June 25, 2022

Volume XII, Number 176

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Essential Diagnostics Lists to be Developed by WHO (World Health Organization)

On June 6, 2017, the 20th World Health Organization (WHO) Model List of Essential Medicines was published containing several important additions.  One important addition was the recommendation by the Expert Committee on the Selection of Essential Medicines (Committee) that WHO develop an Essential Diagnostics List (EDL). Based on this recommendation, WHO has begun to lay the ground for the preparation of such a list which will contribute to Universal Health Coverage.

The EDL is intended to provide evidence-based guidance to countries to create their own national lists of essential diagnostic tests and tools.  According to the WHO, essential medicines lists have been successful in facilitating access to treatment and promoting affordable prices, especially in low-resourced countries, by prioritizing the most important medicines that countries need to make available to their populations.  It is believed that the EDL will provide the similar benefits for diagnostics, such as providing improved patient care, greater capacity to diagnose diseases during outbreaks, increased affordability of tests, improved regulation and quality of diagnostic tests and the strengthening of capabilities of national laboratories.

According to the Committee, diagnostic tests are essential not only to diagnose disease or subpopulations of patients for which certain medicines may be indicated, but also to monitor the effectiveness or toxicity of drugs. Moreover, diagnostic tests are often very important in the prognosis of disease.  The Committee recommended that the EDL list focus initially on in vitro diagnostics for tuberculosis, malaria, HIV and Hepatitis B and C but should be expanded as quickly as possible to other important conditions such as antimicrobials and non-communicable diseases.

The WHO is creating a Strategic Advisory Group of Experts on In Vitro Diagnostics (SAGE IVD) to advise WHO on global policies and the development of the EDL.

©2022 MICHAEL BEST & FRIEDRICH LLPNational Law Review, Volume VII, Number 177
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About this Author

Lisa Mueller, Michael Best, Patent application Attorney, intellectual property lawyer,
Partner, Industry Group Chair, Life Sciences

Lisa provides strategic counsel on complex patent issues to clients in the pharmaceutical, biopharmaceutical, biotechnology and chemistry sectors. She brings an in-depth knowledge and extensive experience to her work advising clients on patent protection, freedom to operate and invalidity of blockbuster drugs they aim to produce and distribute.

Lisa’s advice on the full spectrum of global intellectual property portfolio management includes patent prosecution, opposition and other post-grant proceedings

312-596-5812
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