• Methods and Projects
• Standards and Classifications

• Standardised Methodological Report

Minimise complete Methodological Report Complete Methodological Report Queried fields

Statistics on Biotechnology Use

• 1Contact
  • 1.1Contact organisation
    National Statistics Institute of Spain
    
  • 1.5Contact mail address
    Paseo de la Castellana 183 - 28046 Madrid
    
• 2Metadata update
  • 2.1Metadata last certified
    26/02/2020
  • 2.2Metadata last posted
    19/02/2019
  • 2.3Metadata last update
    26/02/2020
• 3Statistical presentation
  • 3.1Data description

    The Statistics on Biotechnology Use allows us to know the economic and human resources destined to Biotechnology, being the main variables studied the following:

    - Expenditure on R&D activities in Biotechnology by implementation sector, type of expenditure and source of funds.
    - Personnel employed and Researchers in Biotechnology R&D activities by implementation sector and sex.

    The Statistics on Biotechnology Use has been prepared following the OECD methodological guidelines.
    http://www.oecd.org/sti/biotech/aframeworkforbiotechnologystatistics.htm

  • 3.2Classification system
    • Clasificaciones utilizadas

      The units of analysis are grouped by sector, the content of which is largely based on the System of National Accounts, with the difference that Higher Education has been considered as an independent sector.

      More information on the statistics methodology can be obtained at http://ine.es/dyngs/INEbase/en/operacion.htm?c=Estadistica_C&cid=1254736176808&menu=metodologia&idp=1254735576669

  • 3.3Sector coverage

    The population under study is the group of companies, public organisations, higher education institutions and private non-profit institutions (PNPI), which are located in the national territory.

  • 3.4Statistical concepts and definitions
    • Higher education centre
      Higher education centres includes all universities (schools, advanced technical schools and university schools), PNPI serving Higher Education, technological institutes and other post-secondary establishments, regardless of the origin of their financial resources and their legal status.
    • Company
      The company corresponds to an organisation unit that produces goods and services, and that enjoys a certain autonomy in decision-making, mainly at the time of using the available current resources. The company carries out one or more economic activities in one or more places.
    • Gasto en actividades de I+D externa en biotecnología
      Sólo se considerará como gasto externo las cantidades pagadas como contraprestación de los trabajos de I+D en biotecnología encargados específicamente por la unidad a otras unidades. No se incluirán las cuotas institucionales para financiar a otras empresas, asociaciones de investigación ..., que no suponga una compra directa de I+D en biotecnología.
      
      La clasificación básica de los gastos externos en I+D en biotecnología es la siguiente:
      
      - Compra de I+D en biotecnología en España (sin IVA)
      
      - Compra de I+D en biotecnología en el extranjero (sin impuestos)
    • Gasto en actividades de I+D interna en biotecnología
      Se considera I+D en biotecnología a cualquier estudio, prueba, experimento, investigación, etc. que se realice en los campos descritos anteriormente correspondientes a los usos biotecnológicos o en alguna otra rama de la biotecnología.
      Se consideran gastos en actividades de I+D interna en biotecnología a todas las cantidades destinadas a actividades de I+D en biotecnología, realizadas dentro de la unidad o centro investigador (gastos internos), cualquiera que sea el origen de fondos
    • Gasto en actividades relacionadas con la biotecnología
      La biotecnología es la aplicación de la ciencia y la tecnología a los organismos vivos, así como a sus partes, productos y modelos, para alterar el material vivo o inerte, con el fin de producir conocimientos, bienes y/o servicios.
      
      Se consideran gastos en biotecnología a todas las cantidades destinadas a actividades de relacionadas con la biotecnología, realizadas dentro de la unidad, cualquiera que sea el origen de fondos.
    • Public organisations
      These are the organisations that supply society with public interest services that it would be neither economical nor easy to provide otherwise, free-of-charge or at conventional prices, and that administer public affairs and take charge of carrying out the economic and social policy of the group.
      These centres perform very numerous and diverse activities, and are usually related with the public administration, defense, public order, health, education, culture, economic promotion and development, well-being, scientific and technical development, etc.
    • Personal en actividades relacionadas con la biotecnología
      La medición del personal empleado en actividades relacionadas con biotecnología es la otra forma de obtener el input en biotecnología.
      
