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United Kingdom
transparency obligations overview
PHARMACEUTICAL
MEDICAL DEVICE
Pharmaceutical Companies
Note:
“The 2021 APBI Code was approved by ABPI members at a special General Meeting on Tuesday 12 January 2021. It will come into operation on 1 July 2021.” For details, see: https://www.pmcpa.org.uk/the-code/forthcoming-2021-abpi-code-of-practice/
What is reported:
Transfers of value related to:
- “collaborative working, including joint working, in accordance with Clause 20”
- donations and grants provided to healthcare organisations, institutions and other organisations in accordance with Clause 23
- fees and expenses paid for contracted services between companies and institutions, organisations or associations of health professionals in accordance with Clause 24.6
- support of attendance by health professionals and other relevant decision makers at events/meetings whether paid directly, indirectly or via another party in accordance with Clause 10.10
- fees and expenses paid for contracted services to health professionals and other relevant decision makers, or to their employers on their behalf, in relation to Clause 24.6
- sponsorship including contributions to costs related to events/meetings paid to healthcare organisations or to organisations managing events on their behalf, which may include support of health professionals not known to the company via the healthcare organisation by way of registration fees, accommodation and travel. Clause 10.11 “
(the above is based on the latest version of the ABPI Code: https://www.pmcpa.org.uk/media/3292/2021-abpi-code-of-practice-technical-release.pdf)
Medical Device Companies
What is reported:
According to the ABHI Code, Educational Grants will be documented and publicly disclosed by member companies to ensure increased transparency of the funds allocated to medical education.
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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