/01/2007 at 2:52 pm There is a hidden agenda in Thailand. In unilaterally pushing though hasty and ill-conceived polices on stripping drugs firms’ patent assets, the Thai Ministry of Public Health knows it has nothing to fear, the Minister is not accountable to anyone, not the media, not the electorate (in an unelected military installed regime), not even the other Ministries, particularly Commerce and Foreign Affairs, who are cringing at the public pronouncements of this Ministry. The “Ginger” Ministers know they can impose their will on the agenda, even a radical agenda, while they are in power for but a short time, and then the attitude is, let the next elected government clean up the mess. Respectfully, in stripping the assets of foreign drugs firms, it is naive to believe the Thai MoPH is acting solely out of concern for patients, although I do not doubt that is part of the decision matrix. If one examines Thailand’s fractional allocation of budgetary resources for healthcare spending, compared to Thailand’s relatively strong GDP, export performance and current account surplus, the conclusion that Thailand simply does not spend enough to care for her people is inescapable. There is no fiscal crisis in Thailand. The military installed government only a few months ago hiked defense spending after assuming power by a double digit percentage. What threat justified that hike – the threat of an invasion by Singapore? Look at all the money being thrown away with the mega projects. Thailand is not a poor country. It is a country with poor policies and a widening wealth/health gap, but it is not a poor country. At a macro level, there is simply no compelling economic reason to take these steps to save, at most, several tens of millions dollars (the Thai pharmaceutical sector is valued roughly at less than US$1.7 billion) when the consequence of such anti-IP (and radically imposed unilateral) policies in terms of investor sentiment and foreign direct investment will surely damage the overall economy, which is in fragile enough condition as it is. The cost-benefit analysis weighs heavily against such moves. The anti-IP policies announced by the MoPH also seem to the average Thai to come at a strange time, just announced on the same day His Majesty was awarded the first Global Leader Award for His Majesty’s patents and modern, progressive pro-IP policies and initiatives. How one reconciles the MoPH stance on IP with the World Intellectual Property Organization (WIPO) award to His Majesty would seem to be an interesting challenge. The country has spent billions on black hole projects like the cobra swamp airport and these enormous glamorus shopping malls, where none of the goods on sale are affordable to the average Thai. If funds are so desperately needed for the welfare of Thai patients, why then do these white elephant projects continue to be championed within the government? And it is naive to believe the international trade ministers will not react, especially to a precipitous and ill-conceived plan to target disease classes outside of the HIV space. There is no doubt that these polices are in violation of TRIPS standards, which even under Doha flexibilities, require that the CL provisions are interpreted in good faith, without regard to industrial and commercial concerns, according to Dr Carlos Perez del Castillo, the then-chair of the Doha round leading to the so-called Doha declaration. A separate statement by General Council chairperson Dr del Castillo, Uruguay ’s ambassador, was designed to provide comfort to those who feared that the decision might be abused and undermine patent protection. The statement (see link below) describes members’ “shared understanding” on how the decision is interpreted and implemented. It says the decision will be used in good faith in order to deal with public health problems and not for industrial or commercial policy objectives, and that issues such as preventing the medicines getting into the wrong hands are important. http://www.wto.org/english/tratop_e/trips_e/tripfq_e.htm#CompulsoryLicensing What reaction do you think the IP economies will have? To give up patents on medicines? That’s just not realistic. The risk here, sadly, is that these moves by Thailand will damage the CL movement globally, when CL may actually be needed by the least developed economies in Africa, because the policy will trigger an international move to tighten, not to relax, but to tighten the TRIPS/DOHA rules on CL at the WTO level. As such the activists may win the battle in Thailand and lose the war globally. This is an ill-conceived strategy and frankly, irresponsible. The international reaction will not be confined to the narrow issue of CL but will be expanded to draw in issues of Thai rice and shrimp exports, and for every dollar saved in medicine prices, Thai exporters will lose vast multiples in lost exports to their largest export markets. It is a good thing under your plan that medicines will be free in Thailand since Thai people will not have any money left to spend on the medicines anyway. Why do you think international trade ministers are so interested in Vietnam, a country which stands to benefit from Thailand’s losses since it exports essentially the same products to the US as Thailand? The question the Bangkok Post and other media professionals should be examining is the motivation for MoPH to make this move. The primary motive, while cloaked in the altruistic agenda of providing more poor patients with important medicines, is purely commercial and nationalist/protectionist. The MoPH is simply using the convenient pretext of CL to nationalize foreign property rights and assets (in this case, patents) and hand the assets over to its Government