Deprecated (16384): The ArrayAccess methods will be removed in 4.0.0.Use getParam(), getData() and getQuery() instead. - /home/brlfuser/public_html/src/Controller/ArtileDetailController.php, line: 150
 You can disable deprecation warnings by setting `Error.errorLevel` to `E_ALL & ~E_USER_DEPRECATED` in your config/app.php. [CORE/src/Core/functions.php, line 311]
Code Context


        trigger_error($message, E_USER_DEPRECATED);

    }
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 You can disable deprecation warnings by setting `Error.errorLevel` to `E_ALL & ~E_USER_DEPRECATED` in your config/app.php.'
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deprecationWarning - CORE/src/Core/functions.php, line 311
Cake\Http\ServerRequest::offsetGet() - CORE/src/Http/ServerRequest.php, line 2421
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Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Http\Runner::run() - CORE/src/Http/Runner.php, line 51
Cake\Http\Server::run() - CORE/src/Http/Server.php, line 98

Deprecated (16384): The ArrayAccess methods will be removed in 4.0.0.Use getParam(), getData() and getQuery() instead. - /home/brlfuser/public_html/src/Controller/ArtileDetailController.php, line: 151
 You can disable deprecation warnings by setting `Error.errorLevel` to `E_ALL & ~E_USER_DEPRECATED` in your config/app.php. [CORE/src/Core/functions.php, line 311]
Code Context


        trigger_error($message, E_USER_DEPRECATED);

    }
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 You can disable deprecation warnings by setting `Error.errorLevel` to `E_ALL & ~E_USER_DEPRECATED` in your config/app.php.'
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deprecationWarning - CORE/src/Core/functions.php, line 311
Cake\Http\ServerRequest::offsetGet() - CORE/src/Http/ServerRequest.php, line 2421
App\Controller\ArtileDetailController::index() - APP/Controller/ArtileDetailController.php, line 151
Cake\Controller\Controller::invokeAction() - CORE/src/Controller/Controller.php, line 610
Cake\Http\ActionDispatcher::_invoke() - CORE/src/Http/ActionDispatcher.php, line 120
Cake\Http\ActionDispatcher::dispatch() - CORE/src/Http/ActionDispatcher.php, line 94
Cake\Http\BaseApplication::__invoke() - CORE/src/Http/BaseApplication.php, line 235
Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Routing\Middleware\RoutingMiddleware::__invoke() - CORE/src/Routing/Middleware/RoutingMiddleware.php, line 162
Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Routing\Middleware\AssetMiddleware::__invoke() - CORE/src/Routing/Middleware/AssetMiddleware.php, line 97
Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Error\Middleware\ErrorHandlerMiddleware::__invoke() - CORE/src/Error/Middleware/ErrorHandlerMiddleware.php, line 96
Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Http\Runner::run() - CORE/src/Http/Runner.php, line 51
Cake\Http\Server::run() - CORE/src/Http/Server.php, line 98

Warning (512): Unable to emit headers. Headers sent in file=/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Error/Debugger.php line=853 [CORE/src/Http/ResponseEmitter.php, line 48]
Code Context
            if (Configure::read('debug')) {

