Launch of the transparency check-list

"The implementation of this transparency check-list could inform public health, research & development and intellectual property policies, have an impact on the negotiations of drugs prices, and ultimately benefit people’s access to health and protect and strengthen solidarity-based public healthcare systems."

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 SEPTEMBER 2019

The “national transparency check-list on medicines and health products” was developed by the Observatoire de la transparence dans les politiques du medicaments in August 2019.

The idea that underlies this document is that transparency is critical, possible and should be immediately implemented. Although some important tools, including databases, already exist at the global level, we believe that national governments have the power and the responsibility in making sure that comprehensive, accessible and updated in real-time tools are made available in their country without any further delay. The below mentioned databases should be in open-access and its content should be systematically verified by public officers before publication, in particular if the information was provided by private entities.

The implementation of this transparency check-list could inform public health, research & development and intellectual property policies, have an impact on the negotiations of drugs prices, and ultimately benefit people’s access to health and protect and strengthen solidarity-based public healthcare systems.

It is time to move from a general commitment for transparency to which Member States agreed on during the 72th World Health Assembly in May 2019, to concrete actions that can be implemented without delay by various actors of the State level.

This check-list contains detailed steps to promote transparency on 8 topics of the health products chain.

We encourage other civil society organizations to apply and adapt it to their national contexts and to create observatories to monitor its concrete implementation.

 TRANSPARENCY DATABASES

* There is an official public and in open access online database available gathering all information available by medicine or health products.

* For each product, the database includes:

  •  Registration information
  •  Pricing information
  •  Patent information
  •  Clinical trials information
  •  R&D costs information
  •  Drug shortages and risk of shortage information
  •  Government positions in international forums
  •  Conflicts of interest

 1. HEALTH PRODUCTS REGISTRATION INFORMATION

 * There is an official public online database available with information about health products registered in the country

 * It is possible to access:

  •  the full documentation presented by the company
  •  the full decision of the regulatory agency granting or rejecting the registration, including any underlying analyses and/or meetings/hearings that underly the final decision and any conditions or requirements attached

 * The database includes information on:

  •  the health products registered, including specification of each formulation
  •  the company that holds the registration
  •  the validity of the registration
  •  the brand-name and the name of the active ingredient
  •  the place in which the final product is fabricated
  •  the origin of the active pharmaceutical ingredients (API)/raw materials
  •  the regulatory pathway under which the product was registered (regular, abbreviated, etc.)
  •  which part of the data presented is subject to data exclusivity, if any

 2. PRICING INFORMATION

* There is an official public online database available with information about the prices of health products registered in the country

* The database includes price information for:

  •  medicines (chemicals and biologics)
  •  vaccines
  •  gene therapies
  •  diagnostics platforms and kits
  • medical devices

 * Price information include:

  •  prices paid by the government
  •  list prices
  •  transaction prices
  •  public procurement prices
  •  reimbursement rates
  •  prices at private outlets
  •  wholesalers, distributors and other intermediaries margins

 * Information available include:

  •  the supplier
  •  the volume purchased
  •  the date of the purchase
  •  the terms of the contract (e.g. any exclusivity provision, duration of the price, provision not to issue any license, etc.)
  •  the net price
  •  the maximum allowed price, if price control applies
  •  the existence of generic products (including through imports and their prices in other countries)

 3.PATENT INFORMATION

 * There is an official public online database available with information about the patents and other intellectual property rights in the country

  •  If the database contains information provided by private entities, this information is verified by public officers before publication

 * The database is:

  •  regularly updated (at least once every 6 months)
  •  in open access

 * The database easily relates all the patents and other intellectual property rights covering a specific health product in the country, including if they are granted, rejected, expired or if there is an application pending

  • There is an analysis of each listed patent specifying if the patent can block or not block generic competition

 * The database allows the search to be conducted by:

  •  the active ingredient or the international nonproprietary name (INN)
  • the name of a technology or the brand name (e.g for diagnostic platforms)

 * The database includes:

  • links to the WIPO patent number/PCT information
  • link to regional patent procedures, if applicable (e.g : OAPI, EPO)
  • the title, abstract and claims of the patent application are available in the local language
  • current status of the application, that is: pending, granted, rejected, expired, withdrawn, abandoned, etc.
  • updated information about each stage of the examination process
  • the full documents with the analysis and decisions from the patent examiners
  • information about third parties presenting documents related to the examination, including full access to the documents
  • information about compulsory license or government use issued for the patent/application, including full access to the documents
  • information about voluntary licenses related to the patent/application, including full access to the documents
  • information about technology transfer agreements related to the patent/application, including full access to the documents
  • information about any public funding related to the object of the patent
  • the existence and results of legal proceedings regarding the patent application in the country (e.g: non-patentability claim, infringement claims, revocation claims, extension of the patent claims)

* The guidelines for national or regional patent examination of the patent applications are publicly available and easily accessible

* There is information available regarding any agreement involving the national patent office and patenting policies in the country, such as agreements related to the revalidation of the examination conducted in another country or especial pathways for examination (e.g: Patent Prosecution Highway – PPH)

* There is information available regarding the interaction of the patent office with competition authorities in the country, including sharing of information and mutual assistance (e.g: in investigations of anticompetitive practices regarding the use of IPRs)

* There is information available regarding any events and trainings attended by and technical assistance received by the patent office and its staff and collaborators, including information about the sponsors, funders and trainers

  4 CLINICAL TRIALS INFORMATION

 * There is an official public online database available with information about the clinical trials conducted in the country, updated according to each stage of the trial

* The database includes, or links to other databases which include the following information:

