# \[e-drug\] Dr. Thomas Novotny's response regarding WHA Executive Board meeting **URL:** \ **Category:** e-drug\ **Created:** [January 30, 2000, 9:21pm UTC](https://talk.edrugplus.org/t/e-drug-dr-thomas-novotnys-response-regarding-wha-executive-board-meeting/7199 "2000-01-30T21:21:36Z")\ **Posts on this page:** 1\ **Page:** 1
**Author:** ![Dr\_Thomas\_Novotny](https://avatars.discourse-cdn.com/v4/letter/d/51bf81/32.png) [@Dr\_Thomas\_Novotny](https://talk.edrugplus.org/u/Dr_Thomas_Novotny)\ **Post date:** [January 30, 2000, 9:21pm UTC](https://talk.edrugplus.org/t/e-drug-dr-thomas-novotnys-response-regarding-wha-executive-board-meeting/7199/1 "2000-01-30T21:21:36Z")
E-DRUG: Dr. Thomas Novotny's response regarding WHA Executive Board meeting --------------------------------------------------------------------------- [We distributed an earlier Pharm-Policy message about the WHA debate; as this replies to our earlier E-drug message, I am circulating also Dr Novotny's response and Jamie Love's 2nd response below. For further discussion, please see Pharm-Policy at: [http://lists.essential.org/mailman/listinfo/pharm-policy](http://lists.essential.org/mailman/listinfo/pharm-policy) WB] I feel that I need to clarify a few things noted in your recent email traffic (Jan 27) that without clarification might constitute misrepresentation. I am the head of the US Delegate to the WHO Executive Board, and I led a five-person delegation, including Stuart Nightingale, to the ongoing meeting of the Board. In preparation for this meeting, the USG had developed carefully worded interventions in response to the WHO paper on HIV/AIDS. These interventions were vetted around DHHS and other agencies, but our corrections to the WHO draft resolution are subject to a fairly intense consensus process based on vigorous, straightforward exchange with our fellow board members. Although I, as the head of delegation, encouraged the other members of my team to get input from all interested parties, including NGOS and pharmaceutical representatives, I had no contact with any of these groups outside of the meeting I attended with USTR and the invited NGOS earlier this month. 1. You stated that the Clinton/Gore administration "is apparently working with the International Federation of Pharmaceutical Manufacturers, etc." to remove language from the resolution that you described as "similar to the language that passed the World Health Assembly in 1999."    This is completely erroneous on two counts: 1) we are not working with anyone but the USG to contribute to the drafting of the resolutions; this is what we get paid for, and as stated above, our contributions are based on cleared language from the Department and other agencies. 2) We fought hard (and succeeded) to get IDENTICAL language to the Revised Drug Strategy that was the product of intense negotiations at the last World Health Assembly. This language is now included in preamble of the resolution and later with wording that replaces the flawed clause 2(7) that you quoted in your email. The language was agreed on by consensus among a drafting group that included African nations, India, European countries, and Chile, among others. I think there was little dissention to the following language (which we insisted recall the Revised Drug Strategy). In preamble: "Recalling resolution WHA52.19 as approved by the 52nd World Health Assembly, which inter alia requests the Director-General to cooperate with Member States at their request, and with international organizations in monitoring and analysing the pharmaceutical and public health implications of relevant international agreements, including trade agreements, so that Member States can effectively assess and subsequently develop pharmaceutical and health policies and regulatory measures that address their concerns and priorities, and are able to maximize the positive and mitigate the negative impact of those agreements;" As for removing the IPR-related language, we opposed this because it went beyond what was agreed to in the Revised Drug Strategy; following is Clause 2(12) replacing 2(7): TO COOPERATE WITH GOVERNMENTS AT THEIR REQUEST AND OTHER INTERNATIONAL ORGANIZATIONS REGARDING POSSIBLE OPTIONS UNDER RELEVANT INTERNATIONAL AGREEMENTS, INCLUDING TRADE AGREEMENTS TO IMPROVE ACCESS TO HIV/AIDS-RELATED DRUGS; We believe this covers WHO responsibilities and opportunities to work with WTO and WIPO on trade agreements to improve access to drugs (just as USDHHS now cooperates with USTR to insure the flexibility of US Trade Policy in health crises). 