<div dir="ltr"><div class="gmail_default" style="font-size:large"><br></div><br><div class="gmail_quote"><div dir="ltr" class="gmail_attr">From: <b class="gmail_sendername" dir="auto">David G Legge</b> <span dir="auto"><<a href="mailto:dlegge@phmovement.org">dlegge@phmovement.org</a>></span><br></div></div><div class="gmail_quote"><br></div><div class="gmail_quote"><br><u></u>
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<h1 style="text-align:center;display:block;margin:0;padding:0;color:#202020;font-family:Helvetica;font-size:26px;font-style:normal;font-weight:bold;line-height:125%;letter-spacing:normal">WHO adopts Roadmap on access to medicines and resolves to promote market transparency</h1>
<p style="margin:10px 0;padding:0;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left">The price of medicines is a major barrier to achieving universal health cover. The underlying contradiction, between access to medicines and pharma profit, was on display at the Seventy Second World Health Assembly in May 2019 (WHA72).</p>
<p style="margin:10px 0;padding:0;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left">The interplay of policy logic and political power was enacted in three major debates:</p>
<ul>
<li>The Roadmap debate (agenda item 11.7) highlighted the role of intellectual property (IP) protection in keeping prices high and the significance of the research and development (R&D) expenditure argument in defending this regime;</li>
<li>The Transparency debate (also agenda item 11.7) highlighted the significance of secrecy in keeping prices high (for some) and the critical importance, for pharma, of keeping secret the real costs of R&D;</li>
<li>The Substandard &/or Falsified (S/F) debate (agenda item 12.2) highlighted conflicts over regulatory purpose and role of scaremongering (over substandard &/or not-approved &/or falsified) in protecting originator drugs from generic competition.</li>
</ul>
<h2 style="display:block;margin:0;padding:0;color:#202020;font-family:Helvetica;font-size:22px;font-style:normal;font-weight:bold;line-height:125%;letter-spacing:normal;text-align:left">The Roadmap</h2>
<p style="margin:10px 0;padding:0;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left">In May 2017 the WHA asked the WHO Secretariat to prepare a Roadmap outlining the programming of WHO’s work on access to medicines and vaccines for 2019−2023 to be submitted to WHA72 in May 2019.</p>
<p style="margin:10px 0;padding:0;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left">The proposed Roadmap arose out of a serious tension among member states in 2017 over the report of the high level panel (HLP) appointed by the UN Secretary General (and hosted by the UN Development Program, UNDP) to advise on access to medicines. The HLP (appointed in 2015) was a flow on from the work of the <a href="https://phmovement.us20.list-manage.com/track/click?u=559d715f58f654accf3de987e&id=dc28d8ab7c&e=916df65fd1" style="color:#007c89;font-weight:normal;text-decoration:underline" target="_blank">Global Commission on HIV and the Law</a> (2010-2012) which was convened by UNDP on behalf of UNAIDS. Several of the commissioners also served on the HLP. The report of the HLP (September 2016) provided a broad sweep of recommendations (see <a href="https://phmovement.us20.list-manage.com/track/click?u=559d715f58f654accf3de987e&id=145f3dc914&e=916df65fd1" style="color:#007c89;font-weight:normal;text-decoration:underline" target="_blank">Executive Summary</a>) relating to:</p>
<ul>
<li>TRIPS flexibilities and TRIPS-plus provisions (more on TRIPS below);</li>
<li>publicly funded research;</li>
<li>new incentives for research;</li>
<li>stronger accountability of governments;</li>
<li>a stronger role for the UN SG and UN General Assembly;</li>
<li>greater disclosure and transparency by corporations;</li>
<li>complete transparency regarding clinical trials; </li>
<li>publicly accessible databases regarding patents and related data regarding medicines and vaccines. </li>
</ul>
<p style="margin:10px 0;padding:0;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left">When this came before the WHO Executive Board (EB) in Jan 2017, the USA (supported by Europe, Switzerland and Japan) was opposed to any consideration of the HLP report. Contrary views were presented by Colombia, India, Thailand, Algeria, Brazil, Iran and South Africa</p>
<p style="margin:10px 0;padding:0;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left">The sparring continued at the WHA70 in May 2017 and was picked up again at the EB142 in Jan 2018 where a decision was recommended that WHO develop a Roadmap bringing together all of its various activities around access to medicines. This was confirmed at WHA71 in May 2018 in <a href="https://phmovement.us20.list-manage.com/track/click?u=559d715f58f654accf3de987e&id=205af9e9f4&e=916df65fd1" style="color:#007c89;font-weight:normal;text-decoration:underline" target="_blank">WHA71(8)</a>.</p>
<p style="margin:10px 0;padding:0;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left">WHO already had a range of resolutions on its books regarding various aspects of medicines policy (regulatory strengthening, rational use, quality, safety and efficacy, etc) but nothing which effectively addressed high prices as barriers to access. For many low and middle income countries medicines account for between 25-60% of their total health expenditure; hence prices are a priority concern for most countries and affordable prices a critical prerequisite for universal health cover.</p>
<p style="margin:10px 0;padding:0;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left">The proposed Roadmap was considered by EB144 in Jan 2019 and forwarded to WHA72 for confirmation (as <a href="https://phmovement.us20.list-manage.com/track/click?u=559d715f58f654accf3de987e&id=11d6631118&e=916df65fd1" style="color:#007c89;font-weight:normal;text-decoration:underline" target="_blank">A72/17</a>). The debate over the Roadmap at the Assembly in May 2019, was generally very positive although there was some disagreement as to whether the Roadmap was simply a re-packaging of previously mandated resolutions (the US position) or whether there was some scope for picking up some of the more radical recommendations of the HLP (in particular, those relating to market transparency). (When it was clear that this was not going to happen, the scene was set for the launch of the Transparency Resolution, see below.)</p>
<p style="margin:10px 0;padding:0;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left">The Roadmap was noted (approved) with the support of many member states. See PHM commentary and WHO Watch report of this item at WHA72 <a href="https://phmovement.us20.list-manage.com/track/click?u=559d715f58f654accf3de987e&id=24875bd5a7&e=916df65fd1" style="color:#007c89;font-weight:normal;text-decoration:underline" target="_blank">here</a>.</p>
<p style="margin:10px 0;padding:0;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left">Several of the issues raised during the debate of the Roadmap warrant further detail, including: delinking, TRIPS, rational use of medicines, and budget.</p>
<h3 style="display:block;margin:0;padding:0;color:#202020;font-family:Helvetica;font-size:20px;font-style:normal;font-weight:bold;line-height:125%;letter-spacing:normal;text-align:left">Delinking</h3>