      Se incluye como personal en actividades relacionadas con la biotecnología, a todo el personal empleado directamente en actividades biotecnológicas, sin distinción de nivel de responsabilidad, así como a los que suministran servicios ligados directamente a los trabajos de uso de la biotecnología, como gerentes, administradores y personal de oficina.
      
      Los datos de personal se pueden medir de dos formas, en número de personas físicas y en equivalencia a jornada completa:
      
      A. Número de personas físicas. Los datos sobre el número total de personas que están completa o parcialmente empleadas en actividades relacionadas con la biotecnología permiten establecer correspondencias con otras series de datos como, por ejemplo, los de enseñanza o empleo o los de los censos de población.
      
      B. Equivalencia a jornada completa (EJC) durante un año. A efectos de medición del personal conviene introducir el concepto de equivalencia a jornada completa ya que las actividades relacionadas con la biotecnología suele ser en muchos casos una actividad parcial o secundaria.
    • Uso actual de biotecnologías
      Se pregunta entre una serie de actividades de biotecnología cuales de ellas realiza la empresa. Entre los usos de las actividades de biotecnología por los que se pregunta se incluyen: el código genético, las unidades funcionales, los cultivos de ingeniería celular y los tejidos, bioprocesos, organismos subcelulares, bioinformática, nanotecnología y otros. Este apartado incluye la investigación en cualquiera de los campos de la biotecnología. Puede ser biotecnología en salud humana, animal, vegetal, industrial o ambiental. Para mayor desglose, consultar la metodología de la estadística.
  • 3.5Statistical unit

    The statistical units used are: the company, the public body, the university or higher education institution and the private non-profit institution (PNPI).

  • 3.6Statistical population

    The statistical population is made up of all companies, public bodies, universities or higher education institutions and private non-profit institutions (PNPI) that make use of Biotechnology in their activity.

  • 3.7Reference area

    It covers the entire Spanish territory.

  • 3.8Time coverage

    The statistics are carried out annually since the reference year 2004.

  • 3.9Base period

    The Statistics on Biotechnology Use has been collected since the reference year 2004. The evolution of the Statistics on Biotechnology Use in recent years has been as follows:

    * In 2006, the type of biotechnological activities and the areas of final application of the products obtained from them were introduced as an object of study.

    * In 2007, the internationalisation of biotechnology related activities was introduced.

    * In 2008, expenditure on external R&D activities in Biotechnology was included.

    Since 2010, part of the companies researched for the publication of the Statistics on Biotechnology Use is obtained through a random sample. Until then, the units of the companies sector that intervened in the compilation of the statistics were treated on a census basis.

    The first year of collection is 2004, but in 2010 there is a change in methodology (the series is carried back to 2008). That is to say, the base period (as the first starting year of the comparable series) would be 2008.
    

• 4Unit of measure
  • 4.1Unit of measure

    Economic data are provided in thousand euros.

    Data referring to personnel in R&D are provided in number of persons and number of persons in full-time equivalence.

• 5Reference period
  • 5.1Reference period

    The reference period is the year immediately prior to the year of data collection.