2. You suggested that we were trying to include language from the IPFMA. That is completely wrong. The language we support is based on our conversations with the WHO Secretariat and which was also published as a result of the first IPFMA-WHO Roundtable on Pharmaceuticals. I believe this product is a result of the pursuit of "dialogue with the pharmaceutical industry" referred to above. WHO agreed to it, and we think it makes perfect sense. We developed as new clause 2(9): "to pursue dialogue with the pharmaceutical industry with a view to making HIV/AIDS-related drugs increasingly accessible to Member States and their populations through drug development, cost reduction, and strengthening reliable distribution;" and new clause 2(10): "to reinforce, promote, and explore partnerships in order to make HIV/AIDS-related drugs accessible through affordable prices, adequate financing, and effective health-care systems, and to ensure that drugs are safely and effectively used;" We believe this wording represents a comprehensive approach to drug accessibility and care. I believe that the EB will think so too, as we have had frank, open, and productive discussions to reach agreement. I think that what we have said here is perfectly consistent with what the VP spoke about at the UN Security Council; what it does not do, and we feel strongly that it must not do, is refer solely to price as the answer to accessibility. Please feel free to let me know how "drug development, cost reduction, and strengthening reliable distribution" or "affordable prices, adequate financing, and effective health-care systems" do not lead to improved accessibility. Again, we worked hard not to let only the price issue drive accessibility concerns. To limit accessibility concerns only to price would be terribly mistaken. Your position on this is far to narrow. Price reduction is only one tool to improve access. Drugs could be free and still not be effective without effective health care systems. In fact, they would rapidly become ineffective. Finally, you must now realize the dialogue that continues between DHHS and USTR is already showing results. Today, USTR released a paper in which they stated, "If the Thai government determines that issuing a compulsory license is required to address its health care crisis, the United States will raise no objection, provided the compulsory license is issued in a manner fully consistent with the WTO Agreement on Trade Related Aspects of Intellectual Property RIghts (TRIPS)." We are still working on the details of our collaboration, and during my visits here to WHO and UNAIDS, we obtained important input on just how we might work with USTR to follow through on the President's directives. We still need more time to work this out, but we consider it a major priority for our Global Health Strategy on HIV/AIDS. On a personal note, Jamie, this is the second time you have disseminated factually incorrect information around the world regarding our work with USTR, and now about our work with the WHO Executive Board. This only damages our relationship with the NGOS and undermines our work with WHO. I am sure that is not your objective, and I hope you will try harder to represent our actions with more balance and accuracy. Thomas Novotny Email: TNovotny@OSOPHS.DHHS.GOV ------ 2nd Response by Jamie Love: I appreciate Dr. Thomas Novotny's willingness to provide information about the US government's positions at the WHO Executive Board (EB) meetings in Geneva this week, and welcome a continued dialogue on these matters, so that US policy is truly transparent. One can draw different conclusions as to how and why US policy evolved as it did over the past week in Geneva and at USTR, and I will not address these issues in detail in this note. I remain somewhat puzzled over the US government (USG) policy with respect to the WHO and trade policy, including trade policy as it relates to intellectual property rights on pharmaceuticals. I would appreciate a clarification from Dr. Novotny on a few points. And since Dr. Novotny is concerned about the US government position being misrepresented, I would encourage him to respond directly, once again. Several persons in Geneva have reported that Dr. Novotny expressed opposition to the WHO playing a role in policy making on intellectual property right (IPR) issues, and Dr. Novotny acknowledges that the USG did ask that the EB remove the following language from the original EB AIDS resolution:           The Executive Board . . . REQUESTS the           Director-General:         7) on their request, to advise governments         on their options under the Agreement on         Trade-Related Aspects of Intellectual Property         Rights (TRIPS) to increase their capacity to         negotiate for more affordable HIV/AIDS-related         drugs; According to Dr. Novotny, "we [the USG] opposed this because it went beyond what was agreed to in the Revised Drug Strategy." I would point out that "going beyond" the RDS isn't bad, from our point of view, and in any case, it is a stretch to say this is "going beyond." It looks to me like an effort to implement the RDS, and to give some plain language support for WHO doing something