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        LATEST NEWS UPDATES | Conflict of interest in setting norms for pharmaceuticals in WHO -Rema Nagarajan    </title>
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NEW DELHI: The World Health Organisation's (WHO) work of setting up norms and standards for production of medicines seems to be flawed by a fundamental conflict of interest. At the heart of its standard setting work is..."/>
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                            <div style="text-align: justify">-The Times of India</div><div style="text-align: justify">&nbsp;</div><p style="text-align: justify"><em>NEW DELHI: </em>The World Health Organisation's (WHO) work of setting up norms and standards for production of medicines seems to be flawed by a fundamental conflict of interest. At the heart of its standard setting work is an entity the International Conference on Harmonization (ICH) in which majority of the WHO member countries have no voting rights and which is dominated by pharmaceutical industry groups. This glaring conflict of interest seems to fly in the face of WHO's policy on engagement with private entities which states that the development of norms, standards, policies and strategies which lies at the heart of WHO's work would be protected from influence by any form of vested interest. </p><p style="text-align: justify">To begin with, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), closely involved with ICH since its inception, hosts the ICH secretariat in Geneva. So, the two share the same address --15, chemin Louis-Dunant, PO Box 195, 1211 Geneva-20. IFPMA participates in the steering committee of the ICH as a non-voting member. </p><p style="text-align: justify">The six sponsors of ICH are the European Commission and the European Federation of Pharmaceutical Industries' Associations (EFPIA); the Japanese Ministry of Health, Labour and Welfare (JMHLW) and the Japan Pharmaceutical Manufacturers Association (JPMA); and the United States Food and Drug Administration (FDA) and the Pharmaceutical Research and Manufacturers of America (PhRMA). These six are the voting members of the ICH Steering Committee. Thus, ICH represents big multinational drug companies and 17 countries comprising 15% of the world's population and accounting for more than three quarter of the global pharmaceutical sales. The WHO, Health Canada and the European Free Trade Association (EFTA) are just observers in ICH. When WHO gets influenced by ICH guidelines, these guidelines made by a small section becomes applicable to the bulk of the world's population without any of these populations having a say in their framing. </p><p style="text-align: justify">In the name of global cooperation, the ICH also invites representatives of many countries including India, China, Brazil and so on. But none of these countries have any participation in the decision-making process or any voting rights in the ICH. The ICH also does not have any representation of generic manufacturers from outside the ICH regions (EU, US and Japan) or members of the civil society, professional groups, patient or consumer advocacy groups. </p><p style="text-align: justify">ICH is primarily an attempt to harmonise drug approval requirements to enable industry to bring drugs into the market faster and start earning maximum revenue during the period the drug is under patent. Harmonisation helps prevent loss of patent period time and money on regulatory hurdles. However, most of the rhetoric on harmonization is about how ICH serves public interest by bringing new breakthrough or innovative drugs faster to patients. However, there has been wide-spread criticism that the drug industry, through the ICH, influences not only regulatory approvals mechanism for drugs introduction but also guidelines for pharmacovigilance in the form of post marketing surveillance and reporting of adverse drug reactions and guidelines for clinical trials, trying to relax the safety standards for trials. According to critics it would be naive to see the ICH process as involving purely technical matters as it also affects patients and consumers. Hence, there has been a push for greater public debate, scrutiny and accountability in the harmonization process. </p><p style="text-align: justify">A WHO publication of 2002 titled The Impact of ICH Guidelines in Non-ICH Countries stated: &quot;In many countries, essential drugs required for the prevention and treatment of locally endemic conditions are not supplied by the major multinationals, but by local industry or by generic manufacturers. If these suppliers are unable to meet what may be unsubstantiated quality standards, the adverse impact of the withdrawal of these drugs on the health of the population might well be far more dramatic than that of any hypothetical risk posed by failing to achieve the ICH standards.&quot; Critics have also warned that harmonisation of regulatory standards is being used by the drug industry to create new entry barriers for drugs from the developing world to prevent competition. </p><p style="text-align: justify">The WHO document stated that although ICH countries import large quantities of pharmaceuticals from non-ICH countries with weak regulatory systems, many countries are led to think that adoption of the guidelines is a necessary move to gain access to the pharmaceutical markets of ICH countries.