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Latvia
transparency obligations overview

Last reviewed: January 2024 | Important Notes
PHARMACEUTICAL

Report Due Date

Code: Within 6 months after the end of the relevant Reporting Period

Law: 30th of June

Authority

Code: Association of International Research-based Pharmaceutical Manufacturers (SIFFA) and Latvian Generic Medicines Association (LPMA)

Law: Ministry of Health

Who Must Report

Code: SIFFA and LPMA Members

Law: the owner of a marketing authorization for medicinal products (or an authorized representative thereof) or another person who is the advertiser or distributor of advertising.

Covered Recipients

Code: HCPs and HCOs

Law: HCPs and HCOs (as specified in article 32 of Regulation No. 378; see Resources)

MEDICAL DEVICE

Report Due Date

Yearly, within 6 months of the end of the relevant reporting period

Authority

MedTech Europe

Who Must Report

Members of MedTech Europe

Covered Recipients

Healthcare organizations

Pharmaceutical Companies

What is reported:

Code:

Transfers of value related to:

  • Sponsorships/Donations/Grants
  • Contribution to event-related costs
  • Fees for Services and Consultancy
  • Research and development

Law:

“submit an electronic notification to the Health Inspectorate regarding the material or other support provided to associations, foundations, and medical treatment institutions in the previous year, using the form available on Health Inspectorate’s website.”

How to Report

Code:

Fill-in the template provided in Annex 2 to the Code and publish it in one of the manners described below under section “Platform of Disclosure”

Template

Disclosures shall be made using a standardised template set forth in Annex 2, reflecting the requirements of the Disclosure Code. Deviations from this List shall be acceptable only in cases when the legislation justifies complete non-implementation of this Code. In such case, only one template shall be used in the definite country.

Platform of Disclosure

Disclosures can be made in either of the following ways, provided that they are unrestricted and publicly available, and, so far as possible, using a template set forth in Annex 2:

  • on a common data base provided by SIFFA and/or LPMA; or
  • on the Member Company’s website in accordance with Section 2.05; or
  • in the common database provided by the relevant governmental institutions, regulatory or professional institutions.

Law:

Fill-in the report template available here.

Sign the filled template with a qualified electronic signature and send it to the Health Inspectorate at vi@vi.gov.lv. Alternatively, submit the filled template to Health Inspectorate using the e-service available here.

Resources

Code: https://siffa.lv/en/etika-un-atklatiba/

Law:

English: https://likumi.lv/ta/en/en/id/230392-procedures-for-advertising-medicinal-products-and-procedures-by-which-a-medicinal-product-manufacturer-is-entitled-to-give-free-samples-of-medicinal-products-to-physicians

Latvian: https://likumi.lv/ta/id/230392-zalu-reklamesanas-kartiba-un-kartiba-kada-zalu-razotajs-ir-tiesigs-nodot-arstiem-bezmaksas-zalu-paraugus

Note

The Latvian authority (SIFFA) mentioned that – as of 2021 – data will be disclosed in line with local law. In addition (in line with the code) the following ToV are made public:

  • Re publications (individually, by HCP’s) and
  • Re R&D (only total sum of R&D)

Medical Device Companies

If your company is a member of MedTech Europe, disclosure should be done in line with the Disclosure Guidelines of the MedTech Europe Code of Ethical Business Practice (‘MedTech Code’).

The information included in this overview is based on the Disclosure Guidelines of the MedTech Code.

What is reported:

Transfers of value related to Educational Grants.

How to Report

Template, and other useful resources, could be found here: https://www.ethicalmedtech.eu/resources/

Resources

Link to website of MedTech that contains a link to the MedTech Europe Code of Ethical Business Practice:
https://www.medtecheurope.org/resource-library/medtech-europe-code-of-ethical-business-practice/

 

Important notes:

  • This information is provided for your convenience and should not be construed as legal advice. The applicability of these requirements to your organization depends on individual circumstances. The information is not exhaustive.
  • Kindly check with your legal department and do not depend solely on the information provided here. Moreover, the rules mentioned could be subject to interpretation of local authorities/courts in the applicable jurisdiction. Lastly, be mindful of the latest update mentioned above. These rules and regulations change frequently, so it is important to determine whether the information provided reflects the most recent changes and is still applicable.
  • Reporting dates are related to the transparency obligation regarding transfers of value by pharmaceutical companies and/or medical device companies (excluding – in most cases – suppliers of in vitro diagnostics) to HCPs and HCOs. These often are based on laws or rules in codes of conduct of industry associations. In case it is based on codes of conduct, your company only needs to disclose the transfers of value on the mentioned due date if your company is a member of the association that follows that code.
  • Including a jurisdiction in the Legislative Watch does not guarantee that jurisdiction is available for reporting via the MediSpend Transparency Reporting Solution.
  • Reporting date normally means the date the transfers of value need to be published. The deadline for e.g. submission/sending the complete information to the authority could be before that date, for example to give HCPs and/or HCOs and/or the authority/association who publishes the information, the possibility to check the data the pharmaceutical companies/medical device companies are going to disclose.
  • The information does not take into consideration (unless explicitly mentioned):
    • Transparency related to clinical trials (unless it concerns transfers of value as mentioned above)
    • Transparency related to patient organizations (unless the patient organization is considered an HCO)


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