21.1 Companies must document and publicly disclose certain transfers of value made directly or indirectly to health professionals and healthcare organisations located in Europe.
21.2 The transfers of value covered by Clause 21.1 are:
21.3 Clause 21.1 does not apply to transfers of value to patient organisations. These transfers of value are covered by Clauses 24.7 and 24.8.
21.4 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.
21.5 The information disclosed must remain in the public domain for at least three years from the time of disclosure.
21.6 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.
21.7 Different categories of transfers of value 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.
21.8 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.
21.9 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.
21.10 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.
Clause 21.1 Transfers of Value
The term ‘transfer of value’ is defined in Clause 1.8 above.
The term ‘Europe’ comprises those countries that are within the EU and other countries with a trade association that is a member of EFPIA.
Disclosure is required even if the payments etc are made by overseas affiliates, head offices in the UK or overseas and UK based offices.
Clause 21.1 Consent to Disclosure
Companies are encouraged to include in a contract involving a transfer of value provisions regarding the consent of the recipient to its disclosure. In addition, companies are encouraged to renegotiate existing contracts at their earliest convenience to include such consent to disclosure. Companies must ensure that they have appropriate arrangements in place to lawfully disclose information about transfers of value.
Clause 21.1 Mode of Disclosure
Disclosure will be on the company’s website but, if a central platform for disclosure in the UK is established, the use of that platform is likely to be obligatory.
The decision as to whether there will be a central platform for disclosure in the UK will be made by the end of 2014.
A template which can be used is available to download from the Authority’s website (www.pmcpa.org.uk).
Clause 21.1 Date of Implementation
The information required by Clause 21.1 must be disclosed in respect of transfers of value made in 2015 and each calendar year thereafter.
The disclosure of information about certain transfers of value was a requirement of the Second 2012 Edition of the Code and its immediate predecessors. The provisions in the Second 2012 Edition of the Code (Clauses 18.6, 19.4, 20.2 and 20.3) continue to apply in relation to transfers of value made in calendar years prior to 2015.
Clause 21.2 Further Information
The clauses of the Code noted in Clause 21.2 should be consulted for further information about the requirements. In addition, the requirements of Clauses 19.1 and 19.5 should be borne in mind in relation to sponsorship of meetings.