This tutorial has been designed to help you as focal points (or mapCrowders) to enter data in the mapCrowd data fields related to a country that you agreed to inform.
It will describe all the necessary steps to properly and easily fill in data.
General Tips / Section Epidemiological data / Section HCV Diagnostics / Section HCV Treatment / Section HCV Policy / Section Organizations
Before going into details, here are some general tips about the tool:
Within the tool, you will find 3 types of questions:
1. An empty box where you can only enter figures for prices, prevalence estimates, or other numbers;
2. For some questions you will have a simple choice;
3. And for others: multiple choices.
A comment area linked to each data point where you’ll be able to provide sources of the data or/and give more details about a data point.
For instance, we request specific prices on diagnostics and treatments. You should enter the prices paid by public or private health systems. But in the comment section, you can also indicate the out-of-pocket cost for patients, if some patients can get them for free, or other information.
Note that your comments will be automatically translated into the 3 others languages.
We will come back to this new option further in the tutorial.
Prices requested in the sections HCV diagnostics and HCV treatment must to be indicated in the local currency of the country, then it will be automatically converted in US$ for the public section, taking into account the current exchange rates.
Save your work!
After entering data, please remember to save your work by clicking on this icon at the end of each sections:
or this one is accessible on the right side, at any moment:
And now let’s explore together the mapCrowd tool
To start filling in data go to: www.mapcrowd.org
You can login into the private section.
Don’t worry, we won’t go into detail for all questions, but we will provide you an overview of the tool and when necessary explain some questions.
Login into mapCrowd
You are landing on the public section of the website.
Please click on ’Menu’ then Login to access the private section of the tool and to begin filling in data.
Enter the login and the password you received from the mapCrowd administrators.
Please respect the exact writing of the password. It includes capital letters and/or numbers.
Click on ‘Sign in’.
You are landing on your country page. Here, “Åland Islands” will be our country example.
You are now able to enter data into 5 sections. You can start with any of these sections.
For more fluidity and better understanding, this tutorial will follow the order of the sections and start with Section 1. Epidemiological data.
There are 6 questions related to this topic that appear. For some of them, there is a chance that some fields have been already filled with data.
These data come from reviewing the HCV epidemiology literature, which has been conducted by the mapCrowd administrators.
The source, when available, is indicated in the comment area that you can access by clicking on the small triangle at the top right of the data point.
Please note: If you have more accurate and recent data on this topic, please enter the new data by simply clicking in the box. Then be as precise as possible in the comment space to give the source or any other relevant information.
After entering data, please remember to save your work at the end of each section.
The next section, section 2. HCV Diagnostics, automatically opens.
Two maps in the public section are linked to data entered in this section:
1) Worldwide relative burden of HCV among people who inject drugs applies to questions 1.1 and 1.6 .
The second map, the estimated adult prevalence of HCV (antibody), is directly linked to question 1.1 (overall prevalence).
To go back to your country profile, click on the Menu, then Administration.
You’re landing on your assigned country, let’s see section 2!
2. Section HCV Diagnostics
This section is comprised of 9 questions. All start with the diagnostics availability, then prices.
Keep in mind that the prices we request are:
- In your currency. The price will be automatically converted into $US dollars in the public section.
- And the prices paid by health systems, not those paid by patients.
- You may get price information from the procurement agencies, central labs in your country or infectious disease doctors.
2.3 Dried blood spot testing (DBS)
A dried blood spot test is when blood samples are blotted and dried on filter paper. Depending on the transportation and lab infrastructure in countries, the dried samples can be easily shipped to a laboratory and analysed using RNA/PCR diagnostic platforms.
2.4 Viral Load
There are two types of viral load tests : Quantative or Qualitative. A quantitative HCV RNA PCR test measures the amount of hepatitis C virus in the bloodstream. These tests, while not available in every country, are used during HCV treatment to see if it is working.