    Data referred to the period: Anual A: 2018

• 6Institutional mandate
  • 6.1Legal acts and other agreements

    The compilation and dissemination of the data are governed by the Statistical Law No. 12/1989 "Public Statistical Function" of May 9, 1989, and Law No. 4/1990 of June 29 on “National Budget of State for the year 1990" amended by Law No. 13/1996 "Fiscal, administrative and social measures" of December 30, 1996, makes compulsory all statistics included in the National Statistics Plan. The National Statistical Plan 2009-2012 was approved by the Royal Decree 1663/2008. It contains the statistics that must be developed in the four year period by the State General Administration's services or any other entity dependent on it. All statistics included in the National Statistics Plan are statistics for state purposes and are obligatory. The National Statistics Plan 2017-2020, approved by Royal Decree 410/2016, of 31 October, is the Plan currently implemented. This statistical operation has governmental purposes, and it is included in the National Statistics Plan 2017-2020. (Statistics of the State Administration).

    
    

    Decision No. 1608/2003/EC of the European Parliament and of the Council of 22 July 2003 concerning the production and development of Community statistics on science and technology https://www.ine.es/normativa/leyes/UE/minine.htm#30224

  • 6.2Data sharing
    The exchanges of information needed to elaborate statistics between the INE and the rest of the State statistical offices (Ministerial Departments, independent bodies and administrative bodies depending on the State General Administration), or between these offices and the Autonomic statistical offices, are regulated in the LFEP (Law of the Public Statistic Function). This law also regulates the mechanisms of statistical coordination, and concludes cooperation agreements between the different offices when necessary.
    

    There is an agreement with ASEBIO (Spanish Association of Biocompanies), which helps to prepare the directory of companies that are comprehensively researched.

    Apart from this, data is sent to the OECD for the preparation of international statistics.

• 7Confidentiality
  • 7.1Confidentiality - policy
    The Statistical Law No. 12/1989 specifies that the INE cannot publish, or make otherwise available, individual data or statistics that would enable the identification of data for any individual person or entity. Regulation (EC) No 223/2009 on European statistics stipulates the need to establish common principles and guidelines ensuring the confidentiality of data used for the production of European statistics and the access to those confidential data with due account for technical developments and the requirements of users in a democratic society
    
  • 7.2Confidentiality - data treatment
    INE provides information on the protection of confidentiality at all stages of the statistical process: INE questionnaires for the operations in the national statistical plan include a legal clause protecting data under statistical confidentiality. Notices prior to data collection announcing a statistical operation notify respondents that data are subject to statistical confidentiality at all stages. For data processing, INE employees have available the INE data protection handbook, which specifies the steps that should be taken at each stage of processing to ensure reporting units' individual data are protected. The microdata files provided to users are anonymised.
    

    In the questionnaire sent to the collaborating units, it is stated that “Personal data obtained by the statistical services both directly from the informants and through administrative sources will be subject to protection and will be covered by statistical secrecy (art. 13.1 of the Law on the Public Statistical Function [LFEP] of 9 May 1989). All statistical personnel are obliged to preserve statistical secrecy (art. 17.1 of the LFEP)”.

• 8Release policy
  • 8.1Release calendar
    The advance release calendar that shows the precise release dates for the coming year is disseminated in the last quarter of each year.
    
  • 8.2Release calendar access
    The calendar is disseminated on the INEs Internet website (Publications Calendar)
    
  • 8.3User access
    The data are released simultaneously according to the advance release calendar to all interested parties by issuing the press release. At the same time, the data are posted on the INE's Internet website (www.ine.es/en) almost immediately after the press release is issued. Also some predefined tailor-made requests are sent to registered users. Some users could receive partial information under embargo as it is publicly described in the European Statistics Code of Practice
    
• 9Frequency of dissemination
  • 9.1Frequency of dissemination

    The statistics are disseminated annually.

• 10Accessibility and clarity
  • 10.1News release
    The results of the statistical operations are normally disseminated by using press releases that can be accessed via both the corresponding menu and the Press Releases Section in the web
    
  • 10.2Publications

    The results of the statistics are disseminated through the INE website and some results are included in publications such as the Statistical Yearbook, INE Figures, etc.

  • 10.3On-line database

    INEbase is the system the INE uses to store statistical information on the Internet. It contains all the information the INE produces in electronic formats. The primary organisation of the information follows the theme-based classification of the Inventory of Statistical Operations of the State General Administration . The basic unit of INEbase is the statistical operation, defined as the set of activities that lead to obtaining statistical results on a determined sector or subject based on the individually collected data. Also included in the scope of this definition are synthesis preparation.

    
    

    You can access tables and time series on INEbase within the section "Science and technology" at www.ine.es

    https://www.ine.es/dyngs/INEbase/en/operacion.htm?c=Estadistica_C&cid=1254736176808&menu=ultiDatos&idp=1254735576669

  • 10.4Micro-data access
    A lot of statistical operations disseminate public domain anonymized files, available free of charge for downloading in the INE website Microdata Section
    

    Statistics microdata are not available.

  • 10.5Other

    There is the possibility of requesting customised information from the INE User Service Area. Limitations on confidentiality or accuracy are taken into account when processing such requests.

    See: https://www.ine.es/ss/Satellite?c=Page&p=1254735550786&pagename=ProductosYServicios%2FPYSLayout&cid=1254735550786&L=1

  • 10.6Documentation on methodology

    A detailed description is available at:

    http://ine.es/dyngs/INEbase/en/operacion.htm?c=Estadistica_C&cid=1254736176808&menu=metodologia&idp=1254735576669

  • 10.7Quality documentation

    Fields 10.7 to 17 of this document are the user-oriented quality report for this operation.

• 11Quality management
  • 11.1Quality assurance

    Quality assurance framework for the INE statistics is based on the ESSCoP, the European Statistics Code of Practice made by EUROSTAT. The ESSCoP is made up of 16 principles, gathered in three areas: Institutional Environment, Processes and Products. Each principle is associated with some indicators which make possible to measure it. In order to evaluate quality, EUROSTAT provides different tools: the indicators mentioned above, Self-assessment based on the DESAP model, peer review, user satisfaction surveys and other proceedings for evaluation.

    
    

    To ensure quality information, the information received is treated by following the steps listed below:

    - Manual control and cleaning of the questionnaires by the units involved in the collection of the information, in order to recover the possible lack of data or correct the errors of the questionnaires before their recording.

    - Interactive recording with cleaning and correction of errors of the information obtained by the units involved in the collection of information.

    - Control of the information received by the unit responsible for the statistics.

    - Control of coverage and processing of identification errors.

    - Information quality validation.

    - Imputation of partial non-response.

    - Interactive cleaning and correction of inconsistencies in the validated information.

    - Preparation of a first phase of results analysis tables.

    - Macro-editing of the main aggregates to correct the errors not detected in the previous phase of micro-cleaning.

    - Data analysis.

    - Creation of the final data file.

    - Obtaining tables of final results in the unit responsible for the statistics prepared from the final data file.

  • 11.2Quality assessment

    Among the main strengths of this operation are the following:

    1) Collection, analysis and publication of the results quickly so that their publication is carried out within 14 months following the end of the reference period.

    2) In recent years, an effort has been made to collect information via the Internet in order to facilitate its completion.

• 12Relevance
  • 12.1User needs

    Among the users of the statistics are:

    · Ministries and other public bodies.

    · Territorial administrations (Autonomous Communities, City Councils...).

    · Companies and non-profit institutions.

    · Researchers and universities.

    · Individuals.

    Each of these users has different needs according to the destination and usefulness of the information they need.

    Among the uses of the users are the "Annual Report: News and trends from the Spanish Biotech sector" published by ASEBIO based on data provided by the INE. Internationally, OECD prepares the OECD Biotechnology Statistics publication, which collects information at the international level.

  • 12.2User satisfaction

    The INE has carried out general user satisfaction surveys in 2007, 2010, 2013 and 2016 and it plans to continue doing so every three years. The purpose of these surveys is to find out what users think about the quality of the information of the INE statistics and the extent to which their needs of information are covered. In addition, additional surveys are carried out in order to acknowledge better other fields such as dissemination of the information, quality of some publications...

