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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
IMPORTANT NOTE ON THE STATISTICAL CONCEPT OF 'ENTERPRISE':
Due to coordination with R&D Statistic in Business Enterprise Sector (BES) and the methodological change carry out in the latter for 2021 where the statistical unit has been changed from legal unit to a new practical application of the statistical concept of 'Enterprise', the Biotechnology Statistic has implemented the same statistical unit.
Under this new approach, an Enterprise can be formed by one or several Legal Units, and in the latter case, the Statistical Enterprise will condense the economic and employment variables of the Legal Units that comprise it. This criterion differs from that previously applied, by which each separate Legal Unit was considered a business. Although the new approach affects only Legal Units that are part of business groups -which are highly relevant entities in terms of economics and employment- the statistical results of the Biotechnology in BES and its distribution by activities and sizes is affected. So that users can compare the Biotechnology in BES data under the traditional approach (based on separate Legal Units) and the new approach (based on Statistical Enterprises for the 2021 reference period the INE has released both versions of the statistical results.
Since the reference period 2022, for the purposes of disseminating results, only the version based on Statistical Enterprises will prevail.
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
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.
Business Enterprise Sector:
The basic statistical unit for these operations is the enterprise, which is understood as “the smallest combination of legal units that is an organizational unit producing goods or services, which benefits from a certain degree of autonomy in decision-making, especially for the allocation of its current resources. An enterprise carries out one or more activities at one or more locations. An enterprise may be a sole legal unit “’ (definition of the Regulation of the European Union 696/93).
As previously explained in section 3.1, a new operational concept for 'Enterprise' is applied for the Biotechnology Statistic in BES 2021, which we will hereinafter call the Statistical Enterprise and which differs from previous years in that, beginning this year, the Enterprise = Legal Unit analogy will no longer always be true. In other words, some Statistical Enterprises may be made up of two or more Legal Units.
The reporting unit , or rather, the unit from which the basic information is obtained is the Legal Unit. Given that it is perfectly defined and located and has accounting and employment data, the answer is facilitated and homogeneous information is obtained. The Legal Units can be legal persons (mercantile enterprises) or physical persons (individual entrepreneurs).
And so:
Business Enterprise Sector comprises:
Government sector:
The Government sector is composed of the following groups of resident institutional units:
This sector does not include public enterprises, even when the entire capital of the enterprises belongs to a unit of the Administration. Public enterprises are included in the Business Enterprise Sector, the difference that characterises them is that public enterprises are market producers, while the units classified as being in the Government sector are not.
Higher education sector:
The higher education sector consists of all universities, technical schools and other institutions that offer official university education programmes, whatever the source of funding or legal nature, and all research institutes, centres, experimental stations and research clinics that carry out R&D activities under the direct control or administration of a higher education institution.
Private non-profit institution (PNPI) sector:
This sector includes:
Excluded from this sector are the following private non-profit institutions:
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.
It covers the entire Spanish territory.
The statistics are carried out annually since the reference year 2004.
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.
Business Enterprise Sector:
For the 2021 reference period, the new practical application of the statistical concept of 'enterprise' is implemented. This change affects the statistical results of the Biotechnology in Business Enterprise Sector (BES), and its distribution by activities and sizes. So that users can compare the Biotechnology Statistics in BES data under the traditional approach (based on separate Legal Units) and the new approach (based on Statistical enterprises), for the 2021 reference period the INE has released both versions of the statistical results .
Since the reference year 2022, only the version based on Statistical enterprises prevails.
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.
The reference period is the year immediately prior to the year of data collection.
Data referred to the period: Anual A: 2022
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 2021-2024, approved by Royal Decree 1110/2020, of 15 December, is the Plan currently implemented. This statistical operation has governmental purposes, and it is included in the National Statistics Plan 2021-2024. (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
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.
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
In the questionnaire sent to the collaborating units, it is stated that âPersonal 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)â.
The advance release calendar that shows the precise release dates for the coming year is disseminated in the last quarter of each year.
The calendar is disseminated on the INEs Internet website (Publications Calendar)
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
The statistics are disseminated annually.
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
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.
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
Statistics microdata are not available.
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.
A detailed description is available at:
Fields 10.7 to 17 of this document are the user-oriented quality report for this operation.
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.
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.
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.
The INE has carried out general user satisfaction surveys in 2007, 2010, 2013, 2016 and 2019 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)
The information collected covers the most relevant variables related to biotechnology.
The statistics provide 100% of the results requested by the National Statistical Plan.
Therefore, the rate of statistical information supplied is R=100%.
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.
Since the Statistics on Biotechnology use is a census operation, there are no sampling errors
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) = 3.62 %
A7 (Imputation rate) = 1.36%
Statistic is published the year following of reference period.
TP2 (time interval until publication of final data) = 16 months.
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.
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.
For the 2021 reference period, the new practical application of the statistical concept of 'enterprise' is implemented. This change affects the statistical results of the Biotechnology Statistics in BES, and its distribution by activities and sizes. So that users can compare the Biotechnology Statistics in BES data under the traditional approach (based on separate Legal Units) and the new approach (based on Statistical enterprises), for the 2021 reference period the INE has released both versions of the statistical results .
Since the reference year 2022, only the version based on Statistical enterprises prevails.
Length of the comparable time series under the Statistical Enterprise approach:CC2=2
For the rest of the sectors CC2=15
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.
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).
The estimated budget appropriation necessary to finance the Statistics on Biotechnology Use (companies, public administration, higher education and PNPI) foreseen in the 2024 Annual Programme is 37.58 euros.
The use of electronic questionnaires has been implemented to facilitate their completion and reduce the burden on the respondents.
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-.
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
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.
As of the 2021 reference period, it is collected in coordination with the R&D statistics for the odd reference years and for even reference years, it continues to be collected in coordination with the Innovation Survey in Enterprises.
The collection of data is carried out annually during the months from April to August of each year
Business Sector: As of the 2021 reference period, it is collected in coordination with the R&D statistics for the odd reference years and for even reference years, it continues to be collected in coordination with the Innovation Survey by means of an additional module addressed to all those units potentially linked to Biotechnology.
In the case of the rest of the sectors, 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.
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.
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.
Business Enterprise Sector:
After the phases described above at the legal unit level, proceed as follows for the "Statistical enterprises":
For the elaboration of the BIOTECHNOLOGY Statistics in Business Enterprises Sector (BES) under the 'Statistical enterprise' approach, a method has been developed that is based on the following steps, each of which is described in more detail in the BIOTECHNOLOGY Statistics Methodology document available on the INE website together to the statistical results of the operation.
The essential idea is that if the Legal Units of a Statistical enterprise serve, exclusively or mainly, other Legal Units of the same enterprise (for example, because they sell products under a vertical integration of the production process or provide services as an auxiliary relationship) , said servile Legal Units must be combined with the others to which they support to form the authentic statistical unit "enterprise", therefore having to combine and consolidate the corresponding variables.
Given the annual character of the statistics, no seasonal adjustment is made.