2.5 Qualitative polymerase chain reaction (PCR)
• This is a test that checks whether there is hepatitis C virus in the bloodstream. The test result is either positive (virus is detectable) or negative (virus is undetectable).
Save your work !
Two maps are linked to two questions from this section: Viral Load and Fibroscan (which monitors liver disease progression).
3. Section HCV Treatment
This section is comprised of 14 questions in 2 sub-sections:
- Registration and patent issues;
- Availability and prices for 8 DAAs, DAA combinations, and DAA interactions with ARVs
Question 3.1 - Registration
Before drugs can be sold in a country, they must be registered through the national drug regulatory authority. For this question, both originator and generic drugs are included.
The main source is your national drug regulation body within your Ministry of Health or separate authority (such as a food authority, national pharmaceutical control organisation, safety drug agency, etc.)
Sometimes you can access an online database where you can check if a drug has been registered or not in your country. Otherwise a list of all drugs registered can be downloaded. If none of these options are available, directly contact your regulation authority. They know and usually can provide updated information.
For example, to find your national body in charge of the regulation of drugs, a non-exhaustive list of Global Regulatory Authority Websites is available here:
And a less updated list of medicines regulatory authorities is published by the World Health Organisation:
Question 3.2 - Patent
The aim of the question 3.2 is to check if a drug is under a 20-year or longer monopoly in your country. The difficulty here is a drug can be protected by numerous patents. Some of them are considered ‘weak’ and won’t prevent generic introduction on the national market. But others, like key patents, can really block generic competition. You should consult your national body in charge of granting patents to check if a key patent has been granted, withdrawn or is still under examination. You may also find your national or regional online patent register office from the World Intellectual Property Organization Patent Register Portal: https://www.wipo.int/patent_register_portal/en/index.html
You can also get information from the database MedsPals (http://www.medspal.org) that cover low and middle-income countries.
For mapCrowd, we intentionally simplify the request, so if at least one key patent is granted for one drug the answer will be yes and means that competition with generics will be prevented. Of course, you can provide more precise information about the patent situation on the drug in the comment space.
Question 3.3 -Term extension
3.3 Has there been patent term extension (beyond the standard 20 years) on the following medicines in your country?
Following the global Agreement on Trade Related Intellectual Property Rights (TRIPS), most patent laws grant a patent term for 20 years from the filing date of the application. However, this does not prevent World Trade Organization members states to extend the duration of the patent protection, which is essentially granting a monopoly, in their national law. These extensions are requested by the patent owner and usually cover a period from the date of filling and the date of consent from the national authority and/or marketing authorization. The extension can be for an additional several years.
To know if your country allows such patent term extension, check your national patent laws, bilateral and multilateral agreements, or with legal experts in your country.
Question 3.4 - IIs there any initiative to overcome patents barriers and curb excessive prices in your country?
Generics can be introduced on the market using legal tools, such as patent oppositions and compulsory licenses.
Depending on your national or regional legislation, a patent opposition can be filled before (“pre grant opposition”) and/or after (“post grant opposition”) a patent has been granted. A patent opposition usually targets key patents to unlock generic production. Please be precise on which patent(s) the opposition has been filed. And please state whether a patent opposition has been partially rejected, not rejected, or agreed upon.
Through compulsory licensing, governments can allow generic producers to manufacture a patented medicine without the consent of the patent owner, in exchange for royalties granted to the patent owner as compensation.
Voluntary license: on this sub-question, data have been systematically completed by mapCrowd’s administrators. Data comes from voluntary licenses agreements.
To curb excessive prices, your government might have implemented policies to contain exorbitant prices. If so, please be precise whether or not these policies have worked.
Question 3.5 - Data exclusivity
Data exclusivity refers to exclusive rights granted to the original manufacturer of a medicine over the use of test data required for the registration of the product. These exclusive rights are distinct from patent rights. Data exclusivity is granted by the medicines regulatory authority in relation to safety and efficacy data, which needs to be submitted to approve originator medicines.