<p style="margin:10px 0;padding:0;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left">One of the main hostilities regarding the HLP report from pharma and its member state allies concerned its support for delinking and the references to delinking in the Roadmap attracted sharp words from the US delegation.</p>
<p style="margin:10px 0;padding:0;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left">Delinking is shorthand for a package of policies aimed at delinking the funding of pharmaceutical R&D from high profit margins on successful drugs (recognising also the role of IP protection in maintaining high prices).</p>
<p style="margin:10px 0;padding:0;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left">Delinking proposals had been under consideration in WHO’s governing bodies since the 2006 report of the WHO <a href="https://phmovement.us20.list-manage.com/track/click?u=559d715f58f654accf3de987e&id=c3e84d3140&e=916df65fd1" style="color:#007c89;font-weight:normal;text-decoration:underline" target="_blank">Commission on Intellectual Property Rights, Innovation and Public Health</a> and the 2012 report of the Consultative Expert Working Group on Research and Development: Financing and Coordination (<a href="https://phmovement.us20.list-manage.com/track/click?u=559d715f58f654accf3de987e&id=a999f38d6d&e=916df65fd1" style="color:#007c89;font-weight:normal;text-decoration:underline" target="_blank">CEWG</a>) and a number of initiatives arising from this report had been progressed although well short of the R&D Treaty many were calling for. The HLP report of 2016 was strong in its support for delinking, particularly for treatments for diseases predominantly affecting developing countries, and suggested that a R&D Treaty could be progressed under the aegis of the UN Secretary General rather than the WHO.</p>
<p style="margin:10px 0;padding:0;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left">The opposition of the US to delinking was evident in the US criticisms, during the EB144 and WHA72 debates, of the references to the CEWG in the draft Roadmap.</p>
<p style="margin:10px 0;padding:0;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left">The role of the TRIPS agreement (the World Trade Organisation (WTO) agreement on Trade-related Aspects of Intellectual Property Rights) in maintaining high drug prices for longer terms has been contentious within WHO governing bodies since the adoption of TRIPS in 1994 and was critically examined by the HLP in 2016.</p>
<p style="margin:10px 0;padding:0;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left">There are two aspects to the focus on TRIPS: first, the ability of countries to fully deploy the flexibilities which are built into TRIPS and as a consequence achieve lower prices; and second, the option of adopting (or not) TRIPS plus provisions in bilateral or plurilateral trade agreements. (TRIPS plus provisions include making patenting easier, patenting new uses of old drugs, extending the term of protection, harnessing the power of medicines regulatory authorities in policing patent claims, and authorising direct-to-consumer marketing.)</p>
<p style="margin:10px 0;padding:0;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left">The HLP recommended that WHO should work with UNDP and the UN Conference on Trade and Development (UNCTAD) as well as with the WTO and the World Intellectual Property Organisation (WIPO) supporting countries to ensure the full use of TRIPS flexibilities. UNDP and UNCTAD are much more sympathetic to the claims of developing countries, including access to medicines and UHC, than WTO and WIPO.</p>
<p style="margin:10px 0;padding:0;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left">Under ‘Provide technical support and capacity-building’ the Roadmap proposes ‘support for the consideration of public health implications when negotiating bilateral or multilateral trade agreements’. At the core of this part is the provision of advice and assistance to countries so that when they legislate commitments under the TRIPS Agreement they ensure that they fully enable the use of TRIPS flexibilities and likewise avoid commitments to TRIPS plus provisions in other trade agreements (bilateral or regional).</p>
<p style="margin:10px 0;padding:0;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left">The previous commitment to providing such trade-related technical support (<a href="https://phmovement.us20.list-manage.com/track/click?u=559d715f58f654accf3de987e&id=4ef4e91b30&e=916df65fd1" style="color:#007c89;font-weight:normal;text-decoration:underline" target="_blank">WHA59.26</a> in 2006) has largely withered on the vine for lack of funding and periodic bullying of the Secretariat by the US. Further background regarding the non-implementation of <a href="https://phmovement.us20.list-manage.com/track/click?u=559d715f58f654accf3de987e&id=89be7b5e75&e=916df65fd1" style="color:#007c89;font-weight:normal;text-decoration:underline" target="_blank">WHA59.26</a> is provided in PHM’s comment on this item at WHA71, <a href="https://phmovement.us20.list-manage.com/track/click?u=559d715f58f654accf3de987e&id=8a7a4d5151&e=916df65fd1" style="color:#007c89;font-weight:normal;text-decoration:underline" target="_blank">here</a>.</p>
<p style="margin:10px 0;padding:0;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left">The trade-related deliverables in the Roadmap were the principal targets for US criticism at both EB144 (in Jan 2019) and at WHA72 (in May 2019). The US insisted that WHO work with WTO and WIPO on all issues relating to IP and trade (and was supported by Canada and Japan in this). However, the references in the Roadmap to working with UNDP and UNCTAD remain in place.</p>
<p style="margin:10px 0;padding:0;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left">High prices are a barrier to access but government expenditure is a function of volume as well as price and one of the drivers of volume is pharma marketing. It is here that the rational use of medicines and the regulation of pharma marketing can contribute to ensuring access to appropriate treatments.</p>
<h3 style="display:block;margin:0;padding:0;color:#202020;font-family:Helvetica;font-size:20px;font-style:normal;font-weight:bold;line-height:125%;letter-spacing:normal;text-align:left">Rational use of medicines</h3>
<p style="margin:10px 0;padding:0;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left">The Roadmap includes a commitment to action around the rational use of medicines. This commitment dates back to <a href="https://phmovement.us20.list-manage.com/track/click?u=559d715f58f654accf3de987e&id=85f23409e8&e=916df65fd1" style="color:#007c89;font-weight:normal;text-decoration:underline" target="_blank">WHA39.27</a> in 1986, and has been reiterated in many subsequent resolutions (most recently <a href="https://phmovement.us20.list-manage.com/track/click?u=559d715f58f654accf3de987e&id=da36d69034&e=916df65fd1" style="color:#007c89;font-weight:normal;text-decoration:underline" target="_blank">WHA60.16</a> in 2007) but action has been largely stymied through the lack of funding.</p>
<p style="margin:10px 0;padding:0;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left">The latest report on progress with respect to WHA60.16 (<a href="https://phmovement.us20.list-manage.com/track/click?u=559d715f58f654accf3de987e&id=de17d76b37&e=916df65fd1" style="color:#007c89;font-weight:normal;text-decoration:underline" target="_blank">in A72/59</a>) advises of action around antimicrobial resistance but provides no evidence of broader progress regarding the ‘overuse, underuse and misuse’ of medicines. The report concludes that:</p>