useful on IPR issues. In any event, the language Dr. Novotny did not like was later replaced, by the EB, which this language:      To cooperate with governments at their request and      other international organizations regarding possible      options under relevant international agreements,      including trade agreements to improve access to      HIV/AIDS-related drugs; Dr. Novotny says: "We believe this covers WHO responsibilities and opportunities to work with WTO and WIPO on trade agreements to improve access to drugs (just as USDHHS now cooperates with USTR to insure the flexibility of US Trade Policy in health crises)." Which is true, but it is certainly less specific with regarding the IPR than was the language it replaced. I had predicted earlier and Dr. Novotny points out now, language was added to make reference to the RDS. However, again the words intellectual property rights don't appear in the AIDS resolution. The new "sanitized" version of the AIDS resolution doesn't mention patents or intellectual property rights anywhere anymore, as if this isn't a matter of controversy the should be addressed by the WHO. Dr. Novotny's interventions as to how WIPO and the WTO should be the lead players on this issue, and his efforts to remove reference to intellectual property rights from the document, have given us a new more industry friendly resolution. Dr. Novotny also takes credit for inserting more of the familiar "industry partnership" language into the resolution, specifically on the issue of pricing problems. So, while Vice President Gore on the campaign trail is concerned about price gouging by the drug companies, WHO is to told to "reinforce, promote, and explore partnerships" with the drug companies, to make drugs more affordable. Addressing a red herring, Dr. Novotny says "what it [the AIDS resolution] does not do, and we feel strongly that it must not do, is refer solely to price as the answer to accessibility." To drive the point home and make it personal, Dr. Novotny says:                                          "Again, we worked hard not to let only the price issue      drive accessibility concerns. To limit accessibility      concerns only to price would be terribly mistaken.      Your position on this is far too narrow. Price      reduction is only one tool to improve access. Drugs      could be free and still not be effective without      effective health care systems. In fact, they would      rapidly become ineffective." Now I don't recall ever saying that accessibility concerns are limited to issues of price, and I don't know any serious people who would say this. Perhaps Dr. Novotny will issue a similar statement lambasting those who advocate investments infrastructuring saying:      "Again, we worked hard not to let only the      infrastructure issue drive accessibility concerns. To      limit accessibility concerns only to infrastructure      would be terribly mistaken. Your position on this is      far to narrow. Infrastructure investment is only one      tool to improve access. The infrastructure could be      world class, and if drugs were unaffordable, people      would still die." Of course, it would be a taboo for a public health official to issue such a statement, because it would undermine funding for health care infrastructure, which we all agree is important. And more importantly, it should be obvious to most people that both issues (and many others) are important. Of course, intellectual property issues are more controversial than spending on public health professionals. This is because the drug companies care about this issue a lot. Dr. Novotny then says:      Finally, you must now realize the dialogue that      continues between DHHS and USTR is already showing      results. Today, USTR released a paper in which they      stated, "If the Thai government determines that issuing      a compulsory license is required to address its health      care crisis, the United States will raise no objection,      provided the compulsory license is issued in a manner      fully consistent with the WTO Agreement on Trade      Related Aspects of Intellectual Rigths (TRIPS)." Now, with all due respect to Dr. Novotny, I find it amazing that he would pick this example, because as far as I know (and I know a lot on this one), DHHS had nothing to do with the USTR/Thailand letter. The NGO lobbying on this issue could not have been more intense, and no one was talking with (or about) DHHS at all. I wouldn't mind Dr. Novotny claiming credit for future Act UP!, MSF, CPT campaign efforts, if he plays a role of some type, and we look forward to the day when he does. Here are questions for Dr. Novotny: 1. Will the US government support or oppose WHO playing an      active and indeed a pro-active role providing poor countries      with information on IPR disputes as they related to trade      policy and public health? 