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India Statement at the Second Session of the Working Group on Substandard/spurious/falsely-labelled/falsified/counterfeit medical products

India’s Statement at the Second Session of the Working Group on  Substandard/spurious/falsely-labelled/falsified/counterfeit medical products
(October 25-28, 2011)

 

  1. At the commencement of the deliberations of the second session of the Working Group on Substandard and other categories of medical products, it is important to remember the genesis behind its creation. The momentous decision which the 63rd session of the World Health Assembly undertook in establishing this Working Group aimed to put to rest, decisively, the deliberate and growing confusion that had been introduced between intellectual property rights issues and quality, safe and efficacious issues, variously labeled as QSE in the context of WHO in general and pharma medical products in particular.
  2. Let me acknowledge right at the outset that access to quality, safe and efficacious and affordable medical products continues to present enormous challenges to the world in general but to the developing world in particular. Medical products of compromised quality continue to affect the health and well-being of our populations. The demand side for it is often affected by prevailing high prices of branded pharmaceutical products, weak drug regulatory capacities, inadequate infrastructure and poor quality of monitoring, distribution and storage capacities for medical products in many countries.
  3. India is strongly committed to the deliberations within the context of this Working Group and I would specifically like to congratulate the efforts of the Chairman of the Working Group Ambassador Darlington Nwapeswage and the Bureau. The foremost responsibility of this Working Group would be to ensure that medical products of compromised QSE are effectively prevented and controlled. An accompanying critical output would be to promote and guarantee WHO’s role in ensuring the availability of such QSE products strictly from the perspective of its public health mandate. It would thus clearly eliminate the issue of intellectual property rights enforcement from infringing into the public health mandate of this esteemed organization, the WHO.
  4. Some important milestones have been marked in the 1st meeting of this Working Group. A clear distinction between public health issues and IPR issues had been brought to light and WHO’s work to combat medical products of compromised QSE has been identified. We will of course have to continue our deliberations in order to provide the right template for identifying and controlling medical products of compromised quality. In this context, I would like to assure my delegation’s constructive cooperation to support the Working Group. Our DG Madam Margaret Chan, has correctly identified the priority of WHO’s approach being to include strict regulatory control on the market and strict enforcement of quality standards and diligent pharma covigilance. Her support for promoting the use of generic medical products through suitable bio equivalence guidelines and pre-qualification programmes is an important element in our quest for ensuring access to affordable medical products to our populations.
  5. During the deliberations leading to the run up of this Working Group meeting, various suggestions have been made regarding the kinds of mechanisms that could be put in place to carry forward the work relating to medicines of compromised QSE. My delegation would like to emphasize that the overriding principle that should govern the work of these mechanisms is the importance of inter-governmental supervision. It is with considerable effort that the focus on medical products of compromised quality within WHO has been directed along the perspectives of public health necessities. In order to guarantee this in the future, effective inter-governmental supervision through an inter-governmental mechanism where member-States deliberate on the policies and programmes for WHO to follow within the domains of access and control of quality medical products is very critical. Of course, various mechanisms through committees or sub-committees could be periodically tasked to address specific technical issues that would support the principle of close inter-governmental supervision.
  6. During the deliberations leading to the run up of this Working Group meeting, various suggestions have been made regarding the kinds of mechanisms that could be put in place to carry forward the work relating to medicines of compromised QSE. My delegation would like to emphasize that the overriding principle that should govern the work of these mechanisms is the importance of inter-governmental supervision. It is with considerable effort that the focus on medical products of compromised quality within WHO has been directed along the perspectives of public health necessities. In order to guarantee this in the future, effective inter-governmental supervision through an inter-governmental mechanism where member-States deliberate on the policies and programmes for WHO to follow within the domains of access and control of quality medical products is very critical. Of course, various mechanisms through committees or sub-committees could be periodically tasked to address specific technical issues that would support the principle of close inter-governmental supervision.