<p class="m_8157414343491712204tab" style="margin:10px 0;padding:0;margin-left:40px;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left"><i>further efforts are needed to address the rational use of medicines including through stronger and more focused guideline implementation activities, by means of national policies and plans integrating WHO standards and norms with regional initiatives and by investing sufficiently in human and financial resources as recommended in resolution WHA60.16</i></p>
<p style="margin:10px 0;padding:0;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left">The proposed delinking of R&D expenditure from medicines prices would have far reaching implications for pharma’s marketing expenditures as well as access to treatment.</p>
<p style="margin:10px 0;padding:0;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left">The Roadmap notes, at para 41 that:</p>
<p class="m_8157414343491712204tab" style="margin:10px 0;padding:0;margin-left:40px;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left"><i>Factors that contribute to inappropriate prescribing, dispensing and use include an inadequately trained workforce, incorrect diagnoses, the prohibitive costs or simple unavailability of medicines, and activities related to product marketing and promotion. Policy approaches and interventions have been identified to improve the use of health products but have generally not been implemented over the past decade. </i></p>
<p style="margin:10px 0;padding:0;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left">Despite this recognition there are no ‘deliverables’ in the Roadmap which might promote the more effective regulation of the marketing of health products in accordance with <a href="https://phmovement.us20.list-manage.com/track/click?u=559d715f58f654accf3de987e&id=7c3de02530&e=916df65fd1" style="color:#007c89;font-weight:normal;text-decoration:underline" target="_blank">WHA60.16</a>. (WHA60.16 urges member states to “to enact new, or enforce existing, legislation to ban inaccurate, misleading or unethical promotion of medicines, to monitor promotion of medicines”.) While pharmaceutical companies defend their high profits in terms of the need to recoup expenditure on R&D, in fact, such companies spend much more on marketing than they do on R&D; marketing which often drives inappropriate use.</p>
<p style="margin:10px 0;padding:0;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left">Delinking, through its effect on price, would notionally free up government resources to invest in health needs directed R&D <i>and</i> to invest in the rational use of medicines. If only a fraction of corporate marketing expenditure were to be redirected to supporting publicly accountable independent therapeutic advice platforms, including academic detailing, the rational and appropriate use of medicines would be greatly improved. Academic detailing is one of the most powerful tools for promoting rational use but is not mentioned in the Roadmap.</p>
<h3 style="display:block;margin:0;padding:0;color:#202020;font-family:Helvetica;font-size:20px;font-style:normal;font-weight:bold;line-height:125%;letter-spacing:normal;text-align:left">Budget</h3>
<p style="margin:10px 0;padding:0;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left">A number of speakers at WHA72 (including Brazil and several of the non-state actors (<a href="https://phmovement.us20.list-manage.com/track/click?u=559d715f58f654accf3de987e&id=c0e1670115&e=916df65fd1" style="color:#007c89;font-weight:normal;text-decoration:underline" target="_blank">Save the Children</a>, the World Medical Association (<a href="https://phmovement.us20.list-manage.com/track/click?u=559d715f58f654accf3de987e&id=cde274b7d3&e=916df65fd1" style="color:#007c89;font-weight:normal;text-decoration:underline" target="_blank">WMA</a>) and <a href="https://phmovement.us20.list-manage.com/track/click?u=559d715f58f654accf3de987e&id=09f92af6f4&e=916df65fd1" style="color:#007c89;font-weight:normal;text-decoration:underline" target="_blank">Medicus Mundi International</a> with PHM and TWN) expressed concern about the funding of the Roadmap.</p>
<p style="margin:10px 0;padding:0;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left">The budget estimates for Outcome 1.3 of the <a href="https://phmovement.us20.list-manage.com/track/click?u=559d715f58f654accf3de987e&id=7732d1779e&e=916df65fd1" style="color:#007c89;font-weight:normal;text-decoration:underline" target="_blank">Programme Budget for 2020-21 (A72/4)</a> (improved access to essential medicines, vaccines, diagnostics and devices for primary health care) project a total expenditure of USD131m per year which is ridiculously small compared with the activities included under the Roadmap.</p>
<p style="margin:10px 0;padding:0;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left">The Secretariat estimates (in <a href="https://phmovement.us20.list-manage.com/track/click?u=559d715f58f654accf3de987e&id=43ebb79727&e=916df65fd1" style="color:#007c89;font-weight:normal;text-decoration:underline" target="_blank">A72/17</a>) that this funding will be distributed 58% ($76m per year) on regulatory system strengthening (Output 4.3.3), 11% ($14.4m) on R&D and IP related activities (Output 4.3.2), and 31% ($40m) on selection, fair and affordable pricing, procurement and supply chain and appropriate prescribing dispensing and use (Output 4.3.1).</p>
<p style="margin:10px 0;padding:0;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left">Compare this budget projection (which is unlikely to be fully subscribed by the donors) with US pharma expenditure on marketing which <a href="https://phmovement.us20.list-manage.com/track/click?u=559d715f58f654accf3de987e&id=7b00be5b9b&e=916df65fd1" style="color:#007c89;font-weight:normal;text-decoration:underline" target="_blank">Gagnon and Lexin in 2008</a> estimated to range from $28-58 billion in 2004. Extrapolating this to the globe and to the present suggests as much as $1 trillion per year for the years of this budget.</p>
<p style="margin:10px 0;padding:0;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left">The donor chokehold over WHO (through the freeze on ACs and the tight earmarking of donor funds) means that while some deliverables in the Roadmap may be trickle-funded others will be completely unfunded. In particular, it is likely that virtually no donor funds will be available to support technical advice regarding trade negotiations or effective action on rational use and ethical promotion.</p>
<p style="margin:10px 0;padding:0;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left">Powerful member states, led by the US, do not want WHO to be effective in promoting affordable reliable access to safe, effective and appropriately used medicines and vaccines if, in doing so, it undercuts the interests of the transnational pharmaceutical corporations. </p>
<p style="margin:10px 0;padding:0;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left">The three countries which spoke against considering the recommendations of the HLP at EB140, the US, Switzerland and Japan, are the homes of some of the biggest pharmaceutical companies in the world. Not only are their governments harnessed to defend the interests of their corporations but these are some of the very few countries in the world which are net ‘exporters’ of intellectual property (with implications for their balance of payments).</p>
