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07/03/2024

BIFAP, the largest Spanish database of medical records for independent research, is integrated into the big data network of the European Medicines Agency.

BIFAP is an electronic database made up of medical records from Primary Care destined for pharmacoepidemiological studies and belonging to the Spanish Agency of Medicines and Medical Devices (AEMPS). It features the collaboration of the Autonomous Communities and the support of the main scientific societies involved.

Confidentiality

We protect the confidentiality of patient information contained in the database in accordance with current data protection legislation.

Collaboration

We promote the collaboration of Primary Care physicians and maintain high standards of information quality and benefits.

Research

We encourage quality research from Primary Health Care, ensuring high levels of scientific quality.

Independence

We develop independent research lines on aspects relevant to the Scientific community and the Public Health of the population.

Data for Public Health and Drug Safety.

BIFAP includes information provided by general practitioners and primary care paediatricians from the National Health System.

15.373

General practitioners and paediatricians quotas

22 millions

Anonymised Electronic Medical Records

222 millions

Person-years of follow-up

10

Average years of follow-up per patient

950 millions

Health problem records

3.100 millions

Medication records

133 millions

Immunisation records

10.500 millions

General and analytical data records

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Collaborators

If you are a primary care physician from the National Health System in one of the participating autonomous communities you can actively collaborate in the BIFAP programme. As a partner you can also request research studies.

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Researchers

If you are a researcher attached to a public body you can use BIFAP as a source of information to conduct research. Sign up to learn about the process and we'll be in touch with you.

BIFAP Collaborators

Currently, family doctors or paediatricians who perform a primary care activity of the National Health System in one of the participating Autonomous Communities may be BIFAP collaborators.

It is not an indispensable requirement that they hold a quota, so resident internal doctors, alternate, interim or continued care doctors at Primary Care may also apply to be collaborators. 

BIFAP collaborators are Primary Care professionals in participating communities who voluntarily choose to help the BIFAP programme. This help is firstly realized by improving the way they record information during their usual clinical practice. To this end, recommendations on how best to record information are sent to collaborators on a regular basis so that it can be used in epidemiological studies.

Collaborating physicians may, on a voluntary basis, actively participate in improving the quality of BIFAP research by performing some more specific tasks whose dedication time can be quantified to be subsequently recognised:

1. Participating in database quality improvement tasks, dedicating time to perform standardisation tasks related to diagnostic and prescription drug information contained in BIFAP. This standardisation is carried out using online tools made available to collaborating physicians.

2. Providing expert clinical knowledge to help improve the quality of specific studies by other researchers by responding to surveys or conducting their own studies as a principal investigator. 

In addition to assisting in the maintenance of a national and public-owned epidemiological source of information aimed at improving the safety of the medicinal product, collaborating physicians are beneficiaries of the following services:

1. They access the BIFAP Services website where they have aggregate statistics on BIFAP patients both globally and within their Autonomous Community. Collaborators who hold a quota also have access to the aggregate data of their patients.

2. They have the specific support of the BIFAP Collaborator Support Unit to carry out their own research studies using BIFAP data.

3. In addition, by filling-in the Profile-Plus, they can share their interests in different areas of research and participate in research studies conducted at BIFAP.

4. All physicians who are registered as BIFAP collaborators and show their commitment to good HCE registration will receive, upon request, a document certifying that as of the day of issue they are listed as BIFAP collaborating physicians.

5. Physicians who have also performed specific database improvement tasks for which the time to perform can be quantified will receive a document certifying the number of hours for each calendar year, provided that they exceed a minimum of 10 hours in that period. 

Advisory Committee

El Comité Asesor tiene funciones consultivas y vela para que BIFAP se consolide y se desarrolle dentro de lo establecido en los convenios de colaboración con las CCAA participantes.  

Está compuesto por dos representantes de la Agencia Española de Medicamentos y Productos Sanitarios y un representante de cada una de las Comunidades Autónomas que participan en BIFAP.