  7. A word of caution that my delegation would like to sound is regarding any exercise that we may undertake to individually define each of the components that make up the compromised medical product basket, i.e., SSFFC. These terms do not have have uniform definitions and are understood by different member-States differently. The ability to arrive at a consensus on terminology will be a very difficult one. The solution therefore is to create a universal template for medical products of compromised quality by defining their context of circumstance. The principle of our joint endeavour will thus be to promote access to QSE medical products and to combat medical products with compromised QSE. The task of interpreting what QSE means should be determined by national authorities within the parameters of their national standards and appropriate terminology.
  8. This brings me to the other critical issue, an important matter, which requires WHO’s stringent efforts. That is, to provide guidelines, mobilize support, provide technical assistance and make efforts to train manpower for enhancing and strengthening drug regulatory authorities in developing countries. This would require countries to have in place appropriate medicines regulation, appropriate regulatory infrastructure, appropriate laboratory facilities for quality control and testing facilities and effective expertise and manpower to ensure the availability of QSE medical products. To this effect any inter-governmental mechanism that we decide on, will have to think of the ways and means of enhancing affordability of the medical products while strengthening the necessary regulatory environment and capacity enhancements at national levels, to ensure delivery and availability of quality, safe and efficacious medical products. We have to think of the tools and policies necessary to monitor prices of medicines, to provide technical assistance to member-States, to have mechanisms in place to check the escalating price of medical products, encourage measures to promote and stimulate local production at regional and country levels, find ways to promote rational prescription of medicines, develop comprehensive curriculum for strengthening human resources in these areas, and actively promote and encourage policies that favour procurement and rational use of essential medicines including generic medicines.
  9. A member-driven mechanism within WHO to deal with QSE issue sincluding strengthening of drug regulatory authorities is essential and needs to be drawn up in a transparent manner, but that avoids conflicts and interests, that is member-State driven and critical, has a clear mandate from WHO governance mechanisms.
  10. For the sake of repetition, my delegation would like to emphasize once again that organizations whose mandates give predominance to IPR enforcement issues should be outside the scope of our work relating to QSE issues. I would also like to point out the potential obstacles to access to affordable medicines that arise from the TRIPS+ IPR initiatives that we are seeing in the multilateral fora including through various kind of plurilateral agreements as well as negotiations of IPR chapters in regional trade agreements. In that context, therefore, the disassociation of WHO from IMPACT while being welcome should also be formalized in a transparent manner. Entities which have a predominant IPR agenda cannot infringe into the public health perspective of WHO. What we are aspiring for from the outcome of this Working Group is a member-State driven process that focuses on public health considerations exclusively while grappling with issues of access to medical products and prevention of control of medical products of compromised quality.
  11. I would also like to share some of my delegation’s concerns that might arise from the mechanisms of promoting active collaboration between international agencies on this issue. Foremost in our minds is the way in which enforcement issues tend to acquire importance in such efforts. Moreover, enforcement issues are often on the basis of international legal agreements. Therefore, we have to be alert to the potential drawbacks that may arise from any proposals to link QSE issue to international legal instruments.
  12. In conclusion, therefore, Chairperson, I would like to reiterate the importance India attaches to access to affordable quality, safe and efficacious medicines. This is critical both from the need to promote the right to health as an integral part of economic, social and cultural rights as well as the concomitant requirement of international cooperation to promote universal access to medicines and health in the global context. In this domain, WHO will play the central role. We have high expectations from WHO, being the apex international organization on public health, to continue to play its role in strengthening national health surveillance systems, drug regulatory authorities, promoting access to medicines and clearly and forcefully emphasizing the paramount importance of public health considerations over IPR enforcement matters. We have an intensive schedule ahead of us but let me remind you the outcome of our deliberations will play a critical role in promoting the right to health of all of us. A member-State driven mechanism within the WHO to deal with QSE issues, having a clear mandate from the WHO governing bodies, is the surest way forward in this matter.

 

 

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