2. Would you oppose or not oppose the publication of a paper by      the WHO that would call for "fast track" compulsory      licensing of essential medicines in poor countries? 3. Will DHHS intervene with USTR on the dispute over the      Dominican Republic's proposed patent law, which includes      fast track compulsory licensing? 4. Will you support or oppose our request that the USTR provide      a communication to the WTO on the issue of patent exceptions      (under Article 30) for production for export? (Needed for      poor countries to benefit from compulsory licensing.)      PUBLIC CONSULTATION I would also like to comment on consultation with the public. When Dr. Novotny met with about a dozen HIV/AIDS, public health and consumer groups on January 12, to discuss trade policy as it relates to IPR and pharmacueticals, he never mentioned that the USG had a problem with the December 22, 1999 draft of the WHO AIDS resolution. None of the many groups that I work with was given a heads up that the US would ask that the language on intellectual property rights be removed. I think it should be clear that it is possible to consult with interested parties in advance, and it should be obvious who the interested parties are. As Dr. Novotny notes, the USG solicited input from pharmaceutical companies. My advice is pick upon the phone and raise these issues before, to see how it is going to be received by consumer interests and public health groups (including ones not funded by drug companies).      Final comments      We are facing a big crisis in access to medicines, and the issues will become even more explosive with the next generation of medicines, which should include products that will be better for use in developing countries. (For example, from a compliance point of view, or products that actually cure conditions).      We want our government, the USG, to be strong for the poor. We want the USG to say things in international forums that make us proud.      For decades, the USG has been strong for the rich and powerful. In the WHO, the USG has a well deserved reputation for being very strong for the drug companies. We want to see a change. The drug companies have plenty of power already. They don't need our government to act as their guardian angel or global apologist.      There are many good points you can make for the drug companies. You can repeat the IFPMA talking points endlessly, including the ones that even we would agree with. You can talk about the virtues of protecting intellectual property, the need to develop new medicines, and you can explain how it isn't all their fault. And even after you remove all the exaggeration and eliminate patently false claims, they will still have some good points. We recognize this as well as anyone. And by repeating these points endlessly, you will make them even stronger.      But there are another set of talking points that are not on the IFPMA web page. The IFPMA doesn't point out that compulsory licensing is part of the TRIPS, or that it permits governments rather than companies to determine how much money the poor should pay for patents. The IFPMA has its favorite parts of the TRIPS, but it leaves out the parts that give rights to the poor. The IFPMA doesn't provide accurate information about the costs of drug development or the role of taxpayer supported research in the development of essential medicines. The IFPMA doesn't discuss the high pricing of government funded pharmacuetical inventions.      The IFPMA doesn't talk about the pricing of fluconazole, and how this medication can help AIDS patients right now, for a tiny fraction of the Pfizer price. The IFPMA doesn't talk about how the industry uses the legal system to block the introduction of generic drugs, or how costly and difficult it is for poor countries to litigate against the best law firms in world. The IFPMA doesn't talk about how it can get patents in developing countries that would not pass the examination process in the USA. The IFPMA doesn't talk about the importance of domestic industries in providing generic competition. The IFPMA doesn't talk about abuses of the US orphan drug marketing exclusivity, the abuses of health registration data exclusivity, or the countless other regulatory barriers they lobby for.      There are lots of things the IFPMA doesn't talk about. So by using your position to advance the IFPMA agenda, you leave out other agendas, and other talking points. The world for the poor is the same world for the rich, but it is perceived differently. Try to see things from the point of view of the poor. Make the poor more powerful. This is what we are asking.    Jamie Love \ -- James Love, Consumer Project on Technology P.O. Box 19367 | [http://www.cptech.org](http://www.cptech.org) Washington, DC 20036 | [mailto:love@cptech.org](mailto:love@cptech.org) Voice 1.202.387.8030 | fax 1.202.387.8030