    On the INE website, in its section Methods and Projects / Quality and Code of Practice / INE quality management / User surveys are available surveys conducted to date.(Click  next link)

     

    
    

  • 12.3Completeness

    The information collected covers the most relevant variables related to biotechnology.

    The statistics provide 100% of the results requested by the National Statistical Plan

• 13Accuracy and reliability
  • 13.1Overall accuracy

    The statistics are subjected to different processes, ranging from the design of the statistics to the obtaining of final results (coverage, collection, cleaning of errors, imputation of non-response, etc.). These processes are aimed at obtaining the highest degree of statistical reliability.

  • 13.2Sampling error

    Since the Statistics on Biotechnology use is a census operation, there are no sampling errors

  • 13.3Non-sampling error

    During the entire statistical process, non-sampling errors are monitored. Two types of errors are checked:

    Congruence errors (very high variations with respect to the previous year, lack of obligatory data, incorrect sums, ...)

    Range errors (invalid value of variables)

    Specific information on the non-response rate is also available.

    A4 (Non-response rate) = 5.45 %

• 14Timeliness and punctuality
  • 14.1Timeliness

    Statistic is published the  year following of reference period.

    TP2 (time interval until publication of final data) = 14 months.

  • 14.2Punctuality

    The dissemination of the data is carried out in accordance with the structural statistics availability calendar that the INE prepares and publishes for each year.

• 15Coherence and Comparability
  • 15.1Comparability - geographical

    The availability of a methodology, a design and a common process of collection, cleaning, edition and elevation in all its geographical scope, guarantees the comparability of the results between the different Autonomous Communities.

    Likewise, the Statistics on Biotechnology Use has been prepared following the methodological guidelines of the OECD, which facilitates international comparability.

  • 15.2Comparability - over time

    In 2008, expenditure on external R&D activities (Extramural R&D) in Biotechnology was included.

     

    As of 2010, part of the companies researched for the publication of the Statistics on Biotechnology Use was obtained through a random sample. Until then, the units involved in compiling the statistics were processed by census.

    The number of comparable elements of the time series of the variable R&D expenditure and personnel is 8 elements.

    This methodological change was applied until the 2008 data collection (The series was again updated in time until 2008). Therefore, the first year of comparability of the expenditure and personnel variables is 2008.

     

  • 15.3Coherence - cross domain

    Regarding the different sectors (Companies, Public Administrations, Higher Education, PNPI) for which the INE collects information, the data provided by the Statistics on Biotechnology Use are consistent with each other, as each follows the OECD harmonised recommendations. In the same way, the concepts and classifications used in R&D activities are framed within the definitions of the Frascati Manual, and are therefore fully consistent with the Statistics on R&D activities.

  • 15.4Coherence - internal

    Consistency is a fundamental question both in the statistical methodology approach and in all its development process. Consistency between variables is contrasted in all phases of the statistical process. The internal consistency level of the statistics is 100% (for example, arithmetic and accounting identities are observed).

• 16Cost and burden
  • 16.1Cost and burden

    The estimated budget appropriation necessary to finance the Statistics on Biotechnology Use (companies, public administration, higher education and PNPI) foreseen in the 2019 Annual Programme is 30.55 euros.

    The use of electronic questionnaires has been implemented to facilitate their completion and reduce the burden on the respondents.

• 17Data revision
  • 17.1Data revision - policy

    The INE of Spain has a policy which regulates the basic aspects of statistical data revision, seeking to ensure process transparency and product quality. This policy is laid out in the document approved by the INE board of directors on 13 March of 2015, which is available on the INE website, in the section "Methods and projects/Quality and Code of Practice/INE’s Quality management/INE’s Revision policy" (link).

    This general policy sets the criteria that the different type of revisions should follow:  routine revision- it is the case of statistics whose production process includes regular revisions-; more extensive revision- when methodological or basic reference source changes take place-; and exceptional revision- for instance, when an error appears in a published statistic-.