<h2 style="display:block;margin:0;padding:0;color:#202020;font-family:Helvetica;font-size:22px;font-style:normal;font-weight:bold;line-height:125%;letter-spacing:normal;text-align:left">The transparency resolution</h2>
<p style="margin:10px 0;padding:0;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left">At the Executive Board in Jan 2019 (EB144) several member states called for new commitments in the proposed Roadmap which would progress some of the recommendations of the HLP on access to medicines. Chile said that mechanisms for promoting market competition and transparency should be top priorities. Colombia said explicitly that the road map should incorporate the recommendations contained in the report of the United Nations Secretary-General’s High-level Panel on Access to Medicines. India called on the Secretariat to align the draft road map with the recommendations of the report of the High-level Panel, particularly with respect to the use of the flexibilities provided in the TRIPS Agreement. Ecuador argued that the draft road map should include a greater focus on aspects such as the development of strategies on pooled procurement for purchasing and, in line with the recommendations of the report of the United Nations Secretary-General’s High-Level Panel on Access to Medicines, strategies regarding the adoption and application of rigorous definitions of invention and patentability that were in the best interests of the public health of the country.</p>
<p style="margin:10px 0;padding:0;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left">The USA, on the other hand, was adamant at the Executive Board (and later at the Assembly) that there would be nothing in the Roadmap which was not explicitly mandated in previous resolutions. </p>
<p style="margin:10px 0;padding:0;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left">The scene was set for the Transparency resolution proposed by Italy.</p>
<p style="margin:10px 0;padding:0;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left">During the EB debate in January 2019 Italy had noted that the draft Roadmap called for international action to make reporting and the production costs of cancer medicines more transparent. Thus, she hoped that WHO would take on a greater role by issuing an appropriate instrument and continuing the discussion at the Seventy-second World Health Assembly. Similar calls were made by Portugal, Spain, Chile, Philippines, Bolivia, Russia, Bangladesh and many of the non-state actors.</p>
<p style="margin:10px 0;padding:0;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left">On the last day of EB meeting, the Italian health minister wrote to the DG proposing a draft resolution which would “provide WHO with the mandate to: collect and analyse data on clinical trial outcomes and adverse effects of health technologies; provide a forum for governments to share information on drug prices, revenues, R&D costs, the public sector investments and subsidies for R&D, marketing costs, and other related information”.</p>
<p style="margin:10px 0;padding:0;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left">The draft resolution included provisions for transparency in relation to prices, revenues, units sold, marketing costs, clinical trial enrolments and outcomes, clinical trial costs, government R&D subsidies, patent landscapes and manufacturing know-how.</p>
<p style="margin:10px 0;padding:0;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left">The Italian draft resolution appears to have been prepared for Executive Board consideration although it was not raised during the adoption of the agenda. When the revised version of the resolution was finally considered at the Assembly in May several high income members states protested at the failure to introduce the resolution for consideration by the Executive Board.</p>
<p style="margin:10px 0;padding:0;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left">Germany, UK and Hungary claimed it had been rushed and should have gone through the EB and dissociated themselves from the resolution as adopted. Germany complained that the confidentiality of the negotiations around the proposed resolution had been breached. The German delegation was particularly upset by the reaction in Germany to a leak to the effect that, “a group of Northern European countries, led by Germany, Denmark, Sweden and the UK, plus Australia, led an effort to gut the resolution” (as reported by KEI).</p>
<p style="margin:10px 0;padding:0;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left">Brazil supported by Spain, Burundi and Portugal, rejected the allegation of lack of time and failure to go through EB. </p>
<p style="margin:10px 0;padding:0;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left">It has been suggested that the opposition of the UK and Germany was due to the large discounts that they are able to extract from the pharmaceutical companies through their national pharmaceutical procurement programs (involving a single purchaser and huge volumes). Presumably the pharma companies had advised the UK and Germany that those large discounts would be jeopardised if all countries were able to bargain on the basis of published net prices (net of discounts). </p>
<p style="margin:10px 0;padding:0;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left">In sharp contrast to the opposition of the UK, Hungary and Germany, the USA was enthusiastic in its support for the resolution as finally adopted (after successfully weakening the reference to clinical trial costs during the negotiations). The US Medicare is by law not allowed to negotiate prices with pharma and pays very high prices. The Trump administration claims that the US tax payer / enrollee subsidises access to medicines (and the cost of innovation) for the rest of the world through the high prices prevailing in the US.</p>
<p style="margin:10px 0;padding:0;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left">It may be that Italy and its supporters judged that the opposition of certain high income countries might have been more effective in the Executive Board than in the informal and formal negotiations which led to the final resolution as adopted.</p>
<p style="margin:10px 0;padding:0;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left">The Portuguese intervention in support of the resolution reflects the position adopted by many speakers.</p>
<p class="m_8157414343491712204tab" style="margin:10px 0;padding:0;margin-left:40px;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left"><i>The very high price of some medicines and vaccines remains one of the main barriers in this regard. We are fully convinced that the existence of transparency in the markets for medicines would be a decisive factor to improve access to medicines and thus contribute to universal health coverage and to the realization of the human right to health.</i><br>
<i>As the Minister of Health of Portugal stated last week at a side-event in this Assembly, “transparency is a fundamental value of modern, open and democratic societies. However, lack of transparency prevails throughout the pharmaceutical value chain. (…) We need to know how costly R&D is in order to understand how fairly or not is it being reflected in the final price of the medicine, especially in the cases where R&D is financed or conducted by the State; this is a matter of good governance, of respect for tax payer’s money and ultimately of respect for human rights”.</i><br>
