Update of the list of essential tests of the WHO

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The World Health Organization (WHO) today published two key lists for global health: the 21st Model List of Essential Medicines& nbsp; (EML), and the 2nd WHO Model List of Essential Diagnoses& nbsp; (EDL). The purpose of these lists is to help & nbsp;Countries prioritize essential health products that should be widely available, accessible and affordable in all health systems, especially in low- and middle-income countries (LMICs).

As countries prepare to deliver on their commitment to deliver Universal health coverage (CSU)it is essential for them to guarantee access to essential products, including tests, vaccines and medicines. Tests are particularly crucial& nbsp; for UHC, because the quality of care depends on our ability to detect conditions and ensure& nbsp; appropriate treatment. Testing is also essential to ensure the optimal use of essential drugs, detect outbreaks, and have robust surveillance systems for antimicrobial resistance and pandemics.

"As countries move closer to universal health coverage and drugs become more available, it will be critical to have the right diagnostic tools to ensure appropriate treatment." & Nbsp;Mari & acirc; ngela Sim & atilde; o, Assistant Director-General for Drugs and Health Products, WHO, Geneva

In one 2016 post at ForbesWith colleagues, I proposed 10 reasons for creating a list of essential diagnoses. Fortunately, the WHO has developed and published the first list of essential diagnoses in 2018. I had the privilege of participating in the expert advisory group charged with developing and updating the PC Plus.

What's in the list?

The first list covered & nbsp; a limited number of priority diseases. & Nbsp;The second list published today has been expanded to include more noncommunicable and communicable diseases.

The 2nd EDL includes 122 categories of tests, presented as follows:

• 46 general IVD tests that can be used for routine patient care, as well as for the detection and diagnosis of a wide range of conditions;
• 69 IVD for the detection, diagnosis and follow-up of specific diseases. The first tests listed in the EDL list concern the following priority disease areas of WHO: HIV, tuberculosis, malaria and hepatitis B and C, syphilis and human papillomavirus infection. The second EDL extends diseases to & nbsp; includes gonorrhea, chlamydia, & nbsp;cholera, leishmaniasis, schistosomiasis, dengue, zika, influenza and blood cultures for bacterial and fungal sepsis.& nbsp; In addition, the list includes several noncommunicable diseases (NCDs), with a new comprehensive chapter covering cancer tests (for example:& nbsp; solid tumors such as colorectal, liver, cervical, prostate, breast and germ cell cancers, as well as leukemia and lymphoma)& nbsp; as well as a new section on & nbsp; anatomopathology facilitating the detection of cancer in general; and
• 7 categories of tests to screen donated blood to ensure safer blood transfusions.

The second EDL is presented by level of health care facility in two levels: 1) & nbsp; community and health settings without laboratory; and 2) & nbsp; Health facilities with clinical laboratories. WHO plans to keep the list up to date every year and the 3rd edition of the JEL is expected by 2020. Although the current list contains only in vitro diagnostics (IVD), I hope future lists will go to beyond in vitro diagnostics. cover others essential diagnostic technologies such as tensiometers, X-rays, ultrasound and electrocardiograms.

How to operate the list?

The WHO Model Lists are intended to provide guidance to countries. For example, the WHO Model List of Essential Medicines has guided and encouraged more than 150 countries to develop their own national lists and use them in their health care delivery strategies. The same approach is needed for PC Plus to have an impact: every country with a national LEM needs to develop a national Plus PC.

Fortunately, countries are starting to adapt and develop their own PC Plus, with India in the lead. On the basis of the national burden of disease and the capacity of the health system, countries can modify and adapt the WHO EDL list according to their priorities and needs.

To ensure the availability of essential tests in the health system, it is important to ensure that they are integrated into the UHC benefit packages. & Nbsp;When the tests are not recognized as an essential component of the UHC package, they & nbsp;attract little attention, budget and implementation support. If the tests are not explicitly listed in national health plans or benefit packages, there is no mechanism for supply, supply and reimbursement.

Once national essential test lists have been developed and included in UHC packages, countries will need to invest in multi-level, connected and efficient laboratory networks, including sample transport and reference systems. For decades, LICs and LICs have neglected laboratories and favored drugs for testing. & Nbsp;Consequences of underinvestment & nbsp; in diagnostics and laboratories are clear. Laboratory infrastructure in most low- and middle-income countries & nbsp;is very weak. same simple tests are missing in many health facilities in middle-income countries.

So it's not shocking that & nbsp; dDiagnosis is the biggest gap in the cascade of care. This is true for a range of communicable devices (for example, tuberculosis, HIV, Hepatitis C) as well as noncommunicable diseases (eg. Diabetes, hypertension, Cancer). & nbsp;

Although the traditional approach of using drugs at the expense of testing may have worked in the past, this certainly can not work in the era of UHC. All countries must invest in laboratories and ensure that tests are available at all levels of the health system (community, primary, secondary and tertiary health care).

Can the diagnostic industry help?

The & nbsp; in vitro diagnostics industry, which has received the EDL from the WHO positively, can play a key role here and support the strengthening of laboratories in PRFMs as a key activity for global health. The in vitro diagnostic industry can also improve access to essential testing through special access programs for low- and middle-income countries (for example, preferential rapid test of molecular tuberculosis, and HIV viral load test). Currently, special access programs are generally limited to a few priority infections. This needs to change, as PRFMs are increasingly fighting NCDs and will have to diagnose a wide range of noncommunicable diseases.

The right to diagnosis

As I already explained, & nbsp; the global health community must& nbsp;reject the mentality& nbsp; simple and rapid tests and empirical treatments are "sufficient for poor countries". LMIC decision-makers need to start investing in diagnostic tests and laboratories. And advocates for patients' rights and civil society must demand better access to early and accurate diagnosis as a fundamental right.

All patients deserve to know their diagnosis no matter where they live or what they earn. The implementation of PC Plus on the CSU agenda is the surest way to achieve this.

Disclosure: I served in WHO & nbsp;Strategic Advisory Group on In Vitro Diagnostics (SAGE IVD) which has developed and updated the list of essential diagnoses. I have no financial or industrial interest in a business or diagnostic product.

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The World Health Organization (WHO) today released two key lists for global health: the 21st WHO Model List of Essential Medicines (EML) and the second WHO Model List of Essential Medicines for Diagnostics (EDL). The purpose of these lists is to help Countries prioritize essential health products that should be widely available, accessible and affordable in all health systems, especially in low- and middle-income countries (LMICs).

As countries prepare to deliver on their commitment to universal health coverage, it is essential for them to ensure access to essential products, including tests, vaccines and medicines. Testing is especially important for UHC because the quality of care depends on our ability to detect conditions and ensure appropriate treatment. Testing is also essential to ensure the optimal use of essential drugs, detect outbreaks, and have robust surveillance systems for antimicrobial resistance and pandemics.

"As countries move closer to universal health coverage and medicines become more available, it will be crucial to have the right diagnostic tools to ensure appropriate treatment." Mariângela Simão, Assistant Director-General for Drugs and Diseases health products, WHO, Geneva

In an article published in 2016 in Forbes, I had, along with my colleagues, 10 reasons to create a list of essential diagnoses. Fortunately, the WHO has developed and published the first list of essential diagnoses in 2018. I had the privilege of participating in the expert advisory group charged with developing and updating the PC Plus.

What's in the list?

The first list covered a limited number of priority diseases. The second list published today has been expanded to include more noncommunicable and communicable diseases.

The 2nd EDL includes 122 categories of tests, presented as follows:

• 46 general IVD tests that can be used for routine patient care, as well as for the detection and diagnosis of a wide range of diseases;
• 69 IVD for the detection, diagnosis and follow-up of specific diseases. The first LDC listed tests for the following priority disease areas of WHO: HIV, tuberculosis, malaria and hepatitis B and C, as well as for syphilis and human papillomavirus infection. The second EDL extends diseases to gonorrhea, chlamydia, cholera, leishmaniasis, schistosomiasis, dengue, zika, influenza and blood cultures for bacterial and fungal sepsis. In addition, the list includes several noncommunicable diseases (NCDs), with a new comprehensive chapter covering cancer tests (for example: solid tumors such as colorectal, hepatic, cervical, prostate, breast and germ cell cancers, as well as leukemia and lymphomas) as well as a new section on pathology to facilitate the detection of cancer in general; and
• 7 categories of tests to screen donated blood to ensure safer blood transfusions.

The second EDL is presented by level of health care facility in two levels: 1) community and health environments without laboratories; and 2) health facilities with clinical laboratories. WHO plans to keep the list up to date every year and the 3rd edition of the JEL is expected by 2020. Although the current list contains only in vitro diagnostics (IVD), I hope that the future lists will go beyond IVDs and will cover other critical diagnostic technologies such as blood pressure, X-ray, ultrasound and electrocardiograms.

How to operate the list?

The WHO Model Lists are intended to provide guidance to countries. For example, the WHO Model List of Essential Medicines has guided and encouraged more than 150 countries to develop their own national lists and use them in their health care delivery strategies. The same approach is needed for PC Plus to have an impact: every country with a national LEM needs to develop a national Plus PC.

Fortunately, countries are starting to adapt and develop their own PC Plus, with India in the lead. On the basis of the national burden of disease and the capacity of the health system, countries can modify and adapt the WHO EDL list according to their priorities and needs.

To ensure the availability of essential tests in the health system, it is important to ensure that they are incorporated into the UHC benefit packages. When testing is not recognized as an essential component of the UHC package, they attract little attention, budget and implementation support. If tests are not explicitly listed in national health plans or benefit packages, there is no mechanism for purchase, supply and reimbursement.

Once national essential test lists have been developed and included in UHC packages, countries will need to invest in multi-level, connected and efficient laboratory networks, including sample transport and reference systems. For decades, LMICs have neglected laboratories and have focused on drugs over tests. The consequences of underinvestment in diagnostics and laboratories are clear. Laboratory infrastructure in most low- and middle-income countries is very weak. Even simple tests are lacking in many health facilities in middle-income countries.

So it's not shocking thatDiagnosis is the biggest gap in the cascade of care. This is true for a range of communicable diseases (eg, tuberculosis, HIV, hepatitis C) and noncommunicable diseases (eg diabetes, hypertension, cancer).

Although the traditional approach of using drugs at the expense of testing may have worked in the past, this certainly can not work in the era of UHC. All countries must invest in laboratories and ensure that tests are available at all levels of the health system (community, primary, secondary and tertiary health care).

Can the diagnostic industry help?

The IVD sector, which has received the JED from the WHO in a positive way, can play a key role in this regard and support the strengthening of laboratories in the LMICs as a key activity of global health. The IVD industry can also improve access to essential testing through special access programs for low- and middle-income countries (eg, preferential pricing for early detection of molecular TB) and the HIV viral load test). Currently, special access programs are generally limited to a few priority infections. This needs to change, as LMICs face increasing numbers of NCDs and will need to diagnose a wide range of noncommunicable diseases.

The right to diagnosis

As I have already explained, the global health community must reject the mentality simple and rapid tests and empirical treatments are enough "for poor countries". Policymakers in low- and middle-income countries need to start investing in diagnostic tests and laboratories. Donors and donors need to go beyond test purchases and invest in laboratories and health systems. And advocates for patients' rights and civil society must demand better access to early and accurate diagnosis as a fundamental right.

All patients deserve to know their diagnosis no matter where they live or what they earn. The implementation of PC Plus on the CSU agenda is the surest way to achieve this.

Disclosure: I served with the WHO Strategic Advisory Group on In Vitro Diagnostics (SAGE IVD) which has developed and updated the list of essential diagnoses. I have no financial or industrial interest in a business or diagnostic product.