    
    

    The INE has a Policy that regulates the basic aspects of the revision of statistical data, guaranteeing the transparency of the processes and the quality of the products. This policy is described in the document approved by the Board of Directors at the meeting held on 13 March 2015. The document is available in the "Quality and good practices" section of the INE website:

    http://ine.es/ss/Satellite?c=Page&p=1259943453642&pagename=MetodologiaYEstandares%2FINELayout&cid=1259943453642&L=1

     

    This general policy sets out the criteria to be followed for the different types of revisions:

    1. Routine: due to statistics that by their nature are reviewed on a regular basis.

    2. Major revisions: produced by methodological changes or changes in the basic reference sources of the statistics.

    3. Extraordinary revisions: due, for example, to an error in already published statistics.

    In the R&D Statistics, only extraordinary revisions are carried out that are due to errors detected once the data have been published.

    .

  • 17.2Data revision - practice

    During the period, there has been no situation giving rise to the revision of data, neither of a methodological nature nor of an extraordinary type

• 18Statistical processing
  • 18.1Source data

    There is a directory of potential biotechnology research units (companies, public bodies, higher education institutions and private non-profit institutions [PNPI]) which is updated annually. This directory is researched comprehensively on an annual basis.

    Since 2010, part of the companies researched is obtained by means of a random sample coordinated with the sample of the Innovation in Companies Survey. Until then, the companies involved in the compilation of statistics were treated on a census basis.

  • 18.2Frequency of data collection

    The collection of data is carried out annually during the months from March/April to July of each year in the case of companies, and in the period from March to July for the rest of the units.

  • 18.3Data collection

    In the case of companies, the information is collected by means of an additional module attached to the Companies Innovation Survey, and addressed to all those units potentially linked to Biotechnology. In the case of the rest of the units, the information is collected by means of a module attached to the Statistics on R&D Activities and is addressed to all units that carry out R&D statistics, whether they are Higher Education centres, Public Administration or PNPI.

    The information collection method is a mixed system that includes postal mailings and the participation of interviewers, with an important telephone support in its collection. The reporting units can send their data via internet, by ordinary mail (questionnaires filled in paper) or by e-mail.

  • 18.4Data validation

    The initial stage of the processing of the operation's information coincides in time with the collection work itself, and develops parallel to it, during the entire duration of the operation.

    The articulated system focuses on the following fundamental aspects: a process of continuous updating and an integrated cleaning of the questionnaire content.

    The recording and cleaning of the questionnaires is carried out continuously by the units responsible for collecting them, establishing the necessary control standards to ensure an adequate level of quality throughout the process. This makes it possible to control, already at this stage, errors that may affect the data obtained from the reporting units.

    Once the data have been received in computer media in the unit responsible for the survey, a coverage control of the information is carried out, in order to guarantee the completeness of the recorded data, detect duplicates and coverage errors, and, at the same time, to be able to carry out an initial assessment of the quality of the variables collected in the questionnaires. This phase is carried out on each of the fortnightly files of recorded questionnaires, and its execution is prior to the preparation of the complete file of the operation and, therefore, at the beginning of the joint processing of the information.

  • 18.5Data compilation

    During the micro-cleaning process, the detection and cleaning of errors and inconsistencies in the identification variables of each record is carried out, as well as the cleaning and imputation of content errors. Depending on the characteristics of each type of error, in certain cases automatic imputation procedures are used, and in others updates of the file are carried out in order to incorporate the corrections of the detected errors. Likewise, the systemic errors detected in the previous studies and analyses carried out on the recorded data are corrected.

    Once the micro-cleaning phase is over, the last stage before the tabulation and dissemination of the results is the obtaining of analysis tables to use macro-cleaning techniques to eliminate the errors and inconsistencies detected in this phase.

  • 18.6Adjustment

    Given the annual character of the statistics, no seasonal adjustment is made.

• 19Comment
  • 19.1Comment