This means that a generic applicant cannot submit a market authorization based solely on bioequivalence data before the expiration of eight years. Instead the generics would have to provide self-generated pre-clinical and clinical trial test data, which generic companies typically do not do.
You will find information in your national medicines regulations or in relation to the use of compulsory licenses in the national patent laws.
Some countries provide data exclusivity waivers like:
- If a compulsory license is issued;
- If it is in public interest; or
- With the consent of the data exclusivity holder (such as in the voluntary licenses agreement).
8 drugs and drug combinations are present. They are those recommended by WHO updated treatment guidelines or those still widely available on world market.
Like questions on HCV diagnostics, all starts with availability then prices.
Keep in mind that prices requested are:
- in your currency, the price will be automatically converted into $US dollars in the public section.
- And the prices paid by health systems, not those paid by patients.
You may get pricing information from the procurement agencies, central pharmacy of your country, or at the pharmacy department of state hospitals.
DAAs and ARV
This is the last question of the main section of the mapCrowd. The aim of this question is to check the risk of drug-drug interactions between antiretrovirals (ARVs) and DAAs.
This is similar to previous questions except the price is not requested. You can add details in the comment section. You may find answers to availability from the procurement agencies, central pharmacy of your country, at the pharmacy department of state hospitals, or from HIV/AIDS organisations.
Save your work!
HCV Treatment/2 maps
2 maps are linked to this section.
Map 1: Registration status of Sovaldi® and Daklinza® worldwide
Reflect answers to question 3.1 Are the following medicines registered in the country? For Sovaldi® and Daklinza®
Map 2: ‘Gilead and BMS’s Voluntary Licenses’ reflect answers from the voluntary licenses for Gilead’s and BMS’s products in question
4. Section HCV Policy
This section is comprised of 4 questions, of which 2 maps are linked.
4.1 Is there a national plan for viral hepatitis? If yes, what is the status of people who inject drugs in the plan?
You should find the national plan at your Ministry of Health. It may also be available online. If so, please provide the hyperlink to access the national plan in the comment area.
For some countries some fields have been already filled with data. These data come from UN Office of Drugs and Crime (UNODC), the World Drug Report, and the Global Policy Report on the Prevention and Control of Viral Hepatitis in WHO Member States.
An increased number of countries have been establishing or revising national plans. Please check and update the answer, if needed.
For question 4.2 Treatment Eligibility criteria: Here the potential sources are from the national guidelines and from your own field experiences. If there is a gap between official guidelines and the reality, please briefly indicate in the comment area.
The last sub-question: Who can prescribe HCV treatment? This question has multiples choices.
Harm Reduction services
Question 4.3 focuses on the availability of harm reduction services within the country as well as in closed settings, such as prisons.
Question 4.4 is related to the estimated number of persons treated. This estimate can be difficult to find. Your Ministry of Health, hepatologists, or other focal points at national or regional levels should be able to provide the treatment uptake.
The data ideally will cover the last 3 years, in order to show the progression of treatment uptake.
For some countries, data were available from the WHO Progress Report on Access to Hepatitis C Treatment. Overcoming Access Barriers: The Experiences of Selected Countries, published in 2018 March. However, please check the data and update as needed!
Section HCV Policy/2 Maps
Two maps are directly linked to this Section 4: Question 4.1 on the national policy plan and Question 4.4 related to treatment uptake.
Section 4 is finished, again remember to save your work and let’s go to the final, short section 5.
For section 5, you will find the first space dedicated to governmental contacts, who are ideally the person(s) or service who are able to provide relevant information on hepatitis C in your country. Of course, contacts should be the professional ones, which are usually accessible online.
Then, 5 areas are dedicated to non-governmental organizations which are working or advocating on hepatitis C issues.
Section 5 HCV/Organisations/2maps
Do not hesitate to provide contact details. They will then appear on these maps:
Thank you and congratulations!
You have just finished. You can check on the public section your country profile.
If you want to modify and update data, you can always come back to the private section.
And of course if you have any questions, please don’t hesitate to contact us at: