Subscription of UK Healthcare Databases

Item Description:

The European Medicines Agency (referred to below as ‘EMA’ or ‘the Agency’) is planning to award the contract(s) resulting from the above procurement procedure. The procurement documents consist of the contract notice in the Official Journal of the European Union, the invitation letter, the tender specifications and their annexes including the draft contract. All documents are available in the attached ZIP File.

Purpose of this procurement

The purpose of this procurement is to set up a contract for a subscription of UK healthcare databases. The Agency considers that it requires access to two databases drawn from the population of the United Kingdom:

• an electronic primary health care database (with at least 1,000,000 currently active patients) allowing to link drug utilisation to subsequent clinical events and to existing clinical status and demographic variables at the patient level, and
• a linked hospital care database providing information on hospitalisation episodes, hospital treatments and diagnoses at the patient-level.

Availability of information on causes of death, pregnancy status and pregnancy outcomes, including ability to link mothers and babies, through linkages or through providing access to additional databases, is desirable. The inclusion in the offer of linked database(s) with this information will be taken into account in the evaluation of the tender (see section 16.1 of the Technical Specifications).

The Agency must have electronic in-house access to both the source and the OMOP Common data model versions of the primary health care database, in a format analysable with SAS. Remote access to the data may be proposed in addition if the version of the database accessible remotely is updated more frequently than the version provided for in-house access. In case of remote access, the database shall be continuously and directly accessible by several users (at least 5), analyses using standard statistical software (e.g. SAS, R) should be able to be performed, and analytical datasets and aggregated results should be able to be exported.

The hospital care database and any other linked database may be provided with in-house or remote (direct or indirect through third-party) access in the source format. Remote access should allow performing analyses with standard statistical software (e.g. SAS, R) and exporting aggregated results and analytical datasets.

No restriction on the use of data that could cause avoidable delay in the regulatory actions of the Agency is acceptable. Any restrictions in place for the publication of results obtained from analyses of the data should be explained, as well as the possibilities that are available in case publication is needed for public health reason, such as in situations of public health emergencies. Availability of a “blanket approval” for the publication of results of certain types of studies (e.g. studies with similar objective, design or analysis) should be presented. For complex studies where an approval process of the protocol by a scientific committee is required to verify the suitability of the database or the study design, an approval process can be accepted provided that access to the data and the analyses can continue whilst the approval process is carried-out.

Coding practices should conform to an accepted standard and coding dictionaries relevant to the dataset should be made available with the data if requested. Requests for information and clarifications of codes or technical details of the data structure should be responded to without undue delay.

The selected supplier must ensure that each database is in compliance with applicable Union data protection legislation, including the General Data Protection Regulation (GDPR) (Regulation (EU)2016/679) as well as other data protection legislation as relevant. The data must be made accessible to the Agency in such a manner that the data subjects (individual patients) are not or no longer identifiable.

Download all available documents in: [ZIP]