Pharmaceutical Organization [nb to readers, GPO is controlled by MoPH, a conflict of interest if ever there was one]. The GPO stands to earn billions in profit from production of the formerly patented drugs, as it has no R&D cost, no marketing costs and essentially operates as a monopoly. In a monopoly, prices don’t go down, do they? GPO plans not only to supply the domestic market, but also to export. It operates for profit, it is a pure commercial/industrial concern, controlled by figures who are immune to public opinion and the rule of law. And the prices the Post should be focusing on should not be ex factory prices. In Thailand, between the time a drug is made available by an originator until the time the drug is dispensed to the patient, there are so many middlemen involved in the process, each marking up the price, and so much corruption in the process (it should not be surprising to learn that government owned hospitals, which make up the lion’s share of the Thai market for pharmaceuticals, actively solicit tea money payments to “influence” the purchasing decision when it comes to purchase of medicines) that the net effect on price at dispensation will be marginal if anything. My bet is that at the patient level, the savings are marginal. The practical effect will simply be to move profit from the books of several multi-national companies (who actually put the profit to good use in R&D and philanthropy) to the books of the GPO (where it does not take a lot of imagination where the profits will go). Why is there no call for GPO to become a non-profit and use any surplus generated by sales to fund infrastructure improvements? If lack of funding is really the issue, why does the MoPH not levy a heavy tax on socially irresponsible and problematic industries such as the commercial sex industry, an enormously profitable business. Raising funds from taxing such an activity will (a) provide more than enough funding for universal coverage in Thailand, and (b) will tend to drive out undesirable foreigners who are in Thailand merely to exploit Thai women and children, while at the same time (c) tending to reduce the potential for further HIV transmission arising from the largely unregulated sex industry, killing several birds with one stone. Thai pharmaceutical companies are just now waking up to the fact that they too have been duped by the altruistic agenda. They had believed that they would be able to produce and sell drugs under CL, but now they see the only beneficiary of the MoPH policy is GPO. TPMA will be largely shut out. One also is naive if one thinks that GPO produced drugs will be dispensed to patients within the framework of any sound healthcare policy. There is not enough infrastructure, not enough physicians and not enough supervision to assure that patients will take the medicines as prescribed. This will lead to resistance inevitably, and worse. Worth noting also is Thailand’s very real role as a trans-shipment hub in the global distribution of counterfeit medicines. No matter how one defines counterfeits, the availability of cheap drugs produced in or imported into Thailand will not be adequately regulated by the Thai FDA, and this is not because the FDA does not care, the FDA simply doesn’t have the resources to pro-actively monitor and police the market. One can find counterfeit medicines at points of sale very easily already in Thailand. Although by law, drug stores and pharmacies are supposed not to be able to sell medicines without a physician prescription, in practice drugs like Valium, Xanax, Reductyl, Viagra, Cialis, Dormicum, Codeine, Propecia, Proscar, Tenormin, Lipitor, etc., are all sold openly over the counter with a minimum of professional advice on how to take the medicine, contra-indications, allergies, etc. WHO estimates that fully 10 % of all medicines in circulation are counterfeit, with the penetration of counterfeits in SE Asia markets higher by a staggering degree. There are only a handful (5-10) of FDA led prosecutions of counterfeit medicine suppliers in Thailand each year. The unregulated presence of a new low cost supply of medicines in Thailand will create opportunities for enormous profits by traffickers in the black and grey markets. The traffickers are already here. The networks are already vigorous and immune to law enforcement. Handing them an opportunity like this to supply the black market is simply irresponsible And is the Ministry pro-patient? Why then is MoPH pursuing a policy that will call for immunity for physicians from malpractice and product liability tort suits? Why has the Ministry recently approved a measure that allows physicians to decline treatment of patients in cases deemed non-emergent? Pro-patient? I think not.. My wife’s family and our Thai-born son live in the upcountry (as do 55 million other rural poor Thais) and I am witness to the inability to receive timely and professional treatment at the village level. Go to the clinic after having been poisoned by an unregulated pesticide doled out to farmers? You are told you have gas, given a plastic baggie of placebos, and sent home. For any person with serious medical conditions, the choice is to travel to Bangkok and find a way to pay a relatively expensive city hospital or resort to traditional knowledge, which in the case of the rural poor, is more closely related to the practice of magic than the practice of medicine. The government should concentrate on moving toward the goal of establishing an elected democracy with a world-class constitution as quickly as possible, and stop taking precipitous, unexplained and unilateral actions which are damaging the Kingdom’s prestige and standing on the global stage. Respectfully MS, a very concerned resident Reply