Clause 21 - Transfers of Value to Health Professionals and Healthcare Organisations

Clause

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.

  • 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.

21.2 The transfers of value covered by Clause 21.1 are:

  • joint working in accordance with Clause 18.5
  • donations, grants and benefits in kind provided to institutions, organisations and associations in accordance with Clause 18.6
  • contracts between companies and institutions, organisations and associations in accordance with Clause 18.7
  • sponsorship of attendance by health professionals and appropriate administrative staff at meetings in accordance with Clause 19.5
  • fees paid to health professionals and appropriate administrative staff, or to their employers on their behalf, in accordance with Clauses 20.2 and 20.3
  • 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.

  • 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.

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 disclosur

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.

Interactive 2014 Code