&quot; This &quot;spontaneous&quot; dissemination of ICH products is not necessarily consistent with national priorities and represents a pressure that may lead to diverting limited national resources to unnecessary expenses entailed by the adoption of more costly regulatory requirements,&quot; said the document. </p><p style="text-align: justify">The document further noted that &quot;appropriate strategies for consultation and communication with Member States need to be developed to ensure that WHO is not seen as de facto automatically endorsing ICH products, but as providing advice on the potential impact of those products on non-ICH Member States&quot;. It added that ICH process has involved only 17 industrialized countries in the decision-making process, and that the views, priorities, and needs of the majority of WHO Member States have only sporadically been taken into consideration.Despite being aware of this conflict, the ICH has not been democratized or made more transparent in its working and it continues to influence WHO guidelines. </p><p style="text-align: justify">Yet, many of the ICH guidelines have become part of the WHO guidelines on pharmaceutical manufacture and registration process despite questions being raised about the guidelines of the WHO being influenced or even being decided by an organization which is primarily driven by business interests of association whose primary purpose is to protect their own commercial interests. WHO is yet to respond in any effective manner to these concerns. And in the upcoming World Health Assembly the WHO is pushing a resolution that urges member nations to implement relevant guidance and science-based outputs of international regulatory harmonization and convergence efforts and to use where applicable, the Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.</p>                                                           
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    <br><a href="http://timesofindia.indiatimes.com/city/delhi/Conflict-of-interest-in-setting-norms-for-pharmaceuticals-in-WHO/articleshow/35261958.cms" class="re" target="_blank">The Times of India, 17 May, 2014, http://timesofindia.indiatimes.com/city/delhi/Conflict-of-interest-in-setting-norms-for-pharmaceuticals-in-WHO/articleshow/35261958.cms</a><div class="clear"></div>
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        LATEST NEWS UPDATES | Conflict of interest in setting norms for pharmaceuticals in WHO -Rema Nagarajan    </title>
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    <h1 class="cat-box-title">Conflict of interest in setting norms for pharmaceuticals in WHO -Rema Nagarajan</h1>
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                            <div style="text-align: justify">-The Times of India</div><div style="text-align: justify">&nbsp;</div><p style="text-align: justify"><em>NEW DELHI: </em>The World Health Organisation's (WHO) work of setting up norms and standards for production of medicines seems to be flawed by a fundamental conflict of interest. At the heart of its standard setting work is an entity the International Conference on Harmonization (ICH) in which majority of the WHO member countries have no voting rights and which is dominated by pharmaceutical industry groups. This glaring conflict of interest seems to fly in the face of WHO's policy on engagement with private entities which states that the development of norms, standards, policies and strategies which lies at the heart of WHO's work would be protected from influence by any form of vested interest. </p><p style="text-align: justify">To begin with, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), closely involved with ICH since its inception, hosts the ICH secretariat in Geneva. So, the two share the same address --15, chemin Louis-Dunant, PO Box 195, 1211 Geneva-20. IFPMA participates in the steering committee of the ICH as a non-voting member. </p><p style="text-align: justify">The six sponsors of ICH are the European Commission and the European Federation of Pharmaceutical Industries' Associations (EFPIA); the Japanese Ministry of Health, Labour and Welfare (JMHLW) and the Japan Pharmaceutical Manufacturers Association (JPMA); and the United States Food and Drug Administration (FDA) and the Pharmaceutical Research and Manufacturers of America (PhRMA). These six are the voting members of the ICH Steering Committee. Thus, ICH represents big multinational drug companies and 17 countries comprising 15% of the world's population and accounting for more than three quarter of the global pharmaceutical sales. The WHO, Health Canada and the European Free Trade Association (EFTA) are just observers in ICH. When WHO gets influenced by ICH guidelines, these guidelines made by a small section becomes applicable to the bulk of the world's population without any of these populations having a say in their framing. </p><p style="text-align: justify">In the name of global cooperation, the ICH also invites representatives of many countries including India, China, Brazil and so on. But none of these countries have any participation in the decision-making process or any voting rights in the ICH. The ICH also does not have any representation of generic manufacturers from outside the ICH regions (EU, US and Japan) or members of the civil society, professional groups, patient or consumer advocacy groups. </p><p style="text-align: justify">ICH is primarily an attempt to harmonise drug approval requirements to enable industry to bring drugs into the market faster and start earning maximum revenue during the period the drug is under patent. Harmonisation helps prevent loss of patent period time and money on regulatory hurdles. However, most of the rhetoric on harmonization is about how ICH serves public interest by bringing new breakthrough or innovative drugs faster to patients. However, there has been wide-spread criticism that the drug industry, through the ICH, influences not only regulatory approvals mechanism for drugs introduction but also guidelines for pharmacovigilance