« back to GLOBAL TRANSPARENCY PAGE

Ireland
transparency obligations overview

Latest update: 29 November 2018 | Important Notes
PHARMACUETICAL

Report Due Date

Annually, within 6 months after the end of the relevant reporting period. Each reporting period shall cover a full calendar year.

Authority

IPHA

Who Must Report

Members of IPHA

Covered Recipients

Healthcare professionals (HCPs) or healthcare organizations (HCOs)
MEDICAL DEVICE

Report Due Date

Annually, not later than 6 months after the end of the relevant reporting period. Each reporting period covers full calendar year, starting on 1 January and ending 31 December.

Authority

MedTech

Who Must Report

Members of MedTech

Covered Recipients

Healthcare organizations

Pharmaceutical Companies

What is reported:

Transfers of value in connection with:

  • Donations and grants
  • Contribution to costs related to events
  • Fees for service and Consultancy

How to Report

Refer to template under 5 in Annex V of the Code (see resources below).

“Except as expressly provided by this Code, Transfers of Value shall be disclosed on an individual basis. Each company shall disclose, on an individual basis for each clearly identifiable recipient, the amounts attributable to Transfers of Value to such recipient in each reporting period which can be reasonably allocated to one of the categories set out below. Such Transfers of Value may be aggregated on a category-by-category basis, provided that itemised disclosure shall be made available upon request to (i) the relevant recipient, and/or (ii) the relevant authorities.”

“For Transfers of Value where certain information, which can be otherwise reasonably allocated to one of the categories set forth in Section 4.1 above, cannot be disclosed on an individual basis for valid legal reasons, a company shall disclose the amounts attributable to such Transfers of Value in each reporting period on an aggregate basis. Such aggregate disclosure shall identify, for each category, (i) the number of recipients covered by such disclosure, on an absolute basis and as a percentage of all recipients, and (ii) the aggregate amount attributable to Transfers of Value to such recipients.”

“Each company shall document and publicly disclose Transfers of Value it makes, directly or indirectly on the IPHA Central Report (www.transferofvalue.ie), subject to internal corporate compliance and feasibility, to enable a comprehensive report being made available from IPHA on ToVs within Ireland. Provided that they are unrestricted and publicly available, such disclosures may also be made on the relevant Company website.”

Medical Device Companies

If applicable (Irish Medtech follows the MedTech Code), kindly refer to ‘Europe – Medical Device Companies’ for the summary in line with the MedTech Europe Code of Ethical Business Practice.

What is reported:

If not already obliged by local laws/regulations, companies need to make public the aggregate spend regarding educational grants on a yearly basis.

How to Report

An example of the template can be found in annex II of the following source:
MedTechEurope_Code_of_Ethics.pdf
Disclosures shall be made on the EthicalMedTech website (ethicalmedtech.org) unless the Member Company is already bound by national laws, regulations or professional codes as regulated in Section 1.2 Applicability of these Disclosure Guidelines.

Resources

MedTech Code:
MedTechEurope_Code_of_Ethics.pdf
Link to MedTech Code currently published on MedTech website:
http://www.medtecheurope.org/legal-and-compliance/code
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 reflects that 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 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 such cases, your company only needs to disclose the transfers of value on the mentioned due date if your company is a member of that association).
  • “Due date” means the date on which the transfers of value need to be published. For example, the deadline for submitting/sending the complete information to the authority could be before the due date to give HCPs/HCOs the opportunity to check the data that the pharmaceutical companies/medical device companies are going to disclose.
  • The information does not take into consideration:
    • 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)
  • If your company is a member of MedTech/EFPIA (or if the industry association your company belongs to is a member of MedTech/EFPIA), the due dates are as mentioned above for MedTech/EFPIA (end of June), unless a law/regulation specifically states otherwise (e.g., the jurisdiction is suspended/exempted from following MedTech/EFPIA).

Disclaimer:

The information contained in this website is for general information purposes only. The information is provided by MediSpend and, while we endeavor to keep the information up to date and correct, we make no representations or warranties of any kind, express or implied, about the completeness, accuracy, reliability, suitability or availability with respect to the website or the information, products, services, or related graphics contained on the website for any purpose. Any reliance you place on such information is, therefore, strictly at your own risk.

In no event will MediSpend be liable for any loss or damage including, without limitation, indirect or consequential loss or damage, or any loss or damage whatsoever arising from loss of data or profits arising out of, or in connection with, the use of this website.

Through this website you may be able to link to other websites which are not under the control of MediSpend. We have no control over the nature, content and availability of those sites. The inclusion of any links does not necessarily imply a recommendation or endorse the views expressed within them.

Every effort is made to keep the website up and running smoothly. However, MediSpend takes no responsibility for, and will not be liable for, the website being temporarily unavailable due to technical issues beyond our control.