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<b><span lang="EN-US" style="font-family:ArialMT,sans-serif;color:rgb(34,34,34)">Statement to the 65^th WHA on Agenda item 13.13: Substandard/spurious/falsely-labelled/falsified/ counterfeit medical products</span></b></p>

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<span lang="EN-US" style="font-family:Helvetica,sans-serif;color:rgb(34,34,34)">Thank you, Mr. Chairman. </span></p><p class="MsoNormal" style="margin-top:0px;margin-right:0px;margin-bottom:0px;margin-left:0px"><font face="Helvetica, sans-serif"><br>

</font></p><p class="MsoNormal" style="margin-top:0px;margin-right:0px;margin-bottom:0px;margin-left:0px"><span lang="EN-US" style="font-family:Helvetica,sans-serif;color:rgb(34,34,34)">My name is Heba Wanis and I am making this statement on behalf of CMC Churches Action for Health, Third World Network and People's Health Movement, which is represented in more than 80 countries worldwide, calling for "Health for All". </span><span lang="EN-US" style="font-family:Helvetica,sans-serif;color:rgb(34,34,34)"><u></u><u></u></span></p>

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<font face="Helvetica, sans-serif">Mr. Chairman, we have three points to make under this agenda item. </font></p><p class="MsoNormal" style="margin-top:0px;margin-right:0px;margin-bottom:0px;margin-left:0px">
<font face="Helvetica, sans-serif"><br></font></p><p class="MsoNormal" style="margin-top:0px;margin-right:0px;margin-bottom:0px;margin-left:0px"><span lang="EN-US" style="font-family:Helvetica,sans-serif;color:rgb(34,34,34)">First, we welcome the establishment of a Member State mechanism to address the issue of quality, safely and efficacy of medical products, from a public health perspective, excluding trade and intellectual property considerations.</span><span lang="EN-US" style="font-family:Helvetica,sans-serif;color:rgb(34,34,34)"><u></u><u></u></span></p>

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<p class="MsoNormal" style="margin-top:0px;margin-right:0px;margin-bottom:0px;margin-left:0px"><span lang="EN-US" style="font-family:Helvetica,sans-serif;color:rgb(34,34,34)">We believe that this intergovernmental mechanism is the appropriate forum for WHO to deal with the problem of compromised medicines. With the establishment of this mechanism, it is time to dissociate WHO from IMPACT (International Medical Products Anti-Counterfeit Taskforce).</span><span lang="EN-US" style="font-family:Helvetica,sans-serif;color:rgb(34,34,34)"><u></u><u></u></span></p>

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<span lang="EN-US" style="font-family:Helvetica,sans-serif;color:rgb(34,34,34)">Second, the WHO has to focus on ensuring the quality and safety of medicines and ensuring they are affordable.<u></u><u></u></span></p><p class="MsoNormal" style="margin-top:0px;margin-right:0px;margin-bottom:0px;margin-left:0px">

<span lang="EN-US" style="font-family:Helvetica,sans-serif;color:rgb(34,34,34)"><u></u> <u></u></span></p><p class="MsoNormal" style="margin-top:0px;margin-right:0px;margin-bottom:0px;margin-left:0px"><span lang="EN-US" style="font-family:Helvetica,sans-serif;color:rgb(34,34,34)">The public has a right to expect that the medicines are available and affordable and that medicines on offer are of high quality, are safe and are efficacious. One of the root causes of the problem of compromised medicines is the unaffordability of quality medicines.<u></u><u></u></span></p>

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<span lang="EN-US" style="font-family:Helvetica,sans-serif;color:rgb(34,34,34)">This issue has not been given sufficient attention and we urge the Member States, through the proposed new mechanism, to agree to bold solutions to deal with the unaffordability of medicines.<u></u><u></u></span></p>

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<span lang="EN-US" style="font-family:Helvetica,sans-serif;color:rgb(34,34,34)">Third, t</span><span lang="EN-US" style="font-family:Helvetica,sans-serif">he effective regulation of quality, safety and efficacy depends on adequately resourced and well-functioning drug regulatory agencies at country level.</span><span lang="EN-US" style="font-family:Helvetica,sans-serif;color:rgb(31,89,197)"> </span><span lang="EN-US" style="font-family:Helvetica,sans-serif;color:rgb(34,34,34)">An important study conducted by WHO on drug regulatory systems in 26 African countries concluded that many countries did not have the capacity to control the quality of medicines circulating in their markets.<u></u><u></u></span></p>

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<span lang="EN-US" style="font-family:Helvetica,sans-serif;color:rgb(34,34,34)">The WHO has a critical mandate to support the development of drug regulatory capacity. This needs to be done urgently.</span><span lang="EN-US" style="font-family:Helvetica,sans-serif;color:rgb(34,34,34)"><u></u><u></u></span></p>

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<span lang="EN-US" style="font-family:Helvetica,sans-serif;color:rgb(34,34,34)">WHO needs to make a clear distinction between the regulation of quality, safety and efficacy on the one hand and the inspection and policing of claimed intellectual property rights. Conflating these two purposes serves the interests of big pharma but it does not assist in the establishment of effective drug regulation to protect consumers from compromised medicines. </span><span lang="EN-US" style="font-family:Helvetica,sans-serif;color:rgb(34,34,34)"><u></u><u></u></span></p>

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<span lang="EN-US" style="font-family:Helvetica,sans-serif">We urge MS to properly fund WHO so it can carry out its proper role including building drug regulatory capacity at global, regional and country levels. We urge MS to resolve the financial crisis of WHO by increasing assessed contributions and converting tied donor funding to untied donations.</span></p>

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<font face="Helvetica, sans-serif">Thank you, Mr. Chairman.</font></p><p class="MsoNormal" style="margin-top:0px;margin-right:0px;margin-bottom:0px;margin-left:0px"><font face="Helvetica, sans-serif"><br>
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<font face="Helvetica, sans-serif"><br></font></p><p class="MsoNormal" style="margin-top:0px;margin-right:0px;margin-bottom:0px;margin-left:0px"><font class="Apple-style-span" face="Helvetica, sans-serif"><br></font></p>
<p class="MsoNormal" style="margin-top:0px;margin-right:0px;margin-bottom:0px;margin-left:0px"><font class="Apple-style-span" face="Helvetica, sans-serif"><span class="Apple-style-span" style="border-collapse:separate;color:rgb(0,0,0);font-family:arial;font-size:small">Heba Wanis</span></font></p>
<font class="Apple-style-span" face="Helvetica, sans-serif"><div>Project Coordinator</div><div>Democratising Global Health Governance</div><div>People's Health Movement</div><div>Global Secretariat Office, Cairo</div>
<div><br></div><div>Tel:   +2 022 268 22 78</div><div>Mob: +20 122 314 0318 (Egypt)</div><div>        +41 7677 07800 (Switzerland)</div><div><div>Web: <a href="http://www.phmovement.org" target="_blank">www.phmovement.org</a></div>
<div>         <a href="http://www.ghwatch.org" target="_blank">www.ghwatch.org</a> </div><div><br></div></div></font></span><font class="Apple-style-span" face="Helvetica, sans-serif"></font><p></p>