<i>This is why Portugal decided to join, from the very beginning, the core-group of countries responsible for the presentation of the draft resolution on improving the transparency of markets for medicines, vaccines and other health-related technologies. Quoting again the Minister of Health of Portugal, “we believe that it can represent a step forward in pragmatically addressing this issue since it stimulates the sharing of international information which is essential to achieve enhanced transparency, notably the dissemination of the results and costs of human subject clinical trials and generic product policies. (…) Countries have to continue to collaborate between themselves and pursue the ultimate goal of defending the public interest. The current situation where we have to wait for the industry, where we are bound to confidential agreements, where companies select preferences needs to change”.</i><br>
<i>To conclude, promoting transparency throughout the value chain, strengthening pricing policies, cross-sector and cross-border collaboration for information-sharing, regulation and joint assessment and procurement of medicines are paramount to enhance affordability and accessibility of medicines allowing at the same time real innovation in this area.</i><br>
<i>Access to quality, safe and affordable medicines has to be seen from a human rights and public health lens since it constitutes an essential element of universal health coverage and of the right to health. WHO has an essential role to play in this regard by helping and guiding States to address the existing obstacles to access to medicines. </i></p>
<p style="margin:10px 0;padding:0;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left">Many other member states made similar comments. Thailand argued that separating R&D expenditure from price setting was necessary to ensure fair pricing and expressed concern that ‘some countries’ act as if they are representing the interests of the drug companies, not the people.</p>
<p style="margin:10px 0;padding:0;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left">However, the <a href="https://phmovement.us20.list-manage.com/track/click?u=559d715f58f654accf3de987e&id=cd90feeba7&e=916df65fd1" style="color:#007c89;font-weight:normal;text-decoration:underline" target="_blank">International Federation of Pharmaceutical Manufacturers and Associations</a> was not happy.</p>
<p class="m_8157414343491712204tab" style="margin:10px 0;padding:0;margin-left:40px;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left"><i>… we are concerned that some proposals in the Roadmap and at this Assembly focusing on transparency and IP would deter from holistic and sustainable solutions to access.</i><br>
<i>Long-term solutions to access challenges must promote sustained investments in health systems strengthening, together with an innovation ecosystem that incentivises research in new products - the generics of tomorrow. Strong IP protection is a key component of such ecosystem, and WHO’s activities in the area should support the private sector’s vibrant pipeline to address today’s unmet medical needs.</i><br>
<i>We have heard the concerns raised regarding transparency and understand the call for more information about our scientifically complex, and high-risk business model […].</i><br>
<i>We urge MS to carefully consider potential risks to patients, particularly in less developed countries, of sharing outcomes of confidential prices negotiations. We also caution against disclosure requirements on R&D costs that underscore “cost-plus” models. Prices should reflect the therapeutic value of a medicines and positive outcomes to society, rather than simply the cost “input” of a medicine.</i></p>
<p style="margin:10px 0;padding:0;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left"><a href="https://phmovement.us20.list-manage.com/track/click?u=559d715f58f654accf3de987e&id=82185ecee3&e=916df65fd1" style="color:#007c89;font-weight:normal;text-decoration:underline" target="_blank">Médecins Sans Frontières</a>, in contrast welcomed the Roadmap and the resolution:</p>
<p class="m_8157414343491712204tab" style="margin:10px 0;padding:0;margin-left:40px;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left"><i>Exorbitant medicine prices limit MSF’s ability to provide the best possible treatment for people in our care. The same holds true for governments represented here today. This week, Member States are negotiating an important resolution on medicines transparency – covering four areas where full transparency is urgently needed: R&D costs, clinical trial results, medicines patents, and the real prices of medicines.</i><br>
<i>This resolution could help save lives by setting strong norms and standards to help correct the unacceptable power imbalance that exists between those who need and purchase medicines – and those who produce and sell them.</i><br>
<i>Pharmaceutical corporations do not set medicine prices with the objective of ensuring access for all people in need. They set them in order to maximise profit, which leads to rationing of medicines when patients and health systems cannot afford the prices they charge. When governments sign confidentiality agreements on prices, they give companies the upper hand in price negotiations. But countries do not have to consent to being blindfolded. There are no legal barriers that mandate this damaging secrecy.</i><br>
<i>Transparency can help level the playing field and give governments the information they need to negotiate fairly and responsibly for people and their health. We ask Member States to require transparency on the prices countries pay for medicines, the mark-ups companies charge, and companies’ production costs. And governments need to know who pays what for R&D – how much investment is really covered by companies, and how much is underwritten by taxpayers and non-profit groups.</i><br>
<i>MSF urges Member States to adopt a bold and clear resolution to set strong standards that mandate transparency on medicine prices and R&D costs.</i></p>
<p style="margin:10px 0;padding:0;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left">17 countries spoke in favour of the final draft of the resolution in unqualified terms (including the US, Costa Rica, Indonesia, Norway, Botswana, South Africa, Algeria, Malta, Kenya, France, Zimbabwe, Tanzania, Ecuador, Colombia, Peru, Mexico and Iran).</p>
<p style="margin:10px 0;padding:0;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left">Thailand felt that the resolution was too much weakened by the compromises reached during the drafting negotiations, particularly in relation to ‘voluntarily provided’ in operative para 1.2 which urges member states:</p>
<p class="m_8157414343491712204tab" style="margin:10px 0;padding:0;margin-left:40px;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left"><i>to take the necessary steps, as appropriate, to support dissemination and enhanced availability of, and access to, aggregated results data and, if already publicly available or <u>voluntarily provided</u>, costs from human subject clinical trials regardless of outcomes or whether the results will support an application for marketing approval, while ensuring patient confidentiality</i></p>
<p style="margin:10px 0;padding:0;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left">Knowledge Ecology International (KEI) stated that ‘Drug companies are concerned that if the actual costs are disclosed, narratives about massive R&D costs will be undermined, by facts, for a number of products.’ See <a href="https://phmovement.us20.list-manage.com/track/click?u=559d715f58f654accf3de987e&id=6f0d0622fb&e=916df65fd1" style="color:#007c89;font-weight:normal;text-decoration:underline" target="_blank">KEI commentary on the final resolution</a> and its comparison of the sequence of drafts during the negotiations (<a href="https://phmovement.us20.list-manage.com/track/click?u=559d715f58f654accf3de987e&id=ccb7cdede7&e=916df65fd1" style="color:#007c89;font-weight:normal;text-decoration:underline" target="_blank">here</a>).</p>
<h2 style="display:block;margin:0;padding:0;color:#202020;font-family:Helvetica;font-size:22px;font-style:normal;font-weight:bold;line-height:125%;letter-spacing:normal;text-align:left">Member State Mechanism on Substandard and Falsified Medical Products (MSM)</h2>
<p style="margin:10px 0;padding:0;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left">Item 12.2 at WHA72 was a recurring item under which the Member State Mechanism on Substandard and Falsified Medical Products was required to report to the Assembly on its work over the last two years.</p>
<p style="margin:10px 0;padding:0;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left">The Member State Mechanism (MSM) arose out of concern (arising from the <a href="https://phmovement.us20.list-manage.com/track/click?u=559d715f58f654accf3de987e&id=d80c56cb99&e=916df65fd1" style="color:#007c89;font-weight:normal;text-decoration:underline" target="_blank">IMPACT scandal</a>) that WHO’s use of the term ‘counterfeit’ was being used to obscure the difference between pharma claims that their IP was being infringed and public health concerns about the circulation of substandard, non-approved and falsified medicines. See <a href="https://phmovement.us20.list-manage.com/track/click?u=559d715f58f654accf3de987e&id=e36f744271&e=916df65fd1" style="color:#007c89;font-weight:normal;text-decoration:underline" target="_blank">Tracker links to WHA discussions</a> since 2010 of substandard and falsified medicines. See <a href="https://phmovement.us20.list-manage.com/track/click?u=559d715f58f654accf3de987e&id=a93aaf6d57&e=916df65fd1" style="color:#007c89;font-weight:normal;text-decoration:underline" target="_blank">PHM Comment on Item 12.2</a> for more background on the MSM.</p>
<p style="margin:10px 0;padding:0;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left">The purpose of the Member State Mechanism is to promote the effective regulation of the medicines market in order to prevent the circulation of substandard, non-approved and falsified medicines but without having regard to IP claims.</p>
<p style="margin:10px 0;padding:0;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left">In contrast pharma has sought to harness the statutory powers of the national medicines regulatory authorities to protect claimed intellectual property rights against generic competition. Conflating IP status with questions of quality, safety and efficacy and scare-mongering around quality and safety have been key strategies in this project.</p>
<p style="margin:10px 0;padding:0;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left">The workplan of the Mechanism is structured around a number of ‘prioritised activities’ including:</p>
<ol style="list-style-type:upper-alpha">
<li>developing training materials and guidance documents for regulatory authorities;</li>
<li>expanding the network of national focal points;</li>
<li>exploring technologies for detecting substandard products;</li>
<li>highlighting the links between promoting affordable access to quality, safe and efficacious medicines and reducing the demand for substandard and falsified products;</li>
<li>risk communication and awareness campaigns;</li>
<li>awareness of the work of the MSM;</li>
<li>awareness regarding the interdiction of medical products in transit;</li>
<li>distribution of substandard and falsified products via the internet.</li>
</ol>
<p style="margin:10px 0;padding:0;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left">The substance of the agenda item for WHA72 was consideration of the reports of the sixth and seventh meetings of the MSM.</p>
<p style="margin:10px 0;padding:0;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left">Various aspects of the work of the MSM were noted in contributions to the debate at WHA72.</p>
<p style="margin:10px 0;padding:0;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left">Spain, Tanzania, Russia and Thailand expressed appreciation of progress on track and trace technologies.</p>
<p style="margin:10px 0;padding:0;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left">Several member states highlighted the continuing need for regulatory system strengthening, variously appreciating WHO for its contribution to such strengthening and asking for ongoing assistance (Algeria, Iraq, Kiribati, Zambia, Costa Rica).</p>
<p style="margin:10px 0;padding:0;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left">Medicus Mundi International (with PHM and TWN) highlighted the importance of the work on transit:</p>
<p class="m_8157414343491712204tab" style="margin:10px 0;padding:0;margin-left:40px;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left"><i>there should not be any interception of movement of medicines in transit without the request from the regulatory authorities of either export or importing country. The interception in the name of checking movement of substandard or falsified will result in the interception of generic medicines and compromises access.</i></p>
<p style="margin:10px 0;padding:0;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left">Two NSAs highlighted the link between prices and the circulation of substandard and falsified products.</p>
<p style="margin:10px 0;padding:0;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left">The International Association for Hospice and Palliative Care said:</p>
<p class="m_8157414343491712204tab" style="margin:10px 0;padding:0;margin-left:40px;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left"><i>The trade in falsified medicine flourishes in the shadow of unmet health needs. All over the world people are seeking help to cure infectious diseases or to ease acute untreated pain. In the absence of bona fide health services they turn to informal providers who are poorly qualified and insufficiently motivated to properly assess the quality of the medicines they supply. While we strongly support the strengthening of measures to address the production and trade in falsified and substandard medicines and call on all member states to sign up to the Medicrime Convention, we also contend that looking for scapegoats does not bring us further. It ends up by turning public health into an arm of law enforcement and runs the risk of criminalizing the very people our health care has failed to serve.</i></p>
<p style="margin:10px 0;padding:0;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left">MMI (with PHM and TWN) recalled that</p>
<p class="m_8157414343491712204tab" style="margin:10px 0;padding:0;margin-left:40px;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left"><i>… in 2014 MSM called on the Secretariat to provide a Study to deepen understanding of the link between access to quality, safe, efficacious and affordable medical products and the emergence of substandard and falsified medical products. However, there is no progress in concluding the study. We would like to stress that access to medicines can eliminate the incentive for the circulation of falsified medicines.</i></p>
<p style="margin:10px 0;padding:0;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left">MMI (with PHM and TWN) were particularly critical of the participation of WHO in the conflation of substandard and falsified as one phenomenon:</p>
<p class="m_8157414343491712204tab" style="margin:10px 0;padding:0;margin-left:40px;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left"><i>… even after the finalization of definitions WHO continues to conflate substandard and falsified medicines. Instead of giving separate data on the circulation of substandard and falsified medicine, the Secretariat provides aggregate data of substandard and falsified. This approach is not only erroneous but also helps the scaremongering on quality of medicines.</i></p>
<p style="margin:10px 0;padding:0;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left">This statement appears to be referring to WHO’s 2017 <a href="https://phmovement.us20.list-manage.com/track/click?u=559d715f58f654accf3de987e&id=47d946befa&e=916df65fd1" style="color:#007c89;font-weight:normal;text-decoration:underline" target="_blank">study on the public health and socioeconomic impact of substandard and falsified medical products</a> (funded by the US FDA) which provides aggregate data regarding the incidence of “substandard <i>and</i> falsified” samples with no attempt to distinguish between the two. In fact as the report notes, three different categories have been recognised and defined by WHO in <a href="https://phmovement.us20.list-manage.com/track/click?u=559d715f58f654accf3de987e&id=923c169ecc&e=916df65fd1" style="color:#007c89;font-weight:normal;text-decoration:underline" target="_blank">Decision WHA70(21)</a> as presented by the MSM in <a href="https://phmovement.us20.list-manage.com/track/click?u=559d715f58f654accf3de987e&id=92a936637d&e=916df65fd1" style="color:#007c89;font-weight:normal;text-decoration:underline" target="_blank">Appendix 3 to Annex, A70/23</a>, (2017). These are:</p>
<p class="m_8157414343491712204tab" style="margin:10px 0;padding:0;margin-left:40px;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left"><b>Substandard medical products.</b> Also called “out of specification”, these are authorized medical products that fail to meet either their quality standards or their specifications, or both.<br>
<b>Unregistered/unlicensed medical products</b>. Medical products that have not undergone evaluation and/or approval by the national or regional regulatory authority for the market in which they are marketed/distributed or used, subject to permitted conditions under national or regional regulation and legislation.<br>
<b>Falsified medical products</b>. Medical products that deliberately/fraudulently misrepresent their identity, composition or source.</p>
<p style="margin:10px 0;padding:0;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left">Not only was the study funded by the US FDA but the largest single source of data was the US Pharmacopeia Medicines Quality Database (MQDB). The MQDB reports samples as ‘pass’ or ‘fail’ in relation to the method of testing but does not provide a breakdown in relation to these three categories.</p>
<p style="margin:10px 0;padding:0;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left">Clearly these three categories have different causes and call for different responses. The MMI/PHM/TWN statement comments that this lumping together ‘helps the scaremongering on quality of medicines’.</p>
<p style="margin:10px 0;padding:0;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left">The charge of scaremongering gains in credibility from the gaggle of non-state actors whose statements to WHA72 highlighted the Fight the Fakes Campaign whose partners include the IFPMA and a number of companies and other industry bodies. The NSAs celebrating the Fight the Fakes campaign included the International Council of Nurses, the International Pharmaceutical Federation and the International Pharmaceutical Students’ Federation all of whom are partners of the campaign. Clearly falsified medicines are fakes but substandard and unlicensed products present different problems. It would appear that the Fight the Fakes Campaign is deliberately conflating the three categories listed above under the ‘falsified’ category. Whether the ‘partners’ understand how they are being used is not clear. It looks like scaremongering.</p>
<h2 style="display:block;margin:0;padding:0;color:#202020;font-family:Helvetica;font-size:22px;font-style:normal;font-weight:bold;line-height:125%;letter-spacing:normal;text-align:left">PHM Comment</h2>
<p style="margin:10px 0;padding:0;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left">Affordable access to appropriately used, good quality, safe and efficacious medicines is a huge public health challenge.</p>
<p style="margin:10px 0;padding:0;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left">Price barriers to procuring necessary medicines prevent many families from accessing treatment and prevent many governments from providing decent health care to their people. UHC means nothing if people cannot afford medicines.</p>
<p style="margin:10px 0;padding:0;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left"><a href="https://phmovement.us20.list-manage.com/track/click?u=559d715f58f654accf3de987e&id=6eceeb36d6&e=916df65fd1" style="color:#007c89;font-weight:normal;text-decoration:underline" target="_blank">WHO (2018)</a> reports that in 2010, an estimated 808 million people – 11.7% of the world’s population – spent at least 10% of their household budget paying out of their own pocket for health services. An estimated 97 million people were impoverished by out-of-pocket health-care spending in 2010.</p>
<p style="margin:10px 0;padding:0;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left"><a href="https://phmovement.us20.list-manage.com/track/click?u=559d715f58f654accf3de987e&id=7effede43c&e=916df65fd1" style="color:#007c89;font-weight:normal;text-decoration:underline" target="_blank">WHO (2015)</a> reports that medicines account for 20–60% of health spending in low- and middle-income countries, compared with 18% in countries of the OECD. Up to 90% of the population in developing countries purchase medicines through out-of-pocket payments, making medicines the largest family expenditure item after food.</p>
<p style="margin:10px 0;padding:0;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left">Drug price surveys in L&MICs (<a href="https://phmovement.us20.list-manage.com/track/click?u=559d715f58f654accf3de987e&id=26eeb514e5&e=916df65fd1" style="color:#007c89;font-weight:normal;text-decoration:underline" target="_blank">Cameron and colleagues 2008</a>) found that private sector patients paid 9–25 times international reference prices for lowest-priced generic products and over 20 times international reference prices for originator products across WHO regions.</p>
<p style="margin:10px 0;padding:0;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left">The following extracts provide an indication of the disease burden arising from lack of affordable access.</p>
<ul>
<li>An estimated 940 000 people died of HIV-related illnesses in 2017, 110 000 of whom were children. However, 41% of people living with HIV were still not receiving treatment. (<a href="https://phmovement.us20.list-manage.com/track/click?u=559d715f58f654accf3de987e&id=2befb0bf99&e=916df65fd1" style="color:#007c89;font-weight:normal;text-decoration:underline" target="_blank">A72/11 Rev.1</a>)</li>