  • Antonio Blázquez - Jefe del Departamento de Medicamentos de Uso Humano AEMPS
  • Edurne Lázaro -Jefe División Farmacovigilancia y Farmacoepidemiología AEMPS
  • Antonio Poncel Falcó, Aragón
  • Jesús Ruíz Salazar, Asturias
  • Fidelina de la Nuez Viera, Canarias
  • Mario González Ruiz, Cantabria
  • Judith Ceruelo Bermejo, Castilla y León
  • María José Calvo Alcántara , Madrid
  • María José Peñalver Jara, Murcia
  • Juan Erviti López, Navarra
  • Francisco Cabrera Díaz, Castilla - La Mancha
  • Laia Buigues Pastor, Comunidad Valenciana

Data Access Governance 

The document entitled “BIFAP Data Access Governance” reflects the action protocol that is carried out to ensure data protection.
It describes the different treatments to which the data is subjected, the management of access to the data, the use of the data by virtue of the user type, and the requirements and conditions applicable to the BIFAP studies researchers.
The main recipients of this document are:

  1. Potential researchers from the public field who are proposed to carry out studies using BIFAP, and who must take into account the conditions and procedures established for it.
  2. The collaborating institutions, physicians, patients and the general population, since the dissemination of the requirements and processes involved in accessing the data contained in BIFAP supports the necessary trust that health data is used safely in order to obtain, through quality research studies, relevant knowledge to improve the health of the population.
  3. 3. In addition, the AEMPS database administrators and all its users have an obligation to know and apply it.
In addition, essential information on BIFAP's data processing activities, in compliance with the duty of information and transparency in accordance with data protection regulations, is presented in the “Information clause on the processing of personal data”.

Autonomous Communities  

BIFAP draws on the data provided by the autonomous communities that voluntarily participate through collaboration agreements. These agreements detail the commitments of the Autonomous Community and the Spanish Agency of Medicines and Medical Devices , as well as other operational aspects related to data processing, monitoring commissions, etc.
You can access the agreements of the different participating autonomous communities as follows:

Navarra (Adhesión 28 Junio 2021)
Aragón (Adhesión 12 Mayo 2021)
Cantabria (BOE 18 Febrero 2021)
Castilla y León (Adhesión 22 Abril 2021)
Madrid (Adhesión 27 Abril 2021)
Murcia (Adhesión 17 febrero 2023)
Asturias (BOE 20 Julio 2016)
Canarias (Adhesión 26 Abril 2022)
Castilla-La Mancha (Adhesión 24 Marzo 2021)
Comunidad Valenciana (Adhesión 14 Mayo 2021)


BIFAP Scientific Committee

The BIFAP Scientific Committee’s mission is to ensure the scientific and technical quality of the projects carried out with the database as well as the implementation of activities that may have an impact on the quality of the information contained in the database. It meets on a monthly basis.

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1) To promote quality research with the BIFAP database.
2) To evaluate the scientific quality, relevance, feasibility and interest of the study proposals received.
3) To prioritise, if necessary, the implementation of certain projects.



Spokesperson designated by the AEMPS: Lucía Cea Soriano (President)
Spokesperson acting on behalf of the AEMPS: Miguel Ángel Maciá Martínez (Secretary)
Spokespeople acting on behalf of the Advisory Committee: Mar García Saiz, José Luís Trillo Mata
Spokesperson acting on behalf of public research bodies: Beatriz Pérez Gómez
Spokesperson acting on behalf of the collaborating physicians: Aida Moreno Juste
Spokesperson acting on behalf of the BIFAP team: Elisa Martín Merino

The following are the planned meeting dates of the BIFAP Scientific Committee (Note: they could be changed if necessary):

January 30th, 2024
February 27th, 2024
March 19th, 2024
April 23rd, 2024
May 28th, 2024
June 25th, 2024

In order to evaluate the protocols at each meeting, all the necessary documentation must be submitted at least 10 working days before the corresponding meeting. The Scientific Committee will communicate its opinion to the principal investigator normally in less than one month from the request, and within two months at most.

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Research Projects

Scientific Publications

Address

Agencia Española de Medicamentos y Productos Sanitarios.
División de Farmacovigilancia.
Programa BIFAP
Calle Campezo 1, Edificio 8
Madrid, 28022

Contact

Email: bifap@aemps.es  
Teléfono: +34 918 225 173