  • Trial information, subject disposition, baseline characteristics, end points, adverse events, more information and the protocol and its subsequent modifications
  • the area/condition/disease
  • the specific intervention being tested
  • the purpose(s) of the trial
  • the phase of the trial
  • the study design and analysis plan
  • the actual number of participants enrolled
  • the eligibility criteria for enrollment
  • the actual duration of the trial (start and end dates)
  • the location(s)
  • the sponsor(s)/funder(s), including detailed amount of funding and in-kind contribution by each one
  • the full trial budget
  • detailed information about any public funding received to conduct the trials, including direct grants, tax credits or any other
  • all collaborators involved in the trial
  • the responsible party
  • a clear description of the study
  • the complete results
  • link(s) to any publication related to the trial

 5. RESEARCH & DEVELOPMENT (R&D) INFORMATION

 5.1 PRECLINICAL DEVELOPMENT

* There is an official public online database available with timely information about the preclinical studies (data and methodology), particular pharmacology and toxicology

5.2 BY EACH HEALTH PRODUCT REGISTERED IN THE COUNTRY

* There is an official public online database available with information about the research and development expenditures for all health products registered in the country

* The database includes:

  • disaggregated figures on the expenditures by stage of development and over time (discovery, pre-clinical development broken down by type, clinical development by phase, pharmaceutical development and clinical trial material manufacturing)
  •  detailed list of all institutions involved in each stage/phase of development
  •  detailed list of all sources/amounts of funding by stage/phase of development, including private, philanthropic and public sector
  •  information about any public funding received by stage/phase of development, including direct grants, subsidies and tax credits
  •  start/end date of each stage/phase of development
  •  information about other countries and institutions in other countries involved

 5.3 BY EACH GRANT, DIRECT OR INDIRECT, GIVEN BY THE GOVERNMENT OR PUBLIC INSTITUTIONS

* There is an official public online database available with information about all public funding directed to research and development of health products given by the country

* The database includes:

  • the public institution giving the funding
  • the recipient of the public funding
  • the total amount of the public funding
  • the percentage that the public funding represents in the full cost of the project or of the recipient institution/department if core funding
  • the stage/phase of development covered by the public funding
  • start/end date of the public funding
  • a clear description of the project, including methodology if applicable
  • the conditions attached to the public funding (e.g. open access publication of the results, licensing of intellectual property, technology transfer policies, price of the end product, etc.)
  • the complete results of the project
  • link(s) to any publication related to the project
  • information about any intellectual property (e.g. patents) created during the project, including full access to the documents
  • information about any licensing agreements related to project, including full access to the documents
  • information about any technology transfer agreements related to the project, including full access to the documents

 5.4 FAILED PROJECTS

* All the information listed above is also made available for product development projects that did not reach the end of the development process (failures)

 6. SHORTAGES AND STOCK-OUTS

 * There is an official public online database available with information about/on:

  • shortages and stock-outs (or risk of) of medicines and health products in the country
  • the availability and stocks of health products in each region/state/municipality of the country, including in public and private facilities
  • the production capacity of the active pharmaceutical ingredient (API), raw materials and the final products
  • the root causes of drugs shortages 
  • the sanctions and timely publication of the sanctions taken toward industrials, distributors and wholesalers
  • the legal economic sanctions framework available in the country

 7. POSITION IN MULTILATERAL/INTERNATIONAL ORGANIZATIONS AND BILATERAL/MULTILATERAL AGREEMENTS

* There is an official real-time public online database with the official position of the government adopted in international meetings and negotiations on multilateral/international resolutions or agreements

* There is an official public online database with the information of all bilateral/multilateral agreements signed or under negotiation by the country

  •  The texts of the documents signed or under negotiation are fully available

 * The official position of the government adopted in multilateral/international organizations and bilateral agreements is available regarding transparency in:

  • Registration information
  • Pricing information
  • Patent information
  • Clinical trials information
  • R&D costs information
  • Drug shortages and risk of shortage information
  • Conflicts of interest

 * The position of the government is publicly available regarding provisions that would increase opacity such as:

  • Data exclusivity on clinical trials
  • Enhanced trade secret protection
  • National security-related documents in area of research

 * The government’s positions on transparency are made available in real-time, as well as its supports and co-/sponsors concrete initiatives, at:

  • Regional level institutions (e.g: European Union, ARIPO, Mercosur, ASEAN)
  • United Nations (including: high level meetings and special sessions)
  • The World Health Organization
  • The World Trade Organization
  • The World Intellectual Property Organization
  • Other regional or international institutions

 8. CONFLICTS OF INTEREST

* There is an official public online database available with information on the links between decision makers and pharmaceutical companies/private sector.

* This information is available for:

  • Heads of States
  • Members of the government and their cabinet
  • Members of the Parliament
  • Members of health regulatory authorities, including those in charge of negotiating the price of medicines and health products

* The database includes:

  • Former contracts or jobs related to the industry
  • Contracts or salaries signed with or delivered by the industries during the mandate
  • Gift or reimbursement of expenses delivered by the industry during the mandate

This document was prepared by the Observatoire de la transparence dans les politiques du médicament by Pauline Londeix & Jérôme Martin, with the contribution of I-MAK and Global Health Advocates France, and Morgane Ahmar, Tahir Amin, Claire Baudot, Carine Baxerres, Fanny Chabrol, Marcela Fogaça Vieira, Vitor Ido, Priti Krishtel, Yann Mazens, Bruno Rivalan, Els Torreele.

It can be edited and adapted under the Creative Common license CC-BY-NC

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