<li>Progress on malaria has stalled with 435,000 deaths in 2017. There were an estimated 3.5 million more malaria cases in the 10 highest burden African countries in 2017 compared with the previous year. (<a href="https://phmovement.us20.list-manage.com/track/click?u=559d715f58f654accf3de987e&id=a10406f10d&e=916df65fd1" style="color:#007c89;font-weight:normal;text-decoration:underline" target="_blank">A72/11 Rev.1</a>)</li>
<li>Globally, an estimated 71 million people have chronic hepatitis C virus infection. A significant number of those who are chronically infected will develop cirrhosis or liver cancer. WHO estimated that in 2016, approximately 399 000 people died from hepatitis C, mostly from cirrhosis and hepatocellular carcinoma (primary liver cancer). Antiviral medicines can cure more than 95% of persons with hepatitis C infection, thereby reducing the risk of death from cirrhosis and liver cancer, but access to diagnosis and treatment is low. A record 3 million people accessed treatment in 2016 and 2017. (<a href="https://phmovement.us20.list-manage.com/track/click?u=559d715f58f654accf3de987e&id=e352aa9ef2&e=916df65fd1" style="color:#007c89;font-weight:normal;text-decoration:underline" target="_blank">WHO hepatitis page 2019</a>)</li>
</ul>
<p style="margin:10px 0;padding:0;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left">The shortfalls reported are multifactorial, including, in particular, weak health systems. However, it is undeniable the cost of medicines is a major factor.</p>
<p style="margin:10px 0;padding:0;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left">The three debates at WHA72 reported above illustrate the technical complexity of the issues as well as the corporate and political forces at play.</p>
<p style="margin:10px 0;padding:0;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left">The Roadmap debate highlighted the role of intellectual property (IP) protection in keeping prices high and the significance of the R&D expenditure argument in defending this regime. The transparency debate highlighted the significance of secrecy in keeping prices high (for some) and the critical importance, for pharma, of keeping secret the real costs of R&D. The substandard and falsified debate highlighted conflicts over regulatory purpose and role of scaremongering in protecting originator drugs from generic competition.</p>
<p style="margin:10px 0;padding:0;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left">The adoption of the transparency resolution (albeit somewhat watered down) shows that pharma and its nation state representatives are not all powerful. In this case they have been defeated by a combination of good technical people in the UN system (including WHO and UNDP); an alliance of governments, largely from low and middle income countries, and a network of progressive civil society organisations. The forces behind the Secretary General’s High Level Panel included UNDP, UNAIDS and the international AIDS movement.</p>
<p style="margin:10px 0;padding:0;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left">Ongoing research and advocacy at all levels has been critical in this confrontation. Behind the diplomatic engagements, for pharma and its allies, is the threat of delegitimation; the prospect of the whole system coming into question. The leadership role of the AIDS movement around access reflects the significance of popular mobilization in driving such change. The burden of health care costs more generally and the role of medicines in this burden points to the possibility of this movement having a determining influence on access.</p>
<p style="margin:10px 0;padding:0;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left">Working with other organisations and networks, the People’s Health Movement will continue to research and share the technical and the political dimensions of this confrontation; we will continue to advocate and mobilise among the communities whose health care is at stake; and we will continue to promote that Another World is Possible.</p>
<h1 style="display:block;margin:0;padding:0;color:#202020;font-family:Helvetica;font-size:26px;font-style:normal;font-weight:bold;line-height:125%;letter-spacing:normal;text-align:left">More</h1>
<p style="margin:10px 0;padding:0;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left">For full coverage of the WHA consideration of access to medicines see the <a href="https://phmovement.us20.list-manage.com/track/click?u=559d715f58f654accf3de987e&id=ca9d871c99&e=916df65fd1" style="color:#007c89;font-weight:normal;text-decoration:underline" target="_blank">PHM item page</a>. The PHM item page for the Member State Mechanism debate, is <a href="https://phmovement.us20.list-manage.com/track/click?u=559d715f58f654accf3de987e&id=0bf9386c2d&e=916df65fd1" style="color:#007c89;font-weight:normal;text-decoration:underline" target="_blank">here</a>. Each item page includes: summary of issues in focus at the Assembly; background notes; PHM commentary and the WHO watchers' notes of the debate.</p>
<p style="margin:10px 0;padding:0;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left">Access all of the documents and debates from the World Health Assembly from the WHO Tracker at <a href="https://phmovement.us20.list-manage.com/track/click?u=559d715f58f654accf3de987e&id=bb42948a7e&e=916df65fd1" style="color:#007c89;font-weight:normal;text-decoration:underline" target="_blank">who-track.phmovement.org/wha72</a>. Review previous Update Reports from WHA72 <a href="https://phmovement.us20.list-manage.com/track/click?u=559d715f58f654accf3de987e&id=3cbdf8763a&e=916df65fd1" style="color:#007c89;font-weight:normal;text-decoration:underline" target="_blank">here</a>.</p>
<h2 style="display:block;margin:0;padding:0;color:#202020;font-family:Helvetica;font-size:22px;font-style:normal;font-weight:bold;line-height:125%;letter-spacing:normal;text-align:left">Spread the word</h2>
<p style="margin:10px 0;padding:0;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left">The purpose of WHO Watch is to contribute to democratising global health governance, through new alliances and new information flows. You can help by forwarding our updates, disseminating on social media and inviting others to <a href="https://phmovement.us20.list-manage.com/track/click?u=559d715f58f654accf3de987e&id=ddc71435c4&e=916df65fd1" style="color:#007c89;font-weight:normal;text-decoration:underline" target="_blank">subscribe to the Updater</a>.</p>
<p style="margin:10px 0;padding:0;color:#202020;font-family:Helvetica;font-size:16px;line-height:150%;text-align:left">WHO Watch is a project of the <a href="https://phmovement.us20.list-manage.com/track/click?u=559d715f58f654accf3de987e&id=25d260aa1f&e=916df65fd1" style="color:#007c89;font-weight:normal;text-decoration:underline" target="_blank">People's Health Movement</a> in cooperation with <a href="https://phmovement.us20.list-manage.com/track/click?u=559d715f58f654accf3de987e&id=0ab87ab66d&e=916df65fd1" style="color:#007c89;font-weight:normal;text-decoration:underline" target="_blank">Medicus Mundi International</a>, <a href="https://phmovement.us20.list-manage.com/track/click?u=559d715f58f654accf3de987e&id=71defe6bc9&e=916df65fd1" style="color:#007c89;font-weight:normal;text-decoration:underline" target="_blank">Third World Network</a> and a number of other civil society networks.<br>
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