in the form of post marketing surveillance and reporting of adverse drug reactions and guidelines for clinical trials, trying to relax the safety standards for trials. According to critics it would be naive to see the ICH process as involving purely technical matters as it also affects patients and consumers. Hence, there has been a push for greater public debate, scrutiny and accountability in the harmonization process. </p><p style="text-align: justify">A WHO publication of 2002 titled The Impact of ICH Guidelines in Non-ICH Countries stated: &quot;In many countries, essential drugs required for the prevention and treatment of locally endemic conditions are not supplied by the major multinationals, but by local industry or by generic manufacturers. If these suppliers are unable to meet what may be unsubstantiated quality standards, the adverse impact of the withdrawal of these drugs on the health of the population might well be far more dramatic than that of any hypothetical risk posed by failing to achieve the ICH standards.&quot; Critics have also warned that harmonisation of regulatory standards is being used by the drug industry to create new entry barriers for drugs from the developing world to prevent competition. </p><p style="text-align: justify">The WHO document stated that although ICH countries import large quantities of pharmaceuticals from non-ICH countries with weak regulatory systems, many countries are led to think that adoption of the guidelines is a necessary move to gain access to the pharmaceutical markets of ICH countries.&quot; This &quot;spontaneous&quot; dissemination of ICH products is not necessarily consistent with national priorities and represents a pressure that may lead to diverting limited national resources to unnecessary expenses entailed by the adoption of more costly regulatory requirements,&quot; said the document. </p><p style="text-align: justify">The document further noted that &quot;appropriate strategies for consultation and communication with Member States need to be developed to ensure that WHO is not seen as de facto automatically endorsing ICH products, but as providing advice on the potential impact of those products on non-ICH Member States&quot;. It added that ICH process has involved only 17 industrialized countries in the decision-making process, and that the views, priorities, and needs of the majority of WHO Member States have only sporadically been taken into consideration.Despite being aware of this conflict, the ICH has not been democratized or made more transparent in its working and it continues to influence WHO guidelines. </p><p style="text-align: justify">Yet, many of the ICH guidelines have become part of the WHO guidelines on pharmaceutical manufacture and registration process despite questions being raised about the guidelines of the WHO being influenced or even being decided by an organization which is primarily driven by business interests of association whose primary purpose is to protect their own commercial interests. WHO is yet to respond in any effective manner to these concerns. And in the upcoming World Health Assembly the WHO is pushing a resolution that urges member nations to implement relevant guidance and science-based outputs of international regulatory harmonization and convergence efforts and to use where applicable, the Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.</p>                                                           
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    <br><a href="http://timesofindia.indiatimes.com/city/delhi/Conflict-of-interest-in-setting-norms-for-pharmaceuticals-in-WHO/articleshow/35261958.cms" class="re" target="_blank">The Times of India, 17 May, 2014, http://timesofindia.indiatimes.com/city/delhi/Conflict-of-interest-in-setting-norms-for-pharmaceuticals-in-WHO/articleshow/35261958.cms</a><div class="clear"></div>
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        LATEST NEWS UPDATES | Conflict of interest in setting norms for pharmaceuticals in WHO -Rema Nagarajan    </title>
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                            <div style="text-align: justify">-The Times of India</div><div style="text-align: justify">&nbsp;</div><p style="text-align: justify"><em>NEW DELHI: </em>The World Health Organisation's (WHO) work of setting up norms and standards for production of medicines seems to be flawed by a fundamental conflict of interest. At the heart of its standard setting work is an entity the International Conference on Harmonization (ICH) in which majority of the WHO member countries have no voting rights and which is dominated by pharmaceutical industry groups. This glaring conflict of interest seems to fly in the face of WHO's policy on engagement with private entities which states that the development of norms, standards, policies and strategies which lies at the heart of WHO's work would be protected from influence by any form of vested interest. </p><p style="text-align: justify">To begin with, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), closely involved with ICH since its inception, hosts the ICH secretariat in Geneva. So, the two share the same address --15, chemin Louis-Dunant, PO Box 195, 1211 Geneva-20. IFPMA participates in the steering committee of the ICH as a non-voting member. </p><p style="text-align: justify">The six sponsors of ICH are the European Commission and the European Federation of Pharmaceutical Industries' Associations (EFPIA); the Japanese Ministry of Health, Labour and Welfare (JMHLW) and the Japan Pharmaceutical Manufacturers Association (JPMA); and the United States Food and Drug Administration (FDA) and the Pharmaceutical Research and Manufacturers of America (PhRMA). These six are the voting members of the ICH Steering Committee. Thus, ICH represents big multinational drug companies and 17 countries comprising 15% of the world's population and accounting for more than three quarter of the global pharmaceutical sales. The WHO, Health Canada and the European Free Trade Association (EFTA) are just observers in ICH. When WHO gets influenced by ICH guidelines, these guidelines made by a small section becomes applicable to the bulk of the world's population without any of these populations having a say in their framing. </p><p style="text-align: justify">In the name of global cooperation, the ICH also invites representatives of many countries including India, China, Brazil and so on. But none of these countries have any participation in the decision-making process or any voting rights in the ICH. The ICH also does not have any representation of generic manufacturers from outside the ICH regions (EU, US and Japan) or members of the civil society, professional groups, patient or consumer advocacy groups. </p><p style="text-align: justify">ICH is primarily an attempt to harmonise drug approval requirements to enable industry to bring drugs into the market faster and start earning maximum revenue during the period the drug is under patent. Harmonisation helps prevent loss of patent period time and money on regulatory hurdles. However, most of the rhetoric on harmonization is about how ICH serves public interest by bringing new breakthrough or innovative drugs faster to patients. However, there has been wide-spread criticism that the drug industry, through the ICH, influences not only regulatory approvals mechanism for drugs introduction but also guidelines for pharmacovigilance in the form of post marketing surveillance and reporting of adverse drug reactions and guidelines for clinical trials, trying to relax the safety standards for trials. According to critics it would be naive to see the ICH process as involving purely technical matters as it also affects patients and consumers. Hence, there has been a push for greater public debate, scrutiny and accountability in the harmonization process. </p><p style="text-align: justify">A WHO publication of 2002 titled The Impact of ICH Guidelines in Non-ICH Countries stated: &quot;In many countries, essential drugs required for the prevention and treatment of locally endemic conditions are not supplied by the major multinationals, but by local industry or by generic manufacturers. If these suppliers are unable to meet what may be unsubstantiated quality standards, the adverse impact of the withdrawal of these drugs on the health of the population might well be far more dramatic than that of any hypothetical risk posed by failing to achieve the ICH standards.&quot; Critics have also warned that harmonisation of regulatory standards is being used by the drug industry to create new entry barriers for drugs from the developing world to prevent competition. </p><p style="text-align: justify">The WHO document stated that although ICH countries import large quantities of pharmaceuticals from non-ICH countries with weak regulatory systems, many countries are led to think that adoption of the guidelines is a necessary move to gain access to the pharmaceutical markets of ICH countries.&quot; This &quot;spontaneous&quot; dissemination of ICH products is not necessarily consistent with national priorities and represents a pressure that may lead to diverting limited national resources to unnecessary expenses entailed by the adoption of more costly regulatory requirements,&quot; said the document. </p><p style="text-align: justify">The document further noted that &quot;appropriate strategies for consultation and communication with Member States need to be developed to ensure that WHO is not seen as de facto automatically endorsing ICH products, but as providing advice on the potential impact of those products on non-ICH Member States&quot;. It added that ICH process has involved only 17 industrialized countries in the decision-making process, and that the views, priorities, and needs of the majority of WHO Member States have only sporadically been taken into consideration.Despite being aware of this conflict, the ICH has not been democratized or made more transparent in its working and it continues to influence WHO guidelines. </p><p style="text-align: justify">Yet, many of the ICH guidelines have become part of the WHO guidelines on pharmaceutical manufacture and registration process despite questions being raised about the guidelines of the WHO being influenced or even being decided by an organization which is primarily driven by business interests of association whose primary purpose is to protect their own commercial interests. WHO is yet to respond in any effective manner to these concerns. And in the upcoming World Health Assembly the WHO is pushing a resolution that urges member nations to implement relevant guidance and science-based outputs of international regulatory harmonization and convergence efforts and to use where applicable, the Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.</p>                                                           
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    <br><a href="http://timesofindia.indiatimes.com/city/delhi/Conflict-of-interest-in-setting-norms-for-pharmaceuticals-in-WHO/articleshow/35261958.cms" class="re" target="_blank">The Times of India, 17 May, 2014, http://timesofindia.indiatimes.com/city/delhi/Conflict-of-interest-in-setting-norms-for-pharmaceuticals-in-WHO/articleshow/35261958.cms</a><div class="clear"></div>
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Conflict of interest in setting norms for pharmaceuticals in WHO -Rema Nagarajan

Published on May 18, 2014   Modified on May 18, 2014

-The Times of India   NEW DELHI: The World Health Organisation's (WHO) work of setting up norms and standards for production of medicines seems to be flawed by a fundamental conflict of interest. At the heart of its standard setting work is an entity the International Conference on Harmonization (ICH) in which majority of the WHO member countries have no voting rights and which is dominated by pharmaceutical industry groups. This glaring conflict of interest seems to fly in the face of WHO's policy on engagement with private entities which states that the development of norms, standards, policies and strategies which lies at the heart of WHO's work would be protected from influence by any form of vested interest. To begin with, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), closely involved with ICH since its inception, hosts the ICH secretariat in Geneva. So, the two share the same address --15, chemin Louis-Dunant, PO Box 195, 1211 Geneva-20. IFPMA participates in the steering committee of the ICH as a non-voting member. The six sponsors of ICH are the European Commission and the European Federation of Pharmaceutical Industries' Associations (EFPIA); the Japanese Ministry of Health, Labour and Welfare (JMHLW) and the Japan Pharmaceutical Manufacturers Association (JPMA); and the United States Food and Drug Administration (FDA) and the Pharmaceutical Research and Manufacturers of America (PhRMA). These six are the voting members of the ICH Steering Committee. Thus, ICH represents big multinational drug companies and 17 countries comprising 15% of the world's population and accounting for more than three quarter of the global pharmaceutical sales. The WHO, Health Canada and the European Free Trade Association (EFTA) are just observers in ICH. When WHO gets influenced by ICH guidelines, these guidelines made by a small section becomes applicable to the bulk of the world's population without any of these populations having a say in their framing. In the name of global cooperation, the ICH also invites representatives of many countries including India, China, Brazil and so on. But none of these countries have any participation in the decision-making process or any voting rights in the ICH. The ICH also does not have any representation of generic manufacturers from outside the ICH regions (EU, US and Japan) or members of the civil society, professional groups, patient or consumer advocacy groups. ICH is primarily an attempt to harmonise drug approval requirements to enable industry to bring drugs into the market faster and start earning maximum revenue during the period the drug is under patent. Harmonisation helps prevent loss of patent period time and money on regulatory hurdles. However, most of the rhetoric on harmonization is about how ICH serves public interest by bringing new breakthrough or innovative drugs faster to patients. However, there has been wide-spread criticism that the drug industry, through the ICH, influences not only regulatory approvals mechanism for drugs introduction but also guidelines for pharmacovigilance in the form of post marketing surveillance and reporting of adverse drug reactions and guidelines for clinical trials, trying to relax the safety standards for trials. According to critics it would be naive to see the ICH process as involving purely technical matters as it also affects patients and consumers. Hence, there has been a push for greater public debate, scrutiny and accountability in the harmonization process. A WHO publication of 2002 titled The Impact of ICH Guidelines in Non-ICH Countries stated: "In many countries, essential drugs required for the prevention and treatment of locally endemic conditions are not supplied by the major multinationals, but by local industry or by generic manufacturers. If these suppliers are unable to meet what may be unsubstantiated quality standards, the adverse impact of the withdrawal of these drugs on the health of the population might well be far more dramatic than that of any hypothetical risk posed by failing to achieve the ICH standards." Critics have also warned that harmonisation of regulatory standards is being used by the drug industry to create new entry barriers for drugs from the developing world to prevent competition. The WHO document stated that although ICH countries import large quantities of pharmaceuticals from non-ICH countries with weak regulatory systems, many countries are led to think that adoption of the guidelines is a necessary move to gain access to the pharmaceutical markets of ICH countries." This "spontaneous" dissemination of ICH products is not necessarily consistent with national priorities and represents a pressure that may lead to diverting limited national resources to unnecessary expenses entailed by the adoption of more costly regulatory requirements," said the document. The document further noted that "appropriate strategies for consultation and communication with Member States need to be developed to ensure that WHO is not seen as de facto automatically endorsing ICH products, but as providing advice on the potential impact of those products on non-ICH Member States". It added that ICH process has involved only 17 industrialized countries in the decision-making process, and that the views, priorities, and needs of the majority of WHO Member States have only sporadically been taken into consideration.Despite being aware of this conflict, the ICH has not been democratized or made more transparent in its working and it continues to influence WHO guidelines. Yet, many of the ICH guidelines have become part of the WHO guidelines on pharmaceutical manufacture and registration process despite questions being raised about the guidelines of the WHO being influenced or even being decided by an organization which is primarily driven by business interests of association whose primary purpose is to protect their own commercial interests. WHO is yet to respond in any effective manner to these concerns. And in the upcoming World Health Assembly the WHO is pushing a resolution that urges member nations to implement relevant guidance and science-based outputs of international regulatory harmonization and convergence efforts and to use where applicable, the Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.

The Times of India, 17 May, 2014, http://timesofindia.indiatimes.com/city/delhi/Conflict-of-interest-in-setting-norms-for-pharmaceuticals-in-WHO/articleshow/35261958.cms

Tagged with: medicines Health Public Health

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