Essential medicines and health products

A new setting for the work on Medicines and other Health Technologies at the World Health Organization’s Headquarters in Geneva.

WHO, 19 December 2013

“Access to essential, quality-assured and affordable medical products...”

Dr Margaret Chan, Director General WHO

Over the last few months the Essential Medicines and Health products (EMP) department has gone through a reorganization to better address priority areas, achieve synergies, concentrate resources, and streamline operations, in line with the WHO programme of reform.

Access to essential, quality-assured and affordable medical products is one of the six leadership priorities articulated by the WHO Director General (for more information on WHO’s six leadership priorities, please go to: http://www.who.int/about/who_reform/change_at_who/leadership_priorities/en/#.UrLt4jaA19B
Moreover, a focus on improved access to medicines, vaccines, diagnostics and devices will be key to the achievement of the other leadership priorities, and in particular of Universal Health Coverage, the acceleration of achievement of the MDGs and the reduction of deaths from non-Communicable diseases.

The WHO General Programme of Work and Programme budget for 2014-2014 organize the work of WHO towards increased access to medicines and other health technologies in three broad areas, which correspond to the three functional units in the new EMP structure, placed under the overall leadership of Kees de Joncheere.

These three are as follows:

  • Policy, Access and Use (Coordinator Gilles Forte) addresses the issue of access to medicines and other health technologies (e.g. selection of essential medicines and technologies, pricing and supply, rational use of medicines/technologies, and controlled medicines)
  • Public health, Innovation and Intellectual property (Coordinator Zafar Mirza) coordinates WHO’s work on the Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property (GSPA-PHI), on transfer of technology and local production of medicines, vaccines and other technologies.
  • Regulation of Medicines and other Health Technologies (Head of Unit Lembit Rägo) comprises four teams, focusing each on a specific regulatory function:
    • Technologies’ Norms and standards (Coordinator David Wood) concentrates on core normative work, notably through providing secretariat support to the Expert Committees on Specifications on Pharmaceutical Preparations and on Biological Standardization, the International Pharmacopeia, and the work on International Nonproprietary Names (INN).
    • Regulatory systems strengthening (Coordinator Nora Dellepiane del Rey Tolve) covers the work on National Regulatory Authority (NRA) assessment, technical support to regulatory authorities and the facilitation of regulatory harmonization initiatives.
    • Prequalification of medicines, vaccines, diagnostics and devices – Lembit Rägo as acting coordinator – is in charge of prequalification of priority health products for international procurement.
    • Safety and Vigilance (Coordinator Clive Ondari) is concerned with pharmacovigilance and vaccine safety, acts as focal point for interactions with the Uppsala WHO Collaborating Center, and is in charge of the Secretariat function to assist the Member State mechanism on substandard/spurious/falsely-labeled/falsified/counterfeit (SSFFC) medical products.

To ensure that the quality of the work is maintained and enhanced in relation to the specific product categories, EMP has also decided to supplement the areas of work detailed above with four product specific “horizontal streams” which will cut across the functional areas, in recognition of the specific nature and scientific features of each of these product streams, and which will participate to EMP’s effort to operate in a more integrated way.

These four product streams are the vaccines stream, focal point David Wood; the medicines regulation stream; focal point Lembit Rägo (on an ad interim basis); the diagnostics stream, focal point Irena Prat; and the medical devices stream, focal point Adriana Velazquez Berumen.

The EMP department is collaborating with WHO Regional and Country offices and consulting with major stakeholders towards the articulation of a strategic plan of action that will set out WHO’s vision for the coming years to promote increased access in all countries to essential medicines and other health technologies.

EMP’s leadership and WHO’s Senior Management are confident that this reorganization will help us consolidate our strengths and further improve our contribution to access to essential quality assured medical products, to the benefit of Member States and their citizens; and we look forward to this new phase in the organizational life of the department

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