Clause 24 - Transfers of Value to Health Professionals and Healthcare Organisations
- Can a company proactively notify a patient organisation of recruiting clinical trials? Does this depend on the phase of the study?
- How does the prohibition on medical and educational goods and services (MEGS) being provided to individuals for personal benefit apply to the provision of training or support to attend a conference?
- If a health professional works for a patient organisation (eg is a trustee/chairperson) and provides some work specifically in relation to their representation of the PO would the disclosure be against the PO? Should the monies be paid to the PO?
- Should pharmaceutical companies disclose Transfers of Value made for market research?
- Should Transfers of Value to patient organisations be disclosed on Disclosure UK?
- What are the Code requirements in respect to travel?
- What are the relevant requirements for meetings when UK health professionals/other relevant decision makers are supported by pharmaceutical companies as delegates to a meeting outside the UK not organised by a pharmaceutical company?
- What are the relevant requirements for meetings when UK health professionals/other relevant decision makers attend a company organised meeting outside the UK as delegates?
- What should pharmaceutical companies do if a healthcare professional wishes to disclose some, but not all, transfers of value against their name?
- What should pharmaceutical companies include in the 'Total' column on the Disclosure template?
- When completing the Disclosure template what should pharmaceutical companies include in the 'total' column?
- Where healthcare organisations receive monies from companies should the disclosure be against individual institutions (hospitals prescribing) or at a Foundation Trust level?
24.1 Companies must document and publicly disclose certain transfers of value made directly or indirectly to health professionals and healthcare organisations located in Europe.
Please check the date of the Code that applies to the Case that you are looking at. The date of the complaint may vary from the activity/material alleged to have been in breach.
24.2 The transfers of value covered by Clause 24.1 are
- joint working in accordance with Clause 20
- donations, grants and benefits in kind provided to institutions, organisations and associations in accordance with Clauses 19.1 and 19.2
- contracts between companies and institutions, organisations and associations in accordance with Clause 21
- sponsorship of attendance by health professionals and other relevant decision makers at meetings in accordance with Clause 22.5
- fees and expenses paid to health professionals and other relevant decision makers, or to their employers on their behalf, in accordance with Clauses 23.2, 23.3 and 23.4
- contributions towards the costs of meetings paid to healthcare organisations or to third parties managing events on their behalf, which may include sponsorship of health professionals by way of registration fees and accommodation and travel.
Please check the date of the Code that applies to the Case that you are looking at. The date of the complaint may vary from the activity/material alleged to have been in breach.
24.3 Clause 24.1 does not apply to transfers of value to patient organisations. These transfers of value are covered by Clauses 27.7 and 27.8.
24.4 Disclosures must be made annually in respect of each calendar year. Disclosure must be in the first six months after the end of the calendar year in which the transfers of value were made.
Please check the date of the Code that applies to the Case that you are looking at. The date of the complaint may vary from the activity/material alleged to have been in breach.
24.5 The information disclosed must remain in the public domain for at least three years from the time of disclosure.
24.6 Companies must document all disclosures and retain the records for at least five years after the end of the calendar year to which they relate.
Please check the date of the Code that applies to the Case that you are looking at. The date of the complaint may vary from the activity/material alleged to have been in breach.
24.7 Different categories of transfers of value to individual health professionals can be aggregated on a category by category basis, provided that itemised disclosure would be made available upon request to the relevant recipient or the relevant authorities.
Payments to healthcare organisations are required to be disclosed on a per activity basis.
Please check the date of the Code that applies to the Case that you are looking at. The date of the complaint may vary from the activity/material alleged to have been in breach.
24.8 Where a transfer of value is made to a health professional indirectly via a healthcare organisation such a transfer should be disclosed once only, preferably as being a transfer to the health professional.
24.9 Where recipients of transfers of value cannot be identified for legal reasons, the amount attributable to such transfers must be disclosed on an aggregate basis. The number of recipients involved must be stated together with the percentage of all recipients that they represent and the aggregate amount attributable to transfers of value to such recipients.
Please check the date of the Code that applies to the Case that you are looking at. The date of the complaint may vary from the activity/material alleged to have been in breach.
24.10 Each company providing transfers of value must publish a note summarising the methodologies used by it in preparing the disclosures and identifying each category of transfer of value. The note, including a general summary and/or country specific considerations, must describe the recognition methodologies applied and should include the treatment of multi-year contracts, VAT and other tax aspects, currency aspects and other issues relating to the timing and amount of transfers of value for the purposes of this Code.
Please check the date of the Code that applies to the Case that you are looking at. The date of the complaint may vary from the activity/material alleged to have been in breach.